August 12, 2025
Source: drugdu
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On the evening of August 11, Huaxi Bio(688363) announced that the company's independently developed fermentation-based chondroitin sodium raw material (hereinafter referred to as "chondroitin sodium") has successfully passed the National Medical Products Administration's Medical Device Approval.The company has registered its master document with the Technical Review Center and has become the first company in my country to achieve regulatory compliance for its fermentation-based chondroitin sodium.
Huaxi Bio said that the sodium chondroitin that has been registered this time is a new type of pharmaceutical-grade raw material of the company and can be used in Class II and Class III medical devices . It is expected to provide core raw materials for high-end medical devices in the future .
It is reported that traditional chondroitin sulfate is mainly extracted from animal cartilage (such as pig, cow, chicken, and shark), which has problems such as animal immunogenicity, unsustainable raw material sources, and high pollution in the extraction process. Huaxi Bio said that the next step is to use the sodium chondroitin obtained by fermentation as a basis and use synthetic biology to produce it .We use scientific technology to develop chondroitin sulfate raw materials for applications in ophthalmology, orthopedics, medical aesthetics and other fields.
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