Green Valley Pharmaceutical Suspends Production of Controversial Alzheimer's Drug GV-971 Amid License Renewal
核心洞察
Green Valley Pharmaceutical has suspended production and sales of GV-971, China's first indigenous Alzheimer's therapy, after its license expired and entered regulatory review.
The seaweed-derived compound sodium oligomannate received conditional approval in 2019 but faced criticism from medical experts over inconsistent clinical trial results and short study duration.
Hospital and retail sales of GV-971 reached $45.4 million in 2022, while China's dementia patient population represents 17 million people, about 30% of the global total.
Green Valley Pharmaceutical Co. has suspended production and sales of its controversial Alzheimer's drug GV-971 after the treatment's license expired, raising questions about the future of China's first indigenous therapy for the neurodegenerative disease. The Shanghai-based drugmaker announced the halt during the final stages of regulatory review for license renewal, during which commercial production and sales must cease.
The company informed employees of the production suspension in an internal notice at the end of May, according to local media reports. Green Valley stated that the changes are temporary and limited to operations related to sodium oligomannate, emphasizing that drug supply for clinical trials remains unaffected.
Regulatory Challenges and Clinical Concerns
GV-971, a seaweed-derived compound known as sodium oligomannate, received conditional approval from China's drug regulator in 2019 as the first new therapy endorsed for Alzheimer's in 17 years. The approval was initially hailed as a major advance for treating the cognitive disorder.
However, local and international medical experts have since questioned the drug's effectiveness in slowing or reversing cognitive decline in Alzheimer's patients. Critics point to the relatively short duration and inconsistent results shown in the drug's late-stage clinical trial conducted in China.
The company launched an ambitious global clinical trial in 2020, seeking to enroll approximately 2,000 patients across China, the United States, and Europe. The international study was terminated two years later due to funding shortages and disruptions caused by the COVID-19 pandemic.
Market Performance and Post-Marketing Studies
Despite regulatory skepticism, GV-971 achieved notable commercial success in China. The drug was included in national insurance reimbursement in 2022 at a price of approximately $41 per box. Hospital and retail sales topped $45.4 million (326 million yuan) that year, according to data from Pharnexcloud, a database tracking national hospital sales in China.
Green Valley has conducted post-marketing clinical studies involving around 3,300 patients on sodium oligomannate in China. The company plans to present these results at an international academic conference later this year, though the production halt may impact the timing of such presentations.
Competitive Landscape in China's Alzheimer's Market
The suspension comes as China's Alzheimer's treatment landscape has evolved significantly. The country has since approved two new therapies developed by multinational pharmaceutical companies: Leqembi from Biogen Inc. and Eisai Co., and Kisunla from Eli Lilly & Co.
China represents a substantial market for Alzheimer's treatments, with 17 million dementia patients according to a 2024 report led by Shanghai Jiao Tong University School of Medicine. This patient population accounts for approximately 30% of the global total, highlighting the significant unmet medical need in the region.
Company Response and Future Outlook
Green Valley emphasized its ongoing communication with regulatory authorities regarding the license renewal process. "We are in close communications with relevant authorities and believe patients' treatment needs will be met soon," the company stated in its email response.
The closely-held company has not disclosed detailed sales revenue figures for GV-971 in China, maintaining privacy around its financial performance despite the drug's inclusion in national insurance coverage.
The production halt represents a critical juncture for GV-971's future, as the company awaits regulatory decision on license renewal while facing increased competition from established international pharmaceutical companies in China's growing Alzheimer's treatment market.