China-based MediLink Therapeutics has submitted a New Drug Application (NDA) to China’s Centre for Drug Evaluation (CDE) for tambotatug pelitecan, a B7-H3-targeted antibody-drug conjugate (ADC) using the TMALIN tumour-microenvironment-cleavable linker platform, in patients with recurrent or metastatic nasopharyngeal carcinoma who progressed after PD-1/L1 inhibition and at least two lines of chemotherapy.

This marks the first ADC to be filed based on positive Phase III data globally in the B7-H3 space, and the first NDA from MediLink's innovative pipeline. The submission is supported by the TAISHAN-301 trial, which met the co-primary endpoint of objective response rate (ORR) per blinded independent central review (BICR), while overall survival data remain immature.

Tambotatug pelitecan holds multiple Breakthrough Therapy Designations (BTD) in China (small cell lung cancer, nasopharyngeal carcinoma, oesophageal squamous cell carcinoma) and the US (small cell lung cancer), plus three orphan drug designations (ODD) in the US.

Under a January 2026 exclusive global licence (excluding Mainland China, Hong Kong and Macau) with Roche, MediLink received USD 570 million upfront and near-term milestones, with eligibility for further development, regulatory, and commercial milestones plus tiered royalties. The filing reinforces momentum in B7-H3 ADC development alongside assets from MSD and Daiichi Sankyo.