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HitGen Outlicenses TRK/ROS1 Inhibitor to Baiyunshan for Development in Mainland China

NEW YORK – Chengdu, China-based HitGen on Tuesday announced that it has entered into a licensing agreement with state-owned Guangzhou Baiyunshan Pharmaceutical Holdings for the development of HitGen's TRK/ROS1 inhibitor, HG030.

Under the terms of the agreement, Baiyunshan will be responsible for HG030's development and commercialization in mainland China, while HitGen will retain the rights to the agent in all other territories. Baiyunshan paid HitGen RMB 38 million ($5.7 million) upfront, and HitGen is entitled to royalties and milestone payments as HG030's development advances in mainland China.

HG030 is currently entering a Phase I clinical trial in China, which will involve patients with NTRK and ROS1 gene fusion-positive cancers. The agent, according to HitGen, is designed to overcome common resistance mechanisms that patients develop after treatment with existing TKIs, including the acquired resistance mutations G595R and G667C.

"This collaboration and licensing demonstrates HitGen's capability in progressing discovery projects from target nomination to early clinical trials," HitGen CEO Jin Li said in a statement. "With their tremendous clinical development, manufacturing and commercialization capabilities, and track record, I look forward to seeing further progress of HG030 in clinical development and ultimate successful product launch by Baiyunshan."