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 humanised 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 for 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 randomised, 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.”
Founded in 1966, Lotus (1795: TT) is an international pharmaceutical company with a global presence, focused on commercialising 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.
Shanghai Henlius Biotech, Inc. (2696.HK) is a global, innovation-driven biopharmaceutical company committed to delivering high-quality, affordable biologic therapies to patients worldwide. The Company focuses on major disease areas including oncology, autoimmune diseases, and ophthalmic diseases. Founded in 2010, Henlius has established an integrated, end-to-end biopharmaceutical platform encompassing global R&D, clinical operations, regulatory affairs, manufacturing, and commercialisation. The Company employs nearly 4,000 people globally and operates across multiple regions, including China, the United States, and Japan. Leveraging the stable cash flow generated from its biosimilar portfolio to support innovation, Henlius is steadily advancing into its “Globalisation 2.0” phase, building a scalable and sustainable global growth model. Guided by a patient-centred mission, Henlius remains focused on addressing unmet medical needs and translating scientific innovation into meaningful clinical value and patient access, contributing sustainably to the global biopharmaceutical ecosystem.
To learn more about Henlius, visit https://www.henlius.com/en/index.html and connect with us on LinkedIn at https://www.linkedin.com/company/henlius/.
Yihsuan Kuo, Investor Relations Assistant Manager
Jeffrey Tsang, Head of Investor Relations and Corporate Communications
+886 2 2700 5908
investor@lotuspharm.com
Janice Han, jiayi_han@henlius.com
Bella Zhou, wenting_zhou@henlius.com
Venus Hu, junyan_Hu@henlius.com
