Core Viewpoint - Heng Rui Medicine has received approval from the National Medical Products Administration for clinical trials of four injectable drugs, indicating a significant advancement in its oncology pipeline [1][2]. Group 1: Drug Approvals and Clinical Trials - The company’s subsidiaries have been granted approval for clinical trials of SHR-7787, SHR-4849, Bevacizumab, and Adebali monoclonal antibody injections [1]. - SHR-7787 is a first-class therapeutic biological product aimed at activating T cells to target and kill tumor cells, with a cumulative R&D investment of approximately 48.93 million yuan [1]. - SHR-4849 is an antibody-drug conjugate targeting DLL3, designed to treat advanced malignant solid tumors, with a cumulative R&D investment of about 69.67 million yuan [1]. Group 2: Market Context and Competitors - Bevacizumab, a humanized anti-VEGF monoclonal antibody, has a global sales forecast of approximately 5.655 billion USD for 2024, with the company’s related R&D investment totaling around 348.89 million yuan [2]. - Adebali monoclonal antibody injection, a humanized anti-PD-L1 monoclonal antibody, was approved in February 2023 for first-line treatment of extensive-stage small cell lung cancer, with a cumulative R&D investment of about 939.08 million yuan [2]. - Competing products in the market include Atezolizumab, Avelumab, and Durvalumab, which collectively have a global sales forecast of approximately 9.648 billion USD for 2024 [2].

贝伐珠单抗是一种人源化抗 VEGF 单克隆抗体，由中外制药和罗氏的子公司基因泰克合作开发，2004 年在美国获批上市，商品名为Avastin(安维汀)，目前已在中国和全球多个国家上市销售。公司的贝伐珠 单抗注射液已于2021年6月获批上市，国内目前有多个贝伐珠单抗注射液获批上市。经查询，2024 年贝 伐珠单抗全球销售额约为 56.55 亿美元。截至目前，贝伐珠单抗注射液相关项目累计研发投入约 34,889 万元 阿得贝利单抗注射液是公司自主研发的人源化抗 PD-L1 单克隆抗体，能通过特异性结合 PD-L1 分子从 而阻断导致肿瘤免疫耐受的PD-1/PD-L1 通路，重新激活免疫系统的抗肿瘤活性，从而达到治疗肿瘤的 目的。公司阿得贝利单抗注射液已于 2023 年 2 月获批上市，获批的适应症为与卡铂和依托泊苷联合用 于广泛期小细胞肺癌患者的一线治疗。国外有同类产品 Atezolizumab(商品名：Tecentriq)、Avelumab(商 品名：Bavencio)和 Durvalumab(商品名：Imfinzi)于美国获批上市销售，其中 Atezolizumab 和 Durvalumab 已在中国获批上市 ...

SHR-7787注射液为1类治疗用生物制品，通过诱导激活T细胞，使其发挥靶向杀伤肿瘤细胞的作用。目 前国内尚无同类药物获批上市。SHR-4849注射液是公司自主研发的一款以DLL3为靶点的抗体药物偶联 物，可特异性结合肿瘤细胞表面的DLL3抗原，进而被内吞至细胞内并转运至溶酶体中，水解释放游离 毒素，杀伤肿瘤细胞，拟用于治疗晚期恶性实体瘤。 智通财经APP讯，恒瑞医药(600276.SH)发布公告，近日，公司子公司苏州盛迪亚生物医药有限公司、 上海恒瑞医药有限公司、上海盛迪医药有限公司收到国家药品监督管理局(简称"国家药监局")核准签发 关于SHR-7787注射液、SHR-4849注射液、贝伐珠单抗注射液、阿得贝利单抗注射液的《药物临床试验 批准通知书》，将于近期开展临床试验。 贝伐珠单抗是一种人源化抗VEGF单克隆抗体，由中外制药和罗氏的子公司基因泰克合作开发，2004年 在美国获批上市，商品名为Avastin(安维汀)，目前已在中国和全球多个国家上市销售。阿得贝利单抗注 射液是公司自主研发的人源化抗PD-L1单克隆抗体，能通过特异性结合PD-L1分子从而阻断导致肿瘤免 疫耐受的PD-1/PD-L1通路，重 ...