预约演示
更新于：2026-08-12
Olevaprubart
更新于：2026-08-12
概要
基本信息
原研机构 |
非在研机构 |
最高研发阶段临床2期 |
首次获批日期- |
最高研发阶段(中国)临床申请批准 |
特殊审评- |
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结构/序列
Sequence Code 1142967200L
来源: *****
Sequence Code 1142967218H
来源: *****
关联
6
项与 Olevaprubart 相关的临床试验NCT07734415
A Long-term Extension Study to Evaluate the Safety and Efficacy of Subcutaneous IMG-007 in Participants of a Previous IMG-007 Moderate-To-Severe Atopic Dermatitis Clinical Trial
The purpose of this study is to evaluate the safety and efficacy of long-term treatment with IMG-007 in participants with moderate-to-severe atopic dermatitis (AD)
开始日期2026-06-05 |
NCT07037901
A Phase 2b, Multicenter, Randomized, Double-blinded, Placebo-controlled, Parallel-group, Dose-finding Study to Evaluate the Efficacy and Safety of IMG-007 in Adult Participants With Moderate-to-Severe Atopic Dermatitis
The purpose of this study is to evaluate the efficacy and safety of different dose regimens of IMG-007, compared to placebo.
开始日期2025-06-17 |
NCT06304740
A Phase 1 Study to Evaluate the Safety and Pharmacokinetics of a Single Subcutaneous Dose of IMG-007 in Healthy Participants
This is a double-blind, randomized, placebo-controlled study to assess the safety and PK profile of a single subcutaneous dose of IMG-007 in healthy participants. The study will comprise of a 5-week screening period, a 3-day In-patient Period in a clinical research unit (CRU) and an Out-patient Follow-up Period up to 127 days. The study will include 3 dose cohorts which will be enrolled sequentially. Participants will receive a single subcutaneous dose of IMG-007 or placebo at Baseline according to their assigned dose.
开始日期2024-03-06 |
100 项与 Olevaprubart 相关的临床结果
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100 项与 Olevaprubart 相关的转化医学
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100 项与 Olevaprubart 相关的专利（医药）
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2
项与 Olevaprubart 相关的文献（医药）2026-03-01·BIODRUGS
The Role of OX40 Pathway Inhibition as a New Therapeutic Strategy for Atopic Dermatitis
Review
作者: Alvarenga, José Miguel ; Torres, Tiago ; Mohamed, Adam ; Oliveira Dos Santos, David ; Mohamed, Amir
Atopic dermatitis is a chronic inflammatory skin disease affecting approximately 15-20% of children and 2-10% of adults worldwide. Epidermal barrier dysfunction and immune dysregulation are central to its pathogenesis, creating a self-perpetuating cycle in which barrier disruption exacerbates inflammation, which in turn further impairs skin barrier integrity. The OX40/OX40L axis, involving the co-stimulatory receptor OX40 expressed on T cells and its ligand OX40L on antigen-presenting cells, plays a critical role in sustaining T cell-driven inflammatory responses in AD. Despite recent therapeutic advances, many patients remain inadequately controlled, and key unmet needs persist. Inhibitors of the OX40/OX40L pathway represent a novel therapeutic approach by modulating multiple effector and memory T-cell subsets implicated in disease pathogenesis. Amlitelimab, an anti-OX40L monoclonal antibody, has demonstrated sustained efficacy and a favorable safety profile in phase IIa and IIb trials. Rocatinlimab, targeting OX40, has also shown promising results in a phase IIb study and has progressed into multiple phase III trials, with supportive top-line data. In contrast, telazorlimab has shown more modest efficacy and has not advanced to later-stage development. Next-generation agents, including IMG-007, STAR-0310, APG990, and APG279, have been engineered with extended half-lives and attenuated antibody-dependent cellular cytotoxicity to support longer dosing intervals and improve tolerability. While these findings are encouraging, direct comparative studies among agents and versus established therapies are lacking, and long-term efficacy and safety data are still needed. This narrative review explores the role of the OX40/OX40L axis in atopic dermatitis pathogenesis and critically evaluates emerging therapies targeting this pathway, aiming to inform their future integration into clinical practice.
2024-09-01·Dermatology and Therapy
Extended Half-life Antibodies: A Narrative Review of a New Approach in the Management of Atopic Dermatitis
Review
作者: Yilmaz, Orhan ; Torres, Tiago
Atopic dermatitis (AD) is a chronic, inflammatory skin disease characterized by intense pruritus and eczematous lesions, significantly impacting physical health and quality of life. The pathogenesis of AD involves genetic predisposition, immune dysregulation, and environmental factors, with a defective skin barrier playing a crucial role. Treatment options for AD include both topical and systemic therapies, with advanced treatments like Janus kinase inhibitors and biologics offering significant improvements but facing limitations in safety and dosing frequency. Extended half-life antibodies represent a promising advancement for the management of immune-mediated inflammatory diseases, including AD. These antibodies, engineered for prolonged circulation and reduced dosing frequency, target key cytokines and immune pathways known to be involved in the pathogenesis of AD, offering potential for less frequent administration while maintaining efficacy. Currently, two such agents are in phase 2 trials. APG777, targeting interleukin-13 (IL-13), and IMG-007, targeting OX40 receptor, have shown promising preclinical and early clinical results. They demonstrated prolonged half-lives and the potential for less frequent dosage regimen, along with significant improvements in AD symptoms. These therapies could enhance patient adherence and reduce healthcare burdens by decreasing injection frequencies and clinic visits. As research continues, extended half-life antibodies could significantly improve AD management and patient quality of life. Further studies will determine the long-term safety and efficacy of extended half-life antibodies, with ongoing innovations in antibody engineering likely to broaden their applications and benefits.
137
项与 Olevaprubart 相关的新闻（医药）2026-08-07
SAN DIEGO, Aug. 05, 2026 (GLOBE NEWSWIRE) -- ImageneBio, Inc. (Nasdaq: IMA) ("Imagene" or the "Company") today reported financial results for the quarter ended June 30, 2026, and provided a company update.
Company Highlights
Olevaprubart, also known as IMG-007, the potential first-in-class therapeutic targeting the OX40 pathway, is a non-T cell-depleting, ADCC-silenced, anti-OX40 receptor antagonist with an extended half-life.
The Phase 2b ADAPTIVE trial of olevaprubart in moderate-to-severe atopic dermatitis continues to progress as planned under the amended protocol.
A long-term extension (LTE) study has been opened for patients enrolled in ADAPTIVE and sites are actively enrolling patients into the extension protocol.
A Phase 2 clinical trial of olevaprubart in alopecia areata is planned to initiate in 2026.
The company will present two posters on olevaprubart at the 2026 European Academy of Dermatology and Venereology (EADV) Congress.
Imagene strengthened its leadership team with the appointments of Yanina Grant-Huerta as Chief Financial Officer and Matt Robbins as General Counsel.
$136.2 million in cash, cash equivalents and marketable securities as of June 30, 2026, providing anticipated funding for planned operations into the first quarter of 2028.
"Imagene’s olevaprubart is now primed to emerge as the leading OX40 signal blockade program. With our continued progress in advanced clinical development, our conviction remains strong," said Kristin Yarema, Ph.D., chief executive officer of Imagene. "Olevaprubart was engineered to be a genuinely differentiated medicine with the potential for strong, competitive efficacy and a favorable safety profile. This is what our Phase 2b ADAPTIVE study is designed to evaluate and we are very pleased with our progress. Atopic dermatitis and alopecia areata remain areas of significant unmet need, and, as we are following every new development in the field closely, none of it changes what we believe: that direct, T cell-targeted yet non-T cell depleting approaches like ours have the potential to provide durable, safe and strong benefit for patients. Our programs remain on track and we continue to advance as planned, including welcoming patients who have completed a year of treatment into our long-term extension study."
Recent Corporate Updates
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In April 2026, Imagene closed a $30 million private placement with participation from both new and current investors.
In July 2026, Imagene appointed Yanina Grant-Huerta as Chief Financial Officer.
Grant brings 20 years of financial and accounting leadership experience in the biopharma industry.
She most recently served as Chief Accounting Officer at Atara Biotherapeutics and previously spent 14 years at Amgen Inc. in progressively senior finance and business analysis roles.
Imagene also appointed Matt Robbins as General Counsel, bringing more than 15 years of corporate, securities, and transactional experience advising public and private life sciences companies.
Dr. Ben Porter-Brown transitioned to a consulting role at the end of July 2026, continuing to support the Company as a consulting clinical development expert and strategic advisor.
Olevaprubart Program Updates
Atopic Dermatitis:
The previously announced protocol amendment to the ADAPTIVE trial has been implemented, and the study continues to progress under the amended protocol.
The amended protocol introduces a robust design intended to further evaluate the potential of olevaprubart in moderate-to-severe atopic dermatitis.
Topline data from the study is anticipated in the fourth quarter of 2027.
A long-term extension study has been opened for those who have completed one year in the ADAPTIVE study (
NCT07734415
) and patients are actively moving into the LTE.
The Independent Data Monitoring Committee (IDMC) for the ADAPTIVE study recommended the study proceed with no changes to the protocol or monitoring on July 23, 2026.
As of July 31, 2026 no cases of Kaposi sarcoma have been observed across the olevaprubart program, including in ongoing studies.
Alopecia Areata
: Imagene remains on track to initiate a Phase 2 study of olevaprubart in alopecia areata in 2026.
Initial data expected in 2028, leveraging the clinical operations and investigator network the Company has developed through its atopic dermatitis program.
Upcoming Scientific Presentations:
Imagene will present two posters at the 2026 European Academy of Dermatology and Venereology (EADV) Congress:
Title:
IMG-007, a non-depleting OX40 antagonist: Optimizing Peak Loading Concentration and Exposure Range to Unlock the Full Potential of OX40-OX40L Pathway Targeting in Immune Mediated Diseases
Poster Number:
P1683
Abstract ID:
AS-4099
Title:
IMG-007, a non-depleting OX40 mAb, produces durable shift in TCR repertoire and T cell function: Early biomarker insights from a Phase 1b/2a trial in immune-mediated alopecias
Poster Number:
P2203
Abstract ID:
AS-3275
Second Quarter 2026 Financial Highlights
Cash Position:
Following a $30 million PIPE financing completed in April 2026, the Company ended June 30, 2026 with $136.2 million in cash, cash equivalents and marketable securities. The Company expects that such resources will be sufficient to fund planned operations into the first quarter of 2028.
Research and Development (R&D) Expenses:
R&D expenses were $6.7 million for the three months ended June 30, 2026, compared to $5.7 million for the same period in 2025. The Company continues to invest in clinical trial and personnel-related expenses associated with its primary development program.
General and Administrative (G&A) Expenses:
G&A expenses were $5.1 million for the three months ended June 30, 2026, compared to $1.7 million for the same period in 2025.
Net Loss:
Net loss was $10.2 million, or $0.63 loss per share, for the three months ended June 30, 2026, compared to a net loss of $10.7 million, or $4.46 per share, for the same period in 2025.
About Olevaprubart (formerly IMG-007)
Olevaprubart (formerly IMG-007) is an investigational, non-T cell-depleting monoclonal antibody targeting OX40, a receptor protein primarily found on activated human T cells. When OX40 binds its ligand OX40L in human tissue, the signal generated plays a key role in the activation, expansion, and survival of many subtypes of T cells. Targeted inhibition of OX40 is being studied in the clinic across a range of autoimmune, inflammatory and immunological conditions where aberrant signaling of one or more T cell subtypes is believed to drive disease. Olevaprubart has been engineered to include a silenced antibody-dependent cell-mediated cytotoxicity function demonstrated to avoid T cell depletion or killing and intended to minimize safety risk. This technology also resulted in an approximately 5-week half-life, prolonging therapeutic activity with the aim of maximizing time between doses for a patient.
About ImageneBio, Inc.
Imagene is a clinical-stage biotechnology company dedicated to developing therapeutics for patients with immunological, autoimmune and inflammatory diseases with differentiated clinical pro The Company's program, olevaprubart (formerly IMG-007), is a receptor targeting, nondepleting anti-OX40 monoclonal antibody with multiple differentiating features. Imagene has completed Phase 1b/2a clinical trials of olevaprubart in both atopic dermatitis and alopecia areata and is currently conducting a Phase 2b clinical trial of olevaprubart in patients with moderate-to-severe atopic dermatitis. For more information, please visit
Forward-Looking Statements
This press release contains "forward-looking statements" within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995, including, without limitation, statements regarding: the expected timing, progress and results of the Company's ongoing Phase 2b ADAPTIVE trial; the anticipated benefits and potential impact of the amended ADAPTIVE trial protocol; the expected timing of initiation of the Company's Phase 2 alopecia areata trial and the timing of initial clinical data; the therapeutic potential, safety pro clinical differentiation of olevaprubart; the Company's plans to advance the development of olevaprubart across multiple inflammatory and autoimmune indications; the Company's planned scientific presentations and anticipated dissemination of clinical data; the Company's expected cash resources, capital requirements and financing plans; and other statements regarding management's intentions, plans, beliefs, expectations or forecasts for the future. Words such as "will," "can," "expect," "may," "plan," "potential," "goal," or other words that convey uncertainty of future events or outcomes are used to identify these forward-looking statements. These statements are subject to a number of risks, uncertainties and assumptions, including, but not limited to: risks associated with the nonclinical and clinical development and regulatory approval of olevaprubart, including potential delays in the completion of clinical trials and potential safety and other complications thereof; the timing of the availability of data from the Company's clinical trials; the risk that competitor data may materially and adversely impact the Company, its business, and its future prospects; the clinical utility, potential differentiation and/or benefits and market acceptance of olevaprubart; the requirement for additional capital to continue to advance the olevaprubart program, which may not be available on favorable terms or at all; the Company's ability to attract, hire, and retain skilled executive officers and employees; the Company's ability to protect its intellectual property and proprietary technologies; the Company's reliance on third parties, contract manufacturers, and contract research organizations; the possibility that the Company may be adversely affected by other economic, political, business, or competitive factors; and risks associated with changes in applicable laws or regulations or government resources and policies. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties. These and other risks and uncertainties are more fully described in the Company's filings with the Securities and Exchange Commission (the SEC), including the risks set forth under the heading "Risk Factors" in our Annual Report on Form 10-K for the year ended December 31, 2025, and our subsequent Quarterly Reports on Form 10-Q, filed with the SEC, and in our other filings with the SEC. You should not place undue reliance on these forward-looking statements, which are made only as of the date hereof. The Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.
IMAGENEBIO, INC
Condensed Consolidated Balance Sheets
(Unaudited)
(In thousands, except share and per share amounts)
June 30,
December 31,
2026
2025
Assets
Current assets:
Cash and cash equivalents
$
94,677
$
94,532
Marketable securities
41,476
40,817
Prepaid expenses and other current assets
4,959
4,939
Total current assets
141,112
140,288
Operating lease right-of-use assets, net
521
790
Deposits and other non-current assets
7,852
4,878
Promissory note receivable from related party
2,560
7,020
Total assets
$
152,045
$
152,976
Liabilities and Stockholders’ Equity
Current liabilities:
Accounts payable
$
977
$
1,439
Accrued expenses and other current liabilities
3,684
7,533
Operating lease liabilities, current
1,912
2,262
Total current liabilities
6,573
11,234
Operating lease liabilities, non-current
—
713
Other non-current liabilities
838
870
CVR liability due to related party
2,560
7,020
Total liabilities
9,971
19,837
Commitments and contingencies (Note 10)
Stockholders’ equity:
Preferred Stock, $0.001 par value, 10,000,000 shares authorized; no shares issued
and outstanding as of June 30, 2026 and December 31, 2025
—
—
Voting Common Stock, $0.001 par value, 142,000,000 shares authorized; 11,279,130
and 10,650,925 shares issued and outstanding as of June 30, 2026
and December 31, 2025, respectively
11
11
Non-Voting Common Stock, $0.001 par value, 8,000,000 shares authorized;
no shares issued and outstanding as of June 30, 2026 and 530,714 shares
issued and outstanding as of December 31, 2025
—
—
Additional paid-in capital
392,964
363,094
Accumulated other comprehensive income (loss)
(51
)
87
Accumulated deficit
(250,850
)
(230,053
)
Total stockholders’ equity
142,074
133,139
Total liabilities and stockholders’ equity
$
152,045
$
152,976
IMAGENEBIO, INC
Condensed Consolidated Statements of Operations and Comprehensive Loss
(Unaudited)
(In thousands, except share and per share amounts)
Three Months Ended June 30,
Six Months Ended June 30,
2026
2025
2026
2025
License revenue
$
—
$
—
$
—
$
800
Operating expenses:
Research and development
6,669
5,653
12,630
9,693
General and administrative
5,115
1,705
11,233
4,460
Total operating expenses
11,784
7,358
23,863
14,153
Loss from operations
(11,784
)
(7,358
)
(23,863
)
(13,353
)
Other income (expense):
Interest income (expense)
1,248
(236
)
2,377
(313
)
Other income, net
374
9
715
4
Total other income (expense), net
1,622
(227
)
3,092
(309
)
Loss before income taxes
(10,162
)
(7,585
)
(20,771
)
(13,662
)
Income tax expense
(16
)
—
(26
)
—
Net loss
(10,178
)
(7,585
)
(20,797
)
(13,662
)
Accretion of redeemable convertible preferred shares
—
(3,149
)
—
(6,200
)
Net loss attributable to common stockholders
$
(10,178
)
$
(10,734
)
$
(20,797
)
$
(19,862
)
Net loss per common share, basic and diluted
$
(0.63
)
$
(4.46
)
$
(1.52
)
$
(8.26
)
Weighted-average common shares outstanding,
basic and diluted
16,161,721
2,406,516
13,700,170
2,405,680
Comprehensive loss:
Net loss
$
(10,178
)
$
(7,585
)
$
(20,797
)
$
(13,662
)
Other comprehensive loss:
Unrealized loss on marketable securities
(34
)
—
(138
)
—
Foreign currency translation adjustment
—
(17
)
—
(26
)
Total comprehensive loss
$
(10,212
)
$
(7,602
)
$
(20,935
)
$
(13,688
)
Contacts
Investor Contact:
Rebecca Cohen
rcohen@imagenebio.com
Media Contact:
Jason Braco, PhD
Valence Communications
jason@valencecomms.com
临床2期高管变更财报
2026-07-30
中国香港、上海和美国新泽西州: 2026年7月30日，星期四: 和黄医药 (中国) 有限公司 (简称 "和黄医药"、 "HUTCHMED"、 "本公司" 或 "我们") (纳斯达克/ 伦敦证交所: HCM; 香港交易所: 13) 今日公布截至2026年6月30日止六个月的财务业绩以及提供关键临床项目和商业化发展的最新进展。
— 在爱优特®和苏泰达®带领下，中国的产品销售持续复苏，分别增长超过40% —
— 美国以外市场销售推动FRUZAQLA®增长，现已于41个国家获批或上市 —
— 抗体靶向偶联药物 (ATTC) 平台进展强劲，不断推出具备广泛治疗潜力的创新候选药物 —
和黄医药将于今天2026年7月30日 (星期四) 美国东部夏令时间上午8时/ 英国夏令时间下午1时/ 中国时间晚上8时举行业绩会网络直播 (英语场次) ，并于明天2026年7月31日 (星期五) 中国时间上午8时30分举行中文 (普通话) 场次。
投资者可点击底部"阅读原文"链接，登记后参与实时网络直播。
除另有说明外，所有金额均以美元列示。缩写清单可于底部词汇表查阅。
全球销售额增长得益于中国市场强劲复苏及FRUZAQLA®覆盖地域扩张
中国主要商业产品的市场销售额较2025年上半年增长超过40%。爱优特® (呋喹替尼的中国商品名)的市场销售额增长41%至6,080万美元，得益于医保范围扩大至覆盖子宫内膜癌，以及获批用于肾癌适应症。苏泰达®增长45%至1,840万美元，得益于用于治疗神经内分泌瘤的中国临床肿瘤学会 (CSCO) 指南推荐等级提高。
于2026年上半年，FRUZAQLA® (呋喹替尼的海外商品名) 在美国以外市场的销售额增长约70%至6,890万美元，与此同时，美国销售额保持稳定，主要得益于转移性结直肠癌领域对创新的去化疗治疗方案的需求，以及肿瘤科医生在三线治疗中持续的正面使用经验。
在研发投入增加的同时保持盈利能力，和黄医药应占净收益为1,590万美元 (2025年上半年：4.55亿美元，包括出售上海和黄药业有限公司 (上海和黄药业) 45%股权所得收益4.163亿美元)，使公司得以保持13.7亿美元的充裕现金余额。
多个全球首创抗体靶向偶联药物 (ATTC) 候选药物进入临床试验
于2025年12月，启动HMPL-A251的临床研究 (PI3K/PIKK-HER2)，并于2026年3月启动HMPL-A580的临床研究 (PI3K/PIKK-EGFR)，随后于美国癌症研究协会年会公布临床前数据。这两个ATTC均按照计划，正在开展剂量递增临床试验。
于2026年7月，基于另一个ATTC有效载荷平台的HMPL-A830的新药临床试验申请取得批准。
后期临床产品组合的监管及临床进展
于2026年5月，爱优特®联合信迪利单抗用于二线治疗肾癌的新药上市申请于中国获批，FRUSICA-2 Ⅲ期研究的数据支持了此项批准，中位无进展生存期 (PFS) 为22.2个月，对照组则为6.9个月。
于2026年4月，索乐匹尼布用于温抗体型自身免疫性溶血性贫血的中国新药上市申请获受理，该申请是基于ESLIM-02 Ⅲ期研究的数据，其结果已于欧洲血液学协会年会发表，持续应答率为66.0%；于2026年2月，用于免疫性血小板减少症的中国新药上市申请获受理；温抗体型自身免疫性溶血性贫血及免疫性血小板减少症两项适应症均获纳入优先审评。
于2026年1月，沃瑞沙®和泰瑞沙® (奥希替尼) 联合疗法已取得积极结果的SACHI Ⅲ期研究的亚组分析数据发表于《柳叶刀 (The Lancet)》，中位总生存期 (OS) 为22.9个月，而化疗组则为7.9个月。于2026年6月，用于三线治疗MET扩增胃癌的中国新药上市申请获批，支持了此项批准的Ⅱ期临床数据已于美国临床肿瘤学会年会发表，客观缓解率为32.3%。
FGFR抑制剂凡瑞格拉替尼用于治疗肝内胆管癌的关键性Ⅱ期研究的积极数据于欧洲肿瘤内科学会胃肠道肿瘤大会公布。
于2026年3月，BTK抑制剂HMPL-760联合利妥昔单抗和化疗用于二线治疗弥漫性大B细胞淋巴瘤的Ⅲ期临床试验启动。
和黄医药非执行主席艾乐德博士 (Dan Eldar) 表示:
和黄医药拥有清晰的战略焦点：以差异化创新为核心，打造具有全球竞争力的肿瘤产品组合。这一未来蓝图建立于我们全球首创的抗体靶向偶联药物 (ATTC) 创新有效载荷平台，以及其他新兴的大分子创新疗法。这些技术为我们带来了多元化的机遇，以开发全球首创 (First-in-class) 或同类最佳(Best-in-class) 的产品，并且具备与标准疗法或更新的药物联合用药的潜力，从而具备成为一线治疗的潜力。随着这些项目的推进，跨国合作(包括一些正在洽谈中的项目)将提供重要的行业背书与认可，拓宽研发覆盖范围，并加速进入国际主流市场。我们将继续投入建设我们国际一流的研发体系，依托最前沿的科学技术，将资源部署于和黄医药能为全球患者的生活带来重大影响的领域，同时创造商业与股东价值。
和黄医药代理首席执行官兼首席财务官
郑泽锋先生表示:
爱优特®和苏泰达®在上半年取得强劲的市场销售额增长，反映了我们的商业团队在去年为适应中国市场不断变化的监管指引以实现可持续发展所采取的一系列举措的成效，包括精简销售团队以及采取更具针对性的营销策略以提升生产力。我们正加速ATTC的开发，并通过拓展人才和人工智能能力以进一步强化早期药物发现。我们还在与跨国合作伙伴探讨合作机会，以加速我们最具潜力项目的全球开发和商业化。
和黄医药首席执行官 (目前休假中)
兼首席科学官
苏慰国博士表示:
国家药监局在2026年上半年受理索乐匹尼布用于免疫性血小板减少症和温抗体型自身免疫性溶血性贫血的新药上市申请，反映了其扎实的临床数据包，为其潜在的监管和商业化成功奠定坚实基础。索乐匹尼布再次印证了我们产品靶点选择性以及差异化的疗效和毒性特征的重要性。我们的ATTC候选药物亦遵循同样的研发理念，旨在将我们自主研发的强效小分子靶向有效载荷精准输送至肿瘤细胞，同时减少对健康组织的损伤并降低毒副作用。临床前数据显示，与标准疗法及近期上市或正在研发的新兴疗法相比，展现出令人鼓舞的肿瘤缩小效果。来自两个ATTC有效载荷平台的三个高度创新的分子正在或即将启动首次人体临床试验，后续还将有更多的候选药物相继推进，我们正在打造以科学驱动的产品管线，旨在将差异化的生物学机制转化为切实的临床获益。
2026年中期业绩及最新业务进展
一. 商业营运
中国市场销售额强劲复苏，2026年上半年达9,440万美元，较2025年上半年增长32% (7,160万美元)，得益于销售团队的生产力持续提升。这使得2026年上半年肿瘤产品市场销售总额达到2.798亿美元 (2025年上半年：2.344亿美元)。
爱优特®的市场销售额增长41%至6,080万美元，成功将联合信迪利单抗用于二线治疗pMMR子宫内膜癌适应症纳入国家医保药品目录覆盖范围。同时亦成功续约国家医保目录，用于既往接受过化疗以及既往接受过或不适合接受抗VEGF或抗EGFR (RAS野生型) 的转移性结直肠癌患者。
苏泰达®市场销售额增长45%至1,840万美元，得益于中国临床肿瘤学会指南更新，将苏泰达®用于治疗神经内分泌瘤的推荐等级提升至最高的I级推荐，先于竞品生长抑素类似物。同时亦得益于营销策略转向聚焦重点医院。
FRUZAQLA®市场销售额增长主要由美国以外地区的销售推动，其市场增长率约为70%，得益于迄今在41个国家获批或上市，包括于2026年第一季度在法国获纳入医保，以及于2025年底在葡萄牙、比利时、韩国和墨西哥上市。这推动了全球市场销售额增长至1.854亿美元。
肿瘤产品的综合收入总额较2025年上半年增长23%至1.214亿美元，主要得益于爱优特®及苏泰达®市场销售额的强劲增长。
其他肿瘤/免疫业务收入 (包括首付款、监管里程碑付款、研发服务及许可收入)为4,090万美元，其中包括二线治疗肾细胞癌适应症获批触发的来自礼来的1,810万美元里程碑付款。其他业务收入 (主要来自处方药分销) 为1.160亿美元，从而实现综合收入总额为2.783亿美元。
* 就FRUZAQLA®、爱优特®和沃瑞沙®，主要分别代表武田、礼来和阿斯利康提供的对第三方的总销售额。
** 就FRUZAQLA®，代表武田支付给和黄医药的生产收入和特许权使用费；就爱优特®，代表礼来向和黄医药支付的生产收入、推广及营销服务收入和特许权使用费，以及由和黄医药开具发票的对其他第三方的销售额；就沃瑞沙®，代表阿斯利康向和黄医药支付的生产收入和特许权使用费，以及由和黄医药开具发票的对其他第三方的销售额；就苏泰达®及达唯珂®，代表和黄医药对第三方的产品销售额。
*** Ipsen为达唯珂®的上市许可持有人，和黄医药作为其国内代理/被许可方。2026年3月，Ipsen基于进行中的SYMPHONY-1研究出现的安全性数据，自愿从所有Ipsen市场撤回达唯珂®，即时生效。
二. 2026年注册审批进展
于2026年6月，赛沃替尼的新适应症上市申请获国家药监局批准，用于三线治疗MET扩增胃癌。
于2026年2月，赛沃替尼的上市许可申请获瑞士医药管理局 (Swissmedic) 批准 (临时授权)，联合泰瑞沙®用于二线治疗伴有MET扩增和/或过表达的EGFR突变非小细胞肺癌。
于2026年5月，呋喹替尼的新适应症上市申请获国家药监局批准，联合信迪利单抗用于二线治疗肾细胞癌。
于2026年4月，索乐匹尼布的新药上市申请获国家药监局受理，用于二线治疗温抗体型自身免疫性溶血性贫血。
于2026年2月，索乐匹尼布重新提交的新药上市申请获国家药监局受理，用于二线治疗免疫性血小板减少症。
于2026年3月，益普生 (Ipsen) 在中国主动撤回他泽司他。
三. 2026年后期临床项目进展
赛沃替尼 (中国商品名: 沃瑞沙®)，一种高选择性口服的MET抑制剂
继于2025年下半年完成患者招募后，SAFFRON和SANOVO研究的顶线结果预计于2026下半年公布：
◾ SAFFRON全球Ⅲ期研究有望支持于全球提交新药上市申请，用于二线/三线治疗伴有MET扩增和/或过表达的EGFR突变非小细胞肺癌患者 (NCT05261399)。
◾ SANOVO中国Ⅲ期研究有望支持于中国提交新药上市申请，用于一线治疗伴有MET过表达的EGFR突变非小细胞肺癌患者 (NCT05009836)。
SACHI中国Ⅲ期研究的亚组分析结果于2026年1月发表于《柳叶刀》，用于二线治疗伴有MET扩增的EGFR突变非小细胞肺癌患者，在排除后续接受MET抑制剂治疗的对照组患者后，中位OS为22.9个月，而化疗组则为7.9个月 (HR 0.32)。
用于三线治疗MET扩增胃癌的中国Ⅱ期关键性研究的积极数据于2026年6月在ASCO年会上公布，并于《自然·医学 (Nature Medicine)》发表，经独立审查委员会评估的ORR为32.3%，中位PFS为4.0个月，而中位OS则为6.9个月 (NCT04923932)。
索乐匹尼布 (HMPL-523)，一种研究性的高选择性口服Syk抑制剂
用于二线治疗温抗体型自身免疫性溶血性贫血的ESLIM-02中国Ⅲ期研究的积极数据于2026年6月在EHA年会上公布，研究已达到主要终点持续应答率66.0%，出现应答的中位时间为3.1周，而中位累计应答持续时间为16.1周。凡瑞格拉替尼 (fanregratinib, HMPL-453)，一种新型、高选择性及强效的FGFR 1、2和3抑制剂
用于二线治疗FGFR2融合/重排肝内胆管癌的中国Ⅱ期关键性研究的积极数据于2026年7月在ESMO胃肠道肿瘤大会上公布，研究已达到独立审查委员会评估的ORR 42.5%的主要终点，中位PFS为6.9个月，中位OS为16.6个月。用于二线治疗肝内胆管癌的新药上市申请于2025年12月获国家药监局受理，并纳入优先审评 (NCT04353375)。
HMPL-760，一种非共价的第三代BTK (包括野生型和C481S突变型BTK) 抑制剂
于2026年3月启动中国Ⅲ期临床试验，联合R-GemOx方案 (利妥昔单抗、吉西他滨和奥沙利铂) 对比安慰剂联合R-GemOx方案用于二线治疗复发/难治性弥漫性大B细胞淋巴瘤患者 (NCT07409428)。研究的主要终点为研究者评估的PFS和OS。
四. 抗体偶联药物研发
HMPL-A251，一种全球首创的PI3K/PIKK-HER2 ATTC，由高选择性、强效的PI3K/PIKK抑制剂作为有效载荷和人源化抗HER2 IgG1抗体通过可裂解的连接子 (linker) 偶联而成
一项剂量递增和剂量扩展研究正在进行中，用于治疗不可切除、伴有HER2表达的晚期或转移性实体瘤，首位患者已于2025年12月给药 (NCT07228247) 。
临床前数据显示，该药物在DXd抗药细胞系中展现出抗肿瘤活性，且通过差异化的作用机制，在与化疗联合用药时展现出良好的疗效与安全性。
HMPL-A580，一种全球首创的PI3K/PIKK-EGFR ATTC，由高选择性、强效的PI3K/PIKK抑制剂作为有效载荷和抗EGFR IgG1抗体通过可裂解的连接子偶联而成
一项剂量递增和扩展研究正在进行中，用于治疗实体瘤 (包括非小细胞肺癌、结直肠癌、头颈部鳞状细胞癌及食管鳞状细胞癌)，首位患者已于2026年3月给药 (NCT07396584)。
于2026年AACR年会上公布的临床前数据显示，在奥希替尼耐药的EGFR突变非小细胞肺癌细胞系中观察到肿瘤缩小，且联合奥希替尼用于治疗EGFR突变、PAM未改变的非小细胞肺癌细胞系时，展现出良好的疗效与安全性。
HMPL-A830的中国/美国新药临床试验申请已取得批准
计划于2026年下半年启动全球临床试验。临床前数据显示，与针对相同靶点的抗体或小分子相比，展现出更优的药效和安全性特征，相关数据将于学术会议上公布。
五. 合作最新进展
ImageneBio正在开发由和黄医药发现的IMG-007，这是一种非T细胞消耗性、消除了抗体依赖性细胞介导的细胞毒性 (ADCC) 的OX40拮抗剂
用于治疗中重度特应性皮炎患者的Ⅱb期研究 (NCT07037901) 正在进行中，并已修订方案，预计于2027年第四季度公布顶线数据。
计划于2026年启动用于治疗斑秃患者的Ⅱ期研究，初步数据预计于2028年公布。
六. 其他业务
截至2026年6月30日止六个月，其他业务综合收入减少至1.160亿美元 (2025年上半年：1.342亿美元)，对盈利能力的影响甚微，由于该业务分部主要为中国境内低利润的处方药分销业务，且和黄医药持续优化营运资金管理。
和黄医药应占其他业务的综合净收益减少至380万美元 (2025年上半年：2,400万美元) ，主要由于在2025年出售上海和黄药业的45.0%股权后造成权益收益下降。
七. 可持续发展
《2025年可持续发展报告》已于2026年4月与《2025年年报》一并发布。我们已展开新的目标订定工作，根据五大可持续发展支柱 (创新、气候行动、人力资源、医疗保健可及性、道德与透明度)，初步确定了重点计划。我们将于2026年把相关内容细化为最终清单，包括制定目标路线图与监测机制。
于2026年，我们的可持续发展举措继续获得肯定。最近，我们对可持续发展的承诺获MSCI上调至AA评级，并被认可为领导者，并使我们位居医药公司前 19% 行列。此外，和黄医药连续两年被Extel (前身为Institutional Investor Research) 评为 "最受尊崇企业 (Most Honored Company)"，并在其第16届亚洲管理团队调研中被评为ESG领域排名第一。我们在多个其他领域亦名列前茅，包括首席执行官、首席财务官、投资人关系、ESG及公司治理，亦因此获得 "最受尊崇企业" 称号。和黄医药是2026年全亚洲 (不含中国内地) 生物制药领域唯一获得此等评级的公司。
财务摘要
截至2026年6月30日止六个月收入为2.783亿美元，而截至2025年6月30日止六个月为2.777亿美元。
肿瘤/免疫业务综合收入为1.623亿美元 (2025年上半年：1.435亿美元)，包括：
◾ 爱优特®收入为4,710万美元，增长40% (2025年上半年：3,360万美元)，包括生产收入、推广及营销服务收入以及特许权使用费。市场销售额受持续的适应症扩展所支持。
◾ 苏泰达®收入为1,840万美元，增长45% (2025年上半年：1,270万美元)，得益于营销策略聚焦重点医院及受近期肿瘤临床指南的更新所支持。
◾ 沃瑞沙®收入为1,330万美元，增长48% (2025年上半年：900万美元)，受向阿斯利康的生产销售增加所推动，以为三线MET扩增胃癌的上市做准备。
◾ FRUZAQLA®收入为4,310万美元 (2025年上半年：4,310万美元)，与去年同期比较，反映了特许权使用费收入持续增长，而生产收入减少，得益于迄今在41个国家获得批准/上市后市场销售额实现强劲增长。
◾ 武田首付款、监管里程碑及研发服务收入为2,070万美元 (2025年上半年：2,950万美元)，由于提供给武田的研发与监管支持服务的需求减少。
◾ 其他收入为2,020万美元 (2025年上半年：1,490万美元)，包括来自礼来的1,810万美元里程碑付款，该付款由爱优特®与信迪利单抗联合用于二线肾细胞癌在中国获得新药上市申请批准所触发 (2025年上半年：来自阿斯利康的1,110万美元监管里程碑付款，为继SACHI中国新药申请获批后所触发)。
其他业务综合收入为1.160亿美元 (2025年上半年：1.342亿美元)，主要由于考虑到运营资金，缩减了低利润的物流分销销售规模。
截至2026年6月30日止六个月净开支为2.624亿美元，而截至2025年6月30日止六个月为2.390亿美元。
收入成本为1.522亿美元 (2025年上半年：1.676亿美元)，主要原因为与处方药分销业务相关的销售成本下降。收入成本占肿瘤产品收入的百分比改善至33% (2025年上半年：39%)，主要受生产力与效率提升所推动。
研发开支为7,880万美元 (2025年上半年：7,200万美元)，乃由于我们启动了ATTC资产的早期全球临床项目，以及我们仍保持在药物发现领域持续的投资，以实现可持续的创新。
销售及行政开支为4,650万美元 (2025年上半年：4,160万美元)。主要得益于肿瘤/免疫业务商业营运的强劲表现及效率提升。
其他项目产生净收益1,510万美元 (2025年上半年：4,220万美元)，主要包括利息收入和支出、外汇、上海和黄药业权益收益和税务。主要由于在2025年出售上海和黄药业的45.0%股权后造成权益收益下降。
截至2026年6月30日止六个月和黄医药应占净收益为1,590万美元，而截至2025年6月30日止六个月则为4.550亿美元。
2026年上半年每股普通股基本盈利为0.02美元/每份ADS基本盈利为0.09美元 (2025年上半年：每股普通股基本盈利为0.53美元/每份ADS基本盈利为2.65美元)。
于2026年6月30日，现金及现金等价物和短期投资合计为13.748亿美元，而于2025年12月31日则为13.673亿美元。
于2026年上半年，不包括融资活动的调整后的集团 (非GAAP) 净现金流入为1,050万美元，主要由于1,620万美元的净收益，扣除560万美元的资本开支 (2025年上半年：净现金流入为5.191亿美元，主要由于出售部分上海和黄药业所得款项净额5.490亿美元，扣除1,000万美元的监管获批里程碑款项，以及920万美元的资本开支)。
于2026年上半年，融资活动所用现金净额合计为290万美元，主要由于净偿还银⾏贷款 (2025年上半年：净现金流入为930万美元，主要由于820万美元的银行贷款所得款项)。
外汇影响：于2026年上半年，人民币兑美元平均升值约5%，这影响了我们的综合财务业绩，相关情况已如上文所述。
非GAAP财务指标的使用和对账 — 本公告中提及不包括融资活动的调整后集团净现金流及按照固定汇率计算报告的财务指标均基于非GAAP财务指标。请参阅「非GAAP财务指标的使用和对账」，以分别了解这些财务指标的解释，以及这些财务指标与最具可比性的GAAP指标对账的进一步资料。
财务指引
和黄医药重申2026年肿瘤/免疫业务综合收入的全年指引在3.3亿美元至4.5亿美元之间。和黄医药将充分利用其强大的现金资源，加速ATTC项目的全球开发并探索投资机会。股东及投资者应注意：
本公司不保证财务指引中包含的陈述将实现，或其中包含的财务业绩将实现或可能实现；及
本公司过去曾修订我们的财务指引，因此应参考我们在本公告刊发日期后就任何财务指引更新的公告。
财务概要
简明综合资产负债表数据
简明综合经营表数据
和黄医药 (纳斯达克/伦敦证交所：HCM；香港交易所：13)是一家处于商业化阶段的创新型生物医药公司，致力于发现、全球开发和商业化治疗癌症和免疫性疾病的靶向药物和免疫疗法。自成立以来，和黄医药致力于将自主发现的候选药物带向全球患者，首三个药物现已在中国上市，其中首个药物亦于美国、欧洲和日本等全球各地获批。欲了解更多详情，请访问: www.hutch-med.com/sc 。
简称使用
除文意另有所指外，否则本公告中所称 "集团"、"公司"、"和黄医药"、"和黄医药集团"、"我们"和 "我们的" 指和黄医药 (中国) 有限公司及其附属公司，除非文中另有说明或指明。
过往业绩和前瞻性陈述
本公告所载本集团之表现和经营业绩属历史性质，且过往表现并不保证本集团之未来业绩。本公告包含符合1995年《美国私人证券诉讼改革法案》"安全港" 条款中定义的前瞻性陈述。该等前瞻性陈述可以用诸如"将会"、"期望"、"预期"、"未来"、"打算"、"计划"、"相信"、"估计"、"管线"、"可能"、"潜在"、"全球首创"、"同类最佳"、"旨在"、"目标"、"指导"、"追求"或类似术语，或通过对潜在候选药物、潜在候选药物适应症的明示或暗示讨论，或通过讨论战略、计划、预期或意图来识别。阁下请勿过分倚赖这些前瞻性陈述。该等前瞻性陈述反映了管理层根据目前的信念和期望而对未来事件的预期，并受到已知及未知风险与不确定性的影响。如若该等风险或不确定性中的一项或多项出现，或者基本假设被证明属不正确，则实际结果可能与前瞻性陈述中所载之结果有重大出入。和黄医药不能保证其任何候选药物均将会在任何市场上获准销售，亦不能保证已获得的任何批准在未来继续有效，或者由和黄医药及/或其合作伙伴销售或以其他方式将产品商业化 (统称 "和黄医药产品") 将达到任何特定的收入或净收益水平。尤其，管理层的预期可能会受到以下因素的影响：意料之外的监管行动或延迟或一般性的政府监管；研究与开发中固有的不确定性，包括无法满足关键的关于受试者的入组率、时机和可用性的研究假设，其要符合研究的纳入及排除标准以及资金要求，临床方案的变更、意外不利事件或安全性、质量或生产方面的问题；候选药物延迟或无法满足硏究的主要或次要终点；候选药物延迟或无法获得不同司法管辖区的监管批准或和黄医药产品获得监管批准后的使用情况，市场认受性及商业成功；所发现、开发及/或商业化竞争产品和候选药物可能比和黄医药产品及候选药物更有优势或更具成本效益；政府当局和其他第三方的研究 (无论由和黄医药或其他人士进行及无论属强制或自愿) 或建议及指引对和黄医药产品及开发中的候选药物的商业成功的影响；和黄医药制造及管理多种产品及候选药物供应链的能力(包括各种第三方服务)；和黄医药产品能否从第三方支付机构获得报销及获报销的程度，包括私人支付机构的医疗健康及保险计划以及政府保险计划；开发、生产及销售和黄医药产品的成本；在需要时获得额外资金的能力；为和黄医药产品和候选药物获得并维持知识产权保护能力；和黄医药实现其任何财务预测或指引的能力以及该等预测或指引所依据的假设的变化；遏制医疗成本的全球趋势，包括持续的价格压力；实际和潜在法律程序的不确定性，其中包括实际或潜在产品责任诉讼、有关销售和行销行为的诉讼和调查、知识产权纠纷以及一般性的政府调查；以及整体经济和行业状况，包括许多国家持续疲弱的经济和金融环境影响的不确定性，未来全球汇率的不确定性，全球利率、地缘政治关系、制裁和关税的不确定性。有关前述各项和其他风险的进一步讨论，请参阅和黄医药向美国证券交易委员会、伦敦证券交易所和香港交易所提交的文件。和黄医药在本公告中提供之资料截至本公告日期，并且不承担因新的资料、未来事件或其他原因而更新任何前瞻性陈述的义务。此外，本公告包含和黄医药从行业出版物和第三方市场研究公司作出的报告中获得的统计数据和估计。尽管和黄医药认为该等出版物、报告和调查研究是可靠的，但是和黄医药尚未独立验证该等数据，不能保证该等数据的准确性或完整性。请阁下注意不要过度考虑该等数据。该等数据涉及风险和不确定性，并可能根据各种因素(包括前述因素) 有所更改。
内幕消息
本公告包含 (欧盟) 第596/2014号条例(该条例构成《2018年欧洲联盟 (退出) 法》定义的欧盟保留法律的一部分) 第7条规定的内幕消息。
医疗信息
本公告所提到的产品可能并未在所有国家上市，或可能以不同的商标进行销售，或用于不同的病症，或采用不同的剂量，或拥有不同的效力。本文中所包含的任何信息都不应被视为是任何处方药的推销、推广或广告，包括那些正在研发的药物。
词汇表
1L = 一线 (First-line)
2L = 二线 (Second-line)
3L = 三线 (Third-line)
AACR = 美国癌症研究协会 (American Association for Cancer Research)
ADC = 抗体药物偶联物 (Antibody-drug conjugate)
ADS = 美国预托证券 (American depositary shares) ，每一份代表五股普通股
AIHA = 自身免疫性溶血性贫血 (Autoimmune hemolytic anemia)
AKT = 蛋白激酶B (Protein kinase B)
AML = 急性髓系白血病 (Acute myeloid leukemia)
ASCO = 美国临床肿瘤学会 (American Society of Clinical Oncology)
ASH = 美国血液学会 (American Society of Hematology)
阿斯利康 (AstraZeneca) = AstraZeneca AB，AstraZeneca plc 的附属公司
ATTC = 抗体靶向偶联药物 (Antibody-targeted therapy conjugates)
BICR = 盲态独立中心评估 (Blinded independent central review)
BID = 每日两次 (Twice a day)
中国银行 (BOC) = 中国银行股份有限公司 (Bank of China Limited)
BTK = 布鲁顿酪氨酸激酶 (Bruton's tyrosine kinase)
CDMO = 合同研发生产机构 (Contract Development and Manufacturing Organization)
固定汇率 (CER) = Constant exchange rate。我们亦报告按固定汇率 (CER) ，一种非GAAP指标，计算业绩变化。请参阅「非GAAP 财务指标的使用和对账」，以分别了解这些财务指标的解释，以及这些财务指标与最具可比性的GAAP 指标的对账。
CI = 置信区间 (Confidence interval)
CLL = 慢性淋巴细胞白血病 (Chronic lymphocytic leukemia)
CMC = 化学、生产和质量控制 (Chemistry, Manufacturing, and Controls)
CR+CRh = 综合完全缓解或完全缓解伴部分血液学缓解 (Combined complete remission + complete remission with partial hematologic recovery)
CRC = 结直肠癌 (Colorectal cancer)
CSF-1R = 集落刺激因子-1受体 (Colony-stimulating factor 1 receptor)
DCR = 疾病控制率 (Disease control rate)
DLBCL = 弥漫性大B细胞淋巴瘤 (Diffuse large B-cell lymphoma)
DoR = 缓解持续时间 (Duration of response)
DRR = 持续应答率 (Durable response rate)
EASI = 湿疹面积和严重程度指数 (Eczema area and severity index)
EGFR = 表皮生长因子受体 (Epidermal growth factor receptor)
EGFR突变 (EGFRm) = 表皮生长因子受体突变 (Epidermal growth factor receptor mutated)
EHA = 欧洲血液学协会 (European Hematology Association)
ELCC = 欧洲肺癌大会 (The European Lung Cancer Congress)
礼来 (Eli Lilly) = Lilly (Shanghai) Management Company Limited
EMC = 子宫内膜癌 (Endometrial cancer)
EORTC = 欧洲癌症研究和治疗组织 (European Organization for Research and Treatment of Cancer)
Epizyme = Epizyme, Inc.，Ipsen旗下公司
epNET = 非胰腺神经内分泌瘤 (Extra-pancreatic neuroendocrine tumor)
ESCC = 食道鳞状细胞癌 (Esophageal Squamous Cell Carcinoma)
ESG = 环境、社会及管治 (Environmental, Social and Governance)
ESMO = 欧洲肿瘤学会 (European Society for Medical Oncology)
FDA = 美国食品药品监督管理局 (Food and Drug Administration)
FGFR = 成纤维细胞生长因子受体 (Fibroblast growth factor receptor)
FLT3 = FMS样酪氨酸激酶3 (FMS-like tyrosine kinase 3)
首例患者入组 (FPI) = First patient in
GAAP = 一般公认会计原则 (Generally Accepted Accounting Principles)
GC = 胃癌 (Gastric cancer)
GMP = 药品生产质量管理规范 (Good Manufacturing Practice)
HER2 = 人类表皮生长因子受体2 (Human Epidermal growth factor Receptor 2)
香港交易所 (HKEX) = 香港联合交易所有限公司主板 (The Main Board of The Stock Exchange of Hong Kong Limited)
HNSCC = 头颈部鳞状细胞癌 (Head and Neck Squamous Cell Carcinoma)
HR = 风险比 (Hazard Ratio)
IDH1/2 = 异柠檬酸脱氢酶-1或异柠檬酸脱氢酶-2 (Isocitrate dehydrogenase-1 OR isocitrate dehydrogenase-2)
ICC = 肝内胆管癌 (Intrahepatic cholangiocarcinoma)
IIT = 研究者发起的临床试验 (Investigator-initiated trial)
ImageneBio = ImageneBio, Inc
IND = 新药临床试验申请 (Investigational new drug application)
市场销售额 (in-market sales) = 由礼来 (爱优特®) 、武田 (FRUZAQLA®) 、阿斯利康 (沃瑞沙®) 及和黄医药 (爱优特®、苏泰达®、沃瑞沙®及达唯珂®) 所提供向第三方的总销售额
Ipsen = Ipsen SA，Epizyme, Inc.的母公司
IRC = 独立审查委员会 (Independent review committee)
ITP = 免疫性血小板减少症 (Immune thrombocytopenia purpura)
JAMA = 《美国医学会杂志》 (Journal of the American Medical Association)
LPR = 贷款市场报价利率 (Loan Prime Rate)
MAA = 上市许可申请 (Marketing Authorisation Application)
mCRC = 转移性结直肠癌 (Metastatic colorectal cancer)
mDoR = 中位缓解持续时间 (median Duration of response)
MET = 配体上皮间质转化因子 (ligand mesenchymal epithelial transition factor) 或为此配体编码的基因MET
METex14 = MET外显子14跳变 (MET exon 14 skipping alteration)
mOS = 中位总生存期 (median Overall survival)
mPFS = 中位无进展生存期 (median Progression-free survival)
mTOR = 哺乳动物雷帕霉素靶蛋白 (Mechanistic target of rapamycin)
NCCN = 美国国家综合癌症网络 (National Comprehensive Cancer Network)
NDA = 新药上市申请 (New Drug Application)
NET = 神经内分泌瘤 (Neuroendocrine tumor)
NHL = 非霍奇金淋巴瘤 (Non-Hodgkin lymphoma)
国家药监局 (NMPA) = 中国国家药品监督管理局 (China National Medical Products Administration)
国家医保药品目录 (NRDL) = 《中国国家基本医疗保险、工伤保险和生育保险药品目录》 (China National Reimbursement Drug List)
NSCLC = 非小细胞肺癌 (Non-small cell lung cancer)
ORR = 客观缓解率 (Objective response rate)
OS = 总生存期 (Overall survival)
人民银行 (PBOC) = 中国人民银行 (People's Bank of China)
PD-1 = 程序性细胞死亡蛋白-1 (Programmed cell death protein-1)
PDAC = 胰腺导管腺癌 (Pancreatic ductal adenocarcinoma)
PFS = 无进展生存期 (Progression free survival)
PI3K = 磷酸肌醇-3-激酶 (Phosphatidylinositol 3-kinase)
PI3Kδ = 磷酸肌醇-3-激酶δ (Phosphoinositide 3-kinase-δ)
PIKK = 磷脂酰肌醇3-激酶相关激酶 (Phosphatidylinositol 3-kinase-related kinase)
pMMR = 错配修复完整 (Proficient mismatch repair)
pNET = 胰腺神经内分泌瘤 (Pancreatic neuroendocrine tumor)
R/R = 复发及/或难治性 (Relapsed and/or refractory)
RAS = 大鼠肉瘤 (Rat sarcoma)
RCC = 肾细胞癌 (Renal cell carcinoma)
人民币 (RMB) = 中国法定货币
RP2D = II期临床试验推荐剂量 (The recommended phase 2 dose)
销售及行政开支 (S&A) = 销售及行政开支 (Selling and administrative expenses)
上海和黄药业 (SHPL) = 上海和黄药业有限公司 (Shanghai Hutchison Pharmaceuticals Limited)
SLL = 小淋巴细胞淋巴瘤 (Small lymphocytic lymphoma)
sNDA = 新适应症上市申请 (supplemental New Drug Application)
生长抑素类似物 (SSA) = Somatostatin Analogs
Syk = 脾酪氨酸激酶 (Spleen tyrosine kinase)
武田 (Takeda) = Takeda Pharmaceuticals International AG, Takeda Pharmaceutical Company Limited 的附属公司
TEAE = 治疗期间不良事件 (Treatment emergent adverse events)
TKI = 酪氨酸激酶抑制剂 (Tyrosine kinase inhibitor)
TPO = 血小板生成素 (Thrombopoietin)
TPO-RA = 血小板生成素受体激动剂 (Thrombopoietin receptor agonists)
TRAE = 治疗相关不良事件 (Treatment-related adverse events)
VEGFR = 血管内皮生长因子受体 (Vascular endothelial growth factor receptor)
wAIHA = 温抗体型自身免疫性溶血性贫血 (Warm autoimmune hemolytic anemia)
2026-07-30
— China product sales recovery continues led by ELUNATE® and SULANDA® with over 40% growth each — — FRUZAQLA® ex-US sales driving growth – now approved or launched in 41 countries — — Strong progress in ATTCs, a source of novel drug candidates with broad therapeutic potential — HONG KONG and SHANGHAI and FLORHAM PARK, N.J., July 30, 2026 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”, the “Company” or “we”) (Nasdaq/AIM:HCM; HKEX:13) today reports its financial results for the six months ended June 30, 2026 and provides updates on key clinical and commercial developments. All amounts are expressed in US dollars unless otherwise stated. A glossary of abbreviations is on page 25. Global sales growth driven by China rebound and FRUZAQLA® geographical expansion In-market sales from key China commercial products up over 40% compared to the first half of 2025. ELUNATE® (fruquintinib in China) up 41% to $60.8 million as it expanded reimbursement coverage for endometrial cancer and was approved for kidney cancer. SULANDA® up 45% to $18.4 million, boosted by upgraded recommendation in Chinese Society of Clinical Oncology guidelines for neuroendocrine tumors.In-market sales of FRUZAQLA® (fruquintinib ex-China) ex-US up ~70% to $68.9 million during first half of 2026, alongside steady US sales, driven by the need for novel non-chemo treatment options in mCRC and ongoing positive experiences of oncologists in third line setting.Profitability maintained amid higher R&D investment, with net income attributable to HUTCHMED at $15.9 million (H1-25: $455.0m including $416.3m gain on divestment of 45% of Shanghai Hutchison Pharmaceuticals Limited (SHPL)), which allowed the Company to maintain a strong cash balance of $1.37 billion. Multiple first-in-class Antibody-Targeted Therapy Conjugate (ATTC) candidates in clinical trials Initiated clinical trial of HMPL-A251 (PI3K/PIKK-HER2) in December 2025 and of HMPL-A580 (PI3K/PIKK-EGFR) in March 2026 and presented preclinical data at American Association for Cancer Research Annual Meeting. Both ATTCs are progressing through dose escalation as planned.HMPL-A830 clinical trial application approved in July 2026, based on a different ATTC payload platform. Regulatory and clinical achievements across late-stage clinical portfolio New Drug Application (NDA) approval of ELUNATE® with sintilimab for second-line kidney cancer in China in May 2026, supported by FRUSICA-2 Phase III data showing median progression-free survival (PFS) of 22.2 months vs. 6.9 months in control group.NDA acceptance of sovleplenib for warm autoimmune hemolytic anemia (wAIHA) in China in April 2026, supported by ESLIM-02 Phase III data presented at European Hematology Association Congress with durable response rate of 66.0%, along with NDA acceptance for immune thrombocytopenia (ITP) in China in February 2026; both wAIHA and ITP indications received priority review status.Positive SACHI Phase III data of ORPATHYS® in combination with TAGRISSO® (osimertinib) sub-group analysis published in The Lancet in January 2026 with median overall survival (OS) of 22.9 months vs. 7.9 months with chemotherapy. NDA approval for third-line MET-amplified gastric cancer in China in June 2026, supported by Phase II data presented at American Society of Clinical Oncology Annual Meeting with objective response rate of 32.3%.Positive pivotal Phase II data of fanregratinib (FGFR inhibitor) in intrahepatic cholangiocarcinoma presented at European Society for Medical Oncology Gastrointestinal Cancers Congress.Initiated Phase III trial of HMPL-760 (BTK inhibitor) in combination with rituximab and chemotherapy for second-line diffuse large B-cell lymphoma in March 2026. HUTCHMED to host results webcasts today at 8:00 a.m. EDT / 1:00 p.m. BST / 8:00 p.m. HKT in English on Thursday, July 30, 2026, and tomorrow at 8:30 a.m. HKT in Chinese (Putonghua) on Friday, July 31, 2026. After registration, investors may access the live webcast at www.hutch-med.com/event. Dr Dan Eldar, Non-executive Chairman of HUTCHMED, said, “HUTCHMED has a clear strategic focus: to build a globally competitive oncology portfolio anchored by differentiated innovation. This future is shaped by our global first-in-class Antibody-Targeted Therapy Conjugate (ATTC) novel payload platforms and other emerging large-molecule modalities. These give us multiple opportunities to pursue first-in-class or best-in-class assets, with potential to be used in combination with standard-of-care or newer medicines, in turn conferring front-line treatment prospects. As these programs advance, multinational partnerships – some presently under discussion – can provide important external validation, broaden development reach and accelerate access to major international markets. We will continue to invest in our world-class R&D organization and deploy our resources in areas where HUTCHMED can create significant impact on the lives of patients globally, harnessing the most advanced scientific modalities, while creating commercial and shareholder value.” Mr Johnny Cheng, Acting Chief Executive Officer and Chief Financial Officer of HUTCHMED, said, “Strong in-market sales growth from ELUNATE® and SULANDA® in the first half reflects the impact of last year’s streamlining of our salesforce, enhancing productivity with more focused marketing strategies, as we structured our commercial organization to meet the changing China market regulatory guidelines for a sustainable future. We are accelerating ATTC development and strengthening discovery operations through expanding talent and AI capabilities. We are also pursuing business development discussions with multinational partners to expedite global development and commercialization of our most promising programs.” Dr Weiguo Su, Chief Executive Officer (currently on leave of absence) and Chief Scientific Officer of HUTCHMED, said, “The acceptance by the NMPA of the NDA filings for sovleplenib in ITP and wAIHA during the first half of 2026 reflects the strength of the clinical data package, supporting its potential for regulatory and commercial success. Sovleplenib once again attests to the importance of target selectivity, differentiating efficacy and toxicity profiles of our assets. Our ATTC drug candidates are guided by the same principles, designed to navigate our proprietary potent small-molecule targeted therapy payloads to tumor cells while sparing healthy tissues and decreasing side-effects. Pre-clinical data has shown encouraging tumor shrinkage as compared to standard-of-care treatments and emerging therapies recently launched or in development. With three highly novel molecules from two ATTC payload platforms progressing through or about to start first-in-human clinical development, and additional candidates advancing behind them, we are building a science-driven pipeline designed to translate differentiated biology into meaningful clinical benefit.” 2026 INTERIM RESULTS & BUSINESS UPDATES I. COMMERCIAL OPERATIONS There was a strong rebound in China in-market sales, achieving $94.4 million in H1 2026, up 32% vs H1 2025 ($71.6 million) as our sales team continues to improve productivity. This contributed to total in-market sales for oncology products of $279.8 million in H1 2026 (H1-25: $234.4 million). ELUNATE® in-market sales were up 41% to $60.8 million, successfully expanded NRDL coverage to include 2L EMC with pMMR in combination with sintilimab. It also renewed coverage in metastatic CRC for patients who have been previously treated with chemotherapy, and those who have previously received or are not suitable for receiving anti-VEGF or anti-EGFR (RAS wild-type). SULANDA® in-market sales were up 45% to $18.4 million, driven by an update to Chinese Society of Clinical Oncology guidelines upgrading the usage for SULANDA® in neuroendocrine tumors to the highest Level I recommendation standard over competing SSA products. It also benefited from shifting marketing strategies to focus on key hospitals. FRUZAQLA® in-market sales growth was primarily driven by sales outside the US, which had growth of ~70%, contributed by approvals or launches in 41 countries to date, including securing reimbursement in France in Q1 2026 and late 2025 launches in Portugal, Belgium, South Korea and Mexico. This helped boost global in-market sales to $185.4 million. Total consolidated revenue for oncology products increased 23% to $121.4 million as compared to H1 2025, primarily due to strong in-market sales growth in ELUNATE® and SULANDA®. Other Oncology/Immunology revenue, consisting of upfront, regulatory milestones, R&D services and licensing revenue was $40.9 million, including an $18.1 million milestone payment from Eli Lilly, triggered by China approval for 2L RCC. Other Ventures revenue, mainly from prescription drug distribution was $116.0 million, leading to total consolidated revenue of $278.3 million. ($ in millions)In-market Sales*Consolidated Revenue** H1 2026H1 2025% Change(CER)H1 2026H1 2025% Change (CER)FRUZAQLA®$185.4$162.8+14%(+14%)$43.1$43.1— —ELUNATE®$60.8$43.0+41%(+33%)$47.1$33.6+40%(+32%)SULANDA®$18.4$12.7+45%(+37%)$18.4$12.7+45%(+37%)ORPATHYS®$15.7$15.2+3%(-3%)$13.3$9.0+48%(+39%)TAZVERIK®***$(0.5)$0.7— —$(0.5)$0.7— —Oncology Products$279.8$234.4+19%(+17%)$121.4$99.1+23%(+18%)Takeda upfront, regulatory milestones and R&D services$20.7$29.5-30%(-30%)Other revenue (R&D services and licensing)$20.2$14.9+35%(+35%)Total Oncology/Immunology$162.3$143.5+13%(+10%)Other Ventures$116.0$134.2-14%(-19%)Total Revenue$278.3$277.7— (-4%) * FRUZAQLA®, ELUNATE® and ORPATHYS® mainly represent total sales to third parties as provided by Takeda, Eli Lilly and AstraZeneca, respectively. ** FRUZAQLA® represents manufacturing revenue and royalties paid by Takeda to HUTCHMED; ELUNATE® represents manufacturing revenue, promotion and marketing services revenue and royalties paid by Eli Lilly to HUTCHMED, and sales to other third parties invoiced by HUTCHMED; ORPATHYS® represents manufacturing revenue and royalties paid by AstraZeneca to HUTCHMED and sales to other third parties invoiced by HUTCHMED; SULANDA® and TAZVERIK® represent HUTCHMED’s sales of the products to third parties.*** Ipsen is the Marketing Authorization Holder for TAZVERIK®, for which HUTCHMED acts as domestic agent/licensee. In March 2026 Ipsen voluntarily withdrew TAZVERIK® from all Ipsen markets, effective immediately, following emerging safety data from the ongoing SYMPHONY‑1 trial. II. 2026 REGULATORY UPDATES Savolitinib sNDA approved by NMPA in 3L MET-amplified GC in June 2026.Savolitinib MAA approved (temporary authorization) by Swissmedic in combination with TAGRISSO® for 2L EGFRm NSCLC with MET amplification and/or overexpression in February 2026.Fruquintinib sNDA approved by NMPA in combination with sintilimab for 2L RCC in May 2026.Sovleplenib NDA accepted by NMPA for 2L wAIHA in April 2026.Sovleplenib NDA resubmission accepted by NMPA for 2L ITP in February 2026.Tazemetostat voluntary withdrawal by Ipsen in China in March 2026. III. 2026 LATE-STAGE CLINICAL DEVELOPMENT ACTIVITIES Savolitinib (ORPATHYS® in China), a highly selective oral inhibitor of MET Expecting topline results in H2 2026 for SAFFRON and SANOVO, following full enrollment in H2 2025:
SAFFRON global Phase III study for 2L/3L EGFRm NSCLC patients with MET amplification and/or overexpression could support global filings (NCT05261399).SANOVO China Phase III study for 1L EGFRm NSCLC patients with MET overexpression could support China filing (NCT05009836).
Published sub-group analysis of SACHI China Phase III study for 2L EGFRm NSCLC patients with MET amplification in The Lancet in January 2026, showing mOS of 22.9 months vs 7.9 months with chemotherapy (HR 0.32) when excluding control group patients who received subsequent MET inhibitor.Presented and published positive China Phase II pivotal study data in 3L MET-amplified GC at ASCO 2026 and in Nature Medicine in June 2026, respectively, with IRC-assessed ORR of 32.3%, mPFS of 4.0 months and mOS of 6.9 months (NCT04923932). Sovleplenib (HMPL-523), an investigative and highly selective oral inhibitor of Syk Presented positive ESLIM-02 China Phase III study data in 2L wAIHA at EHA 2026 Congress in June 2026, having met its primary endpoint of durable response rate of 66.0%, showing median time to response of 3.1 weeks and median cumulative duration of response of 16.1 weeks. Fanregratinib (HMPL-453), a novel, highly selective and potent inhibitor targeting FGFR 1, 2 and 3 Presented positive China Phase II pivotal study data in 2L FGFR2 fusion/rearrangement ICC at ESMO Gastrointestinal Cancers Congress in July 2026, having met its primary endpoint of IRC-assessed ORR of 42.5%, as well as showing mPFS of 6.9 months and mOS of 16.6 months. An NDA for 2L ICC was accepted by NMPA with priority review status in December 2025 (NCT04353375). HMPL-760, a non-covalent, third generation BTK inhibitor, targeting wild-type and C481S-mutated BTK Initiated China Phase III study in combination with R-GemOx (rituximab, gemcitabine and oxaliplatin) in patients with 2L relapsed/refractory DLBCL versus placebo in combination with R-GemOx in March 2026 (NCT07409428). Primary endpoints are investigator-assessed PFS and OS. IV. ANTIBODY-DRUG CONJUGATES RESEARCH & DEVELOPMENT HMPL-A251, a first-in-class PI3K/PIKK-HER2 ATTC comprising of a highly selective and potent PI3K/PIKK inhibitor payload linked to a humanized anti-HER2 IgG1 antibody, via a cleavable linker Progressing a dose-escalation and expansion trial for unresectable, advanced or metastatic HER2-expressing solid tumors with first patient dosed in December 2025 (NCT07228247).Preclinical data showed anti-tumor activity in DXd-resistant cell line and good efficacy and safety when in combination with chemotherapy via a differentiated mechanism of action. HMPL-A580, a first-in-class PI3K/PIKK-EGFR ATTC comprising of a highly selective and potent PI3K/PIKK inhibitor payload linked to an anti-EGFR IgG1 antibody, via a cleavable linker Progressing a dose-escalation and expansion trial for solid tumors, including NSCLC, CRC, HNSCC and ESCC with first patient dosed in March 2026 (NCT07396584).Preclinical data presented at AACR 2026 showing tumor shrinkage in osimertinib-resistant EGFRm NSCLC cell line and good efficacy and safety when used in combination with osimertinib in EGFRm PAM non-altered NSCLC cell line. HMPL-A830 China/US INDs cleared Plans for global clinical trial initiation in H2 2026. Preclinical data showed superior potency and safety profiles to antibodies or small molecules with the same target, with data to be presented at a scientific conference. V. COLLABORATION UPDATES ImageneBio is developing IMG-007, a non-T cell depleting, antibody-dependent cell-mediated cytotoxicity -silenced OX40 antagonist discovered by HUTCHMED Phase IIb trial (NCT07037901) in patients with moderate-to-severe atopic dermatitis progressing, with an amended protocol and topline data anticipated in the fourth quarter of 2027.Phase II trial initiation in patients with alopecia areata expected in 2026, with initial data expected in 2028. VI. OTHER VENTURES Other Ventures consolidated revenue decreased to $116.0 million for the six months ended June 30, 2026 (H1-25: $134.2 million) which has minimal impact on profitability as the segment is predominantly low-margin prescription drug distribution business in China and HUTCHMED continues to optimize working capital management.Consolidated net income attributable to HUTCHMED from Other Ventures decreased to $3.8 million (H1-25: $24.0m), primarily due to lower equity earnings from SHPL following our 45.0% equity interest disposal in 2025. VII. SUSTAINABILITY The 2025 Sustainability Report was published in April 2026 alongside the 2025 Annual Report. We have initiated a new target-setting cycle. A list of potential focus initiatives has been identified under our five sustainability pillars: Innovation, Climate Action, Human Capital, Access to Healthcare, and Ethics and Transparency. In 2026, we will develop this into a final list, including a roadmap for achievement and monitoring. In 2026, our sustainability initiatives have continued to receive strong recognition. Most recently, our commitment was reflected in an upgraded AA rating by MSCI, recognizing HUTCHMED as a Leader, and placing us among the top 19% of pharmaceutical companies. For its second consecutive year, HUTCHMED was recognized as Most Honored Company and ranked 1st place in ESG in its sector by Extel, formerly Institutional Investor Research, in its 16th Asia Executive Team Survey. It achieved top rankings across several areas – leading CEO, CFO, Investor Relations, ESG and Corporate Governance – earning the Most Honored Company designation. HUTCHMED was the only company to earn these designations in 2026 in All Asia (ex-Mainland China) Biopharmaceuticals. FINANCIAL HIGHLIGHTS Revenue for the six months ended June 30, 2026 was $278.3 million compared to $277.7 million for the six months ended June 30, 2025. Oncology/Immunology consolidated revenue amounted to $162.3 million (H1-25: $143.5m):
ELUNATE® revenue was $47.1 million, up 40% (H1-25: $33.6m), comprising manufacturing revenue, promotion and marketing services revenue and royalties, supported by ongoing label expansions.SULANDA® revenue was $18.4 million, up 45% (H1-25: $12.7m), driven by marketing strategies focusing on key hospitals and supported by recent oncology clinical guideline upgrades.ORPATHYS® revenue was $13.3 million, up 48% (H1-25: $9.0m), driven by higher manufacturing sales to AstraZeneca in preparation for the 3L MET-amplified GC launch.FRUZAQLA® revenue was $43.1 million (H1-25: $43.1m), reflecting continued growth in royalties, offset by reduced manufacturing revenue compared to the prior period, driven by strong in-market sales growth following approvals/launches in 41 countries to date.Takeda upfront, regulatory milestones and R&D services revenue were $20.7 million (H1-25: $29.5m), due to less R&D and regulatory support services to Takeda.Other revenue of $20.2 million (H1-25: $14.9m), includes an $18.1 million milestone payment from Eli Lilly triggered by China approval of ELUNATE® in combination with sintilimab for 2L RCC (H1-25: $11.1 million regulatory milestone from AstraZeneca following China NDA approval for SACHI).
Other Ventures consolidated revenue of $116.0 million (H1-25: $134.2m), primarily due to scaling down low-margin logistics distribution sales after considering working capital. Net Expenses for the six months ended June 30, 2026 were $262.4 million compared to $239.0 million for the six months ended June 30, 2025. Cost of Revenue was $152.2 million (H1-25: $167.6m), predominantly due to a lower cost of sales related to the prescription drug distribution business. Cost of revenue as a percentage of oncology product revenue improved to 33% (H1-25: 39%) driven by enhanced productivity and efficiency.R&D Expenses were $78.8 million (H1-25: $72.0m) as we initiated early-stage global clinical programs for our ATTC assets and we maintain ongoing investment in discovery to deliver sustained innovation.S&A Expenses were $46.5 million (H1-25: $41.6m), driven by strong performance of our Oncology/Immunology commercial operations and enhanced productivity.Other Items generated net income of $15.1 million (H1-25: $42.2m), which mainly includes interest income and expense, foreign exchange, equity in earnings of SHPL and taxes. The decrease was mainly due to lower equity earnings from SHPL following our 45.0% equity interest disposal in 2025. Net Income attributable to HUTCHMED for the six months ended June 30, 2026 was $15.9 million compared to $455.0 million for the six months ended June 30, 2025. $0.02 basic earnings per ordinary share / $0.09 basic earnings per ADS in the first half of 2026 (H1-25: $0.53 basic earnings per ordinary share / $2.65 basic earnings per ADS). Cash, Cash Equivalents and Short-Term Investments were $1,374.8 million as of June 30, 2026 compared to $1,367.3 million as of December 31, 2025. Adjusted Group (non-GAAP) net cash inflow excluding financing activities in the first half of 2026 was $10.5 million mainly due to net income of $16.2 million less $5.6 million in capital expenditures (H1-25: net cash inflow of $519.1m mainly due to the $549.0m net proceeds from the partial divestment of SHPL less a $10.0m regulatory approval milestone payment and $9.2m in capital expenditures).Net cash used in financing activities in the first half of 2026 totaled $2.9 million mainly due to net repayments of bank borrowings (H1-25: net cash inflow of $9.3m mainly due to proceeds from bank borrowings of $8.2m). Foreign exchange impact: The RMB appreciated against the US dollar on average by approximately 5% during the first half of 2026, which has impacted consolidated financial results as highlighted. Use of Non-GAAP Financial Measures and Reconciliation – References in this announcement to adjusted Group net cash flows excluding financing activities and financial measures reported at CER are based on non-GAAP financial measures. Please see the “Use of Non-GAAP Financial Measures and Reconciliation” for further information relevant to the interpretation of these financial measures and reconciliations of these financial measures to the most comparable GAAP measures, respectively. FINANCIAL GUIDANCE HUTCHMED reiterates full year 2026 guidance for Oncology/Immunology consolidated revenue in the range of $330 million to $450 million. HUTCHMED will leverage its strong cash resources to accelerate ATTC global development and explore investment opportunities. Shareholders and investors should note that: The Company does not provide any guarantee that the statements contained in the financial guidance will materialize or that the financial results contained therein will be achieved or are likely to be achieved; andThe Company has in the past revised its financial guidance and reference should be made to announcements it publishes regarding any updates to the financial guidance after the publication of this announcement. FINANCIAL SUMMARY Condensed Consolidated Balance Sheets Data (in $’000)As of June 30, 2026 As of December 31, 2025Assets(Unaudited) Cash and cash equivalents and short-term investments1,374,817 1,367,275Accounts receivable117,556 126,750Other current assets61,036 73,317Property, plant and equipment93,788 94,623Investment in equity investees11,020 10,865Other non-current assets78,210 80,267Total assets1,736,427 1,753,097Liabilities and shareholders’ equityAccounts payable33,646 45,533Other payables and accruals197,627 208,892Bank borrowings94,508 93,160Deferred revenue27,630 51,547Other liabilities108,048 102,703Total liabilities461,459 501,835Company’s shareholders’ equity1,260,776 1,237,926Non-controlling interests14,192 13,336Total liabilities and shareholders’ equity1,736,427 1,753,097 Condensed Consolidated Statements of Operations Data (Unaudited, in $’000, except share and per share data)Six months ended June 30, 2026 2025Revenue:Oncology/Immunology – Marketed Products121,434 99,039 Oncology/Immunology – R&D40,887 44,408 Oncology/Immunology Consolidated Revenue162,321 143,447 Other Ventures115,966 134,230 Total revenue278,287 277,677 Operating expenses:Cost of revenue(152,158) (167,577)Research and development expenses(78,783) (71,990)Selling and administrative expenses(46,477) (41,624)Total operating expenses(277,418) (281,191) Gain on divestment of an equity investee— 477,456 Other income, net12,784 21,650 Income before income taxes and equity in earnings of equity investees13,653 495,592 Income tax expense(1,209) (2,029)Income tax expense – Divestment of an equity investee— (61,133)Equity in earnings of equity investees, net of tax3,798 23,125 Net income16,242 455,555 Less: Net income attributable to non-controlling interests(314) (601)Net income attributable to HUTCHMED15,928 454,954 Earnings per share attributable to HUTCHMED (US$ per share)– basic 0.02 0.53 – diluted0.02 0.52 Number of shares used in per share calculation– basic865,770,498 857,038,725 – diluted872,869,494 872,564,513 Earnings per ADS attributable to HUTCHMED (US$ per ADS)– basic 0.09 2.65 – diluted0.09 2.61 Number of ADSs used in per ADS calculation– basic173,154,100 171,407,745 – diluted174,573,899 174,512,903 About HUTCHMED HUTCHMED (Nasdaq/AIM:HCM; HKEX:13) is an innovative, commercial-stage, biopharmaceutical company. It is committed to the discovery and global development and commercialization of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases. Since inception it has focused on bringing drug candidates from in-house discovery to patients around the world, with its first three medicines marketed in China, and the first of which is also approved around the world including in the US, Europe and Japan. For more information, please visit: www.hutch-med.com or follow us on LinkedIn. Contacts Investor Enquiries+852 2121 8200 /ir@hutch-med.com Media Enquiries FTI Consulting –+44 20 3727 1030 /HUTCHMED@fticonsulting.comBen Atwell / Tim Stamper+44 7771 913 902 (Mobile) / +44 7779 436 698 (Mobile)Brunswick – Zhou Yi+852 9783 6894 (Mobile) /HUTCHMED@brunswickgroup.com Panmure LiberumNominated Advisor and Joint BrokerAtholl Tweedie / Emma Earl / Rupert Dearden+44 20 7886 2500 CavendishJoint BrokerGeoff Nash / Nigel Birks+44 20 7220 0500 Deutsche NumisJoint BrokerDuncan Monteith / Ramin Naji+44 20 7545 8000 References Unless the context requires otherwise, references in this announcement to the “Group,” the “Company,” “HUTCHMED,” “HUTCHMED Group,” “we,” “us,” and “our,” mean HUTCHMED (China) Limited and its subsidiaries unless otherwise stated or indicated by context. Past Performance and Forward-Looking Statements The performance and results of operations of the Group contained within this announcement are historical in nature, and past performance is no guarantee of future results of the Group. This announcement contains forward-looking statements within the meaning of the “safe harbor” provisions of the US Private Securities Litigation Reform Act of 1995. These forward-looking statements can be identified by words like “will”, “expects”, “anticipates”, “future”, “intends”, “plans”, “believes”, “estimates”, “pipeline”, “could”, “potential”, “first-in-class”, “best-in-class”, “designed to”, “objective”, “guidance”, “pursue”, or similar terms, or by express or implied discussions regarding potential drug candidates, potential indications for drug candidates or by discussions of strategy, plans, expectations or intentions. You should not place undue reliance on these statements. Such forward-looking statements are based on the current beliefs and expectations of management regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that any of our drug candidates will be approved for sale in any market, that any approvals which have been obtained will continue to remain valid and effective in the future, or that the sales of products marketed or otherwise commercialized by HUTCHMED and/or its collaboration partners (collectively, “HUTCHMED’s Products”) will achieve any particular revenue or net income levels. In particular, management’s expectations could be affected by, among other things: unexpected regulatory actions or delays or government regulation generally; the uncertainties inherent in research and development, including the inability to meet our key study assumptions regarding enrollment rates, timing and availability of subjects meeting a study’s inclusion and exclusion criteria and funding requirements, changes to clinical protocols, unexpected adverse events or safety, quality or manufacturing issues; the delay or inability of a drug candidate to meet the primary or secondary endpoint of a study; the delay or inability of a drug candidate to obtain regulatory approval in different jurisdictions or the utilization, market acceptance and commercial success of HUTCHMED’s Products after obtaining regulatory approval; discovery, development and/or commercialization of competing products and drug candidates that may be superior to, or more cost effective than, HUTCHMED’s Products and drug candidates; the impact of studies (whether conducted by HUTCHMED or others and whether mandated or voluntary) or recommendations and guidelines from governmental authorities and other third parties on the commercial success of HUTCHMED’s Products and drug candidates in development; the ability of HUTCHMED to manufacture and manage supply chains, including various third party services, for multiple products and drug candidates; the availability and extent of reimbursement of HUTCHMED’s Products from third-party payers, including private payer healthcare and insurance programs and government insurance programs; the costs of developing, producing and selling HUTCHMED’s Products; the ability to obtain additional funding when needed; the ability to obtain and maintain protection of intellectual property for HUTCHMED’s Products and drug candidates; the ability of HUTCHMED to meet any of its financial projections or guidance and changes to the assumptions underlying those projections or guidance; global trends toward health care cost containment, including ongoing pricing pressures; uncertainties regarding actual or potential legal proceedings, including, among others, actual or potential product liability litigation, litigation and investigations regarding sales and marketing practices, intellectual property disputes, and government investigations generally; and general economic and industry conditions, including uncertainties regarding the effects of the persistently weak economic and financial environment in many countries, uncertainties regarding future global exchange rates, uncertainties in global interest rates, and geopolitical relations, sanctions and tariffs. For further discussion of these and other risks, see HUTCHMED’s filings with the US Securities and Exchange Commission, on AIM and on HKEX. HUTCHMED is providing the information in this announcement as of this date and does not undertake any obligation to update any forward-looking statements as a result of new information, future events or otherwise. In addition, this announcement contains statistical data and estimates that HUTCHMED obtained from industry publications and reports generated by third-party market research firms. Although HUTCHMED believes that the publications, reports and surveys are reliable, HUTCHMED has not independently verified the data and cannot guarantee the accuracy or completeness of such data. You are cautioned not to give undue weight to this data. Such data involves risks and uncertainties and are subject to change based on various factors, including those discussed above. Inside Information This announcement contains inside information for the purposes of Article 7 of Regulation (EU) No 596/2014 (as it forms part of retained EU law as defined in the European Union (Withdrawal) Act 2018). Medical Information This announcement contains information about products that may not be available in all countries, or may be available under different trademarks, for different indications, in different dosages, or in different strengths. Nothing contained herein should be considered a solicitation, promotion or advertisement for any prescription drugs including the ones under development. This announcement in its entirety is available at: http://ml.globenewswire.com/Resource/Download/031c06fc-010c-45d1-8c53-ed93a7275b6c
临床2期临床结果临床3期上市批准临床1期
100 项与 Olevaprubart 相关的药物交易
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 特应性皮炎 | 临床2期 | 美国 | 2025-06-17 | |
| 特应性皮炎 | 临床2期 | 加拿大 | 2025-06-17 | |
| 特应性皮炎 | 临床2期 | 新西兰 | 2025-06-17 | |
| 湿疹 | 临床2期 | 美国 | 2025-06-17 | |
| 湿疹 | 临床2期 | 澳大利亚 | 2025-06-17 | |
| 湿疹 | 临床2期 | 加拿大 | 2025-06-17 | |
| 斑秃 | 临床2期 | 美国 | 2023-09-25 | |
| 斑秃 | 临床2期 | 加拿大 | 2023-09-25 | |
| 中度特应性皮炎 | 临床2期 | 美国 | 2023-08-09 | |
| 中度特应性皮炎 | 临床2期 | 加拿大 | 2023-08-09 |
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临床结果
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| 研究 | 分期 | 人群特征 | 评价人数 | 分组 | 结果 | 评价 | 发布日期 |
|---|
临床1/2期 | 29 | (IMG-007 300 mg) | 鹽繭顧淵艱糧遞鬱壓夢 = 鑰鹽齋築醖範壓顧願遞 範築鑰鬱遞淵壓鬱築鏇 (獵遞網淵製鹽網醖鬱餘, 積壓範襯衊壓繭衊艱繭 ~ 鹹夢窪襯膚範觸窪選鏇) 更多 | - | 2026-02-09 | ||
(IMG-007 600 mg) | 鹽繭顧淵艱糧遞鬱壓夢 = 廠襯艱鑰製範憲鹹衊醖 範築鑰鬱遞淵壓鬱築鏇 (獵遞網淵製鹽網醖鬱餘, 範膚鏇顧遞網齋鬱鹹鑰 ~ 顧夢齋壓餘鹹繭淵範築) 更多 | ||||||
临床1/2期 | 13 | 願範糧繭鏇繭遞壓糧選 = 鏇製鏇簾範範糧壓鏇獵 鹹膚築壓蓋夢鏇蓋鏇簾 (鑰憲選鬱構鹽願繭淵鹽, 鬱蓋艱廠夢鏇網夢憲範 ~ 築鏇鏇構齋觸鏇鑰簾範) 更多 | - | 2025-11-06 | |||
临床2期 | 29 | 鹹製製鏇觸餘網艱廠餘(願鹽遞糧鏇鑰築齋遞顧) = 網構繭鹽淵齋糧獵築鏇 醖淵膚選築廠範憲構衊 (繭衊願製繭構鬱鏇襯憲 ) | 积极 | 2025-04-25 | |||
鹹製製鏇觸餘網艱廠餘(願鹽遞糧鏇鑰築齋遞顧) = 簾網壓艱窪遞構壓餘膚 醖淵膚選築廠範憲構衊 (繭衊願製繭構鬱鏇襯憲 ) 更多 | |||||||
临床1期 | 16 | 範廠膚鑰鹹醖襯齋顧襯(憲艱鏇構顧衊壓網夢襯) = 鏇醖艱蓋遞齋鬱齋鏇糧 齋膚築鏇蓋壓糧簾夢蓋 (艱簾鬱網顧鬱膚簾衊壓 ) 更多 | 积极 | 2025-01-10 | |||
Placebo | 衊淵廠製繭選襯廠鬱範(積簾積衊醖網壓簾窪積) = 夢鹹廠齋範壓簾網壓鹹 範壓鹹襯壓觸顧觸簾鏇 (積築繭鹹憲簾廠鹹繭蓋 ) | ||||||
临床2期 | 13 | IMG-007 300 mg | 鏇蓋繭願鹹鬱齋廠繭糧(淵蓋簾構簾衊蓋淵鹽簾) = 顧襯鑰衊鹹餘簾淵醖蓋 範獵餘壓糧構膚構醖蓋 (鹽襯壓顧簾鹽選製夢鹹 ) 更多 | 积极 | 2024-05-06 | ||
临床1期 | 44 | 繭選範壓簾夢顧積衊獵(網繭鏇顧顧夢願襯膚淵) = IMG-007组未见比安慰剂组更高比例的特别不良事件（除了无剂量相关性的一些孤立 COVID-19病例），没有受试者报告任何与治疗相关的不良事件。重要的是，未报告发热或寒战事件。 蓋膚鹹膚憲築築築鏇糧 (願顧簾襯夢蓋夢壓積襯 ) | 积极 | 2023-08-21 | |||
placebo |
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