Advanced Aesthetic Technologies Secures Regulatory Approval for Algeness® VL Dermal Filler in China

30 January 2025 | Thursday | News


AAT’s Algeness® VL becomes the first agarose-based dermal filler approved in China, marking a major milestone in the company’s global expansion and reinforcing its commitment to innovation in aesthetic medicine.
Image Source : Public Domain

Image Source : Public Domain

Advanced Aesthetic Technologies, Inc. (“AAT”) announced today that its partner in China, Lanzhou Biotechnique Development Co., Ltd. ("LanDev"), has secured approval to market Algeness® VL agarose facial injection filler, a 2.5% agarose gel dermal filler. This approval from China’s National Medical Products Administration (NMPA) classifies Algeness® VL as an imported Class III medical device, making it the first officially approved agarose-based injectable filler in China.

LanDev, the aesthetic division of China National Biotec Group Company Limited (CNBG), a subsidiary of Sinopharm Group, acted as the regulatory agent for Algeness® VL and will lead its distribution in the Chinese market.

A Breakthrough in Aesthetic Medicine

Algeness® represents years of scientific and clinical research aimed at developing a biocompatible, natural, and biodegradable dermal filler to address wrinkles and volume loss in facial soft tissues. Designed with a unique rheology and injection technique, Algeness® provides practitioners with an innovative approach to achieving predictable and natural-looking results.

“We are excited about Algeness®’s entry into the large and growing aesthetic market in China through our partner LanDev,” said Doug Abel, President and CEO of AAT. “LanDev is the ideal partner to drive the success of Algeness® in China, as they are the only domestic Chinese manufacturer of botulinum toxin. Their product, Hengli, was the first to launch in China and holds significant market share. This approval is a major milestone for LanDev, CNBG, AAT, and Ghimas, as well as our regulatory advisors and partners.”

Abel added, “This entry into China marks a transformational moment for AAT and demonstrates the clinical performance and unique value of our product in the global aesthetic market.”

Key Milestones Driving Global Expansion

This regulatory approval in China follows several strategic achievements for AAT in recent years, including:

  • Advancing clinical trials for submission to the U.S. FDA as part of the Pre-Market Authorization (PMA) process, with primary safety and efficacy endpoints successfully met and additional follow-up ongoing.
  • Progressing towards a U.S. FDA submission expected in 2025.
  • Obtaining CE Mark approval under the Medical Device Regulations (MDR), initially for therapeutic claims, with a recent expansion to include aesthetic claims under Annex XVI.
  • Acquiring a controlling interest in Ghimas, S.p.A., the original developer and manufacturer of Algeness®.

Global Endorsements from Leading Experts

The unique properties of Algeness® have been widely recognized by leading plastic surgeons and dermatologists worldwide.

Dr. Omer Buhsem, Medical Director for Algeness® and a plastic surgeon based in Istanbul, emphasized the filler’s exceptional safety and efficacy. “Algeness®, with its unique rheology and structure, is an essential addition to the aesthetic practitioner’s toolkit. It enables precise shape definition, and my patients report outstanding results,” said Dr. Buhsem, who previously published a 700-patient retrospective study on the product.

Dr. Tatjana Pavicic, a dermatologist in Munich, Germany, echoed this sentiment: “Algeness® is a true revolution in aesthetic medicine. Its natural composition, biocompatibility, and superior safety profile set it apart. My patients appreciate its immediate lifting effect and long-lasting results, making it a trusted choice for facial enhancement.”

The Future of Algeness® in China and Beyond

With this regulatory approval in place, AAT and LanDev are set to commercialize Algeness® in China, capitalizing on the country's rapidly growing aesthetic market. This expansion, coupled with ongoing U.S. FDA regulatory progress and the strong clinical and market performance data, positions Algeness® as a disruptive force in medical aesthetics worldwide.

About Advanced Aesthetic Technologies, Inc.
Advanced Aesthetic Technologies, Inc. (AAT) is a pioneer in biomaterial-based aesthetic solutions, dedicated to developing innovative dermal fillers for facial contouring and soft tissue augmentation. The company’s flagship product, Algeness®, is a 100% natural, biodegradable injectable filler designed to achieve exceptional, long-lasting results. AAT continues to expand its global reach, working with key scientific, regulatory, and commercial partners worldwide.

News

Stay Connected

Sign up to our free newsletter and get the latest news sent direct to your inbox

Show

Forgot your password?

Show

Show

Lost your password? Please enter your email address. You will receive a link to create a new password.

Back to log-in

Close