July 18, 2026 – MediLink Therapeutics (Suzhou) Co., Ltd.  announced that the New Drug Application (NDA) for its independently developed B7-H3-targeting antibody-drug conjugate (ADC) Tam-Peli (research code: YL201) has been accepted for review by the National Medical Products Administration (NMPA). The submission is for the treatment of adult patients with recurrent or metastatic nasopharyngeal carcinoma (NPC) who have previously failed PD-(L)1 inhibitors and at least two lines of chemotherapy. The application is based on the prespecified interim analysis results from a randomized, controlled, multicenter Phase III study, YL201-CN-301-01 (TAISHAN-301), comparing YL201 versus investigator's choice of chemotherapy in this patient population.

Dr. Xue Tongtong, CEO of MediLink , commented: "The formal acceptance of YL201's NDA by the CDE marks a significant milestone for MediLink  as we transition from clinical development toward commercialization. It is also an important testament to our team's innovation and execution capabilities. We fully recognize that patients in the later-line NPC setting have extremely limited treatment options and face a huge unmet medical need. We are fully committed to cooperating with the regulatory review process and striving to bring this internationally competitive innovative therapy to Chinese patients as soon as possible."

Current Status of Advanced Nasopharyngeal Carcinoma Treatment

Nasopharyngeal carcinoma (NPC) is a malignant tumor arising from the epithelial lining of the nasopharynx, primarily associated with Epstein–Barr virus (EBV) infection, genetic predisposition, and environmental factors. NPC exhibits significant racial and geographic disparities. Among the three major racial groups worldwide, Asian populations have the highest incidence, followed by Black populations, while NPC is extremely rare in Caucasians. According to World Health Organization (WHO) data published in 2022, China bears a heavy disease burden of NPC: approximately half of global new cases (51,000 out of 120,000) and over one-third of global deaths (28,000 out of 73,000) occur in China, placing the country's morbidity and mortality burden among the highest worldwide [1][2].

About Tam-Peli 

Tam-Peli (YL201) is an ADC targeting B7-H3, developed using MediLink 's proprietary TMALIN® (Tumor Microenvironment-Activable Linker-payload) platform, which features a tumor-cleavable camptothecin-based linker-payload technology. In January 2026, Yilong Biomedical entered into an exclusive licensing agreement with Roche for the YL201 program, granting Roche exclusive global development, manufacturing, and commercialization rights outside mainland China, Hong Kong SAR, and Macau SAR. The two parties will jointly accelerate global R&D and regulatory filings, advancing development and commercialization across multiple solid tumor indications. Under the agreement, MediLink received an upfront payment and near-term milestones totaling $570 million, and is eligible for additional development, regulatory, and commercial milestone payments, as well as tiered royalties on net overseas sales.

On May 23, 2026, MediLink announced that in the Phase III trial for recurrent/metastatic NPC (TAISHAN-301), an Independent Data Monitoring Committee (IDMC) confirmed that the prespecified interim analysis had met the co-primary endpoint of objective response rate (ORR) assessed by blinded independent central review (BICR). This is the first positive Phase III result globally for a B7-H3 ADC.

Currently, YL201 is being evaluated in global clinical studies across multiple advanced solid tumor types. In China, YL201 has initiated three separate Phase III registrational trials for NPC, small cell lung cancer (SCLC), and esophageal squamous cell carcinoma (ESCC). Previously, YL201 has received five Breakthrough Therapy Designations from the NMPA's Center for Drug Evaluation (CDE) for indications including SCLC, NPC, ESCC, and pancreatic cancer, as well as a Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for SCLC. In addition, YL201 has been granted three Orphan Drug Designations by the FDA for SCLC, NPC, and ESCC.

About MediLink 

Founded in 2020, MediLink is a clinical-stage biotechnology company focused on developing innovative conjugated drugs. The company has independently developed the differentiated TMALIN® technology platform, whose diversity and efficacy have been consistently validated through preclinical studies and ongoing global clinical trials across 14 ADC candidates currently in clinical stages. MediLink  is dedicated to providing better treatment options for patients worldwide to address unmet medical needs. Headquartered in Suzhou, the company has R&D branches in Shanghai, Boston, and Singapore.

Company Statement

This press release is intended for information sharing and is not for promotional purposes. Certain forward-looking statements contained herein are inherently subject to risks and uncertainties. This material is for healthcare professional reference only and is not a product recommendation nor should it be construed as medical advice.

Inference:

[1]Bray F, Laversanne M, Sung H, et al. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2024;74(3):229-263.[2]Han B, Zheng R, Zeng H, et al. Cancer incidence and mortality in China, 2022. J Natl Cancer Cent. 2024;4(1):47-53.