San Diego, CA, USA – January 12, 2015 – HUYA Bioscience International (HUYA) announced today that Shenzhen Chipscreen Biosciences (Chipscreen) has obtained marketing approval from the Chinese FDA for the world's first oral HDAC inhibitor, chidamide, for the treatment of relapsed or refractory peripheral T-cell lymphoma. Chidamide (Epidaza®) is an orally bioavailable, benzamide-class small molecule, that selectively inhibits cancer-associated HDAC (histone deacetylase) enzymes. Chidamide has anti-tumor activity through various mechanisms of action, including epigenetic reprogramming and immunomodulation. HUYA has exclusive rights to chidamide (HBI-8000) worldwide, excluding China, and is developing HBI-8000 for the treatment of hematological and solid tumors.
"Chidamide's marketing approval in China for the treatment of relapsed or refractory peripheral T-cell lymphoma (PTCL) represents a major milestone and its approval bodes extremely well for the ongoing clinical development of HBI-8000 in the rest of the world for the treatment of cancers associated with drug resistance and tumor recurrence," said Mireille Gillings Ph.D., CEO of HUYA.
Peripheral T-cell lymphoma (PTCL) is a subtype of non-Hodgkin's lymphoma (NHL) with poor outcome and limited treatment options. PTCL consists of a group of rare and usually aggressive NHL that develops from mature T-cells and natural killer (NK) cells. Most T-cell lymphomas are PTCLs, which collectively account for about 25 to 30 percent and 10 to 15 percent of all NHL cases in China and the United States, respectively. In Japan, the rate of PTCL is estimated at 2-3 patients/100,000 population.
About HBI-8000 (chidamide)
HBI-8000 (chidamide) is a member of the benzamide class of histone deacetylase (HDAC) inhibitors designed to block the catalytic pocket of Class I HDACs. HBI-8000 is an orally bioavailable, low-nanomolar inhibitor of cancer-associated HDAC enzymes with favorable pharmacology and safety profiles. HBI-8000 inhibits cancer-associated Class I HDAC1, HDAC2, HDAC3, as well as Class IIb HDAC10 at nanomolar concentrations and stimulates accumulation of acetylated histones H3 and H4 in tumor cells. Studies with human-derived tumor cell lines have demonstrated that HBI-8000 inhibits the growth of many tumor cell lines via multiple mechanisms of action, including epigenetic regulation of tumor cell growth and apoptosis, immunomodulatory effects such as activation of NK- and CD8 T-cell-mediated antitumor activity, as well as repression of genes associated with drug resistance. To date, HBI-8000 has been dosed globally in more than 280 patients with various types of hematological and solid tumors in several clinical trials, including a Phase 1 trial completed in the U.S.
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 of biopharmaceutical innovation in China. HUYA has offices in the US, the UK, Japan and in eight strategic locations across China, with joint headquarters in San Diego and Shanghai. HUYA's team is practiced in guiding pharmaceuticals and medical devices through FDA and PMDA submission to approval and commercialization. With 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. www.huyabio.com
CTO and COO, Asia
HUYA Bioscience International