Recently, China’s National Medical Products Administration (NMPA) granted approval for Seysara (sarecycline hydrochloride), developed by Almirall, as a treatment for inflammatory lesions associated with non-nodular moderate-to-severe acne vulgaris in patients aged nine years and older.
Sarecycline is a unique oral antibiotic derived from the tetracycline class, distinguished as the first medication specifically formulated for the treatment of acne.
The approval in China mirrors its established use in other international markets for addressing inflammatory lesions in cases of moderate-to-severe, non-nodular acne. “The NMPA approval, alongside our licensing agreement with Sinomune, provides critical access to a differentiated treatment in China, highlighting our commitment to expanding access to transformative therapies globally,” remarked Karl Ziegelbauer, PhD, Executive Vice President of R&D and Chief Scientific Officer at Almirall, in a statement.
Mechanistically, sarecycline is notable for its narrow-spectrum action within the tetracycline class. It functions through a dual-binding mechanism with the bacterial 70S ribosome, potentially reducing the likelihood of developing antimicrobial resistance in Cutibacterium acnes, which is a significant concern in acne management.
In addition to its antimicrobial effects, sarecycline possesses anti-inflammatory properties, aligning with the broader attributes of tetracycline antibiotics. Approved for use in the United States in 2018, it has been commercially available since early 2019.
“The FDA’s approval in 2018 marked a groundbreaking innovation following decades without a new systemic antibiotic specifically for acne treatment,” Ziegelbauer noted.
The recent approval in China is backed by substantial clinical data showcasing the effectiveness and safety profile of sarecycline.
In clinical trials conducted across the United States and China, sarecycline demonstrated statistically significant reductions in inflammatory lesion counts from baseline measurements. Additionally, there were notable improvements in global assessments, with a higher percentage of patients achieving “clear” or “almost clear” status on the Investigator’s Global Assessment (IGA) scales.
Clinical responses were observed as early as week three in some studies, persisting through 12 weeks of treatment. Almirall also emphasizes that real-world evidence further supports the product’s efficacy across various patient demographics.
Data from the PROSES study and other clinical evaluations in diverse settings reinforce both the effectiveness and tolerability of sarecycline in everyday practice.
“Skin diseases extend beyond physical symptoms—acne’s visibility can lead to stigma and emotional distress, especially among adolescents,” Ziegelbauer expressed. “Having a once-daily, well-tolerated oral treatment option is a vital advancement for enhancing daily quality of life and overall wellness.”
To facilitate the commercialization process in China, Almirall has established a licensing agreement with Sinomune, which has secured exclusive rights to market and distribute sarecycline within the country.
This partnership aims to ensure the treatment reaches Chinese physicians and patients by 2026. The collaboration is designed to optimize local market access and distribution channels while leveraging Almirall’s expertise in dermatology and Sinomune’s regional knowledge.
“At Almirall, our mission is to focus on medical dermatology and to meet the unmet medical needs of individuals suffering from skin conditions such as moderate to severe acne. We are thrilled that, with the approval of Seysara in China, we can provide more patients with access to this pioneering treatment, which is the first oral antibiotic developed specifically for dermatological use,” Ziegelbauer added. “We look forward to collaborating with Sinomune to reach patients and the medical community in China as swiftly as possible.”
