Aphranel® MagiCCrystal CaHA Filler from Shanghai MOYOM Biotec, Obtains NMPA Class III Medical Device Certificate in China

——The World's First Precisely Regulated Injectable CaHA Filler, Accelerating Compliance in the Medical Aesthetics Industry in China.

SHANGHAI, March 21, 2025 /PRNewswire/ -- Shanghai Moyom Biotechnology's high-profile brand, Aphranel® MagiCCrystal CaHA Filler, has officially obtained Class III Medical Device Certificate from the China National Medical Products Administration (NMPA) (Registration Certificate Number.: 20253130390). This makes it the first calcium hydroxylapatite microsphere (CaHA) injectable product approved in China for facial soft tissue augmentation. This certificate not only signifies the elevation of regulatory standards in China's medical aesthetics industry but also provides a safer and more efficient bio-stimulating medical aesthetics solution for the global market.

Technological Breakthrough: Defining New Global Standards for Bio-stimulating Medical Aesthetics

Calcium hydroxylapatite (CaHA) microspheres have become a core material in the global bio-stimulating injection field due to their excellent biocompatibility and biodegradability, with a market adoption rate 71% higher than poly-L-lactic acid (PLLA). Leveraging proprietary technology, Moyom has precisely controlled CaHA microsphere size (30-35μm), through-hole structure, and degradation rate, successfully developing the Aphranel® MagiCCrystal CaHA Filler. Its raspberry-like through-hole design increases porosity by 40%, with the number of microspheres per unit volume exceeding 6 times that of competing product. The viscoelastic modulus (G' value) reaches 5500Pa, enabling long-lasting 3D supporting effect.

The product employs a pre-mixing technology combining CaHA and CMC (carboxymethyl cellulose), ensuring uniform particle suspension and a smoother injection push force. Validated by 31 biochemical tests, its inflammation rate is 30% lower than the state of art, and it is fully biodegradable. Its safety has been certified by Notified bodies in the EU (MD, MDSAP), Brazil(ANVISA), Russia(RZN), Saudi Arabia(SFDA), Mexico (COFEPRIS), and other countries.

Global Expansion: Innovation-Academia-Research Ecosystem

As a National high-tech enterprise, Shanghai Moyom Biotechnology has built an innovation network through a "Chinese R&D + Local transformation" model:

Research Collaboration: Partnering with institutions such as Nanjing Tech University and the Chinese Academy of Sciences to advance biomaterial technology.

Clinical Validation: Collaborating with authoritative institutions like the Plastic Surgery Hospital of the Chinese Academy of Medical Sciences and Shanghai Ninth People's Hospital to complete multicenter clinical trials.

International Expansion: Establishing joint laboratories with medical aesthetics experts from Germany and Brazil to promote localized adaptation of technology.

The company's core team brings together PhDs from top universities such as Fudan University and Shanghai Jiao Tong University, as well as technical experts from listed healthcare companies. Additionally, Moyom has engaged in cross-disciplinary collaboration with the Shanghai Theatre Academy, integrating medical and aesthetic design principles.

Capital Empowerment, Reshaping Industry Value

In 2024, Moyom Biotechnology completed nearly 100 million RMB of Plan B+ financing, led by Boyuan Capital and SAIC Hengxu Capital, with a cumulative financing of over 500 million RMB. The funds will be used for globalization capacity expansion and second-generation absorbable implant research and development.

"The approval of the Aphranel® MagiCCrystal CaHA Filler is an important node in the industry's compliance," said the CEO of Moyom Biotechnology, "We are committed to providing safer and more accessible products for the global medical aesthetics market through technological innovation, and promoting the sustainable development of the industry."

SOURCE SHANGHAI MOYOM BIOTECHNOLOGY CO., LTD