ZUG, Switzerland--(BUSINESS WIRE)--Galderma today announced the launch of Sculptra, the first proven regenerative biostimulator with a unique poly-L-lactic acid (PLLA-SCA™) formulation, in China.1-7,11-14 This follows Sculptra’s approval by China’s National Medical Products Administration for correcting mid-facial volume loss and/or contour deficiencies last year. Sculptra – which works with the body’s natural processes to achieve healthier, radiant skin and a more youthful appearance – will now be available in China, where growth of aesthetics has outpaced the global market in the past decade.15-18 This launch is indicative of Galderma’s commitment to expanding its unparalleled aesthetics portfolio into new geographies, in order to meet the needs of even more patients and healthcare professionals.

The approval was based on results from a study in China, which showed Sculptra’s ability to achieve high and maintained response rates in the correction of midface volume/contour deficit through to two years, building on its 25 years of clinical evidence.7-10 Over this time, Sculptra has proven to be a premium, versatile treatment which consistently meets the needs of patients and healthcare providers.4,8,19,20 Sculptra’s unmatched long-term safety data make it a reliable choice, and its unique PLLA-SCA formulation provides differentiated advantages such as volumization, skin firmness, structural support, radiance, overall skin quality and natural-looking results.1,2,7,12-16,21-24

China is a major market for Galderma, where sales have fueled the company’s strong performance across product categories.25 The aesthetics industry in China has also experienced remarkable growth in recent years, driven by increasing consumer demand for beauty and wellness treatments.18 The market is expected to continue expanding at a rate of up to 15% in the coming years, and research has shown that many Chinese consumers prioritize the safety and outcomes of their aesthetic treatments.18,26 Sculptra is well placed to meet these expectations as its extensive safety profile and high satisfaction rate has been demonstrated in more than 10,000 patients in clinical studies over 25 years.1,5-10,21,27

This launch further expands Sculptra’s global reach, which already spans over 40 countries and regions worldwide, and underscores Galderma’s commitment to meeting the diverse patient needs and beauty standards across different parts of the world. As the pure-play dermatology category leader, Galderma’s story is one of continuous growth, and it is committed to bringing innovative aesthetics solutions to patients across the world.

Watch this video to find out more about the value of introducing Sculptra to the injectable aesthetics market in China.

About Sculptra
Sculptra is the first proven regenerative biostimulator, with a unique PLLA-SCA formulation, to provide rapid, progressive, and sustained regenerative effect across all three skin layers.1-14 Sculptra addresses the underlying causes of facial aging, including degradation of the extracellular matrix, which results in volume loss, laxity, and the appearance of wrinkles.1,11,28-30 Sculptra encourages the remodeling of components of the extracellular matrix, such as elastin and collagen, helping to gradually restore facial volume and the look of fullness to wrinkles and folds over time.31-34 The results from Sculptra are long-lasting, with optimal correction seen in approximately three months and results lasting for more than two years.2,15,30,35

About Galderma
Galderma (SIX: GALD) is the pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that span the full spectrum of the fast-growing dermatology market through Injectable Aesthetics, Dermatological Skincare and Therapeutic Dermatology. Since our foundation in 1981, we have dedicated our focus and passion to the human body’s largest organ – the skin – meeting individual consumer and patient needs with superior outcomes in partnership with healthcare professionals. Because we understand that the skin we are in shapes our lives, we are advancing dermatology for every skin story. For more information: www.galderma.com

References

1. Sculptra®. EU Instructions for Use. 2021.
2. Widgerow A, et al. A randomized, comparative study describing the gene signatures of Poly-L-Lactic Acid (PLLA-SCA) and Calcium Hydroxylapaptite (CaHA) in the treatment of nasolabial folds. Poster presented at IMCAS World Congress, February 1-3, 2024, Paris, France.
3. Zhang Y, et al. In vivo inducing collagen regeneration of biodegradable polymer microspheres. Regen Biomater. 2021;8(5):rbab042. doi: 10.1093/rb/rbab042.
4. Huth S, et al. Molecular Insights into the effects of PLLA_SCA on Gene Expression. J Drugs Dermatol. 2024;23(4):285-288. doi: 10.36849/JDD.7791.
5. Fabi S, et al. Effectiveness and safety of correction of cheek wrinkles using a biostimulatory poly-L-lactic acid injectable implant – Clinical study data up to 24 months. Poster presented at the IMCAS World Congress. 26–28 January 2023. Paris, France.
6. Brandt FS, et al. Investigator global evaluations of efficacy of injectable poly-L-lactic acid versus human collagen in the correction of nasolabial fold wrinkles. Aesthet Surg J. 2011;31(5):521–8.
7. Narins RS, et al. A randomized study of the efficacy and safety of injectable poly-L-lactic acid versus human-based collagen implant in the treatment of nasolabial fold wrinkles. J Am Acad Dermatol. 2010;62(3):448–62.
8. Galderma. Data on File (MA-47133).
9. Mu X, et al. 12-Month Effectiveness and Safety of PLLA Treatment of Midface in Chinese Subjects: A Multicenter, Randomized, No-Treatment Controlled Study. Presented at AMWC. March 30 to April 1, 2023. Monte-Carlo, Monaco.
10. U.S. Food and Drug Administration. Sculptra summary of safety and effectiveness data. Available online. Accessed April 2025.
11. Zhang S and Duan E. Fighting against Skin Aging: The Way from Bench to Bedside. Cell Transplant. 2018;27(5):729-738. doi: 10.1177/0963689717725755.
12. Asius J, et al. Inventors. US patent US 7,731,758 B2.2010. Available online. Accessed April 2025.
13. Morgan P, et al. Product Manufacturing Process for Poly-L-lactic acid (PLLA-SCA). Poster presented at IMCAS World Congress, January 26–28, 2023, Paris, France.
14. Galderma. Data on File (MA-53568).
15. Hexsel D, et al. Introducing the L-Lift-A Novel Approach to Treat Age-Related Facial Skin Ptosis Using A Collagen Stimulator. Dermatol Surg. 2020;46(8):1122–1124. doi:10.1097/DSS.0000000000002015.
16. Fabi S, et al. A multi-center, retrospective, chart review to evaluate the safety of poly-L-lactic acid injectable implant when used in non-facial areas. Poster presented at IMCAS World Congress, January 26–28, 2023, Paris, France.
17. Kwon SH, et al. Experiences and attitudes toward aesthetic procedures in East Asia: a cross-sectional survey of five geographical regions. Arch Plast Surg. 2021;48(6):660-669. doi: 10.5999/aps.2020.02565.
18. Deloitte. China Aesthetic Medicine Outlook Report. Accessed April 2025. Available online.
19. Bohnert K, et al. Plast Reconstr Surg. 2019;45(5):718–24.
20. Valantin MA, et al. Polylactic acid implants (New-Fill) to correct facial lipoatrophy in HIV-infected patients: results of the open-label study VEGA. AIDS. 2003;17(17):2471–7. doi: 10.1097/00002030-200311210-00009.
21. Redaelli A et al. European Expert Recommendations on the Use of Injectable Poly-L-Lactic Acid for Facial Rejuvenation. JDD. 2014;13(9):1057–1066.
22. Palm M et al. A Randomized Study on PLLA Using Higher Dilution Volume and Immediate Use Following Reconstitution. J Drugs Dermatol. 2021;20(7):760-766. doi: 10.36849/JDD.6034.
23. Avelar LE and Haddad A. Facial assessment for poly-l-lactic acid application—One product, different outcomes. J of Derm & Cos. 2023;7,3. doi: 10.15406/jdc.2023.07.00239.
24. Snyder A, et al. Sculptra®—History and how it is best used today. Derm Reviews. 2023;4(3). doi: 10.1002/der2.186.
25. Galderma. Annual Report 2024. Available online. Accessed April 2025
26. Aesthetics Today. Chinese Beauty Industry Trends in 2023. Available online. Accessed April 2025
27. Rayess HM et al. A Cross-sectional Analysis of Adverse Events and Litigation for Injectable Fillers. JAMA Facial. Plast Surg. 2018;20(3):207-214. doi: 10.1001/jamafacial.2017.1888.
28. Shuster S, et al. The influence of age and sex on skin thickness, skin collagen and density. Br J Dermatol. 1975;93(6):639-43. doi: 10.1111/j.1365-2133.1975.tb05113.x.
29. Zarbafian M, et al. The emerging field of regenerative aesthetics—where we are now. Dermatol Surg. 2022;48: 101–108. doi: 10.1097/DSS.0000000000003239.
30. Goldberg D, et al. Single-arm study for the characterization of human tissue response to injectable poly-L-lactic acid. Dermatol Surg. 2013;39:915–22.
31. Waibel J, et al. Gene Analysis of Biostimulators: PLLA-SCA Triggers Regenerative Morphogenesis while CaHA-R Induces Inflammation upon Facial Injection. Poster presented at ASDS 2024, October 17-20, 2024, Orlando, Floria, United States.
32. Waibel J, et al. Bulk RNA-seq Analysis of Poly-L-Lactic Acid (PLLA-SCA) vs Calcium Hydroxyapetite (CaHA-R) Reveals a Novel, Adipocyte Mediated Regenerative Mechanism of Action Unique to PLLA. Poster presented at ASDS 2024 Annual Meeting, October 17-20, 2024, Orlando, Floria, United States.
33. Haddad S, et al. Evaluation of the biostimulatory effects and the level of neocollagenesis of dermal fillers: a review. Int J Dermatol. 2022;61:1284–1288. doi: 10.1111/ijd.16229.
34. Vleggaar D, et al. Consensus recommendations on the use of injectable poly-L-lactic-acid for facial and nonfacial volumization. J Drugs Dermatol 2014;13(4 Suppl):s44–s51.
35. Fabi S, et al. 24-month clinical trial data on effectiveness and safety after correction of cheek wrinkles using a biostimulatory poly-L-lactic acid injectable implant. Poster presented at AMWC, March 30 - April 1, 2023, Monaco.