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

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].