Core Viewpoint - Heng Rui Medicine (01276.HK) has received approval from the National Medical Products Administration for the clinical trial of HRS-8364 tablets, which will commence shortly [1] Group 1 - The company has announced the approval of a clinical trial for HRS-8364 tablets [1] - The clinical trial is expected to start in the near future [1]

Group 1 - The core point of the article is that Heng Rui Pharmaceutical (01276.HK) has seen its stock price increase by over 5%, specifically by 5.61%, reaching a price of 74.3 HKD [1] - The trading volume for Heng Rui Pharmaceutical is reported at 126 million HKD [1]

Core Viewpoint - Heng Rui Medicine (01276) experienced a stock price increase of over 5%, currently up 5.61% at HKD 74.3, with a trading volume of HKD 126 million [1] Group 1: Clinical Trial Approvals - On November 25, Heng Rui Medicine announced the approval from the National Medical Products Administration for two drug clinical trial notifications [1] - The HRS-8364 tablet will soon commence clinical trials for advanced solid tumors, with no similar drugs approved for market domestically or internationally [1] - Cumulative R&D investment for the HRS-8364 project is approximately RMB 21.65 million [1] Group 2: Additional Drug Development - The injectable Rukang Trastuzumab will also begin clinical trials for patients with HER2-positive solid tumors [1] - Cumulative R&D investment for the injectable Rukang Trastuzumab project is around RMB 1.41 billion [1]

Core Insights - Heng Rui Medicine's subsidiary, Suzhou Shengdiya Biopharmaceutical Co., Ltd., has received approval from the National Medical Products Administration for the clinical trial of injection-based Rukang Qutuzumab [1] - The drug is set to be launched in China in May 2025, targeting adult patients 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 treatment [1] Group 1 - Rukang Qutuzumab works by binding to HER2-expressing tumor cells, leading to internalization and release of toxins in the tumor cell lysosome, which induces cell cycle arrest and triggers tumor cell apoptosis [2] - The released toxins exhibit high membrane permeability and can exert bystander killing effects, enhancing anti-tumor efficacy [2] - Similar products already on the market include Roche's Ado-trastuzumab emtansine and AstraZeneca's Fam-trastuzumab deruxtecan, both of which have been launched in China [2] Group 2 - The global sales of similar products are projected to reach approximately $6.557 billion from 2024 onwards [2] - The cumulative R&D investment for Rukang Qutuzumab has reached approximately 141.475 million yuan [2]

Core Viewpoint - Heng Rui Medicine has received approval from the National Medical Products Administration for clinical trials of HRS-8364 tablets, an innovative anti-tumor drug developed by the company, aimed at treating advanced solid tumors [1] Group 1: Product Development - HRS-8364 tablets are a self-developed innovative anti-tumor drug [1] - The drug is intended for the treatment of advanced solid tumors [1] - Currently, there are no similar drugs approved for sale in both domestic and international markets [1] Group 2: Financial Investment - The total research and development investment for the HRS-8364 project has reached approximately 21.65 million yuan [1]

Core Viewpoint - Heng Rui Medicine has received approval from the National Medical Products Administration for the clinical trial of HRS-8364 tablets, which will be conducted for advanced solid tumors [1] Group 1: Drug Information - Drug Name: HRS-8364 tablets [1] - Dosage Form: Tablet [1] - Application Type: Clinical trial [1] - Acceptance Numbers: CXHL2500944, CXHL2500945 [1] - Approval Conclusion: The clinical trial application for HRS-8364 tablets, accepted on September 2, 2025, meets the requirements for drug registration and is approved for clinical trials in advanced solid tumors [1]

Core Viewpoint - The announcement highlights that Jiangsu Hengrui Medicine Co., Ltd.'s subsidiary, Suzhou Merrimack Biopharmaceutical Co., Ltd., has received approval from the National Medical Products Administration for clinical trials of injection-based Rukang Trastuzumab, which is set to be launched in China by May 2025 for treating specific lung cancer patients [1][2]. Group 1 - The injection-based Rukang Trastuzumab is indicated for adult patients 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 [1]. - The mechanism of action involves binding to HER2-expressing tumor cells, leading to internalization and release of toxins within the tumor cells' lysosomes, inducing cell cycle arrest and apoptosis [1]. - The released toxins exhibit high membrane permeability, enhancing the anti-tumor efficacy through a bystander killing effect [1]. Group 2 - Competing products in the market include Roche's Ado-trastuzumab emtansine and AstraZeneca's collaboration with Daiichi Sankyo on Fam-trastuzumab deruxtecan, both of which are already available in China [1]. - Other similar products include Rongchang Biopharmaceutical's Vedisizumab, approved in 2021, and Kelun's Botuzumab, expected to be approved in 2025 [2]. - The global sales of similar products are projected to reach approximately $6.557 billion from 2024 onwards, with the cumulative R&D investment for Rukang Trastuzumab amounting to about 141.475 million yuan [2].

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11月25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。 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 ...

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。 江苏恒瑞医药股份有限公司 关于获得药物临床试验批准通知书的公告 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。 近日，江苏恒瑞医药股份有限公司（以下简称"公司"）收到国家药品监督 管理局（以下简称"国家药监局"）核准签发关于 HRS-8364 片的《药物临床试 验批准通知书》，将于近期开展临床试验。现将相关情况公告如下： 中國上海 2025年11月25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 ...

Core Insights - The article highlights the top and bottom AH share premium rates, with Northeast Electric (00042) leading at 831.03% and Ningde Times (03750) at -4.55% [1][2][3] Premium Rate Rankings - The top three AH share premium rates are: - Northeast Electric (00042): 831.03% - Hongye Futures (03678): 270.00% - Sinopec Oilfield Service (01033): 268.92% [1][2] - The bottom three AH share premium rates are: - Ningde Times (03750): -4.55% - China Merchants Bank (03968): -1.71% - Heng Rui Medicine (01276): 3.65% [1][3] Deviation Value Rankings - The top three stocks with the highest deviation values are: - China Shipbuilding Defense (00317): 53.01% - Guanghetong (00638): 25.36% - GAC Group (02238): 22.12% [1][4] - The bottom three stocks with the lowest deviation values are: - Longpan Technology (02465): -31.76% - Northeast Electric (00042): -23.74% - Ganfeng Lithium (01772): -14.15% [1][5]