Market Performance - The Hang Seng Index (HSI) rose by 469 points or 1.8%, closing at 26,908 points, reaching a four-year high of 26,936 points during the day[1] - The Hang Seng Tech Index increased by 256 points or 4.2%, closing at 6,334 points[1] - The total market turnover for the day was HKD 360.284 billion[1] Economic Indicators - The People's Bank of China conducted a reverse repurchase operation of CNY 418.5 billion at a steady rate of 1.4%, resulting in a net injection of CNY 114.5 billion for the day[1] - The RMB/USD midpoint was adjusted up by 14 points to 7.1013[1] U.S. Federal Reserve Actions - The Federal Reserve announced its first rate cut since December, lowering the benchmark overnight rate by 25 basis points to a range of 4% to 4.25%[2] - The Dow Jones Industrial Average rose by 260 points or 0.6% to close at 46,018 points following the rate cut[2] - The S&P 500 index fell by 6 points or 0.1%, while the Nasdaq dropped by 72 points or 0.3%[2] Trade Statistics - In July, Hong Kong's overall export volume increased by 12.6% and import volume rose by 14.3% compared to July of the previous year[3] - The overall export prices and import prices in July increased by 1.7% and 2% respectively compared to the same month last year[3]

Core Viewpoint - Heng Rui Medicine (01276) saw a significant stock price increase of over 7%, reaching a new high of 91 HKD, following the acceptance of its drug application by the National Medical Products Administration [1] Group 1: Company Developments - Heng Rui Medicine's subsidiary received an acceptance notice for the marketing license application of SHR-A1811, a drug for treating HER2-positive breast cancer patients [1] - The drug has been included in the priority review process, indicating its potential significance in the market [1] Group 2: Financial Performance - In the first half of 2025, Heng Rui Medicine achieved a net profit attributable to shareholders of 4.45 billion CNY, representing a year-on-year growth of 29.67% [1] - The net profit for the second quarter of 2025 was reported at 2.58 billion CNY, with a year-on-year increase of 24.88% [1] Group 3: Future Outlook - The company is expected to see rapid growth in its innovative drugs, with international contributions to profits continuing to rise [1] - Since the beginning of 2025, the company has secured 700 million USD in upfront licensing fees, indicating strong overseas revenue growth [1] - With a rich pipeline of products, the company is projected to maintain high-speed growth in innovative drugs over the next three years [1]

Group 1 - Chery Automobile (09973) plans to globally offer 297 million shares from September 17 to September 22 [1] - Heng Rui Medicine (01276) has its HRS-5635 injection included in the list of proposed breakthrough treatment varieties [1] - Dongfeng Group (00489) intends to establish a joint venture to develop and sell smart vehicles [1] Group 2 - First Journey Holdings (00697) has Beijing Shouda Xingye Fund investing in Micro Differentiation Technology [1] - Brilliant Tomorrow (01351) has a change in controlling interest, receiving a discount of approximately 41.18% for the full acquisition offer, and will resume trading on September 18 [1] - Tencent Holdings (00700) plans to issue 9 billion yuan in notes [1] Group 3 - New China Life Insurance (01336) reported a cumulative original insurance premium income of 158.086 billion yuan for the first eight months, representing a year-on-year increase of 21% [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, 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) ...

Jiangsu Hengrui Pharmaceuticals Co., Ltd. 江蘇恒瑞醫藥股份有限公司 （於中華人民共和國註冊成立的股份有限公司） （股份代號：1276） 海外監管公告 本公告乃根據香港聯合交易所有限公司證券上市規則第13.10B條刊發。 根據中華人民共和國的有關法例規定，江蘇恒瑞醫藥股份有限公司（「本公司」）在 上海證券交易所網站( www.sse.com.cn )刊發了以下公告。茲載列如下，僅供參閱。 香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責，對其準確性 或完整性亦不發表任何聲明，並明確表示概不就因本公告全部或任何部分內容所產生或因依賴 該等內容而引致的任何損失承擔任何責任。 证券代码：600276 证券简称：恒瑞医药 公告编号：临2025-146 江苏恒瑞医药股份有限公司 关于药物纳入拟突破性治疗品种公示名单的公告 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。 承董事會命 江蘇恒瑞醫藥股份有限公司 董事長 孫飄揚先生 中國上海 2025年9月17日 於本公告日期，董事 ...

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 of SHR-A1811, a drug for treating HER2-positive breast cancer in patients previously treated with one or more anti-HER2 therapies, which has been included in the priority review process [1] Group 1 - The drug SHR-A1811 is intended for adult patients with locally advanced or metastatic HER2-positive breast cancer [1] - The acceptance of the new indication application indicates potential growth opportunities for the company in the oncology market [1] - The inclusion in the priority review process may expedite the approval timeline, enhancing the company's competitive position [1]

香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責，對其準確性 或完整性亦不發表任何聲明，並明確表示概不就因本公告全部或任何部分內容所產生或因依賴 該等內容而引致的任何損失承擔任何責任。 Jiangsu Hengrui Pharmaceuticals Co., Ltd. 江蘇恒瑞醫藥股份有限公司 （於中華人民共和國註冊成立的股份有限公司） （股份代號：1276） 海外監管公告 本公告乃根據香港聯合交易所有限公司證券上市規則第13.10B條刊發。 根據中華人民共和國的有關法例規定，江蘇恒瑞醫藥股份有限公司（「本公司」）在 上海證券交易所網站( www.sse.com.cn )刊發了以下公告。茲載列如下，僅供參閱。 承董事會命 江蘇恒瑞醫藥股份有限公司 董事長 孫飄揚先生 中國上海 2025年9月17日 於本公告日期，董事會成員包括(i)執行董事孫飄揚先生、戴洪斌先生、馮佶女 士、張連山先生、江寧軍先生及孫杰平先生；(ii)非執行董事郭叢照女士；及(iii) 獨立非執行董事董家鴻先生、曾慶生先生、孫金雲先生及周紀恩先生。 证券代码：600276 证券简称：恒瑞医药 公告编号：临 2025-14 ...