"身高70%靠遗传，30%靠后天，定制身高不是梦" 民营医院的广告语还在滚动，生长激素的龙头却准备 要换赛道。 未来，作为市场上唯一一家长效生长激素生产销售方，金赛药业受到的冲击无疑最大。而作为行业老二 的安科生物的竞争优势也会被削弱，目前其有两款长效生长激素在研，生长激素PEG-rhGH在2018年完 成3期试验，至今为止尚未获得上市批准。 转型成效待观察，方向包括儿科、女性健康、抗衰老等 5月28日晚间，国内两家生长激素公司——长春高新（000661）（000661.SZ）、安科生物（300009） （300009.SZ）分别宣布了新药研发或上市进展，前者子公司的GenSci128片在美国获批开展临床试验， 适应证为携带TP53 Y220C突变的局部晚期或转移性实体瘤；后者的醋酸阿托西班注射液在国内获批上 市，可以治疗孕妇早产。 此前，两家公司都交出了增长乏力的年报成绩单。过去三年，生长激素行业格局发生剧变，"一品鲜"的 日子一去不复返，生长激素双龙头都希望能找到第二增长曲线，但新产品变现还需要时间。 两家头部公司2024年收入、归母净利润均出现下滑 在对孩子有身高焦虑的父母眼里，生长激素是一款增高"神药 ...

Core Viewpoint - The company has received FDA approval for clinical trials of GenSci128 tablets, a targeted therapy for patients with TP53 Y220C mutation in advanced or metastatic solid tumors [1][2]. Group 1: Drug Information - Product Name: GenSci128 tablets - Application: Clinical trial approval in the US - Acceptance Number: IND 174059 - Applicant: Changchun JinSai Pharmaceutical Co., Ltd. - Approval Conclusion: Permission granted for clinical trials in the US - Indication: Local advanced or metastatic solid tumors with TP53 Y220C mutation [1]. Group 2: Drug Mechanism and Development - GenSci128 is a class 1 new chemical drug designed as a selective reactivator for TP53 Y220C mutation, aiming to restore the normal conformation and function of the mutated protein [2]. - Preclinical data indicates that GenSci128 has good efficacy and safety [2]. - The drug has also been approved for clinical trials in China for the same indication [2]. Group 3: Company Impact - Successful progress in clinical trials could help the company expand its business structure, optimize product offerings, and enhance core competitiveness [3]. - The company will actively promote the research and development of this project and comply with disclosure obligations regarding project progress [4].

Core Viewpoint - Changchun High-tech (000661.SZ) announced that its subsidiary, Jinsai Pharmaceutical, received approval from the US FDA to conduct clinical trials for GenSci128 tablets, a selective reactivator targeting the TP53 Y220C mutation for treating locally advanced or metastatic solid tumors carrying this mutation [1] Group 1 - GenSci128 tablets have already been approved for clinical trials in China [1] - Successful progress in the clinical trial application will help the company broaden its business structure and optimize its product portfolio [1] - The development of GenSci128 is expected to enrich and enhance the strategic product line layout, thereby improving the company's core competitiveness [1]