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。 自願公告 WUHAN YZY BIOPHARMA CO., LTD. Y225「艾美賽珠單抗注射液」取得NMPA的IND批准 本 公 告 由 武 漢 友 芝 友 生 物 製 藥 股 份 有 限 公 司（「本 公 司」， 連 同 其 附 屬 公 司 ， 統 稱 「本 集團」）自 願作 出 ，以 告知 本 公司 股東 及 潛在 投 資者 有關 本 公司 的 最新 業務 發 展情況。 本公司欣然宣佈，於2025年12月23日，其生物類似藥Y225的臨床試驗（「IND」）申 請已獲中華人民共和國國家藥品監督管理局（「NMPA」）批准。 武 漢 友 芝 友 生 物 製 藥 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） （股份代號：2496） 香港聯合交易所有限公司證券上市規則第18A .05條規定的示警聲明：本公司無法 保證能 ...

Core Viewpoint - The announcement indicates that the drug Daratumumab injection developed by the company has received approval from the National Medical Products Administration of the People's Republic of China to conduct clinical trials in China [1] Group 1: Product Information - The product is a recombinant fully human IgG1 monoclonal antibody targeting ADP-ribosyl cyclase (CD38) and is a biosimilar to the original drug Darzalex [1] - It is classified under Category 3.3 for therapeutic biological products and is intended for the treatment of adult patients with multiple myeloma [1] Group 2: Research and Development - The development of the product follows the relevant research guidelines for biosimilars, and the pharmaceutical and non-clinical research results indicate that the product is highly similar to the reference drug in terms of quality, safety, and efficacy [1] - These findings support the initiation of subsequent clinical research [1]

Core Viewpoint - The announcement indicates that the subsidiary of XinNuoWei, Shiyao Group Jushi Biopharmaceutical Co., Ltd., has received approval from the National Medical Products Administration for the clinical trial of Daratumumab injection, a biosimilar to the original drug, which is intended for the treatment of adult patients with multiple myeloma [1] Group 1 - The clinical trial approval notification for Daratumumab injection has been issued, allowing the company to commence clinical trials shortly [1] - Daratumumab injection is a recombinant fully human IgG1 monoclonal antibody targeting ADP-ribosylation factor (CD38) [1] - The drug is a biosimilar to the original drug, Zhaoke®, which is used for treating multiple myeloma [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 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., 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 - The company, Fuhong Hanlin (02696), has received FDA approval for the IND application of its self-developed biosimilar HLX18, a recombinant anti-PD-1 humanized monoclonal antibody, for the treatment of various solid tumors [1] Group 1: Clinical Development - The company plans to conduct Phase 1 clinical trials in the United States once conditions are met [1] - HLX18 targets multiple potential 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] Group 2: Mechanism of Action - The PD-1 receptor expressed on T cells binds to its ligands PD-L1 and PD-L2, which can inhibit T cell proliferation and cytokine production [1] - Some tumor cells upregulate PD-1 ligands, leading to the suppression of activated T cell immune surveillance through this signaling pathway [1] - Nivolumab, a human immunoglobulin G4 (IgG4) monoclonal antibody, binds to the PD-1 receptor, blocking its interaction with PD-L1 and PD-L2, thereby inhibiting the immune suppressive response mediated by the PD-1 pathway, including anti-tumor immune responses [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） （股份代號：2696） 自願公告 HLX18是本公司自主研發的納武利尤單抗生物類似藥，潛在適應症包括黑色 素瘤、非小細胞肺癌、惡性胸膜間皮瘤、腎細胞癌、經典型霍奇金淋巴瘤、 頭頸部鱗狀細胞癌、尿路上皮癌、胃癌、胃食管連接部癌或食管腺癌、食管 癌、結直腸癌、肝細胞癌等原研藥已獲批的適應症。T細胞中表達的PD-1受 體與其配體PD-L1和PD-L2結合，可以抑制T細胞增殖和細胞因子生成。部 分腫瘤細胞的PD-1配體上調，通過這個通路信號傳導可抑制激活的T細胞對 腫瘤的免疫監視。納武利尤單抗是一種人類免疫球蛋白G4(IgG4)單克隆抗體 (HuMAb)，可與PD-1受體結合，阻斷其與PD-L1和PD-L2之間的相互作用， 阻斷PD1通路介導的免疫抑制反應，包括抗腫瘤免疫反應 ...

Core Viewpoint - The stock of CSPC Pharmaceutical Group (01093) has increased by over 4%, currently trading at HKD 8.36 with a transaction volume of HKD 579 million, following the announcement of positive results from a Phase III clinical trial for its biosimilar drug, Secukinumab Injection [1] Group 1: Clinical Trial Results - CSPC's subsidiary, CSPC Zhongqi Pharmaceutical Co., Ltd., has developed Secukinumab Injection, which has shown clinical equivalence to the reference drug in a Phase III trial for moderate to severe plaque psoriasis [1] - The key study achieved its primary endpoint and demonstrated positive topline results, indicating that the product is clinically equivalent to the reference drug with good safety profiles [1] - No new or unexpected safety signals were reported, suggesting that the product may meet long-term safety requirements for patients [1] Group 2: Product Information - Secukinumab Injection is a fully human IgG1 monoclonal antibody and is a biosimilar to Cosentyx, which has been approved in China for indications including plaque psoriasis in patients aged 6 and above, psoriatic arthritis, ankylosing spondylitis, and hidradenitis suppurativa [1] - The efficacy and safety of Cosentyx have been widely recognized, supporting the potential market acceptance of the biosimilar [1]

Core Viewpoint - The announcement highlights the successful top-line analysis data from a Phase III clinical trial of the drug Secukinumab Injection, developed by the subsidiary of the company, for the treatment of moderate to severe plaque psoriasis, indicating its clinical equivalence to an existing treatment [1][2] Group 1: Product Development - The product is a fully human IgG1 monoclonal antibody drug, serving as a biosimilar to Cosentyx, which has been approved in China for multiple indications including plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, and hidradenitis suppurativa [1] - The company follows the research guidelines for biosimilars and conducted a head-to-head equivalence study to validate the product's efficacy against Cosentyx in treating moderate to severe plaque psoriasis [2] Group 2: Clinical Trial Details - The Phase III clinical trial was a multicenter, randomized, double-blind, parallel, positive-controlled study, aimed at verifying the consistency of treatment efficacy between the product and Cosentyx [2] - The trial enrolled patients with moderate to severe plaque psoriasis, randomly assigning them in a 1:1 ratio to either the test group (the product) or the control group (Cosentyx), with the primary endpoint being the proportion of patients achieving a 75% improvement in the Psoriasis Area and Severity Index (PASI) score by week 12 [2] - The key study achieved its pre-set primary endpoint, demonstrating clinical equivalence to Cosentyx, with good safety profiles and no new or unexpected safety signals, indicating potential for long-term patient safety [2]

Core Viewpoint - The company announced that its subsidiary, Stone Pharma Biotech Co., Ltd., has achieved positive topline analysis data from a Phase III clinical trial for its drug, Secukinumab Injection, aimed at treating moderate to severe plaque psoriasis [1][2] Group 1: Product Development - Secukinumab Injection is a fully human IgG1 monoclonal antibody that specifically binds to IL-17A, a key molecule in the pathogenesis of psoriasis, thereby inhibiting inflammatory signals [1] - The product is a biosimilar to Cosentyx® (Secukinumab), which has been approved in China for multiple indications including plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, and hidradenitis suppurativa [1] Group 2: Clinical Trial Details - The clinical trial was a multicenter, randomized, double-blind, parallel, positive-controlled equivalence study designed to verify the consistency of efficacy between Secukinumab Injection and Cosentyx® in treating moderate to severe plaque psoriasis [2] - The study enrolled patients with moderate to severe plaque psoriasis, randomly assigning them in a 1:1 ratio to either the trial group (Secukinumab Injection) or the control group (Cosentyx®) [2] - The primary endpoint was the proportion of patients achieving a 75% improvement in the Psoriasis Area and Severity Index (PASI-75) score from baseline at week 12, which the study successfully met [2] Group 3: Safety and Future Plans - The study demonstrated clinical equivalence between the two products, with good safety profiles and no new or unexpected safety signals, indicating potential for long-term safety in patients [2] - Detailed data from the study will be presented at upcoming academic conferences and published in journals [2]