Henlius (02696.HK) announced on July 2 that the notification of the international multicenter phase 3 clinical trial of Hansitu (sludalimumab injection) combined with bevacizumab injection and chemotherapy as first-line treatment for metastatic colorectal cancer (mCRC), which was submitted to the Pharmaceutical and Medical Devices Agency (PMDA) of Japan, has received tacit approval and relevant clinical trials can be conducted in Japan in accordance with relevant regulations.

Hansitu is an innovative PD-1 antibody independently developed by the company, which was approved for marketing in Mainland China (excluding Hong Kong, Macao and Taiwan) in March 2022. As of the date of announcement, Hansitu has been approved for four indications in Mainland China: (1) for the treatment of adult advanced solid tumors with microsatellite instability-high (MSI-H) who have failed standard treatment and are unresectable or metastatic; (2) combined with cisplatin and albumin-bound paclitaxel for first-line treatment of locally advanced or metastatic squamous non-small cell lung cancer (NSCLC) who are not suitable for surgical resection; (3) combined with cisplatin and etoposide for first-line treatment of extensive-stage small cell lung cancer (ES-SCLC); and (4) combined with fluorinated pyrimidine and platinum drugs for first-line treatment of unresectable locally advanced/recurrent or metastatic esophageal squamous cell carcinoma (ESCC) with PD-L1 positivity. In addition, the NDA for Hansitu's fifth indication, first-line treatment of non-squamous NSCLC, has also been accepted by the National Medical Products Administration (NMPA). In the international market, Hansitu has been approved by Indonesia's Food and Drug Administration (BPOM) for the treatment of extensive-stage small cell lung cancer (ES-SCLC), making it the first domestically produced PD-1 antibody approved for marketing in Southeast Asian countries. Its marketing authorization application (MAA) in the European Union has also been accepted by the European Medicines Agency (EMA), and bridging trials in the United States are steadily advancing. The company is also systematically conducting multiple clinical trials of Hansitu and related combination therapies worldwide, which cover a wide range of indications such as lung cancer, esophageal cancer, head and neck squamous cell carcinoma, colorectal cancer and gastric cancer.

As of the date of announcement, the phase 2/3 clinical trial of Hansitu combined with bevacizumab injection and chemotherapy as first-line treatment for metastatic colorectal cancer (mCRC) is underway in mainland China. Data from phase 2 clinical studies have shown that the combination regimen can improve patients' progression-free survival and other efficacy indicators, and its safety is controllable. On this basis, the company plans to conduct an international multicenter phase 3 clinical study of the combination regimen. In addition to its approval in Japan, the first patient has also been dosed with this combination regimen in the international multicenter phase 3 clinical study conducted in mainland China.