Core Viewpoint - Changchun High-tech (000661.SZ) is required by the China Securities Regulatory Commission (CSRC) to provide additional explanations regarding the use of raised funds and specific details about its AI large model business as part of its application for listing on the Hong Kong Stock Exchange [1] Group 1: Regulatory Requirements - The CSRC has requested Changchun High-tech to clarify the penetration situation of its controlling shareholder, Jilin Province Xinzhen Fund Partnership, and whether there are any legal restrictions on shareholding [2] - The company must explain the potential impact of its controlling shareholder's equity pledge on the control of the issuer before and after the listing [2] - The CSRC requires a detailed explanation of the company's business related to AI large models, including application scenarios and specific functions [3] Group 2: Fundraising and Business Operations - Changchun High-tech is asked to provide a detailed account of the intended use of the funds raised from the listing [4] - The company must confirm the legality and compliance of its establishment and previous equity changes, focusing on significant aspects [5] - The company operates in various fields, including therapeutic biopharmaceuticals, chemical drugs, vaccines, and traditional Chinese medicine, and is one of the few domestic pharmaceutical companies with full industry chain capabilities in these drug types [5]

Core Viewpoint - Changchun High-tech (000661) announced that its subsidiary, Changchun Jinsai Pharmaceutical Co., Ltd., received approval from the National Medical Products Administration for the clinical trial application of GS3-007a suspension, marking a significant step in the development of pediatric growth products [2]. Group 1: Company Developments - The approval of the clinical trial application for GS3-007a aligns with the company's strategic focus on developing products for children's growth and development [2]. - Currently, there are no similar products available in the domestic market, indicating a potential market opportunity for GS3-007a [2]. - The approval is expected to facilitate the clinical development of the product and address unmet clinical needs for patients [2].

Core Viewpoint - The China Securities Regulatory Commission (CSRC) has published supplementary material requirements for 10 companies, including Changchun High-tech (000661.SZ), which is seeking to list on the Hong Kong Stock Exchange. The CSRC has requested additional information regarding the company's fundraising purposes and its involvement in AI large models [1][2]. Group 1: Regulatory Requirements - The CSRC has requested Changchun High-tech to clarify the ownership structure of its controlling shareholder, Jilin Province Xinzhen Fund Partnership, and whether there are any legal restrictions on shareholding [1]. - The company must provide details on the potential impact of share pledges by its controlling shareholder on the control of the issuer, including the reasons for stock pledges and the repayment capabilities of relevant parties [1]. - The CSRC has asked for a detailed explanation of the company's business related to AI large models, including application scenarios and specific functionalities [1]. Group 2: Fundraising and Business Operations - Changchun High-tech is required to provide a detailed account of the intended use of the funds raised from the listing [2]. - The company must confirm the legality and compliance of its establishment and any changes in shareholding, focusing on significant aspects [3]. - The company needs to elaborate on its subsidiaries' business operations, including internet information services, clinical trial services, and whether they have obtained necessary qualifications and licenses [3]. Group 3: Company Overview - Changchun High-tech is an innovation-driven pharmaceutical group with a comprehensive portfolio covering therapeutic biological agents, chemical drugs, vaccines, and traditional Chinese medicine [3]. - The company is one of the few domestic pharmaceutical enterprises capable of achieving full industry chain capabilities in research and development, production, and commercialization across all major drug registration types in China [3]. - It has established a strong and diversified product portfolio in areas such as endocrine and metabolic diseases, women's health, immune and respiratory diseases, tumors, vaccines, and traditional Chinese medicine [3].

Summary of Key Points Core Viewpoint - Changchun High-tech (SZ 000661) announced a share buyback program, completing the repurchase of approximately 3.89 million shares, which is 0.95% of the total share capital, with a total transaction amount of around 400 million RMB [1]. Company Financials - As of the first half of 2025, the revenue composition of Changchun High-tech is as follows: pharmaceutical industry accounts for 92.83%, real estate for 6.81%, and service industry for 0.36% [1]. - The highest transaction price during the buyback was 112.25 RMB per share, while the lowest was 84 RMB per share [1]. - The current market capitalization of Changchun High-tech is 42.6 billion RMB [1].

Core Viewpoint - Changchun High-tech (000661) announced the approval of clinical trial applications for two products from its subsidiary, Jinsai Pharmaceutical, aimed at treating specific medical conditions [1] Group 1: Product Approvals - Jinsai Pharmaceutical's injection product GenSci140 has received approval for clinical trials, intended for the treatment of locally advanced or metastatic solid tumors [1] - The GS3-007a dry mixed suspension from Jinsai Pharmaceutical has also been approved for clinical trials, targeting growth retardation in children due to endogenous growth hormone deficiency (PGHD) [1]

Core Viewpoint - Changchun High-tech (000661.SZ) has completed a share buyback program, repurchasing a total of 3,894,517 shares, which represents 0.95% of the company's total share capital [1] Summary by Categories Share Buyback Details - The buyback was conducted through a dedicated securities account via centralized bidding [1] - The highest transaction price was 112.25 CNY per share, while the lowest was 84.00 CNY per share [1] - The total transaction amount reached 399,999,400.76 CNY, including transaction fees [1] Compliance and Strategy - The buyback aligns with relevant laws, regulations, and normative documents [1] - The actions taken are consistent with the company's established buyback plan [1]

格隆汇11月14日丨长春高新(000661.SZ)公布，截至2025年11月13日，公司股份回购期限届满。公司累 计通过回购专用证券账户，以集中竞价交易方式累计回购公司股份3,894,517股，占本公司总股本的 0.95%，其中最高成交价为112.25元/股，最低成交价为84.00元/股，合计成交金额为人民币 399,999,400.76元（含交易费用）。本次回购符合相关法律、法规和规范性文件的要求，符合公司既定 的回购方案。 ...

Core Viewpoint - Changchun High-tech (000661.SZ) announced that its subsidiary, Changchun Jinsai Pharmaceutical Co., Ltd., received approval from the National Medical Products Administration for the clinical trial of GS3-007a, a drug aimed at treating pediatric growth hormone deficiency [1] Group 1 - Changchun Jinsai Pharmaceutical has developed GS3-007a, an oral small molecule growth hormone secretagogue [1] - The drug is classified as a Class 1 chemical drug and is intended for the treatment of pediatric growth hormone deficiency (PGHD) [1] - The approval marks a significant milestone for the company in advancing its product pipeline [1]

证券代码：000661 证券简称：长春高新 公告编号：2025-147 长春高新技术产业（集团）股份有限公司 关于子公司注射用 GenSci140 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。 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《药物临床试验批准通知书》，金赛药业注射用 GenSci140 的 境内生产药品注册临床试验申请获得批准，现将相关情况公告如下： 一、药品的基本情况 产品名称：注射用 GenSci140 申请事项：境内生产药品注册临床试验 受理号：CXSL2500763 申请人：长春金赛药业有限责任公司 审批结论：经审查，同意本品开展临床试验 适应症：晚期实体瘤 二、药品的其它情况 GenSci140 是金赛药业自主研发的一款新型靶向叶酸受体α亚型（Folate Receptor Alpha, 以下简称"FRα"）的双表位抗体药物偶联物，属治疗用生物制品 1 类药物，拟用于局部晚期或转 ...

证券代码：000661 证券简称：长春高新 公告编号：2025-148 申请事项：境内生产药品注册临床试验 受理号：CXHL2500968 申请人：长春金赛药业有限责任公司 审批结论：经审查，同意本品开展临床试验 长春高新技术产业（集团）股份有限公司 关于子公司 GS3-007a 干混悬剂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。 近日，长春高新技术产业（集团）股份有限公司（以下简称"公司"）控股 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《药物临床试验批准通知书》，金赛药业 GS3-007a 干混 悬剂的境内生产药品注册临床试验申请获得批准，现将有关情况公告如下： 一、药品的基本情况 产品名称：GS3-007a 干混悬剂 适应症：用于生长激素缺乏症所致的儿童生长缓慢 二、药品的其它情况 GS3-007a 干混悬剂是金赛药业自主研发的口服小分子生长激素促分泌药物， 注册分类为化药 1 类，拟用于因内源性生长激素缺乏所引起的儿童生长缓慢 （PGHD）的治疗。 PG ...