TLC's Lipotecan accepted for Green Path programme by SFDA
Taiwan Liposome Company's (TLC) multi-mechanistic anticancer new chemical entity (NCE), Lipotecan, has been accepted into the Green Path programme by the Chinese State Food and Drug Administration (SFDA). The Green Path programme (also known as the Green Channel) is an accelerated approval process for innovative new drugs. The selected NCE has to be innovative and/or targeted at treating a rare disease for which there is no effective treatment currently available. Once selected, the drug should receive priority review from the SFDA and be granted preferential pricing given its uniqueness and competitiveness, providing the innovator company with both time and financial incentives.
TLC previously reported that Phase I and II results for Lipotecan demonstrated significant therapeutic effectiveness in patients with hepatocellular carcinoma (HCC). According to TLC, currently there are 370,000 liver cancer patients in China, with 340,000 new cases diagnosed every year, and HCC is considered a serious unmet medical need in Chinese populations. This country is one of the most rapidly growing pharmaceutical markets in the world and the prevalence of HCC is very high due to its high hepatitis rates (approximately 10 per cent of the 1.3 billion people). TLC plans to start a Phase II trial in China towards the later part of 2013.
Lipotecan was granted orphan drug designation in 2010 for the treatment of HCC by both the EC and US FDA. The sizeable pool of liver cancer patients in China should contribute significantly to the rate of patient enrolment, and coupled with the accelerated approval process through both Green Path and orphan drug status, TLC expects that the amount of time required before approval would be substantially reduced.