Core Viewpoint - The company has resubmitted its Biologics License Application (BLA) for injection of Carrelizumab in combination with Apatinib for the first-line treatment of unresectable or metastatic hepatocellular carcinoma, which has been accepted by the FDA [1] Group 1 - The target review date set by the FDA for the injection of Carrelizumab is July 23, 2026, according to the Prescription Drug User Fee Act (PDUFA) [1]

FF305 翌日披露報表 (股份發行人 ── 已發行股份或庫存股份變動、股份購回及/或在場内出售庫存股份) 表格類別： 股票 狀態： 新提交 如上市發行人的已發行股份或庫存股份出現變動而須根據《香港聯合交易所有限公司（「香港聯交所」）證券上市規則》(「《主板上市規則》」)第13.25A條 / 《香港聯合交易所有限公司GEM證券 上市規則》(「《GEM上市規則》」)第17.27A條作出披露，必須填妥第一章節 。 | 第一章節 | | | | | | | | | --- | --- | --- | --- | --- | --- | --- | --- | | 1. 股份分類 | 普通股 | 股份類別 A | | | 於香港聯交所上市 | 否 | | | 證券代號 (如上市) | 600276 | 說明 | A股（於上海證券交易所上市） | | | | | | A. 已發行股份或庫存股份變動 | | | | | | | | | | | 已發行股份（不包括庫存股份）變動 | | | 庫存股份變動 | | | | 事件 | | 已發行股份（不包括庫存股份）數 目 | 佔有關事件前的現有已發 | 行股份（不包括庫存股 ...

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 药品名称：注射用卡瑞利珠单抗 剂型：注射剂 中國上海 2026年2月2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 ...

Core Viewpoint - Heng Rui Medicine has received a confirmation letter from the FDA regarding its biologics license application (BLA) for injectable carrelizumab combined with apatinib mesylate for first-line treatment of unresectable or metastatic hepatocellular carcinoma patients, with a target review date set for July 23, 2026 [1] Group 1 - The FDA has accepted the BLA for injectable carrelizumab [1] - The application is intended for use in patients with unresectable or metastatic hepatocellular carcinoma [1] - The target review date under the Prescription Drug User Fee Act (PDUFA) is July 23, 2026 [1]

Core Viewpoint - Heng Rui Medicine has received a confirmation letter from the FDA regarding the acceptance of its Biologics License Application (BLA) for injection of Carrelizumab combined with Apatinib for first-line treatment of unresectable or metastatic hepatocellular carcinoma patients [1] Group 1 - The FDA has accepted the BLA submitted by Heng Rui Medicine for Carrelizumab [1] - The target review date set by the FDA under the Prescription Drug User Fee Act (PDUFA) is July 23, 2026 [1]

恒瑞医药公告称，公司于2025年8月20日起实施股份回购计划，预计金额10亿元 - 20亿元，用于员工持 股计划或股权激励。截至2026年1月31日，累计回购股份978.84万股，占总股本0.15%，已支付总金额 64,628.87万元，回购价格区间为56.10 - 70.00元/股。2026年1月回购88.97万股，占总股本0.013%，支付 5,107.24万元。 ...

Core Viewpoint - The report highlights the premium rates of AH shares, with Northeast Electric (00042), Sinopec Oilfield Service (01033), and Zhejiang Shibao (01057) leading in premium rates, while CATL (03750), China Merchants Bank (03968), and Heng Rui Medicine (01276) are at the bottom of the list [1] Premium Rate Rankings - The top three AH shares by premium rate are: - Northeast Electric (00042) with a premium rate of 864.29% - Sinopec Oilfield Service (01033) with a premium rate of 361.80% - Zhejiang Shibao (01057) with a premium rate of 345.22% [1] - The bottom three AH shares by premium rate are: - CATL (03750) with a premium rate of -14.10% - China Merchants Bank (03968) with a premium rate of -4.16% - Heng Rui Medicine (01276) with a premium rate of 0.99% [1] Deviation Value Rankings - The top three AH shares by deviation value are: - Sinopec Oilfield Service (01033) with a deviation value of 89.71% - Northeast Electric (00042) with a deviation value of 34.53% - Zhongwei New Materials (02579) with a deviation value of 25.28% [1] - The bottom three AH shares by deviation value are: - Zhejiang Shibao (01057) with a deviation value of -53.92% - Changfei Optical Fiber (06869) with a deviation value of -35.50% - Nanhua Futures (02691) with a deviation value of -30.81% [1] Additional Insights - The report includes detailed tables showing the premium rates and deviation values for various AH shares, indicating significant disparities in market valuations between H-shares and A-shares [2]

Core Viewpoint - Jiangsu Hengrui Medicine Co., Ltd. has received acceptance from the National Medical Products Administration for the marketing authorization application of HR20013, an injectable drug for preventing nausea and vomiting caused by moderately emetogenic chemotherapy in adult patients [1][2]. Drug Basic Information - Drug Name: Injectable Phosphor-Rolapitant Palonosetron - Dosage Form: Injectable - Acceptance Number: CXHS2600019 - Application Stage: Marketing - Applicant: Fujian Shengdi Pharmaceutical Co., Ltd. - Indication: Prevention of acute and delayed nausea and vomiting induced by moderately emetogenic anticancer drugs in adult patients [1]. Clinical Trial Information - The application for the new indication is based on a Phase III clinical trial (HR20013-302) evaluating the efficacy and safety of the drug. The trial was led by Sun Yat-sen University Cancer Center and involved 96 clinical research centers across the country, enrolling 706 participants [2]. - The primary and key secondary endpoints were the proportion of patients achieving complete response during the delayed and overall phases after administration of moderately emetogenic anticancer drugs. Results showed that the trial group had significantly higher complete response rates compared to the control group, with consistent advantages in symptom control, quality of life improvement, and time to treatment failure [2]. Other Drug Information - Nausea and vomiting induced by anticancer drugs are common adverse reactions in cancer treatment, potentially leading to dehydration, electrolyte imbalance, nutritional deficiencies, and esophageal mucosal tears, significantly affecting patients' quality of life and treatment adherence [3]. - Current guidelines recommend using NK1 receptor antagonists and 5-HT3 receptor antagonists in combination for preventing nausea and vomiting from highly emetogenic chemotherapy, while a dual regimen is suggested for moderately emetogenic drugs. However, adherence to these guidelines is often suboptimal due to various clinical factors [3]. Drug Characteristics - Injectable Phosphor-Rolapitant Palonosetron is a combination formulation that activates both NK-1 and 5-HT3 receptors to inhibit the vomiting reflex. It has a long half-life and high central nervous system penetration, providing advantages in preventing delayed and ultra-delayed vomiting [4]. - The product was approved for marketing in May 2025 for preventing acute and delayed nausea and vomiting caused by highly emetogenic chemotherapy in adults. Similar products available internationally include Helsinn Healthcare's AKYNZEO [4]. Research and Development Investment - Cumulative R&D investment for Injectable Phosphor-Rolapitant Palonosetron is approximately 247 million yuan (unaudited) [5].

Core Viewpoint - Heng Rui Medicine's subsidiary, Fujian Shengdi Pharmaceutical Co., Ltd., has received the acceptance notice from the National Medical Products Administration for the drug listing application of HR20013, an injectable formulation of fosaprepitant dimeglumine, indicating progress in its regulatory approval process [1] Group 1: Drug Development and Clinical Trials - The new indication application is based on a multicenter, randomized, double-blind, positive-controlled Phase III clinical trial (HR20013-302) evaluating the efficacy and safety of HR20013 for preventing nausea and vomiting induced by moderately emetogenic anticancer drugs [1] - The study was led by Sun Yat-sen University Cancer Prevention and Treatment Center, with Professors Zhang Li and Li Yuhong as principal investigators, and involved 96 clinical research centers nationwide, enrolling a total of 706 subjects [1] - The primary and key secondary endpoints of the study were the proportion of subjects achieving complete response during the delayed phase and overall phase after administration of moderately emetogenic anticancer drugs [1] Group 2: Study Results - The results indicated that the complete response rates during the delayed phase and overall phase in the trial group were significantly superior to those in the control group [1] - The trial group demonstrated consistent advantages over the control group in multiple dimensions, including symptom control, quality of life improvement, time to treatment failure, and various subgroup characteristics [1] - Regarding safety, the trial group exhibited good safety and tolerability, with no new safety signals identified [1]

Core Viewpoint - Heng Rui Medicine's subsidiary, Fujian Shengdi Pharmaceutical Co., Ltd., has received a notice of acceptance from the National Medical Products Administration for the drug application of HR20013, an injectable formulation of fosaprepitant for a new indication [1] Group 1: Drug Application and Clinical Trials - The application for the new indication is based on a multicenter, randomized, double-blind, positive-controlled Phase III clinical trial (HR20013-302) evaluating the efficacy and safety of HR20013 in preventing nausea and vomiting induced by moderately emetogenic chemotherapy [1] - The study was led by Sun Yat-sen University Cancer Prevention Center, with Professors Zhang Li and Li Yuhong as principal investigators, and involved 96 clinical research centers nationwide, enrolling a total of 706 subjects [1] Group 2: Study Results - The primary and key secondary endpoints of the study were the proportion of subjects achieving complete response during the delayed phase and overall phase after the administration of moderately emetogenic chemotherapy [1] - Results indicated that the complete response rates in the delayed phase and overall phase for the trial group were significantly better than those of the control group, with consistent advantages in symptom control, quality of life improvement, time to treatment failure, and various subgroup analyses [1] - The trial group demonstrated good safety and tolerability, with no new safety signals identified [1]