SAN DIEGO & RESEARCH TRIANGLE PARK, N.C. – September 28, 2010 – HUYA Bioscience International (HUYA), the leader in U.S.-China pharmaceutical co-development, and Quintiles, the only fully integrated biopharmaceutical services company offering clinical, commercial, consulting and capital solutions worldwide, today announced an agreement to co-develop a new cancer drug, HBI-8000, sourced in China by HUYA.
HUYA was one of the first companies to recognize the potential of China as a source for novel pre-clinical and clinical stage compounds and pioneered an innovative co-development model. HUYA partners with Chinese research institutions and pharmaceutical companies to leverage and extend their research efforts, accelerate development, and provide a bridge to the U.S. development process and worldwide pharmaceutical markets. HUYA licensed all ex-China rights to HBI-8000 from Chipscreen Bioscience.
HBI-8000 has now entered a Phase I clinical trial in the U.S. under an IND application with the FDA. This trial is designed to assess safety, tolerability and antitumor activity of HBI-8000 in patients with advanced solid tumors and lymphomas. Currently, HUYA is planning U.S. Phase II clinical trials and discussing partnerships with pharmaceutical companies interested in advancing the development and commercialization of HBI-8000. The drug has completed Phase I trials in China, in which it exhibited encouraging antitumor efficacy and a favorable toxicity profile. Chipscreen Bioscience is now conducting Phase II studies in China.
“This alliance with Quintiles further validates HUYA’s business model of co-developing novel compounds originating in China as therapies for global markets,” said Mireille Gingras, Ph.D., CEO of HUYA. “The initiation of the Phase I trial for HBI-8000 in the U.S. is a significant achievement for HUYA. It represents both an important development milestone for this promising cancer drug and illustrates the benefits of Chinese and Western biopharmaceutical companies working together to efficiently carry out drug development. This important step will expedite the clinical development process of HBI-8000 in the U.S. and Europe. Our hope is that this drug will benefit cancer patients globally.”
“This agreement will help accelerate the development of medicines from China,” said Tom Perkins, Senior Vice President of the Capital group at Quintiles. “It illustrates Quintiles’ ability to draw upon its breadth of services to build alliances that help biopharmaceutical companies navigate the New Health, and further illustrates our strategy to maximize the potential of global biopharmaceutical development and innovation for the benefit of patients.”
HBI-8000 is an orally bioavailable histone deacetylase (HDAC) inhibitor. HDAC activity plays a key role in the regulation of gene expression, and HDAC is a clinically validated cancer target. HDAC inhibitors are a newer class of cancer drugs that can, as single agents or in combination with other anticancer agents, kill cancer cells. However, existing HDAC inhibitors can exhibit low potency, lack of selectivity, and poor pharmacokinetic or toxicity profiles. The preclinical efficacy and pharmacokinetic properties of HBI-8000 may translate into an improved clinical profile over other HDAC inhibitors currently being marketed or in development. The advantages of HBI-8000, including its oral availability, safety profile, and preliminary antitumor activity in the clinic, make it potentially safer and more efficacious than other agents in its class.
HUYA Bioscience International is the leader in global co-development of pharmaceutical products originating in China and has pioneered the most innovative and productive approach to pharmaceutical collaboration between the U.S. and China. With six offices strategically located in China, the most comprehensive Chinese compound portfolio, and a rapidly growing number of exclusive agreements with premier Chinese research and development organizations, HUYA is uniquely positioned to identify and license novel Chinese compounds. HUYA’s international, multidisciplinary team collaborates with its Chinese partners and leverages the combined efforts as the compounds enter the development process in the U.S. In addition to HBI-8000, HUYA is also developing two promising cardiovascular compounds using the same co-development model. HUYA has joint headquarter offices in San Diego, CA, USA and Shanghai, China. Additional information about the company is available at www.huyabio.com.
Quintiles is the only fully integrated biopharmaceutical services company offering clinical, commercial, consulting and capital solutions worldwide. The Quintiles network of more than 20,000 engaged professionals in 60 countries works with an unwavering commitment to patients, safety and ethics. Quintiles helps biopharmaceutical companies navigate risk and seize opportunities in an environment where change is constant. For more information, please visit www.quintiles.com.