格隆汇11月24日丨恒瑞医药(01276.HK)公告，近日，江苏恒瑞医药股份有限公司收到国家药品监督管理 局下发的《受理通知书》，公司提交的硫酸艾玛昔替尼片药品上市许可申请获国家药监局受理。现将相 关情况公告如下： 一、药品的基本情况 药品名称：硫酸艾玛昔替尼片 剂型：片剂 受理号：CXHS2500141 申报阶段：上市 申请人：江苏恒瑞医药股份有限公司 拟定适应症(或功能主治)：本品适用于对非甾体抗炎药(NSAID)应答不佳或不耐受且存在客观炎症征象 (表现为 C 反应蛋白[CRP]升高和/或磁共振成像[MRI]异常)的活动性放射学阴性中轴型脊柱关节炎成人 患者。 ...

Core Viewpoint - Heng Rui Medicine has received approval from the National Medical Products Administration for the launch of Paricalcitol soft capsules, marking a significant milestone as the first domestic generic drug for this product [1] Group 1: Product Approval - The approval allows Heng Rui Medicine's subsidiary, Chengdu Shengdi Pharmaceutical Co., Ltd., to market Paricalcitol soft capsules in China [1] - Paricalcitol is a synthetic vitamin D analog that helps manage secondary hyperparathyroidism (SHPT) in chronic kidney disease (CKD) patients [1] Group 2: Market Context - SHPT is a common and serious complication in CKD patients, appearing early when the glomerular filtration rate is below 80 mL/[min·1.73m2] and worsening with declining kidney function [1] - The product was originally developed by AbbVie and received FDA approval in May 2005, but had not been launched in the domestic market until now [1] Group 3: Investment and Development - The total research and development investment for the Paricalcitol soft capsule project has reached approximately 57.94 million yuan [1] - The approval signifies that the product has passed the consistency evaluation of quality and efficacy for generic drugs in China [1]

Core Viewpoint - Heng Rui Medicine has received approval from the National Medical Products Administration for the launch of its drug, Paricalcitol Soft Capsules, which is aimed at treating secondary hyperparathyroidism in adults with chronic kidney disease stages 3-4 [1] Group 1: Drug Information - Drug Name: Paricalcitol Soft Capsules [1] - Dosage Form: Capsule [1] - Specifications: 1μg, 2μg [1] - Registration Classification: Class 3 Chemical Drug [1] - Prescription Status: Prescription Drug [1] - Approved Indication: Prevention and treatment of secondary hyperparathyroidism (SHPT) in adults with chronic kidney disease (CKD) stages 3-4 [1] Group 2: Clinical Significance - SHPT is a common and serious complication in CKD patients, which can occur early in CKD (glomerular filtration rate <80 mL/[min·1.73m²]) and worsens with declining kidney function [1] - Paricalcitol is a synthetic vitamin D analog that inhibits the secretion of parathyroid hormone (PTH) by binding to vitamin D receptors, thereby reducing serum PTH levels [1] Group 3: Development and Investment - The drug was developed by AbbVie and received FDA approval in May 2005, but has not been launched in China until now [1] - The company is the first generic drug manufacturer for this product in China, and the approval is considered equivalent to passing the consistency evaluation of generic drug quality and efficacy [1] - Cumulative R&D investment for the Paricalcitol Soft Capsules project is approximately 57.94 million yuan [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11月24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。 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 ...

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。 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 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） 证券代码：600276 证券简称：恒瑞医药 公告编号：临 2025-186 江苏恒瑞医药股份有限公司 关于获得药品注册批准的公告 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"）子公司成都盛迪医 药有限公 ...

Core Insights - The article highlights the top and bottom AH premium rates for various stocks, indicating significant discrepancies between H-shares and A-shares [1][2][3] Group 1: Top AH Premium Rates - Northeast Electric (00042) leads with a premium rate of 847.37%, followed by Sinopec Oilfield Service (01033) at 270.27% and Hongye Futures (03678) at 269.94% [1][2] - Zhejiang Shibao (01057) and Fudan Zhangjiang (01349) also show high premium rates of 263.16% and 250.00% respectively [2] Group 2: Bottom AH Premium Rates - The lowest premium rates are observed in CATL (03750) at -4.68%, China Merchants Bank (03968) at -1.05%, and Heng Rui Medicine (01276) at 4.32% [1][2] - Other companies like WuXi AppTec (02359) and Midea Group (00300) also show modest premium rates of 5.49% and 5.97% respectively [2] Group 3: Top AH Deviation Values - Guanghe Tong (00638) has the highest deviation value at 32.28%, followed by Beijing Jingcheng Machinery Electric (00187) at 21.40% and Fudan Zhangjiang (01349) at 17.42% [1][3] - Nanjing Panda Electronics (00553) also shows a significant deviation value of 17.34% [3] Group 4: Bottom AH Deviation Values - The lowest deviation values are recorded for Zhongwei New Materials (02579) at -23.92%, Longpan Technology (02465) at -15.25%, and Anhui Wanshan Expressway (00995) at -12.36% [1][3] - Other companies like Ganfeng Lithium (01772) and China Life (02628) also show negative deviation values of -11.85% and -9.94% respectively [3]

Group 1 - Hong Kong's Hang Seng Index rose by 1.42%, gaining 358 points to close at 25,578 points, while the Hang Seng Tech Index increased by 1.65% [1] - Alibaba-W (09988) surged over 4%, with its Qianwen App surpassing 10 million downloads in its first week of public testing [1] - Sinopharm (01801) rose over 3%, with plans to officially go blue starting December 8 [1] - Hengrui Medicine (01276) increased by over 5%, as nine drugs including SHR-9839 received approval for clinical trials [1] - Beijing Automotive (01958) gained over 3%, planning to sell 51% of its stake in Beiqi International for approximately 1.608 billion yuan to accelerate its international strategy [1] - WeRide (00800) jumped over 6%, having obtained Switzerland's first pure driverless license, with Q3 earnings report upcoming [1] - Rusal (00486) saw an intraday increase of over 4%, announcing plans to cease operations at the Krymni silicon plant by 2026 [1] - GAC Group (02238) surged over 12%, with its all-solid-state battery pilot production line officially completed and put into production [1] - Sino Biopharmaceutical-B (02591) rose over 20%, being included in the Hang Seng Composite Index effective December 8 [1] - 3SBio (01530) increased by over 4%, planning to spin off its subsidiary Mandi International for independent listing [1] Group 2 - Oil stocks continued to decline, with CNOOC (00883) dropping by 2.4% amid easing tensions in the Russia-Ukraine situation [2] - Semiconductor stocks faced significant declines, with Hua Hong Semiconductor (01347) falling over 9% and SMIC (00981) down over 5%, as reports indicated the Trump administration is considering approving exports of Nvidia's H200 AI chips to China [2] - Ganfeng Lithium (01772) dropped over 7%, facing potential downward risks in lithium spot prices, leading Goldman Sachs to downgrade the company to a "sell" rating [2]

Group 1 - The core viewpoint of the article highlights a significant rally in Hong Kong's innovative drug concept stocks on November 24, with notable gains among several companies [1] Group 2 - Three-Sixty Pharmaceutical (01530.HK) experienced an increase of over 6% [1] - Hengrui Medicine (01276.HK) saw a rise of more than 5% [1] - Innovent Biologics (01801.HK) and Hansoh Pharmaceutical (03692.HK) both rose by over 3% [1]

Core Viewpoint - Heng Rui Pharmaceutical (01276.HK) has seen a stock price increase of over 5%, currently trading at 69.3 HKD with a transaction volume of 141 million HKD [1] Group 1 - The stock price of Heng Rui Pharmaceutical rose by 5.08% [1] - The current trading price is 69.3 HKD [1] - The total transaction volume reached 1.41 billion HKD [1]

Core Viewpoint - Heng Rui Medicine (01276) experienced a stock price increase of over 5%, reaching HKD 69.3 with a trading volume of HKD 141 million following the announcement of new clinical trial approvals by the National Medical Products Administration [1] Group 1: Company Developments - On November 21, Heng Rui Medicine announced that it, along with its subsidiaries, received approval for clinical trials for multiple injectable drugs including SHR-9839(sc), SHR-A2009, SHR-1826, HRS-4642, and others [1] - The approved drugs include monoclonal antibodies and various formulations, indicating a broadening of the company's clinical pipeline [1]