PRINCETON, N.J.—Covance Drug Development, a leading contract research organization that offers drug development services from research to commercialization, is now looking to the east with a first-of-its-kind drug development partnership. Laboratory Corporation of America Holdings (LabCorp) and Shandong XuanZhu Pharma Co. Ltd., the wholly owned subsidiary of Sihuan Pharmaceutical Holdings Group Ltd., announced that Covance would be starting a long-term partnership with Sihuan Pharmaceutical to support the global development of the latter’s drug candidate pipeline.
“This agreement is the first of its kind signed with a partner in the Asia Pacific region, and Covance looks forward to collaborating with Sihuan Pharmaceutical in its efforts to potentially bring global filing strategies to realization,” Honggang Bi, Covance’s corporate vice president and general manager for China, commented in a news release. “With multiple compounds in its development pipeline, Sihuan Pharmaceutical is a promising pharmaceutical company to watch for groundbreaking new therapies.”
Per the agreement, Covance will support preclinical and clinical development of Sihuan Pharmaceutical’s drug candidates, specifically by providing global drug development and regulatory expertise, especially in terms of dual or multiple regulatory filings such as Investigational New Drug (IND) applications and New Drug Applications (NDA) in China and the global market. Covance will collaborate with Sihuan Pharmaceutical to implement a customized program for drug development to help bring best-in-class solutions to market. No financial details were disclosed.
“The partnership joins the forces of two market leaders, bringing together Sihuan Pharmaceutical’s strong product pipeline and extensive marketing network in China and Covance’s expertise and experience in bringing compounds to market internationally,” noted Dr. Frank Wu, chief scientific officer of Sihuan Pharmaceutical. “The partnership is another milestone for our international collaboration and R&D team, which will enable us to accelerate the development of our pipeline, in turn helping to bring treatments to multiple markets faster, a key point of differentiation in the Chinese pharmaceutical industry.”
Sihuan is the largest cardio-cerebral vascular drug franchise in China’s prescription drug market by market share, and grew to be the fourth-largest pharmaceutical company in terms of hospital purchase in the country’s hospital market by the end of 2013. The company’s top five therapeutic focus areas are the cardio-cerebral vascular system, central nervous system, metabolism, oncology and anti-infectives.
Bi notes that Sihuan’s portfolio includes several “very innovative and very unique” compounds, even within the global market, and adds that “Many of their research leaders are U.S.-trained scientists, so they have a very broad global vision, and they wanted to have their experience benefiting the U.S. and European markets as well as Chinese markets.”
He tells DDNews that Covance is familiar with aiding companies with both early- and late-stage development, adding that the company also brings with it experience in China and the rest of the world. Covance first began establishing itself in China about 15 years ago, he says, where they wanted to build their capabilities and capacities in order to help global clients enter the Chinese market. In recent years, Bi notes, the trend of domestic Chinese companies breaking into the global market has become much more prominent, which he says has “really helped our growth in China, because we have a much bigger flow now from the domestic market to go global.” Covance’s long-term experience in China lets them offer clients “one-stop shopping,” he adds, especially considering the fact that “China has a unique set of requirements for drug development and registration in terms of IND process as well as NDA process.”
“We do these types of partnerships in the U.S. and Europe, but I think for China and Asia, for the Asian clients, this is probably the first significant collaboration, just because it’s a growing industry,” Bi notes, “especially now the Chinese pharmaceutical industry is going from a more generic-driven industry to a more innovative product-driven industry. So that’s where we, from a Covance perspective, can provide a lot more effective support for their innovative product drug development process.”
“For us to have that type of collaboration, to really build on how do we bridge the two major markets, China and Western markets, for our clients … that’s really something that we wanted, to build our model to help our clients to go from either side to the other side of the world. So that’s really very exciting to us, and certainly we would like to do more of those in the future,” says Bi.