Narrow-Spectrum Sarecycline Approved for Moderate to Severe Acne in China

Last week, China’s National Medical Products Administration (NMPA) approved Almirall’s Seysara (sarecycline hydrochloride) for the treatment of inflammatory lesions of non-nodular moderate-to-severe acne vulgaris in patients aged 9 years and older.¹ Sarecycline is a tetracycline-derived, narrow-spectrum oral antibiotic and the first in its class to be purpose-built for acne. The indication in China aligns with its established positioning in other markets for inflammatory lesions in moderate-to-severe, non-nodular acne.

“NMPA approval and our license agreement with Sinomune enables timely access to a differentiated treatment in China, underscoring our commitment to expanding access to innovative treatments worldwide,” Almirall Executive Vice President, R&D, and Chief Scientific Officer, Karl Ziegelbauer, PhD, said to Dermatology Times.

Background

Mechanistically, sarecycline is distinguished by its narrow-spectrum activity within the tetracycline class and a dual-binding interaction with the bacterial 70S ribosome. This dual-binding capability is thought to contribute to a lower propensity for the development of antimicrobial resistance in C. acnes, an issue of ongoing concern in acne management. In addition to its antimicrobial activity, the agent has anti-inflammatory properties, consistent with the broader tetracycline class. Sarecycline was first approved in the US in 2018 and has been commercially available since early 2019.

“Its approval in the US in 2018 represented a major innovation milestone after decades without the introduction of a new systemic antibiotic for acne,” Ziegelbauer noted.

Support from Clinical Data

The Chinese approval builds on an existing body of clinical data demonstrating efficacy and a favorable safety profile. Across clinical trials conducted in the US and China, sarecycline has shown consistent and statistically significant reductions from baseline in inflammatory lesion counts. Improvements in global assessments have also been reported, with a higher proportion of patients achieving “clear” or “almost clear” status on Investigator’s Global Assessment (IGA) scales. Clinical responses were observed as early as week 3 in some studies and were maintained through 12 weeks of treatment.

Almirall highlights that, beyond controlled trials, real-world evidence has supported the product’s relevance across diverse patient populations. Data from the PROSES study and additional clinical investigations in different geographic and demographic settings were cited as reinforcing both effectiveness and tolerability in routine practice contexts.² This global evidence base is presented as part of the company’s effort to address the needs of patients with skin disease across varied healthcare systems.

“Skin diseases affect far more than the skin—acne’s visibility can lead to stigma and emotional distress, especially for adolescents,” Ziegelbauer said. “A once-daily, well-tolerated oral treatment option is an important step towards meaningful day-to-day benefits and improved wellbeing.”

Next Steps

To support commercialization in China, Almirall has entered into a license agreement with Sinomune, which has been granted exclusive rights to commercialize and distribute sarecycline in the country. Through this partnership, the companies aim to make the treatment available to Chinese physicians and patients in 2026. The collaboration is intended to facilitate local market access and distribution while leveraging Almirall’s dermatology expertise and Sinomune’s regional capabilities.

“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. 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. We are looking forward to collaborating with Sinomune in China to reach patients and the medical community in China as soon as possible,” Ziegelbauer said in the press release.¹

References

1. Almirall Announces the Approval of Seysara® in China for the Treatment of Moderate-to-Severe Acne. News release. Business Wire. Published January 29, 2026. Accessed February 3, 2026. https://www.businesswire.com/news/home/20260128234524/en/Almirall-Announces-the-Approval-of-Seysara-in-China-for-the-Treatment-of-Moderate-to-Severe-Acne

2. Baldwin HE, Graber E, Harper JC, et al. INDIVIDUAL ARTICLE: Sarecycline Improves Acne Severity, Symptoms, and Psychosocial Burden in Non-nodular Acne Vulgaris: PROSES Study. J Drugs Dermatol. 2024;23(2):SF405634s12-SF405634s18. doi:10.36849/JDD.SF405634