Core Viewpoint - A controversial Alzheimer's drug, known as "971," has regained the possibility of being sold after a recent acquisition by Fosun Pharma, which plans to invest approximately 1.412 billion yuan to acquire 51% of Green Valley Pharmaceutical [1][2]. Group 1: Acquisition and Financial Implications - Fosun Pharma's acquisition of Green Valley Pharmaceutical marks the first purchase under the leadership of newly appointed Chairman Chen Yuqing [2]. - The market reacted negatively to the acquisition, with Fosun Pharma's A-shares dropping by 4.22% and Hong Kong shares by 5.81% on December 16 [2]. - The acquisition is expected to have a minimal impact on Fosun Pharma's financial statements in the coming years, as Green Valley will focus on clinical trials post-acquisition [10]. Group 2: Drug Development and Clinical Trials - Fosun Pharma aims to complete post-marketing confirmatory clinical trials for 971, with an optimistic timeline for approval in the first half of 2029 and potential inclusion in medical insurance by 2030 [2][3]. - The estimated cost for domestic Phase III clinical trials is around 685 million yuan, with plans for international multi-center trials if suitable conditions arise [3]. - The target patient population for 971 is approximately 3.56 million, with a projected market penetration rate of 22% [4]. Group 3: Controversies and Efficacy Concerns - The drug's efficacy has been heavily criticized, with notable academic figures questioning its mechanism and clinical trial data [6][7]. - Despite the controversies, there is a significant demand for the drug, with prices reportedly reaching 1,600 to 2,400 yuan, significantly higher than its previous insurance-covered price [8]. - Clinical data from over 800 patients reportedly shows that 971 performs better than a placebo, and there is a growing body of real-world evidence supporting its effectiveness [7]. Group 4: Company Background and Future Prospects - Green Valley Pharmaceutical, founded by Lü Songtao, has faced scrutiny in the past, including allegations of fraudulent claims regarding its products [9][10]. - The company reported revenues of 572 million yuan in 2024, but faced significant losses in the first nine months of 2025 due to the suspension of 971 [10]. - Following the acquisition, Green Valley will operate as a subsidiary of Fosun Pharma, with a focus on completing necessary clinical trials to regain market approval [10].

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 the treatment of various solid tumors [1] Group 1: FDA Approval and Clinical Trials - The FDA has approved HLX18 for clinical trials, which is a biosimilar to Nivolumab [1] - The Phase I clinical trial will target 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., received FDA approval to conduct Phase I clinical trials for HLX18, a biosimilar to Nivolumab, targeting various solid tumors [1] Group 1: FDA Approval - The FDA has approved HLX18 for clinical trials, marking a significant milestone for the company [1] - HLX18 is a recombinant humanized monoclonal antibody injection targeting PD-1 [1] Group 2: Indications - HLX18 is intended for the treatment of multiple solid tumors, including melanoma, non-small cell lung cancer, malignant pleural mesothelioma, renal cell carcinoma, classic 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 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]

HLX18是集团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。 智通财经APP讯，复星医药(600196.SH)发布公告，近日，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。 ...

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 ...

Market Performance - The chemical pharmaceutical sector increased by 1.95% on December 19, with XinNuoWei leading the gains [1] - The Shanghai Composite Index closed at 3890.45, up 0.36%, while the Shenzhen Component Index closed at 13140.22, up 0.66% [1] Top Gainers in Chemical Pharmaceutical Sector - XinNuoWei (300765) closed at 34.69, up 11.44%, with a trading volume of 311,700 shares and a transaction value of 1.069 billion [1] - KangYi Pharmaceutical (300086) closed at 11.02, up 11.43%, with a trading volume of 965,500 shares and a transaction value of 1.018 billion [1] - MuNanHai Pharmaceutical (000566) closed at 7.24, up 10.03%, with a trading volume of 1,325,900 shares and a transaction value of 914 million [1] Market Capital Flow - The chemical pharmaceutical sector saw a net inflow of 68.1822 million from institutional investors, while retail investors contributed a net inflow of 31.3 million [2] - The sector experienced a net outflow of 381 million from speculative funds [2] Individual Stock Capital Flow - ST Renfu (600079) had a net inflow of 92.7508 million from institutional investors, while it faced a net outflow of 26.4283 million from speculative funds [3] - GuangShengTang (300436) recorded a net inflow of 49.2520 million from institutional investors, with a net outflow of 17.4322 million from speculative funds [3] - KangZhi Pharmaceutical (300086) had a net inflow of 28.1873 million from institutional investors, while it faced a net outflow of 3.1280 million from retail investors [3]