Taipei, Taiwan, April 25, 2025 —Lotus Pharmaceutical Co., Ltd. (“Lotus”, TWSE Stock Code: 1795) today announced that its wholly owned subsidiary, Alvogen Korea Co., Ltd. (“Alvogen Korea”), has entered into an exclusive license agreement with Shanghai Henlius Biotech, Inc. (2696.HK), granting Alvogen Korea exclusive rights for the commercialization and co-exclusive rights for the development of Henlius’ independently developed anti-PD-1 monoclonal antibody, HANSIZHUANG (serplulimab, trade name: Hetronifly® in Europe), in South Korea for several indications, including extensive-stage small cell lung cancer (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).
Petar Vazharov, Chief Executive Officer of Lotus Pharmaceutical, commented:
"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 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.”
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’s proven commercialization 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.”
Serplulimab is the first anti-PD-1 mAb for the first-line treatment of small cell lung cancer (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.
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.
Media Inquiries:
Yu-ying Yang, Associate Director, Corporate communication.
+886 2 2700 5908
investor@lotuspharm.com
About Henlius
Henlius (2696.HK) is a global biopharmaceutical company with the vision to offer high-quality, affordable and innovative biologic medicines for patients worldwide with a focus on oncology, autoimmune diseases and ophthalmic diseases. Up to date, 6 products have been launched in China, 4 have been approved for marketing in overseas markets, and 5 marketing applications have been accepted for review in China, the U.S. and the EU, respectively. Since its inception in 2010, Henlius has built an integrated biopharmaceutical platform with core capabilities of high-efficiency and innovation embedded throughout the whole product life cycle including R&D, manufacturing and commercialization. It has established global innovation centre and Shanghai-based commercial manufacturing facilities certificated by China, the EU and U.S. GMP.
Henlius has pro-actively built a diversified and high-quality product pipeline covering about 50 molecules and has continued to explore immuno-oncology combination therapies with proprietary HANSIZHUANG (anti-PD-1 mAb) as the backbone. To date, the company's launched products include HANLIKANG (rituximab), the first China-developed biosimilar, HANQUYOU (trastuzumab, trade name: HERCESSI™ in the U.S., Zercepac® in Europe), a China-developed mAb biosimilar approved in China, Europe and U.S., HANDAYUAN (adalimumab), HANBEITAI (bevacizumab), HANSIZHUANG (serplulimab, trade name: Hetronifly® in Europe), the world’s first anti-PD-1 mAb for the first-line treatment of SCLC, and HANNAIJIA (neratinib). What’s more, Henlius has conducted over 30 clinical studies for 19 products, expanding its presence in major markets as well as emerging markets.
Media Inquiries:
Bella Zhou, Senior Director, Public Relations
wenting_zhou@henlius.com
Janice Han, Associate Director, Public Relations
jiayi_han@henlius.com