Core Viewpoint - The company, Junshi Biosciences, has announced the completion of the first patient dosing in a Phase 1 clinical trial for its self-developed biosimilar HLX13, targeting unresectable hepatocellular carcinoma (HCC) patients in China [1] Group 1: Clinical Trial Details - The study is an international, multicenter, randomized, double-blind, parallel-controlled Phase 1 clinical trial [1] - The trial aims to evaluate the pharmacokinetic (PK) characteristics, safety, efficacy, and immunogenicity similarities between HLX13 and its reference drug YERVOY® when combined with OPDIVO® in previously untreated advanced HCC patients [1] - Eligible participants will be randomly assigned in a 1:1 ratio to receive either HLX13 or YERVOY® combined with OPDIVO® for the first four cycles, followed by OPDIVO® monotherapy for maintenance treatment every four weeks [1] Group 2: Study Endpoints - The primary endpoint includes the area under the concentration-time curve (AUC0-21d) from pre-dosing to 21 days post-first dosing and the steady-state AUC during the dosing interval after the fourth administration [1] - Secondary endpoints encompass other PK parameters, efficacy assessments, safety, and immunogenicity evaluations [1]

Core Viewpoint - The company, Junshi Biosciences, has announced the completion of the first patient dosing in a Phase 1 clinical trial for its self-developed biosimilar HLX13, targeting unresectable hepatocellular carcinoma (HCC) patients in China [1] Group 1: Clinical Trial Details - The study is an international, multicenter, randomized, double-blind, parallel-controlled Phase 1 clinical trial [1] - The trial aims to evaluate the pharmacokinetic (PK) characteristics, safety, efficacy, and immunogenicity similarities between HLX13 and its reference drug YERVOY® when combined with OPDIVO® in previously untreated advanced HCC patients [1] - Eligible participants will be randomly assigned in a 1:1 ratio to receive either HLX13 or YERVOY® combined with OPDIVO® for the first four cycles, followed by OPDIVO® monotherapy for maintenance treatment every four weeks [1] Group 2: Study Endpoints - The primary endpoint includes the area under the concentration-time curve (AUC0-21d) from pre-dosing to 21 days post-first dosing and the steady-state AUC during the dosing interval after the fourth administration [1] - Secondary endpoints encompass other PK parameters, efficacy assessments, safety, and immunogenicity evaluations [1]

Core Insights - Company announced the completion of the first patient dosing in a Phase 1 clinical trial for HLX13, a biosimilar of ipilimumab, for the treatment of unresectable hepatocellular carcinoma (HCC) in China [1] - The trial is a multicenter, randomized, double-blind, parallel-controlled study aimed at evaluating the pharmacokinetics, safety, efficacy, and immunogenicity of HLX13 compared to the original drug YERVOY® in previously untreated advanced HCC patients [1][2] - HLX13 is also being developed for multiple indications including melanoma, renal cell carcinoma, colorectal cancer, non-small cell lung cancer, malignant pleural mesothelioma, and esophageal squamous cell carcinoma [2] - The global sales of ipilimumab are projected to be approximately $2.873 billion in 2024 [3] Group 1 - HLX13 is a biosimilar of ipilimumab, designed to enhance immune response by blocking CTLA-4, thereby targeting tumors [2] - The Phase 1 trial involves a 1:1 random allocation of participants to receive either HLX13 or YERVOY® combined with OPDIVO® treatment [1] - The primary endpoint of the trial is the area under the concentration-time curve (AUC) from dosing to 21 days post-administration [1] Group 2 - The clinical trial application for HLX13 in HCC was approved by the National Medical Products Administration in June 2023 [2] - The company has entered into a licensing agreement with Sandoz AG for the commercialization of HLX13 in the U.S. and select European regions, Japan, Australia, and Canada [2] - The sales figure for ipilimumab indicates a significant market potential for HLX13 as a biosimilar in the oncology sector [3]

Core Viewpoint - 百奥泰 reported a revenue of 684 million yuan for the first three quarters of 2025, representing a year-on-year growth of 17.57%, while the net loss narrowed to 224 million yuan, indicating improved financial performance [1] Group 1: Financial Performance - The company achieved a revenue of 684 million yuan in the first three quarters, marking a 17.57% increase year-on-year [1] - The net loss for the same period was 224 million yuan, showing a reduction in losses compared to the previous year [1] Group 2: Product Development and Approvals - Several products have been approved for sale, including Adalimumab and Tocilizumab in China and other regions, and Bevacizumab in multiple countries [1] - BAT1806 (Tocilizumab) and BAT2206 (Ustekinumab) have been approved in Europe, with sales managed by partners [2][3] - The company is advancing its innovative drug pipeline, with BAT5906 and BAT4406F expected to submit applications for market approval soon [2][3] Group 3: Market Expansion and Strategy - The company is preparing for participation in centralized procurement, optimizing production capacity and supply chain to enhance competitiveness [2] - New guidelines in the EU and the US for biosimilars are expected to lower R&D costs, providing a competitive advantage for the company [2] Group 4: Clinical Trials and Research - BAT6026 is currently in Phase II clinical trials for atopic dermatitis, while BAT8008 is set to begin Phase III trials for cervical cancer and HER2-negative breast cancer in mid-2026 [3] - Ongoing clinical research for BAT8008 in combination with BAT1308 has shown positive efficacy signals, leading to an expansion of the sample size [3] - BAT7111 is in Phase I dose escalation studies, progressing smoothly with three doses explored [3]

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]

Overview - Shanghai Fosun Pharmaceutical (Group) Co., Ltd. announced that its subsidiary, Shanghai Fuhong Hanlin Biotechnology Co., Ltd., received FDA approval for its self-developed biosimilar POHERDY? (HLX11) for specific indications in HER2-positive metastatic breast cancer [2][6]. Product Information - HLX11 is a biosimilar of Pertuzumab, with a specification of 420mg/14mL (30mg/mL) for intravenous injection [2]. - The approved indications include treatment in combination with Trastuzumab and Docetaxel for adult patients with HER2-positive metastatic breast cancer who have not previously received anti-HER2 treatment or chemotherapy [2]. - It is also indicated for use in early breast cancer as part of a comprehensive treatment plan for HER2-positive locally advanced, inflammatory, or early breast cancer patients [2]. Regulatory Progress - HLX11's registration progress includes: - Acceptance of the marketing authorization application by the National Medical Products Administration of China in December 2024 [3]. - Acceptance of the marketing authorization application by the European Medicines Agency in March 2025 [3]. - Acceptance of the new drug submission by Health Canada in May 2025 [3]. Financial Investment - As of October 2025, the cumulative R&D investment for HLX11 is approximately RMB 225 million (unaudited) [4]. Market Potential - According to IQVIA MIDAS data, the global sales of Pertuzumab products are projected to be approximately $3.304 billion in 2024 [5]. Strategic Impact - The approval of POHERDY? marks the fourth product approved for Fuhong Hanlin in the U.S., enhancing the company's international market presence [6]. - Commercial rights for HLX11 outside of mainland China and Hong Kong, Macau, and Taiwan were granted to Organon LLC in June 2022, allowing Fuhong Hanlin to benefit from sales milestones and royalties following the U.S. approval [6].

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 ...

香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責，對其準確性 或完整性亦不發表任何聲明，並明確表示概不就因本公告全部或任何部分內容而產生或因倚賴 該等內容而引致的任何損失承擔任何責任。 Shanghai Henlius Biotech, Inc. 上海復宏漢霖生物技術股份有限公司 （於中華人民共和國註冊成立的股份有限公司） 本公司董事會（「董事會」）欣然宣佈，近日，本集團收到美國食品藥品管理 局（「FDA」）的批准函，POHERDY® （帕妥珠單抗）420mg/14mL(30mg/mL)注 射液（供靜脈注射使用）的生物製品許可申請(BLA)獲FDA批准，該商品名 由N.V.Organon於美國註冊商標。本次獲批適應症為：(1)與曲妥珠單抗和多 西他賽聯合，用於治療既往未接受過針對轉移性疾病抗HER2治療或化療的 HER2陽性、轉移性乳腺癌(MBC)成人患者；(2)與曲妥珠單抗和化療聯合， 作為：(i)早期乳腺癌整體治療方案的一部分，用於HER2陽性、局部晚期、 炎性或早期乳腺癌成人患者（直徑＞2cm或淋巴結陽性）的新輔助治療；及(ii) 用於具有高複發風險的HER2陽性早期乳腺癌成人患者 ...