China’s pharmaceutical market is facing an unusual supply crisis as GV-971 (marketed as “Nine-One”), the controversial Alzheimer’s treatment, has disappeared from hospital shelves since mid-May, with prices soaring in private channels. Manufacturer Green Valley Pharmaceuticals confirmed to Health Insights on June 9 that production has ceased completely due to an expired drug registration certificate pending renewal approval.
A Drug Born From Controversy
Originally conditionally approved in November 2019 by China’s National Medical Products Administration (NMPA), GV-971 became the first new Alzheimer’s medication globally since 2003. The approval required post-market studies including a 2-year rat carcinogenicity test and ongoing mechanism research – unusual conditions reflecting regulatory concerns.
Developed from marine-derived oligosaccharides (reportedly seaweed extract), GV-971’s proposed mechanism targeting gut microbiota to reduce brain inflammation has drawn skepticism. Peking University professor Rao Yi famously questioned: “If 971 is real medicine rather than fake medicine, one could say making real medicine only requires street vendor skills.”
Clinical Trial Controversies
Doubts persist about GV-971’s evidence base:
Trial Design Issues
Phase II failed statistical significance
Phase III lasted only 9 months – unusually short for Alzheimer’s research
Abandoned Global Ambitions
A 2020 international Phase III trial intended for FDA approval was quietly terminated in 2022, with Green Valley citing pandemic-related patient dropout and funding issues. Industry observers note Alzheimer’s trials typically require 12-18 months to show effects.
Market Performance vs. Scientific Scrutiny
Despite unanswered questions, GV-971 achieved commercial success:
Pricing Trajectory
Launched at ¥895/box (¥3,580 monthly)
After 2021 Health insurance negotiation: 66.92% price cut to ¥1,184/month
Sales Growth
343.2% hospital sales growth post-approval
2022 revenues: ¥170M (hospital), ¥156M (retail)
Green Valley now faces severe financial strain, with production restart timelines uncertain pending NMPA review. The company maintains it submitted carcinogenicity data in 2019 and remains committed to global trials “when conditions permit.”
The Bigger Picture
GV-971’s predicament highlights the challenges of Alzheimer’s drug development – an area where even pharma giants like Pfizer and GSK have struggled. As China’s aging population grows, the demand for effective treatments intensifies, putting pressure on regulators to balance innovation with rigorous standards.
For now, patients and families are left waiting – both for GV-971’s potential return to market, and for clearer answers about whether this controversial medication truly represents the breakthrough it promised to be.
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