Chong Kun Dang Obtains MFDS Approval for Natural Product New Drug 'Jitec' for Gastritis Treatment

Applied Self-Developed Innovative Extraction Method to Broiler Chickens
Proven Superiority Over Existing Drugs in Phase 3 Clinical Trials
Targeting Domestic Gastritis Treatment Market Worth 350 Billion KRW Annually

Exterior view of Chong Kun Dang headquarters.

[Asia Economy Reporter Lee Gwan-ju] Chong Kun Dang announced on the 19th that it has obtained product approval from the Ministry of Food and Drug Safety for 'Zitek' (active ingredient: Cinnamomi Cortex Extract), an acute and chronic gastritis treatment developed in-house.

Zitek is a natural medicine that applies a newly developed extraction method by Chong Kun Dang to Cinnamomi Cortex, a dried medicinal herb made from the bark of the Cinnamomum tree of the Lauraceae family, and is the first to prove efficacy against gastritis.

Since 2013, Chong Kun Dang has explored materials and extraction methods with potential differentiation compared to existing drugs targeting various herbal medicines, confirmed the gastritis treatment efficacy of Cinnamomi Cortex, and began development. In preclinical studies, anti-inflammatory effects and enhancement of protective factors that promote mucus secretion in the stomach were confirmed, leading to full-scale clinical trials. In Phase 2 clinical trials, Zitek showed superior gastritis improvement effects compared to placebo, existing synthetic drugs, and natural medicines.

The Phase 3 clinical trial, conducted since October 2019, was designed to prove superiority rather than non-inferiority compared to existing drugs. The Phase 3 trial involved 242 domestic patients with acute and chronic gastritis, divided into the Zitek administration group and the control drug (Artemisia Argyi 95% ethanol soft extract) administration group. As a result, in the primary efficacy evaluation variable, the effective rate based on gastroscopy examination, the Zitek group showed a 2.25 times higher improvement rate compared to the control drug group, statistically proving the superiority of the drug effect (p=0.0063). In the secondary efficacy evaluation variables, including gastritis cure rate, edema, erythema, and bleeding incidence, the symptom improvement effect of the Zitek tablet group was also superior.

With this product approval, Chong Kun Dang plans to actively target the domestic gastritis treatment market, which is worth 350 billion KRW annually. A Chong Kun Dang official stated, “Unlike most comparative clinical trials that are designed to prove non-inferiority of efficacy compared to existing drugs, Zitek is differentiated by proving superiority in efficacy compared to existing drugs,” adding, “We are negotiating overseas expansion with multiple countries including Japan, and domestically, we plan to launch after completing health insurance registration procedures and preparing for release.”

This content was produced with the assistance of AI translation services.