Core Viewpoint - Heng Rui Medicine announced that its subsidiary, Suzhou Shengdiya Biopharmaceutical Co., Ltd., received a "Notice of Acceptance" from the National Medical Products Administration for the marketing authorization application of SHR-A1811, an injection for treating locally advanced or metastatic HER2-positive breast cancer in adults who have previously received one or more anti-HER2 therapies. The application has been included in the priority review process [2]. Group 1 - The company has received regulatory acceptance for a new indication of SHR-A1811 [2]. - The new indication targets adult patients with locally advanced or metastatic HER2-positive breast cancer who have undergone prior anti-HER2 treatment [2]. - The application is part of a priority review process by the National Medical Products Administration [2].

Group 1: Fiscal Revenue and Budget - In the first eight months of 2025, the national general public budget revenue reached 148198 billion yuan, showing a year-on-year growth of 0.3% [1] - Tax revenue amounted to 121085 billion yuan, with a slight increase of 0.02% year-on-year, while non-tax revenue was 27113 billion yuan, growing by 1.5% [1] - Central government budget revenue was 64268 billion yuan, reflecting a year-on-year decline of 1.7%, whereas local government budget revenue was 83930 billion yuan, increasing by 1.8% [1] Group 2: Smart Connected Vehicles - The Ministry of Industry and Information Technology is soliciting public opinions on mandatory national standards for smart connected vehicle combination driving assistance systems [2] - The proposed standards aim to establish a safety baseline for smart connected vehicle products, requiring systems to activate only under designed operating conditions [2] - The standards include comprehensive safety technical requirements covering human-machine interaction, functional safety, information security, and data recording, creating a "triple safety guarantee" [2] Group 3: Service Consumption Policies - The Ministry of Commerce plans to introduce a series of specialized documents to promote high-quality development in the accommodation industry and the integration of railways and tourism [3] - Over 30 policies have already been implemented to establish a "1+N" policy system for service consumption [3] Group 4: Financial Support for Consumption - The People's Bank of China is actively supporting qualified financial institutions to issue financial bonds and credit asset-backed securities to enhance consumer credit supply capacity [4] - From January to July this year, automotive financial companies issued financial bonds totaling 215 billion yuan and credit asset-backed securities amounting to 484 billion yuan [4] Group 5: Corporate News - Shanghai Construction Group reported that its gold business revenue constitutes a low proportion of total operating income [6] - NIO received an investment of 1.16 billion USD [6] - New materials company plans to reduce its stake by no more than 2% [6] - Huazhu Group intends to invest up to 10 billion yuan in financial products [6] - Several companies, including Maimai Bio and Xinyuan Technology, are involved in significant partnerships and developments [6]

Group 1 - The core point of the article is that Heng Rui Medicine announced that its subsidiary, Fujian Shengdi Pharmaceutical Co., Ltd., has had its HRS-5635 injection included in the list of proposed breakthrough therapies by the National Medical Products Administration [2] Group 2 - The announcement was made on the evening of September 17, and the public notice period for this inclusion is set for 7 days [2]

Core Insights - The Medical Health Index (980016) closed at 7114.13 points on September 17, with a slight increase of 0.22% and a trading volume of 34.146 billion yuan, indicating a turnover rate of 1.06% [1] Group 1: Index Performance - Among the constituent stocks of the Medical Health Index, 18 stocks rose while 30 stocks fell on the same day [1] - Bai Li Tian Heng led the gains with a rise of 4.08%, while Junshi Biosciences recorded the largest decline at 2.52% [1] Group 2: Top Constituents - The top ten constituents of the Medical Health Index are as follows: - WuXi AppTec (603259) with a weight of 13.58%, latest price at 109.29 yuan, and a market cap of 322.57 billion yuan, increased by 2.09% [1] - Hengrui Medicine (600276) with a weight of 10.87%, latest price at 70.13 yuan, and a market cap of 465.47 billion yuan, increased by 1.42% [1] - Mindray Medical (300760) with a weight of 8.17%, latest price at 66.66 yuan, and a market cap of 290.25 billion yuan, decreased by 0.09% [1] - United Imaging Healthcare (688271) with a weight of 4.14%, latest price at 151.60 yuan, and a market cap of 124.94 billion yuan, decreased by 0.90% [1] - Other notable constituents include Pianzai Shou (600436), Aier Eye Hospital (300015), and Fosun Pharma (600196) [1] Group 3: Capital Flow - The Medical Health Index constituents experienced a net outflow of 601 million yuan from major funds, while retail investors saw a net inflow of 615 million yuan [1] - Detailed capital flow for major stocks indicates that WuXi AppTec had a net inflow of 4.28 million yuan from major funds, while Hengrui Medicine saw a net outflow of 3.43 million yuan [2]

公告显示，HRS—5635注射液为恒瑞医药自主研发的新一代肝靶向HBV的siRNA药物，其单药治疗慢乙 肝的Ⅱ期临床研究结果显示，HRS—5635有提高慢乙肝功能性治愈的潜力，且同时具备良好的安全性特 征。 北京商报讯(记者王寅浩实习记者宋雨盈)9月17日，恒瑞医药（600276）发布公告称，公司子公司福建 盛迪医药有限公司的HRS—5635注射液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。 ...

北京商报讯(记者王寅浩实习记者宋雨盈)9月17日，恒瑞医药（600276）发布公告称，公司子公司苏州 盛迪亚生物医药有限公司收到国家药品监督管理局下发的《受理通知书》，公司注射用瑞康曲妥珠单抗 (SHR—A1811)用于治疗既往接受过一种或一种以上抗HER2药物治疗的局部晚期或转移性HER2阳性成 人乳腺癌患者的新适应症上市许可申请获国家药监局受理，且已被纳入优先审评程序。 ...

Core Viewpoint - Heng Rui Medicine's subsidiary, Fujian Shengdi Pharmaceutical Co., Ltd., has had its HRS-5635 injection included in the list of proposed breakthrough therapies by the National Medical Products Administration's Drug Review Center, indicating potential for significant advancements in hepatitis B treatment [1] Group 1 - HRS-5635 injection is a new generation liver-targeting siRNA drug developed by the company [1] - The Phase II clinical study results show that HRS-5635 has the potential to improve functional cure rates for chronic hepatitis B [1] - The drug also demonstrates good safety characteristics alongside its therapeutic potential [1]

Core Viewpoint - Heng Rui Medicine's subsidiary, Fujian Shengdi Pharmaceutical Co., Ltd., has had its HRS-5635 injection included in the list of proposed breakthrough therapies by the National Medical Products Administration, with a public announcement period of 7 days [1] Group 1 - HRS-5635 injection is a new generation liver-targeted siRNA drug independently developed by the company [1] - The Phase II clinical study results indicate that HRS-5635 has the potential to improve functional cure rates for chronic hepatitis B, while also demonstrating good safety characteristics [1]

Core Insights - Company subsidiary Suzhou Shengdiya Biopharmaceutical Co., Ltd. received a Notice of Acceptance from the National Medical Products Administration for the new indication application of SHR-A1811 for treating locally advanced or metastatic HER2-positive breast cancer patients who have previously received one or more anti-HER2 therapies, and it has been included in the priority review process [1] Group 1 - SHR-A1811-Ⅲ-301 study is a randomized, open-label, positive drug-controlled, multi-center Phase III clinical trial designed to compare the efficacy and safety of SHR-A1811 with pyrotinib combined with capecitabine in HER2-positive breast cancer patients who have previously received one or more anti-HER2 therapies [2] - The primary endpoint is progression-free survival (PFS) assessed by a blinded independent radiology committee (BIRC) based on RECIST v1.1, with secondary endpoints including investigator-assessed PFS, overall survival (OS), objective response rate (ORR), and duration of response (DoR) [2] - In July 2025, the Independent Data Monitoring Committee (IDMC) reviewed the data and confirmed that the primary endpoint of BIRC-assessed PFS met the pre-specified superiority criteria, indicating that SHR-A1811 significantly reduces the risk of disease progression/death compared to the control group, with good safety [2] Group 2 - SHR-A1811 was approved for marketing in China in May 2025 for the treatment of adults with unresectable locally advanced or metastatic non-small cell lung cancer (NSCLC) who have HER2 (ERBB2) activating mutations and have previously received at least one systemic therapy [3]

据悉，SHR-A1811-Ⅲ-301 研究为一项随机、开放、阳性药物对照、多中心设计的Ⅲ 期临床试验，旨在 比较 SHR-A1811 与吡咯替尼联合卡培他滨在既往接受过一种或一种以上抗 HER2 药物治疗的 HER2 阳 性乳腺癌患者中的有效性和安全性。本研究由中山大学孙逸仙纪念医院宋尔卫院士、姚和瑞教授共同担 任主要研究者，全国54 家中心共同参与。主要终点为盲态独立影像评审委员会(BIRC)基于 RECIST v1.1 评估的无进展生存期(PFS)。次要终点包括研究者基于 RECIST v1.1 评估的 PFS、总生存期(OS)、客观 缓解率(ORR)、缓解持续时间(DoR)等。2025 年 7 月，独立数据监查委员会(IDMC)审查数据并确认，在 方案预设的期中分析中，主要研究终点 BIRC 评估的 PFS 达到预设的优效标准。结果表明，与对照组 相比，瑞康曲妥珠单抗可显著降低患者疾病进展/死亡风险，且安全性良好。 公司注射用瑞康曲妥珠单抗已于 2025年5月在国内获批上市，适用于治疗存在 HER2(ERBB2)激活突变 且既往接受过至少一种系统治疗的不可切除的局部晚期或转移性非小细胞肺癌(NSCLC) ...