Zhejiang Jingjia Medical Secures NMPA Approval for New Hyaluronic Acid 'Hydroshine' Injection

The approved sodium hyaluronate solution for injection is classified as a Class III medical device, with all registration and production qualifications, product parameters, and technical standards fully disclosed. The product model is uniformly 15 mg/mL, available in four specifications: 2.0 mL, 2.5 mL, 3.0 mL, and 5.0 mL, to meet varying clinical injection volume requirements.

The complete product consists of a pre-filled syringe and sodium hyaluronate solution. The core ingredient, sodium hyaluronate, is prepared using microbial fermentation technology. Excipients include sodium chloride, phosphate buffer system, and water for injection, resulting in a simple and safe formulation. The finished product is sterilized by high-temperature steam and is intended for single-use as a medical device, with a shelf life of 3 years.

As specified in the registration certificate, this product is intended solely for injection into the superficial dermis of the face, with the expected effect of temporarily improving skin dryness and dull complexion in adults. Promotional materials and clinical use are strictly limited to the indications stated in the registration, without any design elements that exaggerate medical aesthetic enhancement effects.

Jingjia Medical, established in July 1995, is a national high-tech enterprise. Its Cross-linked Sodium Hyaluronate Gel Technology Center has been accredited as a provincial-level R&D center for high-tech enterprises. Since 1996, the company has achieved mass production and sales of its sodium hyaluronate product series. It was among the first domestic manufacturers in its sector to obtain EU CE certification, laying an international foundation for the clinical application of its products.

Jingjia Medical’s main products are categorized into four standardized series, while also providing OEM customization services for Class I, II, and III medical devices. Production is supported by a 100,000-grade cleanroom workshop, with raw materials undergoing more than 30 purification processes and using water for injection throughout the entire manufacturing process.

Anti-Adhesion Series:Medical Sodium Hyaluronate Gel for Prevention of Postoperative Adhesions in the Abdominal and Pelvic Cavities;

Hysteroscopy Series:Cross-linked sodium hyaluronate gel, aiding in postoperative repair after severe intrauterine adhesion surgery;

Ophthalmology Series:Ophthalmic Surgical Viscoelastic Agent: Protects Intraocular Tissues During Surgery;

Medical Aesthetics Series:The existing cross-linked sodium hyaluronate filler injection (approved as a Class III medical device in 2022 for the correction of nasolabial fold wrinkles) combined with the newly launched hydrating skin booster injection forms a comprehensive portfolio of aesthetic injectable products.

From a technical perspective, Jingjia Medical has filed more than 19 patent applications. In terms of regulatory compliance, the company holds six NMPA medical device registration certificates, including five Class III certificates and one Class II certificate. On the industrial chain front, the company is simultaneously advancing the construction of two major production bases: an 85-mu raw material base in Qiantang District for the independent production of core raw materials such as medical- and cosmetic-grade sodium hyaluronate, ensuring a stable upstream supply chain; and a 24-mu formulation base in Hangzhou Beicheng, which, upon completion, will have an annual production capacity of 10 million units of Class III hyaluronic acid gel, along with a supporting production line for Class I photon cooling gel and reserved space for Class II device manufacturing, thereby highlighting significant advantages in scale.

In the current compliant medical aesthetics market, demand for superficial hydration skin booster devices continues to rise. With this new product launch, Jingjia Medical provides healthcare institutions with another domestically produced, compliant hyaluronic acid skin booster. Distinct from mid-to-deep dermal fillers, it establishes a tiered supply of injectable medical aesthetic consumables, catering to diverse basic skincare needs.

Jingjia Medical has achieved an integrated model of independent production of hyaluronic acid raw materials and in-house research, development, and manufacturing of formulations. Leveraging its two proprietary production bases, the company ensures stable control over product quality and supply lead times, thereby mitigating upstream consumable supply risks for medical aesthetic institutions.

As a high-tech enterprise with years of expertise in medical biomaterials, Jingjia Medical strictly adheres to the NMPA Class III medical device standards for the research, development, and registration of all its aesthetic medicine products. The efficacy and usage methods are fully defined in accordance with the registered documentation, providing aesthetic clinics with compliant and standardized injectable consumables, thereby supporting the compliant operation of the aesthetic medicine industry.