A Phase 2a Study to Evaluate Safety and Tolerability After Single Administration of PER-001 Intravitreal Implant in Participants With Diabetic Retinopathy

This is a Phase 2a, randomized, single-masked (participant), sham controlled clinical study.

开始日期2023-08-05

申办/合作机构

Perfuse Therapeutics, Inc.

NCT05822245

/ Completed临床1/2期

A Phase 1/2a Study to Evaluate Safety, Tolerability, and Pharmacodynamic Effect After Single Administration of PER-001 Intravitreal Implant in Participants With Open-Angle Glaucoma

This clinical study has two phases: Phase 1 and Phase 2a. Phase 1 is an open-label, single ascending dose (SAD), while Phase 2a is a randomized, single-masked (participant) with a sham control.

开始日期2023-05-25

申办/合作机构

Perfuse Therapeutics, Inc.

100 项与 PER-001 相关的临床结果

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100 项与 PER-001 相关的转化医学

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100 项与 PER-001 相关的专利（医药）

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项与 PER-001 相关的文献（医药）

2019-06-12·Endocrine, metabolic & immune disorders drug targets

Prevalence of Extended-Spectrum β-Lactamases in Multi-drug ResistantPseudomonas aeruginosafrom Diabetic Foot Patients

Article

作者: Arshad, Muhammad ; Sehgal, Sheikh Arslan ; Qudus, Muhammad Suhaib ; Ul Hassan, Faaiz ; Siraj, Sami ; Mumtaz, Shahina ; Ul Haq, Khayam ; Khan, Momin ; Ahmed, Jawad

Introduction::

Pseudomonas aeruginosa is one of the major pathogens associated with the acute tissue damage in patients having Diabetic Foot Ulcer (DFU). The treatment of such infections can be an uphill battle due to the serious resistance to all the mainstay antibiotics, owing to overzealous production of Extended-Spectrum Beta-Lactamases (ESBLs). Pakistan also has a high prevalence of diabetes and complications related to it, however genetic disposition of the pathogens remains underinvestigated.

Aim::

The main objective of the study was to determine the frequency of ESBLs in Multi-drug resistant P. aeruginosa from diabetic foot patients.

Methods::

The duration of the present study was one year and 100 patients having DFU were enrolled. All the pus samples were subjected to the bacterial culture, gram staining, catalase test, oxidase test and antimicrobial susceptibility pattern to various antibiotics for the confirmation of P. aeruginosa. Of 23 positive isolates of P. aeruginosa, 10 were ESBLs positive as detected by double disk diffusion test. The positive ESBL strain shows an increase of ≥5mm in the zone of inhibition of the combination discs in comparison to the alone ceftazidime disc.

Results::

The ESBLs positive strains were also tested for TEM-1, SHV-1, PER-1, and VEB-1, where: (07/10) strains carried SHV-1, (05/10) strains were positive for TEM-1, while none of the isolates were PCR-positive for PER-1 and VEB-1.

Conclusion::

The findings of the current study show a difference in the pattern of ESBL genes compared to that of other such endeavors. The present study also warrants the PCR-based detection of the type of ESBL as a potential factor to consider in deciding the therapeutic strategy at any point during the treatment.

2006-12-01·Microbial drug resistance (Larchmont, N.Y.)3区 · 医学

Occurrence of Extended Spectrum β -Lactamases Among Isolates of Enterobacteriaceae from Urinary Tract Infections in Southern Italy

3区 · 医学

Article

作者: Caccamo, Marisa ; Perilli, Mariagrazia ; Tempera, Gianna ; Bonfiglio, Giovanni ; Amicosante, Gianfranco ; Celenza, Giuseppe

The present investigation was undertaken to assess the prevalence of extended-spectrum β -lactamases (ES β Ls) among urinary tract infection (UTI) isolates. During 4 months in 2004, a total of 650 Enterobacteriaceae strains from UTIs was collected by five clinical microbiology laboratories located in southern Italy and the β -lactamase production was investigated. A total of 50 of the 650 isolates were double-disk positive and suspected of producing an ES β L; Escherichia coli (36.0%) and Klebsiella pneumoniae (32.0%) were the most common species among all ES β L producers. Characterization of ES β L determinants was carried out by the colony blot hybridization method, and polymerase chain reaction (PCR) and DNA sequencing in order to identify the presence of blaTEM , blaSHV , blaPER , and blaCTX-M determinants. The ES β L variants found in this study were the following: TEM-15, TEM-24, TEM-52, TEM-134, SHV-12, CTX-M-1, CTX-M-3, CTX-M-15, and PER-1. As expected, the majority of the isolates were found to be susceptible to imipenem (94%), cefepime (54%) and piperacillin-tazobactam (54%). The results of this survey show the prevalence of ES β L enzymes among enterobacterial pathogens causing UTIs in southern Italy.

1998-12-01·The Journal of hospital infection3区 · 医学

An outbreak of extended-spectrum, β-lactamase-producing Salmonella senftenberg in a burns ward

3区 · 医学

Review

作者: G.L French ; B.K. Jain ; P.D. Stapleton ; K.P. Shannon ; G. Revathi

A strain of Salmonella senftenberg resistant to ceftazidime, gentamicin, chloramphenicol and ciprofloxacin was isolated from burn wounds of eight patients on a burns ward of a hospital in Delhi, India. The organism, which had probably been spread from patient to patient on staff hands, produced the extended-spectrum beta-lactamase SHV-5 and the aminoglycoside-modifying enzymes AAC(3)II + AAC(6'). The strain was not isolated from stool cultures of any of the patients or staff, apart from the index patient who had a history of diarrhoea and fever before admission. The outbreak ended in three weeks, after the implementation of strict handwashing. This is the first report of SHV-5 beta-lactamase in Salmonella spp. and also the first report of SHV-5 in India. The extended-spectrum beta-lactamases that have been reported in Salmonella spp. now include the Group 2 be enzymes SHV-2, SHV-5, TEM-3, TEM-25, TEM-27, CTX-M2, PER-1 and PER-2, and the Group 1 enzymes DHA-1 and CMY-2. The types of extended-spectrum beta-lactamases produced by salmonellas, their association with aminoglycoside resistance and their geographical distribution are now similar to those seen in klebsiella. Increasing antibiotic resistance in these organisms is reducing therapeutic options for the treatment of invasive disease.

项与 PER-001 相关的新闻（医药）

2026-06-18

·GBIHealth

填补全球空白！天广实倍捷欣获批原发性膜性肾病适应证

药械追踪 No.1 / 天广实CD20抗体倍捷欣在华获批pMN新适应证 2026年6月18日，北京天广实生物技术股份有限公司（以下简称“天广实”）宣布，其自主研发的创新型第三代CD20抗体药物倍捷欣（奥妥珠单抗β注射液）用于治疗原发性膜性肾病（pMN）的新药上市许可申请（NDA）已获国家药品监督管理局（NMPA）批准。中国是全球pMN发病率最高的国家之一，而pMN是终末期肾病主要的病因之一，需要肾移植或长期肾透析治疗。此前，全球范围内尚未批准任何一款针对pMN治疗的特效药物。倍捷欣是天广实自主研发的创新型第三代CD20抗体药物，此前已于2026年2月在中国获批用于治疗视神经脊髓炎谱系疾病（NMOSD）。其治疗pMN临床III期研究显示，倍捷欣单药治疗组的76周基于尿蛋白（UPCR）和肾小球滤过率（eGFR）评估的完全缓解率（CRR）显著优于环孢素组 (49.4% vs 3.9%，P＜0.0001)，且其104周CRR进一步提高至57.1%，总缓解率（ORR）为 85.7%。倍捷欣组中位至免疫缓解时间（1.2个月vs 3.0个月）和中位至肾脏缓解时间（3.8个月 vs 4.7个月）均显著优于环孢素组（P均<0.0001）。安全性方面，倍捷欣组第104周时肾脏治疗相关不良事件（TRAE）发生率为0.0%，而环孢素组的肾脏TRAE发生率高达30.3%。 ->点击文末阅读原文，解锁完整双语新闻 No.2 / 施维雅拓舒沃在华获批新适应证，联合阿扎胞苷一线治疗AML 2026年6月18日，施维雅旗下创新靶向药物拓舒沃（艾伏尼布片）获得国家药品监督管理局（NMPA）批准新增适应证，用于联合阿扎胞苷治疗携带易感异柠檬酸脱氢酶-1（IDH1）突变，因合并症无法使用强诱导化疗或者年龄≥75岁的新诊断急性髓系白血病（AML）患者。艾伏尼布是全球首个且目前中国唯一获批的IDH1抑制剂，此前已在中国获批用于治疗携带IDH1突变的复发性或难治性急性髓系白血病成人患者。此次一线适应证获批基于全球多中心、随机、双盲、安慰剂对照的III期AGILE研究，该研究共纳入146例不适合强化诱导化疗的新诊断IDH1突变急性髓系白血病患者。结果显示，艾伏尼布联合阿扎胞苷治疗组的mEFS可达22.9个月，mOS达29.3个月；47%的患者获得完全缓解（CR），其中88%的患者随访1年仍维持完全缓解。艾伏尼布联合阿扎胞苷整体安全性可控。 ->点击文末阅读原文，解锁完整双语新闻企业动态 No.1 /拜耳完成对Perfuse Therapeutics的收购 2026年6月17日，拜耳（德国证券交易所代码：BAYN）宣布已完成对Perfuse Therapeutics, Inc.的收购，拥有与PER-001玻璃体腔植入物相关的全部权益。该药物是一款同类首创（first-in-class）、缓释的小分子内皮素受体拮抗剂，目前处于治疗青光眼和糖尿病视网膜病变（DR）的Ⅱ期临床开发阶段。根据协议条款，拜耳支付了3亿美元的首付款。该交易的总潜在价值高达24.5亿美元，其中包括首付款以及未来基于成功标准的里程碑付款。 ->点击文末阅读原文，解锁完整双语新闻 No.2 /渤健拟10亿美元收购RayThera，扩充免疫学产品管线权益渤健（Nasdaq: BIIB）近日宣布与RayThera达成最终协议，同意以最高10亿美元的价格收购RayThera，其中包括一笔预付款以及主要取决于未来临床和监管里程碑达成情况的后续付款。 RayThera是一家专注于免疫学领域小分子疗法发现与开发的私有生物技术公司。该公司的产品组合涵盖多个抗炎分子，有潜力治疗免疫介导性疾病相关适应证。其领先候选药物预计将于2026年第三季度初进入Ⅰ期临床开发阶段。此项收购完成后，渤健将主导这些资产的开发、生产及全球商业化。 ->点击文末阅读原文，解锁完整双语新闻全球医疗情报领导者解锁隐藏在数据中的商业潜力关于 G B I ” 自从2002年成立以来，GBI始终以技术为驱动，为药企、器械及行业相关服务商提供贯穿生命周期的全球药品市场竞争数据、全球行业资讯、HCPs洞察、全国医疗器械数据等商业信息与洞察，助力企业在进行战略布局和决策时，脱颖而出。历经20余年的深耕细作GBI已成为95%以上跨国药企、国内头部药企、咨询与投资机构等医疗圈灯塔用户值得信赖的长期合作伙伴。联系我们投稿 | 发稿 | 媒体合作 ▶ olivia.xu@generalbiologic.com 数据库 | 咨询服务 | 资讯追踪 ▶ 点击左下“阅读原文”完成表单填写点击阅读原文，解锁完整双语新闻

2026-06-17

·创投风暴

拜耳完成Perfuse Therapeutics收购；航天驭星完成近20亿元D轮系列融资；富林岚科技完成数千万元Pre-A++轮融资；蓝星光域获数千万C+轮融资

拜耳完成Perfuse Therapeutics收购 6月17日，拜耳（Bayer）宣布完成对眼科生物制药公司Perfuse Therapeutics的收购。此次交易预付款为3亿美元，叠加研发、监管及商业化里程碑付款后，总潜在价值最高达24.5亿美元。 Perfuse总部位于加州南旧金山，研发设施设于北卡罗来纳州达勒姆。收购完成后，Perfuse将全面并入拜耳。通过此次收购，拜耳获得Perfuse核心资产PER-001的全部权益。此次收购是拜耳自2020年以40亿美元收购AskBio以来规模最大的一笔并购。航天驭星完成近20亿元D轮系列融资 6月16日，商业卫星在轨“运管服”企业航天驭星宣布完成D轮、D+轮及D++轮融资，累计近20亿元，估值突破百亿元，正式跻身独角兽行列。本轮融资汇聚红杉中国、前海方舟、联通战新、紫金矿业、中保投、上汽集团、五粮液、普华资本、小苗朗程、华安嘉业、赛纳资本等数十家头部产业资本与财务投资方。航天驭星成立于2016年10月，总部位于北京，是国内领先的商业航天测运控基础设施服务商，提供火箭发射测控、卫星测运控、载荷数据接收、空间碰撞预警及空间碎片清理等一站式在轨运管服务。截至6月15日，公司累计有偿服务684星/箭，2025年度在商业卫星测控有偿服务市场覆盖率达92.8%。公司已于6月5日在北京证监局完成IPO辅导备案，辅导机构为国泰海通证券。富林岚科技完成数千万元Pre-A++轮融资 6月16日，江苏富林岚科技有限公司宣布完成数千万元人民币Pre-A++轮融资。本轮投资方为荷塘创投（增资）与园丰资本（追投），由万创投行担任长期财务顾问。作为深耕倾转旋翼领域的国家高新技术企业，富林岚业务覆盖航空航天、船舶制造及低空经济产业。蓝星光域获数千万C+轮融资 6月16日，全场景激光通信解决方案提供商蓝星光域宣布完成数千万元C+轮融资，由永鑫方舟独家领投。今年5月，公司刚宣布在2025年完成近5亿元C轮融资，投资方包括粤开资本、银河创新资本、苏创投等多家机构。蓝星光域成立于2021年，核心团队来自中科院、清华、哈工大等机构，主攻精密光机载荷整机与组部件，产品应用于星载、机载及地面通信等领域。截至目前，公司已建成国内首个商业化千台量级批产孵化基地，并成功为卫星互联网试验卫星等任务提供了多套核心产品。 Flutterwave完成E轮融资 6月16日，非洲支付基础设施企业Flutterwave宣布完成E轮融资，投后估值达32亿美元。本轮由美国区块链支付公司Ripple进行战略投资，投资金额未披露，但Flutterwave创始人确认Ripple进行了“重大的实际现金投资”并获得股权。 Flutterwave成立于2016年，总部位于尼日利亚拉各斯，是非洲估值最高的金融科技公司。公司累计融资已超5亿美元，平台累计处理交易超10亿笔、总额突破500亿美元，业务覆盖34个非洲国家。 Foundation Alloy完成2200万美元A轮融资 6月16日，材料科学初创公司Foundation Alloy宣布完成2200万美元A轮融资。本轮由Voyager Ventures领投，参投方包括Trust Ventures、雅马哈发动机（Yamaha Motor Ventures）、America‘s Frontier Fund、Overlap Holdings、Material Impact、Engine Ventures、El Cap以及日本兼松株式会社（Kanematsu Corporation）。 Foundation Alloy总部位于美国马萨诸塞州波士顿，其核心创新在于摒弃了自青铜时代以来沿用数千年的“熔化-混合”合金制造工艺。公司通过一种特殊的研磨设备，将不同金属粉末在固态下反复撞击锻压，形成性能更优的新型合金。该固态工艺能耗仅为传统方法的十分之一，并能创造出兼具高强度和耐高温特性的材料。目前，公司已与汽车、航空航天、半导体及国防等行业的客户展开合作。 Aplagon完成480万欧元融资 6月16日，临床阶段生物技术公司Aplagon宣布完成480万欧元（约560万美元）融资，本轮融资由现有投资者Fåhraeus Startup and Growth AB（FSG）和欧洲创新委员会基金（EIC Fund）领投，Jenny and Antti Wihuri Foundation、Innovestor及Gösta Serlachius Fine Arts Foundation等芬兰投资者持续跟投。 Aplagon总部位于芬兰赫尔辛基，成立于2009年。公司核心候选药物APAC是一种首创的肝素蛋白聚糖模拟物，兼具抗血小板、抗凝血和抗炎活性，可靶向定位至血管损伤部位，在需要处发挥持续的抗血栓和抗炎作用。昊舜视讯完成A轮融资 6月15日，杭州昊舜视讯科技有限公司宣布完成A轮融资，由亚投（上海）私募基金管理有限公司（简称“亚投基金”）旗下基金独家投资。昊舜视讯成立于2015年，专注于无人机增值应用及全自动无人机机场研发生产，是国内少数具备“软件平台+硬件机库+后端识别”全栈自研能力的国家级高新技术企业和浙江省专精特新企业。产品已落地全国20余个省市，累计安全飞行超数万小时。 HMNC Brain Health完成5000万美元B轮融资首关 6月15日，德国临床阶段神经科学公司HMNC Brain Health宣布完成5000万美元B轮融资首关。本轮由德国医疗健康公司MEDICE领投，现有投资者The Maschmeyer Group继续跟投。 HMNC专注于精准精神病学治疗，资金将用于推进其两个抑郁症项目的临床后期开发，包括为抗药性抑郁症口服氯胺酮疗法Ketabon (KET01) 和生物标志物引导的精准疗法Nelivabon (BH-200) 的III期临床试验做准备。与此同时，HMNC还与MEDICE签订了战略许可协议，授予其在欧洲独家商业化KET01的权利。 Cellares D轮融资扩至3.27亿美元 6月15日，全球首家细胞治疗集成开发与制造组织（IDMO）Cellares宣布，其D轮融资总额已扩大至3.27亿美元。本轮D轮融资的投资方阵容豪华，包括：BlackRock、Eclipse、T. Rowe Price、Baillie Gifford、Duquesne Family Office、Intuitive Ventures、EDBI、Gates Frontier、DC Global Ventures、DFJ Growth、Willett Advisors及ARK Invest。此外，私募股权公司Prime Radiant Partners于6月15日追加5000万美元投资。 Cellares成立于2019年，总部位于美国加州，致力于通过自动化技术实现细胞治疗的大规模工业化生产。其核心产品Cell Shuttle平台可将劳动力需求减少80%、设施占地面积减少90%。公司已与百时美施贵宝签署3.8亿美元全球制造协议，并与Cabaletta Bio签订10年商业供应合同。 Nuvei以27.5亿美元收购Payoneer派安盈 6月15日，加拿大金融科技公司Nuvei与跨境支付平台Payoneer（派安盈）宣布达成最终收购协议。根据协议，Nuvei将以每股7.40美元现金收购Payoneer全部已发行普通股，交易股权总价值约27.5亿美元。此次收购溢价约44%，交易预计将于2027年年中完成。合并后公司年收入预计达30亿美元，年处理支付交易额超5000亿美元，服务超240万客户。双方将整合Nuvei的收单能力与Payoneer的跨境支付及多币种账户优势，为亚马逊、eBay、Shopify等平台商户提供一体化金融基础设施。福克斯220亿美元吞下Roku 6月15日，美国传媒巨头福克斯公司与流媒体平台Roku达成约束性协议，将以现金加股票的方式，以每股160美元、总价约220亿美元的价格收购Roku。此次交易后，福克斯股东将持有合并后公司约73%的股权，Roku股东持约27%。双方预计，合并后的公司按观众观看时长计算，将成为美国电视行业第三大玩家。Roku覆盖全球超过1亿户流媒体家庭，与福克斯的体育、新闻内容及免费流媒体平台Tubi形成强力互补，预计每年可带来约4亿美元的成本协同效应。目前该交易已获双方董事会批准，还需等待股东及监管审批，预计将于2027年上半年完成。 Diamond Brew完成七位数Pre-Seed轮融资 6月11日，手工咖啡胶囊品牌Diamond Brew宣布完成一笔七位数的Pre-Seed轮融资。本轮融资由G/7 Venture Studio领投，参投方包括SGL Acquisitions、Nobel Partners、Kingsland Capital Partners、Beckett Industries、Filipp Chebotarev、Daniel Faierman、音乐高管Charlie Walk、多位快消品行业资深人士，以及NFL球员DeAndre Hopkins和Sean Clifford等。该公司总部位于美国芝加哥，主打无需咖啡机、可常温储存的“免冲煮”咖啡胶囊，采用液氮速冻技术锁鲜。

2026-06-17

·BioSpace

Bayer Completes Acquisition of Perfuse Therapeutics

BERLIN--(BUSINESS WIRE)--Bayer today announced the completion of the acquisition of Perfuse Therapeutics, Inc. As a result, Perfuse Therapeutics will now be fully integrated into Bayer. As announced previously , Bayer now holds the full rights pertaining to PER-001 intravitreal implant, a first in class, sustained release small molecule endothelin receptor antagonist currently in Phase II clinical development for the treatment of Glaucoma and Diabetic Retinopathy (DR). This acquisition strengthens Bayer’s pharmaceutical pipeline and strategically fits with Bayer’s strong footprint and expertise in ophthalmology. Under the terms of the agreement, Bayer paid an upfront payment of USD 300 million. The transaction carries a total potential value of up to USD 2.45 billion, comprising of the upfront payment and additional success-based milestone payments. For Bayer, BofA Securities acted as exclusive financial advisor and Baker McKenzie acted as legal counsel. For Perfuse, Centerview Partners LLC acted as exclusive financial advisor and Goodwin Procter LLP acted as legal counsel. About Perfuse Therapeutics Perfuse Therapeutics is a biopharmaceutical company pioneering transformational research into the treatment of ischemia-induced ocular diseases. Enabled by its proprietary sustained-release drug delivery platform, the company is advancing its lead asset PER-001 for global leading causes of blindness. Headquartered in South San Francisco, Calif., and with R&D facilities in Durham, N.C., Perfuse Therapeutics has established a strong team committed to advancing disease-modifying therapies to patients with ocular disease around the world. About Bayer Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, “Health for all, Hunger for none,” the company’s products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2025, the Group employed around 88,000 people and had sales of 45.6 billion euros. R&D expenses amounted to 5.8 billion euros. For more information, go to . Find more information at Follow us on Facebook: Forward-Looking Statements This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at . The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments. Bayer AG is a holding company with operating subsidiaries worldwide. References to “Bayer” or “the company” herein may refer to one or more subsidiaries as context requires. Contacts Contact for media inquiries (U.S.) Elaine Colon, phone +1-732-236-1587 Email: elaine.colon@bayer.com Contact for media inquiries (Global): Lisa Varrelmann, phone: +49 1746466492 Email: lisa.varrelmann@bayer.com Contact for investor inquiries: Bayer Investor Relations Team, phone +49 214 30-72704 Email: ir@bayer.com

并购临床2期

100 项与 PER-001 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
非增殖性糖尿病视网膜病变	临床2期	美国	Perfuse Therapeutics, Inc.	2023-08-05
青光眼相关色素分散综合征	临床2期	美国	Perfuse Therapeutics, Inc.	2023-05-25
干性年龄相关性黄斑病变	药物发现	美国	Perfuse Therapeutics, Inc.	2024-07-18
地图样萎缩	药物发现	美国	Perfuse Therapeutics, Inc.	2024-07-18
视网膜静脉阻塞	药物发现	美国	Perfuse Therapeutics, Inc.	2024-07-18

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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


NCT05822245 (PRNewswire) 人工标引	临床1/2期	青光眼	33	PER-001 low dose	糧網窪廠願鑰壓範構構(憲壓餘糧艱築顧簾簾築) = 艱餘襯艱觸選積襯製壓醖鹽夢餘鏇顧網壓範窪 (窪窪顧餘窪獵選鹽繭繭 ) 更多	积极	2025-05-06
				PER-001 high dose	糧網窪廠願鑰壓範構構(憲壓餘糧艱築顧簾簾築) = 襯淵壓淵簾範願廠簾獵醖鹽夢餘鏇顧網壓範窪 (窪窪顧餘窪獵選鹽繭繭 ) 更多