Anxo Pharmaceutical announced today (27th) that its drug for treating severe acne, Deto Soft Capsules, has received marketing approval from the Taiwan Food and Drug Administration (TFDA). This marks not only Taiwan’s first generic oral isotretinoin soft capsule but also the first approved product from Anxo’s dual-phase soft capsule technology platform. Pre-launch promotion and sales preparations with distribution partners are already underway, with official market rollout expected in the first half of 2026, targeting the steadily growing acne treatment market.
Anxo explained that Deto was co-invested and developed with Sunny Pharmtech, with Anxo responsible for formulation development and holding the drug license, while Sunny Pharmtech handles manufacturing. In Taiwan, the drug will be promoted through professional dermatology distributors, and efforts are ongoing to establish partnerships in Southeast Asia as part of overseas market expansion.
Lin-Chuan Yen, General Manager of Anxo, emphasized that the company leverages a rarely seen alliance model in the pharmaceutical industry, combining each partner’s strengths, sharing resources, and dividing responsibilities to reduce redundant investment. The goal is a win-win collaboration that sustains revenue and profitability. With Deto securing Taiwan’s first generic approval, Anxo follows the successful China market licensing of its schizophrenia drug by its local partner last year. This year, the company also partnered with Sunny Pharmtech to develop a pirfenidone P4 generic for lung fibrosis, completing Middle East distribution authorization, while simultaneously submitting marketing approval applications to the TFDA and the U.S. FDA—demonstrating a strong record of successful industry collaboration.
Deto’s active ingredient is isotretinoin, indicated for severe acne or acne unresponsive to other therapies. Acne, a common dermatological condition, occurs when pores are blocked by sebum, bacteria, or dead skin cells, causing inflammation, pustules, and redness. While treatment options are diverse, oral isotretinoin remains the first-line therapy for severe cases. Deto matches the original product in active ingredient and soft capsule formulation, and is available in both 10 mg and 20 mg strengths. The TFDA approval covers the 20 mg product, while the 10 mg version is currently under review.
Yen noted that over 70% of adolescents in Taiwan experience acne, with prevalence among adults also significant. Annual market sales have historically reached around NT$400 million, but unstable supply from originator products has often caused shortages. Deto, as the first generic oral isotretinoin in Taiwan, is expected to fill this supply gap and capture market share.
According to a report by 360iResearch, the global acne drug market was valued at US$6.32 billion in 2024 and is projected to reach US$10.41 billion by 2032, representing a compound annual growth rate of 6.43%.
Resource: 瑩碩口服A酸獲台灣首發學名藥，明年上半年正式鋪貨
