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.
“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.”
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."