登录新浪财经APP 搜索【信披】查看更多考评等级 证券代码：603669 证券简称：灵康药业 公告编号：2025-079 公司积极抢抓新一轮国采及国采到期续约机遇，推动中选国采品种的市场放量，保障好中选国采品种在 中选区域的产品供应；密切关注集中带量采购政策，做好政策信息的收集和研判，积极响应政策并制定 相应策略措施；公司独家剂型品种注射用石杉碱甲在治疗轻度认知障碍和阿尔茨海默病方面显示出了显 著的疗效，公司将深入推进注射用石杉碱甲的国家医保谈判工作；强化潜力品种开发，深挖产品价值， 提升产品市场覆盖率，持续加强市场推广和客户服务，同时确保产品持续稳定供应，聚焦集团化民营医 院和专科民营医院市场的开发；为更好适应行业政策发展，公司将充分利用销售体系优势，积极探索向 医药流通板块转型，以做大做强公司规模；做好新上市产品的市场开拓，通过自主研发与外部引进相结 合的方式，积极打造新的战略支撑品种；公司将进一步加快数字化和智能化建设，积极推动数字化、智 能化与各产业环节的融合发展，强化技术赋能，加强新技术在药物研发、生产优化、数据分析及药物警 戒等方面的应用，推动研发、生产技术不断创新升级。 公司将依托海南自贸港的政 ...

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].

Core Viewpoint - The credit rating agency maintains the credit rating of Lingkang Pharmaceutical Group Co., Ltd. at A- with a stable outlook, indicating a consistent assessment of the company's creditworthiness and financial stability [1][4]. Company Overview - Lingkang Pharmaceutical primarily engages in the research, production, and sales of chemical prescription drugs, with a diverse product range including cardiovascular, anti-infection, parenteral nutrition, and digestive system medications [4][12]. - As of March 2025, the company holds a total asset value of 1.23 billion yuan and equity of 0.75 billion yuan, with a debt-to-asset ratio of 39.00% [4][12]. Financial Performance - The company reported a significant increase in operating revenue and gross profit, achieving 3.80 billion yuan in revenue and 1.78 billion yuan in gross profit in 2024, reflecting a substantial year-on-year growth [11][13]. - The gross profit margin for the company was 46.88%, showing a slight decrease compared to previous periods due to pricing pressures from centralized procurement policies [11][13]. Market Position and Strategy - Lingkang's main products include the unique injection of Huperzine A, which maintains a competitive edge in the market, and the company has strengthened its R&D efforts to enhance product quality and clinical application value [4][12]. - The company has adjusted its sales strategy to increase the promotion of centrally procured products and expand sales channels in private hospitals, which has contributed to the growth of its revenue and gross profit [4][13]. Challenges and Risks - The company faces challenges such as low capacity utilization of production lines and ongoing losses in total profit due to the impact of centralized procurement policies on its anti-infection drug profitability [5][12]. - Lingkang has decided to terminate the construction of the "Lingkang Convertible Bond" fundraising project due to changes in industry policies and market conditions, leaving future funding plans uncertain [5][6]. Industry Analysis - The pharmaceutical manufacturing industry in China is experiencing growth driven by increasing demand due to rising disposable income and an aging population, with the industry expected to continue evolving under ongoing policy reforms [8][9]. - The overall revenue of the pharmaceutical manufacturing sector remained stable, while total profits saw a decline, indicating a challenging environment influenced by centralized procurement and pricing regulations [8][9].