• HANSIZHUANG (serplulimab) is the world's first anti-PD-1 monoclonal antibody (mAb) approved for the first-line treatment of small cell lung cancer (SCLC)
• Serplulimab has been approved in 30+ markets including China, Europe, and Southeast Asia, benefiting 100,000+ patients
• Orphan Drug Designation (ODD) granted to serplulimab for the treatment of SCLC by U.S. FDA, EC, and Swissmedic, and for Extensive-Stage SCLC (ES-SCLC) by Korea MFDS
Shanghai, China, April 25, 2025 - Shanghai Henlius Biotech, Inc. (2696.HK) today announced it has entered into a license agreement with the wholly-owned subsidiary of Lotus Pharmaceutical Co. Ltd. (TWSE Stock code: 1795), Alvogen Korea Co., Ltd. (“Lotus”), granting Lotus exclusive license for the commercialization and co-exclusive for the development of Henlius’ independently developed anti-PD-1 mAb HANSIZHUANG (serplulimab, trade name: Hetronifly® in Europe) in South Korea for several indications including ES-SCLC. In March 2025, serplulimab was granted orphan drug designation for the treatment of ES-SCLC by the Korean Ministry of Food and Drug Safety (MFDS).
Lotus has a solid track record for oncology, immunology, and central nervous system (CNS) therapies, bringing extensive regional commercialization expertise across Asia. Under the agreement, Henlius will be responsible for post-approval manufacturing and supply upon launch in South Korea and will receive a $5 million upfront payment, up to $9.5 million in regulatory milestones, up to $97.5 million in commercial sales milestones, and double-digit royalties on annual net sales from Lotus in the licensed territory.
Ping Cao, Senior Vice President and Chief Business Development Officer of Henlius, said, “This collaboration with Lotus marks a pivotal step in Henlius’ ongoing commitment to global expansion. Lotus’ proven commercialisation expertise and agile execution capabilities in the Korean market will accelerate the introduction of serplulimab to local patients. By synergizing our complementary strengths, we aim to deliver high-quality, affordable innovative therapies to Korean patients and further solidify our strategic footprint across Asia.”
Petar Vazharov, Chief Executive Officer of Lotus Pharmaceutical, continued, “We are thrilled to partner with Henlius to bring serplulimab, a promising immuno-oncology therapy, to patients in South Korea. This collaboration marks a significant milestone in our continued efforts to expand our oncology footprint across Asia. The recent orphan drug designation granted by the MFDS underscores the potential of serplulimab to address critical unmet needs in small cell lung cancer. We look forward to working closely with Henlius to accelerate access to this innovative therapy and improve outcomes for patients in Korea.”
Serplulimab is the first anti-PD-1 mAb for the first-line treatment of SCLC and has been approved in China, EU and several Southeast Asian countries. Focusing on lung and gastrointestinal cancer, the synergy of serplulimab with in-house products of the company and innovative therapies are being actively promoted. Up to date, serplulimab has been approved by the National Medicinal Products Administration (NMPA) for the treatment of squamous non-small cell lung cancer (sqNSCLC), ES-SCLC, esophageal squamous cell carcinoma (ESCC) and non-squamous non-small cell lung cancer (nsNSCLC). Beyond South Korea, serplulimab was granted orphan drug designations by the United States Food and Drug Administration (FDA), the European Commission (EC), and the Swiss Agency for Therapeutic Products (Swissmedic) for the treatment of SCLC, and its bridging head-to-head trial in the United States to compare HANSIZHUANG to standard of care atezolizumab (anti-PD-L1 mAb) for the first-line treatment of ES-SCLC is well under way.
In the meantime, Henlius pro-actively advances the commercialisation of serplulimab in global markets at high speed. To date, HANSIZHUANG has been licensed out to more than 100 countries and regions including the U.S., Europe, Southeast Asia, the Middle East, and North Africa. In the future, Henlius will join hands with its international partners to make full use of their respective resources and advantages to actively promote the development and commercialisation of serplulimab globally, to enable it to cover a wider range of countries and regions and to provide more therapeutic choices for more patients.
About Lotus Pharmaceutical
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.
