Core Viewpoint - Changchun High New Technology Industry Group Co., Ltd. (000661.SZ) announced that its subsidiary, Changchun JinSai Pharmaceutical Co., Ltd., has received the acceptance notice from the National Medical Products Administration for the clinical trial application of GenSci141 ointment [1] Group 1 - The GenSci141 ointment is a dihydrotestosterone ointment developed by JinSai Pharmaceutical, which acts on target tissues through a paracrine mechanism [1] - The product is classified as a chemical drug under categories 2.2 and 2.4 [1]

证券代码：000661 证券简称：长春高新 公告编号：2025-155 长春高新技术产业（集团）股份有限公司 关于子公司 GenSci141 软膏境内生产药品注册临床试验申请 获得受理的公告 本公司及董事会全体成员保证信息披露的内容真实、准确、完整，没有虚假记 载、误导性陈述或重大遗漏。 近日，长春高新技术产业（集团）股份有限公司（以下简称"公司"）子公 司——长春金赛药业有限责任公司（以下简称"金赛药业"）收到国家药品监督 管理局核准签发的《受理通知书》，金赛药业 GenSci141 软膏注册临床试验申请 获得受理，现将相关情况公告如下： 一、药品的基本情况 产品名称：GenSci141 软膏 申请事项：境内生产药品注册临床试验 受理号：CXHL2501394、CXHL2501395、CXHL2501396 和 CXHL2501397 申请人：长春金赛药业有限责任公司 审批结论：经审查，决定予以受理 适应症：用于改善因高促性腺激素性性腺功能减退症、5α-还原酶 2 缺乏症、 雄激素合成减少的先天性肾上腺皮质增生症、特发性的原因导致的儿童小阴茎。 二、药品的其它情况 GenSci141 软膏是金赛药业研发的一 ...

Core Viewpoint - Changchun Gaoxin's subsidiary, Jinsai Pharmaceutical, has received the acceptance notice for the clinical trial application of GenSci141 ointment from the National Medical Products Administration, indicating a potential expansion in the company's product line and core competitiveness [1] Group 1: Clinical Trial Approval - Jinsai Pharmaceutical's GenSci141 ointment is aimed at treating conditions such as hypergonadotropic hypogonadism, 5α-reductase type 2 deficiency, congenital adrenal hyperplasia, and idiopathic causes of micropenis in children [1] - The acceptance of the clinical trial application is a significant step that could enhance the company's business structure and product offerings [1] Group 2: Business Implications - Successful progress in the clinical trial could lead to a broader product line and improved strategic positioning within the industry [1] - The company aims to optimize its product structure and enhance its core competitiveness through this development [1] Group 3: R&D Challenges - The pharmaceutical industry is characterized by high technology, high risk, and high added value, with lengthy and complex processes from research and development to clinical trial approval and production [1] - There are inherent uncertainties in the clinical trial process that could impact the timeline and success of the product [1]

Core Viewpoint - Changchun High-tech (000661.SZ) announced that its subsidiary, Changchun Jinsai Pharmaceutical Co., Ltd. (referred to as "Jinsai Pharmaceutical"), has received the Acceptance Notice issued by the National Medical Products Administration for the clinical trial application of GenSci141 ointment, a dual dihydrotestosterone ointment developed by Jinsai Pharmaceutical [1] Group 1 - Jinsai Pharmaceutical's GenSci141 ointment is designed to act through paracrine mechanisms in target tissues [1] - The product falls under chemical drugs categories 2.2 and 2.4 [1]

Core Viewpoint - Changchun High-tech announced that its subsidiary, Jinsai Pharmaceutical, received the Acceptance Notice from the National Medical Products Administration for the clinical trial application of GenSci141 ointment, which is a dihydrotestosterone ointment aimed at improving children's micropenis [1] Group 1 - The drug is classified as a chemical drug of categories 2.2 and 2.4 [1] - Successful progress in clinical trials could help the company expand its business and optimize its product structure [1] - The pharmaceutical product development cycle is long and involves multiple stages, leading to uncertainties in the clinical trial process [1]

Group 1 - The core announcement is that Changchun High-tech Industry (Group) Co., Ltd. has received approval from the National Medical Products Administration for the clinical trial application of GenSci145 tablets, a new selective PI3Kα inhibitor developed by its subsidiary, Changchun Jinsai Pharmaceutical Co., Ltd. [2] - GenSci145 is aimed at treating locally advanced or metastatic solid tumors with PIK3CA mutations, which are prevalent in up to 40% of HR+/HER2- primary and metastatic breast cancers, indicating a significant market opportunity [2] - The current standard treatment for HR+/HER2- locally advanced or metastatic breast cancer involves endocrine therapy combined with CDK4/6 inhibitors, but there is a clinical need for targeted therapies like PI3K pathway inhibitors for patients with PIK3CA mutations who develop resistance [2] Group 2 - Early-stage PI3Kα inhibitors have shown significant improvements in progression-free survival (PFS) in clinical studies but have limitations due to toxicity issues, highlighting the need for new generation PI3Kα inhibitors [3] - GenSci145 has demonstrated strong selective inhibitory activity against various hotspot mutations in the PIK3CA gene in preclinical studies, showing clear efficacy and good safety profiles in animal models [3] - The successful progression of the clinical trial application for GenSci145 could enhance Changchun High-tech's business structure, optimize product offerings, and strengthen its competitive edge in strategic areas [3]

Core Viewpoint - The company, Changchun High-tech Industry (Group) Co., Ltd., announced that its subsidiary, GenSci Pharmaceutical Co., Ltd., has received acceptance for the clinical trial application of GenSci145 tablets from the National Medical Products Administration, which is aimed at treating locally advanced or metastatic solid tumors with PIK3CA mutations [1][2]. Group 1: Drug Information - Product Name: GenSci145 tablets [1] - Application: Clinical trial for domestic production [1] - Indication: Local advanced or metastatic solid tumors with PIK3CA mutations [1] - Acceptance Number: CXHL2501450, CXHL2501451, CXHL2501452 [1] Group 2: Clinical Context - PIK3CA mutations are found in up to 40% of HR+/HER2- primary and metastatic breast cancers, leading to significant risks of recurrence and mortality due to disease heterogeneity and resistance [2] - Current guidelines recommend endocrine therapy combined with CDK4/6 inhibitors as the first-line treatment for HR+/HER2- locally advanced or metastatic breast cancer, but targeted therapies like PI3K pathway inhibitors are needed for patients with PIK3CA mutations who have developed resistance [2] Group 3: Development and Competitive Advantage - GenSci145 tablets are a new generation of mutation-selective PI3Kα inhibitors, showing strong selective inhibition of various hotspot mutations in preclinical studies, with clear efficacy and good safety profiles in animal models [2] - The drug has significant clinical development value and potential differentiation advantages, aiming to provide better treatment options for patients with PIK3CA mutations [2]

Core Viewpoint - Changchun High-tech's subsidiary, Gensci Pharmaceutical, has received approval from the National Medical Products Administration for the clinical trial application of GenSci145 tablets, a new selective PI3Kα inhibitor aimed at treating advanced solid tumors with PIK3CA mutations [1][2]. Group 1: Clinical Development - GenSci145 is designed to target PIK3CA mutations, which are present in up to 40% of HR+/HER2- primary and metastatic breast cancer cases, providing a new treatment option for patients who have developed resistance to current therapies [1][2]. - Early-stage PI3Kα inhibitors have shown significant improvements in progression-free survival (PFS) but have limitations due to toxicity and impact on long-term treatment adherence, highlighting the need for new generation inhibitors like GenSci145 [2]. Group 2: Business Strategy and Market Position - The successful progression of the clinical trial for GenSci145 is expected to enhance the company's business structure, optimize product offerings, and strengthen its core competitiveness in the pharmaceutical industry [3]. - Changchun High-tech has been actively adjusting its strategy and increasing innovation investments, developing multiple core technology platforms with independent intellectual property rights, covering the entire process of innovative drug design, screening, evaluation, and formulation research [3]. - The company is focusing on high-demand therapeutic areas, particularly in endocrine metabolism and pediatric fields, to support sustainable development and diversification goals [3]. Group 3: Recent Developments - Recently, Gensci Pharmaceutical has disclosed multiple advancements in its drug development pipeline, including the approval of clinical trials for GenSci142 capsules and GS3-007a, both targeting specific medical conditions [4]. - The company has also received approval for GenSci140, a novel targeted antibody-drug conjugate for the treatment of advanced solid tumors, further expanding its product portfolio [4].

Core Viewpoint - Changchun High-tech (000661.SZ) announced that its subsidiary, Changchun Jinsai Pharmaceutical Co., Ltd., received the acceptance notice from the National Medical Products Administration for the clinical trial application of GenSci145 tablets, a novel selective PI3Kα inhibitor developed by the company [1] Group 1 - GenSci145 tablets have demonstrated strong selective inhibitory activity against various hotspot mutations in the PIK3CA helix and kinase domains during preclinical studies [1] - The drug has shown clear efficacy and good safety characteristics in animal models, indicating its potential for clinical development [1] - GenSci145 tablets are expected to provide better treatment options for patients with locally advanced or metastatic solid tumors carrying PIK3CA mutations, highlighting its clinical development value and potential differentiation advantages [1]

Core Viewpoint - Changchun High-tech (000661.SZ) announced that its subsidiary, Changchun Jinsai Pharmaceutical Co., Ltd. (referred to as "Jinsai Pharmaceutical"), has received the Acceptance Notice from the National Medical Products Administration for the clinical trial application of GenSci145 tablets, indicating a significant step in the drug's development process [1] Group 1: Product Development - GenSci145 is a novel selective PI3Kα inhibitor developed by Jinsai Pharmaceutical, demonstrating strong selective inhibitory activity against various hotspot mutations in the PIK3CA helix and kinase domains during preclinical studies [1] - The drug has shown clear efficacy and good safety characteristics in animal models, supporting its potential for clinical use [1] Group 2: Clinical Relevance - GenSci145 is expected to provide better clinical treatment options for patients with locally advanced or metastatic solid tumors carrying PIK3CA mutations, highlighting its clinical development value and potential differentiation advantages [1]