Taipei, Taiwan, February 20, 2025 —Lotus Pharmaceuticals, a multinational pharmaceutical company (1795:TT), has announced that U.S. Food and Drug Administration (FDA) has accepted the Potential First-to-File Abbreviated New Drug Application (ANDA) for Voclosporin soft gelatin capsules, a generic equivalent to Lupkynis® from Aurinia Pharmaceuticals Inc.
Lupkyins® is the first and only FDA approved oral medication for adult patients with active lupus nephritis (LN), it is indicated in combination with a background immunosuppressive therapy. According to Aurinia Pharmaceuticals Inc.'s SEC filing in November 2024, Lupkynis® has generated approximately $159 million in U.S. sales over the past nine months, highlighting the significant demand for this treatment among LN patients. Also, according to GlobalData, the peak US sales forecast for Lupkynis® is projected to reach ~$420 Million by 2030.
Petar Vazharov, CEO of Lotus, stated: "We have invested in unique capabilities such as soft gelatin capsules, which continue to provide us with a significant competitive edge in the market. This submission demonstrates our ongoing success in developing unique and complex products. The majority of our R&D pipeline is focused on complex products, allowing us to enhance our diverse portfolio with sustainable long-term growth drivers."
About Lotus
Founded in 1966, Lotus (1795: TT) is a global pharmaceutical company focused on delivering novel and generic medicines that are safer, better, and more accessible. With a best-in-class R&D and manufacturing platform in Asia, Lotus has partnerships in key markets including the U.S., Europe, Japan, China, and Brazil. The company manages over 100 strategic projects in development and registration across Asia and the U.S., with a portfolio of more than 250 commercial products. Lotus invests in a diversified pipeline of high-barrier oncology treatments, complex generics, 505(b)2 products, and new chemical entities (NCEs), through internal R&D and licensing partnerships. Additionally, it bolsters its portfolio with biosimilars, supported by strategic alliances. Lotus's facilities are certified by top regulatory bodies, including the US FDA, EU EMA, Japan PMDA, China FDA, and Brazil ANVISA.
Media Inquiries:
Yu-ying Yang, Associate Director, Corporate communication.
+886 2 2700 5908
investor@lotuspharm.com