RemeGen Gets Orphan Drug Designations from FDA for Anti-Cancer Drug RC118

Healthcare Author: Lingxi Peng Editor: Mianmian Wang Dec 09, 2022 06:57 PM (GMT+8)

RC118, an ADC drug targeting Cludin18.2, was granted Orphan Drug designation by FDA for the treatment of gastric cancer and pancreatic cancer


Bio-pharmaceutical company RemeGen Co., Ltd (RemeGen) (Chinese:荣昌生物), announced that FDA has granted two orphan drug designations for RC118 on 8 December. RC118 is RemeGen's self-developed innovative antibody-drug conjugate (ADC) drug targeting Claudin 18.2 for the treatments of gastric cancer (including gastroesophageal junction caner) and pancreatic cancer. RC118 was RemeGen's fourth ADC product that enters clinical trials. It has obtained the approval for its Phase I clinical trial from the Center for Drug Evaluation (CDE) of the National Medical Products Administration in September 2021 and entered Phase I clinical trials in both Australia and China for the treatment of locally advanced unresectable or metastatic solid tumors at the end of 2021. Currently RC118 has been showing safety and tolerability in ongoing dose-escalation studies.

Founded in 2008, RemeGen is a Chinese leading bio-pharmaceutical company with its comprehensive and integrated ADC platform, which supports RemeGene’s integrated production capacities and strong pipelines to produce monoclonal antibodies, bifunctional antibodies, ADC and other innovative drugs. RemeGen has developed more than 20 drug candidates and four drugs has entered into the clinical trial stage or reached the market. Before RC118, two biologic candidates have already gained FDA’s Orphan Drug designation, Telitacicept for the treatment of myasthenia gravis and Disitamab Vedotin for gastric cancer. In addition, Disitamab Vedotin is the first Chinese ADC drug created and developed by RemeGen to receive breakthrough designations in both the United States and China, for the treatment of gastric cancer and urothelial carcinoma had been granted approval by NMPA in 2021.

RemeGen's Competitors include Hengrui Medicine (Chinese:恒瑞医药), Kelun Pharmaceutical (Chinese: 科伦药业), and Tot Biopharm (Chinese: 东曜药业).