GLX002
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亚宝药业集团股份有限公司关于GLX002获得药物临床试验批准通知书的公告
Shang Hai Zheng Quan Bao· 2025-12-17 19:35
Core Viewpoint - The announcement highlights that Yabao Pharmaceutical's subsidiary has received approval for clinical trials of GLX002, a new drug aimed at treating pulmonary arterial hypertension (PAH) [1][2]. Group 1: Drug Information - Drug Name: GLX002 [2] - Dosage Form: Tablet [2] - Registration Category: Class 2.2 Chemical Drug [2] - Applicant: Beijing Yabao Biological Pharmaceutical Co., Ltd. [2] - Acceptance Number: CXHL2501089 [2] - Approval Conclusion: The drug meets the requirements for registration and is approved for clinical trials for PAH treatment [1][2]. Group 2: Drug Development and Market Context - GLX002 is a modified new drug based on bosentan dispersible tablets, targeting PAH in patients aged 1 and older [2]. - The drug aims to improve pulmonary vascular resistance (PVR) and enhance exercise capacity in both pediatric and adult patients with WHO functional class II-IV PAH [2]. - In 2024, the sales amount for bosentan dispersible tablets in China is projected to be approximately 20.32 million RMB, with public medical market sales around 17.61 million RMB and retail pharmacy sales about 2.71 million RMB [2]. - Currently, there are no other modified new drugs based on bosentan dispersible tablets available in the domestic or international markets [2]. Group 3: R&D Investment - As of the announcement date, the company has invested approximately 1.6343 million RMB in the R&D of the GLX002 project [3]. - The drug must undergo clinical trials and receive approval from the National Medical Products Administration before it can be manufactured and marketed [3].
亚宝药业:获得《药物临床试验批准通知书》
Mei Ri Jing Ji Xin Wen· 2025-12-17 09:39
Group 1 - The core point of the article is that Yabao Pharmaceutical has received approval from the National Medical Products Administration for the clinical trial of GLX002 [1] Group 2 - Yabao Pharmaceutical's wholly-owned subsidiary, Beijing Yabao Biopharmaceutical Co., Ltd., is responsible for the development of GLX002 [1]
亚宝药业:子公司GLX002用于治疗肺动脉高压(PAH)(WHO 第1 组)的临床试验获批
Xin Lang Cai Jing· 2025-12-17 07:53
Core Viewpoint - The company announced that its wholly-owned subsidiary, Beijing Yabao Biopharmaceutical Co., Ltd., has received approval from the National Medical Products Administration for the clinical trial of GLX002, aimed at treating pulmonary arterial hypertension (PAH) [1] Group 1 - GLX002 is intended to improve pulmonary vascular resistance (PVR) in pediatric patients aged 1 year and older with idiopathic or congenital PAH [1] - The treatment is also aimed at adult patients with WHO functional class II-IV PAH to enhance exercise capacity and reduce clinical deterioration [1]
亚宝药业(600351.SH):GLX002获得药物临床试验批准通知书
智通财经网· 2025-12-17 07:43
Core Viewpoint - The company, Yabao Pharmaceutical (600351.SH), announced that its wholly-owned subsidiary, Beijing Yabao Biological Pharmaceutical Co., Ltd., has received the clinical trial approval notice for GLX002 from the National Medical Products Administration of China [1] Group 1: Product Information - GLX002 is a modified new drug based on bosentan dispersible tablets, indicated for pulmonary arterial hypertension (PAH) classified as Group 1 by WHO [1] - The drug aims to improve pulmonary vascular resistance (PVR) in pediatric patients aged 1 year and older with idiopathic or congenital PAH, and to enhance exercise capacity in adult patients with WHO functional classification II to IV PAH [1]
亚宝药业:GLX002获得药物临床试验批准通知书
Xin Lang Cai Jing· 2025-12-17 07:37
Core Viewpoint - The announcement indicates that the company's subsidiary, Yabao Biotech, has received approval from the National Medical Products Administration for the clinical trial of GLX002, a modified new drug based on bosentan dispersible tablets, aimed at treating pulmonary arterial hypertension (PAH) [1] Group 1: Product Details - GLX002 is designed for patients aged 1 year and older with idiopathic or congenital PAH, targeting improvements in pulmonary vascular resistance (PVR) [1] - The drug is intended to enhance exercise capacity in adult patients with WHO functional class II-IV PAH [1] Group 2: Regulatory Approval - The approval from the National Medical Products Administration is a significant milestone for the company, allowing it to proceed with clinical trials for GLX002 [1]