Overview - The demand for Edaravone in China is driven by a large population of stroke patients, with sales peaking at 5.548 billion yuan in 2016 [1][8]. - The sales dropped significantly to 1.53 billion yuan by 2024 due to regulatory changes and market dynamics [1][9]. Development History - Edaravone was first approved in Japan in 2001 and introduced to China by Xiansheng Pharmaceutical in 2003 [3][4]. - The market demand grew rapidly from 2015 to 2018, establishing Edaravone as a key product in the neuropharmaceutical sector [3][5]. Market Dynamics - In 2019, Edaravone was included in the first batch of the National Key Monitoring Rational Drug Use Directory, leading to a decline in sales [4][5]. - The seventh batch of national drug procurement initiated in 2022 further impacted sales, with Edaravone being the only drug from the monitoring list to be included in the procurement [5][9]. Industry Chain - The upstream of the Edaravone industry includes raw materials, intermediates, packaging, and pharmaceutical equipment [6]. - The midstream consists of production companies, while the downstream includes hospitals and pharmacies, with hospitals being the primary distribution channel [7]. Market Background - Edaravone is primarily used for treating acute ischemic stroke, with its effectiveness linked to timely administration within 48 hours post-stroke [8]. - The aging population in China has led to an increase in stroke and other neurological disease incidences, with stroke patients reaching 27.461 million by 2024 [8]. Competitive Landscape - The Edaravone market in China is highly concentrated, with 54 approved products from 32 companies as of August 2025 [10]. - Xiansheng Pharmaceutical is the leading company, having launched the first Edaravone injection in China [10][11]. Company Profiles - Xiansheng Pharmaceutical reported a total revenue of 6.635 billion yuan in 2024, with a gross profit of 5.325 billion yuan and a gross margin of 80.25% [11]. - Jilin Boda Pharmaceutical, a key player, has a production capacity of 3 million 10ml and 2 million 20ml Edaravone injections annually, with a revenue of 733.38 million yuan in 2024 [12]. Future Trends - Innovations in Edaravone formulations are expected, including the development of oral tablets, which could enhance patient compliance [13]. - The expansion of insurance coverage and accelerated drug approvals are anticipated to increase market accessibility and demand, although cost control will be essential due to potential pricing pressures from insurance policies [13].

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].