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

- Link: https://www.thailand-business-news.com/pr-news/aphranel-marks-first-anniversary-with-eu-mdr-certification-arc-launch-and-over-150000-syringes-delivered
- Published: 2026-06-05T12:20:00+07:00
- Author: 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.

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[⌊Aphranel® celebrates its first anniversary at the Waldorf Astoria Shanghai on 
the Bund.⌉⌊Aphranel® celebrates its first anniversary at the Waldorf Astoria Shanghai
on the Bund.⌉[
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.⌉⌊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.⌉[
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.⌉⌊A live artistic performance brings Aphranel®’s brand philosophy,“
The Poetics of Time,” to life.⌉[
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.⌉⌊The launch of The Norns’ Plan and expert presentations highlighted Aphranel
®’s commitment to global collaboration, scientific exchange, and regenerative aesthetics
education.⌉[
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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  |  This article was produced by Cision PR Newswire, our trusted news partner. The views expressed and the content presented here are solely those of the author and may not fully reflect the opinions of Thailand Business News. |

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