Core Viewpoint - Heng Rui Medicine announced the approval of clinical trials for SHR-3045 injection, a self-developed biological product aimed at treating rheumatoid arthritis by inhibiting immune cell function and reducing inflammation [1] Group 1 - The company received the clinical trial approval notice from the National Medical Products Administration for SHR-3045 injection [1] - SHR-3045 is expected to improve clinical symptoms in the treatment of rheumatoid arthritis [1] - The clinical trials are set to commence in the near future [1]

格隆汇9月18日｜渤海证券研报指出，恒瑞医药为我国制药龙头企业，坚持科技创新和国际化双轮驱 动，拥有110多款商业化药物，包括23款新分子实体创新药和4款其他创新药。公司股权结构稳定，员工 持股计划激发创新活力，在研管线不断丰富，技术平台多维度广泛开拓，研发投入继续加大，2024年营 收净利创新高。公司2025-2027年预计获批上市创新药及适应症约47项，涵盖肿瘤、自免、减重等多个 领域。公司BD进程不断加快，与MNC加强合作，历次BD合作中首付款和里程碑金额稳步提升，2025 年已实现与默沙东、默克、GSK多家MNC的BD合作，同时再次采用NewCo模式实现对外授权。公司从 前期follow-on到单个创新药获批上市到如今多种类创新药全面储备，以平台化保障公司长期创新药商业 化进程，促进营收放量。首次覆盖给予"买入"评级。 ...

Core Viewpoint - Heng Rui Medicine (01276) announced that its subsidiary, Guangdong Heng Rui Medicine Co., Ltd., has received approval from the National Medical Products Administration for the clinical trial of SHR-1139 injection, which is expected to begin soon [1] Group 1: Product Development - SHR-1139 injection is a self-developed biological product aimed at treating ulcerative colitis, expected to enhance treatment by inhibiting inflammatory responses and maintaining epithelial barriers [1] - Currently, there are no similar drugs approved for marketing domestically or internationally [1] Group 2: Financial Investment - The cumulative research and development investment for the SHR-1139 injection project has reached approximately 71.28 million yuan [1]

北京商报讯(记者王寅浩实习记者宋雨盈)9月18日，恒瑞医药（600276）发布公告称，公司子公司上海 恒瑞医药有限公司的注射用SHR—1501被国家药品监督管理局药品审评中心纳入拟突破性治疗品种公示 名单，公示期7日。 公告显示，SHR—1501为恒瑞医药自主研发并具有知识产权的白细胞介素—15(IL—15)融合蛋白，可以 刺激体内T细胞、B细胞和NK细胞增殖，发挥调动机体免疫系统清除体内异物(如肿瘤)的作用，其与 BCG联用可明显增强膀胱内的免疫反应，达到协同抗肿瘤的效果。 ...

Core Viewpoint - Heng Rui Medicine's subsidiary Shanghai Heng Rui Medicine Co., Ltd. has announced that its injectable SHR-1501 has been included in the list of proposed breakthrough therapeutic varieties by the National Medical Products Administration's Drug Review Center, with a public announcement period of 7 days [1] Group 1: Product Information - SHR-1501 is a self-developed interleukin-15 (IL-15) fusion protein with intellectual property rights, designed to stimulate the proliferation of T cells, B cells, and NK cells in the body [1] - The product enhances the immune response in the bladder when used in conjunction with BCG, achieving a synergistic anti-tumor effect [1] - Unlike IL-2, IL-15 does not stimulate the proliferation of regulatory T cells or induce T cell apoptosis [1] Group 2: Market Context - The foreign counterpart of SHR-1501, Nogapendekin Alfa Inbakicept (marketed as Anktiva), has already been approved for sale in the United States [1] - Currently, there are no approved products targeting the same pathway in the domestic market [1] Group 3: Financial Investment - The cumulative research and development investment for injectable SHR-1501 has reached approximately 102.18 million yuan [1]

Core Viewpoint - Heng Rui Medicine's subsidiary, Shanghai Heng Rui Medicine Co., Ltd., has announced that its injectable SHR-1501 has been included in the list of proposed breakthrough therapeutic varieties by the National Medical Products Administration's Drug Review Center, with a public announcement period of 7 days [1] Group 1 - SHR-1501 is a proprietary interleukin-15 (IL-15) fusion protein developed by the company [1] - The drug stimulates the proliferation of T cells, B cells, and NK cells in the body, enhancing the immune system's ability to eliminate foreign substances such as tumors [1] - When used in conjunction with BCG, SHR-1501 significantly enhances the immune response within the bladder, achieving a synergistic anti-tumor effect [1]

Core Viewpoint - Heng Rui Medicine has received approval from the National Medical Products Administration for clinical trials of SHR-3045 injection, a self-developed biological product aimed at treating rheumatoid arthritis [1] Company Summary - The SHR-3045 injection is designed to suppress immune cell function, reduce inflammation, and improve clinical symptoms in rheumatoid arthritis treatment [1] - The total research and development investment for the SHR-3045 injection project has reached approximately 35.54 million yuan [1] Industry Summary - Currently, there are no similar drugs approved for market use domestically or internationally [1]

Core Viewpoint - Heng Rui Medicine (01276.HK) has received approval from the National Medical Products Administration for clinical trials of SHR-1139 injection, a self-developed biological product aimed at treating ulcerative colitis through mechanisms that inhibit inflammation and maintain epithelial barrier [1] Group 1 - The approval notification for SHR-1139 injection was issued to Guangdong Heng Rui Medicine Co., Ltd., a subsidiary of the company [1] - The clinical trials for SHR-1139 injection are expected to commence shortly [1] - SHR-1139 injection is designed to enhance treatment efficacy in ulcerative colitis by targeting inflammation and epithelial barrier maintenance [1]

Core Viewpoint - Heng Rui Medicine has received approval from the National Medical Products Administration for clinical trials of SHR-3045 injection, a self-developed biological product aimed at treating rheumatoid arthritis [1] Group 1: Product Development - SHR-3045 injection is designed to inhibit immune cell function, reduce inflammation, and improve clinical symptoms in rheumatoid arthritis treatment [1] - The company has invested approximately 35.54 million yuan in the research and development of SHR-3045 injection to date [1] Group 2: Market Position - Currently, there are no similar drugs approved for market in both domestic and international markets [1]

SHR-1139 注射液是公司自主研发的一种治疗用生物制品，预期可在溃疡性结肠炎治疗过程中,通过抑制 炎症反应和维持上皮屏障等机制协同增效。经查询，目前国内外尚无同类药物获批上市。截至目前， SHR-1139 注射液相关项目累计研发投入约 7,128 万元。 智通财经APP讯，恒瑞医药(01276)公布，近日，公司子公司广东恒瑞医药有限公司收到国家药品监督管 理局核准签发关于 SHR-1139 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。 ...