Ribupatide

IND for ribupatide oral active with U.S. FDA, initiation of global Phase 3 obesity trials planned for the first half of 2027 Ribupatide injection Phase 2b high-dose trial in obesity fully enrolled, data anticipated in mid-2027 Expanded executive team to strengthen technical operations capabilities and corporate affairs leadership Cash, cash equivalents, and marketable securities expected to support execution of multiple clinical milestones with runway into mid-2028 WALTHAM, Mass., Aug. 12, 2026 (GLOBE NEWSWIRE) -- Kailera Therapeutics, Inc. (Nasdaq: KLRA) (Kailera), a clinical-stage biotechnology company focused on elevating the next era of obesity care, today reported financial results for the second quarter ended June 30, 2026, and provided a summary of recent business highlights. Kailera is advancing a diversified GLP-1-based pipeline of clinical-stage therapeutic candidates for the treatment of obesity. The company’s approach seeks to improve upon currently available treatments by bringing forward product candidates that have the potential to maximize weight loss, improve tolerability, and address other critical needs in the current therapeutic landscape. The Kailera portfolio includes single-, dual-, and triple-agonist mechanisms and both oral and injectable formulations. "Our second quarter marked another period of strong execution across the Kailera portfolio. We advanced our global Phase 3 KaiNETIC program for ribupatide injection, completed enrollment in our U.S. Phase 2b high-dose ribupatide injection trial with data expected in mid-2027, and opened our ribupatide oral IND, with initiation of our global Phase 3 obesity program planned for the first half of 2027," said Ron Renaud, President and Chief Executive Officer of Kailera. “With a strong balance sheet and multiple clinical milestones expected over the next 18 months, we believe Kailera is well positioned to deliver differentiated treatment options to people living with obesity." Second Quarter Business Highlights and Recent Developments ezstandalone.cmd.push(function () { ezstandalone.showAds(131); }); Pipeline Highlights Ribupatide Injection (KAI-9531), GLP-1/GIP Receptor Dual Agonist Enrollment on track in global Phase 3 KaiNETIC program with data anticipated in 2028: The program encompasses three global, double-blind, randomized, placebo-controlled Phase 3 trials (KaiNETIC-1, NCT07284875 ; KaiNETIC-2, NCT07284901 ; KaiNETIC-3, NCT07284979) enrolling more than 4,700 participants. The program is evaluating once-weekly ribupatide injection doses of up to 10 mg over 76 weeks in adults living with obesity or overweight. Data are anticipated in 2028. Phase 2b high-dose clinical trial in obesity fully enrolled: The Phase 2b trial ( NCT07458269 ) enrolled 264 participants in the U.S. with a BMI of 35 or greater with no type 2 diabetes (T2D). The trial is evaluating once-weekly ribupatide injection doses of 10 mg, 13 mg, 16 mg, and 20 mg over 48 weeks. Data are anticipated in mid-2027. Phase 1 ribupatide injection site trial data to be presented at the 2026 European Association for the Study of Diabetes Annual Meeting (EASD): The oral presentation titled “Effect of Injection Site on the Relative Bioavailability and Safety of Ribupatide, a Novel Dual GLP-1/GIP Receptor Agonist: Phase 1, Randomized, Single-Dose Crossover Study Results,” will detail Kailera’s Phase 1 injection site trial, which supported the ongoing global Phase 3 KaiNETIC clinical program. P hase 1 data presented at the 86th Scientific Sessions of the American Diabetes Association (ADA 2026): Results from Kailera’s Phase 1 single ascending dose trial, the first ribupatide injection clinical data generated outside of China, were presented at ADA 2026. The trial demonstrated similar exposure, tolerability, and weight reduction in participants of Asian and non-Asian descent, which supported the ongoing global Phase 3 KaiNETIC clinical program. Positive topline data from Hengrui-conducted trials in indications beyond obesity further strengthen the growing body of clinical evidence supporting ribupatide: Two Phase 3 trials in T2D: In Hengrui’s Phase 3 trial in T2D patients with inadequate glycemic control despite diet and exercise interventions ( NCT06650007 ), once-weekly ribupatide injection (4 mg and 2 mg) vs. placebo showed significant reductions in HbA1c from baseline, with a maximum mean reduction of 2.67%, based on the efficacy estimand 1 . In an additional Phase 3 trial in adults with T2D with inadequate glycemic control after metformin monotherapy or combination therapy with an SGLT2 inhibitor ( NCT06649344 ), the mean HbA1c reductions in the ribupatide injection 4 mg and 2 mg groups reached 2.78% and 2.34%, respectively, compared to 2.29% in the semaglutide injection 1 mg group, with the primary endpoint achieving non-inferiority in both dose groups at Week 36, based on the efficacy estimand 2 . In addition, ribupatide injection 4 mg demonstrated statistically significant superior HbA1c reduction compared to semaglutide 1 mg. In both trials, safety and tolerability data were consistent with other GLP-1-based treatments, with most treatment-emergent adverse events (TEAEs) being mild to moderate and gastrointestinal-related. Hengrui plans to present additional data from these trials at upcoming medical congresses. Phase 2 trial in obesity with polyendocrine metabolic ovarian syndrome (PMOS) : In Hengrui’s Phase 2 trial in adults with obesity and PMOS ( NCT06595797 ), once-weekly ribupatide injection (4 mg, 2 mg, or 1 mg) vs. placebo demonstrated a mean weight loss of up to 21.2% based on the efficacy estimand 3 with no plateau at Week 32. Additionally, the mean change from baseline in the number of menstrual cycles reported by participants taking ribupatide injection 4 mg increased by 0.9 cycles during the final 12 weeks of treatment. Safety and tolerability data were consistent with other GLP-1-based treatments, with most TEAEs being mild and gastrointestinal-related. Hengrui plans to present additional data from this trial at EASD 2026. Ribupatide Oral (KAI-9531-T), GLP-1/GIP Receptor Dual Agonist Investigational New Drug (IND) application active with U.S. FDA: With an active IND, Kailera remains on track to initiate planned global Phase 3 trials in obesity in the first half of 2027. Hengrui’s Phase 2 obesity trial presented at the 86th Scientific Sessions of the American Diabetes Association (ADA 2026): In Hengrui’s Phase 2 trial in adults with obesity, participants taking ribupatide oral (25 mg and 50 mg) achieved a mean weight loss of up to 12.1%, based on the efficacy estimand 3 , with no observed plateau at Week 26. Additionally, up to 38.6% of participants taking ribupatide oral achieved at least 15% weight loss. Incidence of gastrointestinal adverse events was low, with vomiting reported in 11.4% and 7.5% of participants taking 25 mg and 50 mg ribupatide oral, respectively. KAI-7535, Oral Small Molecule GLP-1 Receptor Agonist Phase 2 trial in obesity ongoing to further optimize KAI-7535's clinical profile: Kailera’s global Phase 2 trial is a multicenter, randomized, double-blind, placebo-controlled clinical trial conducted by Kailera in the U.S. and Australia. This trial is designed to further optimize KAI-7535's clinical pro the treatment of obesity by evaluating a wide range of doses, starting at a lower dose of 15 mg, and following a more gradual, stepwise titration schedule designed to improve tolerability and determine the optimal balance between weight loss and tolerability. The trial is expected to enroll approximately 320 adult participants with a BMI of 30 or greater, or a BMI of 27 or greater with at least one co-morbidity, which may include T2D. The primary endpoint is percent change in body weight from baseline at Week 44. The trial initiated in April 2026, with data expected in 2027. Positive topline data from two Hengrui Pharma Phase 3 trials in obesity/overweight and T2D: In Hengrui’s Phase 3 trial in adults with obesity (HARBOR-1, NCT06904105 ), participants taking HRS-7535 180 mg achieved a mean weight loss of up to 11.1% from baseline at Week 50, based on an ad hoc analysis under the efficacy estimand 3 . In Hengrui’s Phase 3 trial in adults with T2D (OUTSTAND-2, NCT06589765 ), HRS-7535 lowered HbA1c by an average of 1.50% to 1.68% across all dose groups (30 mg, 60 mg, 90 mg), based on the efficacy estimand 2 . In both trials, most TEAEs were mild to moderate and gastrointestinal-related. No liver safety signal was observed in either trial, consistent with prior HRS-7535 clinical trials. Hengrui plans to present further data from OUTSTAND-2 at EASD 2026, and additional data from HARBOR-1 at an upcoming medical congress. KAI-4729, Injectable GLP-1/GIP/glucagon Receptor Tri-Agonist On track to begin global clinical development: Kailera remains on track to begin a Phase 1 trial in 2026 with data anticipated in 2027. Additional data to be presented by Hengrui at EASD and AASLD: Building on Hengrui’s previously reported topline data demonstrating HRS-4729 (12 mg) achieved a mean weight loss of up to 16.0% from baseline at Week 12, compared to 5.4% with placebo, Hengrui will present additional HRS-4729 Phase 1 clinical trial data at EASD 2026 and AASLD 2026. Corporate Highlights Expanded leadership team to support the next phase of growth: Appointed Nur Nicholson as Chief Technology Officer: Nur brings nearly three decades of experience leading global technical operations, manufacturing, quality, supply chain and other organizations across the pharmaceutical and biotechnology industries. She previously served as Chief Technical Operations Officer at Apellis Pharmaceuticals, where she built and led the company’s technical operations organization through its transition from clinical-stage biotech to commercial-scale enterprise. Appointed Kathleen Tregoning as Chief Corporate Affairs Officer : Kathleen brings more than two decades of experience leading global corporate affairs organizations and guiding innovative biopharmaceutical companies through complex policy, regulatory, reputational, and stakeholder environments. She previously served as Chief Corporate Affairs Officer and Head of Commercial Strategy at Cerevel Therapeutics, where she helped lead the neuroscience company through a period of significant growth prior to its acquisition by AbbVie in 2024. Added to the Russell 2000® Index: Effective on June 29, Kailera was added to the Russell 2000® Index as part of the first 2026 Russell indexes reconstitution. The June reconstitution of the Russell US indexes captures up to the 4,000 largest US stocks as of April 30, ranking them by total market capitalization. FTSE Russell determines membership for its Russell indexes primarily by objective, market-capitalization rankings and style attributes. Anticipated Key Milestones Ribupatide injection: U.S. Phase 2b high dose obesity data anticipated in mid-2027; global Phase 3 obesity data anticipated in 2028 Ribupatide oral: Global Phase 3 obesity trial initiations anticipated in the first half of 2027 KAI-7535: Global Phase 2 obesity data anticipated in 2027 KAI-4729: Phase 1 trial initiation anticipated by end of year 2026; data anticipated in 2027 Second Quarter 2026 Financial Results As of June 30, 2026, Kailera had cash, cash equivalents and marketable securities of $1,171.8 million, which is expected to fund operations into mid-2028. R&D expenses were $101.1 million for the quarter ended June 30, 2026, compared to $19.5 million for the same period in 2025. The increase of $81.5 million was primarily driven by the increase in product candidate development and the related nonclinical, clinical, and contract manufacturing costs associated with the Company's portfolio, as well as the increase in personnel-related costs to support its ongoing R&D activities. General and administrative expenses were $20.3 million for the quarter ended June 30, 2026, compared to $11.1 million for the same period in 2025. The increase of $9.2 million was primarily driven by personnel-related costs and professional service costs as the Company continues to expand its operations. Net loss was $111.3 million for the quarter ended June 30, 2026, compared to a net loss of $28.9 million for the same period in 2025. Upcoming Events Kailera expects to participate in the following upcoming investor conferences and medical congresses: Bernstein’s 3 rd Annual Healthcare Forum – September 23-24, 2026 2026 European Association for the Study of Diabetes (EASD) Annual Meeting – September 28-October 2, 2026 About Kailera Therapeutics Kailera Therapeutics (Kailera) is a clinical-stage biotechnology company focused on elevating the next era of obesity care by progressing a diversified pipeline to provide options for people living with obesity no matter where they are in their treatment journey. With an obesity-first focus, Kailera is advancing four clinical-stage product candidates leveraging multiple GLP-1-based mechanisms of action and routes of administration specifically designed to address critical needs in the current therapeutic landscape with a lead product candidate, ribupatide injection (also known as KAI-9531), that has the potential for the greatest weight loss. Ribupatide injection is in global Phase 3 trials as a once-weekly injectable GLP-1/GIP receptor dual agonist. Kailera is expanding the ribupatide franchise by developing a once-daily oral formulation with the goal of providing an oral option with the potential for compelling weight loss and highly differentiated tolerability. Additionally, Kailera is advancing the development of KAI-7535, a once-daily oral small molecule GLP-1 receptor agonist, and KAI-4729, a once-weekly injectable GLP-1/GIP/glucagon receptor tri-agonist. Kailera’s vision is to deliver category-leading obesity management medications that give people the power to restore their health and transform their lives. Kailera is based in Waltham, MA. For more information, visit and follow us on LinkedIn and X . Special Note Regarding Kailera Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve substantial risks and uncertainties. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, but not limited to, statements regarding the pro product candidates, the potential of Kailera’s portfolio, the timing, design and outcome of research and development activities, including with respect to the timing of initiation and completion of clinical trials and the design and goals of clinical trials, market opportunities for product candidates, the competitive landscape, timing and format of sharing of full clinical trial data, future results of operations and financial position, sufficiency of cash position to fund operations, and participation in upcoming events. Forward-looking statements can be identified by terms such as "anticipate," "believe," "contemplate," "continue," "could," "estimate," "expect," "intend," "may," “suggest,” "plan," “goal,” “vision,” "potential," "predict," "project," "should," "target," "will," "would," or similar expressions and the negatives of those terms. Kailera cannot assure you that the forward-looking statements in this press release will prove to be accurate. Information in this press release may also include statements relating to past performance, which should not be regarded as a reliable indicator of future performance. Forward-looking statements are based on current expectations and assumptions together with projections of the future which are inherently uncertain, and involve risks and uncertainties that could cause actual results to differ materially from those expressed or implied. These risks and uncertainties include, among others, uncertainties inherent in clinical development, regulatory review, manufacturing, competition, market opportunities, reliance on third parties, estimates of capital requirements, needs for additional financing, and other important factors, including those discussed under the caption “Risk Factors” in Kailera’s filings with the Securities and Exchange Commission. These statements speak only as of the date of this press release, and Kailera undertakes no obligation to update or revise any forward-looking statements. Kailera may not actually achieve the plans, intentions, or expectations disclosed in its forward-looking statements, and you should not place undue reliance on these forward-looking statements. 1 Based on the efficacy estimand, which was pre-specified as the supplementary estimand: treatment effect assuming participants adhered to protocol treatment and excludes data collected after premature treatment discontinuations or use of other glucose-lowering medications from the analysis. 2 Based on the efficacy estimand, which was pre-specified as the primary estimand: treatment effect assuming participants adhered to protocol treatment and excludes data collected after premature treatment discontinuations or use of other glucose-lowering medications from the analysis . 3 Based on the efficacy estimand, which was pre-specified as the supplementary estimand: treatment effect assuming participants adhered to protocol treatment and excludes data collected after premature treatment discontinuations or use of other medications with a substantial effect on body weight from the analysis . Contact Information Maura Gavaghan Vice President, Investor Relations maura.gavaghan@kailera.com Anna Robinson Vice President, Communications anna.robinson@kailera.com KAILERA THERAPEUTICS, INC. CONDENSED CONSOLIDATED BALANCE SHEETS (IN THOUSANDS) (UNAUDITED) June 30, 2026 December 31, 2025 Assets Current assets: Cash and cash equivalents $ 130,301 $ 160,267 Marketable securities 786,440 385,789 Prepaid expenses and other current assets 12,426 11,481 Total current assets 929,167 557,537 Property and equipment, net 1,753 1,955 Restricted cash 761 761 Long-term marketable securities 255,076 106,672 Non-current clinical deposits 14,671 12,185 Operating lease right-of-use assets 9,898 10,463 Other non-current assets 90 2,721 Total assets $ 1,211,416 $ 692,294 Liabilities, convertible preferred stock and stockholders’ equity (deficit) Current liabilities: Accounts payable $ 19,202 $ 7,529 Accrued expenses and other current liabilities 63,399 37,836 Operating lease liabilities, current 1,050 1,040 Total current liabilities 83,651 46,405 Operating lease liabilities, non-current 9,166 9,713 Other non-current liabilities 135 270 Total liabilities 92,952 56,388 Commitments and contingencies Convertible preferred stock: Series A convertible preferred stock — 390,306 Series B convertible preferred stock — 602,058 Stockholders’ equity (deficit): Preferred stock — — Common stock — — Additional paid-in capital 1,679,098 11,981 Accumulated other comprehensive (loss) income (1,794 ) 229 Accumulated deficit (558,840 ) (368,668 ) Total stockholders’ equity (deficit) 1,118,464 (356,458 ) Total liabilities, convertible preferred stock and stockholders’ equity (deficit) $ 1,211,416 $ 692,294 KAILERA THERAPEUTICS, INC. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (IN THOUSANDS) (UNAUDITED) Three Months Ended June 30, Six Months Ended June 30, 2026 2025 2026 2025 Operating expenses Research and development $ 101,061 $ 19,522 $ 171,934 $ 29,651 General and administrative 20,312 11,129 34,099 21,457 Total operating expenses 121,373 30,651 206,033 51,108 Loss from operations (121,373 ) (30,651 ) (206,033 ) (51,108 ) Other income Interest income 9,994 2,126 15,710 3,801 Other income (expense), net 72 (422 ) 151 377 Total other income 10,066 1,704 15,861 4,178 Net loss $ (111,307 ) $ (28,947 ) $ (190,172 ) $ (46,930 )

注：本文不构成任何投资意见和建议，以官方/公司公告为准；本文仅作医疗健康相关药物介绍，非治疗方案推荐（若涉及），不代表平台立场。任何文章转载需要得到授权。 PART 01 周报概述 随着全球医药行业的快速发展，新药研发与创新已成为推动行业进步的重要动力。近期，根据摩熵医药数据统计，新药申请与审批获批频繁，显示出医药创新领域的活跃态势。 本文将深入分析2026年8月3日至2026年8月9日期间，国内外新药申请、临床试验批准、仿制药一致性评价等多个方面的最新进展，为用户提供全面的行业资讯。 PART 02 国内54款新药IND获批 根据摩熵医药数据库统计，2026年8月3日至2026年8月9日期间，共有106个创新药/改良型新药临床申请/上市申请获国家药品监督管理局药品审评中心（CDE）承办（按受理号统计，不含补充申请）。其中国产药品受理号70个，进口药品受理号36个。 本周共计54款创新药/改良型新药临床试验申请获得“默示许可”，包括化学药16款，生物药35款，3款中药。 本周获批临床创新药/改良型新药部分信息速览（不含补充申请） 注：完整数据可识别“文末”二维码下载查看 PART 03 本周全球TOP10创新药研发进展 8月3日，CDE网站显示，罗氏的伐米奇拜单抗（vamikibart）拟纳入优先审评，用于治疗葡萄膜炎性黄斑水肿（UME）。伐米奇拜单抗是罗氏自Sesen Bio（已被Carisma Therapeutics收购）引进的一款IL-6单抗，具有较长的玻璃体内滞留时间和较快的系统性清除速度。该药物结合、阻断IL-6信号的活性是托珠单抗的1000倍。III期MEERKAT研究显示，在UME患者中，治疗第16周，伐米奇拜单抗（1mg，每4周1次）组实现最佳矫正视力（BCVA）评分较基线至少改善15个字母的患者比例显著高于安慰剂组（+36.9%，P<0.0001）。 截图来源：摩熵医药全球药物研发数据库（查数据.找摩熵） 8月5日，美国FDA宣布，批准武田（Takeda）开发的Orzeyful（oveporexton）片剂，用于治疗成人1型发作性睡病。FDA新闻稿指出，Orzeyful是首款通过直接靶向导致该疾病的食欲素信号缺失而发挥作用的药物。Orzeyful的有效性和安全性在两项随机、双盲、安慰剂对照的12周研究中进行了评估，共纳入273名1型发作性睡病成人患者。在两项研究中，与接受安慰剂的患者相比，服用Orzeyful（2 mg）的患者日间保持清醒的能力均有所改善。患者报告的日间嗜睡也显著减轻，猝倒发作次数显著减少，并且发作性睡病的整体症状获得具有临床意义的改善，包括睡眠瘫痪、幻觉和夜间睡眠中断。 本周全球 TOP10 创新药研发进展 截图来源：摩熵医药周报 PART 04 本周全球TOP10积极/失败临床结果 本周全球Top 10积极/失败临床进展盘点：8月4日，恒瑞医药宣布瑞普泊肽（HRS9531，KAI-9531-T，Ribupatide）头对头司美格鲁肽注射液的中国降糖III期研究（HRS9531-303）取得积极顶线结果。瑞普泊肽注射液4mg和2mg两个剂量组均达到预设的主要终点，即HbA1c相对基线的变化均非劣于司美格鲁肽注射液1mg组。基于本研究结果，恒瑞医药计划近期在中国提交瑞普泊肽注射液用于成人2型糖尿病患者血糖控制的新药上市申请。瑞普泊肽是恒瑞医药自主研发的胰高血糖素样肽‑1受体（GLP-1R）和葡萄糖依赖性促胰岛素肽受体（GIPR）双重激动剂。2024年5月，恒瑞医药将包括瑞普泊肽在内的GLP-1类创新药组合在大中华区以外开发、生产和商业化的独家权利授予Kailera。恒瑞医药就该药物开发了每周1次的皮下注射剂和每日1次的口服片剂。其中，瑞普泊肽注射液已于2025年9月在中国申报上市，适应症为成人长期体重管理。 截图来源：摩熵医药全球药物研发数据库（查数据.找摩熵） 同日，大冢制药（Otsuka）公布了III期VISIONARY试验数据，在具有疾病进展风险的原发性IgA肾病（IgAN）成人患者中，VOYXACT®（sibeprenlimab-szsi）在两年内稳定了估算肾小球滤过率（eGFR），让肾功能下降恢复到了基线生理速率。基于此次2年的数据，公司向FDA提交sBLA，为了传统批准。VOYXACT单抗，是目前首个且唯一获FDA批准的APRIL抑制剂，皮下注射给药，每四周一次。通过阻断APRIL，减少致病性半乳糖缺陷型IgA1（Gd-IgA1）的产生，从而干预IgAN发病机制中的关键环节。该药于2025年11月获FDA加速批准，用于具有疾病进展风险的原发性IgAN成人患者。 本周全球 TOP10 积极/失败临床结果 截图来源：摩熵医药周报 PART 05 117款品种过评，山东鲁抗医药领跑 根据摩熵医药数据库统计，2026年8月3日至2026年8月9日期间共有86项仿制药申报上市/申报临床获CDE承办，其中新注册分类上市申请受理号83项（包括化药3类，4类，5.2类），新注册分类临床申请受理号1项，一致性评价申请2项。本周5个品种通过一致性评价（按受理号计6项），本周112个品种视同通过一致性评价（按受理号计186项）。本周3项生物类似物注册申报动态：包括君合盟生物制药（杭州）股份有限公司的人生长激素注射液，连云港润众制药有限公司的司美格鲁肽注射液以及上海复宏汉霖生物技术股份有限公司的西妥昔单抗注射液。 本周过评/视同过评品种主要为消化系统与代谢药物；过评/视同过评产品剂型主要为注射剂。 截图来源：摩熵医药周报 本周洛索洛芬钠贴剂过评/视同过评受理号最多为10个，本周布美他尼注射液过评/视同过评企业最多为6家；本周山东鲁抗医药股份有限公司过评/视同过评品种最多为4种，本周过评/视同过评企业包括山东鲁抗医药集团赛特有限责任公司、河南欣泰药业有限公司和湖北神州华瑞医药有限公司共130家。 截图来源：摩熵医药周报 本周有巴氯芬注射液、乙酰唑胺缓释胶囊、依达拉奉右莰醇注射用浓溶液等5款是首次过评/视同过评品种。 截图来源：摩熵医药周报 本周丙戊酸钠缓释片（Ⅰ）、洛索洛芬钠贴剂、乌帕替尼缓释片3款是过评/视同过评达7家企业品种。 截图来源：摩熵医药周报 摩熵咨询本期周报领取方式 END 本文为原创文章，转载请留言获取授权 点击阅读原文，申请摩熵医药企业版免费试用！