PMDA accepts accelerated development strategy for HBI-8000, a novel cancer drug
San Diego, CA, USA – January 8, 2015 –HUYA Bioscience International (HUYA) announced today that the Pharmaceutical and Medical Devices Agency (PMDA) has accepted its accelerated development strategy for the novel cancer drug HBI-8000. HUYA is developing HBI-8000 for the treatment of adult T-cell leukemia/lymphoma (ATL) and peripheral T-cell lymphoma (PTCL) in Japan.
HBI-8000 is a next generation histone deacetylase (HDAC) inhibitor with proven efficacy and safety in lymphomas and, due to its superior properties and immunomodulatory effects, has potential for the treatment of a wide range of hematological and solid tumors.
ATL is a disease of high unmet medical need in Japan where it is responsible for 700-1,000 deaths per year. HTLV-1, the virus that causes ATL, has a high prevalence in Japan with more than one million people infected. Worldwide, HTLV-1 infects an estimated 10 million or more, and is endemic in countries including the Caribbean islands and certain regions of Africa, Central and South America and the Middle East.
HUYA’s unprecedented use of the China-Japan-South Korea Tripartite Cooperation represents a significant achievement for public health drivers which support the use of Chinese data to accelerate the development of an active treatment for Japanese patients afflicted by this devastating disease. “This represents both a milestone for this promising cancer drug and illustrates an expedited clinical development process for HBI-8000 in wider markets,” said Mireille Gillings Ph.D., CEO of HUYA.
With eight offices in China and the largest team of scientists working with Chinese innovators, HUYA identifies and advances promising drug candidates. HUYA licensed HBI-8000 from Shenzhen Chipscreen Biosciences and continues to grow and develop relationships with top tier universities and biotechnology companies in China.
About HUYA Bioscience International
HUYA Bioscience International is a leader in enabling and accelerating the global development of novel biopharmaceutical product opportunities originating in China. HUYA has established extensive collaborations with Chinese biopharmaceutical academic and commercial organizations to speed development and value creation in worldwide markets for China-sourced product candidates. With the largest Chinese compound portfolio covering all therapeutic areas, HUYA has emerged as the partner-of-choice for building and maximizing the value for biopharmaceutical innovation in China. HUYA has offices in the US, the UK, and Japan, and in eight strategic locations across China, with joint headquarters in San Diego and Shanghai. HUYA’s team is practiced in leading pharmaceuticals and medical devices through FDA and PMDA submission and approval to commercialization. www.huyabio.com
ABOUT TRIPARTITE COOPERATION ON HEALTH – China, Japan and South Korea
In 2007 the Health Ministers of China, Japan and South Korea met to discuss concerns in common healthcare issues, including pandemic influenza, emergency preparedness and response, clinical research, and traditional medicine. In a joint statement, the Health Ministers affirmed the significance of Tripartite Cooperation on clinical research, including clinical trials, especially in clarifying ethnic factors in clinical data in order to facilitate drug development. The first Director-General (DG) Meeting on Pharmaceutical Affairs was held in 2008 in Tokyo with participation by the State Food and Drug Administration (now the China Food and Drug Administration – CFDA), Korea Food and Drug Administration (now the Ministry of Food and Drug Safety – MFDS), and the Pharmaceuticals and Medical Devices Agency (PMDA). These DG Meetings were held annually to discuss how to accelerate availability of new drugs in each of the regions.
Clement Gingras CTO and COO Asia
HUYA Bioscience International