Medilink announces NMPA acceptance of marketing application for Tam-Peli in 3L+ NPC

CAR-T Digest - August 2020

18 July 2026: Medilink announces NMPA acceptance of marketing application for Tam-Peli in 3L+ NPC

MediLink Therapeutics announced that China’s NMPA has accepted the new drug application for Tam-Peli, its B7-H3-targeted antibody-drug conjugate, for the treatment of adults with recurrent or metastatic nasopharyngeal carcinoma who have progressed following PD-(L)1 inhibitors and at least two prior lines of chemotherapy
The submission is supported by the pivotal phase 3 TAISHAN-301/YL201-CN-301-01 trial, where an independent data monitoring committee confirmed that the pre-specified interim analysis met the co-primary endpoint of confirmed objective response rate versus investigator’s choice chemotherapy, representing the first positive phase 3 result globally for a B7-H3-targeted ADC
The application addresses a significant unmet need in recurrent or metastatic NPC, where patients progressing after immunotherapy and multiple lines of chemotherapy have limited effective treatment options. China bears approximately half of the global NPC disease burden, underscoring the importance of new targeted therapies in this setting

Tam-Peli is a B7-H3-directed ADC developed using MediLink’s proprietary TMALIN platform, featuring a tumor microenvironment-cleavable camptothecin-based payload designed to improve tumor selectivity and therapeutic efficacy
Strategically, the NDA acceptance advances MediLink’s transition toward commercialization, further validates its proprietary TMALIN ADC platform, and strengthens the global development of YL201 through its partnership with Roche, reinforcing the company’s position in the emerging B7-H3 ADC landscape

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