Chinese Firm Halts Production of Controversial Alzheimer's Drug
(Bloomberg) -- A Chinese company that developed the country's first indigenous therapy for Alzheimer's disease has suspended production and sales of the drug, casting doubts on the treatment's future.
The drug's license has expired and its renewal is now in the final stages of a regulatory review, during which it must stop commercial production and sales, Green Valley Pharmaceutical Co. said in an emailed statement to Bloomberg News on Tuesday. The Shanghai-based drugmaker informed employees of the production halt in an internal notice at the end of May, local media Yicai reported first on Monday.
Green Valley's drug — a seaweed-derived compound known as sodium oligomannate, or GV-971 — was hailed as a major advance when China's drug regulator gave it conditional approval in 2019, as the first new therapy endorsed for Alzheimer's in 17 years.
Local and international medical experts have since questioned how effective it really is in slowing or reversing the cognitive declines of Alzheimer's patients given the relatively short duration of — and the inconsistent results shown in — its late-stage clinical trial in China.
The company launched a global clinical trial in 2020, seeking to enroll some 2,000 patients across China, the US and Europe. It was terminated two years later due to a lack of funding and Covid pandemic disruptions.
Green Valley previously conducted post-marketing clinical studies on around 3,300 patients on sodium oligomannate in China and has planned to present the results at an international academic conference later this year, according to the company.
The changes are temporary and limited to operations related to sodium oligomannate, the company said, adding that drug supply for clinical trials is unaffected. 'We are in close communications with relevant authorities and believe patients' treatment needs will be met soon,' it said in the email.
The closely-held company has not disclosed sales revenue for GV-971 in China, where it was included for national insurance reimbursement in 2022 at a price of around $41 per box.
Hospital and retail sales of GV-971 topped $45.4 million (326 million yuan) that year, Yicai reported, citing figures from Pharnexcloud — a database of national hospital sales in China.
China has since approved two new Alzheimer's therapies developed by multinational drugmakers: Biogen Inc. and Eisai Co.'s Leqembi, and Kisunla from Eli Lilly & Co. The country has 17 million dementia patients — about 30% of the global total — per a 2024 report led by Shanghai Jiao Tong University School of Medicine.
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