On April 13, 2021 - Huadong Medicine Co., Ltd. (hereinafter referred to as Huadong Medicine) officially received Medical Device Registration Certificate issued by National Medical Products Administration for its product the Ellansé® (a polycaprolactone microsphere facial filler for injection use).
Ellansé® is made of polycaprolactone microspheres (PCL) and carboxymethyl cellulose (CMC)having a dual effects of “filling+ repairing”. Primarily, Ellansé® implants CMC spontaneously, then PCL microspheres will stimulate one’s own collagen production process under the skin of the injection site and reshape the original scaffold to produce a natural, safe, and long-lasting effect. PCL and CMC can be completely degraded and are deemed as the safer products. Ellansé® currently obtained registration certification or market access in more than 60 countries or regions.
As Huadong Medicine obtained the Ellansé® Medical Device Registration Certificate in Mainland China, it has enriched and improved the product lines of non-surgical aesthetic medicine of the company, achieving major milestone in “global operation layout, and dual-cycle business development” strategy for aesthetic medicine business. The Ellansé® product launching work is processing in an orderly manner. It is expected to be officially launched in Mainland China in the second half of 2021.
Currently, Huadong Medicine's core aesthetic medicine products landing work is progressing smoothly. The Clinical Trail of Silhouette®InstaliftTM, the only FDA-approved absorbable embedding suture for midfacial tissue lifting, is proceeding in China as planned; Launching related preparation work of GlacialTM Spa (F0), a cold-touch cosmetic instrument, introduced from a US company named R2, has been carried out neatly; GlacialTM Rx (F1), a frozen freckle removal medical instrument, has advanced fast with its registration in China; MaiLi® series products, a new filler containing Lidocaine hyaluronic acid, based on OXIFREE™ patent technologies and process, will go on sale in the European market in the first half of 2021, and started its market registration in China; Cooltech Define, a frozen fat-melting product, newly purchased by Sinclair from High Tech Company (Spain) has obtained EU CE certification.
Huadong Medicine, relying on four R&D centers in its wholly-owned subsidiaries, Sinclair (UK) and High Tech (Spain), and its joint stock companies, R2 (USA), and Kylane (Switzerland) as well as its five production bases in Holland, France, America, Switzerland and Bulgaria, will promote the aesthetic medicine products go on sale in a shorter time.
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Huadong Medicine obtained the Ellansé® (Apolycaprolactone Microsphere Facial Filler for Injection Use) Medical Device Registration Certificate