Lotus Pharmaceutical Announces FDA Acceptance of NDA for LP757 (Cabozantinib)

Taipei, Taiwan, 15 July 2026 — Lotus Pharmaceutical Co., Ltd. (Taiwan Stock Exchange: 1795), a leading global pharmaceutical company, today announced that the United States Food and Drug Administration ("US FDA") has accepted for substantive review the New Drug Application ("NDA") for LP757 (cabozantinib) under the 505(b)(2) regulatory pathway. As previously announced1, the NDA was submitted on 23 February 2026 as Lotus' first oral oncology product filed in the United States via the 505(b)(2) pathway. The FDA's acceptance confirms that the application is sufficiently complete to permit a substantive review, with a Prescription Drug User Fee Act (PDUFA) target action date of 23 December 2026.Cabozantinib is a kinase inhibitor indicated for the treatment of patients with advanced renal cell carcinoma (RCC), patients with advanced RCC, as a first-line treatment in combination with nivolumab, patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib, adult patients with previously treated, unresectable, locally advanced or metastatic, well-differentiated pancreatic neuroendocrine tumors (pNET), and adult patients with previously treated, unresectable, locally advanced or metastatic, well-differentiated extra-pancreatic neuroendocrine tumors (epNET) in the United States.

According to IQVIA MAT December 2025 data, U.S. sales of cabozantinib were approximately US$2.0 billion.

Petar Vazharov, Chief Executive Officer of Lotus, commented, "FDA acceptance of the LP757 NDA is a significant milestone for Lotus and reflects the progress of our oncology pipeline. It marks another important step in the regulatory review process while supporting our strategy to expand Lotus' oncology portfolio in the United States."

¹ https://www.lotuspharm.com/en/newsroom/news-page/314

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.