SHANGHAI, Sept. 18, 2021 /PRNewswire/ — The 24th Annual Meeting of Chinese Society of Clinical Oncology (CSCO) will be held online and in-person from 25th to 29thSeptember 2021. In this meeting, Henlius will release 4 study results of 2 products to be commercialized, the novel anti-PD-1 mAb serplulimab and the bevacizumab biosimilar HLX04. The study results will all be reported in oral presentations.
Serplulimab injection is an innovative anti-PD-1 mAb independently developed by Henlius. In April, the New Drug Application (NDA) of serplulimab injection for the treatment of microsatellite instability-high (MSI-H) solid tumours was accepted by the National Medical Products Administration (NMPA) and granted priority review, which is expected to be approved in the first half of 2022. With the “Combo+Global” strategy, serplulimab has been approved for clinical trials in China, the United States, the European Union, as well as other countries and regions. To evaluate the safety and efficacy of serplulimab, Henlius has conducted 10 immuno-oncology therapy clinical studies covering cancers with high incidence rates, including lung cancer, esophageal cancer, hepatocellular cancer, gastric cancer, head and neck cancer, etc. Up to date, about 2300 patients have been enrolled worldwide, proving that the quality of serplulimab has built trust in foreign markets. Clinical data of 3 serplulimab indications will be presented in the meeting, including MSI-H solid tumours, hepatocellular carcinoma (HCC), cervical cancer (CC). And the phase 2 clinical study for advanced HCC has been selected for the Innovation Session due to its excellent results.
HLX04 is a bevacizumab biosimilar developed by Henlius independently. The NDA of HLX04 was accepted by NMPA in September 2020 and is expected to be approved in Q4 2021. Unlike the marketed products in China, mCRC was explored in the phase 3 clinical study of HLX04, making HLX04 the only bevacizumab biosimilar holding mCRC clinical data in China.
Details of these studies are as follows:
Title: Phase 2 study of HLX10, a novel anti-PD-1 antibody, in patients with previously treated unresectable or metastatic microsatellite instability-high or mismatch repair-deficient solid tumours (ID: 9951)Co-Leading PI: Shukui Qin, Chinese People’s Liberation Army Cancer Center of Nanjing Bayi Hospital; Jin Li, Shanghai East Hospital, Tongji UniversityForm: Oral presentationPresenter: Ye Guo, Shanghai East Hospital, Tongji UniversityTime: 2021.09.26 17:15–17:23, Parallel Session 6, Immunotherapy session
Title: Phase 2 study of HLX10 (a novel anti-PD-1 antibody) plus HLX04 (an anti-VEGF antibody) in patients with advanced hepatocellular carcinoma (ID: 9949)Co-Leading PI: Jia Fan, Zhongshan Hospital, Fudan University; Zhenggang Ren, Zhongshan Hospital, Fudan UniversityForm: Oral presentationPresenter: Zhenggang Ren, Zhongshan Hospital, Fudan UniversityTime: 2021.09.28 15:00–15:10, Main Session, Innovation session 2 (Shanghai)
Title: Phase 2 study of HLX10 (a recombinant humanised anti-PD-1 monoclonal antibody) plus albumin-bound paclitaxel in patients with advanced cervical cancer who have progressive disease or intolerable toxicity after first-line standard chemotherapy (ID: 9943)Leading PI: Lingying Wu, Cancer Hospital Chinese Academy of Medical SciencesForm: Oral presentationPresenter: Jusheng An, Cancer Hospital Chinese Academy of Medical SciencesTime: 2021.09.26 15:24 –15:30, Parallel Session 5, Cervical and endometrial cancer session
Title: HLX04 (a bevacizumab biosimilar candidate) versus reference bevacizumab in combination with XELOX or mFOLFOX6 as first-line therapy for metastatic colorectal cancer: a randomised, double-blind phase 3 study (ID: 9949)Co-Leading PI: Shukui Qin, Chinese People’s Liberation Army Cancer Center of Nanjing Bayi Hospital; Jin Li, Shanghai East Hospital, Tongji UniversityForm: Oral presentationPresenter: Ye Guo, Shanghai East Hospital, Tongji UniversityTime: 2021.09.26 10:27 –10:34, Parallel Session 3, Colorectal cancer immunotherapy session 2