China-based MediLink Therapeutics has announced that its B7-H3-targeting ADC, tambotatug pelitecan, met one of the dual primary endpoints in the Phase III TAISHAN-301 trial for recurrent/metastatic nasopharyngeal carcinoma (NPC). The study achieved a statistically significant improvement in the objective response rate (ORR) as assessed by blinded independent central review (BICR), while overall survival (OS) data remain immature. This is the first global Phase III success for a B7-H3 ADC candidate.

The trial evaluated tambotatug pelitecan against investigator’s choice of chemotherapy in patients who had failed prior PD-1/L1 inhibitor therapy and at least two lines of chemotherapy. The asset utilises MediLink’s proprietary TMALIN linker-payload platform.

In January 2026, the company entered an exclusive licensing agreement with Roche, granting the latter global rights outside Greater China in exchange for upfront and near-term milestone payments totalling USD 570 million, plus additional royalties. Tambotatug pelitecan has previously received multiple Breakthrough Therapy designations (BTDs) in China and the US, as well as three US Orphan Drug designations (ODDs).

PharmCube's NextBiopharm® database shows that MediLink's candidate is poised to challenge MSD's ifinatamab deruxtecan. Click here to request a free trial for NextBiopharm®.