12月15日，长春高新子公司长春金赛药业有限责任公司(以下简称金赛药业)宣布，就GenSci098注射液 项目，全资子公司上海赛增医疗科技有限公司(以下简称赛增医疗)与Yarrow Bioscience，Inc.(以下简称 Yarrow)签订独家许可协议，赛增医疗预计可获得1.2亿美元首付款及近期开发里程碑款项，其中7000万 美元是不可退还、不可抵扣的首付款。此外，赛增医疗有权就本次独家许可至多获得13.65亿美元里程 碑付款。 据《每日经济新闻》记者了解，在创新药领域，这笔首付款未超过1亿美元的BD(商业拓展)项目算不上 大额交易，但能引发广泛关注，与长春高新的发展阶段有关。作为生长激素龙头，公司近年来启动多元 化转型，去年就经历了收入、净利润齐降的阵痛。 今年9月，长春高新向港交所递交发行上市申请，募集资金用途之一指向了国际化。 12月16日，长春高新（000661）(SZ000661，股价95.31元，市值388.81亿元)股价开盘大涨，当日收涨 3.77%。 预计获1.2亿美元首付款 长春高新加大研发投入 2024年，长春高新的长效生长激素产品——聚乙二醇重组人生长激素注射液在国内占据100%的市场 ...

据《每日经济新闻》记者（以下简称"每经记者"）观察，在创新药领域，这笔首付款未超过1亿美元的BD（商业拓展）项目算不上大额交易，但能引发广泛 关注，与长春高新的发展阶段有关。作为生长激素龙头，公司近年来启动多元化转型，去年就经历了收入、净利润齐降的阵痛。 今年9月，长春高新向港交所递交发行上市申请，募集资金用途之一指向了国际化。 资料显示，GenSci098注射液目前分别用于治疗甲状腺相关眼病（TED）和弥漫性毒性甲状腺肿（GD）相关适应证研究。去年8月，该药物已获批于中国境 内及美国同步开展用于甲状腺相关眼病的临床试验。 预计可获得首付款及近期开发里程碑款项1.2亿美元 根据协议，Yarrow将获得GenSci098注射液除中国以外的全球独家开发、生产和商业化权利，用于GenSci098注射液分别针对甲状腺相关眼病（TED）和弥漫 性毒性甲状腺肿（GD）等适应证的研究开发和商业化。赛增医疗则保留GenSci098注射液产品在中国的开发与商业化权利。未来双方各自研发的知识产权归 各自所有，但会互相给予使用该等知识产权的许可和授权。 作为基因工程制药领域的头部企业，金赛药业不仅是长春高新的子公司，还被视作长春高 ...

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]