生长激素龙头企业长春高新（SZ000661）交出了一份令市场震惊的业绩预告。 2026年1月30日晚间，公司发布2025年度业绩预告，预计全年实现归母净利润1.5亿元至2.2亿元，与上年 同期的25.83亿元相比，同比大幅下滑91.48%至94.19%。 对于业绩的急剧下滑，长春高新在公告中列举了多重原因。其中包括：伴随公司相关研发工作推进及多 款产品进入临床阶段，相关研发费用同比增加；长效生长激素等产品纳入国家医保目录后，相关产品销 售策略及定价进行了调整，影响了收入和利润；同时，控股子公司长春百克生物科技股份公司因行业竞 争加剧等因素预计出现亏损，进一步拖累整体业绩。 具体数据显示，该公司预计2025年度实现的归母净利润区间为1.5亿元至2.2亿元。而在2024年，这一数 字为25.83亿元，最高降幅高达94.19%。 与此同时，长春高新预计2025年扣除非经常性损益后的净利润（下称扣非净利润）同样呈现出下跌态 势。业绩预告显示，公司预计2025年扣非净利润为4.37亿元至5.07亿元，而上年同期为28.30亿元，同比 下降幅度预计在82.09%至84.56%之间。 另外，长春高新控股子公司长春百克生物科 ...

Core Viewpoint - Changchun High-tech (000661) has seen a significant stock price increase following the announcement of a licensing agreement for the GenSci098 injection project, indicating a strategic move towards internationalization and diversification in its product offerings [1][2]. Group 1: Licensing Agreement Details - Changchun High-tech's subsidiary, Changchun Jinsai Pharmaceutical, has entered into an exclusive licensing agreement with Yarrow Bioscience, which includes an upfront payment of $120 million, with $70 million being non-refundable [1][2][3]. - The agreement allows Yarrow to develop and commercialize GenSci098 outside of China, while Changchun retains rights for development and commercialization within China [2][3]. Group 2: Financial Implications - The total potential milestone payments from the agreement could reach up to $1.365 billion, in addition to a sales commission exceeding 10% of net sales once the product is launched [3][4]. - The financial performance of Changchun High-tech has faced challenges, with a reported revenue decline of 7.55% and a net profit drop of 43.01% last year, primarily due to decreased sales of its short-acting growth hormone product [6][7]. Group 3: Strategic Focus and Market Position - Changchun High-tech is focusing on expanding its product lines beyond growth hormones, targeting areas such as pediatrics, women's health, and anti-aging [6][7]. - The company has increased its R&D investment by 17.32% year-on-year, indicating a commitment to innovation and product development [6][7]. - The company is also pursuing international market expansion, having submitted a listing application to the Hong Kong Stock Exchange to raise funds for global collaboration and development [7].

Core Viewpoint - Changchun High-tech's stock price surged by 3.77% following the announcement of a licensing agreement with Yarrow Bioscience, which includes a $120 million upfront payment and potential milestone payments totaling up to $1.365 billion [1][5]. Group 1: Licensing Agreement Details - The agreement involves Changchun High-tech's subsidiary, Shanghai Saizeng Medical Technology, which will receive a $120 million upfront payment, including a non-refundable $70 million [1][5]. - Saizeng Medical retains the rights to develop and commercialize the GenSci098 injection in China, while Yarrow gains exclusive global rights outside of China [3][5]. - The GenSci098 injection is a monoclonal antibody for treating thyroid-related diseases, with clinical trials already approved in China and the U.S. [3][5]. Group 2: Strategic Rationale - The choice of Yarrow, a new biotech company, over traditional multinational pharmaceutical companies was based on the potential for faster overseas development and commercialization [6][7]. - Changchun High-tech's strategy includes diversifying its product lines beyond growth hormones, with a focus on pediatric, women's health, and anti-aging products [8][9]. Group 3: Financial Performance and Future Outlook - In 2024, Changchun High-tech's revenue and net profit are projected to decline by 7.55% and 43.01%, respectively, primarily due to decreased sales of its short-acting growth hormone product [8][9]. - The company has increased its R&D investment by over 17% year-on-year, indicating a commitment to innovation and international expansion [8][9]. - Despite a significant increase in overseas sales for its subsidiary, the contribution to total revenue remains below 1%, highlighting the need for further international market development [9].

Core Viewpoint - The introduction of the long-acting growth hormone, Pasi Growth Hormone Injection, in Hainan Boao Lecheng International Medical Tourism Pilot Zone provides a new treatment option for children with growth hormone deficiency (GHD), despite the availability of domestic alternatives. This is attributed to its advanced technology, clinical efficacy, and international safety standards [1][8]. Group 1: Technology and Efficacy - The Pasi Growth Hormone Injection utilizes a mature fatty acid derivatization technology, differing significantly from the domestic product that employs PEG technology. This allows for a longer half-life and reduced dosing frequency, requiring only weekly administration instead of daily [3][6]. - Clinical data indicates that children treated with Pasi Growth Hormone can achieve an annual height increase of approximately 11.0 cm, with reported height growth of 3-4 cm within three months of treatment in the Boao Lecheng area [6][8]. Group 2: Safety and Metabolism - The drug demonstrates a high metabolic recovery rate, with over 94% of the administered dose being excreted through urine and feces by day 28, surpassing the European Medicines Agency's standard of 90% [5]. - Safety profiles show that the adverse reactions reported are common childhood illnesses, with no new safety concerns arising from the use of Pasi Growth Hormone, indicating a safety level comparable to traditional short-acting growth hormones [6][8]. Group 3: Market Implications - The introduction of Pasi Growth Hormone in the Boao Lecheng area highlights China's commitment to synchronizing international medical resources and providing better treatment options for domestic patients, thereby enhancing the overall healthcare landscape [1][8].

Core Insights - The National Healthcare Security Administration (NHSA) has published the preliminary review results for the 2025 medical insurance and commercial insurance innovative drug directory, with significant changes in the approval status of six drugs compared to the previous version [1][2]. Summary by Categories Drug Approval Changes - Six drugs have had their approval status changed, with two drugs (Injectable Risperidone Microspheres and Injectable Triptorelin Acetate) being disapproved, while two others (Levodopa Injection and Calcium Gluconate Sodium Chloride Injection) have been approved [1][3]. - The oral suspension of Ursodeoxycholic Acid remains approved, but the conditions for approval have been adjusted [1][3]. Application Statistics - For the 2025 directory adjustment, the NHSA received 718 applications, involving 633 drug generic names, with 535 passing the preliminary review [1][2]. - The approval rate has increased significantly, reaching 84.52% this year, compared to 68.42% in 2023 and 76.66% in 2024 [2]. Notable Drugs - Levodopa Injection, used for Parkinson's disease, has been approved and is not an exclusive product, indicating its potential for broader market access [4]. - Injectable Ceftriaxone Sodium Sulbactam, another approved drug, is noted for its broad antibacterial spectrum and safety profile [4]. - The oral suspension of Ursodeoxycholic Acid has had its approval conditions modified to include rare disease categories [6]. Innovative Drug Directory - The commercial insurance innovative drug directory has been introduced alongside the basic medical insurance directory, with 141 applications received, of which 121 passed the preliminary review [2]. - A significant number of drugs in both directories are new, with 303 in the basic medical insurance directory meeting specific conditions for approval [7]. Rare Disease Drugs - The directories include a total of 37 rare disease drugs in the basic medical insurance directory and 35 in the commercial insurance innovative drug directory, with 19 drugs approved in both [10][11]. - Notable rare disease drugs include those from Merck and other companies, which have gained attention for their potential market impact [11][12]. Market Trends - The introduction of the commercial insurance innovative drug directory is expected to enhance market access for several high-profile drugs, including CAR-T therapies that have previously struggled to gain approval [9][12]. - The performance of rare disease drug companies has seen significant stock price increases, indicating strong market interest and potential for growth [13].

Core Viewpoint - The National Healthcare Security Administration (NHSA) has officially announced the preliminary review results for the adjustment of the 2025 medical insurance and commercial insurance innovative drug catalog, indicating an increase in the number of drugs passing the review and the overall approval rate compared to previous years [1][2]. Summary by Relevant Sections Drug Review Changes - Six drugs underwent changes in their review status, with two drugs, injectable risperidone microspheres and injectable triptorelin, being disapproved, while injectable levodopa and calcium gluconate sodium injection were approved [1][5][6]. - The injectable risperidone microspheres, an exclusive product of Shengzhao Pharmaceuticals, was first launched in mainland China in February 2025 for treating mental disorders [6][7]. - The injectable triptorelin, also an exclusive product, was launched in 2023 for treating prostate cancer and precocious puberty [7]. Approval Statistics - A total of 718 applications were received for the 2025 catalog adjustment, involving 633 drug generic names, with 535 passing the preliminary review, resulting in an approval rate of 84.52% [1][2]. - The approval rates have shown a significant increase over the past three years, with 68.42% in 2023, 76.66% in 2024, and 84.52% in 2025 [2]. Innovative Drug Catalog - The commercial insurance innovative drug catalog was introduced for the first time, with 141 applications received, involving 141 drug generic names, and 121 passing the review [3]. - Among the drugs, 79 were submitted for both the basic medical insurance catalog and the commercial insurance innovative drug catalog [3]. Notable Products - Several notable products are highlighted, including CAR-T products that have previously failed to enter the medical insurance catalog but are now included in the commercial insurance innovative drug catalog [11][12]. - Unique products such as the first and only AKT inhibitor and the only Trop-2 ADC for breast cancer treatment are also included in the catalogs, indicating a focus on innovative therapies [13][14]. Rare Disease Medications - The review process has also included rare disease medications, with 37 drugs in the basic medical insurance catalog and 35 in the commercial insurance innovative drug catalog, of which 19 are approved in both [15][16]. - The approval of rare disease drugs is seen as a significant development, with companies like Beihai Kangcheng gaining attention for their innovative products [20].

Investment Rating - The report does not explicitly state an investment rating for the industry [5] Core Insights - The pharmaceutical and biotechnology sector saw a weekly increase of 1.06%, underperforming compared to the Wind All A index (2.43%) and the CSI 300 index (1.39%). The AI + healthcare sector experienced a significant rebound [10][11] - Key sectors that performed well include in vitro diagnostics (4.45%), active pharmaceutical ingredients (2.08%), and hospitals (1.85%). Conversely, offline pharmacies (-0.59%) and medical devices (-0.08%) saw declines [10][11] - The government work report emphasized strengthening basic medical and health services, implementing a health-first development strategy, and promoting the coordinated development of healthcare, medical insurance, and pharmaceuticals [12][14] - On March 8, Huawei announced the establishment of a healthcare division, aiming to integrate its expertise in 5G, cloud computing, and edge computing to develop AI-assisted diagnostic solutions [12][14] Weekly Market Review - The pharmaceutical and biotechnology sector increased by 1.06%, lagging behind the Wind All A index (2.43%) and the CSI 300 index (1.39%). The AI + healthcare direction showed a notable rebound [10] - The top-performing sub-sectors included in vitro diagnostics (4.45%), active pharmaceutical ingredients (2.08%), and hospitals (1.85%), while offline pharmacies (-0.59%) and medical devices (-0.08%) were the worst performers [10][11] - The top three gaining stocks were Hotgen Biotech (38.63%), Berry Genomics (34.39%), and Anbiping (25.72%), while the top three losing stocks were Jiangsu Wuzhong (-14.34%), ST Sansheng (-9.83%), and Baile Tianheng-U (-9.44%) [12][14] Industry News and Key Company Announcements - The government work report highlighted the need to enhance basic medical services and improve the healthcare system, including reforms in public hospitals and drug procurement policies [12][14] - Huawei's new healthcare division aims to leverage its technological strengths to accelerate the development of medical AI models for clinical applications [12][14] - On March 8, Ausgen announced that the FDA accepted its new drug application for AUKONTALS, a treatment for amyotrophic lateral sclerosis, with a decision expected by October 23, 2025 [12][14] - CloudTop announced the successful administration of its mRNA personalized cancer vaccine EVM16 in a clinical trial, marking a significant milestone in its development [12][14]