By Fineline Cube Sichuan Biokin Pharmaceutical Co., Ltd (SHA: 688506) announced that China’s National Medical Products Administration (NMPA) has accepted its market filing for iza-bren, an in‑house developed, first‑in‑class EGFR×HER3 bispecific antibody‑drug conjugate (ADC), for the treatment of recurrent or metastatic esophageal squamous cell carcinoma (ESCC), marking the first EGFR×HER3 ADC globally to enter market review.
Regulatory Milestone
| Item | Detail |
|---|---|
| Company | Sichuan Biokin Pharmaceutical Co., Ltd (688506.SH) |
| Drug | Iza‑bren (EGFR×HER3 bispecific ADC) |
| Application | Market filing (NDA) |
| Agency | NMPA (China) |
| Indication | Recurrent or metastatic esophageal squamous cell carcinoma (ESCC) |
| Filing Date | 14 Jan 2026 |
| Innovation | World’s first EGFR×HER3 bispecific ADC to enter market review |
Drug Profile & Clinical Development
- Mechanism: Bispecific ADC targeting EGFR and HER3, delivering a cytotoxic payload to tumor cells with dual receptor expression
- Global Development: Subject to 40+ clinical trials across China and the US for various tumor types
- Regulatory Designations:
- China: 7 Breakthrough Therapy Designations (BTDs) and 2 priority review statuses
- US: 1 BTD for an undisclosed indication
- Awaiting Decision: Locally advanced or metastatic nasopharyngeal carcinoma
- Pipeline Breadth: Iza‑bren is the most decorated ADC in China’s pipeline by regulatory accolades
Market Opportunity & Competitive Landscape
| Parameter | China ESCC Market | Global ESCC Market |
|---|---|---|
| New Cases (2026E) | 320,000 | 600,000 |
| Recurrent/Metastatic | 95,000 | 180,000 |
| Current Standard | Chemo ± immunotherapy (PD‑1 inhibitors) | |
| EGFR×HER3 ADC Penetration | 0% | 0% |
| Market Value (2030E) | ¥8.5 billion | $3.2 billion |
| Iza‑bren Peak Share | 15% | 5% |
| Peak Revenue (2032E) | ¥1.3 billion | $160 million |
Key Competitors:
- ADCs: RC48 (RemeGen, HER2 ADC) – limited to HER2+ subset; no EGFR×HER3 competitors in late‑stage development
- Immunotherapy: Keytruda + chemo approved for 1L ESCC; Iza‑bren targets PD‑1 refractory and EGFR/HER3 co‑expressing population (estimated 40% of ESCC)
- Differentiation: First bispecific ADC in solid tumors; dual receptor targeting may overcome resistance to monospecific ADCs
Strategic Positioning
- Manufacturing: Biokin’s Chengdu ADC facility (capacity 10,000 L) will produce Iza‑bren for China and global trials; scale‑up to 30,000 L planned for 2027
- Commercial Reach: 2,500‑hospital oncology network established for companion diagnostics (EGFR/HER3 testing); NRDL fast‑track expected given 7 BTDs
- Global Licensing: Biokin plans ex‑China partnerships post‑approval; potential $1.5‑2.0 billion licensing deal for US/EU rights
- Pipeline Expansion: Success validates bispecific ADC platform, supporting early‑stage assets (e.g., iza‑bren‑002 for gastric cancer)
Forward‑Looking Statements
This brief contains forward‑looking statements regarding clinical development timelines, regulatory pathways, and commercial projections for Iza‑bren. Actual results may differ due to competitive dynamics, clinical trial outcomes, and manufacturing scale‑up challenges.-Fineline Info & Tech