#China #Suzhou #Roche #MediLink #YL201

MediLink Expands Partnership with Roche for YL201 Development

In a significant move in the biopharmaceutical sector, MediLink Therapeutics has announced a new exclusive licensing agreement with Roche for the development and commercialization of YL201, an investigational antibody-drug conjugate (ADC) aimed at treating solid tumors. This partnership not only underscores the collaboration that began in January 2024 but also highlights both companies' commitment to addressing unmet medical needs in oncology.

MediLink is granting Roche an exclusive license to develop, manufacture, and commercialize YL201 globally, except for regions of mainland China, Hong Kong, and Macau. Under the terms of this agreement, MediLink stands to gain an upfront payment of $570 million and additional milestone payments contingent on the progression of the therapy through various development and regulatory stages. They will also receive tiered royalties on sales outside of China once YL201 is approved.

Dr. Tongtong Xue, the founder and CEO of MediLink, expressed excitement about the new collaboration, praising Roche’s extensive experience and capability in global clinical development, particularly in oncology. He emphasized that this partnership would facilitate quicker patient access to YL201 upon receiving regulatory approvals.

Dr. Jiaqiang Cai, co-founder and co-CEO of MediLink, shared insights about the encouraging clinical data for YL201 and underscored the importance of this agreement in propelling the drug toward becoming a viable treatment option for patients with solid tumors, which traditionally have had limited effective therapies.

Roche's Head of Corporate Business Development, Boris L. Zaïtra, commented on the partnership, noting that it reflects Roche's strategy to harness global innovation in addressing patient needs, especially in oncology—one of Roche's main priorities. The collaboration aims to merge the strengths of both organizations in the development of ADCs and accelerate the availability of YL201 to a wider patient population.

About YL201

YL201 is developed using MediLink's proprietary Tumor Microenvironment-Activatable LINker-payload (TMALIN®) technology. The ADC currently undergoes testing in multinational clinical trials targeting multiple advanced solid tumors. In China, it is entering Phase III registrational trials specifically for small cell lung cancer (SCLC) and nasopharyngeal carcinoma (NPC). Preliminary findings indicate meaningful response rates and survival enhancements for patients with relapsed SCLC. Recently, the FDA designated YL201 as a Breakthrough Therapy for SCLC, reinforcing its potential as a transformative treatment option.

About MediLink

Founded in 2020, MediLink Therapeutics specializes in developing innovative ADCs that focus on addressing significant gaps in cancer treatment. With their TMALIN® technology platform, they have launched 13 clinical-stage ADC candidates and continue to support their research and trials from hubs in Suzhou, Shanghai, Boston, and Singapore. MediLink's mission revolves around improving treatment access and addressing the pressing medical needs of patients worldwide.