香港联交所最新资料显示，11月20日，GIC Private Limited增持恒瑞医药（600276）(01276)95.2万股， 每股作价68.7975港元，总金额约为6549.52万港元。增持后最新持股数目为5766.56万股，最新持股比例 为22.33%。 ...

Core Viewpoint - Heng Rui Medicine announced the approval of its subsidiary Chengdu Shengdi Pharmaceutical's paricalcitol soft capsules by the National Medical Products Administration for the treatment of secondary hyperparathyroidism in adults with chronic kidney disease stages 3-4 [1] Group 1 - The approved indication for the drug is to prevent and treat secondary hyperparathyroidism in adults with chronic kidney disease [1]

公告显示，硫酸艾玛昔替尼片已在国内获批上市四个适应症，分别为用于对一种或多种TNF抑制剂疗效 不佳或不耐受的活动性强直性脊柱炎成人患者；用于对一种或多种TNF抑制剂疗效不佳或不耐受的中重 度活动性类风湿关节炎成人患者；用于对局部外用治疗或其他系统性治疗应答不充分或不耐受的中重度 特应性皮炎成人患者；用于成人重度斑秃患者。 北京商报讯（记者 王寅浩 宋雨盈）11月24日，恒瑞医药发布公告称，公司近日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，拟定适 应症为适用于对非甾体抗炎药应答不佳或不耐受且存在客观炎症征象的活动性放射学阴性中轴型脊柱关 节炎成人患者。 ...

智通财经APP获悉，香港联交所最新资料显示，11月20日，GIC Private Limited增持恒瑞医药(01276)95.2 万股，每股作价68.7975港元，总金额约为6549.52万港元。增持后最新持股数目为5766.56万股，最新持 股比例为22.33%。 ...

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子公司成都盛迪医药有 限公司收到国家药品监督管理局的通知，批准公司帕立骨化醇软胶囊上市。现将相关情况公告如下： 规格：1μg、2μg 注册分类：化学药品3类 受理号：CYHS2400770、CYHS2400772 处方药/非处方药：处方药 一、药品的基本情况 药品名称：帕立骨化醇软胶囊 剂型：胶囊剂 批准的适应症：用于预防和治疗成人慢性肾脏病(CKD)3-4期继发性甲状旁腺功能亢进症(SHPT)。 SHPT是CKD患者常见的严重并发症之一，在CKD早期(肾小球滤过率<80mL/[min·1.73m2])即可出现， 并随着肾功能的恶化而加重。帕立骨化醇是一种合成的维生素D类似物，通过与维生素D受体结合抑制 甲状旁腺激素(PTH)的分泌，从而降低血清PTH水平。帕立骨化醇软胶囊由Abbvie公司研制开发，于 2005年5月获FDA批准上市，尚未在国内上市。公司为该品种在国内的首家仿制药企业，本次获批视同 通过仿制药质量和疗效一致性评价。截至目前，帕立骨化醇软胶囊项目累计研发投入约5,794万元。 ...

Core Viewpoint - Heng Rui Medicine has received acceptance for its drug application for Sulfate Emmaxetine Tablets from the National Medical Products Administration, marking a significant step in expanding its product portfolio in the autoimmune disease treatment market [1][2]. Group 1: Drug Development and Clinical Trials - The clinical trial for Sulfate Emmaxetine Tablets in treating radiographic negative axial spondyloarthritis achieved its primary endpoint as planned by September 2025, demonstrating efficacy and safety in a multicenter, randomized, double-blind, placebo-controlled Phase III study involving 304 adult patients [1]. - The Emmaxetine group showed significant superiority over the placebo group in both primary and key secondary endpoints, with good safety and tolerability profiles compared to other JAK1 inhibitors, without new safety signals identified [1]. Group 2: Market Context and Competitive Landscape - Sulfate Emmaxetine Tablets have already been approved for four indications in China, including active ankylosing spondylitis and moderate to severe rheumatoid arthritis, among others [2]. - The drug is a highly selective JAK1 inhibitor, which exerts anti-inflammatory and immunosuppressive effects by inhibiting JAK1 signaling [2]. - Currently, the only similar oral drug approved globally for radiographic negative axial spondyloarthritis is AbbVie's Upadacitinib (RINVOQ), which is projected to generate approximately $5.971 billion in global sales in 2024 [2]. - The total R&D investment for Sulfate Emmaxetine projects has reached approximately 1.091 billion yuan [2].

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： 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。 一、药品的基本情况 药品名称：硫酸艾玛昔替尼片 剂型：片剂 ...

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]