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。 证券代码：000661 证券简称：长春高新 公告编号：2025-059 长春高新技术产业（集团）股份有限公司 关于子公司重组带状疱疹疫苗（CHO 细胞） 带状疱疹是由潜伏在机体内的水痘-带状疱疹病毒（VZV）重新被激活引起的 急性感染性皮肤病，该病毒具有嗜神经性，初次感染后可长期潜伏在脊髓神经后 根或脑神经节的神经元内，在某些诱因的刺激下，潜伏的病毒沿感觉神经移动到 达支配的皮肤，迅速增殖复制使受感染细胞发炎、坏死造成神经痛，并沿着神经 纤维通路到达皮肤表面，出现呈带状分布的红斑及簇集水疱。带状疱疹多发于老 年人和免疫低下人群，常伴剧烈的顽固性带状疱疹后神经痛（PHN），严重影响 患者生活质量。 本次百克生物获批临床的重组带状疱疹疫苗（CHO 细胞）接种对象为 40 岁 及以上成人，接种后可刺激机体产生抗水痘-带状疱疹病毒的免疫力，用于预防 带状疱疹。 1 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——长春百克生物科技股份公司（以下简称"百克生物"）收到国家 ...

证券代码：000661 证券简称：长春高新 公告编号：2025-058 长春高新技术产业（集团）股份有限公司 关于回购股份进展情况的公告 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。 长春高新技术产业（集团）股份有限公司（以下简称"公司"）于2024年 11月14日召开了第十一届董事会第六次会议，审议通过了《关于公司回购股份 方案的议案》，同意公司使用自有资金及金融机构股票回购专项贷款资金以集 中竞价交易方式回购部分公司已在境内发行的人民币普通股（A股）股票，全 部用于后续实施公司及子公司核心团队股权激励或员工持股计划。拟用于回购 资金总额不低于人民币3亿元（含）、不超过人民币5亿元（含），回购价格不 超过人民币160.00元/股。具体回购股份数量以回购期限届满时实际回购的股份 数量为准。 上述内容详见公司于2024年11月16日、2024年11月21日在《中国证券报》 《 证 券 时 报 》 《 上 海 证 券 报 》 《 经 济 参 考 报 》 及 巨 潮 资 讯 网 （ http://www.cninfo.com.cn）上分别披露的《关于公司回购股份方 ...

Core Viewpoint - Changchun High-tech Industry (Group) Co., Ltd. has announced the establishment of a partnership with professional investment institutions to enhance its investment capabilities and improve capital efficiency [1]. Group 1 - The company held its 11th Board of Directors' fifth meeting on October 24, 2024, where it approved a proposal to jointly invest with professional investment institutions to establish a partnership enterprise [1]. - The company will act as a limited partner alongside CITIC Jin Investment Management Co., Ltd. and Changchun Changfa Private Fund Management Co., Ltd. to establish an investment fund [1]. - The fund has completed the registration process with the Asset Management Association of China and has obtained the Private Investment Fund Registration Certificate [1]. Group 2 - The fund is named Changchun Xinghe Runxin Venture Capital Center (Limited Partnership) [1]. - The fund manager is CITIC Jin Investment Management Co., Ltd., and the custodian is CITIC Bank Co., Ltd. [1]. - The registration date for the fund is May 28, 2025, with the registration code SAXV26 [1].

证券代码：000661 证券简称：长春高新 公告编号：2025-057 长春高新技术产业（集团）股份有限公司 关于公司与专业投资机构共同投资进展 暨完成私募投资基金备案登记的公告 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。 为进一步提升产业投资能力，提高资金使用效率，长春高新技术产业（集团） 股份有限公司（以下简称"公司"）于 2024 年 10 月 24 日召开第十一届董事会第 五次会议审议通过了《关于公司拟与专业投资机构共同投资设立合伙企业的议案》， 同意公司作为有限合伙人与中信建投资本管理有限公司（以下简称"中信建投资 本"）、长春长发私募基金管理有限公司及其他有限合伙人共同出资成立投资基 金。具体内容详见公司于 2024 年 10 月 26 日披露的《关于公司拟与专业投资机构 共同投资设立合伙企业的公告》（公告编号：2024-107）。 近日，公司收到基金管理人通知，该基金已在中国证券投资基金业协会完成 备案手续，取得了《证券公司私募投资基金备案证明》，备案信息如下： 基金名称：长春星河润信创业投资中心（有限合伙） 管理人名称：中信建投资本管理有限 ...

Core Viewpoint - The company has received FDA approval for clinical trials of GenSci128 tablets, a targeted therapy for patients with TP53 Y220C mutation in advanced or metastatic solid tumors [1][2]. Group 1: Drug Information - Product Name: GenSci128 tablets - Application: Clinical trial approval in the US - Acceptance Number: IND 174059 - Applicant: Changchun JinSai Pharmaceutical Co., Ltd. - Approval Conclusion: Permission granted for clinical trials in the US - Indication: Local advanced or metastatic solid tumors with TP53 Y220C mutation [1]. Group 2: Drug Mechanism and Development - GenSci128 is a class 1 new chemical drug designed as a selective reactivator for TP53 Y220C mutation, aiming to restore the normal conformation and function of the mutated protein [2]. - Preclinical data indicates that GenSci128 has good efficacy and safety [2]. - The drug has also been approved for clinical trials in China for the same indication [2]. Group 3: Company Impact - Successful progress in clinical trials could help the company expand its business structure, optimize product offerings, and enhance core competitiveness [3]. - The company will actively promote the research and development of this project and comply with disclosure obligations regarding project progress [4].

Group 1: Company Strategy and Development - The company aims to establish a globally influential biopharmaceutical group, focusing on innovation in the health sector and internationalization as a guiding strategy [2] - The company will enhance innovation investment and cooperation to cultivate new economic growth points, while also improving brand value and operational efficiency [2][3] - The company emphasizes a principle of "optimizing existing resources, enhancing new growth, and strengthening research and development" [2] Group 2: Product Development and Market Position - The company has approved 12 indications for its growth hormone products, maintaining a leading market share in China [4][5] - The long-acting growth hormone has undergone extensive clinical trials, demonstrating safety and efficacy with over 10,000 real-world applications [4] - The company is actively promoting its growth hormone products through educational initiatives to enhance understanding among healthcare professionals and patients [5] Group 3: Financial Performance and Investor Relations - As of April 30, 2025, the company has repurchased 3,894,517 shares, accounting for 0.95% of its total share capital, with a total transaction amount of approximately RMB 399.99 million [15] - The company is committed to optimizing resource allocation while controlling costs to ensure a balance between research investment and output efficiency [13][14] - The company will continue to enhance transparency in investor relations through various communication channels [15] Group 4: Research and Development - The company is focused on high-quality development through innovation, with plans to explore cutting-edge technologies and establish an intelligent research platform [10][14] - The company is preparing for European market applications for several products, including short-acting growth hormone and other innovative drugs [8] Group 5: Real Estate and Asset Management - The company is actively managing its real estate segment, focusing on inventory reduction and transitioning to a light asset operation model [11][12] - The real estate division is involved in urban renewal projects, integrating with the pharmaceutical sector to enhance resource utilization [11]

Core Viewpoint - Changchun High-tech (000661.SZ) announced that its subsidiary, Jinsai Pharmaceutical, received approval from the US FDA to conduct clinical trials for GenSci128 tablets, a selective reactivator targeting the TP53 Y220C mutation for treating locally advanced or metastatic solid tumors carrying this mutation [1] Group 1 - GenSci128 tablets have already been approved for clinical trials in China [1] - Successful progress in the clinical trial application will help the company broaden its business structure and optimize its product portfolio [1] - The development of GenSci128 is expected to enrich and enhance the strategic product line layout, thereby improving the company's core competitiveness [1]

Core Viewpoint - Changchun High-tech's reliance on its subsidiary, Jinsai Pharmaceutical, raises concerns about governance issues amid rapid expansion, particularly regarding recruitment practices and potential favoritism [1][2]. Group 1: Company Overview - Jinsai Pharmaceutical, established in 1996, is a core subsidiary of Changchun High-tech, known for launching China's first recombinant human growth hormone, significantly reducing reliance on imports [1]. - The company has maintained a market share exceeding 80% in the growth hormone sector, with its main products contributing nearly 90% of its revenue in 2023 [1][2]. Group 2: Financial Performance - In 2023, Changchun High-tech reported revenue of 14.566 billion yuan, with Jinsai contributing 11.084 billion yuan, accounting for 76% of total revenue [2]. - Jinsai's net profit for 2023 was 4.514 billion yuan, representing 99.6% of the group's total profit, highlighting the company's heavy dependence on Jinsai's performance [2]. - Jinsai's revenue in 2024 decreased by 3.73% to 10.671 billion yuan, with net profit dropping by 40.67% to 2.678 billion yuan, indicating significant challenges ahead [2]. Group 3: Recent Developments - In Q1 2025, Jinsai achieved revenue of 2.617 billion yuan, a year-on-year increase of 5.94%, driven by improved market penetration of long-acting growth hormones [2][3]. - Despite revenue growth, net profit attributable to the parent company fell by 38.31% to 535 million yuan due to increased sales expenses and ongoing investments in R&D for new products [2][3]. - Jinsai is focusing on product structure optimization, with long-acting growth hormone sales increasing to 35% of total revenue, and a 60% growth in nutritional product sales [3]. Group 4: Strategic Initiatives - Jinsai is actively pursuing business diversification and international expansion, with overseas sales revenue increasing by 454% in 2024 [3]. - The company aims to strengthen its internal management and operational efficiency to better compete in the increasingly crowded growth hormone market [3].

Group 1 - The company has established a partnership with Tianlu Technology to create a new AI pharmaceutical company, Saiwu Jianfei, to enhance collaboration and expand related business [1] - The management highlighted that Meishiya possesses significant advantages in technology, clinical needs, and commercialization capabilities, with minimal competition in the short term as the only nano-formulation in a blue ocean market [1] - The company is actively promoting the approval process for its products, with the powder formulation expected to be approved this year, while similar products from competitors are still in clinical stages [2] Group 2 - The company has implemented a series of compliance management systems for recruitment and assessment over its 30-year development, addressing concerns about hiring practices and employee experiences [3] - The company plans to optimize a small portion of its workforce while ensuring the stability of its core team, aiming to enhance efficiency and reduce costs in alignment with its strategic planning [3] - The company is committed to responding to industry trends by increasing innovation investments and introducing cutting-edge pharmaceutical products and technologies across various sectors [2]