Green Valley Suspends Sodium Oligomannate Manufacturing as 500,000 Patients Face Shortages
SHANGHAI, June 10 (Xinhua) – Green Valley Pharmaceuticals has suspended production of its Alzheimer’s treatment Sodium Oligomannate (GV-971), triggering nationwide shortages and price surges while awaiting regulatory recertification, the company confirmed today.
Production Halt and Employee Impact
The Shanghai-based manufacturer has:
- Closed GV-971 production lines and related offices
- Placed affected staff on Shanghai minimum wage (2,690 yuan/month)
- Maintained social security and housing fund payments
Company executives promise full wage restoration upon production resumption.
Drug Background and Market Impact
| Milestone | Detail |
|---|---|
| Development | Jointly created by Ocean University of China, CAS Shanghai Institute |
| Approval | Conditional NMPA clearance (Nov 2019) |
| Insurance | Added to NRDL in 2021 |
| Sales | 2.1M boxes sold in 2024 (>500,000 patients treated) |
Current shortages have sparked:
- 9300+ patient requests via company hotlines
- Daily price fluctuations on online pharmacies
Scientific Validation and Clinical Trials
The marine-derived drug has shown:
- 783 global citations since 2019 Cell Research publication
- 16% disease stabilization/improvement in 3,300-patient China study
- 31% “reversal trend” in newly-treated monotherapy patients
However, its international Phase III trial (2,046 patients across US/EU/China) was halted in May 2022 due to:
- High participant dropout rates
- Financial constraints
- Unspecified “external environmental factors”
Alzheimer’s Treatment Landscape
GV-971’s suspension highlights challenges in neurodegenerative drug development:
- Only a few new Alzheimer’s drugs approved globally since 2003
- Major pharma efforts (Lilly, Roche, Pfizer) yet to yield breakthroughs
- Shift from amyloid-focused to neuroinflammation-targeting therapies
“Treatment strategies are rapidly diversifying beyond amyloid proteins,” noted Dr. Richard Hodes of the US National Institute on Aging, citing April 2024 data showing neuroinflammation trials surpassing anti-Aβ studies.
Next Steps
Green Valley anticipates:
- Regulatory decision on certification renewal
- Final post-market study results by late 2025
- Potential international academic conference presentations
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