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]

在针对NTRK融合基因阳性的晚期实体瘤患者的注册临床试验中，佐来曲替尼展示了卓越的有效性和安 全性，同时可以克服第一代TRK抑制剂的耐药性。 据了解，佐来曲替尼是诺诚健华自主研发的泛TRK抑制剂。佐来曲替尼治疗携带NTRK融合基因的晚期 实体瘤成人和青少年(12周岁≤年龄<18周岁)患者的新药上市申请(NDA)已在中国获受理并纳入优先审 评，佐来曲替尼针对儿童患者(2周岁≤年龄<12周岁)的注册临床试验正在进行中，目标于2025年下半年 提交新药上市申请(NDA)。 诺诚健华联合创始人、董事长兼CEO崔霁松表示："NTRK基因融合在儿童肿瘤中非常常见。佐来曲替 尼纳入'星光计划'是对诺诚健华创新能力的高度认可，我们将加速推进其临床开发，为儿童患者带来更 优治疗方案。" "星光计划"是药审中心为了落实国家药监局"提前介入、一企一策、全程指导、研审联动"的要求，在儿 童药物研发领域开展的一项试点工作，旨在通过申请人填写提交《儿童抗肿瘤药物研发实施框架》的方 式，与药审中心及早进行沟通，获得其抗肿瘤药物在儿童人群研究过程中技术问题的相应指导，并在研 发过程中，与药审中心保持紧密沟通，最终提高儿童抗肿瘤药物的研发效率 ...