MediLink and Roche announce exclusive licensing agreement for YL201c

Under the agreement, MediLink will receive upfront and near-term milestone payments totalling $570m.

Additional development, regulatory, and commercial milestone payments are included in the deal, along with tiered royalties on net sales of YL201 outside China once the product receives approval.

The licensing agreement gives Roche rights to develop, manufacture, and commercialise YL201 globally, except in mainland China, the Hong Kong Special Administrative Region (SAR), and Macau SAR.

This new arrangement for YL201 builds on the companies’ previous collaboration announced in January 2024 concerning the YL211 (c-Met ADC) programme.

Through the expanded partnership, both companies will use their respective strengths to accelerate global regulatory approvals for YL201.

Roche corporate business development head Boris Zaïtra said: “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.”

YL201 is an ADC that targets B7H3 and has been developed with MediLink’s proprietary Tumour Microenvironment-Activatable LINker-payload (TMALIN) platform. The therapy is presently being evaluated in multinational clinical trials involving patients with advanced solid tumours.

In China, YL201 has progressed to two Phase III registrational trials for nasopharyngeal carcinoma (NPC) and small cell lung cancer (SCLC).

Preliminary clinical results indicate objective response rates and survival benefits in second-line SCLC patients.

In June 2025, the Food and Drug Administration (FDA) granted breakthrough therapy designation for YL201 in SCLC treatment, which followed earlier orphan drug designations covering SCLC, NPC, and oesophageal squamous cell carcinoma (ESCC).

In October 2024, Amgen and MediLink Therapeutics entered a research and supply collaboration to develop a combination therapy for extensive-stage small cell lung cancer (ES-SCLC).

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