The Shanghai Pudong New Area Market Supervision Administration issued an administrative penalty against Green Valley (Shanghai) Pharmaceuticals Co., Ltd., levying a RMB 400,000 fine for alleged commercial bribery in the promotion of its sodium oligomannate capsules (“GV‑971”). The decision categorizes the conduct as an improper benefit to medical‑institution officials, procurement staff, physicians, pharmacists, or other drug users—a breach of the drug‑marketing‑authorisation holder’s duties.
Key Points
• Fine Amount: RMB 400,000
• Allegations: Payments to healthcare‑sector insiders for drug promotion
• Outcome: No illicit financial benefit proved; the agency found no link between the payments and GV‑971 procurement volumes.
GV‑971: From Approval to Production Halt
Sodium oligomannate was conditionally approved by China’s National Medical Products Administration (NMPA) in November 2019 for Alzheimer’s disease treatment and subsequently entered the National Reimbursement Drug List (NRDL) in January 2022. Despite initial commercial success, Green Valley shut down its GV‑971 office and production facilities in June 2025 after the drug’s registration certificate expired on November 2, 2024 and the company failed to secure timely re‑registration.
Regulatory Status
• Re‑registration Notice: August 2025 NMPA denied approval for GV‑971’s re‑registration
• Impact: Production ceased and the drug was removed from the market, undermining Green Valley’s Alzheimers‑drug portfolio and eroding supplier confidence.
Implications for China’s Biopharma Oversight
The fine underscores the growing emphasis on ethical marketing within China’s rapidly evolving biopharma landscape. While the agency did not uncover direct financial gain, the case highlights the critical importance of maintaining valid registration and adherence to NMPA timelines—failure to do so can lead to production shutdowns, market exit and reputational damage.-Fineline Info & Tech
