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 ...

石药集团(01093)再涨超4%，截至发稿，涨4.37%，报8.36港元，成交额5.79亿港元。 消息面上，12月18日，石药集团发布公告，本公司附属公司石药集团巨石生物制药有限公司开发的司库 奇尤单抗注射液(该产品)在用于治疗中度至重度斑块状银屑病的等效性III期临床试验中获得顶线分析数 据。 该产品是本集团开发的全人源IgG1单克隆抗体药物，为司库奇尤单抗注射液(可善挺)的生物类似药。可 善挺在中国获批的适应症包括6岁及以上斑块状银屑病、银屑病关节炎、强直性脊柱炎及化脓性汗腺 炎，其疗效与安全性已获得广泛认可。 该项关键研究已达到预设主要终点，并取得积极的顶线结果。统计分析表明，该产品与可善挺具有临床 等效性，且安全性良好，未出现新的或非预期的安全性信号，有望能满足患者长期用药的安全性需求。 该研究的有关详细数据将于后续学术会议及期刊上发布。 ...

石药集团(01093)发布公告，本公司附属公司石药集团巨石生物製药有限公司开发的司库奇尤单抗注射 液(该产品)在用于治疗中度至重度斑块状银屑病的等效性III期临床试验中获得顶线分析数据。 银屑病是一种免疫相关的慢性、炎症性、系统性疾病。目前，中国约有超700万银屑病患者。全人源白 介素(IL)-17A(IL-17A)主要由活化T细胞产生，是银屑病发病机制中的关键分子。司库奇尤单抗可特异性 结合IL-17A，阻断IL-17受体的信号传导，从而抑制银屑病炎症。 该产品是本集团开发的全人源IgG1单克隆抗体药物，为司库奇尤单抗注射液(可善挺)的生物类似药。可 善挺在中国获批的适应症包括6岁及以上斑块状银屑病、银屑病关节炎、强直性脊柱炎及化脓性汗腺 炎，其疗效与安全性已获得广泛认可。 本集团遵循生物类似药的研究指导原则开展该产品的研发，并与可善挺进行了"头对头"等效性研究。该 研究是一项多中心、随机、双盲、平行、阳性对照等效性Ⅲ期临床试验，旨在验证该产品与可善挺治疗 中度至重度斑块状银屑病患者疗效的一致性。该研究的入组人群为中度至重度斑块状银屑病患者，按照 1:1比例随机分配至试验组(该产品)和对照组(可善挺)，其主 ...

该产品是本集团开发的全人源IgG1单克隆抗体药物，为司库奇尤单抗注射液(可善挺®)的生物类似药。 可善挺®在中国获批的适应症包括6岁及以上斑块状银屑病、银屑病关节炎、强直性脊柱炎及化脓性汗 腺炎，其疗效与安全性已获得广泛认可。 智通财经APP讯，石药集团(01093)发布公告，本公司附属公司石药集团巨石生物製药有限公司开发的司 库奇尤单抗注射液(该产品)在用于治疗中度至重度斑块状银屑病的等效性III期临床试验中获得顶线分析 数据。 银屑病是一种免疫相关的慢性、炎症性、系统性疾病。目前，中国约有超700万银屑病患者。全人源白 介素(IL)-17A(IL-17A)主要由活化T细胞产生，是银屑病发病机制中的关键分子。司库奇尤单抗可特异性 结合IL-17A，阻断IL-17受体的信号传导，从而抑制银屑病炎症。 本集团遵循生物类似药的研究指导原则开展该产品的研发，并与可善挺®进行了"头对头"等效性研究。 该研究是一项多中心、随机、双盲、平行、阳性对照等效性Ⅲ期临床试验，旨在验证该产品与可善挺® 治疗中度至重度斑块状银屑病患者疗效的一致性。该研究的入组人群为中度至重度斑块状银屑病患者， 按照1:1比例随机分配至试验组(该产 ...

Core Viewpoint - The company announced that its subsidiary, Stone Pharma, has achieved positive topline results in a Phase III clinical trial for its biosimilar drug, Secukinumab injection, aimed at treating moderate to severe plaque psoriasis [1][2] Group 1: Product Development and Clinical Trials - The product, Secukinumab injection, is a fully human IgG1 monoclonal antibody that specifically binds to IL-17A, a key molecule in the pathogenesis of psoriasis [1] - The Phase III clinical trial was a multicenter, randomized, double-blind, parallel, positive-controlled equivalence study designed to verify the consistency of efficacy between the product and Cosentyx in treating moderate to severe plaque psoriasis patients [2] - The primary endpoint of the study 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 2: Market Context and Patient Impact - There are over 7 million psoriasis patients in China, highlighting a significant market opportunity for effective treatments [1] - The safety profile of the product was found to be good, with no new or unexpected safety signals, indicating it may meet the long-term safety needs of patients [2] - The detailed data from the study will be published in upcoming academic conferences and journals, which may further validate the product's efficacy and safety [2]