Almirall has received regulatory approval in China for its oral acne treatment Seysara, marking a new geographic expansion for the product and strengthening the company’s presence in medical dermatology in Asia.

China’s National Medical Products Administration has approved Seysara (sarecycline hydrochloride) for the treatment of inflammatory lesions of non-nodular moderate-to-severe acne vulgaris in patients aged nine years and older. The decision brings the narrow-spectrum oral antibiotic to one of the world’s largest dermatology markets, where acne remains a common chronic inflammatory skin disease, particularly among adolescents.

Sarecycline hydrochloride is a tetracycline-derived oral antibiotic developed specifically for use in dermatology. Unlike broader-spectrum antibiotics, sarecycline was designed to target Cutibacterium acnes, the bacteria associated with acne pathogenesis, while limiting activity against other bacterial populations. Oral antibiotics are recommended in clinical guidelines for moderate-to-severe acne, where they are used to reduce bacterial load and inflammation.

Acne vulgaris is characterised by inflammatory and non-inflammatory lesions and can have a significant psychosocial impact, particularly during adolescence. The burden of disease, combined with concerns around antimicrobial resistance, has driven interest in more targeted antibiotic therapies in dermatology.

Sarecycline was first approved in the USA in 2018 and has since been used in clinical practice for several years. The drug is described as a narrow-spectrum tetracycline-class antibiotic with dual binding to the 70S ribosome, a mechanism that is thought to contribute to a lower propensity for the development of antimicrobial resistance in C acnes.

Almirall said the China approval aligns with its focus on medical dermatology and expanding access to treatments across different patient populations. Karl Ziegelbauer, executive vice president, R&D, and chief scientific officer at Almirall, said: “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.”

He added: “We are looking forward to collaborating with Sinomune in China to reach patients and the medical community in China as soon as possible.”

The approval is supported by clinical trial data demonstrating efficacy and a favourable safety profile, as well as real world evidence generated through the Proses study. Additional studies have been conducted in a range of patient populations in both the USA and China to assess the product’s relevance across different demographic groups.

As part of its China strategy, Almirall has entered into a licence agreement granting Sinomune exclusive rights to commercialise and distribute sarecycline in the country. Under the terms of the agreement, Sinomune will be responsible for local commercial activities, while Almirall retains ownership of the product. The companies expect the treatment to become available to physicians and patients in China during 2026.

The latest approval adds to Almirall’s growing international dermatology portfolio and reflects continued regulatory momentum for targeted therapies addressing chronic inflammatory skin diseases.