By Fineline Cube Sichuan Biokin Pharmaceutical Co., Ltd (SHA: 688506) announced that its iza‑bren, a first‑in‑class EGFR×HER3 bispecific antibody‑drug conjugate (ADC), has met both primary endpoints in a Phase III study for unresectable locally advanced or metastatic triple‑negative breast cancer (TNBC). The trial (BL‑B01D1‑307) demonstrated statistically significant and clinically meaningful improvements in progression‑free survival (PFS) and overall survival (OS) in patients who had previously failed taxane‑based therapy. This marks the third Phase III success for iza‑bren and makes it the world’s first bispecific ADC to achieve positive PFS and OS results in TNBC.
Clinical Milestone – Phase III TNBC Study (BL‑B01D1‑307)
| Item | Detail |
|---|---|
| Sponsor | Sichuan Biokin Pharmaceutical Co., Ltd (SHA: 688506) |
| Product | Iza‑bren (EGFR×HER3 bispecific ADC) |
| Study Protocol | BL‑B01D1‑307 |
| Patient Population | Unresectable locally advanced or metastatic TNBC, post‑taxane failure |
| Primary Endpoints | Progression‑free survival (PFS) + Overall survival (OS) |
| Result | Statistically significant and clinically meaningful improvement in both PFS and OS |
| Significance | World’s first bispecific ADC with positive PFS and OS in TNBC |
| Phase III Success Count | 3rd Phase III study to meet primary endpoint |
Drug Profile – Iza‑Bren
- Class: First‑in‑class EGFR×HER3 bispecific ADC
- Mechanism: Dual‑targeting of EGFR and HER3 receptors for enhanced tumor selectivity and payload delivery
- Differentiation: Only EGFR×HER3 bispecific ADC to advance to Phase III clinical trials globally
- Clinical Footprint: 40+ active clinical trials across China and the United States spanning multiple tumor types
Regulatory Status & Designations
| Regulatory Agency | Designation | Indications |
|---|---|---|
| CDE/NMPA (China) | Breakthrough Therapy Designation | 7 indications granted |
| FDA (U.S.) | Breakthrough Therapy Designation | 1 indication granted |
| CDE/NMPA | Priority Review | NDA accepted for nasopharyngeal carcinoma |
| CDE/NMPA | Priority Review | NDA accepted for esophageal squamous cell carcinoma |
Strategic Implications
- TNBC Unmet Need: Triple‑negative breast cancer represents an aggressive subtype with limited targeted therapy options; iza‑bren’s dual survival benefit positions it as a potential new standard of care in the post‑taxane setting.
- Bispecific ADC Leadership: As the first‑in‑class and only Phase III‑stage EGFR×HER3 bispecific ADC, Biokin has established first‑mover advantage in a novel therapeutic class.
- Regulatory Momentum: With 7 Chinese and 1 U.S. Breakthrough Therapy designations, plus 2 NDAs under priority review, iza‑bren is on an accelerated path to market in multiple indications.
- Global Expansion: The extensive 40+ trial portfolio across China and the U.S. supports potential worldwide commercialization and label expansion beyond TNBC into nasopharyngeal and esophageal cancers.
Market Outlook
- Revenue Potential: TNBC, nasopharyngeal carcinoma, and esophageal squamous cell carcinoma represent multi‑billion‑dollar addressable markets in China and globally, with significant unmet medical need.
- Competitive Positioning: Iza‑bren’s bispecific mechanism may offer superior efficacy and safety compared to single‑target ADCs, potentially capturing market share from existing standards of care.
- Valuation Catalyst: The dual PFS/OS positive readout and third Phase III success strengthen Biokin’s investment case and partnership attractiveness ahead of anticipated NMPA approvals.
Forward‑Looking Statements
This brief contains forward‑looking statements regarding regulatory approvals, commercial expectations, and clinical outcomes for iza‑bren. Actual results may differ due to risks including regulatory review timelines, competitive dynamics, and manufacturing scalability.-Fineline Info & Tech