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]

证券代码：000661 证券简称：长春高新 公告编号：2026-004 长春高新技术产业（集团）股份有限公司 关于子公司 GenSci145 片境内生产药品注册临床试验申请 获得批准的公告 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。 二、药品的其它情况 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。 PIK3CA 基因突变在乳腺癌中占 30%～40%，是乳腺癌发生和进展的重要因 素。PIK3CA 基因编码 PI3Kα的催化亚基 p110α是 PI3K-AKT-mTOR 信号通路 的核心，PIK3CA 基因突变可导致该通路异常激活，促进肿瘤细胞的生长和抗凋 亡能力，并且可导致乳腺癌内分泌治疗、化疗和靶向治疗的耐药。对于携带 PIK3CA 突变的患者，开发针对性的 PI3K 通路抑制剂，将有助于改善患者的疗 效和预后。 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 ...

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。 ...

Core Viewpoint - The recent surge in the stock price of Changchun High-tech (000661.SZ) is attributed to the announcement of a new drug, GenSci141 ointment, aimed at treating a sensitive condition in children, which has sparked investor interest reminiscent of past successes with growth hormone products [1][2][4][6][9]. Group 1: Stock Performance and Market Reaction - From January 5 to January 12, 2025, Changchun High-tech's stock experienced a price increase of 5.79% with a trading range of 9.35% [1][2]. - As of January 22, 2025, the stock price fell by 0.19% to 97.50 CNY per share, with a total market capitalization of 39.77 billion CNY [2][23]. - The stock price did not return to its initial level after the surge, indicating some sustained interest despite the subsequent decline [1][2]. Group 2: Product Details and Market Expectations - GenSci141 ointment is a topical hormone treatment for children with a specific condition related to low testosterone signaling, aiming to provide a new therapeutic option [6][28]. - The unique positioning of the drug has led to significant speculation among investors, with discussions about its potential consumer market appeal and possible expansion of its target demographic [29]. - The condition targeted by GenSci141 is rare, with an incidence rate of approximately 0.0015% in the U.S. and 0.14% reported in Zhengzhou, China [29]. Group 3: Historical Context and Business Strategy - Changchun High-tech previously achieved significant success with growth hormone products, establishing a near-monopoly and reaching a market capitalization of over 210 billion CNY [10][32]. - The company has faced challenges since 2022 due to price reductions from centralized procurement and increased competition, leading to a decline in revenue and profit margins [10][34]. - The management has shifted focus towards innovative drug development, with expectations of surpassing 1 billion CNY in revenue from new products by 2025 [36][15]. Group 4: Financial Performance and Challenges - In 2024, the company reported its first negative revenue growth in nearly two decades, with a 43.01% year-over-year decline in net profit [10][34]. - For the first three quarters of 2025, net profit decreased by 58.23%, with a significant drop of 82.98% in the third quarter alone [10][34]. - The company has increased its R&D spending to support its innovation pipeline, with a 17.32% year-over-year increase in R&D investment [15][36]. Group 5: Future Prospects and Risks - The success of GenSci141 and other innovative products is critical for the company to overcome the decline in its core growth hormone business [17][40]. - The company is exploring a listing on the Hong Kong stock exchange to alleviate cash flow pressures and support international expansion [40]. - There are concerns regarding the sustainability of its business model and the potential for regulatory challenges in the current healthcare environment [41].

Core Insights - The article highlights the participation of Gensci Pharmaceutical at the 44th JPMorgan Healthcare Conference, showcasing its innovative drug development and research capabilities, which attracted significant investor interest [1][2]. Group 1: Innovative Drug Pipeline - Gensci Pharmaceutical presented seven innovative drug pipelines targeting major disease areas such as oncology, respiratory, immunology, endocrinology, and women's health, with potential First-in-Class (FIC) or Best-in-Class (BIC) profiles [2][3]. - The company emphasized its advanced technology platforms, including long-acting release, conjugation technology, targeted delivery, and AI-assisted drug design, which are crucial for developing competitive drug candidates [2][3]. Group 2: Clinical Development Highlights - Gensci's GenSci134, a long-acting growth hormone analog, is in Phase I clinical trials, aimed at improving patient compliance in growth hormone deficiency [3]. - The NK3R antagonist GenSci074 for menopausal vasomotor symptoms has met all primary endpoints in Phase II trials, showing significant improvement over placebo, with plans for a global Phase III trial in Q2 2026 [3]. - The PD-1 agonist GenSci120 has received clinical approval in China and the U.S., demonstrating potential for chronic immune inflammatory diseases [4]. Group 3: Oncology Advancements - Gensci's GenSci128, targeting TP53 Y220C mutations, has entered clinical trials, addressing a significant unmet need in solid tumors [5]. - The new PI3Kα inhibitor GenSci145, recently accepted for IND, shows selective inhibition of PIK3CA mutations and potential for treating advanced solid tumors with brain metastases [5]. Group 4: Strategic Development and Global Expansion - Gensci is advancing over 40 clinical research projects and has achieved a milestone with the overseas licensing of GenSci098, totaling $1.365 billion, marking international recognition of its innovation [9]. - The company aims to develop a robust pipeline through a strategy that combines growth hormone, innovative drugs, and overseas business development, positioning itself for high-quality growth [9]. - The JPM conference serves as a platform for Gensci to showcase its innovations and foster global partnerships, reflecting a shift in the industry towards quality and global outreach [9].

Core Viewpoint - The company has signed an exclusive licensing agreement for the GenSci098 injection project with Yarrow Bioscience, which includes a $70 million upfront payment to support its cash reserves and future development plans [2][3]. Group 1: Licensing Agreement Details - The exclusive licensing agreement was approved by the company's board on December 15, 2025, allowing Yarrow to develop, produce, and commercialize GenSci098 outside Greater China [3]. - The first payment of $70 million was received by the company on January 14, 2026, which will enhance the company's cash reserves and support its international strategy [3]. Group 2: GenSci098 Injection Project - GenSci098 is a humanized monoclonal antibody designed to treat thyroid-related conditions, specifically targeting TSHR to inhibit thyroid hormone synthesis and release [4]. - Clinical trials for GenSci098 have been approved in both mainland China and the United States for thyroid eye disease (TED) and Graves' disease (GD), indicating its potential as a new treatment option [4].