Securities Code: 000963
Securities Abbreviation: Huadong Medicine
Announcement No.: 2026-047
Huadong Medicine Co., Ltd.
Announcement on Wholly-Owned Subsidiary's Medical Device Obtaining EU MDR CE Certification
The Company and all members of the Board of Directors guarantee that the information disclosed is true, accurate, and complete, and contains no false records, misleading statements, or major omissions.
Recently, Huadong Medicine Co., Ltd. (hereinafter referred to as the "Company")'s wholly-owned UK subsidiary, Sinclair Pharma Limited (hereinafter referred to as "Sinclair"), obtained EU MDR CE certification for its novel patented ingredient injectable carboxymethyl chitosan solution KIO015. This grants market access in the EU and marks the world's first and currently only innovative non-animal derived chitosan medical aesthetic injection product. The relevant situation is announced as follows:
I. MDR CE Certificate Information
Product Name: KIO015 (Brand Name: Kytogen® Defend)
Indications: Product for intradermal injection, superficial filling, skin texture improvement, skin hydration
Certificate Type: MDR CE Certificate
Certificate Number: 2290556CE01
Manufacturer: KiOmed Pharma SA
II. Product Introduction
KIO015 (Brand Name: Kytogen® Defend) utilizes a new patented technology and is currently the world's only chitosan medical aesthetic product that can simultaneously achieve superficial filling, skin texture improvement, and skin hydration. Its core ingredient is KiOmedine® CM-chitosan, a highly purified polysaccharide prepared using KiOmedine® patented technology. The KiOmedine® patented technology extracts high-purity non-animal derived medical-grade chitosan from Agaricus bisporus, which can reduce the potential for adverse reactions and allergies associated with traditional animal-derived materials. Compared to traditional moisturizers like glycerin, chitosan materials have stronger water absorption capabilities and exhibit properties such as antibacterial and antioxidant effects.