Core Viewpoint - Fosun Pharma's subsidiary, Shanghai Fuhong Hanlin Biotechnology Co., Ltd., has received FDA approval to conduct Phase I clinical trials for HLX18, a biosimilar to Nivolumab, targeting multiple solid tumors [1] Group 1: FDA Approval and Clinical Trials - The FDA has approved the initiation of Phase I clinical trials for HLX18, a recombinant anti-PD-1 humanized monoclonal antibody injection, for the treatment of various solid tumors [1] - Fuhong Hanlin plans to conduct the Phase I clinical trial in the United States once conditions are met [1] Group 2: Product Details and Market Potential - HLX18 is a biosimilar to Nivolumab, intended for indications including melanoma, non-small cell lung cancer, malignant pleural mesothelioma, renal cell carcinoma, classical Hodgkin lymphoma, head and neck squamous cell carcinoma, urothelial carcinoma, gastric cancer, gastroesophageal junction cancer, esophageal adenocarcinoma, esophageal cancer, colorectal cancer, and hepatocellular carcinoma [1] - As of November 2025, the cumulative R&D investment for HLX18 is approximately RMB 52.53 million (unaudited) [1] - According to IQVIA MIDAS data, global sales of Nivolumab are projected to be around USD 11.1 billion in 2024 [1]

Core Viewpoint - Fosun Pharma's subsidiary, Shanghai Fuhong Hanlin Biotechnology Co., Ltd., has received FDA approval to conduct Phase I clinical trials for HLX18, a biosimilar to Nivolumab, targeting various solid tumors [1] Group 1: FDA Approval and Clinical Trials - The FDA has approved the initiation of Phase I clinical trials for HLX18, a recombinant anti-PD-1 humanized monoclonal antibody injection, for the treatment of multiple solid tumors [1] - Fuhong Hanlin plans to conduct the Phase I clinical trial in the United States once conditions are met [1] Group 2: Product Development and Market Potential - HLX18 is developed by the group and is intended for use in indications where the original drug has been approved, including melanoma, non-small cell lung cancer, and several other cancers [1] - As of November 2025, the group's cumulative R&D investment in HLX18 is approximately RMB 52.53 million (unaudited) [1] - According to IQVIA MIDAS data, global sales of Nivolumab are projected to be around USD 11.1 billion in 2024 [1]

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，概不對因本公告全部或任何部份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。 上 海 復 星 醫 藥（ 集 團 ）股 份 有 限 公 司 Shanghai Fosun Pharmaceutical (Group) Co., Ltd.* （於中華人民共和國註冊成立的股份有限公司） （股份代號：02196） 海外監管公告 本公告乃根據香港聯合交易所有限公司證券上市規則第13.10B條而作出。 茲載列上海復星醫藥（集團）股份有限公司（「本公司」）在上海證券交易所網站刊登的《關於 控股子公司藥品獲美國FDA臨床試驗批准的公告》，僅供參閱。 承董事會命 上海復星醫藥（集團）股份有限公司 董事長 陳玉卿 中國，上海 2025 年1 2 月1 9 日 於本公告日期，本公司之執行董事為陳玉卿先生、關曉暉女士、文德鏞先生、王可心先生及劉毅先生； 本公 司之非執行董事為陳啟宇先生及潘東輝先生； 本公司之獨立非執行董事為余梓山先生、王全弟先生、Chen Penghui先生及楊玉成先生；以及本公司職工董 ...

Core Viewpoint - Fosun Pharma's subsidiary, Shanghai Fuhong Hanlin Biotechnology Co., Ltd., has received FDA approval to conduct Phase I clinical trials for HLX18, a recombinant anti-PD-1 humanized monoclonal antibody injection for various solid tumors [1] Group 1 - HLX18 is a biosimilar to the original drug Nivolumab, targeting multiple indications including melanoma, non-small cell lung cancer, malignant pleural mesothelioma, renal cell carcinoma, classical Hodgkin lymphoma, head and neck squamous cell carcinoma, urothelial carcinoma, gastric cancer, gastroesophageal junction cancer, esophageal adenocarcinoma, esophageal cancer, colorectal cancer, and hepatocellular carcinoma [1]

Core Viewpoint - Fosun Pharma's subsidiary, Shanghai Fuhong Hanlin Biotechnology Co., Ltd., has received FDA approval to conduct Phase I clinical trials for HLX18, a monoclonal antibody for treating various solid tumors [1] Group 1: FDA Approval - The FDA has approved the initiation of Phase I clinical trials for HLX18, a recombinant anti-PD-1 humanized monoclonal antibody [1] - The trials will be conducted in the United States once conditions are met [1] Group 2: Drug Indications - HLX18 is a biosimilar to the original drug Nivolumab and is intended for use in multiple indications including melanoma, non-small cell lung cancer, malignant pleural mesothelioma, renal cell carcinoma, classical Hodgkin lymphoma, head and neck squamous cell carcinoma, urothelial carcinoma, gastric cancer, gastroesophageal junction cancer, esophageal adenocarcinoma, esophageal cancer, colorectal cancer, and hepatocellular carcinoma [1]

证券代码：600196 股票简称：复星医药 编号：临 2025-201 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述 或者重大遗漏，并对其内容的真实性、准确性和完整性承担法律责任。 一、概况 近日，上海复星医药（集团）股份有限公司（以下简称"本公司"）控股子公 司上海复宏汉霖生物技术股份有限公司及其控股子公司（以下合称"复宏汉霖"） 获美国 FDA（即美国食品药品监督管理局）批准开展 HLX18（即重组抗 PD-1 人源化 单克隆抗体注射液）用于治疗多种实体瘤的 I 期临床试验。复宏汉霖拟于条件具备 后于美国开展该药品的 I 期临床试验。 二、HLX18 的基本信息及研究情况 根据 IQVIA MIDAS™最新数据 1，2024 年，纳武利尤单抗于全球范围的销售额约 为 111 亿美元。 HLX18 是本集团（即本公司及控股子公司/单位）自主研发的纳武利尤单抗生物 类似药，拟用于黑色素瘤、非小细胞肺癌、恶性胸膜间皮瘤、肾细胞癌、经典型霍 奇金淋巴瘤、头颈部鳞状细胞癌、尿路上皮癌、胃癌、胃食管连接部癌或食管腺癌、 食管癌、结直肠癌、肝细胞癌等原研药已获批的适应症。 1 由 IQVIA 提供 ...

Core Viewpoint - Fosun Pharma has entered into a strategic collaboration with Clavis Bio to jointly develop innovative therapies based on cutting-edge targets nominated by Clavis Bio [1] Group 1: Collaboration Details - The collaboration will last for a period of five years, during which up to four targets will be selected and advanced for preclinical development each year [1] - Clavis Bio holds exclusive licensing options for global development, production, and commercialization outside of mainland China and Hong Kong, while Fosun Pharma retains exclusive rights within these regions [1] Group 2: Financial Implications - If Clavis Bio exercises its option for a specific collaboration project, Fosun Pharma could receive up to $362.5 million in payments, which includes non-refundable option fees, development milestone payments, and sales milestone payments [1] - Additionally, Fosun Pharma will receive a percentage-based royalty on net sales of the products involved in the collaboration within the licensed territories [1]

Group 1: Eli Lilly - Eli Lilly has submitted a new oral weight loss drug, orforglipron, for FDA approval, indicating a competitive edge in the weight loss medication market [1] - Participants switching from Novo Nordisk's Wegovy to orforglipron maintained most of their weight loss, with an average rebound of only 0.9 kg [1] Group 2: Fosun Pharma - Fosun Pharma's subsidiary has signed a collaboration agreement with Clavis Bio, which could yield up to $363 million in payments [2] - Clavis Bio will have exclusive global rights (excluding mainland China, Hong Kong, and Macau) for development, production, and commercialization of the selected targets [2] - Fosun Pharma will also gain a minority stake in a new project company established by Clavis Bio for this collaboration [2] Group 3: Baidu - Baidu has announced plans to issue H-shares and list on the Hong Kong Stock Exchange to enhance its global strategy and competitiveness [3] - The issuance and listing are subject to shareholder approval and regulatory approvals, with specific details yet to be finalized [3] Group 4: BeiGene - BeiGene has appointed Dr. Wang Lai as the new President and Global Head of R&D, reflecting the company's commitment to innovation in drug development [4] - Dr. Wang has been with BeiGene since 2011 and has progressively taken on more responsibilities in R&D leadership [4] Group 5: Junshi Biosciences - Junshi Biosciences announced that major shareholder Shanghai Tanying plans to reduce its stake by up to 2%, equating to approximately 2,053,380 shares [5] - The reduction is scheduled between January 13, 2026, and April 10, 2026, despite the shareholder's long-term confidence in the company's prospects [5]

Core Viewpoint - Fosun Pharma has signed a collaboration and option agreement with Clavis Bio to jointly select targets and advance preclinical development of selected compounds, with potential payments of up to $363 million for each project [1][2]. Group 1: Collaboration Details - The agreement allows Fosun Pharma to collaborate with Clavis Bio on selected targets, with Clavis Bio holding exclusive global rights for development, production, and commercialization outside of mainland China, Hong Kong, and Macau [1]. - Fosun Pharma can receive up to $363 million in payments for each selected project, which includes non-refundable option fees, development milestone payments, and sales milestone payments [1]. - Additionally, Fosun Pharma will receive a minority equity stake in a new company established by Clavis Bio's parent fund, Aditum Bio Fund3, at no cost [1]. Group 2: Company Background - Clavis Bio was established in March 2025 and is a wholly-owned subsidiary of Aditum Bio, which focuses on venture capital in the biotechnology sector [2]. - Aditum Bio was co-founded in 2019 by former Novartis CEO Joe Jimenez and former director of the Novartis Biomedical Research Institute Mark Fishman, aiming to accelerate drug development for unmet clinical needs [2]. Group 3: Strategic Implications - The collaboration is intended to leverage the research strengths of both parties, enriching Fosun Pharma's high-value product pipeline and potentially accelerating global clinical development and commercialization of related pipelines [2]. - Fosun Pharma is also pursuing acquisitions to enhance its drug pipeline, as evidenced by its recent announcement to acquire a controlling stake in Green Valley Pharmaceutical for 1.412 billion yuan to obtain its core drug, which treats mild to moderate Alzheimer's disease [3].

New IPOs - The largest biotech IPO in Hong Kong for 2025 is initiated by Insilico Medicine (03696), which boasts the fastest global progress in AI drug development [1] - Lin Qingxuan (02657) will conduct its IPO from December 18 to December 23, attracting cornerstone investors like Fidelity [1] - Woan Robotics (06600) is set to launch its IPO during the same period, with an expected listing date of December 30 [1] - Meilian Holdings (02671) and Wuyi Vision (06651) will also hold their IPOs from December 18 to December 23, both expected to list on December 30 [1] - Xun Ce (03317) will follow the same IPO schedule, with a listing anticipated on December 30 [1] - Zhihui Mining (02546) achieved a remarkable 5248.15 times subscription in its public offering, with a listing date of December 19 [1] - China National Airlines (00753) plans to invest in Shenzhen Airlines' equity financing, with Kunhang Investment, a state-owned entity, being shortlisted [1] - Sensetime-W (00020) intends to place 1.75 billion new Class B shares, aiming to raise approximately HKD 3.146 billion [1] - Fosun Pharma (02196) is enhancing its overseas innovative drug strategy by signing a cooperation and option agreement with Clavis Bio [1] - WuXi AppTec (02359) invested around EUR 30 million to acquire a 3.22% stake in a French biopharmaceutical fund [1] - Minhua Holdings (01999) plans to acquire 100% equity in the American soft furniture company Gainline Recline Intermediate Corp [1] Share Buybacks - Tencent Holdings (00700) repurchased 1.055 million shares for HKD 636 million on December 18 [2] - Xiaomi Group-W (01810) spent HKD 151 million to buy back 3.75 million shares on the same day [2] - COSCO Shipping Holdings (01919) repurchased 5.9 million shares for HKD 80.557 million [2] - Country Garden Services (06098) bought back 2.7 million shares for HKD 17.136 million [2] - Jiangsu Ninghu Expressway (00177) saw an increase of 52.862 million shares by Yunsong Capital [2]