By Fineline Cube 
China‑based Sichuan Biokin Pharmaceutical Co., Ltd. (SHA: 688506) announced today that the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) has granted a second Breakthrough Therapy Designation (BTD) to its bispecific antibody‑drug conjugate (ADC), izalontamab brengitecan (iza‑bren, code BL‑B01D1). The new designation covers patients with unresectable locally advanced or metastatic urothelial carcinoma (UC) who have progressed after platinum‑based chemotherapy and PD‑1/PD‑L1 inhibitor therapy.
What Izalontamab Brengitecan Brings
- First‑in‑class, EGFR×HER3 bispecific ADC – Combines dual antigen targeting with a potent cytotoxic payload, offering a novel mechanism of action in urothelial cancer.
- Phase 3‑ready – The only bispecific ADC in Phase 3 development, currently enrolled in over 40 clinical trials across China and the United States.
- Strategic partnership – Co‑developed with Bristol‑Myers Squibb (BMS), which holds global development and commercialization rights outside mainland China.
Regulatory Milestones
- December 2023 – Biokin signed a licensing and collaboration agreement with BMS, expanding izalontamab brengitecan’s reach worldwide.
- Prior BTD – The ADC previously received Breakthrough Therapy Designation for platinum‑resistant recurrent epithelial ovarian cancer, fallopian‑tube cancer, and primary peritoneal cancer.
- Current BTD – The new designation for urothelial carcinoma underscores the drug’s expanding therapeutic portfolio and the NMPA’s commitment to accelerating high‑impact oncology therapies.
Market Implications
- Competitive Edge – The BTD accelerates clinical development and potential market entry, positioning izalontamab brengitecan against emerging ADCs and immunotherapies in urothelial cancer.
- Investor Appeal – Biokin’s partnership with BMS and multiple BTDs enhance its valuation prospects, appealing to both domestic and international investors.
- Strategic Growth – Success in the U.S. and China markets could catalyze further collaboration with global oncology leaders and drive revenue growth for both Biokin and BMS.-Fineline Info & Tech