格隆汇11月27日丨长春高新(000661.SZ)公布，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 GenSci142 胶囊注册临床试验申请获得批准，GenSci142 胶囊是金赛药业开发的一款 1 类创新生物制 品，拟用于细菌性阴道病的治疗。 ...

Core Viewpoint - Changchun High-tech (000661.SZ) announced that its subsidiary, Changchun Jinsai Pharmaceutical Co., Ltd. (referred to as "Jinsai Pharmaceutical"), has received the Clinical Trial Approval Notification issued by the National Medical Products Administration, allowing the registration clinical trial application for GenSci142 capsules to proceed [1] Group 1 - Jinsai Pharmaceutical's GenSci142 capsules are classified as a Class 1 innovative biological product [1] - The intended use of GenSci142 capsules is for the treatment of bacterial vaginosis [1]

Core Viewpoint - Changchun High-tech announced that its subsidiary, Gensci Pharmaceutical, received approval from the National Medical Products Administration for the clinical trial of GenSci142 capsules, aimed at treating bacterial vaginosis. This marks the first new drug clinical trial application approved under the "30-day channel" for innovative drug review and approval [1] Group 1 - The GenSci142 capsule is classified as a Class 1 innovative biological product [1] - The capsule has advantages such as rapid onset of action and remains effective against metronidazole-resistant infections [1] - Successful progress in clinical trials could help the company optimize its business and product structure [1] Group 2 - There is uncertainty regarding the clinical trial process [1]

Core Viewpoint - Changchun High-tech announced that its subsidiary, Gensci Pharmaceutical, received approval from the National Medical Products Administration for the clinical trial application of GenSci142 capsules, an innovative biological product aimed at treating bacterial vaginosis. This approval marks the first clinical trial application granted under the "30-day channel" for innovative drug review and approval since its introduction [1]. Group 1 - Gensci Pharmaceutical's GenSci142 capsules are classified as a Class 1 innovative biological product [1]. - The approval is significant as it represents a milestone in the expedited review process for innovative drugs in China [1]. - The product is specifically intended for the treatment of bacterial vaginosis, indicating a targeted therapeutic approach [1].

证券代码：000661 证券简称：长春高新 公告编号：2025-150 长春高新技术产业（集团）股份有限公司 关于子公司 GenSci142 胶囊国内生产药品注册临床试验申请 获得批准的公告 细菌性阴道病（BV）是育龄期女性中最常见的阴道感染性疾病之一，存在 巨大的临床未满足需求。BV 病理机制主要表现为兼性及专性厌氧菌，尤其以加 德纳菌的过度增殖最为显著。目前，临床推荐药物主要为抗厌氧菌类抗生素，如 硝基咪唑类（如甲硝唑、替硝唑）和克林霉素。但其长期控制效果不理想，并且 加德纳菌极易对甲硝唑产生耐药，从而导致治疗失败并诱发复发。严重影响患者 1 的生活质量。 GenSci142 胶囊通过生物信息学筛选序列，通过 AI 设计优化分子结构，可 直接破坏细菌细胞壁，选择性快速杀细菌性阴道炎的主要病原体，充分保留保护 性乳杆菌，同时，穿透并瓦解生物膜，使致病菌无藏身死角，减少复发。本产品 临床反应迅速，有望 12 小时内症状显著减轻，对甲硝唑耐药感染（90%的耐药比 例）依然有效，通过阴道局部给药，无全身暴露风险，使用安全。与传统药物相 比，具有快速起效、精准杀菌、深度清除、低耐药风险和局部作用安全等核心优 势。 ...

在痛风防治领域，双方将共同探索构建覆盖尿酸监测、用药管理及长期随访的数字化防治体系；在呼吸 与过敏领域，依托专业管线产品，聚焦于构建从预防、诊断到治疗与康复的线上支持体系，让专业健康 服务更加可及；在营养补充领域，双方将整合研发与渠道优势，最终旨在为各年龄段人群提供精准营养 与体重管理解决方案等。 据介绍，随着本次战略合作的达成，金赛药业全球首款长效痛风药物"金蓓欣"伏欣奇拜单抗将在京东健 康开启预约。 此前在11月13日晚间，京东健康发布的2025年第三季度业绩报告显示，期内实现收入171.2亿元，同比 增长28.7%；非国际财务报告准则指标下(Non-IFRS)净利润为19亿元，同比增长42.4%。报告期内，京东 健康全网首发超30款新特药，持续巩固"新特药全网首发第一站"优势。 11月26日，京东健康与金赛药业签署战略合作协议。双方将聚焦儿童健康、痛风、呼吸与过敏、女性健 康、营养补充等六大领域，打造以患者为中心的疾病全周期健康管理解决方案。 官网显示，金赛药业是一家创新驱动的全产业链制药企业。作为长春高新（000661）控股子公司，金赛 药业拥有完整的研产销全产业链体系，年营收超百亿元，已推出核心产品 ...

Group 1 - The company is currently facing significant price reductions in the long-acting growth hormone due to collective procurement by provincial alliances, raising concerns about the potential impact on net profit when nationwide procurement occurs [1] - The company is unable to predict the future sales policies for new products as they will be determined based on policy requirements, industry conditions, and market situations [1] - The recent change in the controlling shareholder's equity structure is aimed at optimizing the resource allocation of state-owned enterprises and is not expected to affect the company's normal operations [1] Group 2 - The company is exploring the potential revenue and profit from its gout medication, which is anticipated to enter the medical insurance system, although specific timelines and financial impacts remain uncertain [1] - The company emphasizes that any significant developments that meet disclosure standards will be communicated in accordance with information disclosure obligations [1]

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Core Viewpoint - The China Securities Regulatory Commission (CSRC) has issued supplementary material requirements for 10 companies seeking to list in Hong Kong, indicating a rigorous review process for overseas listings by Chinese firms [2][5][7]. Group 1: Regulatory Requirements - Chinese companies must obtain a filing notice from the CSRC before listing in Hong Kong, and this notice must be submitted at least four business days prior to the listing hearing [2]. - The CSRC's International Department has requested additional information from companies including Micro Manufacturing, Rongtai Pharmaceutical, and others regarding their compliance with regulatory guidelines [2][5]. Group 2: Company-Specific Inquiries - **Micro Manufacturing**: The company is required to clarify the reasons for inconsistencies in the identification of controlling shareholders and provide legal opinions on the matter [2]. Additionally, it must explain the reasonableness of the share prices for new shareholders over the past 12 months and whether there are any issues of interest transfer [2][3]. - **Rongtai Pharmaceutical**: Similar to Micro Manufacturing, it must justify the share prices for new shareholders and confirm compliance with regulatory guidelines regarding its business operations [5][6]. - **Hua Heng Biological**: The company needs to provide details on its technology export activities and confirm compliance with regulations prohibiting certain overseas listings [7][8]. - **Magic Vision Technology**: The company is asked to clarify the pricing basis for share transfers and the legality of its historical equity changes [9][10]. - **Wangyuan Technology**: The company must explain the rationale behind share transfer pricing and the implications of its previous A-share listing application [13][14]. - **Jingchen Semiconductor**: The company is required to provide updates on its capital changes and the operational status of its subsidiaries [18][19]. - **Changchun High-tech**: The company must clarify the ownership structure of its controlling shareholders and the implications of any share pledges [20][21]. - **Inpai Pharmaceutical**: The company needs to address the pricing basis for its equity changes and confirm compliance with foreign investment regulations [25][26]. - **Puyuan Precision Electronics**: The company is required to clarify its overseas investment compliance and the operational status of its subsidiaries [27][28]. - **Aimeson**: The company must provide details on its historical equity changes and the implications of its shareholder structure on compliance with foreign investment regulations [29][30].

Core Viewpoint - The article discusses the recent equity transfer of Changchun High-tech Industry (Group) Co., Ltd., which is in the critical phase of its IPO process in Hong Kong, highlighting the company's challenges and strategic moves in the rapidly changing pharmaceutical industry [2][4]. Group 1: Equity Transfer and Control - Changchun High-tech announced that its controlling shareholder, Changchun Chaoda Investment Group Co., Ltd., will transfer 19% of its shares to Changchun New Area Industrial Investment Group Co., Ltd. without compensation [2]. - The equity structure change does not alter the controlling status of Chaoda Group, with the actual controller remaining the New Area State-owned Assets Supervision and Administration Commission [2]. Group 2: IPO Plans - In September 2023, the company submitted its main board listing application to the Hong Kong Stock Exchange, aiming for a dual listing in "A+H" markets [4]. - The IPO proceeds are intended for innovation pipeline research and development, potential global collaborations, overseas market expansion, and enhancing sales and marketing capabilities [4]. Group 3: Financial Performance - As of the third quarter of 2025, Chaoda Group holds 18.69% of Changchun High-tech's shares, with approximately 38.03 million shares pledged, accounting for 9.32% of the total share capital [5]. - The company faced significant financial challenges, with a 7.55% year-on-year revenue decline to 13.466 billion yuan and a 43.01% drop in net profit to 2.583 billion yuan in 2024 [10]. - In the first three quarters of 2025, revenue was 9.807 billion yuan, down 5.60% year-on-year, and net profit was 1.165 billion yuan, down 58.23% [10]. Group 4: Business Challenges - The company’s core subsidiary, Jinsai Pharmaceutical, experienced a slowdown in sales growth, particularly for its long-acting growth hormone product, due to increased competition and price reductions from centralized procurement policies [10][11]. - The vaccine business, seen as a "second growth curve," also faced challenges, with a 53.76% decline in revenue for Baike Biological in the first three quarters of 2025 [11]. Group 5: Strategic Outlook - The company aims to transition from a regional leader to a global biopharmaceutical platform through its dual listing, which is expected to attract international investors and accelerate innovation and international business expansion [11]. - Analysts suggest that without restructuring its product matrix and improving innovation efficiency, the company may struggle to regain investor confidence in the long term [11].