By Fineline Cube 
China‑based Chongqing Genrix Bio Pharmaceutical Co., Ltd. (SHA: 688443) and China Medical System Holdings Ltd. (CMS; HKG: 0867, SGX: 8A8) have inked exclusive cooperation agreements covering the research‑development, registration, production and commercialization of two next‑generation passive‑immunization agents: Vecantoxatug (GR2001) and Silevimig (GR1801).
Agreements Overview
| Item | Genrix Bio | CMS |
|---|---|---|
| R&D & Production | Full responsibility in China | – |
| Commercialization | Mainland China only | Mainland China + APAC (ex‑China), Middle East & North Africa |
| Regulatory | NMPA registration in China | NMPA registration + overseas filings |
| Financials | Up to RMB 510 million in upfront & milestone payments | Promotion service fees based on China sales |
| Revenue Sharing | Mainland sales revenue + supply revenue from non‑China regions | – |
Genrix Bio’s Role
- R&D Leadership – Drives pre‑clinical and clinical development of GR2001 and GR1801.
- Manufacturing Hub – Owns GMP facilities in Chongqing, ensuring supply chain control.
- Regulatory Champion – Secured Breakthrough Therapy Designation for GR2001 and NDA approvals for both products in China.
CMS’s Role
- Commercial Engine – Manages all sales, marketing and distribution activities across China and selected overseas markets.
- Regional Expansion – Leverages existing APAC, Middle East & North Africa networks to accelerate global uptake.
- Revenue‑Based Fees – Pays Genrix Bio promotion service fees tied to domestic sales performance.
Product Highlights
Vecantoxatug (GR2001)
- Mechanism – Recombinant humanized monoclonal antibody that binds the C‑terminus of the tetanus toxin heavy chain, blocking neuronal entry and providing passive protection.
- Regulatory Milestones – BTD listing by China’s CDE (May 2024); NDA for tetanus passive immunization accepted (May 2025).
Silevimig (GR1801)
- Mechanism – Fully human bispecific antibody targeting the rabies virus envelope G protein (epitopes I/III), preventing neural invasion before active vaccine immunity develops.
- Regulatory Milestones – First bispecific antibody for rabies passive immunization; NDA accepted (Jan 2025) for adult exposure; Phase 3 trial underway for pediatric exposure (2‑<18 yrs).
Market Outlook
- Tetanus & Rabies Burden – China remains a high‑risk region for both diseases; passive‑immunization agents can fill a critical unmet need.
- Competitive Edge – Dual‑antibody formats and quick‑action mechanisms differentiate Genrix Bio’s portfolio from existing antitoxins.
- Revenue Potential – With a projected RMB 510 million upfront, the partnership positions both companies to capitalize on a growing global demand for rapid‑response biologics.
Conclusion
The Genrix Bio‑CMS partnership combines Genrix Bio’s scientific expertise and regulatory traction with CMS’s expansive commercial network, setting the stage for accelerated market entry of Vecantoxatug and Silevimig across China and beyond.-Fineline Info & Tech