Recently, the injectable hydroxyapatite microsphere facial filler (registration certificate number: National Medical Device Approval No. 20253130390) applied by Shanghai Moyang Biotechnology Co., Ltd. has been approved for market by the National Medical Products Administration.

At the same time, Merz North America Inc., a subsidiary of Merz North America Inc., which is represented by Merz Business Management Consulting (Shanghai) Co., Ltd., also obtained market approval on March 10, 2025 for the injectable hydroxyapatite microsphere facial filler produced by Merz North America Inc. (Registration number: National Medical Device Injection No. 20253130124).

1st domestically produced product
Shanghai Moyang Biotechnology Co., Ltd.'s injectable hydroxyapatite calcium phosphate microsphere facial filler is the first officially approved hydroxyapatite based facial injection filler material in China, suitable for subcutaneous injection in the nasolabial folds to correct moderate to severe nasolabial folds.

According to publicly available information, the main components of this product are: calcium hydroxyphosphate, sodium carboxymethyl cellulose, glycerol, and injection water. This product selects the modified sodium hyaluronate gel for injection produced by Q-Med AB Company as the clinical control group, and carries out clinical trials in four clinical trial institutions. The results of the complete analysis set and the clinical trials conforming to the protocol set show that the efficacy of the test group is not worse than that of the control group.

1st import
Merz North America Inc. produces in Radiesse ® The product is also composed of hydroxyapatite, sodium carboxymethyl cellulose, glycerol, and injection water. The hydroxyapatite particles have a particle size of 25-45 microns and are used as subcutaneous implants for correcting moderate to severe facial wrinkles and folds, such as nasolabial folds, to repair and/or correct patients with facial fat atrophy caused by human immunodeficiency virus.
Radiesse ® The product was first approved in the United States in 2006, and it is worth mentioning that it is suitable for PMA (pre-market approval) and has the strictest marketing pathway among the three types of devices. Radiesse ® The listing selected collagen implants as the control group, and the 3-month clinical trial results showed non inferiority, while the control group did not have effectiveness; The 6-month nasolabial groove treatment showed superiority. Radiesse ® The product is currently available for sale in Europe, North America, and South America.

Similar listed products
The molecular formula of hydroxyapatite is Ca5 (PO4) 3 (OH), which is the main component of human bone tissue. As an implant device, a large number of products have already been launched in the fields of orthopedics and dentistry. As subcutaneous implants for plastic surgery, in addition to the two products mentioned above, there are at least four similar products that have already been launched abroad. Overall, there are not many products on the market that use hydroxyapatite for plastic surgery and cosmetic injections.

Current market analysis
At present, there are 90 valid registration certificates for injection materials used in plastic surgery and beauty in China, of which 80% are products based on hyaluronic acid.

From the first registration year of the registration certificate, it can be seen that there has been a significant increase in the batch of registration certificates for plastic surgery and beauty injection materials in 2024. Faced with fierce market competition, various manufacturers are competing to launch new products.

Currently, some beauty institutions are using hydroxyapatite products from orthopedics or dentistry for facial cosmetic filling, which are beyond the indications for use. Due to the excellent biocompatibility of hydroxyapatite itself, even if used beyond the indications, there will not be significant safety issues, which makes people dare to inject it without a license. The strength of hydroxyapatite itself is higher than that of traditional gel products, and its supporting effect is more lasting. However, in the products implanted subcutaneously, its particle size needs to be reduced to reduce the osteogenic effect and make it gradually absorbed by the human body. Hydroxyapatite products used in orthopedics or dentistry generally have larger particle sizes and require a certain osteogenic effect after implantation.

The American Society of Plastic Surgeons (ASPS) conducts annual statistics on plastic and cosmetic surgeries, and for minimally invasive surgeries, hyaluronic acid products (brand examples: Juvederm Ultra ®, Ultra Plus ®, Voluma ®, Volbella ®, Vollure ®, Restylane Lyft ®, Restylane Silk ®, Belotero ®, Bolvella ®, Restylane ®） And non hyaluronic acid products (brand examples: Radiesse ®, Sculptra ®, Bellafill ®, Renuva ®） By distinction, compared to 2022, the usage of both hyaluronic acid and non hyaluronic acid products will increase by about 8% in 2023, while the usage of non hyaluronic acid products will only account for 15% of the total usage.

According to the injection materials used in minimally invasive plastic surgery for different age groups in 2023 published by the American Society of Plastic Surgeons, the relative usage ratio difference between non hyaluronic acid products and hyaluronic acid products is smaller in lower age groups.

Conclusion
With the continuous growth of demand for plastic surgery and beauty in society, major production enterprises have launched new products to seize market opportunities. At the same time, the standardization process in the medical beauty industry is accelerating, making market competition increasingly fierce. At the product technology level, without significant clinical breakthroughs, industry competition will further intensify.

Source: https://news.yaozh.com/archive/45148.html