Head and neck tumors are one of the common malignant tumors in China, including a series of tumors occurring in the oral cavity, pharynx, larynx, salivary glands, nasal cavity, and sinuses. Among head and neck malignant tumors, head and neck squamous cell carcinoma (HNSCC) is the most common pathological type, accounting for about 90%. 70%-80% of patients with head and neck squamous cell carcinoma are already in the locally advanced stage (stage III or IV) at initial diagnosis, and the 5-year survival rate for recurrent or metastatic head and neck squamous cell carcinoma is less than 10%.

On March 19, 2026, according to the latest announcement on the official website of the China National Medical Products Administration (CDE), Lepu Biopharma Co., Ltd.'s clinical trial application for a new indication of Becotatug Vedotin for Injection, submitted under registration category 2.2, has received implicit approval. The proposed indication is: This product, in combination with Pucotelimab Injection, for perioperative treatment of patients with locally advanced resectable head and neck squamous cell carcinoma.

According to Lepu Biopharma's press release, Becotatug Vedotin is the world's first approved epidermal growth factor receptor (EGFR) antibody-drug conjugate (ADC). The drug is formed by conjugating a humanized EGFR monoclonal antibody with the potent microtubule inhibitor payload monomethyl auristatin E (MMAE) via a valine-citrulline linker. It can specifically bind with high affinity to EGFR on the surface of tumor cells. After internalization and lysosomal protease cleavage, it releases the potent payload, leading to tumor cell death. EGFR is highly expressed in various malignant solid tumors such as colorectal cancer, lung cancer, and head and neck cancer, with 89% of advanced NPC showing EGFR expression. Therefore, EGFR is an important target for cancer treatment.

EGFR is a transmembrane protein and a member of the epidermal growth factor receptor family, playing a crucial role in cell growth, development, and differentiation. Among these, the overexpression of EGFR and its binding with specific ligands such as EGF and TGFα can lead to abnormal activation of EGFR. The activated EGFR can further activate and regulate multiple signal transduction pathways, thereby inhibiting tumor cell apoptosis, promoting tumor cell proliferation and migration, and promoting tumor angiogenesis by mediating VEGF expression. Consequently, it plays a significant role in the occurrence, development, malignancy, and prognosis of tumors. Therefore, blocking the EGFR-mediated signal transduction pathway can achieve the effect of treating tumors.

Data shows that on October 30, 2025, Lepu Biopharma's self-developed innovative drug Becotatug Vedotin (MRG003) was officially approved for the first time. This drug is indicated for the treatment of adult patients with recurrent/metastatic nasopharyngeal carcinoma who have failed at least two lines of systemic chemotherapy and PD-1/PD-L1 inhibitor therapy. Its approval undoubtedly brings new hope for nasopharyngeal carcinoma patients.

At the 2025 American Society of Clinical Oncology (ASCO) annual meeting, the key study on Becotatug Vedotin for recurrent metastatic nasopharyngeal carcinoma was presented as a Late-Breaking Abstract (LBA) oral report, attracting widespread attention from the global medical community. As of June 30, 2024, the objective response rate (ORR) assessed by independent central review (BICR) in the Becotatug Vedotin group was 30.2%, while the ORR in the chemotherapy group was only 11.5%, achieving a

nearly threefold improvement. Furthermore, the median progression-free survival (PFS) benefit in the Becotatug Vedotin group doubled, significantly reducing the risk of disease progression or death by 37% (5.82 months vs. 2.83 months; HR=0.63, P=0.0146). An interim analysis as of December 30, 2024, showed that the median overall survival (OS) for the two groups of patients was 17.08 months and 11.99 months, respectively (HR=0.73), and Becotatug Vedotin has already shown a clear trend of benefit.

Finally, we hope that Lepu Biopharma's subsequent clinical trials for the new indication of Becotatug Vedotin for Injection will proceed smoothly and provide more treatment options for patients as soon as possible.

Source: Beijing Yaoyanhui

$LEPU BIO-B(02157.HK) 

​