China's CDE Eyes First-Ever Breakthrough Therapy Designation for HER3 ADC YL202 in Melanoma

Sept. 1, 2026

BEIJING — China's drug regulator has signaled a potential breakthrough for a domestic antibody-drug conjugate targeting HER3, a move that would mark the first such designation for the target class in the country and underscore the growing competitiveness of Chinese biotech in oncology.

The Center for Drug Evaluation (CDE), under the National Medical Products Administration, posted on Monday that YL202 — an injectable ADC developed by MediLink Therapeutics — is being considered for Breakthrough Therapy Designation for the treatment of patients with previously treated, unresectable locally advanced, recurrent or metastatic melanoma.

If approved through the expedited review pathway, YL202 would become the first HER3 ADC to receive breakthrough therapy status in China, according to data from the Insight database.

YL202, also known as BNT326, is designed on MediLink's proprietary TMALIN platform and is currently in Phase III clinical development. The drug targets HER3, a member of the epidermal growth factor receptor family that has emerged as a promising target in solid tumors.

The designation comes amid a significant partnership between MediLink and German biotech company BioNTech. In October 2023, the two companies struck a licensing deal under which MediLink received an upfront payment of $70 million and is eligible for total potential payments exceeding $1 billion, including development, regulatory and commercial milestones.

The deal highlights the growing interest from global pharmaceutical companies in Chinese-developed oncology therapies, particularly in the rapidly expanding ADC space.

The HER3 ADC landscape remains highly competitive. According to the Insight database, no HER3 ADC has been approved for marketing anywhere in the world to date. In China alone, 23 HER3 ADC programs are in active development.

Among them, Jiangsu Hengrui Pharmaceuticals' ruikang luzetotuomab has had its new drug application accepted by the CDE and is currently under review. Two other products — one from Daiichi Sankyo/Merck and YL202 from MediLink — have advanced to Phase III clinical trials.

The potential breakthrough designation for YL202 reflects the unmet medical need in melanoma treatment, particularly for patients whose disease has progressed after first-line therapy. Melanoma, the most aggressive form of skin cancer, has limited treatment options in the advanced setting, especially for tumors that have become resistant to standard therapies.

ADCs have emerged as one of the hottest areas in oncology drug development globally. These drugs combine the targeting specificity of monoclonal antibodies with the potency of cytotoxic payloads, delivering chemotherapy directly to cancer cells while minimizing damage to healthy tissue.

MediLink's advancement with YL202 positions the company as a key player in the HER3-targeted therapy space, potentially challenging established competitors and offering new hope for patients with difficult-to-treat solid tumors.

Source: CDE official website, Insight database