On January 22, 2018 TLC (4152.TT) reported that it has signed an agreement with Jixi Biotechnology Partners to form a joint venture in TLC Biopharmaceuticals (H.K.) Limited (TLCHK) with the purpose to conduct clinical studies, register, and commercialize TLC’s pipeline for the China market (Press release, Taiwan Liposome Company, JAN 22, 2018, View Source [SID1234523434]).
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The new partnership’s efforts will take place pursuant to recent reforms by the China Food and Drug Administration office (CFDA), which include 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.
"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 agreements, TLC is entitled to receive US$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 US$50 million to TLC. Moreover, if TLCHK further fulfills certain corporate events, TLC would also be entitled to an additional payment up to US$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. TLC399 is a sustained release dexamethasone injection which aims to treat macular edema due to retinal vein occlusion, a disease estimated to affect around 7.4 million patients in China. TLC590 is a sustained release post-surgical analgesic which has the potential to manage pain following surgical operations, of which there are nearly 40 million in China per year. TLC178 is a liposomal formulation of the anticancer drug vinorelbine which has received a Rare Pediatric Disease Designation from the FDA for rhabdomyosarcoma, which will qualify TLC178 in this indication for priority review in the US and may result in the granting of a transferable Priority Review Voucher that can reduce the standard ten-month FDA review time to six months. TLC has two approved products in oncology which are branded generics or off-patent drugs, a fast-growing sector in China.