2025 年 05 月 18 日 生物医药Ⅱ 新药周观点：脓毒症治疗迎来新突破， 远大医药 STC3141 中国 2 期成功 本周新药行情回顾： 2025 年 5 月 12 日-2025 年 5 月 16 日，新药板块涨幅前 5 企业：君 圣泰（19.78%）、德琪医药（18.34%）、嘉和生物（14.48%）、科济 药业（14.46%）、复宏汉霖（12.34%）；跌幅前 5 企业：歌礼制药（- 17.10%）、康宁杰瑞（-8.72%）、云顶新耀（-7.77%）、泽璟制药（- 7.18%）、创胜集团（-6.96%）。 本周新药行业重点分析： 脓毒症治疗存在严重未满足临床需求，近日远大医药宣布其开发的全 球创新药物 STC3141 在中国开展的用于治疗脓毒症的 II 期临床研究 成功达到临床终点，标志着脓毒症治疗迎来新的突破。 脓毒症(sepsis)是感染引起宿主反应失调,导致危及生命的器官功能 损害的症候群,是一个高病死率的临床综合征。根据 WHO 的数据，2017 年全球估计有 4890 万例脓毒症病例和 1100 万例脓毒症死亡病例。 当前脓毒症治疗主要以对症治疗为主，主要包括药物治疗（抗生素、 血管加压 ...

Investment Rating - The report maintains an investment rating of "Outperform the Market - A" [7] Core Insights - The treatment of sepsis has significant unmet clinical needs, with recent success in the Phase II clinical trial of STC3141 by Yuan Da Pharmaceutical, marking a breakthrough in sepsis treatment [2][19] - Sepsis is a high-mortality clinical syndrome caused by infection, with an estimated 48.9 million cases and 11 million deaths globally in 2017 according to WHO [2][21] - Current treatments for sepsis primarily focus on symptomatic care, with no effective therapeutic options available [23] - The market for sepsis treatment is vast due to the severe unmet clinical needs, highlighting the potential for new drug developments [2][26] Summary by Sections 1. Weekly New Drug Market Review - From May 12 to May 16, 2025, the top five companies in the new drug sector by stock price increase were Junshengtai (19.78%), Deqi Pharmaceutical (18.34%), Jiahe Biotech (14.48%), Keji Pharmaceutical (14.46%), and Fuhong Hanlin (12.34%) [1][15] - The top five companies by stock price decrease included Gilead Sciences (-17.10%), CanSino Biologics (-8.72%), Yunding New Medicine (-7.77%), Zai Lab (-7.18%), and Chuangsheng Group (-6.96%) [1][15] 2. Key Analysis of the New Drug Industry - Sepsis treatment faces serious unmet clinical needs, with Yuan Da Pharmaceutical's STC3141 achieving clinical endpoints in its Phase II trial in China [2][19] - Sepsis is characterized by a dysregulated host response to infection, leading to life-threatening organ dysfunction [20] - In China, approximately 2.93 million cases of sepsis occur annually, with around 709,315 related deaths [21] - Current therapies are mainly symptomatic, including antibiotics, vasopressors, and supportive care, with no effective treatment options available [23] - The development of new drugs for sepsis is challenging, with many innovative therapies failing in clinical trials [26] 3. New Drug Application Approvals and Acceptances - No new drug or new indication applications were approved this week, but eight new drug applications were accepted [4] 4. New Drug Clinical Application Approvals and Acceptances - This week, 40 new drug clinical applications were approved, and 30 new drug clinical applications were accepted [5] 5. Key Domestic Market Events - Notable events included the initiation of a Phase III trial by BeiGene for its BTK-targeting drug BGB-16673 and the priority review application for a new indication by Kelun-Biotech for SKB264 [11] 6. Key Overseas Market Events - AbbVie announced FDA approval for its c-Met-targeting ADC drug Telisotuzumab Vedotin, marking a significant milestone in the treatment of non-small cell lung cancer [12]