11月18日晚间华润双鹤（600062）公告，近日公司控股子公司湖南省湘中制药有限公司收到了国家药监 局颁发的奥卡西平片《药品注册证书》。奥卡西平片用于治疗成年人和5岁及以上儿童的原发性全面性 强直-阵挛发作和部分性发作，伴有或不伴有继发性全面性发作。 华润双鹤表示，该药品获得《药品注册证书》，将进一步丰富公司产品线，有助于提升公司产品的市场 竞争力，并为后续其他产品研发积累了宝贵的经验。不过，由于医药产品具有高科技、高风险、高附加 值的特点，药品的销售情况可能受到国家政策、市场环境变化等因素影响，具有较大不确定性。 公告显示，湘中制药于2021年8月启动该药品的仿制药研发工作，于2024年7月26日向国家药监局提交上 市许可申请，于2024年8月14日获得受理通知书，并于2025年11月12日获得国家药监局批准上市。根据 国家相关政策规定，本次获得《药品注册证书》视同通过一致性评价。截至公告日，公司针对该药品累 计研发投入为1421.64万元(未经审计)。 关于同类药品的市场状况，公告显示，奥卡西平片由诺华(NovartisPharmaceuticalsCorp)研制开发，于 2000年1月在美国获批上市， ...

Core Viewpoint - The company announced that its wholly-owned subsidiary, Huaren Shuanghe Limin Pharmaceutical (Jinan) Co., Ltd., has received a drug registration certificate for Bosentan dispersible tablets from the National Medical Products Administration (NMPA) [1][2]. Group 1: Drug Registration and Development - The drug Bosentan dispersible tablets are indicated for pulmonary arterial hypertension (PAH) in pediatric patients aged 3 years and older, as well as for adult patients classified as WHO functional class II to IV [1][2]. - The development of this generic drug began in 2022, with the application for marketing authorization submitted on June 14, 2024, and approval granted on September 23, 2025 [2]. Group 2: Market Situation - Bosentan dispersible tablets were developed by Actelion Pharmaceuticals Ltd and were approved for sale in the EU in 2009 under the brand name "Tracleer." The drug was imported into China in September 2019 under the brand name "Quankeli" [3]. - In 2024, the global sales of Bosentan dispersible tablets reached approximately $35.9 million, with "Tracleer" accounting for about $31.3 million of that total [3]. - In the Chinese market, the total sales of Bosentan dispersible tablets were approximately 2.126 million yuan in 2024, with Johnson & Johnson holding a 100% market share [3]. Group 3: Impact on the Company - The acquisition of the drug registration certificate is expected to enhance the company's product line and market competitiveness, while also providing valuable experience for future product development [4].

Group 1 - The core point of the article is that China Resources Double Crane has received a drug registration certificate for Bosentan dispersible tablets from the National Medical Products Administration [2] Group 2 - The announcement was made by China Resources Double Crane on the evening of September 29 [2] - The certificate was issued to the company's wholly-owned subsidiary, China Resources Double Crane Limin Pharmaceutical (Jinan) Co., Ltd. [2]

华润双鹤（600062）(600062.SH)发布公告，近日，公司全资子公司华润双鹤利民药业(济南)有限公司 (简称"双鹤利民")收到了国家药品监督管理局(简称"国家药监局")颁发的波生坦分散片《药品注册证 书》。 波生坦分散片的适应症为肺动脉高压(PAH)(WHO第1组)：用于在年龄≥3岁的儿科特发性或先天性PAH 患者中改善肺血管阻力(PVR);用于WHO功能分级II级-IV级的肺动脉高压(PAH)(WHO第1组)的成人患者 的治疗。 ...

Core Viewpoint - China Resources Double Crane (华润双鹤) announced that its wholly-owned subsidiary, China Resources Double Crane Limin Pharmaceutical (济南) Co., Ltd. (referred to as "Double Crane Limin"), has received the Drug Registration Certificate for Bosentan Dispersible Tablets from the National Medical Products Administration (国家药监局) [1] Group 1 - The indication for Bosentan Dispersible Tablets is for pulmonary arterial hypertension (PAH) (WHO Group 1) [1] - The drug is intended to improve pulmonary vascular resistance (PVR) in pediatric patients aged 3 years and older with idiopathic or congenital PAH [1] - It is also used for the treatment of adult patients with WHO functional class II to IV pulmonary arterial hypertension (PAH) [1]

Core Viewpoint - China Resources Double Crane announced that its wholly-owned subsidiary, China Resources Double Crane Limin Pharmaceutical (Jinan) Co., Ltd., has received the drug registration certificate for Bosentan dispersible tablets from the National Medical Products Administration [1] Group 1: Product Development - Bosentan dispersible tablets are indicated for pulmonary arterial hypertension (PAH) in pediatric patients aged ≥3 years and adult patients classified as WHO functional class II to IV [1] - The company initiated the development of this generic drug in 2022, receiving the acceptance notice on June 20, 2024, and obtaining approval for market launch on September 23, 2025 [1] - As of the announcement date, the total R&D investment for this drug has reached 8.4359 million RMB [1]