Taipei, Taiwan, 24 February 2026 — Lotus Pharmaceutical Co., Ltd. (Taiwan Stock Exchange: 1795), a leading global pharmaceutical company, today announced that it has filed a New Drug Application (“NDA”) under the 505(b)(2) regulatory pathway with the United States Food and Drug Administration (“US FDA”) on 23 February, seeking approval to market LP757 (cabozantinib) in the United States. This submission represents a significant milestone for Lotus as its first oral oncology product filed in the United States via the 505(b)(2) pathway.
Cabozantinib is indicated for the treatment of multiple advanced solid tumors, including renal cell carcinoma (RCC), hepatocellular carcinoma (HCC), and certain types of thyroid cancer. As an oral tyrosine kinase inhibitor, cabozantinib targets multiple signaling pathways involved in tumor growth and angiogenesis, including MET, VEGFR1/2/3, and AXL, thereby inhibiting tumor vascularization, suppressing tumor proliferation, and helping overcome resistance mechanisms. It has become an established therapy in the management of advanced RCC and HCC in the United States.
According to IQVIA data, the US sales of cabozantinib were approximately US$1.67 billion while the global sales were approximately US$2.62 billion in 2024. According to industry estimates1, the global cabozantinib market was valued at approximately US$3.0 billion in 2025 and is projected to reach US$8.4 billion by 2035, representing a compound annual growth rate (CAGR) of approximately 10.9%.
Petar Vazharov, Chief Executive Officer of Lotus, commented, “This 505(b)(2) submission reflects Lotus’ dedication to innovation and our capability to bring differentiated products to regulated markets through sophisticated development strategies. Cabozantinib is an established targeted therapy in the treatment of solid tumors and represents a strategically meaningful addition to our U.S. oncology platform. By expanding our oncology and immunology portfolio through innovative pathways, we aim to broaden patient access to high-quality treatment options while reinforcing Lotus’ long-term sustainable growth.”
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1. https://www.futuremarketinsights.com/reports/cabozantinib-cometriq-market
About Lotus
Founded in 1966, Lotus (1795: TT) is an international pharmaceutical company with a global presence, focused on commercializing both novel and generic pharmaceuticals to provide patients with better, safer, and more accessible medicines. The company boasts a best-in-class R&D and manufacturing platform in Asia, certified by leading regulatory authorities around the world, including the US FDA, EU EMA, Japan PMDA, China FDA, and Brazil ANVISA. Lotus has established partnerships in nearly every major global market, including the U.S., Europe, Japan, China, and Brazil. The company is currently developing and registering over 100 strategically selected pharmaceutical projects across Asia and the U.S., with more than 250 commercial products. Lotus invests in a diversified portfolio, consisting of high-barrier oncology, complex generics, 505(b)2, NCEs, and biosimilars, through both internal R&D investments and licensing-in partnerships to strengthen its portfolio competitiveness.
Media Inquiries:
Yihsuan Kuo, Investor Relations Assistant Manager
Jeffrey Tsang, Head of Investor Relations and Corporate Communications
+886 2 2700 5908
investor@lotuspharm.com