Shanghai Henlius Biotech, Inc. announced that, recently, the notification for the international multicentre phase 3 clinical trial of HANSIZHUANG (serplulimab injection) ("HANSIZHUANG") in combination with bevacizumab injection and chemotherapy for the first-line treatment of metastatic colorectal cancer (mCRC) submitted to the Pharmaceuticals and Medical Devices Agency (PMDA) of Japan obtained an implied approval. According to the relevant regulations, the related clinical trial is allowed to be commenced in Japan. About HANSIZHHUANG.

HANSIZHUang is an innovative anti-PD-1 monoclonal antibody independently developed by the Company and was approved for marketing in mainland China (excluding Hong Kong, Macau and Taiwan regions, the same as below) in March 2022. As of the date of this announcement, HANSIZHUANSIZHUANG has been approved for four 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; (3) the first- line treatment of patients with extensive-stage small cell lung cancer (ES-SCLC) in combination with Carboplatin and etoposide; and (4) the first-line treatment the patients with PD-L1 positive unresectable locally advanced/recurrent or metastatic esophageal squamous cell carcinoma (ESCC) in combination with drugs containing fluorouracil and platinum. In addition, the new drug application (NDA) for the fifth indication for HANSIZHUanger for the first-line treatment the first-line treatment of non-squamous nonsmall cell lung cancer (nsNSCLC) has also been accepted by the NMPA.

In the international market, HANSIZH UANG has been approved by the Indonesian Food and Drug Authority (BPOM) for the treatment of extensive-stage small cell lung Cancer (ES-SCLC), becoming the first domestic anti-PD-1 monOClonal antibody approved for marketing in Southeast Asia. The marketing authorisation application (MAA) of HANSIZH Uang in the European Union has also been validated by the European Medicines Agency (EMA), and the bridging study in the United States is progressing steadily. The Company is also in the process of advancing a number of clinical studies of HANSIZHuANG and related combination therapies globally, covering a wide range of indications such as lung cancer, esophageal carcinoma, head and neck squamous cell carcinoma, colorectal cancer and gastric cancer.

As of the date of This announcement, HANSI ZHUANG in combination with bevACizumab injection and chemotherapy For the first-line treatment of cancer (mCRC) is in the phase 2/3 clinical trial in mainland China. The data of the phase 2 clinical study demonstrated that the combination therapy improved progression-free survival and other efficacy endpoints with a manageable safety profile. On this basis, the Company plans to conduct the international multicentre phase3 clinical study of the combination therapy.

In addition to being approved in Japan, such international multicentre phase 3clinical study has also completed the first patient dosing in mainland China.