On July 18, China’s Center for Drug Evaluation (CDE) accepted the New Drug Application (NDA) for icontamrotamab for injection (Tam-Peli, YL201), a B7-H3-targeted ADC independently developed by MediLink Therapeutics. As the world’s first B7-H3 ADC with positive Phase III results, YL201 has officially entered its launch phase, offering a promising new treatment option for patients with recurrent or metastatic nasopharyngeal carcinoma (NPC).

Medicilon has served as a long-term R&D partner for the YL201 program. We delivered dedicated FTE support to optimize the candidate molecule and collaborated closely on building MediLink Therapeutics’ proprietary TMALIN® ADC platform. Our team completed the first synthesis of key platform components, including payloads C24 and C57, and the linker-payload conjugate B81. We also established a cost-effective, streamlined manufacturing route for C24 intermediates, strengthening the technical foundation for future TMALIN®-based ADC pipeline development.

The Global Disease Burden of NPC and the Later-Line Treatment Dilemma

NPC is an epithelial malignancy strongly linked to EBV infection, genetics and environmental factors, with a disproportionately high prevalence among East Asian populations. According to 2022 WHO data, approximately half of new cases worldwide (51,000 / 120,000) and more than one-third of deaths (28,000 / 73,000) occur in China, placing China’s incidence and mortality burden among the highest globally. Patients with later-line NPC face extremely limited treatment options, representing a substantial unmet clinical need.

First-in-Class Phase III Positive B7-H3 ADC Breaks NPC Treatment Barriers

Developed on MediLink Therapeutics’ TMALIN® ADC platform, YL201 stands out as a novel, first-in-class targeted therapy for hard-to-treat NPC, with compelling clinical and commercial advantages:

Landmark Phase III clinical efficacy:In its Phase III trial for recurrent/metastatic NPC, YL201 met the co-primary endpoint of BICR-assessed objective response rate per pre-specified interim analysis, verified by the Independent Data Monitoring Committee (IDMC). This is the first positive Phase III outcome globally for any B7-H3 ADC.

Broad anti-tumor potential with global regulatory recognition:YL201 is currently being evaluated in three Phase III registration trials in China for NPC, small cell lung cancer (SCLC) and esophageal squamous cell carcinoma (ESCC). It has secured five Breakthrough Therapy Designations from China NMPA for SCLC, NPC, ESCC and pancreatic cancer. In the U.S., the FDA has granted it a Breakthrough Therapy Designation for SCLC and three Orphan Drug Designations for SCLC, NPC and ESCC.

Global commercial validation via overseas licensing:In January 2026, MediLink Therapeutics licensed YL201’s ex-Greater China global rights to Roche in a high-value deal, including a USD 570 million upfront payment plus tiered milestone payments and sales royalties. The partnership strongly validates the global competitiveness of China-originated innovative ADCs.

With no B7-H3 ADC approved worldwide to date, YL201’s NDA acceptance marks a major innovation milestone for China’s ADC industry, placing the country among the global leaders in next-gen ADC development. Powered by the fully independent TMALIN® platform, MediLink Therapeutics will continue advancing novel ADC therapies to deliver differentiated treatment solutions for global cancer patients.

First-in-Class Phase III Positive B7-H3 ADC Breaks NPC Treatment Barriers

Medicilon has partnered with MediLink Therapeutics since its early-stage development, jointly advancing multiple novel ADC programs. The NDA approval milestone for icontamrotamab reflects the solid results of our long-term strategic collaboration.

Boasting comprehensive preclinical ADC capabilities, Medicilon provides one-stop services covering payload synthesis, conjugation technology, pharmacodynamic, pharmacokinetic and safety evaluation. To date, we have supported 35 ADC candidates to reach clinical stage, with a robust pipeline of ongoing ADC projects.

Medicilon congratulates MediLink Therapeutics on the successful NDA submission of YL201. We anticipate smooth regulatory review and look forward to this novel therapy benefiting NPC patients as soon as possible. Moving forward, Medicilon will continue advancing R&D technologies for ADCs, AOCs and other novel conjugate drugs, empowering global biotech partners to accelerate innovative drug development from concept to IND.