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MediLink Therapeutics Announces B7-H3 ADC YL201 Met Primary Endpoint in Phase 3 Nasopharyngeal Carcinoma Study

2026-05-30

SUZHOU, China – May 29, 2026 – MediLink Therapeutics (Suzhou) Co., Ltd. today announced that tambotatug pelitecan (tam-peli, R&D code: YL201), its investigational B7-H3 targeted antibody-drug conjugate (ADC), has achieved positive results in the pre-specified interim analysis of the Phase 3 registrational clinical trial (TAISHAN-301) for recurrent or metastatic nasopharyngeal carcinoma (NPC). The Independent Data Monitoring Committee (IDMC) confirmed that the trial met the endpoint of confirmed objective response rate (cORR) as assessed by Blinded Independent Central Review (BICR), demonstrating a statistically significant improvement compared to chemotherapy. The second co-primary endpoint of overall survival (OS) is not yet mature. This marks the first positive Phase 3 result for any B7-H3 targeted ADC worldwide.

 

About TAISHAN-301

TAISHAN-301 is a randomized, controlled, multicenter Phase 3 trial led by Sun Yat-sen University Cancer Center, conducted across more than 60 sites in China. The study enrolled its first patient in December 2024. Primary endpoints are ORR assessed by BICR and OS; key secondary endpoints include progression-free survival (PFS).

 

About YL201 (tambotatug pelitecan, tam-peli)

YL201 is an anti-B7-H3 ADC built on MediLink Therapeutics’ proprietary TMALIN® (Tumor Microenvironment-Activatable Linker) platform with a camptothecin payload. It is being evaluated globally in multiple advanced solid tumors.

In January 2026, MediLink Therapeutics announced the     exclusive licensing agreement with Roche for YL201. Under the terms of the agreement, MediLink will grant Roche an exclusive license to develop, manufacture, and commercialize YL201 worldwide, excluding the mainland of China, the Hong Kong Special Administrative Region, and the Macau Special Administrative Region. MediLink will receive upfront and near-term milestone payments of US$ 570 million, together with additional development, regulatory, and commercial milestone payments, as well as tiered royalties on net sales of YL201 outside of China, once approved.

In China, YL201 is in three Phase 3 registration trials for NPC, small cell lung cancer (SCLC), and esophageal squamous cell carcinoma (ESCC). It has been granted four Breakthrough Therapy Designations (BTDs) by CDE and one BTD by the U.S. FDA for SCLC. YL201 also holds three U.S. FDA Orphan Drug Designations for SCLC, NPC, and ESCC.

 

About MediLink Therapeutics

Founded in 2020, MediLink Therapeutics is a clinical-stage biotechnology company focused on innovative conjugated drugs. With its proprietary TMALIN® platform, the company has built a pipeline of 14 clinical-stage ADC candidates validated in preclinical and global clinical studies. Headquartered in Suzhou, MediLink Therapeutics has R&D facilities in Shanghai, Boston, and Singapore, dedicated to addressing unmet medical needs for patients worldwide.


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