Taipei, Taiwan, May 26, 2025 — Lotus Pharmaceuticals (“Lotus”, TWSE Stock Code: 1795) announces a significant strategic advancement with the approval of bosutinib by the Taiwan Food and Drug Administration (TFDA). Bosutinib, developed in-house at Lotus, is a second-generation tyrosine kinase inhibitor (TKI) for the treatment of chronic myeloid leukemia (CML). According to IQVIA, the market size for CML treatment in Taiwan in 2023 was approximately US$100 million.
Bosutinib addresses an unmet need for effective second-line treatment option as it is indicated for adult patients with newly diagnosed chronic-phase Philadelphia chromosome-positive (Ph+) CML, as well as those with resistance or intolerance to prior TKI therapies.
Bosutinib was approved through Taiwan's New Chemical Entity 2 (NCE-2) pathway, reflecting the TFDA’s recognition of its innovative mechanism and clinical benefit in CML treatment.
Petar Vazharov, CEO of Lotus, commented: "Securing TFDA approval for bosutinib marks a pivotal moment for Lotus, demonstrating our strong R&D capabilities in cutting-edge oncology treatments, as well as our ability to navigate regulatory pathways. The increasing prevalence of CML and the growing demand for advanced treatment options make bosutinib a valuable addition to Lotus's oncology pipeline, contributing to the company's long-term growth strategy and enhancing value for our shareholders.”
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
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