On 2 September 2024, Shanghai Henlius Biotech announced that China’s National Medical Products Administration (NMPA) has approved an investigational new drug application (IND) for a clinical trial of HLX17, biosimilar to MSD’s Keytruda® (pembrolizumab). Henlius reports that its independently developed HLX17 is intended for the same indications as Keytruda®.
A number of pembrolizumab biosimilars have entered clinical trials this year, including Celltrion’s CT-P51 (Ph 3 trial plan approved by FDA in August 2024), Formycon’s FYB205 (Ph 3 in NSCLC commenced 30 July 2024; Ph I in malignant melanoma commenced June 2024), Bio-Thera’s BAT3306 (Ph 1/3 in nsNSCLC commenced 25 July 2024), Amgen’s ABP 234 (Ph 3 in nsNSCLC initiated May 2024), Samsung Bioepis’ SB27 (Ph 3 in metastatic nsNSCLC commenced April 2024) and Sandoz’s GME751 (Ph 1 and 3 commenced in April/May 2024).