Almirall’s Seysara receives China NMPA approval for treatment of moderate-to-severe acne

"Almirall, S.A, a global pharmaceutical company dedicated to medical dermatology announced 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 older.

Acne vulgaris, a common chronic inflammatory disease most prevalent among adolescents, 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. Oral antibiotics such as sarecycline are the recommended treatment for moderate to severe acne in clinical guidelines. 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 profile. 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 Study) and through conducting clinical studies in a variety of patient populations in the United States and China.

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.

Almirall, founded in 1944 and headquartered in Barcelona, is publicly traded on the Spanish Stock Exchange. Almirall  has direct presence in 21 countries and marketed products in over 100.

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.

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.

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 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.

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.

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