GLX002是基于波生坦分散片的改良型新药，适应症为肺动脉高压(PAH)(WHO第1组)，主要用于改善年 龄≥1岁的儿科特发性或先天性PAH患者的肺血管阻力(PVR)，预计可使运动能力得到改善;治疗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，以改善运动能力和减少临床恶化。 智通财经APP讯，亚宝药业(600351.SH)发布公告，近日，公司全资子公司北京亚宝生物药业有限公司 (简称"亚宝生物")收到了国家药品监督管理局核准签发的GLX002的《药物临床试验批准通知书》(通知 书编号：2025LP03407)。 ...

Core Viewpoint - Recently, China Resources Double Crane (华润双鹤) announced that its subsidiary, Hunan Xiangzhong Pharmaceutical Co., Ltd., received the drug registration certificate for Oxcarbazepine tablets from the National Medical Products Administration (NMPA), which is expected to enhance the company's product line and market competitiveness [1][2]. Group 1: Drug Registration and Market Potential - The Oxcarbazepine tablets are indicated for the treatment of primary generalized tonic-clonic seizures and partial seizures in adults and children aged 5 and above [1]. - The research and development of this generic drug began in August 2021, with the application for market approval submitted in July 2024 and the approval expected in November 2025 [1]. - The global sales of Oxcarbazepine tablets are projected to reach $351 million in 2024, with the brand "Trileptal" accounting for $162 million of that total [1]. Group 2: Competitive Landscape - In the Chinese market, there are 10 approved manufacturers of Oxcarbazepine tablets, with 9 having passed or deemed to have passed the consistency evaluation [2]. - The total sales of Oxcarbazepine tablets in the domestic medical and retail markets are estimated at 738 million yuan in 2024, with Novartis holding a market share of 74.17%, followed by Beijing Four Ring Pharmaceutical at 13.78% and Wuhan Renfu Pharmaceutical at 11.85% [2]. Group 3: Company Overview and Financial Performance - China Resources Double Crane operates 24 subsidiaries and employs 13,000 staff, focusing on new drug research and development, formulation production, drug sales, and active pharmaceutical ingredient production [2]. - The company reported a third-quarter revenue of 2.542 billion yuan, a year-on-year decrease of 2.96%, while net profit increased by 6.71% to 374 million yuan [3]. - For the first three quarters of 2025, the total revenue was 8.283 billion yuan, down 3.1% year-on-year, with net profit declining by 3.4% to 1.35 billion yuan [3]. Group 4: Recent Drug Approvals - Recently, the company has received multiple drug registration certificates for its subsidiaries, including Bosentan dispersible tablets for pulmonary arterial hypertension and a new injection for acute coronary syndrome [4].

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]

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., has received the drug registration certificate for Bosentan dispersible tablets from the National Medical Products Administration (国家药监局) [1] Group 1: Product Information - Bosentan dispersible tablets are indicated for pulmonary arterial hypertension (PAH) classified as 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 (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]