Almirall, S.A. (ALM) 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 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 profile^6,7 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 Study^8,9) 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.