长春高新公告称，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》，其 GenSci142胶囊注册临床试验申请获批，适应症为细菌性阴道病。该胶囊是1类创新生物制品，是创新药 临床试验审评审批"30日通道"推出后首个获批的新药临床试验申请。它具有快速起效等优势，对甲硝唑 耐药感染依然有效。若临床试验进展顺利，将利于公司优化业务与产品结构。不过，临床试验进程存在 不确定性。 ...

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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来源：瑞恩资本RyanbenCapital 中国企业赴香港上市，需要取得中国证监会的备案通知书。根据港交所上市规则，中国企业需在上市聆 讯审批日期至少4个营业日之前提交"备案通知书"。只有通过港交所的上市聆讯，企业才可以在港交所 挂牌上市。 本周(2025年11月10日至11月14日)中国证监会国际司共对10家企业(全部在香港上市)出具境外发行上市 备案补充材料要求，具体如下：微亿制造、融泰药业、华恒生物、魔视智能、望圆科技、晶晨半导体、 长春高新、英派药业、普源精电、艾米森。 微亿制造 请你公司补充说明以下事项，请律师核查并出具明确的法律意见： 一、请说明备案材料对控股股东认定结果不一致的原因及认定标准，并就控股股东的认定情况出具明确 结论性意见。 二、请说明国资管理程序办理进展。 三、请说明最近12个月内新增股东入股价格的合理性，该等入股价格之间存在差异的原因，是否存在利 益输送。 四、请按照《监管规则适用指引——境外发行上市类第2号：备案材料内容和格式指引》要求说明本次 发行上市方案，备案材料及招股说明书关于发行上市方案内容不一致的原因。 七、请说明发行人及下属公司经营范围涉及广告制作、发布、设计、代理 ...

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].

Core Viewpoint - Changchun High-tech's stock has experienced a decline in recent trading sessions, with significant net outflows of capital and a decrease in both revenue and net profit year-on-year [1][2]. Financial Performance - For the period from January to September 2025, Changchun High-tech reported operating revenue of 9.807 billion yuan, a year-on-year decrease of 5.60% [2]. - The net profit attributable to shareholders was 1.165 billion yuan, reflecting a substantial year-on-year decline of 58.23% [2]. Stock Market Activity - On November 21, Changchun High-tech's stock price fell by 2.01%, trading at 99.65 yuan per share, with a total market capitalization of 40.651 billion yuan [1]. - The stock has seen a year-to-date increase of 2.86%, but has declined by 4.69% over the last five trading days and 15.44% over the last 20 days [1]. Shareholder Information - As of September 30, 2025, the number of shareholders decreased by 4.63% to 104,100, while the average number of circulating shares per person increased by 4.85% to 3,840 shares [2]. - The top ten circulating shareholders include significant institutional investors, with Hong Kong Central Clearing Limited being the third-largest shareholder, increasing its holdings by 1.307 million shares [3]. Dividend Distribution - Since its A-share listing, Changchun High-tech has distributed a total of 4.791 billion yuan in dividends, with 3.259 billion yuan distributed over the past three years [3].

Group 1 - The core point of the announcement is the change in the equity structure of the controlling shareholder, Changchun Chaoda Investment Group, which is aimed at optimizing the resource allocation of state-owned enterprises [1][2]. - Before the change, Longxiang Group held 100% of the shares in Chaoda Group. After the change, Longxiang Group holds 81% and New District Industrial Investment Group holds 19% of Chaoda Group [2]. - The change in the equity structure of the controlling shareholder will not affect the number of shares or the shareholding ratio held by the company, nor will it change the controlling shareholder or actual controller of the company [3].

Group 1 - Changchun High-tech's controlling shareholder, Changchun Chaoda Investment Group, has undergone a change in its equity structure, with 19% of its shares being transferred to Changchun New Area Industrial Investment Group [2] - The transfer of shares is part of an internal optimization of state-owned assets as decided by the Changchun New Area State-owned Assets Supervision and Administration Bureau [2] - Despite the changes, the controlling position of Changchun Chaoda remains unchanged, with the actual controller still being the New Area State-owned Assets Bureau [2] Group 2 - In 2023, Changchun High-tech has made significant progress in the innovative drug sector, including the launch of the first domestic innovative biological agent for acute gouty arthritis [3] - The company has also established a partnership with Denmark's ALK-Abello A/S for allergen-specific immunotherapy products, expanding its product pipeline in the respiratory allergy field [3] - The company is focusing its core resources on promoting new products like Jinbeixin and Meishiya, aiming to cultivate these as new profit growth points [3]