Core Viewpoint - The article discusses the emerging competition and regulatory challenges in the calcium hydroxyapatite (CaHA) market within the medical aesthetics industry, highlighting the recent approvals of CaHA products for facial use and the ongoing issues related to compliance and safety [5][7][11]. Group 1: Market Dynamics - CaHA, originally used in orthopedics and dentistry, is gaining popularity as a facial filler material, alongside PLLA and PCL, driven by market education efforts [3][5]. - In January 2024, it was estimated that the domestic market could consume tens of thousands of CaHA injections, potentially reaching 500,000 units annually, despite a lack of fully compliant products [5][11]. - The approval of two CaHA products for facial use in 2025 marks a significant shift towards regulatory compliance in the industry [5][7]. Group 2: Regulatory Landscape - The first approved CaHA product for facial use, Aphranal® by Moyang Biotechnology, received certification in February 2025, followed by Merz North America's Radiesse, which is the first imported CaHA product approved in China [7][11]. - The competition in the CaHA market is intensifying, with a notable reduction in the time required to obtain regulatory approval, leading to a more crowded market [8][9]. - There are concerns regarding the use of CaHA products beyond their approved indications, with many practitioners using them for facial applications despite their original intended uses being for non-weight-bearing bone defects [13][15]. Group 3: Industry Challenges - The medical aesthetics industry faces significant challenges related to the misuse of products beyond their approved indications, which is prevalent across various injectable products [15][16]. - There is currently no clear legal framework in China to regulate the off-label use of medical devices, leading to potential risks for both practitioners and patients [15][16]. - The article emphasizes the importance of proper patient consent and documentation to mitigate compliance risks in the absence of stringent regulations [16][17].