Croma-Pharma enrolls first patient in hyaluronic acid dermal filler clinical trial in China
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Croma-Pharma enrolls first patient in hyaluronic acid dermal filler clinical trial in China

The randomised, multi-centre, evaluator blinded, parallel group, active controlled Phase 3 trial is being led by Lanhzou Biotechnique Development

  • By IPP Bureau | June 13, 2023

Croma-Pharma 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 Lidocaine in China.

The randomised, multi-centre, evaluator blinded, parallel group, active controlled Phase 3 trial 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 annually over the past years, leading to an increasing demand for safe, high-quality products.

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