Huadong Medicine: Announcement on Obtaining a Medical Device Registration Certificate for a Wholly-Owned Subsidiary
Securities code: 000963 Securities abbreviation: Huadong Medicine Announcement number: 2026-031
East China Pharmaceutical Co., Ltd.
Announcement on Obtaining a Medical Device Registration Certificate for a Wholly-Owned Subsidiary
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.
On April 23, 2026, Xinkeli Aesthetics (Hangzhou) Supply Chain Management Co., Ltd., a wholly-owned subsidiary of Huadong Pharmaceutical Co., Ltd. (hereinafter referred to as the "Company"), received the "Medical Device Registration Certificate" issued by the National Medical Products Administration (NMPA). Its registration application for the Class III medical device injection polycaprolactone microsphere facial filler Ellansé® M type (trade name: Ellansé Hengyao TM) was approved for marketing. The specific situation is now announced as follows:
1. Product registration status
Application matters: Registration application for imported medical devices
Product name: Injectable polycaprolactone microsphere facial filler
Model and specifications: Ellansé-M, 1ml/support
Structure and composition: This product consists of a prefilled syringe, a stainless steel injection needle and a gel particle suspension encapsulated in the syringe. Some specifications include a stainless steel injection needle. The gel part is composed of synthetic polycaprolactone (PCL) microspheres, glycerin, carboxymethyl cellulose, and phosphate buffer solution. The labeled content of PCL microspheres is 33.1%. The product is produced by aseptic technology and has a shelf life of 2 years.
Scope of application: This product is suitable for use in the temporal region and is injected into the upper periosteum to improve mild to moderate temporal depression in adults. It is used in medical institutions.
Registration certificate number: National Machinery Injection 20263130151
Registration classification: Class III medical devices
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Registrant name: AQTIS Medical B.V.
Agent name: Xinkeli Aesthetics (Hangzhou) Supply Chain Management Co., Ltd.
2. Basic product information
Ellansé® is composed of a gel carrier based on polycaprolactone (PCL) microspheres and carboxymethyl cellulose (CMC). Its principle of action is to quickly fill with CMC for instant shaping, and then use PCL microspheres to promote collagen regeneration and reshape the collagen scaffold, bringing natural, safe, and lasting aesthetic improvement. PCL and CMC have good biocompatibility, natural effects, safety and reliability. Ellansé® has now obtained registration certification or marketing access in more than 60 countries or regions around the world. It has been in clinical use for 16 years worldwide, and its clinical safety and effectiveness have been widely recognized.
Ellansé® Type S is the first imported PCL high-end facial filler approved by NMPA in China. It has been officially launched in mainland China in August 2021. In June 2024, the company launched three new high-end regenerative facial fillers: Ellansé®, the second generation of Ellansé®, Ellansé®, Ellansé Firming®, and Ellansé Zhizhen®. By subdividing the core ingredient PCL microspheres into different particle sizes, it brings a more refined layered anti-aging solution to beauty seekers. Since its launch in China, the Yiyanshi® series products have received great attention and recognition from the market, gained a good market reputation, and continued to lead the PCL regeneration track.
The approved Ellansé® M type (trade name: Ellansé HengyaoTM) can permanently activate the orderly regeneration of autologous collagen structure (especially type I collagen), provide better deep support, and achieve facial lifting effects. This further satisfies the demand for refined improvement and natural long-term effects, and provides a better solution for the meticulous refinement of facial contours. This product has been carried out and completed in China "a clinical trial to evaluate the safety and effectiveness of injectable polycaprolactone microsphere facial filler for improving temporal depression", which shows that the product has good effectiveness and safety.
3. Impact on listed companies and risk warnings
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The official approval of Ellansé® M type (trade name: Ellansé HengyaoTM) will further consolidate and expand the company's high-end regenerative medical beauty product pipeline, synergize and complement hyaluronic acid and botulinum toxin products, improve the matrix of high-end injectable medical beauty products, and help create a full-dimensional comprehensive beauty solution covering facial contour shaping and dynamic texture management for the majority of beauty seekers.
Facing the strategic opportunities of the rapid development of the medical aesthetics market in public hospitals, the company's pharmaceutical industry team and the medical aesthetics team have formed an in-depth synergy mechanism to comprehensively deploy the public hospital market through the "two-wheel drive" strategy, and carry out targeted planning, division of labor and access to the medical aesthetics market in public hospitals, aiming to consolidate cooperation with high-end private medical aesthetics institutions and simultaneously expand the company's medical aesthetics business in-depth into the public hospital market.
The successful approval of the listing of Ellansé® M type (trade name: Ellansé HengyaoTM) will have a positive impact on the company's medical beauty business and will not have a significant impact on the company's current financial status and operating results. Future product sales will be affected by various factors such as industry policy changes, market demand and competitive conditions, and the final impact on the company's profits will have certain uncertainties. Investors are advised to make prudent decisions and pay attention to investment risks.
Announcement is hereby made.
Board of Directors of East China Pharmaceutical Co., Ltd. April 24, 2026
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