Core Viewpoint - Heng Rui Medicine has received approval from the National Medical Products Administration for clinical trials of SHR-1894 injection, a self-developed biological product aimed at treating atopic dermatitis [1] Group 1: Product Development - SHR-1894 injection is expected to protect the skin barrier and suppress inflammation during the treatment of atopic dermatitis [1] - Currently, there are no similar drugs approved for market use domestically or internationally [1] - The total research and development investment for the SHR-1894 injection project has reached approximately 40.1 million yuan (unaudited) [1]

Core Viewpoint - Heng Rui Medicine (01276.HK) announced that its subsidiary, Suzhou Shengdiya Biopharmaceutical Co., Ltd., has received approval from the National Medical Products Administration (NMPA) to conduct clinical trials for SHR-1894 injection, a self-developed therapeutic biological product for atopic dermatitis treatment [1] Group 1 - SHR-1894 injection is expected to protect skin barriers and suppress inflammation during atopic dermatitis treatment [1] - As of now, there are no similar drugs approved for market release domestically or internationally [1] - The total research and development investment for SHR-1894 injection has reached approximately 40.1 million yuan (unaudited) [1]

Core Viewpoint - The company has received approval from the National Medical Products Administration for clinical trials of SHR-1894 injection, a self-developed biological product aimed at treating atopic dermatitis [1] Group 1: Product Development - SHR-1894 injection is expected to protect the skin barrier and suppress inflammation during the treatment of atopic dermatitis [1] - There are currently no similar drugs approved for market in both domestic and international markets [1] - The total research and development investment for SHR-1894 injection has reached approximately 40.1 million yuan (unaudited) [1]

Core Viewpoint - Heng Rui Medicine (01276.HK) announced that its subsidiary, Suzhou Shengdiya Biopharmaceutical Co., Ltd., has received approval from the National Medical Products Administration (NMPA) to conduct clinical trials for SHR-1894 injection, a self-developed biological product aimed at treating atopic dermatitis [1] Group 1: Clinical Trial Approval - The NMPA issued a clinical trial approval notice for SHR-1894 injection, allowing the company to commence clinical trials shortly [1] - The approval was based on the review conducted under the Drug Administration Law of the People's Republic of China, confirming that SHR-1894 injection meets the requirements for drug registration [1] Group 2: Product Development - SHR-1894 injection is expected to protect the skin barrier and suppress inflammation during the treatment of atopic dermatitis [1] - Currently, there are no similar drugs approved for market release domestically or internationally [1] - The total research and development investment for the SHR-1894 injection project has reached approximately 40.1 million yuan (unaudited) [1]

Group 1 - The core point of the article is that Heng Rui Medicine has received acceptance for its HR091506 tablet's market approval application from the National Medical Products Administration of China [1] - The application is based on two key Phase III clinical studies, HR091506-301 and HR091506-302, which evaluated the efficacy and safety of HR091506 in patients with gout and hyperuricemia [1] - The HR091506-301 study involved 442 participants across 73 centers, while the HR091506-302 study included 765 participants across 71 centers, both showing significant efficacy over the control group [1] Group 2 - HR091506 is a self-developed oral sustained-release tablet utilizing gastric retention technology, featuring both rapid and delayed release components [2] - The rapid-release part quickly achieves effective blood drug concentration, while the delayed-release part maintains the concentration over a longer period [2] - The total R&D investment for the HR091506 project has reached approximately 127 million yuan (unaudited) [2]

Core Viewpoint - Heng Rui Medicine (01276.HK) has received the acceptance notice from the National Medical Products Administration for the listing application of HR091506 tablets, indicating progress in its drug development pipeline [1] Group 1: Clinical Research - The listing application is based on two key Phase III clinical studies (HR091506-301 and HR091506-302) that are randomized, double-blind, and have a positive control with febuxostat [1] - The HR091506-301 study evaluated the efficacy and safety of HR091506 tablets in patients with gout and hyperuricemia requiring deep uric acid control, involving 442 subjects across 73 centers, led by Professors Zou Hejian and Xue Yu from Huashan Hospital, Fudan University [1] - The HR091506-302 study assessed the efficacy and safety of HR091506 tablets in patients with gout and hyperuricemia, enrolling 765 subjects across 71 centers, with Professor Zhang Zhuoli from Peking University First Hospital as the principal investigator [1] Group 2: Study Results - Results from both studies showed that HR091506 tablets significantly outperformed the control group on primary endpoints [1] - The long-term safety and tolerability of HR091506 tablets in patients with gout and hyperuricemia were found to be good [1]

Core Viewpoint - Heng Rui Medicine has received acceptance for the listing application of HR091506 tablets from the National Medical Products Administration, indicating progress in the drug's approval process [1] Group 1: Clinical Research - The listing application is based on two key Phase III clinical studies (HR091506-301 and HR091506-302) that are randomized, double-blind, and have a positive control with febuxostat [1] - The HR091506-301 study evaluated the efficacy and safety of HR091506 tablets in gout patients with high uric acid levels, involving 442 participants across 73 centers [1] - The HR091506-302 study also assessed the efficacy and safety of HR091506 tablets in gout patients, with 765 participants across 71 centers [1] - Both studies showed that HR091506 tablets significantly outperformed the control group on primary endpoints and demonstrated good long-term safety and tolerability in patients [1] Group 2: Product Development - HR091506 tablets are developed using gastric retention formulation technology, featuring a pulse release characteristic with both immediate and delayed release components [2] - The immediate release part quickly achieves effective blood drug concentration, while the delayed release part maintains the concentration over an extended period [2] - The total R&D investment for HR091506 tablets has reached approximately 127 million yuan (unaudited) [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。 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 2026年2月5日 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 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"）子公司苏州盛迪亚 生物医药有限公司收到国家药品监督 ...

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。 证券代码：600276 证券简称：恒瑞医药 公告编号：临 2026-021 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。 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 2026年2月5日 於本公告日期，董事會成 ...

Core Viewpoint - Heng Rui Medicine has received acceptance notification from the National Medical Products Administration for its HR091506 tablet, aimed at long-term treatment of hyperuricemia in gout patients [1] Group 1: Product Development - HR091506 is a self-developed oral sustained-release tablet utilizing gastric retention technology, featuring pulse release characteristics [1] - The product consists of a rapid-release part and a delayed-release part, designed to quickly achieve effective blood drug concentration and maintain it over an extended period [1] - The cumulative R&D investment for HR091506 has reached approximately 126.7 million yuan (unaudited) [1]