By Fineline Cube 
China‑based Genrix Biopharmaceutical Co., Ltd. (SHA: 688443) announced that the National Medical Products Administration (NMPA) has granted approval for a new clinical‑trial indication of its self‑developed bispecific antibody, GR1803 injection, for the treatment of systemic lupus erythematosus (SLE).
Product Profile
- Drug class: Class 1 therapeutic biologic
- Targets: BCMA and CD3
- Format: Bispecific antibody with a common light chain, mirroring the structure of a conventional monoclonal antibody
- Benefits: Simplified manufacturing process and reduced immunogenicity risk due to structural similarity to native antibodies
Clinical Development
| Indication | Development Stage | Status |
|---|---|---|
| Relapsed/refractory multiple myeloma (RRMM) | Phase II | Ongoing |
| Systemic lupus erythematosus (SLE) | New NMPA‑approved indication | Phase I/II trials slated to begin soon |
The NMPA clearance opens a new therapeutic avenue for GR1803, complementing its existing oncology pipeline.
Market Implications
- Regulatory Milestone – NMPA approval signals strong confidence in GR1803’s safety and efficacy profile, potentially accelerating its entry into the competitive SLE market.
- Strategic Positioning – By targeting both BCMA and CD3, GR1803 represents a versatile platform that could be adapted to other immune‑modulating diseases.
- Pipeline Expansion – The SLE indication broadens Genrix’s clinical portfolio, strengthening its valuation and investor appeal.
Financial Outlook
While Genrix has not yet disclosed detailed financial projections for the SLE program, the NMPA approval is expected to enhance the company’s growth prospects and attract additional capital toward future clinical milestones.-Fineline Info & Tech