Almirall Gains Landmark Approval for Acne Drug Seysara® in China, Tapping into Vast Market

BARCELONA, Spain – January 29, 2026

Spanish pharmaceutical giant Almirall, S.A. has secured a major victory in its global expansion strategy, announcing that China’s National Medical Products Administration (NMPA) has approved Seysara® (sarecycline hydrochloride). The decision marks the introduction of the first oral antibiotic specifically developed and approved for treating moderate-to-severe acne in the world's second-largest economy, offering a new therapeutic option for millions.

The approval covers the treatment of inflammatory lesions of non-nodular moderate-to-severe acne vulgaris in patients aged nine and older. To navigate the complex Chinese market, Almirall has entered into an exclusive licensing agreement with Sinomune Pharmaceutical Co., Ltd., a leading domestic dermatology company that will handle the commercialization and distribution of Seysara®. The product is anticipated to become available to physicians and patients across China in 2026.

A Strategic Entry into a Booming Market

The approval is more than just a regulatory milestone; it is a calculated strategic maneuver that gives Almirall a significant foothold in China's rapidly expanding dermatology sector. The Chinese dermatological drugs market, valued at over $1.8 billion in 2024, is projected to surge to nearly $3.4 billion by 2030, growing at a compound annual rate of over 10%.

Acne treatment represents a particularly lucrative segment within this market. Driven by high prevalence among adolescents and young adults, the demand for effective solutions is soaring. The Chinese anti-acne cosmetics market alone was valued at nearly $800 million in 2024 and is expected to nearly double by 2030. Seysara® enters this landscape not as a cosmetic, but as a targeted prescription medication, addressing a critical gap for patients whose condition requires more than over-the-counter remedies.

The partnership with Sinomune is pivotal to Almirall's strategy. With over three decades of experience and a robust distribution network, Sinomune provides the essential market access and local expertise needed for a successful launch. Sinomune's own formidable R&D infrastructure, including a national postdoctoral research station, underscores its position as a serious player in China's pharmaceutical industry, making it a powerful ally for Almirall.

Addressing a Significant Unmet Need

For countless Chinese adolescents and young adults, the impact of acne extends far beyond skin deep. Acne vulgaris, a chronic inflammatory disease, is known to cause significant psychosocial distress, impacting self-esteem and quality of life during formative years. While a vast market for topical treatments exists, a substantial unmet need remains for patients with moderate-to-severe inflammatory acne who require systemic treatment.

Seysara® is positioned to fill this void. Clinical guidelines recommend oral antibiotics for moderate-to-severe cases, and Seysara® offers a solution specifically engineered for this purpose. Clinical trials conducted in both the United States and China have demonstrated its efficacy and favorable safety profile. Studies showed significant reductions in inflammatory lesions and a notable percentage of patients achieving clear or almost clear skin, with improvements seen as early as three weeks into treatment.

“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's Executive Vice President of R&D and Chief Scientific Officer, in a statement. “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.”

A Targeted Weapon Against Acne and Resistance

Beyond its market potential, Seysara® represents a key scientific advancement in the fight against acne. As a narrow-spectrum antibiotic of the tetracycline class, it is designed to specifically target Cutibacterium acnes, the bacteria primarily associated with inflammatory acne. This targeted approach is a crucial differentiator from older, broad-spectrum antibiotics that can disrupt the body's beneficial microbiome and contribute to the growing global crisis of antimicrobial resistance (AMR).

Sarecycline’s unique molecular action, which involves a dual-binding capability to the bacterial ribosome, is believed to be the reason for the low propensity of C. acnes to develop resistance. In a country like China, where AMR is a significant public health concern, the introduction of a narrow-spectrum antibiotic offers a more responsible and sustainable therapeutic option for long-term dermatological care.

This scientific precision allows the drug to decrease the population of C. acnes on the skin, reducing inflammation and preventing the blockage of hair follicles that leads to acne lesions, all while minimizing collateral damage to other bacteria.

The Road Ahead in China

First approved by the U.S. FDA in 2018 and launched in the American market in 2019, Seysara® has an established track record. Its impending 2026 launch in China will place it in a competitive environment that includes a wide array of topical solutions, cosmetic products, and existing, less-targeted oral medications. However, its status as the first purpose-built oral antibiotic for acne gives it a powerful and unique market position.

Almirall's financial performance has been robust, with the company reporting double-digit net sales growth and reiterating strong guidance for the coming year, driven by its European dermatology portfolio. The successful entry of Seysara® into China is poised to become a new and significant driver of future growth, reinforcing the company's standing as a global leader in medical dermatology. As the 2026 launch date approaches, all eyes will be on Almirall and Sinomune to see how this innovative treatment reshapes the standard of care for acne in one of the world's most important healthcare markets.