Huadong Medicine Co.,Ltd. (ASX: 000963) has announced a significant regulatory development for one of its key medical aesthetic products.
On June 8, 2026, the company's wholly-owned subsidiary, Xinkeli Aesthetics (Hangzhou) Supply Chain Management Co., Ltd., received an acceptance notice from the National Medical Products Administration (NMPA).
The notice pertains to a Class III medical device application for a new indication of the injectable polycaprolactone microsphere facial filler Ellansé® (Yiyanshi®) S-type.
The new indication sought is for subcutaneous or supraperiosteal implantation in the forehead to improve moderate to severe forehead contour defects.
The successful acceptance of this application for the forehead contour improvement indication marks another major milestone in the product's clinical and registration journey within China.
This development is expected to provide domestic consumers with more facial filling solutions.
It is also anticipated to help the company solidify its first-mover advantage, brand strength, and safety profile in the medical aesthetics sector, further enhancing the product's market potential.
The company stated it will continue to fully advance the registration work for this product in China, aiming to secure approval for the new indication as soon as possible.
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