NewGLab Introduces Global Phase 2 Non-Small Cell Lung Cancer Treatment 'Taletrectinib'

[Asia Economy Reporter Hyunseok Yoo] Newgelab is expanding its pipeline by signing a license agreement with a U.S. biotech company for the development of a targeted anticancer drug for non-small cell lung cancer (NSCLC). Through this license agreement, Newgelab will possess a new drug candidate for NSCLC following its metabolic anticancer drug 'KAT' (Ko Anticancer Therapeutics). Newgelab plans to enhance synergy between pipelines through combination therapy of KAT and Taletrectinib in the future.

Newgelab announced on the 16th that it has signed a license agreement for the global Phase 2 non-small cell lung cancer treatment drug 'Taletrectinib' with Anhurt Therapeutics, based in New Jersey, USA.

Taletrectinib is a targeted anticancer therapeutic developed by Japan's Daiichi Sankyo for ROS1 and NTRK positive solid tumors. Daiichi Sankyo signed a license agreement with Anhurt Therapeutics in 2018 and conducted Phase 1 clinical trials. After completing Phase 1 trials in the U.S. and Japan, Taletrectinib demonstrated safety and efficacy in NSCLC patients positive for ROS1 who developed resistance to Pfizer's lung cancer targeted therapy 'Xalkori.'

This contract is valued at USD 7 million (approximately KRW 8.4 billion) with royalties payable after obtaining marketing approval from the Korean Ministry of Food and Drug Safety. Newgelab has secured all commercialization rights in Korea for Taletrectinib, including ▲clinical development ▲MFDS approval ▲exclusive sales rights.

Newgelab plans to participate jointly with Anhurt Therapeutics in multinational Phase 2 clinical trials, not only in Korea but also abroad, and aims to pursue early drug sales through conditional approval applications to the MFDS after completing the Phase 2 trial in Korea.

Dr. Younghee Ko of Newgelab Pharma explained, “Taletrectinib has the advantage of significantly reducing drug resistance when co-administered with the metabolic anticancer drug KAT currently under development, thereby creating synergistic effects between the pipelines.”

Meanwhile, Director Shinyoung Han of Newgelab stated, “We plan to conduct global Phase 2 clinical trials in cooperation with Anhurt Therapeutics and supply the newly developed drug candidate to ROS1-positive NSCLC patients by obtaining domestic marketing approval for Taletrectinib.”

This content was produced with the assistance of AI translation services.