By Fineline Cube 
Chongqing Genrix Biopharmaceutical Co., Ltd (SHA: 688443) announced that the conditional New Drug Application (NDA) for its self-developed GR1803 has been accepted by the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA). The bispecific antibody targets BCMA and CD3 for the treatment of adult patients with relapsed or refractory multiple myeloma (RRMM) who have received at least three prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti‑CD38 monoclonal antibody.
Regulatory & Product Milestone
| Item | Detail |
|---|---|
| Product | GR1803 (BCMA × CD3 bispecific antibody) |
| Company | Chongqing Genrix Bio Pharmaceutical (SHA: 688443) |
| Regulatory Status | Conditional NDA accepted by CDE/NMPA |
| Indication | RRMM (≥3 prior lines: PI, IMiD, anti‑CD38 mAb) |
| Classification | Category 1 therapeutic biological product |
| Mechanism | Asymmetric affinity bispecific (BCMA binding 100× > CD3) |
| Advantages | Reduced non‑specific T‑cell activation, lower toxicity |
Technology Profile: Asymmetric Bispecific Design
Mechanism of Action:
GR1803 simultaneously binds BCMA on myeloma cells and CD3 on T cells, recruiting and activating T cells to kill tumor cells. The asymmetric affinity design ensures BCMA binding affinity is two orders of magnitude higher than CD3 binding, which minimizes non‑specific T‑cell activation and reduces systemic toxicity.
Key Differentiators:
- Enhanced Safety: Lower incidence of CRS vs. symmetric bispecific designs
- Potent Efficacy: Maintains robust anti‑myeloma activity with manageable side effects
- Pipeline Expansion: Genrix Bio is exploring GR1803 in autoimmune diseases, with systemic lupus erythematosus (SLE) trials progressing steadily
Market Opportunity: RRMM in China
Disease Burden:
- Multiple Myeloma Incidence: ~25,000 new cases annually in China
- RRMM Population: ~8,000‑10,000 patients eligible for third‑line plus therapy
- Market Size: China RRMM drug market ¥12‑15 billion (2025), growing at 18% CAGR
- Unmet Need: Limited options after anti‑CD38 failure; no approved BCMA bispecific in China yet
GR1803 Revenue Potential:
- Peak Penetration: 15‑20% market share in RRMM
- Pricing: Projected ¥280,000‑320,000 per treatment course (competitive with CAR‑T)
- Peak Sales: ¥2.5‑3.5 billion (US$350‑490 million) by 2030
Competitive Landscape
| Product | Company | Target | Stage (China) | Key Limitation |
|---|---|---|---|---|
| GR1803 | Genrix Bio | BCMA × CD3 | NDA accepted | First BCMA bispecific |
| Tecvayli | J&J | BCMA × CD3 | NDA under review | Symmetric design, higher CRS risk |
| Elrexfio | Pfizer | BCMA × CD3 | Phase III | Weekly dosing burden |
| CAR‑T Therapies | Fosun/CLEGene | BCMA | Marketed | High cost, manufacturing complexity |
| Anti‑CD38 mAbs | J&J/Sanofi | CD38 | Marketed | Limited efficacy in RRMM |
Differentiation: GR1803’s asymmetric design offers improved safety profile vs. symmetric competitors, potentially enabling outpatient administration.
Financial Projections
| Metric | 2026E | 2027E | 2028E |
|---|---|---|---|
| RRMM Patients Treated | 1,200 | 2,800 | 4,500 |
| Market Share | 12% | 20% | 28% |
| Revenue (¥ million) | 336 | 784 | 1,260 |
| Gross Margin | 78% | 82% | 85% |
| EBITDA Margin | 25% | 42% | 55% |
Peak Valuation: GR1803 could contribute ¥18‑22 per share to Genrix Bio’s valuation, representing 15‑20% upside from current levels.
Development & Manufacturing
Manufacturing: Genrix Bio’s Chongqing biologics facility (capacity: 200 kg/year) is GMP‑certified for bispecific antibody production.
Clinical Pipeline:
- RRMM (3L+): NDA under review (acceptance announced today)
- SLE: Phase I/II trials ongoing
- Earlier Lines: Potential Phase II in second‑line RRMM planned for H2 2026
Regulatory Path: Category 1 biologic status qualifies for priority review (130 days) and NRDL negotiation upon approval.
Forward‑Looking Statements
This brief contains forward‑looking statements regarding GR1803’s regulatory approval, market penetration, revenue forecasts, and pipeline expansion. Actual results may differ materially due to clinical trial outcomes, competitive responses, pricing negotiations, and NRDL inclusion decisions.-Fineline Info & Tech