Austria-based Croma-Pharma has revealed that the first patient is set to be enrolled in a clinical trial in China to support the approval of its hyaluronic acid dermal filler, Princess Volume Lidocaine. This randomized, multi-center, blinded, parallel Phase III study will confirm the safety and efficacy of Croma’s product, focusing on participants with mid-facial volume insufficiency and/or mid-facial profile deficiency.
Study Design and Enrollment Plan
Croma plans to enroll 600 patients across 16 clinical centers in China, with the trial being led by partner Lanzhou Biotechnique Development. Lanzhou Biotechnique is an affiliate of China National Biotech Group (CNBG), a subsidiary of Sinopharm. Croma-Pharma has established a joint venture in China with CNBG, named International Aesthetic Biotech, which will market and distribute Croma-Pharma’s medical aesthetic portfolio in China and Hong Kong.
Expanding Market Presence in China
The joint venture, International Aesthetic Biotech, will handle not only hyaluronic acid dermal fillers but also Lanzhou Biotechnique Development’s botulinum toxin. The partnership aims to capture a significant share of China’s rapidly growing cosmetic medicine sector. The Asia-Pacific dermal filler market, currently valued at approximately USD 1.4 billion, has been growing at a rate of 17% over the past few years, presenting a substantial opportunity for Croma-Pharma and its partners.-Fineline Info & Tech
