Core Viewpoint - Changchun High-tech announced that its subsidiary, Jinsai Pharmaceutical, received approval for clinical trials of GenSci145 tablets, a novel selective PI3Kα inhibitor targeting PIK3CA mutation in advanced or metastatic solid tumors [1][2] Group 1: Product Development - GenSci145 is a first-class innovative chemical drug designed for treating locally advanced or metastatic solid tumors with PIK3CA mutations [1] - PIK3CA mutations are significant in breast cancer, accounting for 30%-40% of cases, and are crucial for tumor growth and resistance to treatments [1] Group 2: Clinical Need and Advantages - Existing PI3Kα inhibitors have poor targeting and can cause side effects like hyperglycemia, rash, and diarrhea, affecting long-term treatment adherence [2] - GenSci145 has shown selective inhibitory activity against various PIK3CA hotspot mutations and good blood-brain barrier penetration without traditional side effects, indicating its potential to meet clinical needs for patients with PIK3CA mutations and brain metastases [2] Group 3: Company Commitment - The company will actively advance the research and development of GenSci145 and comply with information disclosure obligations regarding project progress [2]

Core Viewpoint - Changchun Gaoxin announced that its subsidiary, Changchun Jinsai Pharmaceutical, received approval from the National Medical Products Administration for the clinical trial of GenSci145 tablets, a new selective PI3Kα inhibitor for treating advanced or metastatic solid tumors with PIK3CA mutations [1]. Group 1 - Changchun Jinsai Pharmaceutical has developed GenSci145 tablets, classified as a first-class innovative chemical drug [1]. - The drug is intended for patients with locally advanced or metastatic solid tumors carrying PIK3CA mutations [1].

Core Viewpoint - Changchun High-tech (000661.SZ) announced that its subsidiary, Changchun Jinsai Pharmaceutical Co., Ltd. (referred to as "Jinsai Pharmaceutical"), has received approval from the National Medical Products Administration for the clinical trial application of GenSci145 tablets, a novel selective PI3Kα inhibitor intended for the treatment of locally advanced or metastatic solid tumors with PIK3CA mutations [1] Group 1 - The clinical trial approval for GenSci145 marks a significant milestone for Jinsai Pharmaceutical in the development of innovative drugs [1] - GenSci145 is classified as a Class 1 innovative chemical drug, indicating its potential to address unmet medical needs in oncology [1] - The drug targets specific mutations (PIK3CA) associated with certain types of cancer, highlighting its specialized therapeutic application [1]

Core Viewpoint - Changchun Gaoxin (000661.SZ) announced that its subsidiary, Changchun Jinsai Pharmaceutical Co., Ltd. (referred to as "Jinsai Pharmaceutical"), has received approval from the National Medical Products Administration for the clinical trial application of GenSci145 tablets, a novel selective PI3Kα inhibitor intended for the treatment of locally advanced or metastatic solid tumors with PIK3CA mutations [1] Group 1 - Jinsai Pharmaceutical's GenSci145 tablets are classified as a Class 1 innovative chemical drug [1] - The drug is specifically developed for patients carrying PIK3CA mutations [1] - The approval marks a significant milestone in the company's drug development pipeline [1]

Core Viewpoint - Changchun High-tech (000661.SZ) announced that its subsidiary, Changchun Jinsai Pharmaceutical Co., Ltd. (referred to as "Jinsai Pharmaceutical"), has received approval from the National Medical Products Administration for the clinical trial application of its drug GenSci145 tablets, which is a novel selective PI3Kα inhibitor intended for the treatment of locally advanced or metastatic solid tumors with PIK3CA mutations [1]. Group 1 - Jinsai Pharmaceutical's GenSci145 tablets are classified as a Class 1 innovative chemical drug [1]. - The drug is specifically designed for patients carrying PIK3CA mutations [1]. - The approval marks a significant milestone in the development of targeted therapies for specific cancer mutations [1].

格隆汇1月23日丨长春高新(000661.SZ)公布，子公司——长春金赛药业有限责任公司（简称"金赛药 业"）收到国家药品监督管理局核准签发的《药物临床试验批准通知书》，金赛药业GenSci145片的境内 生产药品注册临床试验申请获得批准。GenSci145片是金赛药业开发的一款新型突变选择性PI3Kα抑制 剂，属1类创新型化学药品，拟用于携带PIK3CA突变的局部晚期或转移性实体瘤的治疗。 ...

长春高新公告称，其子公司金赛药业收到国家药监局核准签发的《药物临床试验批准通知书》， GenSci145片的境内生产药品注册临床试验申请获批。该药品属1类创新型化学药品，拟用于治疗携带 PIK3CA突变的局部晚期或转移性实体瘤。其在临床前研究中展现出对多种PIK3CA热点突变的选择性抑 制活性，有望填补临床需求空白。不过，本次临床试验进程存在不确定性，公司将推进研发并及时披露 进展。 ...

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].