**Title:** Chinese Alzheimer’s Drug Production Halt Raises Concerns
**Meta Description:** Green Valley Pharmaceutical suspends production of its Alzheimer’s drug, GV-971, amid regulatory review, raising questions about its future.
**URL Slug:** chinese-alzheimers-drug-production-halt
**Headline:** Concerns Grow as Chinese Alzheimer’s Drug GV-971 Halts Production
Green Valley Pharmaceutical Co., a Chinese company known for developing the nation’s first indigenous Alzheimer’s therapy, has announced a suspension of production and sales of its drug, sodium oligomannate (GV-971). This decision has sparked uncertainty regarding the future of the treatment, particularly as its license has expired and is currently undergoing a regulatory review for renewal.
In a statement to Bloomberg News, Green Valley explained that during this review process, they are required to cease all commercial production and sales. The company had previously informed its employees about the production halt in an internal notice released at the end of May, as reported by local media.
Sodium oligomannate, derived from seaweed, was celebrated as a significant breakthrough when it received conditional approval from China’s drug regulator in 2019, marking the first new therapy for Alzheimer’s in 17 years. However, the drug’s efficacy in slowing or reversing cognitive decline in Alzheimer’s patients has been met with skepticism from both local and international medical experts, particularly due to the mixed results from its late-stage clinical trials in China.
In 2020, Green Valley initiated a global clinical trial aimed at enrolling approximately 2,000 patients across China, the United States, and Europe. Unfortunately, this trial was terminated two years later due to funding challenges and disruptions caused by the COVID-19 pandemic. Prior to this, the company had conducted post-marketing clinical studies involving around 3,300 patients in China and plans to present these findings at an international academic conference later this year.
Green Valley has assured that the changes are temporary and limited to operations concerning sodium oligomannate, emphasizing that the supply of the drug for clinical trials remains unaffected. The company stated, “We are in close communications with relevant authorities and believe patients’ treatment needs will be met soon.”
Despite the uncertainty surrounding GV-971, the drug was included in China’s national insurance reimbursement list in 2022, priced at approximately $41 per box. Sales of GV-971 in hospitals and retail outlets reached over $45.4 million (approximately 326 million yuan) that year, according to data from Pharnexcloud.
In recent developments, China has also approved two new Alzheimer’s therapies from multinational companies: Leqembi by Biogen Inc. and Eisai Co., and Kisunla from Eli Lilly & Co. With an estimated 17 million dementia patients in China—accounting for about 30% of the global total—per a 2024 report from Shanghai Jiao Tong University School of Medicine, the demand for effective Alzheimer’s treatments remains critical.
**FAQ Section:**
**Q: What is the status of Green Valley’s Alzheimer’s drug GV-971?**
A: Green Valley Pharmaceutical has suspended production and sales of GV-971 due to an expired license currently under regulatory review, raising concerns about the drug’s future availability.
