Lotus Pharmaceutical Announces TFDA Approval of Zepzelca® (lurbinectedin) in Combination with Immunotherapy as First-Line Maintenance Therapy for ES-SCLC

Taipei, Taiwan, 08 April 2026 — Lotus Pharmaceutical Co., Ltd. (Taiwan Stock Exchange: 1795), a global pharmaceutical company headquartered in Taiwan, today announced that Zepzelca® (lurbinectedin), its licensed oncology product, has received approval from the Taiwan Food and Drug Administration (TFDA) for use in combination with atezolizumab as a first-line maintenance treatment for adult patients with extensive-stage small-cell lung cancer (ES-SCLC).

This approval follows Lotus’s press release dated October 30, 2024 (see https://www.lotuspharm.com/en/newsroom/news-page/44/zepzelca-combo-trial-en), which reported positive results from the Phase III IMforte trial. The TFDA approval is supported by these results, demonstrating that lurbinectedin in combination with atezolizumab significantly improved overall survival (OS) and progression-free survival (PFS) compared to atezolizumab alone. Median OS improved to 13.2 months versus 10.6 months with atezolizumab alone, while PFS more than doubled to 5.4 months versus 2.1 months. This combination, used as a first-line maintenance therapy following induction treatment, offers an important extension of disease control for patients who respond to initial therapy.

This approval positions Zepzelca as the first pharmacological agent approved in Taiwan specifically for use in combination with atezolizumab in the maintenance setting for ES-SCLC. Building on its existing use in second-line treatment, this new indication expands Zepzelca’s role into earlier lines of therapy, marking a meaningful advancement in the management of ES-SCLC, which remains a highly aggressive disease with limited treatment options.

This combination indication has already received regulatory approvals in major markets globally, including the United States. While in Europe, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion on 27 March 2026 recommending the granting of a marketing authorisation for Zepzelca.

Petar Vazharov, Chief Executive Officer of Lotus, commented, “This approval marks a meaningful step in advancing Zepzelca into earlier lines of treatment, allowing us to extend its clinical impact to a broader patient population. We will actively pursue reimbursement approval with Taiwan’s National Health Insurance Administration, in line with our broader commitment to improving patient access to high-quality therapies as well as enhancing the quality of life for patients.”

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.