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Eager for the east
SAN DIEGO— Seeking its future—and fortune—in China as a source for new drug discovery and development, HUYA Bioscience International has forged a partnership with Durham, N.C.-based biopharmaceutical Quintiles to co-develop a new cancer drug, HBI-8000, an oral treatment targeted to treat advanced tumors and lymphomas.
The drug, sourced in China, has entered a Phase I clinical trial in the United States under an application with the U.S. Food and Drug Administration. 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 advanced tumors and lymphomas. Previously, HUYA, with six offices in China and headquarters in Shanghai, has partnered with major pharmaceutical companies such as Merck & Co. Inc. and Abbott Laboratories to co-develop its drug candidates.
HUYA is already 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, where it exhibited encouraging anti-tumor efficacy and a favorable toxicity profile, according to the company. Chipscreen Bioscience is now conducting Phase II studies in China.
Since it began six years ago, HUYA has been leveraging its ties with Chinese academic institutes and research hubs interested in learning more about commercial drug development.
Tom Perkins, senior vice president of the Capital group at Quintiles, says the agreement "will help accelerate the development of medicines from China, thus illustrating "Quintiles' ability to draw upon its breadth of services to build alliances that help biopharmaceutical companies navigate the New Health."
Dr. Mireille Gingras, CEO of HUYA, says, "This alliance with Quintiles further validates HUYA's business model of co-developing novel compounds originating in China as therapies for global markets. 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."
Furthermore, this "important step will expedite the clinical development process of HBI-8000 in the U.S. and Europe," she says. "Our hope is that this drug will benefit cancer patients globally."
While HUYA is not a CRO, the company "has many longstanding relationships with top CROs, including Quintiles, in both China and in the rest of the world," Gingras says. "We work with these CROs to do drug development for worldwide markets on therapeutics we have in-licensed from China."
Quintiles is a fully integrated biopharmaceutical CRO with a network 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 of international partners enables us to identify and develop the most promising product opportunities with reduced risk," Gingras says.
The benefits of Chinese and American biotech companies working together are significant, Gingras says.
"The HUYA model focuses on this type of collaboration, which reduces the time, cost, and risk of drug development," Gingras says. "The HUYA teams rigorously search for, screen and evaluate innovative compounds throughout China. Moreover, through continuous feedback from HUYA, we bring drug development expertise to Chinese researchers to help improve the worldwide commercial potential of their pharmaceutical research."
In developing HBI-8000, "we have and will leverage data from preclinical and clinical studies in China to enable optimal trial design of the U.S. clinical studies," she says. "This process expedites the drug's clinical development for global markets."
HBI-8000 is being developed as a cancer therapy to be taken orally, either as a single agent or in combination with other cancer drugs, Gingras explains. Its advantages include oral availability, a good safety profile, excellent pharmacokinetic and pharma-co-dynamic properties and preliminary anti-tumor activity in the clinic.
"We believe HBI-8000 will be better tolerated and more efficacious than other drugs of the same class, and it may well earn 'best in class' designation," she says. "The drug is a potential treatment for advanced solid tumors and lymphomas, including breast carcinoma, prostate cancer, non-small cell lung cancer, liver cancer, non-Hodgkin's lymphoma and T-cell lymphomas."
The commercial potential for HBI-8000 begins at $1 billion.
The drug "addresses many large-market oncology indications with high unmet need," Gingras explains. "It thus, has the potential to achieve blockbuster sales in an overall oncology market of over $48 billion. The compound has exhibited activity in, and has the potential to treat a wide range of tumor types."