MediLink and Roche Expand Partnership with $570 Million Deal for B7H3-Targeting ADC YL201
核心洞察
MediLink Therapeutics (搜索) has signed an exclusive licensing agreement with Roche for YL201, a B7H3 (搜索)-targeting antibody-drug conjugate, with upfront payments of $570 million plus additional milestones and royalties.
YL201 is currently in Phase III registrational trials for small cell lung cancer and nasopharyngeal carcinoma in China, with FDA Breakthrough Therapy Designation granted in June 2025.
The collaboration builds on the companies' existing partnership for YL211 and leverages MediLink's proprietary TMALIN® platform technology for global development of solid tumor treatments.
MediLink Therapeutics (搜索) announced a new collaboration and exclusive licensing agreement with Roche for the development and commercialization of YL201, an investigational antibody-drug conjugate targeting B7H3 (搜索) across numerous solid tumor types. The deal includes upfront and near-term milestone payments of $570 million, with additional development, regulatory, and commercial milestone payments, plus tiered royalties on net sales outside of China.
Strategic Partnership Expansion
This agreement represents the second major collaboration between MediLink and Roche, building on their successful partnership initiated in January 2024 for the YL211 c-Met (搜索) ADC program. Under the new terms, Roche will receive exclusive worldwide rights to develop, manufacture, and commercialize YL201, excluding mainland China, Hong Kong Special Administrative Region, and Macau Special Administrative Region.
Dr. Tongtong Xue, Founder, Chairman and CEO of MediLink, stated: "We are thrilled to again enter into collaboration with our valued partner Roche. We are impressed by Roche's unparalleled expertise in global clinical development for oncology assets and look forward to working jointly to expedite worldwide patient access to YL201 once approved."
Clinical Development Progress
YL201 is currently under investigation in multinational clinical trials for various advanced solid tumors. In China, the drug has advanced into two Phase III registrational trials for small cell lung cancer (SCLC) and nasopharyngeal carcinoma (NPC). Preliminary clinical data have demonstrated promising objective response rates and survival benefits in second-line SCLC patients.
The FDA granted Breakthrough Therapy Designation for YL201 for SCLC treatment in June 2025, following three previous Orphan Drug Designations for SCLC, NPC, and Esophageal Squamous Cell Carcinoma (ESCC).
TMALIN® Platform Technology
YL201 is developed using MediLink's proprietary Tumor Microenvironment-Activatable LINker-payload (TMALIN®) platform. Dr. Jiaqiang Cai, Co-founder, co-CEO and CSO of MediLink, commented: "YL201 has demonstrated promising clinical data, and this collaboration with Roche marks a transformative step for its global development. This agreement provides YL201, a key asset from our innovative TMALIN® platform, with the necessary worldwide reach and resources to potentially become a new treatment option, addressing critical unmet needs for patients with various solid tumors."
The TMALIN® platform's versatility and efficacy have been demonstrated through 13 clinical-stage ADC candidates, supported by data from preclinical studies and ongoing global clinical trials.
Strategic Rationale
Boris L. Zaïtra, Head of Corporate Business Development at Roche, emphasized the strategic importance of the collaboration: "Our deepening collaboration with MediLink on YL201 reflects Roche's commitment to leveraging cutting-edge innovation from around the globe to address unmet patient needs, particularly within oncology and lung cancer as one of our strategic priorities. We are excited to combine MediLink's and Roche's expertise in ADCs with our well established global development and commercial presence to bring this promising potential therapy option to patients."
The partnership aims to leverage complementary strengths to accelerate YL201's path to global regulatory approvals, with both companies committed to bringing this potentially transformative therapy option to patients worldwide.