Core Viewpoint - Fuhong Hanlin (02696) shares rose over 4% following the FDA approval of its biosimilar drug POHERDY, making it the first interchangeable biosimilar of PERJETA in the U.S. market [1] Company Summary - Fuhong Hanlin's stock increased by 4.11%, reaching HKD 67.1, with a trading volume of HKD 31.4021 million [1] - The FDA approved POHERDY, a biosimilar of pertuzumab, allowing it to be used interchangeably with the original product PERJETA, covering all indications previously approved for the original drug in the U.S. [1] - POHERDY is noted as the first biosimilar of pertuzumab in the U.S. and the first interchangeable biosimilar approved for cancer treatment by the FDA [1] - Fuhong Hanlin has submitted applications for HLX11 in China, Europe, and Canada, which have been accepted for review [1] - The company has a total of seven products approved for sale overseas, with four of those approved in the U.S. [1]

Core Viewpoint - Fuhong Hanlin (02696) shares rose over 4% following the FDA approval of its biosimilar drug POHERDY, making it the first interchangeable biosimilar of PERJETA in the U.S. market [1] Group 1: Company Developments - Fuhong Hanlin's stock increased by 4.11%, reaching HKD 67.1, with a trading volume of HKD 31.4021 million [1] - The FDA approved the biosimilar injection of pertuzumab, POHERDY, which can be used interchangeably with the original product PERJETA, covering all indications approved for the original product in the U.S. [1] - POHERDY is noted as the first biosimilar of pertuzumab in the U.S. and the first interchangeable biosimilar approved for cancer treatment by the FDA [1] Group 2: Market Position - Fuhong Hanlin has submitted marketing applications for HLX11 in China, Europe, and Canada, which have been accepted [1] - The company has a total of seven products approved for sale overseas, with four of those products receiving approval in the U.S. [1]

Market Overview - The pharmaceutical and biotechnology index increased by 2.19%, outperforming the Shanghai Composite Index by 2.65 percentage points, ending a nearly two-month period of sluggish performance [4] - The innovative drug index (BK1106) rose by 4.93%, while the Hang Seng Healthcare Index (HSCICH) surged by 7.18%, and the Hong Kong innovative drug ETF (513120) increased by 5.90% [4][5] Investment Insights - The recent rebound in the pharmaceutical sector indicates a recovery in market sentiment, with a notable increase in risk appetite [5] - Investors are advised to focus on two main themes: capitalizing on valuation recovery opportunities in innovative drugs and medical devices, and being cautious of concept stocks lacking fundamental support [5] - Companies with strong global innovation capabilities and progress in international markets are highlighted as key investment targets [5] Company Developments - Fuxiang Pharmaceutical, primarily engaged in the development and sales of anti-infection drug raw materials, has seen its stock performance closely tied to the rising prices of lithium battery electrolyte additives, rather than traditional pharmaceutical concepts [5] - The company is expanding into synthetic biology and microbial protein businesses [5] Clinical Trials and Approvals - A total of 94 new clinical trial registrations were disclosed, with 37 in Phase II or above [9] - Notable clinical trials include the evaluation of HLX43 for late-stage pancreatic cancer, which has commenced its Phase II study [15] - The approval of innovative drugs includes the launch of Vepaglutide by Paig Biological, aimed at improving blood sugar control in adults with type 2 diabetes [13][14] IPO and M&A Activity - Jiahe Biopharma is pursuing a reverse merger with Yiteng Pharmaceutical, marking the first reverse acquisition case under the Hong Kong 18A listing rules for biotech companies [7][8] - Jiahe Biopharma reported a revenue of 32.245 million yuan, a year-on-year increase of 122.84%, despite a loss of 54.373 million yuan during the same period [7]

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 ...