Chong Kun Dang Pharmaceutical : Material Business Matters Related to Investment Decisions (Approval of the product license for ‘GTEC,’ a gastritis treatment, by the Ministry of Food and Drug Safety)
July 21, 2022 at 07:34 am IST
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Material Business Matters Related to Investment Decisions
1. Title
Approval of the product license for 'GTEC,' a gastritis treatment, by the Ministry of Food and Drug Safety
2) Target disease (indication)
Improvement in gastric mucosal lesions for acute gastritis and chronic gastritis
3) Date of application (approval) for product approval and approval agency
- Application date: February 9, 2022
- Approval date: July 18, 2022
- Product approval agency: Ministry of Food and Drug Safety (MFDS)
4) Clinical results
As a result of the phase 3 clinical trial conducted for the patients with acute and chronic gastritis, the GTEC-administered group demonstrated a comparatively 2.25 times higher rate of improvement than the control drug (artemisia 95% ethanol soft extract) in the effective rate of gastroscopy, in terms of the effective rate for the gastroscopy as the primary efficacy, thereby demonstrating superiority in efficacy (p = 0.0063).
5) Expected effect
GTEC is a natural medicine which has proven its efficacy against gastritis by formulating cinnamon, a traditional herbal medicine, with an extraction method developed on its own.
In the phase 3 clinical trial for gastritis patients, a superior therapeutic effect compared to existing drugs has been proven.
6) Future plan
It will be released after undergoing the health insurance registration process.
3. Date of board resolution (decision date) or confirmation date
2022-07-18
- Attendance of outside directors
Present(No.)
-
Absent(No.)
-
- Attendance of auditors (members of Audit Committee who are not outside directors)
-
4. Other matters to be factored into investment decisions
- The above "3. Date of board resolution (decision date) or confirmation date" is the date of receiving approval for the product license from the Ministry of Food and Drug Safety.
※ Related disclosure
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Chong Kun Dang Pharmaceutical Corporation published this content on 21 July 2022 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 21 July 2022 02:03:07 UTC.
Chong Kun Dang Pharmaceutical Corp is a Korea-based company mainly engaged in the manufacture and sale of pharmaceuticals. The Company is mainly involved in the production and sale of prescription drugs such as antidiabetic treatments, cerebrovascular disease treatments, hypertension treatments and hyperlipidemia therapies. In addition, the Company provides over the counter (OTC) drugs including penzal, prefermine and modcol; quasi-drugs including insecticides and hair dyes; and health functional food. The company sells products in domestic and overseas markets.
Chong Kun Dang Pharmaceutical : Material Business Matters Related to Investment Decisions (Approval of the product license for ‘GTEC,’ a gastritis treatment, by the Ministry of Food and Drug Safety)