China Approves Seysara for Moderate-to-Severe Acne Treatment in Patients 9 Years and Older
核心洞察
China's National Medical Products Administration (搜索) has approved Seysara (sarecycline hydrochloride), the first oral antibiotic specifically developed for dermatological use, for treating moderate-to-severe acne (搜索) vulgaris in patients aged 9 and older.
Sarecycline is a narrow-spectrum tetracycline-class antibiotic with unique dual binding to the 70S ribosome (搜索), which reduces the likelihood of Cutibacterium acnes (搜索) developing antimicrobial resistance.
Almirall has partnered with Sinomune (搜索) for commercialization and distribution in China, with the product expected to become available to physicians and patients in 2026.
China's National Medical Products Administration (搜索) (NMPA) has approved Seysara (sarecycline hydrochloride) for the treatment of inflammatory lesions of non-nodular moderate-to-severe acne (搜索) vulgaris in patients 9 years of age and older. The approval marks a significant milestone for Almirall, S.A., the global pharmaceutical company dedicated to medical dermatology that developed this innovative treatment.
Sarecycline hydrochloride represents a breakthrough in acne treatment as the first oral antibiotic specifically developed for use in dermatology. The drug was initially approved in the United States in 2018 and has been commercialized by Almirall since January 2019.
Novel Mechanism Addresses Resistance Concerns
Sarecycline is a narrow-spectrum antibiotic of the tetracycline class with a unique capability of dual binding to the 70S ribosome (搜索). This distinctive mechanism is thought to be the reason for the low propensity of Cutibacterium acnes (搜索) (formerly known as Propionibacterium acnes) to develop antimicrobial resistance, addressing a critical concern in acne treatment.
The drug works by decreasing the population of C. acnes bacteria on the skin, thereby reducing the effects of infection and preventing blockage of hair follicles and sebaceous glands. Oral antibiotics such as sarecycline are recommended treatment for moderate to severe acne in clinical guidelines.
Addressing Significant Medical Need
Acne vulgaris (搜索) is a common chronic inflammatory disease most prevalent among adolescents, characterized by the appearance of inflammatory and non-inflammatory lesions in skin. The condition frequently has significant negative psychosocial impact on patients, which is especially important given its high prevalence during the formative years of adolescence.
Various clinical trials have demonstrated the product's efficacy and favorable safety profile. The drug's relevance for different patient populations was confirmed through real-world evidence generation, including the PROSES Study, and through clinical studies conducted in a variety of patient populations in the United States and China.
Strategic Partnership for Chinese Market
Almirall has entered into a license agreement granting Sinomune (搜索) the exclusive rights for commercialization and distribution of this innovative oral treatment for acne in China. Sinomune Pharmaceutical Co., Ltd. is a leading dermatology-focused pharmaceutical company in China with over thirty years of dedication to the skin health sector.
"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," said Dr. Karl Ziegelbauer, Almirall Executive Vice President, R&D, and Chief Scientific Officer. "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."
Clinical Profile and Availability
Seysara is administered as a once-daily oral treatment with anti-inflammatory properties. Clinical studies conducted in the USA and China demonstrated consistent and significant efficacy, showing reductions from baseline in inflammatory lesion counts and improvements in the percentage of patients with cleared or almost cleared facial lesions based on an Investigator's Global Assessment (IGA). These effects were observed as early as week 3 and maintained through week 12.
The product is expected to be available to physicians and patients in China in 2026, expanding access to this innovative treatment that addresses a significant unmet medical need in dermatology.