The Phase I clinical trial of TY-1091 capsule, a new generation selective inhibitor of RET developed independently by TYK Medicines, Inc. （hereinafter referred to as TYK Medicines）, was led by Professor Ying Cheng from Jilin Provincial Cancer Hospital. The video conference of the clinical protocol discussion was successfully held on August 3, 2022!

Professor Ying Cheng and Dr. Yusheng Wu, Chairman of TYK Medicine, delivered the opening speech respectively. Professor Ying Cheng said that she is very pleased to participate in the project of TYK TY-1091 and continue to explore and research in the field of RET gene driven cancer tumors. Dr. Yusheng Wu said, “TY-1091 is a new generation of highly selective RET inhibitor, which selectivity of RET is significantly improved compared with approved multi-kinase inhibitors. It can inhibit a variety of RET kinase activities and some drug resistance mutations, and has great potential for clinical development. We are very glad to cooperate with professor Ying Cheng to help develop TY-1091.

Adhering to the efficient and pragmatic style, the two teams quickly opened the program seminar and reached a consensus. Ret-activated fusion and mutation is a key disease driver for many types of cancer, including lung cancer, thyroid cancer and some other tumors. Currently, only one RET targeting inhibitor Pralsetinib (BLU-667) has been approved to market in China, and there is still a huge unmet clinical demand for drug accessibility and selectivity for a large number of patients. The clinical development of TY-1091 will bring hope to more patients. In addition, Professor Ying Cheng’s team also shared the experience in clinical practice, combined with the actual diagnosis and treatment of Chinese patients, to help further improve the clinical protocol design.

“After the in-depth discussion, we hope to accelerate the development process of TY-1091 through scientific drug clinical protocol design, and ultimately bring real benefits to patients and their families,” said Mr. Xiugui Chen, vice president of clinical medicine of TYK Medicines.

TY-1091 is currently expected to receive U.S. Food and Drug Administration (FDA) approval for clinical trials in August 2022, and plans to submit a clinical trial application to China National Medical Products Administration (NMPA), which is expected to receive a clinical trial notification from NMPA in December 2022.

About TY-1091

TY-1091, a highly selective new generation of RET (Transfection rearrangement) inhibitor, was independently developed by TYK Medicines, Inc. TY-1091 strongly inhibited RET mutant (RET V804L, RET V804M, and RET M918T) kinases, etc, and inhibited solvent front mutations (G810S single mutation and double mutation) identified as mechanisms of acquired resistance. TY-1091 is a potent inhibitor to treat multiple types of tumors carrying active RET alteration, including RET fusion non-small cell lung cancer (NSCLC), RET mutant medullary thyroid cancer (MCT), and other RET alteration solid tumors, and is expected to break the bottleneck of resistance to the application of first-generation RET kinase inhibitors.

About TYK Medicines, Inc.

TYK Medicines is an innovative biotechnology company based in China, facing the global, focusing on researching and developing international cutting-edge new drugs. The company has established a high-efficiency innovative drug research and development platform, with fully functioned instruments, covering multiple pharmaceutical fields including drug synthesis, biological fermentation, drug analysis, bioanalysis, and formulation research, and is committed to becoming the best domestic and world-class new drug research and development company.