内容概要：庞大的脑卒中患者群体带动我国依达拉奉市场需求持续扩大，2016年，我国依达拉奉注射液 的销售额攀至巅峰，达到了55.48亿元，2019年该药品被正式纳入首批国家重点监控合理用药目录， 2020年销售额骤降至13.85亿元，跌幅高达67.88%，2022年，第七批国家药品集采启动，依达拉奉成为 唯一一个进入《第一批国家重点监控合理用药药品目录》而被集采的产品，依达拉奉注射液销售额进一 步下降，2024年我国依达拉奉注射液销售额降至1.53亿元。 上市企业：博大制药（871194.NQ）、先声药业（02096.HK）、哈三联（002900）、联环药业 （600513）、国药股份（600511）、华润双鹤（600062） 相关企业：长春海悦药业股份有限公司、药源生物科技（启东）有限公司、扬子江药业集团上海海尼药 业有限公司、扬子江药业集团南京海陵药业有限公司、扬子江药业集团江苏海慈生物药业有限公司、西 安利君制药有限责任公司、四川美大康华康药业有限公司、石家庄凯达生物工程有限公司、陕西健民制 药有限公司、山东新华制药股份有限公司、山东罗欣药业集团股份有限公司、山东方明药业集团股份有 限公司、齐鲁制药有限公 ...

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 National Healthcare Security Administration (NHSA) has announced the preliminary review results for the 2025 National Basic Medical Insurance, Maternity Insurance, and Work Injury Insurance drug catalog, along with the commercial insurance innovative drug catalog, indicating a significant increase in the number of drugs under review and the introduction of a new commercial insurance category for innovative drugs [1][3]. Group 1: Drug Catalog Submission and Review - A total of 718 submissions were received for the basic medical insurance catalog, involving 633 drug generic names, with 534 passing the preliminary review [3]. - For the commercial insurance innovative drug catalog, 141 submissions were received, involving 141 drug generic names, with 121 passing the preliminary review, including 79 drugs that may be negotiated under both insurance schemes [3][4]. Group 2: Impact on the Pharmaceutical Industry - The introduction of the commercial insurance innovative drug catalog is expected to create new pathways for multi-channel payment for innovative drugs and promote collaboration between commercial insurance and basic medical insurance [3]. - The review process for drugs that have passed the preliminary review does not guarantee inclusion in the final catalog, as they must undergo strict evaluation and successful negotiations [4]. Group 3: Notable Drugs and Categories - The commercial insurance catalog includes 12 monoclonal antibodies, 3 CAR-T therapies, and other innovative drugs, with notable products like CAR-T therapies and PD-1 inhibitors included [5][6]. - There are 42 drugs that only passed the preliminary review for the commercial insurance catalog, primarily from major pharmaceutical companies [6]. Group 4: Future Negotiation Timeline - The NHSA plans to conduct negotiations for the 2025 insurance catalog between September and October, with results expected to be announced between October and November [7].