【#长春高新回应儿童小阴茎专用药获批#：上市至少要三年】#儿童小阴茎专用药上市至少三年#27日， 长春高新股价开盘走低，一度跌超4%。截至发稿，长春高新报95.88元/股。对于股价走势，@中新经纬 以投资者身份致电长春高新证券部，一位工作人员回应称，"股价涨跌背后，没有特殊原因。"2月24 日，长春高新发布公告称，子公司金赛药业GenSci141软膏境内生产药品注册临床试验申请获得批准。 该药品用于改善因高促性腺激素性性腺功能减退症、5α-还原酶2缺乏症、雄激素合成减少的先天性肾上 腺皮质增生症、特发性原因导致的儿童小阴茎。对于GenSci141软膏的研发进展，上述工作人员回应 称，基于对药物研发的通常理解，一切顺利的情况下，从临床获批到上市的周期，至少也要三年。但每 一个试验阶段都存在不确定性，都会影响到后续药品上市的时间。 转自：贝壳财经 ...

来源：每经网 2月26日，长春高新股价继续收涨，周涨幅超12%。其子公司金赛药业GenSci141软膏临床试验申请获 批，这是全球首款针对儿童小阴茎的药物，但项目尚处早期。近两年，长春高新业绩承压，2025年净利 预计下滑超90%，正转型布局多领域。去年12月金赛药业子公司签订独家许可协议，不过相关款项2025 年度尚未确认，未能改善业绩。 ...

连续多日下跌的长春高新，股价罕见狂拉。 二级市场行情显示，2月25日和26日两个交易日，长春高新股价涨幅达11.4%，截至26日收盘报98.50元/ 股，总市值401.8亿元。 消息层面，长春高新2月25日公告披露，旗下子公司金赛药业GenSci141软膏境内生产药品注册临床试 验申请获国家药监局批准，适应症为改善因高促性腺激素性性腺功能减退症、5α-还原酶2缺乏症、雄激 素合成减少型先天性肾上腺皮质增生症及特发性原因导致的儿童小阴茎。 上述药物本次只是拿到了临床试验的批准，距离上市或还有很长的路要走。 长春高新在公告中指出，本次临床试验进程尚存在不确定性。敬请广大投资者谨慎决策，注意防范投资 风险。 据时代周报报道，长春高新相关人士表示，目前该药物只是拿到了临床试验的批准，暂未开始进行临床 研究。"上市时间还不确定，后续从临床试验、上市申报再到最终获批上市还需较长时间。" 另据智通财经，长春高新称，一切信息应以公告披露内容为准，该产品当前仅获批开展此前公告所述临 床试验，适应症需严格按照批件执行。GenSci141为一款2.2类改良型新药，目前处于临床前向临床过渡 阶段。从研发周期看，即便进展顺利，从临床到 ...

记者丨韩利明 编辑丨季媛媛 张伟贤 曾静娇 2月25日，长春高新（000661.SZ）以涨停收盘，报97.26元/股，收获2026年开年以来首个涨停；2月26日 公司股价持续上行，截至14：30左右，报100元/股，涨幅2.82%，总市值达408亿元，股价两日累计涨超 12%。 | | 100.00 +2.74 +2.82% | | | | | 広官同射 000661 | | --- | --- | --- | --- | --- | --- | --- | | SZSE CNY 14:33:33 交易中 | | | | | | 通融/ + | | 委比 | 80.74% 委差 | 3758 | Wind ESG评级 | BBB | | 详情 | | 卖五 | 100.05 | 122 | રેસ | 8.05% 120日 | | -3.22% | | 卖四 | 100.04 | 42 | 5日 | 13.52% 250日 | | 4.97% | | 卖三 | 100.03 | 130 | 20日 | 2.36% 52周高 | | 141.77 | | 卖二 | 100.02 | વેરુ | 60日 | 0 ...

近日，长春高新发布公告称，子公司金赛药业GenSci141软膏境内生产药品注册临床试验申请获得批准，该药品用于 改善因高促性腺激素性性腺功能减退症、5α-还原酶2缺乏症、雄激素合成减少的先天性肾上腺皮质增生症、特发性的 原因导致的儿童小阴茎。 （长春高新公告） ...

长春高新公告，子公司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GenSci141软膏境内生产药品注册临床试验申请获得批准。GenSci141软膏是金赛药业研发的一款 双氢睾酮软膏，属于化学药品2.2类、2.4类。 ...

尽管隆培生长激素的官方定价尚未公布，但市场对其讨论热度居高不下。参考全球定价，该产品在美国 的年治疗成本高达50万至60万元，而国内市场普遍预判，其本土年治疗费用将大幅低于这一水平。这种 兼顾品质与性价比的潜在优势，进一步放大了市场期待。 一旦这条路径走通，不仅能帮助维昇药业抢占高端市场先机，更有望推动整个生长激素赛道的发展逻辑 重构，这将是一个不同于以往的里程碑式转折。 近日，维昇药业核心产品隆培生长激素注射液（维臻高，Skytrofa）获批上市，用于治疗儿童生长激素 缺乏症（PGHD），是全球唯一优效于日制剂的长效生长激素。 自此，国内长效生长激素阵营已扩容至4款产品，呈现出鲜明的分化特征。其中，唯有隆培生长激素采 用天然分子结构，与人体自身分泌的生长激素氨基酸序列完全一致，而其余产品均为重组分子结构。 可以说，隆培生长激素的登场，既是维昇药业瞄准市场痛点的一次差异化布局，更是长效生长激素赛道 的一次突破性"社会实验"。 2月2日，维昇药业召开投资人交流会，与投资者展开深度交流，围绕这款产品的临床价值与未来商业化 路径，主动、清晰且坦诚地向市场传递公司的判断与战略思考。 唯一实现迭代性突破的产品，拥有独特 ...

Core Viewpoint - Changchun High-tech's 2025 performance forecast indicates a significant decline in key financial metrics, with net profit expected to drop by 91.48%-94.19% compared to 2024, reflecting ongoing challenges in the company's operations [1][2]. Financial Performance - The company anticipates a net profit attributable to shareholders of 150 million to 220 million yuan for 2025, a drastic decrease from 2.583 billion yuan in 2024 [1][2]. - The non-recurring net profit is projected to decline by 82.09%-84.56%, with basic earnings per share shrinking from 6.42 yuan to between 0.37 yuan and 0.55 yuan [1][2]. - For the first three quarters of 2024, the company reported a revenue of 9.807 billion yuan, down 5.60% year-on-year, and a net profit of 1.165 billion yuan, down 58.23% year-on-year, indicating worsening performance in the fourth quarter [2]. Business Challenges - The decline in performance is attributed to multiple pressures, including pricing adjustments in the growth hormone business following its inclusion in the medical insurance catalog, ongoing losses from subsidiary Baike Biology, and high costs associated with R&D and new product market cultivation [2][3]. - The growth hormone business, which is a key revenue driver, faces significant profit margin compression due to new pricing policies and increased competition from generic drug manufacturers [5][6]. Market Dynamics - The inclusion of long-acting growth hormone in the national medical insurance catalog is seen as a double-edged sword; while it expands patient access, it also necessitates price reductions that adversely affect profit margins [5][6]. - The competitive landscape has intensified, with the market no longer dominated by JinSai Pharmaceuticals, leading to increased pricing pressure and reduced profit contributions from the growth hormone segment [6][12]. Innovation and Strategic Initiatives - Despite short-term pressures, JinSai Pharmaceuticals is advancing its innovation and internationalization strategies, with multiple new product approvals and collaborations aimed at expanding market reach [3][8]. - The company has submitted an H-share listing application to the Hong Kong Stock Exchange, aiming to enhance financing channels and support its growth strategy [11]. - Significant R&D investments are being made, with R&D expenses reaching 1.733 billion yuan in the first three quarters of 2025, representing a 22.96% increase year-on-year [9][12]. Future Outlook - The successful commercialization of innovative products, such as JinBeiXin® and MeiShiYa®, which have been included in the medical insurance catalog, is expected to drive revenue growth and offset declines in traditional segments [9][12]. - The internationalization strategy, including partnerships and market expansion efforts, is anticipated to open new growth avenues and enhance the company's competitive position in the global market [11][12].

Core Viewpoint - Changchun High-tech announced that its subsidiary, Jinsai Pharmaceutical, has had its clinical trial application for the domestically produced injectable GenSci136 accepted by the National Medical Products Administration, marking a significant step in the development of a new treatment for myasthenia gravis [1] Group 1: Product Development - GenSci136 is a Class 1 biological product designed to treat generalized myasthenia gravis, featuring a novel drug structure and a dual-target mechanism of action [1] - The drug aims to provide better treatment options for patients with myasthenia gravis in China [1] Group 2: Business Impact - The progress of this application is expected to broaden the company's business structure and enhance its core competitiveness [1] - The clinical trial process, however, still carries uncertainties that could affect the timeline and outcomes [1]

Investment Rating - The report maintains a rating of "Buy" for the pharmaceutical and biotechnology sector [5]. Core Insights - The report emphasizes the continuous focus on investment opportunities related to AI in healthcare, driven by the growth of Tencent's AI applications and the need for data-driven solutions in medical settings [2][21]. - The investment logic centers around "data closed-loop" and "scene demand," highlighting AI's role as a core productivity driver in healthcare under the dual pressures of cost control and technological advancements [22]. - The report outlines a three-stage clinical value investment strategy, focusing on innovative drug chains and medical devices, with specific recommendations for companies in these sectors [3][27]. Summary by Sections Market Review - Last week, the A-share pharmaceutical and biotechnology index fell by 3.31%, underperforming the CSI 300 index by 3.39 percentage points and ranking 22nd among 31 sub-industries [1][15]. - The Hong Kong Hang Seng Medical Health Index also declined by 2.98%, lagging behind the Hang Seng Index by 4.69 percentage points [1][15]. R&D Progress - Recent developments include new drug applications from companies such as Hengrui Medicine and Innovent Biologics, with ongoing clinical trials for various products [30]. Key Companies and Valuation - The report provides a detailed earnings forecast and valuation table for key companies, recommending "Buy" for several firms including Innovent Biologics, WuXi AppTec, and Mindray Medical [4][27]. AI Healthcare Investment Focus - The report identifies several core areas for AI in healthcare, including AI drug development, medical imaging, chronic disease management, and surgical robotics, emphasizing the importance of proprietary data and business scenarios for competitive advantage [22][24]. Annual Investment Strategy - The report suggests that the investment focus should increasingly emphasize the clinical value of pharmaceuticals, with a positive outlook on innovative drug chains and high-end medical devices [3][26].