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 - Huadong Medicine's subsidiary, Hangzhou Zhongmei Huadong Pharmaceutical, has received a drug registration acceptance notice from the National Medical Products Administration (NMPA) for edaravone tablets, aimed at treating acute ischemic stroke [1][3]. Drug Information - Drug Name: Edaravone Tablets - Application: Domestic production drug registration and marketing license - Registration Category: Chemical drug category 2.2 - Specification: 30mg - Indication: To improve neurological symptoms and functional impairments caused by acute ischemic stroke (AIS) and enhance daily living capabilities [1]. R&D and Registration Status - Edaravone is a novel free radical scavenger that has been shown to inhibit lipid peroxidation and endothelial cell damage, improving brain edema and tissue damage [3]. - The injectable form of edaravone has been approved in Japan and China for AIS treatment, but it requires intravenous administration, limiting patient compliance [3]. - The oral formulation, TTYP01, developed by Shanghai Aozong Biotechnology, is a modified new drug that allows for self-administration and room temperature storage, enhancing convenience and compliance [3][4]. - The clinical trial for TTYP01 was completed in June 2024, showing efficacy and safety comparable to the injectable form while improving patient adherence [3]. Impact on the Company - The approval of edaravone tablets is expected to enrich the company's cardiovascular product pipeline and create synergies with existing products [6]. - The drug is anticipated to meet the urgent clinical needs of stroke patients, potentially becoming a significant product in the treatment field [5][6]. - The company has invested approximately 100.81 million yuan in the development of edaravone tablets [5]. Future Considerations - Following the acceptance notice, the drug will undergo review by the NMPA's drug evaluation center, with the approval timeline and market competition remaining uncertain [6].