TLC and Jixi Biotechnology Partners have signed an agreement to form a joint venture in TLC Biopharmaceuticals with the purpose to conduct clinical studies, register, and commercialize TLC’s pipeline for the China market.

The China Food and Drug Administration recently rolled out initiatives designed to accelerate drug approvals and encourage innovation, including greater alignment of China’s review process with that of the US and the EU. This partnership aims to act in line with those initiatives. 

“We are delighted to be collaborating with Jixi Biotechnology, which has resources and networks in regulatory affairs and commercialization in this critically important territory,” says TLC president George Yeh. “This is an important step forward in our support toward China’s ongoing healthcare reforms and is a milestone in our efforts to address the needs of patients worldwide.”

Under the terms of the agreement, TLC is entitled to receive $20 million from Jixi Biotechnology in exchange for a minority stake in TLCHK and TLC will initially retain a majority stake in TLCHK. TLC will grant an exclusive right to TLCHK in the clinical trials, registration and commercialization of TLC’s products and product candidates in China. Upon the achievement of certain milestones prior to obtaining drug approval, Jixi Biotechnology will have the option to acquire additional stakes in exchange for aggregate payments of an additional $50 million to TLC. If TLCHK further fulfills certain corporate events, they would also be entitled to an additional payment up to $60 million.

TLC’s pipeline focuses on the pain management, ophthalmology, and oncology spaces. The leading product candidate, TLC599, is a sustained release dexamethasone injection which has the potential to alleviate pain suffered by some of the estimated 42 million people with knee osteoarthritis in China.