Huadong Medicine: Announcement on the wholly-owned subsidiary’s medical device obtaining EU MDR CE certification
Securities code: 000963 Securities abbreviation: Huadong Medicine Announcement number: 2026-047
East China Pharmaceutical Co., Ltd.
Announcement on the 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, Sinclair Pharma Limited (hereinafter referred to as "Sinclair"), a wholly-owned subsidiary of Huadong Pharmaceutical Co., Ltd. (hereinafter referred to as the "Company") in the UK, has a brand-new patented carboxymethyl chitosan solution for injection, KIO015, which has obtained the EU MDR CE certification and obtained the EU market access qualification. It is the world's first and currently only innovative non-animal-derived chitosan medical aesthetic injection product. The relevant information is now announced as follows:
1. Related information about MDR CE certificate
Product name: KIO015 (trade name: Kytogen® Defend)
Indications: The product is used for intradermal injection, superficial filling, skin texture improvement, and skin hydration. Certificate type: MDR CE certificate
Certificate number: 2290556CE01
Manufacturer: KiOmed Pharma SA
2. Product Introduction
KIO015 (trade name: Kytogen® Defend) adopts a new patented technology and is currently the only chitosan medical beauty product in the world that can achieve the triple functions of superficial filling, skin texture improvement, and skin hydration at the same time. Its core ingredient is KiOmedine® CM-chitosan, which is a highly purified polysaccharide prepared using KiOmedine® patented technology. KiOmedine® patented technology extracts high-purity non-animal source medical grade from Agaricus bisporus
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Chitosan can reduce the potential tolerance and allergy risks of traditional animal-derived materials. Compared with traditional humectants such as glycerol, chitosan materials have stronger water absorption capabilities and exhibit antibacterial, antioxidant and other material properties.
Kytogen® Defend utilizes these properties to protect endogenous hyaluronic acid through mesodermal therapy, reduce oxidative stress in dermal cells, increase skin moisture content, increase skin elasticity and gloss, thereby improving fine lines, dryness and other skin quality problems. Kytogen® Defend also has free radical scavenging ability, which can reduce the damage of extracellular matrix components caused by oxidative degradation. In vitro studies have also confirmed its antioxidant protective effect.
In September 2021, Sinclair obtained the exclusive license for KiOmedine® chitosan-related products from Belgium's KiOmed Pharma SA in the field of dermatology and beauty in other regions around the world except the United States.
In order to promote the launch of this product in the Chinese market, the company has launched a prospective, multi-center, randomized, uncontrolled, evaluator-blinded, superiority clinical trial in China to evaluate the effectiveness and safety of carboxymethyl chitosan solution for injection (product model: KIO021) for improving facial skin condition. In January 2026, all 500 subjects in China's clinical research were enrolled, and all subjects were discharged in June 2026. The clinical trial data is currently being compiled. It is expected to complete the clinical trial by the end of 2026 and submit a marketing application in early 2027. The company will actively promote the progress of clinical trials of KIO021 in China, with a view to meeting the broader needs of Chinese beauty seekers as soon as possible.
3. Impact on listed companies and risk warnings
Skin quality improvement is one of the key areas of the company's medical aesthetics strategy. Kytogen® Defend is the world’s first and currently only non-animal-derived chitosan medical aesthetic injection product, and it is also the company’s first injection product in the skin quality improvement track. Relying on its innovative non-animal-derived chitosan technology, this product is expected to meet the needs of market segments such as sensitive skin and medical and art aftercare, and provide new injection solutions for people with related skin conditions.
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The latest data from the World Beauty and Anti-Aging Conference (AMWC) shows that 59% of consumers tend to choose structured combination treatments, suggesting that "combination treatments" have officially become the mainstream development trend in the medical beauty market. Against this background, the company's new product Kytogen® Defend in the medical aesthetics sector has obtained the EU MDR CE certification and obtained EU market listing access qualifications, further enriching the company's medical aesthetics injection product matrix and improving the medical aesthetics product pipeline layout.
At present, the company's medical beauty business has built a diversified product ecosystem covering injections, energy source equipment (EBD), lifestyle beauty equipment, and functional skin care products. The addition of Kytogen® Defend will form a good synergy with the company's existing regenerative, hyaluronic acid (HA) and energy source equipment medical aesthetic products, covering the entire market demand from contour shaping, filling and improvement to skin texture optimization, empowering medical aesthetic institutions and helping to provide scientific, accurate and personalized "one-stop" aesthetic solutions for beauty seekers.
The company's medical aesthetics business adheres to the strategy of "global operation layout, dual-cycle operation and development", adheres to innovation as the core development driver, and carries out forward-looking layout with an international perspective. It has multiple R&D centers and production bases around the world, focusing on the research and development and production of medical aesthetics injections and energy source equipment. The products are sold to more than 80 countries around the world. At present, the company has created a comprehensive and differentiated product matrix. The number of products and coverage areas are at the forefront of the industry. Among them, there are more than 30 products that have been launched at home and abroad, and all are under research and development. There are nearly 20 innovative products globally, achieving multi-dimensional integration of "non-invasive + minimally invasive" technology, "face + body" parts, "injection + energy source equipment", etc., and achieving full coverage and differentiation in the three major categories of regeneration, hyaluronic acid and botulinum toxin in injection products The pipeline builds core competitive barriers through source material innovation, preparation technology innovation and category scenario innovation, provides more professional, safe, efficient and comprehensive comprehensive solutions to the majority of beauty seekers, and is committed to becoming the world's leading comprehensive medical aesthetic solution provider.
Kytogen® Defend product has obtained the EU MDR CE certification, indicating that the product meets the relevant requirements for EU market listing, has EU market access qualifications, and can be sold in the EU and related overseas markets.
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Market sales. This matter will not have a significant impact on the company's current financial status and operating results, and will have a certain positive effect on the company's future performance improvement.
This product has obtained the EU MDR CE certification, but has not yet obtained the domestic medical device registration certificate, and has not yet actually generated sales revenue. The progress of product overseas commercialization and subsequent actual sales are affected by multiple factors such as industry regulatory policies, market demand, and industry competition, and there is great uncertainty. Investors are advised to make cautious decisions and pay attention to investment risks.
Announcement is hereby made.
Board of Directors of East China Pharmaceutical Co., Ltd. August 10, 2026
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