证券代码：600276 证券简称：恒瑞医药 公告编号：临 2025-145 江苏恒瑞医药股份有限公司 关于药品上市许可申请获受理并纳入优先审评程序 的提示性公告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述 或者重大遗漏，并对其内容的真实性、准确性和完整性承担法律责任。 近日，江苏恒瑞医药股份有限公司（以下简称"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（以下简称"国家药监局"）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。现将 相关情况公告如下： 一、药品的基本情况 药品名称：注射用瑞康曲妥珠单抗 剂型：注射剂 申请人：苏州盛迪亚生物医药有限公司 拟定适应症（或功能主治）：本品适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。 受理号：CXSS2500094 申报阶段：上市 二、药品的临床试验情况 SHR-A1811-Ⅲ-30 ...

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 therapeutic varieties 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-targeted siRNA drug independently 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, while also demonstrating good safety characteristics [1] - The public announcement period for the proposed breakthrough therapy is set for 7 days [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's Drug Review Center, with a public announcement period of 7 days [1] Group 1 - HRS-5635 injection is a new generation liver-targeted siRNA drug developed by the company for the treatment of chronic hepatitis B [1] - Phase II clinical trial results indicate that HRS-5635 has the potential to improve functional cure rates for chronic hepatitis B while demonstrating good safety characteristics [1] - Currently, there are no similar drugs approved for marketing domestically or internationally [1] Group 2 - The cumulative research and development investment for the HRS-5635 injection project has reached approximately 151.68 million yuan [1]

Core Viewpoint - Heng Rui Medicine's subsidiary, Suzhou Shengdiya Biopharmaceutical Co., Ltd., has received a "Notice of Acceptance" from the National Medical Products Administration for the new indication 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 [1] Company Summary - Heng Rui Medicine's subsidiary has made progress in the development of SHR-A1811, which targets a specific patient population with HER2-positive breast cancer [1] - The acceptance of the new indication application signifies a potential expansion of the company's product offerings in the oncology market [1] - The inclusion in the priority review process may expedite the approval timeline, enhancing the company's competitive position in the biopharmaceutical sector [1]

Market Overview - The Shanghai Composite Index rose by 0.37% on September 17, with 20 industries experiencing gains, led by the power equipment and automotive sectors, which increased by 2.55% and 2.05% respectively [1] - Conversely, the agriculture, forestry, animal husbandry, and fishery sectors, along with retail, saw declines of 1.02% and 0.98% respectively [1] - The pharmaceutical and biotechnology sector fell by 0.23% [1] Capital Flow Analysis - The main capital outflow from the two markets totaled 38.306 billion yuan, with five industries seeing net inflows [1] - The power equipment sector led the net inflow with 1.835 billion yuan, followed by the automotive sector with 1.142 billion yuan [1] - The non-bank financial sector experienced the largest net outflow, totaling 5.229 billion yuan, followed by the computer sector with a net outflow of 4.455 billion yuan [1] Pharmaceutical and Biotechnology Sector - The pharmaceutical and biotechnology sector saw a net outflow of 3.977 billion yuan, with 474 stocks in the sector; 135 stocks rose while 327 fell [2] - The top net inflow stocks included WuXi AppTec with 352 million yuan, followed by Hengrui Medicine and Boteng Co., with inflows of 312 million yuan and 55.426 million yuan respectively [2] - Nine stocks in the sector experienced net outflows exceeding 100 million yuan, with the largest outflows from Guangsheng Tang, Sino Medical, and Ganli Pharmaceutical, amounting to 253 million yuan, 164 million yuan, and 140 million yuan respectively [2] Top Gainers in Pharmaceutical Sector - WuXi AppTec: +2.09%, turnover rate 2.01%, net inflow 351.585 million yuan [2] - Hengrui Medicine: +1.42%, turnover rate 0.92%, net inflow 312.024 million yuan [2] - Boteng Co.: -0.93%, turnover rate 6.09%, net inflow 55.426 million yuan [2] Top Losers in Pharmaceutical Sector - Guangsheng Tang: -4.40%, turnover rate 9.74%, net outflow -252.737 million yuan [3] - Sino Medical: -1.74%, turnover rate 5.85%, net outflow -164.152 million yuan [3] - Ganli Pharmaceutical: -1.74%, turnover rate 2.88%, net outflow -139.861 million yuan [3]

Group 1 - The chemical pharmaceutical sector experienced a decline of 0.2% on September 17, with Warner Pharmaceuticals leading the drop [1] - The Shanghai Composite Index closed at 3876.34, up 0.37%, while the Shenzhen Component Index closed at 13215.46, up 1.16% [1] - Notable gainers in the chemical pharmaceutical sector included ST Tian Sheng, which rose by 4.97% to a closing price of 5.28, and Bai Li Tian Heng, which increased by 4.08% to 372.00 [1] Group 2 - Warner Pharmaceuticals saw a significant decline of 9.22%, closing at 57.92, contributing to the overall downturn in the sector [2] - Other notable decliners included Anglikang, down 4.53% to 41.28, and Guangsheng Tang, down 4.40% to 111.91 [2] - The sector experienced a net outflow of 1.541 billion yuan from major funds, while retail investors saw a net inflow of 1.516 billion yuan [2][3] Group 3 - Major fund inflows were observed in companies like Heng Rui Pharmaceutical, which had a net inflow of 3.43 million yuan, while retail investors showed a net outflow of 58.13 million yuan [3] - The top net inflows from retail investors were seen in Hai Zheng Pharmaceutical, with 34.03 million yuan, and Hua Yuan Biological, with 30.05 million yuan [3] - The overall trend indicates a shift in investment dynamics within the chemical pharmaceutical sector, with retail investors showing resilience despite major fund outflows [3]

每经AI快讯，9月17日，恒瑞医药（600276）(600276.SH)公告称，公司子公司苏州盛迪亚生物医药有限 公司收到国家药监局下发的《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。该药品已在国内获批上市，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）成人患者。 ...

Core Viewpoint - 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 therapeutic products 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 HBV 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]

恒瑞医药公告，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》， 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。 ...

Group 1: Key Insights on Macro Economy - In August, industrial added value and retail sales growth rates fell below expectations, with industrial added value growing by 5.2% year-on-year, and retail sales increasing by 3.4% year-on-year [6][8][9] - Fixed asset investment growth for January to August was only 0.5%, with private investment declining by 2.3% [7][9] - The report highlights the need for macro policies to stabilize growth, particularly in light of external uncertainties and domestic climate factors [6][9] Group 2: Real Estate Industry Analysis - In August, new home prices in 70 major cities fell by 0.3% month-on-month, while second-hand home prices decreased by 0.6% [10][11] - The sales area for residential properties in August was 57.44 million square meters, down 10.6% year-on-year, marking the lowest level since 2009 [17][18] - Real estate development investment in August was 672.9 billion yuan, a year-on-year decline of 19.5%, with new construction area down 20.3% [17][20] Group 3: Transportation Sector Insights - SF Holding reported a revenue of 146.858 billion yuan for the first half of 2025, a year-on-year increase of 9.26%, with net profit rising by 19.37% [25][26] - The company’s express logistics segment grew by 10.4%, while supply chain and international segments increased by 9.7% [27]