格隆汇2月24日丨长春高新(000661.SZ)公布，子公司——长春金赛药业有限责任公司（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。 ...

证券代码：000661 证券简称：长春高新 公告编号：2026-010 长春高新技术产业（集团）股份有限公司 关于子公司 GenSci141 软膏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 GenSci141 软膏境内 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：GenSci141 软膏 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：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。 二、药品的其它情况 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。 儿童小阴茎的治疗方法包括药物治疗、手术治疗及心理疏导等 ...

该药品适应症：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。 智通财经APP讯，长春高新(000661.SZ)公告，公司子公司——长春金赛药业有限责任公司(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GenSci141软膏境内 生产药品注册临床试验申请获得批准。 ...

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。 ...

Core Viewpoint - Changchun Gaoxin responded to investor inquiries regarding management expenses, emphasizing the inclusion of employee compensation, depreciation, and office expenses, and stated that detailed information is available in the regular reports [1] Group 1 - The company is committed to establishing and improving expense control, decision-making mechanisms, and internal control systems [1] - The company aims to ensure the compliant use of funds [1]

Group 1 - The company, Changchun Gaoxin, stated that the specifics of the medical insurance negotiation depend on government policies and final results, and currently, there is no detailed information available to share [2]

Group 1 - The company, Changchun Gaoxin (000661), responded to investor inquiries on February 13, indicating that its operating performance should be monitored through regular reports [1]

Core Viewpoint - Changchun Gaoxin (000661) is collaborating with Danish company ALK-Abelló A/S to develop specific immunotherapy products for house dust mite (HDM) allergens, which includes both subcutaneous and sublingual formulations [1] Group 1: Product Information - The house dust mite allergen preparation (Antodada) is a subcutaneous immunotherapy product that is already commercially available [1] - The sublingual tablet (ACARIZAX) is the world's first approved sublingual immunotherapy tablet for allergic asthma and allergic rhinitis, having received regulatory approval in multiple countries including Europe and the US [1] - ACARIZAX is currently being applied in the Greater Bay Area of China and the Boao Lecheng Medical Pilot Zone, with clinical research ongoing in China [1]

Core Viewpoint - Changchun High-tech, known as "Northeast Medicine King," is facing a dramatic decline in performance, with a projected net profit of only 150 million to 220 million yuan for 2025, representing a year-on-year drop of over 90%, marking the worst performance in nearly two decades [1][6]. The company reported a staggering quarterly loss of nearly 1 billion yuan in Q4, with a year-on-year increase in losses of approximately 360% to 390% [1][6]. Group 1: Dependency on Single Product - The core issue behind the sharp decline in Changchun High-tech's performance is its long-standing reliance on the growth hormone business, which has been the company's profit pillar [2][7]. The net profit from its subsidiary, Jinsai Pharmaceutical, was nearly equal to the company's overall net profit in 2022 and 2023, highlighting its over-dependence [2][7]. - The inclusion of the core product, long-acting growth hormone "Jinsai Zeng," in the national medical insurance directory by the end of 2025 led to a price drop of approximately 75% for its 9mg specification, significantly eroding profit margins [2][7]. - The growth hormone market has shifted from a monopoly to intense competition, with similar products from companies like Teva and Novo Nordisk entering the market, breaking Changchun High-tech's previous technical barriers and market monopoly [2][7]. Group 2: Challenges in Transition - Recognizing the risks of putting all eggs in one basket, Changchun High-tech has been actively promoting transformation and increasing R&D investment, with R&D expenses expected to account for 20% of revenue in 2024 and a 23% year-on-year increase in R&D investment in the first three quarters of 2025 [3][8]. - However, the long and risky cycle of innovative drug development means that new products, such as the gout drug "Jin Peixin" and the cancer anorexia treatment "Mei Shiya," generated less than 160 million yuan in sales in the first three quarters of 2025, contributing minimally to overall performance [3][8]. - The company's sales expenses have been rising, with a sales expense ratio of 38.38% in the first three quarters of 2025, reflecting the need for deeper market coverage for mature products and significant resource investment for new product market education [3][8]. Group 3: Future Outlook - Industry analysis indicates that Changchun High-tech is currently in a transitional phase characterized by the "old engine losing power and the new engine not yet reaching speed" [4][9]. The impact of price reductions from medical insurance will take time to digest, and new products face multiple barriers before becoming performance pillars [4][9]. - In the short term, the company's performance may continue to be under pressure due to uncertainties in innovative drug development, underwhelming new product sales, and changes in industry policies [4][9]. - However, from a long-term perspective, as the price system for growth hormones stabilizes and market penetration improves with the support of medical insurance, this business may still provide a stable cash flow foundation for the company [4][9]. The ability to cultivate second and third growth curves through sustained high R&D investment will be crucial for Changchun High-tech to navigate the cycle and return to a growth trajectory [4][9].

Core Viewpoint - The simultaneous release of refinancing optimization measures by Shanghai, Shenzhen, and Beijing stock exchanges marks a significant transformation in China's capital market, aimed at enhancing capital allocation efficiency and reshaping the A-share market landscape [1]. Group 1: Policy Framework and Differences - The policy frameworks of the three exchanges are highly similar, focusing on "supporting the strong, limiting the weak, promoting innovation, and enhancing convenience and regulation" [2]. - Shanghai Stock Exchange emphasizes "main board" characteristics, tailoring financing rules for large, mature technology companies [2]. - Shenzhen Stock Exchange adopts a bolder stance on supporting technology innovation, easing fundraising restrictions for growth-oriented enterprises [2]. - Beijing Stock Exchange focuses on "innovative small and medium-sized enterprises," addressing their financing challenges with flexible policies [2]. Group 2: Strategic Insights on Separate Announcements - The decision to release policies on the same day rather than a joint announcement reflects the nuanced wisdom of tiered regulation in China's capital market [3]. - Different market positioning allows each exchange to cater to the unique characteristics and needs of the enterprises they serve, avoiding a one-size-fits-all approach [3]. - The simultaneous release creates a strong policy resonance, reinforcing market perception of deepening capital market reforms while maintaining the distinct identities of each exchange [3]. Group 3: Deep Impacts on Market Perception - The new measures aim to shift the long-standing fear of "blood-sucking" effects of refinancing, which was believed to drain market funds and destabilize the market [4]. - The principle of "supporting the strong, limiting the weak" will act as a catalyst for market differentiation, favoring quality companies, especially in hard technology, while raising barriers for poorly performing firms [4]. - The policy directs resources towards "new productive forces," providing strong support for leading companies in sectors like semiconductors, AI, biomedicine, and high-end manufacturing [5]. - Allowing companies that have experienced stock price declines to raise funds through methods like private placements and convertible bonds offers a lifeline to solid businesses facing temporary challenges [6]. - A complete regulatory loop is established, tightening post-fundraising supervision while relaxing initial approvals, transforming refinancing from a mere "money-raising tool" to an "engine" for corporate development [7]. Group 4: Implications for Investors - The coordinated actions of the three exchanges signify the entry of China's refinancing mechanism into a "precise drip irrigation" era, providing tailored financing support for different types of enterprises [8]. - Investors are advised to focus on genuinely innovative and well-governed companies while avoiding those that merely chase trends without substance [8]. - The transformation of refinancing from a "blood-sucking machine" to a "blood-producing pump" is expected to enhance the value discovery function of the A-share market, leading to a healthier and more vibrant capital market [8].