Almirall, a pharmaceutical company focused on medical dermatology, has received approval from China’s National Medical Products Administration (NMPA) for Seysara (sarecycline hydrochloride), an oral antibiotic developed specifically for acne treatment.

Seysara is indicated for the treatment of inflammatory lesions associated with non-nodular moderate-to-severe acne vulgaris in patients aged nine years and older. The drug is the first tetracycline-derived oral antibiotic designed exclusively for dermatological use in acne management.

Acne vulgaris is a chronic inflammatory skin condition that predominantly affects adolescents and is often linked to the overgrowth of Cutibacterium acnes bacteria. Beyond its physical symptoms, acne can have a significant psychosocial impact, particularly during adolescence. Clinical guidelines recommend oral antibiotics for moderate-to-severe cases to reduce bacterial load, inflammation and prevent follicular blockage.

First approved by the U.S. Food and Drug Administration (FDA) in 2018, sarecycline is a narrow-spectrum tetracycline-class antibiotic with a unique dual-binding mechanism to the 70S ribosome, which is believed to reduce the likelihood of antimicrobial resistance. Since its U.S. launch in 2019, Seysara has demonstrated consistent efficacy and a favourable safety profile in clinical studies.

Clinical trials conducted in the United States and China showed reductions in inflammatory lesion counts and improvements in Investigator’s Global Assessment (IGA) scores, with results observed as early as week three and sustained through week 12. Additional real-world evidence from the Proses study further supported its effectiveness across diverse patient populations.

Dr. Karl Ziegelbauer, Executive Vice President, R&D, and Chief Scientific Officer at Almirall, said the approval marks an important step in addressing unmet needs in dermatology. He added that the company looks forward to collaborating with Sinomune to bring the treatment to patients and healthcare professionals across China.

Under a licensing agreement, Sinomune Pharmaceutical will hold exclusive rights for the commercialisation and distribution of Seysara in China. The product is expected to be available in the Chinese market in 2026.