Comprehensive Overview

The group is a clinical biopharmaceutical company. The management team and main business (including clinical development, regulatory access and business development) are located in China and the United States, and the discovery, R&D, arts and crafts development and production team are all located in China. The group's drug discovery and global development capabilities enable it to develop innovative and promising diversified antibody pipelines in the fields of tumors, kidney disease and bone diseases. At present, the group has independently discovered and developed eight of the nine drug candidates, including proven, partially proven, and novel biopathways. The Interim Group has 1 core product: MSB2311, a humanized PD-L1 monoclonal antibody (monoclonal) candidate for TMB-H celiac tumors.

Risk Factors

The time required for the National Drug Administration, FDA, EMA, or other similar regulatory body to obtain approval is inherently difficult to estimate and determined by many factors, including the regulatory agency's significant discretion. If the group is eventually unable to obtain regulatory approval for the candidate drug, the business will be seriously damaged. In addition, COVID-19 has had adverse effects on group operations, including the delay of the phase 1 clinical trial of TST001 for patients with solid tumors in the US. Many of the raw materials and excipients used to produce the Group's clinical products were imported from the US. COVID-19 caused supply chain disruptions, and the overall delivery cycle was greatly extended, or even two to three times longer.