- China’s National Medical Products Administration (NMPA) has approved Seysara® (sarecycline hydrochloride) for the treatment of inflammatory lesions of non-nodular moderate-to-severe acne vulgaris in patients 9 years of age and older.
- Sarecycline hydrochloride is an innovative tetracycline-derived oral antibiotic treatment – the first that was specifically developed for use in dermatology.
- Almirall has entered into a licence agreement with Sinomune, who will commercialise and distribute the product in China.
- This approval in China is aligned with Almirall’s ambition to expand access to innovative treatments that make a real difference to more patients and the medical community.
Almirall, S.A. (ALM) a global pharmaceutical company dedicated to medical dermatology announced today that China’s National Medical Products Administration (NMPA) has approved Seysara® (sarecycline hydrochloride). Sarecycline hydrochloride is the first oral antibiotic that was specifically developed for use in acne and is approved for the treatment of inflammatory lesions of non-nodular moderate-to-severe acne vulgaris in patients 9 years of age and older1.
Acne vulgaris, a common chronic inflammatory disease most prevalent among adolescents2, is characterized by the appearance of inflammatory and non-inflammatory lesions in skin and often involves an overgrowth of bacteria such as Cutibacterium acnes (formerly known as Propionibacterium acnes). Acne vulgaris frequently has significant negative psychosocial impact on patients which is especially important given its high prevalence in the formative years of adolescence.3 Oral antibiotics such as sarecycline are the recommended treatment for moderate to severe acne in clinical guidelines.4 They can decrease the population of C. acnes bacteria on the skin and therefore reduce the effects of the infection and prevent blockage of hair follicles and sebaceous glands.
Sarecycline was first approved in the US in 2018 and is a narrow-spectrum antibiotic of the tetracycline-class, with the unique capability of dual binding to the 70S ribosome5 which is thought to be the reason for the low propensity of C. acnes to develop antimicrobial resistance.
“At Almirall, we are dedicated to medical dermatology and to addressing medical unmet needs of people living with skin conditions such as moderate to severe acne. We are delighted that with the approval of Seysara® in China we can give more patients access to this innovative treatment which was the first oral antibiotic developed specifically for the use in dermatology. We are looking forward to collaborating with Sinomune in China to reach patients and the medical community in China as soon as possible,” said Almirall Executive Vice President, R&D, and Chief Scientific Officer Dr. Karl Ziegelbauer.
Various clinical trials have shown the product’s efficacy and favourable safety profile6,7 In line with Almirall’s commitment to addressing the needs of people living with skin diseases in different populations around the world, the product’s relevance for different patient populations was confirmed through the generation of real-world evidence (PROSES Study8,9) and through conducting clinical studies in a variety of patient populations in the United States and China.
Almirall has entered into a license agreement granting Sinomune the exclusive rights for the commercialisation and distribution of this innovative oral treatment for acne in China. It is expected that the product will be available to physicians and patients in China in 2026.
About Seysara®
Sarecycline hydrochloride is a once-daily, oral tetracycline-derived antibiotic with anti-inflammatory properties for the treatment of inflammatory lesions of non-nodular moderate-to-severe acne vulgaris in patients 9 years of age and older. The product was approved by the FDA in October 2018 and has been commercialised by Almirall in the US since its launch in January 2019. The product has a favourable safety profile and demonstrated consistent and significant efficacy in studies conducted in USA and China, showing reductions from baseline in inflammatory lesion counts and improvements in the percentage of patients with cleared or almost cleared facial lesions based on an Investigator’s Global Assessment (IGA); these effects were observed, as early as week 3 and maintained through week 12.
About Almirall
Almirall is a global pharmaceutical company dedicated to medical dermatology. We closely collaborate with leading scientists, healthcare professionals, and patients to deliver our purpose: to transform the patients' world by helping them realize their hopes and dreams for a healthy life. We are at the forefront of science to deliver ground-breaking, differentiated medical dermatology innovations that address patients´ needs.
Almirall, founded in 1944 and headquartered in Barcelona, is publicly traded on the Spanish Stock Exchange (ticker: ALM). Almirall (total revenue in 2023: €898.8 MM, 1900 employees globally) has direct presence in 21 countries and marketed products in over 100.
About Sinomune
Sinomune Pharmaceutical Co., Ltd. is a leading dermatology-focused pharmaceutical company in China, with over thirty years of dedication to the skin health sector. Sinomune’s product portfolio is dedicated to addressing a range of conditions including fungal infections, acne, inflammatory skin diseases, and scalp disorders.
Sinomune operates a national postdoctoral research station, a CNAS-certified laboratory, and several provincial R&D platforms. Moving forward, Sinomune will continue to advance its "Technology + Marketing" dual-drive strategy, expand its product coverage, enrich its product lines, accelerate global expansion, and strive to be a leader in the dermatology field.
For more information, please visit almirall.com
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References
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Deeks ED. Sarecycline: first global approval. Drugs. 2019;79:325-329. doi:10.1007/s40265-019-1053-54 Sarecycline: First Global Approval - PubMed |
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Zhu Z, Zhong X, Luo Z, Liu M, Zhang H, Zheng H, Li J. Global, regional and national burdens of acne vulgaris in adolescents and young adults aged 10-24 years from 1990 to 2021: a trend analysis. Br J Dermatol. 2025 Jan 24;192(2):228-237. doi: 10.1093/bjd/ljae352. PMID: 39271178. |
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Morshed ASM, Noor T, Uddin Ahmed MA, Mili FS, Ikram S, Rahman M, Ahmed S, Uddin MB. Understanding the impact of acne vulgaris and associated psychological distress on self-esteem and quality of life via regression modeling with CADI, DLQI, and WHOQoL. Sci Rep. 2023 Nov 30;13(1):21084. doi: 10.1038/s41598-023-48182-6. PMID: 38030667; PMCID: PMC10687248. |
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Reynolds RV, Yeung H, Cheng CE, Cook-Bolden F, Desai SR, Druby KM, Freeman EE, Keri JE, Stein Gold LF, Tan JKL, Tollefson MM, Weiss JS, Wu PA, Zaenglein AL, Han JM, Barbieri JS. Guidelines of care for the management of acne vulgaris. J Am Acad Dermatol. 2024 May;90(5):1006.e1-1006.e30. doi: 10.1016/j.jaad.2023.12.017. Epub 2024 Jan 30. PMID: 38300170. |
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Batool Z, Lomakin IB, Polikanov YS, Bunick CG. Sarecycline interferes with tRNA accommodation and tethers mRNA to the 70S ribosome. Proc Natl Acad Sci U S A. 2020 Aug 25;117(34):20530-20537. doi: 10.1073/pnas.2008671117. Epub 2020 Aug 12. PMID: 32817463; PMCID: PMC7456112. |
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Zhang J, He L, Chen X, Tu Y, Kostov B, Cabedo J, Baykal T, García Gil E. Efficacy and Safety of Sarecycline in Chinese Patients with Moderate-to-Severe Acne Vulgaris: Randomized Phase 3 Clinical Trial with Open-Label Follow-Up. Dermatol Ther (Heidelb). 2025 Nov;15(11):3285-3300. doi: 10.1007/s13555-025-01526-8. Epub 2025 Aug 28. PMID: 40877730; PMCID: PMC12549459. |
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Moore A, Green LJ, Bruce S, Sadick N, Tschen E, Werschler P, Cook-Bolden FE, Dhawan SS, Forsha D, Gold MH, Guenthner S, Kempers SE, Kircik LH, Parish JL, Rendon MI, Rich P, Stein-Gold L, Tyring SK, Weiss RA, Nasir A, Schmitz C, Boodhoo TI, Kaoukhov A, Berk DR. Once-Daily Oral Sarecycline 1.5 mg/kg/day Is Effective for Moderate to Severe Acne Vulgaris: Results from Two Identically Designed, Phase 3, Randomized, Double-Blind Clinical Trials. J Drugs Dermatol. 2018 Sep 1;17(9):987-996. PMID: 30235387. |
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Baldwin HE, Graber E, Harper JC, Alexis AF, Stein Gold L, Kircik L, Del Rosso J, Hebert AA, Rieder EA, Fried RG, Narayanan S, Koscielny V, Kasujee I. INDIVIDUAL ARTICLE: Sarecycline Improves Acne Severity, Symptoms, and Psychosocial Burden in Non-nodular Acne Vulgaris: PROSES Study. J Drugs Dermatol. 2024 Feb 1;23(2):SF405634s12-SF405634s18. doi: 10.36849/JDD.SF405634. PMID: 38306152. |
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Graber E, Baldwin HE, Fried RG, Rieder EA, Hebert AA, Del Rosso J, Kircik L, Stein Gold L, Harper JC, Alexis AF, Narayanan S, Koscielny V, Kasujee I. INDIVIDUAL ARTICLE: Impact of Acne Vulgaris and Sarecycline on Social/Emotional Functioning and Daily Activities: PROSES Study. J Drugs Dermatol. 2024 Feb 1;23(2):SF405634s5-SF405634s11. doi: 10.36849/JDD.SF405634. PMID: 38306151. |
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