HUYA Bioscience International, a leader in
U.S.-China pharmaceutical co-development, and Quintiles, a fully integrated
biopharmaceutical services company offering clinical, commercial, consulting
and capital solutions worldwide, have 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.”