Core Viewpoint - The approval process for the first domestically developed Alzheimer's drug, "Jiuyiqi" (Glycyrrhizin Sodium Capsules), has encountered significant setbacks, indicating challenges in the drug's re-registration and the broader difficulties in Alzheimer's drug development in China [1][7]. Approval Challenges - "Jiuyiqi" was conditionally approved in November 2019 for treating mild to moderate Alzheimer's disease, but its re-registration application has not been approved, as indicated by the absence of an approval number in the recent notification from the National Medical Products Administration (NMPA) [1][3]. - The NMPA requires companies to submit a new application for re-registration, and "Jiuyiqi" has faced scrutiny regarding its clinical trial data and the adequacy of its ongoing studies [2][3]. Industry Context - The drug's approval difficulties reflect a global challenge in Alzheimer's drug development, primarily due to the unclear pathogenic mechanisms of the disease and the complexities involved in clinical trials [7][8]. - The pricing of "Jiuyiqi" has made it a more accessible option for patients compared to imported alternatives, which can cost significantly more [7]. Controversies and Legal Issues - "Jiuyiqi" has been surrounded by controversy regarding its efficacy and the reliability of its clinical trials, leading to public debates and legal disputes among key figures in the scientific community [4][5]. - Despite the controversies, the drug was included in the national medical insurance directory, highlighting its perceived value in the market [6]. Future Prospects - The future of "Jiuyiqi" and its potential re-registration remains uncertain, as the company must provide additional data to support its application [7][8]. - The case of "Jiuyiqi" serves as a significant example in the history of original drug development in China, illustrating the complexities and challenges faced by pharmaceutical companies in the Alzheimer's treatment landscape [7][8].

Core Viewpoint - The article discusses the ongoing challenges faced by Green Valley Pharmaceutical regarding its Alzheimer's drug GV-971 (甘露特钠胶囊), which has not received re-registration approval, leading to potential production halts and supply shortages [4][21]. Group 1: Drug Approval and Market Status - GV-971, developed for mild to moderate Alzheimer's disease, was conditionally approved in November 2019, marking the first new Alzheimer's drug approval in 17 years [8]. - The drug has faced significant scrutiny regarding its efficacy and clinical trial data, with notable public disputes among experts [8][9]. - As of May 2023, reports indicated nationwide shortages of GV-971, with prices on e-commerce platforms soaring to 5000 yuan per box, compared to its original price of 296 yuan when included in medical insurance [20]. Group 2: Production and Regulatory Challenges - Green Valley announced in May 2023 that it would halt production of GV-971 due to the expiration of its drug registration certificate, which is typically renewed six months prior to expiration [20][21]. - The failure to secure re-registration approval is believed to be linked to poor clinical trial data or unclear efficacy [21]. - The company has faced criticism for its handling of the drug's international clinical trials, which were suspended in May 2022 [8][9]. Group 3: Patient Impact and Alternatives - Patients have expressed concerns over the potential impact of drug shortages, but experts suggest that the drug's mechanism does not lead to immediate adverse effects upon discontinuation [21]. - Alternatives for patients include symptom-targeting medications and non-pharmacological interventions, although no similar mechanism drugs have been approved [21].

Core Viewpoint - The re-registration application for GV-971 (甘露特钠胶囊) by Green Valley Pharmaceutical has been denied, marking a significant challenge for this Alzheimer's disease drug that has been controversial since its conditional approval in 2019 [1][4]. Company Summary - GV-971, developed by Green Valley, is aimed at improving cognitive function in patients with mild to moderate Alzheimer's disease. It was conditionally approved in November 2019, filling a 17-year gap in new Alzheimer's drug approvals [1][2]. - The drug's approval was based on its unique mechanism targeting the gut-brain axis, using low molecular weight acidic oligosaccharides derived from marine brown algae, differing from the mainstream β-amyloid hypothesis [2]. - Following the denial of the re-registration application, Green Valley's production has been halted, and the drug has faced supply shortages and price increases across various platforms [1][4]. Industry Summary - The denial of GV-971's re-registration reflects the complexities involved in the development and approval of Alzheimer's drugs, highlighting potential issues with clinical trial data and efficacy [4][5]. - The drug's conditional approval required the completion of clinical trials and submission of formal reports, which have not been satisfactorily met, leading to the current situation [2][3]. - There are currently no other drugs with a similar mechanism approved, although alternative symptomatic treatments are available, such as donepezil, which some patients have switched to following GV-971's supply issues [5].

Core Viewpoint - Wanbangde Pharmaceutical Holdings Group Co., Ltd. has launched a national conference for the Phase II/III clinical trial of its new drug Huperzine A controlled-release tablets for Alzheimer's disease, emphasizing the importance of local research and collaboration among experts [1][2]. Group 1: Clinical Trial Launch - The national launch conference for the Phase II/III clinical trial of Huperzine A controlled-release tablets was held in Beijing [1]. - Experts gathered to discuss the significance of the trial and to collaborate on high-quality development of the drug [1]. Group 2: Research and Development Insights - Professor Jia Jianping highlighted the trial's importance and encouraged local researchers to take pride in their work [1]. - Zhao Guanjia, the director of Wanbangde's research institute, discussed the company's focus on Huperzine A and its extensive groundwork in related research [1]. Group 3: Safety and Efficacy - Researcher Gan Yong shared the development history of Huperzine A controlled-release tablets, noting the urgent need for effective and well-tolerated drugs for Alzheimer's patients [2]. - Director Yan Feng provided insights into the safety profile of the drug, indicating that preliminary data supports its good safety and pharmacological characteristics [2]. Group 4: Training and Standardization - The conference included comprehensive training on the research protocol, operational processes, and key execution points to ensure a unified understanding among all researchers [2].

Core Viewpoint - The development of Alzheimer's drugs is facing significant bottlenecks, with Biogen and Eli Lilly maintaining a leading position in the market. However, due to research setbacks, safety risks, and slow adoption, the market size forecast for 2030 has been drastically reduced to $6 billion from a previous expectation of $13 billion [3][4]. Group 1: Market Forecast and Sales Predictions - The combined sales of Biogen's Leqembi and Eli Lilly's Kisunla are projected to reach $5.91 billion by 2025, with potential growth to $40 billion by 2030, which is 24% lower than the market's general expectation of $50 billion due to slow drug adoption [4]. - By 2030, the total sales of Alzheimer's drugs are expected to reach $6 billion, with nearly $1 billion coming from new mechanism drugs [5]. Group 2: Impact of Research Failures - A series of late-stage clinical trial failures have led to a 54% reduction in sales forecasts for Alzheimer's drugs since June 2024, with risk-adjusted sales expectations shrinking by over $7 billion for 2025-2030, including a $3 billion reduction for 2030 alone [8][11]. - The decline in sales expectations is attributed to the exit of several late-stage candidates from the market due to research failures or lowered priorities [8]. Group 3: Competitive Landscape - The long-term administration of Leqembi shows limited cognitive improvement, particularly in patients with low or no tau pathology, which affects about 40% of the trial population. This has led to skepticism among physicians and patients regarding the drug's efficacy [11]. - New candidates, such as Novo Nordisk's semaglutide and Roche's trontinemab, are expected to increase competitive pressure, potentially limiting the market share of first-generation amyloid-beta antibodies [11][15]. Group 4: Company-Specific Insights - Biogen's Leqembi faces increasing risks due to limited application, with sales forecasts for 2030 being 20% lower than market expectations, driven by safety concerns and access barriers [13]. - Eli Lilly is expected to surpass Biogen in sales by 2029, driven by the approval of Kisunla and subsequent antibody drugs, indicating a shift in market leadership [15].

Core Viewpoint - Fosun Pharma's stock has increased by over 4%, reaching HKD 20.15 with a trading volume of HKD 201 million, following the announcement of a licensing agreement with NewCo for the development of AR1001 for Alzheimer's disease and other neurological disorders [1] Group 1: Licensing Agreement - Fosun Pharma's subsidiary has signed a licensing agreement with NewCo, granting rights for the development, registration, production, and commercialization of AR1001 in mainland China and Hong Kong-Macau for Alzheimer's disease and other neurological conditions [1] - Fosun Pharma will pay up to RMB 150 million to NewCo for this licensing agreement [1] Group 2: Clinical Trials - The drug AR1001 was licensed from AriBioCO.,Ltd. by NewCo, which will continue its development [1] - NewCo obtained exclusive rights for AR1001 in Greater China in early 2024 and is collaborating with AriBio to conduct global Phase III clinical trials targeting early Alzheimer's disease patients [1] - The global trial has completed recruitment in 13 countries and regions, including North America, Europe, the UK, China, and South Korea, with approximately 1,500 patients recruited worldwide [1]

Core Viewpoint - The news highlights the supply issues surrounding GV-971 (甘露特钠胶囊), a drug for Alzheimer's disease, which has led to a significant price increase and potential production halt due to regulatory challenges and cash flow problems faced by the manufacturer,绿谷制药 [1][3][5]. Group 1: Supply and Demand - GV-971 has been experiencing a supply shortage since six months ago, with recent reports indicating complete stockouts, causing prices to surge from 296 yuan to between 830 yuan and 1,033 yuan per box [1]. - Over 9,300 patients have requested the drug, and more than 1,200 doctors have urged the company to ensure continuous supply [1]. - The company is in communication with relevant authorities to expedite the review process for the drug's certification renewal [1][2]. Group 2: Regulatory and Clinical Background - GV-971 was conditionally approved in November 2019, becoming the first drug targeting the "gut-brain axis" mechanism for Alzheimer's treatment [3]. - The drug's approval was contingent upon the submission of long-term carcinogenicity data, which was completed and submitted in December 2019, showing no carcinogenic risk [3]. - The drug has been under review since October 2024, but its approval status remains pending, possibly due to ongoing debates regarding its efficacy [4]. Group 3: Financial Performance and Market Impact - Since its launch, GV-971 has reportedly benefited over 500,000 patients, with sales reaching 2.13 million boxes in 2024 alone [5]. - The drug's sales have grown at a compound annual growth rate of 343.2% since its approval, with hospital sales reaching 170 million yuan and retail sales at 156 million yuan in 2022 [5]. - The company has faced severe cash flow issues, leading to temporary layoffs and reduced salaries for employees [2]. Group 4: Alternative Treatments and Market Landscape - Despite the supply issues with GV-971, other established treatments for Alzheimer's disease, such as cholinesterase inhibitors and NMDA receptor antagonists, remain available [6]. - Newer drugs like Eli Lilly's donanemab and Eisai's lecanemab have also entered the market, providing additional options for patients [7]. - The Alzheimer's drug development landscape is characterized by high investment and risk, with over $100 billion invested globally, yet only one drug successfully launched from over 200 clinical trials [8][9].

Core Viewpoint - The prescription drug GV-971 (brand name "Jiuyiqi") for Alzheimer's disease has been discontinued, leading to a significant price increase and supply shortages, raising concerns about the company's future and the drug's efficacy [1][3][4]. Group 1: Company Situation - Green Valley Pharmaceutical Technology is facing severe cash flow issues, having notified all employees of a three-month leave starting in June, with salaries reduced to 2,600 yuan per month [3][4]. - The company has indicated that the drug's production halt is due to the expiration of its drug registration certificate, with new approvals pending [5][6]. - There have been over 9,300 patient requests for the drug, and more than 1,200 doctors have urged the company to ensure the supply of GV-971 [6][7]. Group 2: Drug Efficacy and Controversy - GV-971 has been subject to academic controversy, with former president of Capital Medical University, Rao Yi, questioning the authenticity of the research and the drug's effectiveness, alleging research misconduct [4][8]. - The drug was conditionally approved by the National Medical Products Administration in November 2019, and it was included in the medical insurance list in 2021 at a price of 296 yuan per box [4][7]. - Despite the controversies, the company claims that the drug has shown improvements in cognitive function in patients during clinical studies, with results expected to be presented at international academic conferences [7][10]. Group 3: Market Dynamics - The price of GV-971 has surged to between 830 yuan and 1,033 yuan per box due to supply shortages, compared to its original price of 296 yuan [1][4]. - The drug has sold 2.13 million boxes in 2024 alone, indicating a significant market presence despite the ongoing controversies [4][11]. - The approval process for new drugs in the Alzheimer's treatment space is generally slow, with industry insiders suggesting that the ongoing efficacy debates may be contributing to the delays in GV-971's new registration [6][8].