BIOKIN has announced the receipt of a drug registration certificate from the National Medical Products Administration.
This approval grants marketing authorization for the company's internally developed, first-in-class, and novel concept dual-antibody drug conjugate, iza-bren (also known as BL-B01D1).
The drug is the only candidate of its type to have progressed to Phase III clinical trials and is indicated for patients with recurrent or metastatic nasopharyngeal carcinoma.
Eligible patients are those who have experienced treatment failure after receiving at least two prior lines of systemic chemotherapy and PD-1/PD-L1 inhibitor therapy.