儿童抗肿瘤药物研发
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康辰药业:KC1036纳入药审中心“星光计划”试点项目
Xin Lang Cai Jing· 2025-09-05 07:53
Group 1 - The core point of the article is that Kangchen Pharmaceutical's innovative drug KC1036 has been included in the "Children's Antitumor Drug Research and Development Encouragement Pilot Program (Starlight Program)" by the National Medical Products Administration [1] - The company will actively report progress or results related to the implementation framework required by the drug review center to jointly promote the clinical development and market launch of KC1036 in the field of pediatric Ewing's sarcoma [1] - Additionally, the company's controlling shareholder, Liu Jianhua, plans to reduce his holdings by a total of no more than 4.7807 million shares, which is not more than 3% of the company's total shares, through centralized bidding and block trading [1]
诺诚健华:新一代TRK抑制剂佐来曲替尼纳入儿童肿瘤药“星光计划”
Zhong Zheng Wang· 2025-08-29 07:45
Core Insights - Nocera Biopharma's new pan-TRK inhibitor, zurletrectinib (ICP-723), has been included in China's National Medical Products Administration (NMPA) "Star Program" for pediatric oncology drug development [1][2] - The new drug application (NDA) for zurletrectinib targeting adult and adolescent patients with NTRK fusion gene-positive advanced solid tumors has been accepted in China and is under priority review [1] - Clinical trials for zurletrectinib in children aged 2 to 12 years are ongoing, with plans to submit the NDA by the second half of 2025 [1] Company and Industry Summary - The "Star Program" aims to enhance communication between drug applicants and the NMPA to improve the efficiency of pediatric oncology drug development [2] - Nocera Biopharma's CEO highlighted the prevalence of NTRK gene fusion in pediatric tumors and emphasized the recognition of the company's innovation capabilities through the inclusion of zurletrectinib in the program [2] - The clinical trials for zurletrectinib have demonstrated excellent efficacy and safety, overcoming resistance seen with first-generation TRK inhibitors [1]