Hutchison set up China MediTech as a first foray into the international pharmaceutical market and the positive trial data is derived from a compound found in traditional Chinese medicine, seen as a rich source of new drugs by many in the pharmaceutical industry. As a result of its long history of use among Chinese patients, the drug was able to bypass Phase I trials and move straight into FDA-approved Phase II.

What is Intestinal Bowel Disease? Ulcerative colitis and Crohn's Disease are forms of inflammatory bowel disease, which is considered an auto-immune disorder. They are chronic diseases which, once they start, recur regularly and cannot currently be cured. Ulcerative colitis generally affects the large intestine and Crohn's disease generally affects the small intestine. Ulcerative colitis is the inflammation of the gut, which results in extensive ulceration of its inner surface with consequential pain, loss of function and blood loss. The disease can require surgical removal of sections of the gut and, in extreme cases, it may cause death.

Crohn's disease displays similar but more severe laceration of the lining of the small intestine. Current first line treatments have effect on around 60% of patients. They can cause adverse events such as nausea, heartburn, diarrhea and headaches. Second line treatments can cause more severe adverse events and can be significantly more expensive.

In 2005 in the US, ulcerative colitis affected approximately 347,000 patients, an increase from around 300,000 patients in 2001. Potentially a further two to three times as many individuals may suffer from ulcerative colitis but are currently undiagnosed. Crohn's disease is more prevalent with an estimated 558,000 cases in the US in 2005.

Current treatments include Aminosalicylates (5-ASAs) to reduce and control inflammation. In addition, corticosteroids and immunomodulators are prescribed for patients who do not respond to first line treatments.

The Phase II proof-of-concept study was a multicentre, randomized, double-blind, comparator study of 120 patients with mild-to-moderate ulcerative colitis conducted in China. The study evaluated HMPL-004 at 400mg taken three times a day, orally, compared to Mesalazine, the current first-line standard of care. The four trial endpoints were patients: clinical symptom score; overall clinical evaluation; colonoscopic score; and safety evaluation.

After treatment for eight weeks, the percentage of patient's clinical symptom score reduction for HMPL-004 was 56% versus 59% for Mesalazine in the Intent-To-Treat population. The overall remission rate (combination of complete and partial remissions) for HMPL-004 was 57% by clinical score compared to 53% for Mesalazine in the Intent-To-Treat population and 47% for HMPL-004 versus 42% for Mesalazine by colonoscopy in the Intent-To-Treat population.

HMPL-004 was well tolerated in the study and the adverse event rate was half that of the Mesalazine group.