Spanish pharmaceutical company Almirall, S.A. (BME:ALM) announced on Thursday that 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 aged 9 years and older.
Sarecycline, a tetracycline-derived oral antibiotic, was the first in its class specifically developed for dermatology.
The approval follows Almirall's strategy to expand access to innovative dermatology treatments globally. Almirall has entered into a licence agreement with Sinomune, which will commercialise and distribute Seysara in China, with availability expected in 2026.
Sarecycline was first approved in the United States in 2018 and demonstrates efficacy and a favourable safety profile, including a low risk of bacterial resistance due to its dual binding to the 70S ribosome. Clinical trials and real-world evidence studies, including populations in China and the United States, have confirmed its effectiveness across diverse patient groups. The therapy addresses the psychosocial impact of acne vulgaris while reducing Cutibacterium acnes overgrowth and preventing follicle blockage.
DATROWAY receives US priority review for first-line metastatic triple negative breast cancer
Valneva and Instituto Butantan launch pilot chikungunya vaccination campaign in Brazil
Natera submits Signatera CDx PMA to FDA for bladder cancer use
Astrazeneca Imfinzi perioperative regimen gains positive EU CHMP opinion in early gastric cancer
I Peace generates human iPS cells from NKT cells and offers them for research use
Frontage expands early phase clinical research capabilities across US and China
AstraZeneca agrees obesity and type 2 diabetes collaboration with CSPC
Formation Bio acquires worldwide rights to FHND5032 from CTFH
Summit Therapeutics' BLA for ivonescimab in EGFR-mutated NSCLC accepted by FDA
Almirall receives China approval for Seysara to treat moderate-to-severe acne