On September 19, the National Medical Products Administration (NMPA) released a public notice on its drug evaluation center's official website, announcing that Lepu Biotech's injection of Vebecotamab is proposed for priority review. This treatment is intended for patients with recurrent or metastatic nasopharyngeal carcinoma who have previously failed at least two lines of systemic chemotherapy and PD-1/PD-L1 inhibitor therapies.

This drug, developed by Lepu Biotech, is an antibody-drug conjugate (ADC) targeting EGFR, with the development code MRG003. It is composed of an EGFR-targeted monoclonal antibody linked to a potent microtubule inhibitor, MMAE, through a vc linker. The molecular design of this drug has the potential to extend its application to a broader range of cancers that overexpress EGFR and may overcome various types of resistance caused by common mutations.

In its previously published semi-annual report, Lepu Biotech indicated plans to submit a new drug application (NDA) for MRG003 to the NMPA within 2024.

In May 2022, the Journal of the American Medical Association - Oncology published results from a Phase 1 study of MRG003, which demonstrated manageable safety for treating patients with advanced solid tumors and showed good anti-tumor activity against EGFR-positive advanced head and neck squamous cell carcinoma and nasopharyngeal carcinoma.

Lepu Biotech’s 2024 semi-annual report indicates that MRG003 has received breakthrough therapy designation from the U.S. Food and Drug Administration (FDA) for the indication of nasopharyngeal carcinoma. Currently, Lepu Biotech has completed patient enrollment for the Phase 2b registrational clinical study of MRG003 targeting nasopharyngeal carcinoma. Additionally, active enrollment is ongoing for its Phase 3 clinical registrational study targeting head and neck squamous cell carcinoma.

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