Almirall, S.A. (LBTSF) has added another milestone to its dermatology franchise with China's National Medical Products Administration granting approval for Seysara (sarecycline hydrochloride) for the treatment of inflammatory lesions of non-nodular moderate-to-severe acne vulgaris in patients aged nine years and older.
Acne remains one of the most common chronic inflammatory skin conditions, particularly among adolescents, and can have both a physical and psychological burden.
Seysara is described as an innovative, tetracycline-derived oral antibiotic and the first oral antibiotic specifically developed for dermatology. Sarecycline was first approved in the U.S. in 2018 and is described as a narrow-spectrum antibiotic of tetracycline class, developed specifically for dermatological use. According to the company, the therapy has a unique capability of dual binding to the 70S ribosome, which is thought to contribute to the low propensity of C.acnes to develop antimicrobial resistance.
The NMPA approval is supported by clinical studies demonstrating meaningful efficacy and a favorable safety profile. Almirall also pointed to real-world evidence from the PROSES study, along with additional clinical work carried out in patient populations across both the United States and China.
Safety findings from these studies were consistent with the product's established profile, reinforcing its suitability for treating moderate-to-severe acne in the indicated population.
Almirall noted that the approval aligns with its broader strategy to expand access to innovative dermatology treatments worldwide. Dr. Karl Ziegelbauer, the company's Executive Vice President of R&D and Chief Scientific Officer, said the decision underscores Almirall's commitment to addressing unmet needs in dermatology and supporting patients and clinicians in China.
Under a licensing agreement, Sinomune will take responsibility for commercializing and distributing the therapy in China. Seysara is expected to become available to physicians and patients in 2026.
Seysara generated €14.4 million in net sales during the first nine months of 2025, compared to €16.8 in the same period of 2024.
LBTSF has traded between $9.01 and $15.47 over the past year. The stock closed yesterday's trading at $15.47.
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