SAN FRANCISCO - Roche will try to test a foreign-discovered drug in a first-in-man clinical trial in China in the next two years, according to one of the firm's top R&D officials in that country. The move would mark a huge shift in attitude at China's pharmaceutical regulatory agency, which to date only allows in-country discoveries to move into Chinese first-in-man clinical trials.

The revelation came as a surprise to those attending the PharmAsia Summit conference in San Francisco, where China's regulatory system was a major topic of conversation.

Li Chen, chief scientific officer at Roche's research and development center in China, said during the conference that the Swiss-headquartered firm has a compound drawn from the global R&D organization it wants to put into the clinic in China. Chen said Roche is working with regulators at China's State FDA to establish a process and shorten the onerous six-to-nine month delay in approving a compound for the clinic.

Tony Zhang, head of Eli Lilly's R&D center in China, agreed with Chen that SFDA recognizes the problem, which "could be clarified soon."

Chen also said Roche is preparing a second compound for a first-in-man Chinese trial. It's a liver cancer treatment discovered by the China R&D team, aimed solely at Chinese patients. Liver cancer is a huge problem in China in large part from unchecked hepatitis B infection.

Venture capitalists in attendance said Chen's statements were eye-opening. If Roche could open a window for foreign compounds in first-in-man trials, "it would be huge," said one San Francisco-based VC. During the recession, venture-backed biotech outfits have shelved promising compounds to save money. An opening in China for low-cost, early-stage trials could breathe new life into drugs set aside for financial reasons, the VC said.

But another VC cautioned there were other factors at play that could blunt the enthusiasm for moving drugs to China. For example, no drug on the Chinese market has more than $100 million in sales because of demand and a fractured distribution system.

Less than a year ago, SFDA's Yi Feng told a conference audience in Shanghai the administration wanted to speed up registration times, but he was less conciliatory about first-in-man trials for out-of-country drugs. Apparently that attitude could be changing.

Others reported a more flexible stance on the part of SFDA.

For example, Hutchison MediPharma CEO Samantha Du said that her company recently had a pre-IND meeting with SFDA, which was the first one ever for the agency (Also see "With New Crohn's Disease Treatment, China's Hutchison MediPharma Seeks Global Co-development Partner" - Scrip, 17 July, 2009.). This also shows that the agency is evolving and more willing to communicate with industry at an earlier stage of the drug development process.

Jin Kewen, who heads the China affiliate of the U.S.-based contract research organization Charles River, said the Chinese regulatory agency has also started a pilot project to speed up the importation of lab animals and biomaterials (Also see "Charles River Set To Launch First Global CRO Preclinical Testing Center In China" - Scrip, 13 October, 2008.).

- Alex Lash (a.lash@elsevier.com)

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