On the 25th, Lotus Pharmaceutical announced that its wholly owned subsidiary, Alvogen Korea, has signed an exclusive licensing and collaboration agreement with Shanghai Henlius Biotech, Inc. Under the terms of the agreement, Alvogen Korea will obtain exclusive commercialization rights in South Korea for Henlius’ independently developed anti-PD-1 monoclonal antibody, HANSIZHUANG (serplulimab, marketed as Hetronifly® in Europe), across multiple cancer indications, including extensive-stage small cell lung cancer (ES-SCLC). The agreement also includes co-development rights.

In March 2025, the South Korean Ministry of Food and Drug Safety (MFDS) officially designated serplulimab as an orphan drug for the treatment of ES-SCLC.

Petar Vazharov, General Manager of Lotus Pharmaceutical, stated that this partnership marks an important step in expanding the company’s oncology footprint in Asia. The MFDS’s orphan drug designation for serplulimab further underscores the shared commitment of both companies to improving the treatment landscape for small cell lung cancer.

Ping Cao, Senior Vice President and Head of Global Business Development at Henlius, noted that Lotus brings outstanding commercialization capabilities and agile execution, which will significantly accelerate the market entry of serplulimab in South Korea. He expressed confidence that the complementary strengths of both companies will deliver high-quality, affordable, and innovative therapies to patients in South Korea.

Serplulimab is the first anti-PD-1 monoclonal antibody approved for first-line treatment of small cell lung cancer. It has already received marketing approval in China, the European Union, and several Southeast Asian countries. The product is primarily indicated for the treatment of lung and gastrointestinal cancers and is also being evaluated in combination studies with other products and innovative therapies.

To date, serplulimab has received approval from the National Medical Products Administration (NMPA) in China for several indications, including squamous non-small cell lung cancer (sqNSCLC), ES-SCLC, esophageal squamous cell carcinoma (ESCC), and non-squamous non-small cell lung cancer (nsNSCLC). Additionally, it has been granted orphan drug designation for the treatment of small cell lung cancer by the U.S. Food and Drug Administration (FDA), the European Commission (EC), and Swissmedic.

Resource: 引進抗PD-1單株抗體新藥進南韓 美時、上海復宏漢霖簽訂授權協議