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].

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12月17日公告，公司全资子公司北京亚宝生物药业有限公司收到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》，同意其开展适用于治疗肺动脉高压（PAH）（WHO 第1 组）的临床试验。GLX002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。 ...

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)。 ...

亚宝药业公告，全资子公司亚宝生物收到了国家药监局核准签发的GLX002的《药物临床试验批准通知 书》。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。 ...