Aphranel® Marks First Anniversary with EU MDR Certification, Arc™ Launch, and Over 150,000 Syringes Delivered

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Aphranel® Marks First Anniversary with EU MDR Certification, Arc™ Launch, and Over 150,000 Syringes Delivered

PR Newswire

SHANGHAI, June 5, 2026 /PRNewswire/ -- On May 20, 2026, Aphranel® celebrated its first anniversary at the Waldorf Astoria Shanghai on the Bund, marking a major milestone in the brand's international presence in regenerative aesthetics.

 

Aphranel® celebrates its first anniversary at the Waldorf Astoria Shanghai on the Bund.

One year earlier, on May 8, 2025, Aphranel® officially launched globally in Shanghai after obtaining China's first approval for a Calcium Hydroxyapatite (CaHA) Microsphere Injectable Facial Filler. At the time, many questioned how far a regenerative aesthetics brand built on long-term scientific research and biomaterial innovation could go.

One year later, Aphranel® has demonstrated both scientific credibility and market acceptance.

Within its first year on the market, cumulative product deliveries across China exceeded 150,000 syringes. The brand expanded across 28 provinces and 94 cities in China, partnered with more than 620 medical clinics, and certified over 700 physicians nationwide.

In an increasingly competitive regenerative aesthetics market, Aphranel® moved from launch to broad clinical adoption within just 12 months.

During the anniversary summit, Aphranel® announced that it had obtained European Union Medical Device Regulation (EU MDR) certification under Regulation (EU) 2017/745.

With this achievement, Aphranel® became the first China-originated and China-manufactured facial injectable filler to obtain EU MDR certification and the first CaHA microsphere facial injectable filler from the Asia-Pacific region certified under the EU MDR framework.

From China’s first Class III approval for a CaHA Microsphere Injectable Facial Filler in 2025 to EU MDR certification in 2026, Aphranel® continues to advance its global regulatory milestones.

The MDR certification process lasted 2 years and 7 months under the Class III pathway for absorbable implantable medical devices, involving more than 6,381 pages of technical documentation and over 120 internal regulatory meetings. The process was completed in collaboration with BSI, a UK-based Notified Body and one of the world's first MDR-designated organizations.

Over the past 12 years, Shanghai Moyom, the biotechnology company behind Aphranel, has remained committed to long-term biomaterial research and regenerative CaHA technology, driving advances in microsphere structure, degradation pathway validation, and regenerative biomaterial development.

Another major highlight of the anniversary event was the launch of Aphranel® MagicCrystal Arc™, the brand's second flagship product. Arc™ represents a new chapter in "The Poetics of Time," extending the brand's vision through facial contouring and regenerative aesthetics.

A multidisciplinary roundtable examined biomaterial innovation, regenerative medicine, clinical applications, and the growing role of China-originated innovation in the global medical aesthetics landscape.

New perspectives on regenerative aesthetics and tissue remodeling were also presented by researchers and leading experts in the field. Professor Yuan Tun from Sichuan University's National Engineering Research Center for Biomaterials shared preliminary findings on the in vivo degradation kinetics and tissue remodeling mechanisms of Aphranel® CaHA microspheres, providing additional scientific insight into the brand's approach to controlled biodegradation and regenerative aesthetics.

Aphranel® also launched "The Norns' Plan," a global academic initiative designed to foster collaboration and knowledge exchange in regenerative aesthetics.

A live artistic performance brings Aphranel®’s brand philosophy, “The Poetics of Time,” to life.

Built around knowledge sharing, collaboration, and scientific exchange, the initiative aims to advance international medical education, collaborative research, global clinical dialogue, and the development of a worldwide mentor system for regenerative aesthetics.

Aphranel® also signed collaboration agreements with medical experts and partners from Europe, the Middle East, and the Asia-Pacific region, further strengthening the brand's international academic network.

Beyond regenerative medicine, Aphranel® announced a strategic partnership with Langjiu Manor, one of China's leading premium liquor estates known for its philosophy of growth and aging through time.

Throughout the venue, immersive artistic installations inspired by butterflies, architecture, and time transformed the Waldorf Astoria Shanghai into a sensory expression of "The Poetics of Time."

The launch of The Norns’ Plan and expert presentations highlighted Aphranel®’s commitment to global collaboration, scientific exchange, and regenerative aesthetics education.

Looking ahead, Aphranel® will continue expanding into Europe, Latin America, the Middle East, and Southeast Asia while investing in the science and research shaping regenerative aesthetics.

"Being willing to wait is the ultimate hallmark of a brand built for the long term," said Aphranel® founder Guangming Lin.

For Aphranel®, the first anniversary is not the end, but the beginning of its next chapter.

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SOURCE Aphranel