Wyeth Wants to See Faster Action from the SFDA

Wyeth (WYE) told Interfax that it would not create an R&D center in China because the SFDA takes too long to approve initial clinical trials (see article). The IND process in the US and Europe involves only a 30-day waiting period, but the same process in China can be nine months or more.

Other observers have pointed out that the SFDA is faster than the FDA in making a final marketing decision on a drug, though the IND rulings are, as Wyeth points out, considerably slower.

Wyeth made clear that it was not asking the SFDA to lower its requirements for IND submissions. The company simply wants to see faster action. It suggested that the SFDA was understaffed.

On the other hand, even though it will not establish an R&D center in China, Wyeth said it would make several moves to increase its use of China’s R&D expertise. One initiative will take advantage of China’s biopharma industry by contracting more early-stage development work on new drugs to China-based chemical and biological CROs.

Wyeth will also increase the number of China patients involved in its global clinical trials. In 2006, Wyeth moved its Asia-Pacific clinical trial administration offices to China from Australia in support of this initiative. Overall, Wyeth will increase the number of Asia-Pacific patients in global trials from 25% currently to 30%.

As Interfax points out, Wyeth is not currently a big player in the China pharmaceutical market. It does, however, have a large presence in China’s nutritional market, primarily in baby formula and milk products. Separately this week, Wyeth announced that it would invest $96 million to increase the production of its Singapore-based nutritional products manufacturing facility. That investment will bring to total invested in Asia-Pacific nutritional facilities to $500 million.

Wyeth said it would introduce more drugs to China to increase its market share of China’s pharmaceutical sales, but it was not specific about its plans.

Disclosure: none.