Recently, MediLink Therapeutics (Suzhou) Co., Ltd. (“MediLink”) announced that the New Drug Application (NDA) for its independently developed B7-H3-targeting antibody-drug conjugate (ADC) Tam-Peli (research code: YL201) has been accepted for review by the National Medical Products Administration (NMPA). The submission is for the treatment of adult patients with recurrent or metastatic nasopharyngeal carcinoma (NPC) who have previously failed PD-(L)1 inhibitors and at least two lines of chemotherapy. Caidya extends its warmest congratulations to MediLink on achieving this important regulatory milestone.
As MediLink’s clinical development partner, Caidya contributed to key stages of the program, including the statistical design of the Phase III study protocol and the preparation of safety submission documents for the NDA, supporting the advancement of the program to this important regulatory milestone.
Project Background and Milestone
The NDA is based on the prespecified interim analysis results from a randomized, controlled, multicenter Phase III study (YL201-CN-301-01; TAISHAN-301). Acceptance of the NDA marks an important milestone in the development of Tam-Peli and represents another significant step toward providing a new treatment option for the target patient population.
Caidya Supports Key Clinical Development and NDA Preparation
During the Phase III study, Caidya worked closely with MediLink to contribute to the statistical design of the study protocol. Based on the program’s development objectives and regulatory requirements, the joint team developed a scientifically sound interim analysis strategy, providing statistical support for the Phase III study.
Dr. Jie Li, General Manager of Caidya China, commented:
“We warmly congratulate MediLink on reaching this important regulatory milestone. We are honored to have supported this important program during key stages of its clinical development. We believe that sound scientific decision-making and high-quality execution are fundamental to successful clinical development. Guided by our commitment to adapting at the speed of science, we look forward to continuing our collaboration with MediLink, helping address complex clinical development challenges and bringing innovative therapies to patients faster.”
Dr. Steve Chin, Chief Medical Officer of MediLink, commented:
“The acceptance of the NDA for YL201 in nasopharyngeal carcinoma represents a significant breakthrough for MediLink in the development of B7-H3-targeting ADC therapies, as well as an important achievement in our long-term commitment to advancing innovative oncology treatments and addressing unmet medical needs.
Caidya’s drug development expertise and efficient service capabilities provided strong support across multiple critical stages of the program, contributing to its efficient progression and successful NDA acceptance. We sincerely appreciate their partnership.”
Disclaimer
This press release is intended to share publicly available information released by our partner and is provided for industry information purposes only. It does not constitute product promotion, efficacy claims, or investment advice. All information regarding the product and its development is based on publicly available information released by our partner. Please refer to the partner’s official communications for the most up-to-date information.
Read MediLink’s Original Announcement
For more information, please read here
About MediLink
Founded in 2020, MediLink is a clinical-stage biotechnology company focused on developing innovative conjugated drugs. The company has independently developed the differentiated TMALIN® technology platform, whose diversity and efficacy have been consistently validated through preclinical studies and ongoing global clinical trials across 14 ADC candidates currently in clinical stages. MediLink is dedicated to providing better treatment options for patients worldwide to address unmet medical needs. Headquartered in Suzhou, the company has R&D branches in Shanghai, Boston, and Singapore.
About Caidya
Caidya is a global drug development partner dedicated to helping biopharma innovators navigate the complexities of drug development with greater speed, certainty, and confidence. We specialize in the execution of complex clinical trials, including challenging therapeutic areas, innovative study designs, rare patient populations, and cross-border programs. We partner closely with sponsors to advance breakthrough therapies for patients with unmet medical needs worldwide.
With a strategic footprint across the Americas, Europe, and Asia-Pacific, including deep expertise in China, Caidya combines global reach with local knowledge to support regional and global studies. We work as an extension of our clients to overcome complexity, reduce risk, and generate the high-quality data needed to advance critical therapies.