China Denies Renewal for Controversial Alzheimer's Drug, Paving Way for Global Competitors

In a significant development for the Alzheimer's disease treatment landscape, Chinese authorities have declined to renew the conditional approval for Green Valley Pharmaceuticals' controversial drug, sodium oligomannate (GV-971). This decision, revealed through online records from China's National Medical Products Administration (NMPA), marks a potential end to the drug's availability in the world's most populous country and opens doors for international competitors.

Regulatory Setback for Green Valley Pharmaceuticals

The NMPA's routine disclosure on August 12 placed Green Valley's applications to convert GV-971's conditional approval to full approval in the "notification delivery" category rather than the "approval document delivery" list. This categorization strongly suggests that the drug did not receive the necessary regulatory green light to continue its market presence.

Green Valley has not publicly announced the NMPA's feedback, leaving the exact reasons for the rejection unclear. However, this development follows months of speculation about the drug's future, with patients reporting supply difficulties as early as May 2025. The company had previously halted production and sales, citing an ongoing review process that extended beyond its existing permit's expiration date.

GV-971's Controversial History and Market Impact

GV-971, a seaweed-derived treatment, made waves in late 2019 when it entered the Chinese market as a purported breakthrough for Alzheimer's patients. Despite enjoying national reimbursement coverage since 2022, the drug has been mired in controversy from its inception.

Critics have pointed to potential issues with its phase 3 trial results, including an unusual worsening of symptoms in the control group and only nonsignificant improvements on certain cognitive measures. The cancellation of a global phase 3 trial in 2022, attributed to funding challenges and the COVID-19 pandemic, further fueled skepticism.

Despite these controversies, GV-971 reported significant sales in China. In 2024, approximately 2.13 million boxes were sold, generating sales of about $88 million at a reimbursed price of 296 Chinese yuan (roughly $41) per box.

Global Competition Intensifies in Chinese Alzheimer's Market

The denial of GV-971's renewal coincides with the recent approvals of two major international Alzheimer's treatments in China. Eisai's Leqembi received approval in early 2024, followed by Eli Lilly's Kisunla in December of the same year. Both drugs are indicated for patients with mild cognitive impairment and mild dementia stage of Alzheimer's disease.

These approvals underscore the significant market potential for Alzheimer's treatments in China, which Eisai estimates is home to about 17 million patients with early-stage Alzheimer's disease. As GV-971 potentially exits the market, Eisai and Eli Lilly are poised to capture a larger share of this substantial patient population.

The evolving landscape of Alzheimer's treatment in China reflects broader global trends in drug development and approval processes, highlighting the challenges and opportunities in addressing this complex neurodegenerative disorder.