尽管这一消息被视为阿尔茨海默症患者的福音，但Aducanumab跳过二期试验的非连续性数据和自相矛 盾的实验结果还是让这一决定备受争议。 不过，对于业界争议，FDA并非充耳不闻。根据"加速审批"的规则，FDA要求渤健进行新的随机对照临 床试验以验证临床效益。如果该试验未能验证临床效益，FDA可能会启动程序，撤销对该药物的批准。 全文链接：最被患者期待，最受业界争议：FDA十八年后再批阿尔茨海默药，百亿美元市场引关注 每经记者｜金喆 实习生 林姿辰 每经编辑｜宋思艰 当地时间6月7日，FDA宣布批准渤健/卫材公司Aβ（β淀粉样蛋白）抗体Aduhelm（Aducanumab）用于 治疗早期阿尔茨海默症患者的生物制品许可申请，这是继2003年后FDA批准的首款阿尔茨海默药。 ...

Core Viewpoint - The company, TianKang, has officially announced the initiation of preclinical research for its innovative drug CKBA targeting Alzheimer's disease (AD), based on significant findings from a research team at Shanghai Jiao Tong University [1][2]. Group 1: Drug Development and Mechanism - CKBA is a first-in-class innovative drug that targets the newly identified MFE-2 pathway, which plays a crucial role in the lipid metabolism and neuroinflammation associated with AD [2][4]. - The drug demonstrates a differentiated advantage by being orally administered and capable of crossing the blood-brain barrier, showing improvements in cognitive function, reduction of neuroinflammation, and decreased Aβ plaque accumulation in AD model mice [4]. Group 2: Market Potential and Financial Outlook - The Alzheimer's drug market in China is projected to grow from approximately 6 billion yuan in 2023 to over 26 billion yuan by 2030, with a compound annual growth rate (CAGR) of 19.2%, while the global market is expected to reach 31.44 billion USD [4]. - The company anticipates submitting its phase I clinical application for CKBA in the second half of 2026, supported by cash flow from its existing generic drug business [4]. Group 3: Broader Product Pipeline and Growth Strategy - In addition to AD, CKBA is part of a broader pipeline that includes treatments for vitiligo and rosacea, with ongoing clinical trials showing promising results [5]. - The company is also expanding its generic and modified drug segments, with several products in the pipeline expected to contribute to revenue growth [5][6]. Group 4: Institutional Support and Market Confidence - The company has gained recognition from institutional investors, with significant increases in holdings from the basic pension insurance fund, indicating confidence in the company's growth potential [7][9]. - Management has shown commitment to the company's long-term success, with no plans for share reduction post-lockup and active participation in shareholding [9].

Core Viewpoint - The domestic Alzheimer's drug, Ganluo Sodium, developed by Green Valley Pharmaceutical, has faced regulatory challenges, failing to obtain re-registration approval from the National Medical Products Administration (NMPA) [2][11]. Regulatory Status - On August 12, the NMPA issued a notification regarding Ganluo Sodium, indicating that it did not receive a corresponding approval number, suggesting that the drug did not gain re-registration approval [2]. - Ganluo Sodium's registration certificate expired after five years, necessitating a new application for market approval, which Green Valley submitted in 2024 [2][5]. Product Background - Ganluo Sodium, also known as "Jiuyiqi" or "971," is the first domestically developed innovative drug for Alzheimer's disease, conditionally approved for market entry in November 2019 [2][4]. - The drug is derived from algae and targets the gut-brain axis to improve cognitive function by reshaping gut microbiota and reducing neuroinflammation [5]. Controversies and Challenges - The drug has been controversial since its launch, with debates surrounding its mechanism of action and the reliability of its clinical trials, particularly the shortened duration of its Phase III trials [6]. - Following the conditional approval, the NMPA required Green Valley to continue research on the drug's pharmacological mechanisms and long-term safety and efficacy [6]. Market Impact - Reports of drug shortages began in early 2023, leading to public outcry as patients faced difficulties obtaining Ganluo Sodium [7][8]. - The price of Ganluo Sodium surged on e-commerce platforms, with some listings reaching up to 5,000 yuan per box due to supply issues [8]. Patient Perspective - Despite criticisms, many patients and their families reported that Ganluo Sodium was effective, highlighting the lack of alternative affordable treatments for Alzheimer's [9]. - The drug was included in the national medical insurance directory, significantly reducing its price from 895 yuan to 296 yuan per box, making it a more accessible option compared to newer drugs costing 200,000 to 300,000 yuan annually [9]. Future Outlook - With the expiration of Ganluo Sodium's registration, Green Valley faces significant operational challenges, including a reported plan to cut nearly 80% of its workforce [12].

Core Viewpoint - The company Boji Pharmaceutical (300404) is actively engaged in providing research and development services for Alzheimer's disease medications [1] Group 1 - The company responded to investor inquiries on July 29, indicating its involvement in Alzheimer's drug development [1]