Seoul, South Korea, and Shanghai, China, 2 July 2026 — Alvogen Korea Co., Ltd., ("Alvogen Korea") a wholly owned subsidiary of Lotus Pharmaceutical Co., Ltd. (Taiwan Stock Exchange: 1795), and Shanghai Henlius Biotech (“Henlius”, Hong Kong Stock Exchange: 2696) today announced that SERPLUMA® (serplulimab), a humanized anti-PD-1 monoclonal antibody independently developed by Henlius, has received approval from Korea's Ministry of Food and Drug Safety (MFDS) as first-line therapy of extensive-stage small-cell lung cancer (ES-SCLC), providing a new immuno-oncology treatment option to patients in South Korea.
Under the previously announced exclusive licensing agreement with Henlius, Alvogen Korea holds exclusive commercialisation rights and co-exclusive development rights for SERPLUMA® (serplulimab) in South Korea. Serplulimab became the world’s first commercially available anti-PD-1 therapy for the first-line treatment of ES-SCLC. It has also entered routine use in the National Health Service (NHS) following the UK National Institute for Health and Care Excellence (NICE) recommendation, supporting its value proposition in health technology assessment (HTA)-based healthcare systems.
The MFDS approval was supported by results from the global phase 3 ASTRUM-005 study, a randomized, double-blind trial involving 585 treatment-naïve patients with ES-SCLC. In the study, SERPLUMA® in combination with carboplatin and etoposide demonstrated statistically significant and clinically meaningful improvements in survival outcomes compared with chemotherapy alone. These results underscore the potential of SERPLUMA® to address a significant unmet need in ES-SCLC, a highly aggressive disease with historically poor prognosis and limited therapeutic options.
Final analysis showed a 40% reduction in the risk of death (HR=0.60, 95% CI: 0.49–0.73; p<0.001), with median overall survival of 15.8 months compared with 11.1 months in the control arm, among one of the longest survival outcomes reported in pivotal first-line ES-SCLC studies. At follow-up after 19.8 months, the combination regimen also reduced the risk of disease progression or death by 53% (HR=0.47), with median progression-free survival of 5.8 months versus 4.3 months.
Petar Vazharov, Chief Executive Officer of Lotus, commented, “We are pleased to introduce SERPLUMA®, an innovative anti-PD-1 therapy, to patients in South Korea, bringing a new treatment option for extensive-stage small cell lung cancer, an area that has long faced poor outcomes and limited therapeutic options. Following this approval, we will focus on pursuing reimbursement and enhancing treatment accessibility so that more patients in need can benefit from this important therapy. We also look forward to further expanding our oncology portfolio and strengthening our position as a trusted partner in improving patients’ quality of life.”
Ping Cao, Chief Business Development Officer and Senior Vice President of Henlius, said, “This approval further reflects Henlius’ commitment to advancing our Globalization 2.0 strategy by bringing innovative medicines to patients worldwide. We are delighted to partner with Lotus to introduce serplulimab to eligible patients with ES-SCLC in Korea. We believe innovation creates value only when it reaches patients, and we will continue working with partners around the world to expand access to more treatment options.”
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