New drug derived from cinnamon-family bark, developed in-house, outperforms comparator in Phase 3 trial
Erosion improvement odds ratio of 2.25 achieves statistical significance
More than 100 gastroenterologists attend launch symposium as company eyes market shift
Chong Kun Dang held a launch symposium for Zitec, a natural-compound gastritis drug developed in-house from botanical ingredients, marking the company's push into the gastritis treatment market.
The symposium took place Wednesday at the Grand InterContinental Seoul Parnas in Gangnam-gu, Seoul, drawing more than 100 domestic gastroenterologists and medical professionals, the company announced Thursday.
Zitec — whose active ingredient is dried cinnamon bark extract derived from the bark of Cinnamomum cassia, a tree in the laurel family — was developed using a proprietary extraction process Chong Kun Dang built from scratch. The company began screening natural compounds in 2013, confirming anti-inflammatory effects and the promotion of gastric mucus secretion before moving into full development. It also established its own extraction process to ensure raw-material consistency and strict control of potentially harmful substances, including benzopyrene.
The symposium featured results from a large-scale clinical trial demonstrating Zitec's superiority over an existing comparator drug. In a Phase 3 trial involving 242 patients with acute and chronic gastritis in South Korea, the Zitec group achieved statistically significant superiority over the active comparator — a 60-milligram ethanol extract of mugwort — on the primary efficacy endpoint of endoscopic response rate.
Particularly notable was the odds ratio for erosion improvement in the Zitec group: 2.25 compared with the control group (OR 2.25, 95% CI 1.26–4.03, p=0.0063), indicating more than twice the improvement seen with the comparator. The trial also showed broad improvement in erosion complete-cure rates, endoscopic findings including edema, redness and bleeding, and gastrointestinal symptom assessments. No serious adverse drug reactions were reported.
The launch is significant because Zitec cleared a higher bar than natural-compound drugs in South Korea have typically been required to meet. Rather than simply demonstrating non-inferiority to existing treatments — the conventional standard — the drug proved statistical superiority directly through a Phase 3 trial.
Analysts say the launch could reshape the gastritis treatment landscape, which has long been dominated by mugwort-extract formulations, by giving clinicians a new, evidence-based first-line treatment option.
Lee O-young, a gastroenterology professor at Hanyang University Hospital who attended the symposium, said Zitec "has the clinical evidence to prove its superiority over the comparator drug and will offer gastritis patients a new treatment option."
A Chong Kun Dang official described Zitec as "a next-generation natural-compound new drug completed with our own technology," adding that the company plans to "roll out a range of academic marketing activities from this symposium onward to communicate its clinical value to physicians and patients."
silverpaper@heraldcorp.com