证券代码：000661 证券简称：长春高新 公告编号：2026-009 审批结论：经审查，同意本品开展临床试验 长春高新技术产业（集团）股份有限公司 关于子公司注射用 GenSci136 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》，金赛药业注射用 GenSci136 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：注射用 GenSci136 申请事项：境内生产药品注册临床试验 受理号：CXSL2600033 申请人：长春金赛药业有限责任公司 适应症：用于免疫球蛋白 A 肾病（IgAN） 二、药品的其它情况 注射用 GenSci136 是金赛药业自主研发的一款治疗用生物制品 1 类药物，拟 用于治疗免疫球蛋白 A 肾病（IgAN）。 IgAN 是全球范围内最常见的原发性肾小球肾炎之一，在 ...

Core Viewpoint - The company is currently experiencing short-term profit impacts due to increased investments in new product development and global expansion, but management remains focused on enhancing core competitiveness through innovation in the biopharmaceutical sector to achieve sustainable high-quality growth [1] Group 1 - The company is investing heavily in new product layouts and global expansion, which is affecting net profit in the short term [1] - Management emphasizes a commitment to focusing on the biopharmaceutical core business and deepening innovation-driven strategies [1] - The goal is to continuously improve the company's core competitiveness for stable and high-quality development in the long run [1]

Group 1 - The core viewpoint of the article is that Changchun Gaoxin (000661) emphasizes strict adherence to its compensation system for assessing the salaries of relevant personnel [1] Group 2 - The company responded to investor inquiries on its interactive platform regarding its compensation practices [1]

Core Viewpoint - Changchun High-tech emphasizes its commitment to balancing operational development and shareholder returns through strict internal control and auditing mechanisms for all expenditures [2] Group 1: Financial Management - The company states that its three major expenses are focused on the development of the biopharmaceutical industry, research and innovation, market expansion, and compliance operations [2] - All expenditures are subject to strict internal control approval, audit supervision, and information disclosure mechanisms [2] Group 2: Shareholder Returns - The company adheres to profit distribution rules while considering the industry's development stage for comprehensive planning [2] - Future efforts will focus on enhancing the precision of expense management and improving capital efficiency [2] - The company aims to balance long-term development of its core business with reasonable returns for shareholders, ensuring the interests of all shareholders are maintained [2]

Group 1 - Changchun High-tech is expected to incur a loss of 1 billion in the fourth quarter due to product price adjustments, while investing over 2 billion annually in R&D to reduce reliance on growth hormones [1] - Vanke's losses are deepening, with a projected loss of 82 billion by 2025, and a bond extension of 6.8 billion as it seeks financial support [1] - GAC Group has issued a rare profit warning, expecting a loss between 8 billion to 9 billion, as CEO Feng Xingya emphasizes the "three major battles" for a turnaround [1] Group 2 - Nanhai Rural Commercial Bank was fined 3.8 million, with its net interest margin dropping to 1.15% after eight years of no results in the A-share market [1] - Yuanji Food is closing one out of every three new stores, with related party transactions amounting to 130 million involving the wife of its founder [1] - "Cheese Queen" Chai Xiu faced backlash from aggressive marketing strategies, leading to a 70% drop in the stock price of Miao Ke Lan Duo, with Mengniu taking full control [1] Group 3 - Zijin Mining is investing an additional 28 billion in overseas ventures, projecting a profit of 51 billion by 2025, with its market value stabilizing above 1 trillion [1] - Hunan Gold is restructuring 2.7 billion in assets to increase resource reserves, benefiting from rising prices of antimony and tungsten, achieving record profits exceeding 1.27 billion [1] - A major shareholder, Yu Han, was fined over 1 billion for manipulating stock prices, while Doctor Glasses spent 50 million on traffic acquisition but only 3 million on R&D [1] Group 4 - SAIC-GM-Wuling's debt ratio has risen to 85.24%, despite a 20.5% increase in sales, still falling short by 535,000 units compared to peak levels [1] - Su Nong Bank's "village reform branch" faced 18% opposition from minority shareholders, with total assets at 231.1 billion and revenue growth of only 0.41% [1] - Mingming Hen Mang opened 21,000 stores and distributed a pre-IPO dividend of 526 million, with Zhao Ding cashing out 130 million [1] Group 5 - Xibei's new round of financing received support from Zhang Yong and Hu Xiaoming, but the dream of a 100 billion market value faces challenges [1] - China Duty Free Group is acquiring 2.7 billion to build an international business platform, with performance declining for six consecutive quarters, and collaboration with LVMH remains to be observed [1] - Hikvision has returned to growth with an annual profit of 14.2 billion, enhancing cash collection management and recovering 13.7 billion in nine months [1]

Core Viewpoint - Changchun High-tech, a leading company in the growth hormone industry, is experiencing a significant decline in net profit, with a forecasted drop of 91.48% to 94.19% for 2025 compared to the previous year [1] Group 1: Financial Performance - In the third quarter of 2025, Changchun High-tech reported a revenue of 9.807 billion yuan, a decrease of 5.6% year-on-year, and a net profit of 1.165 billion yuan, down 58.23% year-on-year [1] - The peak net profit for Changchun High-tech was 4.532 billion yuan in 2023, but it fell by 43% in 2024, indicating a continuing downward trend into 2025 [1] - The company anticipates a net profit of 150 million to 200 million yuan for 2025, marking a substantial decline from previous years [1] Group 2: Market and Product Dynamics - The sales of growth hormones are influenced by the number of adolescents and newborns, with increased competition also impacting performance [2] - Changchun High-tech's long-acting growth hormone and related products have been included in the new national medical insurance directory, effective January 1, 2026, with a price reduction of approximately 75% [2] - The company has adjusted its sales policies and pricing in response to industry policy changes and market conditions, which has contributed to reduced revenue and net profit [2] Group 3: Subsidiary Performance - Changchun High-tech's subsidiary, Baike Biological, is expected to report a net loss of 220 million to 280 million yuan for 2025, marking its first loss since going public, primarily due to intensified competition and decreased vaccination willingness [3] - The sales revenue of the shingles vaccine from Baike Biological has already seen a decline of 71.54% in 2024, continuing to be negatively affected in 2025 [4] - Factors affecting the shingles vaccine sales include public awareness of the disease, vaccination willingness, and increased market competition, leading to unsold inventory and returns [4]

Group 1 - The core announcement is that Changchun High-tech has received acceptance for the clinical trial application of its subsidiary Changchun Jinsai Pharmaceutical's injectable GenSci136 for domestic drug registration [1] - GenSci136 is a Class 1 therapeutic biological product independently developed by Jinsai Pharmaceutical, intended for the treatment of generalized myasthenia gravis (gMG) [2] - If the clinical trial application progresses smoothly, it will help the company expand its business structure, optimize its product structure, and enhance its core competitiveness [2]

Core Viewpoint - Changchun High-tech has reported its worst performance in nearly two decades, with a projected net profit of 150 million to 220 million yuan for 2025, representing a year-on-year decline of 91.48% to 94.19% [2] Financial Performance - The company experienced a significant decline in net profit for the first three quarters of 2025, amounting to 1.165 billion yuan, a decrease of 58.23% year-on-year [2] - The fourth quarter is expected to incur a massive loss of 945 million to 1.015 billion yuan, with a year-on-year increase in losses of 358.74% to 392.72% [2] Business Dependency - The core issue behind the performance decline is the company's heavy reliance on its growth hormone business, which has historically contributed nearly 100% of its net profit [2] - The net profits of Jinsai Pharmaceutical, a subsidiary responsible for the growth hormone business, were 4.217 billion yuan and 4.514 billion yuan in 2022 and 2023, respectively, closely aligning with the overall net profit of Changchun High-tech during the same periods [2] Market Changes - The long-acting growth hormone Jinsai was included in the national medical insurance directory, with a significant price reduction of approximately 75% for the 9mg specification [3] - The inclusion in the medical insurance directory has ended the high-profit era for this business, leading to a drastic compression of profit margins [3] - The market landscape for growth hormones has fundamentally changed, with competitors like Teva Biopharma and Novo Nordisk entering the market, further intensifying price competition [3] R&D and Sales Strategy - To reduce dependency on a single product, the company has increased R&D investment, reaching 2.69 billion yuan in 2024, accounting for 20.0% of revenue [4] - In the first three quarters of 2025, R&D investment was 1.733 billion yuan, a year-on-year increase of 22.96%, representing 17.68% of revenue [4] - Sales expenses have also risen significantly, reaching 3.764 billion yuan in the first three quarters of 2025, accounting for 38.38% of revenue, up from 32.96% in 2024 [4] Transition Challenges - The company is currently facing a transitional phase characterized by the loss of its "old engine" (growth hormone business) and the underperformance of new products [4] - Short-term risks include uncertainties in innovative drug development and underwhelming commercialization of new products, which may prolong the period of performance stabilization [4] - However, in the long term, the short-term impact of price reductions from medical insurance is expected to be absorbed, with the growth hormone business potentially maintaining stable cash flow as prices stabilize and market penetration increases [4]

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 (000661.SZ) is expected to experience a significant decline in operating performance, with a projected net profit attributable to shareholders of 150 million to 220 million yuan for 2025, representing a year-on-year decrease of over 90% [1][4]. Group 1: Financial Performance - In 2024, Changchun High-tech's net profit attributable to shareholders decreased by over 40% year-on-year [2]. - For 2025, the company anticipates a net profit drop of 24.33 billion to 23.63 billion yuan compared to the previous year, with a decline rate of 91.48% to 94.19% [4]. - The company reported a net profit of 1.165 billion yuan for the first three quarters of 2025, down 58.23% year-on-year, with total revenue of 9.807 billion yuan, a decrease of 5.60% [4]. Group 2: Factors Influencing Performance - The decline in net profit is attributed to adjustments in pricing and sales policies for core products, particularly long-acting growth hormones, due to their inclusion in the national medical insurance directory [2][6]. - Increased research and development (R&D) expenses, which reached 2.690 billion yuan in 2024, and higher sales expenses have also impacted profitability [10][12]. - The company is focusing on R&D in traditional areas such as endocrine metabolism and women's health, as well as innovative directions related to tumors, respiratory, and immune systems [10]. Group 3: R&D and Product Development - Changchun High-tech's R&D investment for the first three quarters of 2025 was 1.733 billion yuan, a year-on-year increase of 22.91% [12]. - The company has successfully advanced several products, including the GenSci098 injection project, which received a 70 million USD upfront payment [3][14]. - The R&D expenses have been steadily increasing, with a total of 2.690 billion yuan in 2024, representing 19.97% of total revenue [10]. Group 4: Market Position and Future Outlook - The company has historically relied heavily on growth hormones, which have been referred to as its "cash cow" [6]. - The future ability of Changchun High-tech to reduce its dependence on growth hormones is a key concern for investors [15].