China IND Requirements Overly Burdensome To Industry - Shanghai R&D Summit

The pharmaceutical industry should lobby the Chinese government to relax requirements for IND approvals that discourage multinational companies from sponsoring clinical trials in China, according to Hutchison MediPharma Managing Director Samantha Du.

Speaking June 7 at the China 2007 R&D Summit in Shanghai, Du noted that "everyone now thinks that China is the solution" for decreasing R&D costs. "China has a huge [treatment]-naive population. ...and produces 4.5 million graduates" annually in the life sciences, she noted. "But when you come here you need to fully appreciate the challenges ... the most important one is regulation."

For instance, it takes an average of 18 months to receive IND approval from the China State Food and Drug Administration, Du said. "To me, that's prohibitive for companies interested in doing first-in-man studies in China."

Du, who previously led metabolic disease licensing activities in Pfizer's Global Strategic Operations Group, joined Hutchison China, a division of Chi-Med, as a senior vice president in 2001, establishing the Hutchison MediPharma R&D subsidiary the following year in Shanghai.

Hutchison's lead candidate, HMPL-004, a cytokine inhibitor, is currently in Phase IIb in the U.S. for Crohn's disease and Phase II in China for ulcerative colitis. The company also has a Phase I/II study underway in the U.S. for HMPL-002 in head and neck cancer and non-small cell lung cancer. HMPL-002 is approved in China as a radiosensitizer for the treatment of head and neck, lung and esophageal cancers when used concomitantly with radiotherapy; Hutchison owns ex-China rights to the compound and global rights for all new indications.

Hutchison also has a discovery deal with Merck KGaA focusing on small molecule oncologics derived from traditional Chinese medicine ("The Pink Sheet" DAILY, Nov. 22, 2006).

China's IND requirements are generally more onerous than in western nations, Du noted. To conduct a one-month Phase I trial in the U.S., for instance, "probably one-month or two-month tox[icology studies are] sufficient. But in China, regardless of the length of your IND, you have to follow a standard protocol ... [that] requires a six to eight, nine months tox, equivalent to a U.S. Phase III trial," Du explained.

"As an industry, we should work together to lobby the government to change this policy," she said. Until it changes, it is a "major hurdle for the pharma industry" and may prevent multinational companies from "taking advantage of China's resources."

An interim solution is for companies to select China as a discovery hub, but to transfer clinical development activities to other countries, Du indicated.

San Diego-based Ascenta Therapeutics is one company that has adopted such a model. Speaking the same day, CEO Mel Sorensen told meeting attendees that Ascenta is capitalizing on China cost advantages via a Shanghai R&D center that focuses on preclinical development.

When it comes time to move a compound into the clinic, Ascenta has based its trials in the U.S., with plans to expand to Eastern European sites later this year, Sorensen said.

Ascenta's lead compound, AT-101, is an oral pan-Bcl-2 inhibitor, currently in Phase II in the U.S. for multiple cancers, including prostate, chronic lymphocytic leukemia, small and non-small cell lung cancer and non-Hodgkin's lymphoma.

However, Ascenta is "closely watching the regulatory situation" in China and is in the process of filing its first IND application with the SFDA. "We'll see how long that takes and how that process goes," Sorensen observed.

"We want to make sure that none of our programs are dependent on delays that may occur anywhere in the world and right now it has proved much easier for us to open trials and to enter a couple of hundred patients already in the United States in a period that would have taken a long time to get an IND approved" in China.

"But the long-term goal is to get into China with respect to clinical trials," which may include Phase III trials for AT-101, he said.

Ultimately, a decision regarding clinical development location will come down to whether data can be derived more efficiently from China than elsewhere, Sorensen said.

"You cannot be here just for cost," he explained. The key question is: "Can I de-risk a compound quicker by doing a portion of that de-risking in China as opposed to in the United States? And right now I'd say the answer is yes at least in preclinical."

- Joshua Berlin

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