Market Overview - The pharmaceutical and biotechnology index increased by 2.19%, outperforming the Shanghai Composite Index by 2.65 percentage points, ending a two-month period of sluggish performance [3] - The innovative drug index (BK1106) rose by 4.93%, while the Hang Seng Healthcare Index (HSCICH) saw a 7.18% increase [3] - The Hong Kong innovative drug ETF (513120) experienced a 5.90% rise [3] Company Highlights - Fuxiang Pharmaceutical, primarily engaged in the research, production, and sales of anti-infection drug raw materials and intermediates, saw its stock price surge by 64.46% [4] - Beibete-U, an innovative drug company that recently listed on the STAR Market, faced a significant decline, attributed to its slow clinical trial progress and lack of immediate product support [5] - Jiayou Bio's merger proposal with Yiteng Pharmaceutical Group marks the first reverse acquisition case under the Hong Kong 18A listing rules for biotech companies [6][7] Clinical Trials - A total of 94 new clinical trial registrations were disclosed, with 37 being in Phase II or above [9] - Notable trials include HLX43, an ADC targeting PD-L1 for advanced pancreatic cancer, which has commenced its Phase II clinical study [18] Product Approvals - Three innovative drugs received approval, including Vepaglutide for type 2 diabetes, marking a significant milestone for Paige Bio [13][15] - The competitive landscape for GLP-1 drugs is intensifying, with major players like Novo Nordisk and Eli Lilly holding a combined market share of 84% [15][16]

Core Insights - Shanghai Junshi Biosciences Co., Ltd. (复宏汉霖) announced that its HLX11 (biosimilar of pertuzumab, marketed as POHERDY in the U.S.) has received FDA approval for interchangeability with the original product PERJETA, making it the first and only biosimilar of PERJETA in the U.S. [1] - HLX11 is the first biosimilar of pertuzumab approved in the U.S. and the first interchangeable biosimilar for cancer treatment approved by the FDA [1] - The company has seven products approved for overseas markets, with four of them approved in the U.S. [1] Product and Market Details - HLX11 targets HER2 receptors and is indicated for metastatic breast cancer, early breast cancer, and adjuvant treatment for high-risk HER2-positive early breast cancer patients [1] - Organon, a New York Stock Exchange-listed company, will handle the commercialization of HLX11 outside of China, following a licensing and supply agreement signed in 2022 [1] Strategic Commitment - The CEO of Junshi Biosciences emphasized the achievement reflects the company's commitment to a sustainable global R&D system and a patient-centered approach, reinforcing its long-term commitment to global expansion [2] - The company aims to accelerate the delivery of quality biopharmaceuticals to benefit more patients worldwide and create greater value for human health [2]

Core Viewpoint - Fuhong Hanlin (02696) saw a stock price increase of over 3%, currently trading at 67.2 HKD, with a transaction volume of 3.9331 million HKD, following the FDA approval of its biosimilar drug POHERDY, which can be used interchangeably with the original product PERJETA [1] Group 1: FDA Approval and Market Impact - Fuhong Hanlin and Organon announced that the injection of patuzumab (POHERDY) received FDA approval, making it the first and only biosimilar of PERJETA in the U.S. market, covering all indications approved for PERJETA [1] - The approval is expected to enhance Fuhong Hanlin's market position and potentially increase revenue streams from the U.S. market [1] Group 2: Additional Developments - On November 12, the CDE announced that Fuhong Hanlin's PD-1 antibody drug, Surulizumab injection (H drug), is proposed to be included in the breakthrough therapy designation for use in combination with chemotherapy for neoadjuvant/adjuvant treatment of gastric cancer, marking its first potential recognition [1] - The H drug is noted as the first PD-1 monoclonal antibody approved for first-line treatment of small cell lung cancer globally, indicating significant advancements in Fuhong Hanlin's product pipeline [1]

Core Viewpoint - Fuhong Hanlin (02696) saw a stock price increase of over 3%, currently trading at 67.2 HKD, following the FDA approval of its biosimilar drug POHERDY, which can be used interchangeably with the original product PERJETA, making it the first and only biosimilar of PERJETA in the U.S. market [1][1][1] Group 1: FDA Approval and Market Impact - Fuhong Hanlin and Organon announced that the injection of patuzumab (POHERDY) received FDA approval, allowing it to be used interchangeably with the original product PERJETA [1][1] - POHERDY is now the first and only biosimilar of PERJETA approved in the U.S., covering all indications for which PERJETA has been approved [1][1] Group 2: Additional Developments - On November 12, the CDE announced that Fuhong Hanlin's PD-1 antibody drug, Surulitin (H drug), is proposed to be included in the breakthrough therapy designation for use in combination with chemotherapy for neoadjuvant/adjuvant treatment of gastric cancer [1][1] - The H drug is noted as the first PD-1 monoclonal antibody approved for first-line treatment of small cell lung cancer globally [1][1]

Core Insights - The biopharmaceutical license application (BLA) for Pertuzumab injection (420mg/14mL) POHERDY has been approved by the U.S. Food and Drug Administration (FDA), making it the first and only biosimilar to PERJETA (pertuzumab) in the U.S. market [1][1][1] - This approval allows for interchangeability with the original product PERJETA and covers all indications for which PERJETA has been approved in the U.S. [1][1][1] - The approval represents a significant milestone in improving access to high-quality and potentially more affordable treatment options for patients with specific HER2-positive breast cancer [1][1][1]

Core Insights - Organon and Henlius have received FDA approval for POHERDY, marking it as the first and only pertuzumab biosimilar in the US that is interchangeable with Perjeta [1] Company Summary - The approval of POHERDY represents a significant milestone for Organon and Henlius in the biosimilar market, particularly for treatments related to breast cancer [1] - This development may enhance competition in the oncology sector, potentially leading to cost savings for patients and healthcare systems [1] Industry Summary - The introduction of POHERDY as an interchangeable biosimilar could influence the dynamics of the oncology drug market in the US, promoting greater accessibility to essential treatments [1] - The approval aligns with ongoing trends in the pharmaceutical industry towards the development and acceptance of biosimilars, which are designed to provide more affordable alternatives to existing biologic therapies [1]

POHERDY®获批上市之后，集团累计已有七款产品于海外获批上市，其中，四款产品于美国获批上 市。本次获批，代表国际主流市场对于公司产品的又一认可，将进一步推进公司国际化布局的进程，提 升公司产品的国际影响力。集团将联合合作伙伴Organon LLC于条件具备后推进当地商业化销售。 此次FDA的批准主要是基于对HLX11(帕妥珠单抗)(HLX11)与其参照药(Perjeta®)一系列比对研究数据的 全面审查，包括分析相似性研究及临床比对研究。这些研究数据充分证明了HLX11与其参照药在质 量、安全性和有效性方面的高度相似。HLX11获准用于参照药Perjeta®在美国已获批的所有适应症。同 时，集团HLX11相关生产场地和设施亦接受了FDA的批准前检查(Pre-License Inspection, PLI)，该等生产 场地和设施均符合FDA的cGMP要求。 复宏汉霖(02696)发布公告，近日，集团收到美国食品药品管理局(FDA)的批准函，POHERDY® (帕妥珠 单抗)420mg/14mL(30mg/mL)注射液(供静脉注射使用)的生物制品许可申请(BLA)获FDA批准，该商品名 由N.V.Organo ...

HLX11是公司自主研发的帕妥珠单抗生物类似药。2022年6月，公司与Organon LLC(Organon&Co.的全 资附属公司)签订协议，向其授出一项独家许可，供其及其附属公司于除中国境内及港澳台地区以外全 球范围内商业化HLX11。2024年12月，HLX11的上市注册申请(NDA)获国家药品监督管理局(NMPA)受 理。2025年3月，HLX11的上市许可申请(MAA)获欧洲药品管理局(EMA)受理。2025年5月，HLX11的上 市注册申请(NDS)获加拿大卫生部(Health Canada)受理。根据IQVIA MIDASTM的最新数据(由IQVIA提 供，IQVIA是全球医药健康产业专业信息和战略咨询服务提供商)，2024年度，帕妥珠单抗产品于全球 范围内的销售额约为33.04亿美元。 POHERDY获批上市之后，集团累计已有七款产品于海外获批上市，其中，四款产品于美国获批上市。 本次获批，代表国际主流市场对于公司产品的又一认可，将进一步推进公司国际化布局的进程，提升公 司产品的国际影响力。集团将联合合作伙伴Organon LLC于条件具备后推进当地商业化销售。 复宏汉霖(02696)发布公告 ...

HLX11是公司自主研发的帕妥珠单抗生物类似药。2022年6月，公司与Organon LLC(Organon & Co.的全 资附属公司)签订协议，向其授出一项独家许可，供其及其附属公司于除中国境内及港澳台地区以外全 球范围内商业化HLX11。2024年12月，HLX11的上市注册申请(NDA)获国家药品监督管理局 (NMPA)受 理。2025年3月，HLX11的上市许可申请(MAA)获欧洲药品管理局(EMA)受理。2025年5月，HLX11的上 市注册申请(NDS)获加拿大卫生部 (Health Canada)受理。根据IQVIA MIDASTM的最新数据(由IQVIA提 供，IQVIA是全球医药健康产业专业信息和战略咨询服务提供商)，2024年度，帕妥珠单抗产品于全球 范围内的销售额约为33.04亿美元。 POHERDY®获批上市之后，集团累计已有七款产品于海外获批上市，其中，四款产品于美国获批上 市。本次获批，代表国际主流市场对于公司产品的又一认可，将进一步推进公司国际化布局的进程，提 升公司产品的国际影响力。集团将联合合作伙伴Organon LLC于条件具备后推进当地商业化销售。 智通财经APP讯，复 ...

格隆汇11月14日丨复宏汉霖(02696.HK)发布公告，近日，集团收到美国食品药品管理局("FDA")的批准 函，POHERDY®(帕妥珠单抗)420mg/14mL(30mg/mL)注射液(供静脉注射使用)的生物制品许可申请 (BLA)获FDA批准，该商品名由N.V.Organon于美国注册商标。本次获批适应症为：(1)与曲妥珠单抗和 多西他赛联合，用于治疗既往未接受过针对转移性疾病抗HER2治疗或化疗的HER2阳性、转移性乳腺癌 (MBC)成人患者；(2)与曲妥珠单抗和化疗联合，作为：(i)早期乳腺癌整体治疗方案的一部分，用于 HER2阳性、局部晚期、炎性或早期乳腺癌成人患者(直径＞2cm或淋巴结阳性)的新辅助治疗；及(ii)用 于具有高复发风险的HER2阳性早期乳腺癌成人患者的辅助治疗。 ...