Hua Xia Shi Bao·2025-12-24 04:12Core Viewpoint - The Alzheimer's treatment drug, Ganluo Sodium Capsule, is entering a new phase under Fosun Pharma after facing scientific scrutiny and market challenges, with plans for post-marketing confirmatory clinical trials approved by the National Medical Products Administration (NMPA) [1][2]. Group 1: Clinical Development and Market Position - Fosun Pharma has announced a post-marketing confirmatory clinical trial plan for Ganluo Sodium Capsule, with an increased sample size of 1,950 participants, aiming for completion by the end of 2027 and data release in early 2029 [1][2]. - The drug was conditionally approved for marketing in November 2019 and has since benefited hundreds of thousands of patients, with sales exceeding 1 billion yuan since its inclusion in the national medical insurance catalog in 2021 [1][2]. - The price of the drug decreased from 895 yuan to 296 yuan after being included in the national medical insurance catalog, with over 2 million boxes expected to be sold in 2024 alone [1]. Group 2: Scientific and Regulatory Challenges - The drug faced challenges due to the NMPA not approving the extension of its conditional marketing authorization, leading to a supply interruption and various criticisms [2]. - Prior to conditional approval, Ganluo Sodium Capsule completed phase III confirmatory clinical trials with 818 participants across 34 clinical research centers, and real-world studies involving 3,300 participants have been submitted to validate its long-term safety and efficacy [3]. Group 3: Market Demand and Strategic Response - Alzheimer's disease has become a significant public health challenge in China, with nearly 17 million patients reported in 2021, representing 29.8% of global cases [4]. - The existing treatment options are limited and primarily symptomatic, highlighting a substantial unmet clinical need for effective therapies [4][5]. - The Chinese government is encouraging innovation in drug development, aligning with Fosun Pharma's strategic focus on addressing unmet clinical needs in the Alzheimer's treatment space [5]. Group 4: Company Capabilities and Future Outlook - Fosun Pharma's confidence in taking over the Ganluo Sodium project stems from its proven integrated capabilities in research, clinical trials, and commercialization, with ongoing investments in CNS-related products [6]. - The company has successfully launched several innovative drugs in China and is expanding its clinical and commercial teams in the U.S. to support global market entry [6]. - If clinical results are positive, Ganluo Sodium could re-enter the market post-2029, enhancing Fosun Pharma's capabilities in CNS diseases and attracting further collaborations [7].