Shanghai Securities News China Securities(Reporter Zhang Xue) According to the official website of the National Medical Products Administration (NMPA), on October 30, Lepu Biopharma's MRG003 (verbicotutomab) received conditional approval for marketing, for the treatment of patients with recurrent/metastatic nasopharyngeal carcinoma who have failed at least two lines of systemic chemotherapy and PD-1/PD-L1 inhibitor therapy. The brand name is Meiyouheng. This indication had previously been included in the priority review list by the NMPA's Center for Drug Evaluation.

　　Data shows that MRG003 is the world's first approved EGFR (epidermal growth factor receptor) ADC (antibody-drug conjugate) drug, marking another newmonument.

　　This drug is composed of a humanized EGFR monoclonal antibody and a potent microtubule-inhibiting payload—methylaurestatin E (MMAE)—conjugated via a valine-citrulline linker. It binds specifically and with high affinity to EGFR on the surface of tumor cells, releasing the potent payload through endocytosis and lysosomal protease cleavage, thereby leading to tumor cell death. EGFR is highly expressed in various malignant solid tumors, including colorectal cancer, lung cancer, and head and neck cancer; 89% of advanced NPCs exhibit EGFR expression.

　　In addition to monotherapy for nasopharyngeal carcinoma, Lepu Biopharma is also exploring combination therapy of MRG003 with the PD-1 inhibitor putelimab.The effects on nasopharyngeal carcinoma patients.

　　In terms of indications, Lepu Bio has also developed multiple indications for MRG003, including head and neck squamous cell carcinoma (stage III), biliary tract cancer (stage II), non-small cell lung cancer (stage II), and gastric cancer (stage II).

　　According to the Insight database, the two most advanced EGFR ADC products are both from China. Besides Lepu's MRG003, CSPC Pharmaceutical Group 's CPO301 is the second most advanced, having already entered Phase III clinical trials in China.

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