作为我国高发的恶性肿瘤之一，胃癌的发病率和死亡率长期位居癌症榜单前列。更令人揪心的是，超过 六成患者确诊时已处于晚期，其中约12%-13%为HER2 阳性分型。这种分型的胃癌侵袭性更强、更易复 发转移，患者在一线治疗失败后，二线治疗可选方案极少，中位生存期不足10个月，生存质量深受影 响。 日前，国家药品监督管理局正式批准一款靶向抗体偶联药物（ADC）——注射用德曲妥珠单抗的新适 应证，用于治疗既往接受过含曲妥珠单抗治疗方案的局部晚期或转移性HER2阳性成人胃或胃食管结合 部腺癌患者。这一突破填补了我国二线HER2阳性胃癌靶向治疗的空白，为众多陷入治疗困境的患者带 来延长生存的新希望。 国际多中心III期临床试验DESTINY-Gastric04数据显示，与传统治疗方案相比，该药物使患者死亡风险 降低30%，中位生存期延长至14.7个月，较传统方案提升近3个月；两年生存率实现翻倍，客观缓解率 达44.3%，其中7例患者达到完全缓解，疾病控制率更是高达91.9%。更重要的是，其安全性特征可接受 且总体可管理，未发现新的安全性问题。该研究结果已在2025 年美国临床肿瘤学会年会上以重磅口头 报告形式发布，并同步发 ...

Core Insights - The national medical insurance negotiation for 2025 has introduced a dual-directory system, marking a significant change in the negotiation process for innovative drugs and commercial insurance [1][2][15] - The negotiation process for innovative drugs has seen a price reduction range suggested by the National Medical Insurance Administration (NMIA) of 15% to 50%, with a focus on the CAR-T drugs [3][4] - The introduction of the innovative drug directory is expected to create a more sustainable market payment mechanism for new drugs, with companies needing to reassess their product positioning and market strategies [15] Summary by Sections National Medical Insurance Negotiation - The negotiation took place from October 30 to November 3, 2025, with the first three days dedicated to the national medical insurance directory and the last two days for the commercial insurance innovative drug directory [1] - This year marks the first introduction of an innovative drug directory, which has altered the negotiation dynamics for drug pricing [1][15] Price Negotiation Mechanism - The NMIA has introduced a new price negotiation mechanism for innovative drugs, allowing for price discussions between drug companies and commercial insurance [1][3] - Companies have been advised to consider a price reduction of 15% to 50% during negotiations, with some expressing skepticism about achieving reductions below 15% [3][4] CAR-T Drugs - CAR-T drugs have been a focal point in the negotiations, with successful negotiations reported for some products, such as the CAR-T drug from HeYuan Biotech priced at 999,000 yuan [3][4] - A limited number of CAR-T drugs are expected to be included in the innovative drug directory, with estimates suggesting around 20 drugs may be approved [1][3] Commercial Insurance Dynamics - The dual-directory negotiation allows companies to choose between reporting to the basic medical insurance directory, the innovative drug directory, or both, creating strategic options for different companies [2][10] - The commercial insurance market has shown limited interest in covering rare disease drugs due to their high costs and small patient populations, which may affect their inclusion in the innovative drug directory [14][15] Focus on ADC and Bispecific Antibodies - ADC (Antibody-Drug Conjugates) and bispecific antibodies remain key focus areas in the negotiations, with several innovative drugs vying for inclusion in the directories [8][10] - Companies are adopting varied strategies based on their market positioning, with some prioritizing the basic medical insurance directory for broader market access, while others focus on maintaining high-end product positioning through the innovative drug directory [10][11]

Investment Rating - The report maintains an investment rating of "Outperform the Market - A" for the biopharmaceutical sector [4]. Core Insights - The report highlights that Heng Rui Medicine has updated its innovative drug pipeline, entering a harvest period with 19 Class 1 innovative drugs approved for market, 11 in NDA stage, and 16 in Phase 3 clinical trials [2][18]. Summary by Sections Weekly New Drug Market Review - From March 31 to April 4, 2025, the top five companies in the new drug sector by stock price increase were: Hai Chuang Pharmaceutical (20.74%), Yi Ming An Ke (17.89%), Jia He Bio (15.20%), Kang Fang Bio (15.15%), and Mai Wei Bio (12.25%). The top five companies with the largest declines were: Chuang Sheng Group (-24.18%), Teng Sheng Bo Yao (-19.92%), He Bo Pharmaceutical (-17.76%), Mai Bo Pharmaceutical (-17.19%), and Ge Li Pharmaceutical (-12.75%) [1][14]. Key Analysis of the New Drug Industry - Heng Rui Medicine's 2024 annual report reveals its latest research pipeline as of March 2025, with 19 Class 1 innovative drugs approved, 11 in NDA stage, and 16 in Phase 3 clinical trials. The approved drugs include various treatments across multiple therapeutic areas [2][18][21]. New Drug Approvals and Acceptance - In the past week, 10 new drugs or new indications were approved for market, 37 new drugs received IND approval, 19 new drugs had IND applications accepted, and 5 new drugs had NDA applications accepted [22][23]. Domestic New Drug Industry Focus - Key highlights include Heng Rui Medicine's JAK1 inhibitor, Aima Xitini (SHR0302), receiving approval for a new indication for adult patients with moderate to severe active rheumatoid arthritis. Additionally, the company has initiated Phase 3 clinical trials for its GLP-1 receptor agonist, HRS-7535, aimed at weight loss [30][31].