Shanghai Henlius Biotech, Inc., a global biopharmaceutical company, announced that the United States Food and Drug Administration (FDA) has granted Orphan-Drug Designation (ODD) for Hansizhuang (serplulimab) for the treatment of small cell lung cancer (SCLC). This is the first such designation granted to Hansizhuang.
The ODD granted by the FDA is beneficial for the continuous development of Hansizhuang and the enjoyment of certain policy support in terms of registration and commercialization in the United States. The company plans to file its NDA in China and MAA in the EU in 2022, making Hansizhuang potentially to be the world's first PD-1 inhibitor for the first-line treatment of SCLC.
Orphan drugs refer to pharmaceutical products developed for the prevention, diagnosis, and treatment of rare diseases or conditions affecting fewer than 200,000 people in the US at the time of designation and to offer certain policy support, including but not limited to: 1) tax credits for clinical trial costs; 2) waiver of application fees for new drugs; and 3) seven years of market exclusivity without being affected by patent.
According to GLOBOCAN 2020, lung cancer (LC) is the second most common cancer around the world. There were 2.2 million new LC cases and 1.8 million new deaths in 2020 worldwide, and LC is the leading cause of cancer deaths. SCLC accounts for 15%
