Shanghai Henlius Biotech, Inc. announced that, recently, the new drug application (NDA) for new indication of HANSIZHUANG (serplulimab injection) ("HANSIZHUANG"), an innovative anti-PD-1 monoclonal antibody independently
developed by the Company, in combination with carboplatin and etoposide for the first-line treatment of patients with extensive stage small cell lung cancer (ES-SCLC), has been approved by the National Medical Products Administration (the "NMPA"). This is the third indication for HANSIZHUANG approved for marketing in mainland China, and HANSIZHUANG is also the first monoclonal antibody drugs targeting PD-1 approved for first-line treatment of extensive stage small cell lung cancer (ES-SCLC) in the world. HANSIZHUANG is an innovative anti-PD-1 monoclonal antibody independently developed by the Company and was approved for marketing in mainland China in March 2022. As of the date of this announcement, HANSIZHUANG has been approved for three indications in mainland China: (1) the treatment of adult patients with advanced unresectable or metastatic Microsatellite Instability-High ("MSI-H") solid tumours that have failed to respond to the standard therapy; (2) the first-line treatment of patients with unresectable locally advanced or metastatic squamous non-small cell lung cancer (NSCLC) in combination with carboplatin and albumin-bound paclitaxel; and (3) the first-line treatment of patients with extensive stage small cell lung cancer (ES-SCLC) in combination with carboplatin and etoposide. In August 2022, the new drug application (NDA) of HANSIZHUANG in combination with chemotherapy for the first-line treatment of patients with locally advanced/recurrent or metastatic esophageal squamous cell carcinoma (ESCC) was accepted by the NMPA. HANSIZHUANG has been granted orphan-drug designations for the treatment of small cell lung cancer (SCLC) by the United States Food and Drug Administration (FDA) and the European Commission (EC) in April 2022 and December 2022, respectively. In September 2022, the results of a phase 3 study of HANSIZHUANG in combination with chemotherapy as first-line treatment for patients with extensive stage small cell lung cancer (ES-SCLC) were published online in The Journal of American Medical Association (JAMA, impact factor of 157.3), one of the top four medical journals in the world. HANSIZHUANG is planned to be used for the treatment of a variety of solid tumours, and in addition to the indications of the MSI-H solid tumours, squamous non-small cell lung cancer (sqNSCLC) and extensive stage small cell lung cancer (ES-SCLC) which have been approved for marketing, HANSIZHUANG is being undergone clinical studies in 10 combination therapies with it as the core in various countries and regions around the world. The approval was primarily based on a randomised, double-blind, international multicentre phase 3 clinical study. The results indicated that HANSIZHUANG in combination with chemotherapy (Carboplatin-Etoposide) could bring significant benefits against chemotherapy (Carboplatin-Etoposide) in the treatment of previously untreated patients with extensive-stage small cell lung cancer (ES-SCLC), met the pre-defined primary endpoint criteria, and had good safety and tolerability. As of the date of this announcement, in addition to HANSIZHUANG of the Company, monoclonal antibody drugs targeting PD-1 that have been marketed globally include Keytruda« of Merck & Co. Inc., Opdivo« of Bristol-Myers Squibb and Libtayo« of Regeneron Pharmaceuticals, Inc., etc. There is no monoclonal antibody drug targeting PD-1 approved for the treatment of extensive-stage small cell lung cancer (ES-SCLC) worldwide. Monoclonal antibody drugs targeting PD-L1 approved for the treatment of extensive-stage small cell lung cancer (ES-SCLC) worldwide include Imfinzi« of AstraZeneca Pharmaceuticals Co. Ltd. and Tecentriq« of Roche Pharmaceuticals. According to the statistics released by IQVIA MIDASTM (IQVIA is the world's leading provider of professional information and strategic consulting services in the pharmaceutical and healthcare industry), the worldwide sales of the monoclonal antibody drugs targeting PD-1 amounted to approximately USD 28.08 billion and USD 15.99 billion in 2021 and the first half of 2022, respectively.