政策动向 和黄医药宣布小分子联合疗法在中国获批 近日，和黄医药宣布，沃瑞沙（ORPATHYS，赛沃替尼/ savolitinib）和泰瑞沙（TAGRISSO，奥希替尼/ osimertinib）的联合疗法的新药上市申请获中国国家药品监督管理局（NMPA）批准，用于治疗表皮生 长因子受体（EGFR）基因突变阳性经EGFR酪氨酸激酶抑制剂（TKI）治疗后进展的伴MET扩增的局部 晚期或转移性非鳞状非小细胞肺癌患者。 资本市场 两部门发文支持创新药高质量发展 7月1日，国家医保局召开新闻发布会介绍《支持创新药高质量发展的若干措施》。其中，从加大创新药 研发支持力度、支持创新药进入基本医保药品目录和商业健康保险创新药品目录、支持创新药临床应 用、提高创新药多元支付能力、强化保障措施等5个方面提出16条具体措施，全链条支持创新药发展。 国家医保局价采中心副主任王小宁表示，中国的创新药产业已经由引进模仿转向了创新输出，为世界提 供了守卫生命健康的中国方案。2024年，中国药企完成了超过90笔海外授权的交易，总金额超过了500 亿美元。未来，国家医保局将支持更多有条件的地区发挥区位优势，搭建创新药交易平台，加强国际推 广。 ...

Core Insights - AstraZeneca announced the approval of the combination therapy of Savolitinib (brand name: Worishe) and Osimertinib (brand name: Taris) by the National Medical Products Administration of China for treating locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) patients with EGFR gene mutations and MET amplification after progression on EGFR tyrosine kinase inhibitors (TKIs) [1][2] Group 1 - Savolitinib is the first selective MET inhibitor approved in China, developed in collaboration with Hutchison China MediTech, and is indicated for adult patients with locally advanced or metastatic NSCLC with MET exon 14 alterations [1] - Osimertinib is an irreversible third-generation EGFR-TKI with confirmed clinical activity in treating NSCLC patients, including those with central nervous system metastases [1][2] Group 2 - The approval is based on the SACHI Phase III clinical trial data, which achieved the predefined primary endpoint of progression-free survival (PFS) in a pre-specified interim analysis [2] - The combination therapy was included in the breakthrough therapy designation by the National Medical Products Administration in 2024 and received priority review for its new drug application in 2025 [2] - The approval marks the third indication for Savolitinib in China, highlighting its significance in addressing complex challenges in lung cancer treatment [2]

Core Viewpoint - The approval of the combination therapy of Savolitinib (ORPATHYS®) and Osimertinib (TAGRISSO®) by the National Medical Products Administration of China represents a significant advancement in the treatment of advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) with EGFR mutations and MET amplification after prior EGFR TKI therapy [1][2]. Company Summary - Hutchison China MediTech Limited (和黄医药) announced the approval of its combination therapy, which is a milestone in addressing the challenges faced by NSCLC patients in China [2]. - The approval will trigger a milestone payment of $11 million from AstraZeneca, which is responsible for the sales of both drugs in China [1]. - The CEO of Hutchison China MediTech emphasized the importance of collaboration with AstraZeneca in achieving this significant progress in treating MET-driven resistance in NSCLC patients [2]. Industry Summary - The combination therapy provides a new oral treatment option for NSCLC patients who develop MET amplification after treatment with EGFR inhibitors, addressing a critical resistance mechanism [2]. - The approval marks the third indication for Savolitinib in China, highlighting the ongoing development and expansion of treatment options for lung cancer patients [2].

扫描二维码 立即订阅 彭博生物制药双周报 本期主题： 中国生物技术行业2025年中展望 本文来自彭博终端，终端用户可运行NSN SXX5B8DWLU68 阅读原文。非终端用户可点击文末 "阅读原文" 预约演示。 全球市场版图日新月异，彭博行业研究（Bloomberg Intelligence）为您的企业战略助力。在 制药与生物技术领域，无论是全球行业资讯与热点，还是制药管线里程碑及催化剂事件、财务 预测…… BI涵盖广泛且深度的关键信息，旨在为您的决策提供可靠且具有竞争力的洞见支撑。 中国生物技术行业下半年三大焦点 随着香港IPO市场回暖以及生物技术公司收益前景更加明朗，市场情绪得到改善，中国生物 技术行业有望延续复苏态势。预计新药密集获批且关键管线数据即将发布，加之市场高度关 注PD- 1 /VEGF通路以及美国临床肿瘤学会(ASCO)会议公布积极数据，这将为更多并购活动 铺平道路。 需要关注的因素 | HK IPO Market Welcomes Biotech | M&A activities Surge on PD-1/VEGF, ASCO | Uncertainties On Tariffs Wei ...

Policy Developments - The State Administration for Market Regulation announced ten typical cases of illegal advertising, with multiple cases involving the medical field, including one case related to medical device advertising and two cases concerning illegal drug advertising [2] - As of the end of April, a total of 11,459 illegal advertising cases were investigated, resulting in fines totaling 88.309 million yuan [2] Drug and Device Approvals - Shuyou Shen announced that its subsidiary received a notice from the National Medical Products Administration regarding the conditional listing application for "STSP-0601," a drug aimed at promoting rapid hemostasis for adult patients with hemophilia A or B [4] - Lepu Medical received registration approval from the NMPA for its self-developed polylactic acid facial filler, known as "童颜针," marking a significant milestone in the dermatology field [5] Capital Market Activities - Baiyang Pharmaceutical announced the release of 5.3 million shares from pledge by its controlling shareholder, representing 1.44% of the shares held by the shareholder and 1.01% of the company's total share capital [7] - Jincheng Pharmaceutical provided a guarantee of 5 million yuan for its wholly-owned subsidiary, Shandong Jincheng Biological Pharmaceutical Co., Ltd. [8] Industry Developments - AstraZeneca announced significant progress in the treatment of EGFR mutation-positive non-small cell lung cancer with MET amplification, with interim results from the SACHI Phase III study to be presented at the ASCO annual meeting [10][11] - Yuheng Pharmaceutical signed a market promotion service agreement with Eisai (China) Pharmaceutical for "Mikobao," which will enhance Yuheng's product pipeline and increase revenue [12] - New Scene Intelligence authorized BeiGene to develop universal cell therapy drugs based on a specific TCR molecule, with potential milestone payments and revenue sharing [13] - Buchang Pharmaceutical withdrew its clinical trial application for a rabies vaccine, indicating the need for further research before resubmission [14] Public Opinion Alerts - Huaxi Biological responded to recent controversies regarding recombinant collagen, emphasizing the importance of product quality over naming conventions [16] - Kangning Jerey announced a share transfer agreement involving 14.6 million shares, amounting to 117 million HKD [17]