恒瑞医药临床试验批准公告要点解读核心事项 公司及子公司获得6个药物临床试验批准通知书，将于近期开展临床试验。 药品明细 2. 阿得贝利单抗注射液 风险提示及免责条款 市场有风险，投资需谨慎。本文不构成个人投资建议，也未考虑到个别用户特殊的投资目标、财务状况 或需要。用户应考虑本文中的任何意见、观点或结论是否符合其特定状况。据此投资，责任自负。 1. SHR-4375注射液 自主研发治疗用生物制品，特异性结合肿瘤细胞表面抗原 拟用于晚期恶性实体瘤，开展Ⅰb/Ⅱ期临床研究 累计研发投入4,488万元 抗PD-L1单抗，已于2023年2月获批上市 本次为新适应症临床试验 累计研发投入96,898万元 3. 贝伐珠单抗注射液 抗VEGF单抗，已于2021年6月获批上市 本次为新适应症临床试验 累计研发投入36,473万元 引进的抗CTLA-4单抗 累计研发投入26,218万元 5. HRS-4642注射液 自主研发KRAS G12D抑制剂脂质体剂型，国内外尚无同类药物获批 累计研发投入19,065万元 自主研发双靶点人源化抗体皮下注射剂 累计研发投入7,231万元 4. SHR-8068注射液 6. 注射用SHR-9 ...

北京商报讯（记者 王寅浩 宋雨盈）12月29日，恒瑞医药发布公告称，公司及子公司上海恒瑞医药有限 公司、上海盛迪医药有限公司、苏州盛迪亚生物医药有限公司收到国家药品监督管理局核准签发关于 SHR-4375注射液、阿得贝利单抗注射液、SHR-8068注射液、贝伐珠单抗注射液、HRS-4642注射液、注 射用SHR-9839（sc）的《药物临床试验批准通知书》，将于近期开展临床试验。具体为一项SHR-4375 注射液联合抗肿瘤治疗在晚期实体肿瘤患者中的安全性、耐受性及有效性的多中心、开放Ⅰb/Ⅱ期临床 研究。 ...

智通财经APP讯，恒瑞医药(600276.SH)公告，近日，公司及子公司上海恒瑞医药有限公司、上海盛迪 医药有限公司、苏州盛迪亚生物医药有限公司收到国家药品监督管理局("国家药监局")核准签发关于 SHR-4375注射液、阿得贝利单抗注射液、SHR-8068注射液、贝伐珠单抗注射液、HRS-4642注射液、注 射用SHR-9839(sc)的《药物临床试验批准通知书》，将于近期开展临床试验。 具体为：一项SHR-4375注射液联合抗肿瘤治疗在晚期实体肿瘤患者中的安全性、耐受性及有效性的多 中心、开放的Ⅰb/Ⅱ期临床研究。 ...

审批结论：根据《中华人民共和国药品管理法》及有关规定，经审查，2025年9月28日受理的SHR-4375 注射液、阿得贝利单抗注射液、SHR-8068注射液、贝伐珠单抗注射液、HRS-4642注射液、注射用SHR- 9839(sc)符合药品注册的有关要求，同意开展临床试验。具体为：一项SHR-4375注射液联合抗肿瘤治疗 在晚期实体肿瘤患者中的安全性、耐受性及有效性的多中心、开放的Ⅰb/Ⅱ期临床研究。 格隆汇12月29日丨恒瑞医药(01276.HK)公告，近日，江苏恒瑞医药股份有限公司及子公司上海恒瑞医药 有限公司、上海盛迪医药有限公司、苏州盛迪亚生物医药有限公司收到国家药品监督管理局核准签发关 于SHR-4375注射液、阿得贝利单抗注射液、SHR-8068注射液、贝伐珠单抗注射液、HRS-4642注射液、 注射用SHR-9839(sc)的《药物临床试验批准通知书》，将于近期开展临床试验。 ...

人民财讯12月29日电，恒瑞医药(600276)12月29日公告，近日，子公司上海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HRS-6257片的《药物临床试验批准通知书》，将于近期开展临床试验。 该药品拟用于治疗急慢性疼痛。经查询，目前国内尚无同靶点药物获批上市。同日公告，公司及子公司 上海恒瑞医药有限公司、上海盛迪医药有限公司、苏州盛迪亚生物医药有限公司收到国家药品监督管理 局核准签发关于SHR-4375注射液、阿得贝利单抗注射液、SHR-8068注射液、贝伐珠单抗注射液、HRS- 4642注射液、注射用SHR-9839（sc）的《药物临床试验批准通知书》，将于近期开展临床试验。 转自：证券时报 ...

恒瑞医药12月29日公告，公司及子公司上海恒瑞医药有限公司、上海盛迪医药有限公司、苏州盛迪亚生 物医药有限公司收到国家药品监督管理局核准签发的关于SHR-4375注射液、阿得贝利单抗注射液、 SHR-8068注射液、贝伐珠单抗注射液、HRS-4642注射液、注射用SHR-9839（sc）的《药物临床试验批 准通知书》，将于近期开展临床试验。 ...

恒瑞医药公告，公司及子公司上海恒瑞医药有限公司、上海盛迪医药有限公司、苏州盛迪亚生物医药有 限公司收到国家药品监督管理局核准签发关于SHR-4375注射液、阿得贝利单抗注射液、SHR-8068注射 液、贝伐珠单抗注射液、HRS-4642注射液、注射用SHR-9839（sc）的《药物临床试验批准通知书》， 将于近期开展临床试验。 ...

Group 1: Market Insights - Morgan Stanley is optimistic about the Chinese stock market, raising the A-share rating to "overweight" due to multiple positive incremental drivers expected next year, such as broader applications of artificial intelligence and consumer stimulus measures [1] - The National Development and Reform Commission warns against the risk of oversaturation in the humanoid robot market, noting that the industry is growing at over 50% annually and is projected to reach a market size of 100 billion yuan by 2030 [2] - The State Administration for Market Regulation is enhancing anti-monopoly enforcement and promoting fair competition to create a market environment that stimulates the vitality of various business entities [3] Group 2: Company News - Moore Threads reported that online investors abandoned the subscription of 29,302 shares, which were fully underwritten by the sponsor, with a total subscription amount of 334.86 thousand yuan [3][4] - Dongxin Co. announced a strategic cooperation framework agreement with a leading domestic cloud computing service provider, focusing on areas such as domestic cloud desktop systems and digital twin solutions [4] - Huayang Group is indirectly supplying optical communication module components to NVIDIA through international clients [4] - Guofeng New Materials plans to acquire 46.26 million shares of Jinzhan Technology, with the Shenzhen Stock Exchange agreeing to resume the review of this transaction [4] - Hunan Gold's subsidiary obtained a mining license for tungsten, magnetite, and silver, with an annual production capacity of 990,000 tons [5] - Jereh Group signed a sales contract for generator sets for North American data centers, exceeding 100 million USD, marking a significant breakthrough in the high-end power market [7] - Saiwei Electronics experienced abnormal stock trading, with the National Integrated Circuit Fund reducing its holdings by 14.26 million shares, dropping below 5% ownership [8] - Fulei New Materials has completed multiple iterations of its self-developed "electronic skin" product and achieved bulk supply, transitioning from a material supplier to a smart sensing solution provider [9] - Tianpu Co. announced a suspension of trading due to significant stock price fluctuations, with a cumulative increase of 452% since August 22 [10] - FAW Jiefang plans to increase capital in its joint venture with CATL and Telda, totaling 412 million yuan, to enhance competitiveness in the new energy commercial vehicle sector [11] - Heng Rui Medicine received clinical trial approval for five drugs, including the anti-PD-L1 monoclonal antibody, with significant research and development investments [12]

Policy Developments - The State Council, led by Li Qiang, held a meeting to advance the provincial coordination of basic medical insurance [2] Medical Device Approvals - Yuhanglong received two medical device registration certificates for diagnostic kits related to primary biliary cholangitis and idiopathic membranous nephropathy, enhancing its product line in liver and kidney disease diagnostics [4] - Hengrui Medicine announced the approval of clinical trial notifications for five drugs, including the humanized anti-PD-L1 monoclonal antibody Abedilizumab, with total R&D investments amounting to approximately 1.1 billion yuan [5] Capital Market Activities - Mindray Medical's chairman, Li Xiting, plans to increase his stake in the company by 200 million yuan, having already purchased shares worth approximately 30 million yuan [7] - Huayu Pharmaceutical intends to establish a private equity fund focused on the biomedical sector, with an initial commitment of 150 million yuan from the company [8][9] Industry Milestones - The first brain-computer interface surgery in China was successfully completed, utilizing a device from Wuhan Zhonghua Brain-Machine Fusion Technology Co., with the procedure priced according to government regulations [11] Clinical Trials and Collaborations - Buchang Pharmaceutical's subsidiary signed a contract for clinical trials of a new product, with a total cost of approximately 60 million yuan, aimed at enhancing the company's drug development capabilities [12] - Jincheng Pharmaceutical terminated negotiations with Giskit Pharma B.V. regarding exclusive commercialization rights, with no financial impact expected [14]

Industry News - The Chinese stock market is expected to have a higher probability of significant gains next year compared to risks of sharp declines, driven by multiple positive factors such as broader applications of artificial intelligence and consumer stimulus measures, leading to an upgrade of A-share rating to "overweight" [8] - The National Development and Reform Commission (NDRC) has expressed concerns about the potential "bubble" in the humanoid robot industry, emphasizing the need to prevent a surge of similar products entering the market and promoting healthy development of embodied intelligence [9] - A research report indicates that in the past year, China accounted for 17% of global AI open-source model downloads, surpassing the 15.8% share of companies like Google and Meta from the United States, marking China's first lead in this field [9] - The first brain-computer interface surgery in China, executed according to government-approved medical service pricing, was successfully completed, utilizing an implantable device developed by Wuhan Zhonghua Brain-Machine Fusion Technology Co., Ltd. [9] - Chongqing has announced measures to promote high-quality development of the low-altitude economy, with subsidies targeting various sectors including general aviation and drone manufacturing, effective until December 31, 2027 [10] - The Qinghai Hainan Clean Energy Transmission Base project, the largest power supply project in China with the highest proportion of renewable energy, has officially commenced construction, expected to generate an average annual power output of 36 billion kilowatt-hours [10] Company News - East Core Co., Ltd. has signed a strategic cooperation framework agreement with a leading domestic cloud computing service provider [11] - More Thread announced that the number of shares abandoned by online investors was 29,302, all of which will be underwritten by the sponsor [11] - Changan Technology announced a potential change in control due to stock issuance to Hefei Guotou, leading to a suspension of trading [11] - YTO Express reported that its third-largest shareholder, Hangzhou Haoyue, transferred 39.925 million shares through block trading from November 10 to November 27 [11]