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Bloomage’s Cross-Linked Sodium Hyaluronate Powder Completes Master File Registration with CMDE

2026.01.21

Recently, Bloomage’s “cross-linked sodium hyaluronate powder” has successfully completed Master File registration with the Center for Medical Device Evaluation (CMDE) of the National Medical Products Administration (NMPA) (Registration No.: M2026052-000).

This achievement represents a phased milestone in Bloomage’s ongoing efforts to strengthen regulatory compliance in the medical device sector, and it also provides robust support for downstream partners by streamlining registration and filing procedures and improving overall efficiency.

Decoding Hyatrue® “Cross-Linked Sodium Hyaluronate Powder”

After undergoing a cross-linking reaction, sodium hyaluronate forms a three-dimensional network structure and is transformed into a hydrophilic elastic gel, thereby providing a certain degree of volumizing, structural support, and shaping effects. At the same time, the cross-linked structure confers resistance to degradation by hyaluronidase, resulting in a more sustained duration of action.

The Hyatrue® cross-linked sodium hyaluronate powder registered on this occasion is an innovative pharmaceutical raw material solution launched by Bloomage based on its independently developed Hyacross® high-efficiency gradient cross-linking technology (cross-linking agent: BDDE). The product is characterized by efficient cross-linking with strong resistance to enzymatic degradation, high purity, a high safety profile, and high batch-to-batch consistency.

In addition, compared with conventional gel formulations, the powder form offers advantages in terms of product stability, convenience and cost-effectiveness in storage and transportation, as well as greater flexibility and convenience for formulation and use by end customers.

Hyatrue® cross-linked sodium hyaluronate powder can be used in the manufacture of products such as aesthetic soft-tissue fillers and long-acting injectable therapies for osteoarthritis (classified as medical devices in major international markets). After adopting this material, finished-product manufacturers are no longer required to perform the technically challenging and time-consuming steps of sodium hyaluronate cross-linking and purification. Instead, production of terminal cross-linked sodium hyaluronate formulations can be achieved through reconstitution, filling, and sterilization, thereby significantly shortening the overall production cycle.

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