Eager for the east

HUYA, Quintiles to co-develop new cancer drug sourced in China

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SAN DIEGO—Seeking its future—and fortune—in China as asource for new drug discovery and development, HUYA Bioscience Internationalhas forged a partnership with Durham, N.C.-based biopharmaceutical Quintiles toco-develop a new cancer drug, HBI-8000, an oral treatment targeted to treatadvanced tumors and lymphomas.
 
 
The drug, sourced in China, has entered a Phase I clinicaltrial in the United States under an application with the U.S. Food and DrugAdministration. Financial terms of the partnership were not disclosed.
 
 
The trial underway is designed to assess safety,tolerability and anti-tumor activity of HBI-8000 in patients with advancedtumors and lymphomas. Previously, HUYA, with six offices in China andheadquarters in Shanghai, has partnered with major pharmaceutical companiessuch as Merck & Co. Inc. and Abbott Laboratories to co-develop its drugcandidates.
 
 
HUYA is already planning U.S. Phase II clinical trials anddiscussing partnerships with pharmaceutical companies interested in advancingthe development and commercialization of HBI-8000. The drug has completed PhaseI trials in China, where it exhibited encouraging anti-tumor efficacy and afavorable toxicity profile, according to the company. Chipscreen Bioscience isnow conducting Phase II studies in China.
Since it began six years ago, HUYA has been leveraging itsties with Chinese academic institutes and research hubs interested in learningmore about commercial drug development.
 
 
Tom Perkins, senior vice president of the Capital group atQuintiles, says the agreement "will help accelerate the development ofmedicines from China, thus illustrating "Quintiles' ability to draw upon itsbreadth of services to build alliances that help biopharmaceutical companiesnavigate the New Health."
 
 
Dr. Mireille Gingras, CEO of HUYA, says, "This alliance withQuintiles further validates HUYA's business model of co-developing novelcompounds originating in China as therapies for global markets. The initiationof the Phase I trial for HBI-8000 in the U.S. is a significant achievement forHUYA. It represents both an important development milestone for this promisingcancer drug and illustrates the benefits of Chinese and Westernbiopharmaceutical companies working together to efficiently carry out drugdevelopment."
 
Furthermore, this "important step will expedite the clinicaldevelopment process of HBI-8000 in the U.S. and Europe," she says. "Our hope isthat this drug will benefit cancer patients globally."
 
While HUYA is not a CRO, the company "has many longstandingrelationships with top CROs, including Quintiles, in both China and in the restof the world," Gingras says. "We work with these CROs to do drug developmentfor worldwide markets on therapeutics we have in-licensed from China."
 
 
Quintiles is a fully integrated biopharmaceutical CRO with anetwork of 23,000 employees in 60 countries.
 
"The synergistic combination of Chinese innovative research,HUYA's ability to navigate the Western regulatory pathways, and our network ofinternational partners enables us to identify and develop the most promisingproduct opportunities with reduced risk," Gingras says.
 
 
The benefits of Chinese and American biotech companiesworking together are significant, Gingras says.
 
 
"The HUYA model focuses on this type of collaboration, whichreduces the time, cost, and risk of drug development," Gingras says. "The HUYAteams rigorously search for, screen and evaluate innovative compoundsthroughout China. Moreover, through continuous feedback from HUYA, we bringdrug development expertise to Chinese researchers to help improve the worldwidecommercial potential of their pharmaceutical research."
 
 
In developing HBI-8000, "we have and will leverage data frompreclinical and clinical studies in China to enable optimal trial design of theU.S. clinical studies," she says. "This process expedites the drug's clinicaldevelopment for global markets."
 
HBI-8000 is being developed as a cancer therapy to be takenorally, either as a single agent or in combination with other cancer drugs,Gingras explains. Its advantages include oral availability, a good safetyprofile, excellent pharmacokinetic and pharma-co-dynamic properties andpreliminary anti-tumor activity in the clinic.
 
"We believe HBI-8000 will be better tolerated and moreefficacious than other drugs of the same class, and it may well earn 'best inclass' designation," she says. "The drug is a potential treatment for advancedsolid tumors and lymphomas, including breast carcinoma, prostate cancer,non-small cell lung cancer, liver cancer, non-Hodgkin's lymphoma and T-celllymphomas."
 
 
The commercial potential for HBI-8000 begins at $1 billion.
 
 
The drug "addresses many large-market oncology indicationswith high unmet need," Gingras explains. "It thus, has the potential to achieveblockbuster sales in an overall oncology market of over $48 billion. Thecompound has exhibited activity in, and has the potential to treat a wide rangeof tumor types."
 
 


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