On February 26, Tyercan announced that its independently developed first-in-class drug, Tye1001, received clinical trial approval from China’s NMPA, following its approval by the US FDA on July 12, 2024. This marks a significant milestone of dual approval in both China and the US.
As Tyercan’s partner, Medicilon delivered comprehensive GLP-compliant preclinical services, including pharmacodynamics, pharmacokinetics, and safety assessment, accelerating the R&D process.
Tye1001: Redefining Targeted Tumor Therapy
Tye1001 is a novel anti-tumor protein drug for advanced solid tumors and lymphomas. It consists of a highly potent and toxic small-molecule toxin conjugated to a specific drug carrier. The drug primarily targets solid tumors through the EPR effect in tumor vasculature and specific receptors on cell surfaces. It enters tumor cells via endocytosis, degrades in lysosomes, and releases the toxin small-molecule, which targets cell microtubules to inhibit tumor growth.
Preclinical data shows that Tye1001 has broad anti-tumor activity, with significant efficacy in various mouse models of gastric cancer, lymphoma, nasopharyngeal cancer, and others. Its high safety profile offers a promising new treatment option for patients and strong scientific support for future clinical development.
The dual approval of Tye1001 in China and the US not only highlights Tyercan ‘s R&D strength but also demonstrates its innovation in the PDC field and leadership in tumor-targeted therapy.
Medicilon’s XDC R&D Platform: Accelerating Preclinical R&D and Dual Submissions
Medicilon’s close collaboration with Tyercan played a key role in Tye1001’s success. Tye1001 is a coupling drug based on the presence of corresponding endogenous protein, with high potential interference and high bioanalytical challenges, Medicilon’s analytical scientists overcame complex bioanalytical challenges through innovative tool antibody development and validation strategies.
It is also worth mentioning that Medicilon’s solid and comprehensive preclinical research capabilities, which have successfully helped 28 ADC drugs to be approved in the clinic, have laid a solid foundation for Tye1001’s dual reporting and approval in China and the US.
As one of China’s earliest CROs to offer full-service preclinical research compliant with both Chinese GLP and U.S. GLP standards, Medicilon has contributed to approximately 520 IND approvals, including 86 U.S. FDA approvals and 60 dual submissions (data as of the end of 2024).
Medicilon congratulates Tailikon on Tye1001’s dual IND approvals and looks forward to its continued success in clinical trials. Medicilon will continue to enhance its integrated preclinical R&D platform, empowering pharmaceutical companies to overcome drug R&D challenges.
