By Fineline Cube 
Lepu Biopharma Co., Ltd. (HKG: 2157) today announced that its antibody‑drug conjugate (ADC) Becotatug Vedotin (MGR003) has received conditional approval from the National Medical Products Administration (NMPA) of China. The drug is cleared for adult patients with recurrent or metastatic nasopharyngeal carcinoma who have progressed after at least two lines of systemic chemotherapy and PD‑1/PD‑L1 inhibitor therapy.
Product Highlights
- Targeted Mechanism – MGR003 couples an EGFR‑specific monoclonal antibody to the microtubule inhibitor MMAE via a vc linker.
- High‑Affinity Binding – The ADC binds EGFR on tumor cells with nanomolar affinity, is efficiently internalized by endocytosis, and releases MMAE intracellularly to trigger apoptosis.
- Clinical Rationale – Designed for a population with limited options, the therapy offers a novel modality that exploits EGFR over‑expression common to nasopharyngeal carcinoma.
Regulatory Milestone
- Conditional Approval – The NMPA approval is contingent upon the completion of post‑marketing surveillance and additional confirmatory studies.
- Market Impact – This approval positions Lepu Biopharma as a leading ADC developer in the Chinese oncology market and expands access to a first‑in‑class therapy for a high‑need patient group.
Forward‑Looking Statements
This release contains forward‑looking statements that involve risks and uncertainties. Actual results may differ materially.-Fineline Info & Tech