On June 22, the NMPA official website showed that Biokin Pharmaceutical’s Category 1 new drug “Lunkang Yilong Tuomab” has been approved for marketing in China for the treatment of adult patients with recurrent/metastatic nasopharyngeal carcinoma who have previously failed at least two lines of systemic chemotherapy and PD-1/PD-L1 inhibitor therapy.
Notably, Lunkang Yilong Tuomab is a global first-in-class, new-concept and the only EGFR×HER3 bispecific ADC to have entered Phase III clinical trials. Following this approval, the drug has become the world’s first approved drug of its kind, and the only bispecific ADC approved to date.
Lunkang Yilong Tuomab (Iza-bren, development code: BL-B01D1) is a bispecific ADC that simultaneously targets EGFR and HER3. Both EGFR and HER3 are highly expressed in most epithelial-derived tumors and are closely associated with tumor cell proliferation and survival. Through a dual mechanism of action, Lunkang Yilong Tuomab blocks EGFR and HER3 signaling to tumor cells, thereby inhibiting proliferation and survival signals, and releases its payload via antibody-mediated internalization, leading to tumor cell death.
The drug utilizes Biokin’s proprietary topoisomerase I inhibitor Ed-04 and an enzyme-cleavable linker, with a DAR value of 8. Its bispecific structure is designed to achieve the highest binding affinity for cells that co-express EGFR and HER3, thereby avoiding damage to skin epithelial cells that highly express EGFR but have low HER3 expression, reducing skin toxicity. By simultaneously targeting both EGFR and HER3, the drug can also effectively overcome tumor antigen heterogeneity, reducing the risk of target loss due to single antigen downregulation.
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