In Sep 20th 2023, TYK Medicines,Inc. announced TY-2136b, its self-developed new generation multi-target tyrosine kinase inhibitor (TKI) with broad spectrum, has been granted Orphan Drug Designation in the US by the Food and Drug Administration (FDA) for the treatment of Non-Small Cell lung Cancer (NSCLC) harboring ALK/ROS1/NTRK fusion or LTK positive, which can be used to support the development of the drug globally.

Orphan Drug, as well as rare disease drug, refer to a potential new medication intended for prevention, diagnosis or treatment of a rare disease or condition. As a result of obtaining orphan drug qualification from the FDA, the company will be able to take advantage of US policy support for product development, registration, and commercialization, and assist in the progress of clinical trials and marketing registration, so that new treatments are available as soon as possible to these patients.

TY-2136b, which was granted Orphan Drug Designation by the U.S. FDA this time, is TYK Medicines’s first US-China IND submission oral anti-tumor agent. This drug has received investigational new drug approval by both the U.S. FDA and Chinese NMPA in 2022. Currently, clinical trial has been initiated for this program in several sites based in the United States and China.

About TY-2136b

The new generation ROS1/NTRK/ALK broad-spectrum small module tyrosine kinase inhibitor, TY-2136b, was independently developed by Zhejiang TYK Medicines.Co. TY-2136b is capable of selectively and effectively inhibiting ROS1/TRKA-C/ALK kinase activity, overcoming drug resistance induced by G2032R, G595R, G667C, G623R, G1202R and other double mutations, while passing through blood-brain barrier (BBB). As a potential treatment for advanced solid tumors and metastatic tumors, especially lung cancer and other cancers with ALK/ROS1/NTRK alterations and ALK/ROS1/NTRK drug-resistant mutations, TY-2136b can effectively address unmet clinical needs.