Croma-Pharma announces enrollment of first patient in hyaluronic acid dermal filler clinical trial in China

13 June 2023 | Tuesday | News

Croma-Pharma® ('Croma') announced that in June the first patient will be enrolled in the clinical trial1 for the approval of its hyaluronic acid dermal filler Princess® Volume Plus Lidocaine2 in China.
Image Source | Public Domain

Image Source | Public Domain

The randomised, multi-centre, evaluator blinded, parallel group, active controlled Phase 3 trial1 is being led by Lanhzou Biotechnique Development  with the intention to confirm the efficacy and safety of Princess® Volume Plus Lidocaine in respect of mid-facial volume insufficiency and/or mid-facial profile deficient participants. The trial is organised and executed by the clinical research organisation Beijing World-Clinical Research Biotechnology Development; the plan is to enroll 15 clinical centres and approximately 600 patients targeting mid-facial augmentation.

Lanhzou Biotechnique Development is an affiliate of China National Biotech Group (CNBG), a subsidiary of Sinopharm, with whom Croma-Pharma has established a joint venture in China. The aim of the joint venture company, named International Aesthetic Biotech, is to market and distribute products from Croma-Pharma's aesthetic portfolio, e.g. hyaluronic acid dermal fillers, and Lanzhou Biotechnique Development's botulinum toxin in China and Hong Kong, covering synergistic medical aesthetic indications.

The dermal filler market in the Asia-Pacific (APAC) region is estimated to be around 1.4 billion USD in size and to have seen an average growth of around 17 percent annually3 over the past years, leading to an increasing demand for safe, high-quality products.

'Asia, and China in particular, represent the fastest growing aesthetic medicine markets worldwide. The Chinese market is therefore an important pillar of our expansion strategy and this clinical trial positions us to enter China as one of only three companies with a full portfolio in this market. We are glad to have partnered with CNBG, a strong and significant player, to drive the growth of our complementing medical aesthetic portfolios in China and Hong Kong', comments Andreas Prinz, CEO of Croma-Pharma®.

The Princess® HA filler range comprises Princess® Rich (non-lidocaine), Princess® Filler, Princess® Volume (lidocaine and non-lidocaine types) and Princess® Volume Plus (lidocaine). The products target the individual needs of patients. Princess® Volume is already registered in China and Hong Kong.

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