CStone Pharmaceuticals announced receipt of a Good Clinical Practice (GCP) inspection notification from the European Medicines Agency (the "EMA") regarding the marketing authorization application (MAA) for sugemalimab in combination with chemotherapy as a first-line treatment for metastatic non-small cell lung cancer (NSCLC). The EMA and the Medicines and Healthcare products Regulatory Agency in the United Kingdom (the "U.K. MHRA") have both accepted applications for sugemalimab combinational therapy as a first-line treatment For metastatic NSCLC, and the two MAAs are currently under review. The receipt of the GCP inspection notification, as anticipated, indicates that the sugemalimab registration process is progressing steadily at the EMA.

CStone has been maintaining smooth communications with the EMA since the MAA acceptance and will continue to work closely with the Agency and investigators to ensure successful inspections. Until the date of this announcement, sugemalimab has achieved success in five registrational clinical trials, covering indications of stage III NSCLC, stage IV NSCLC, lymphoma, gastric cancer, and esophageal cancer. The clinical data of sugemalimab have been presented at multiple international academic conferences and published in top-tier journals such as The Lancet Oncology, Journal of Clinical Oncology, Nature Cancer, etc.

Given its outstanding clinical results from multiple pivotal trials, the board of the Company believes that sugemalimab holds great potential for the global market. CStone will continue to engage health authorities, such as the EMA, the U.K. MHRA and the U.S. Food and Drug Administration. Meanwhile, CStone is actively exploring partnership for the development and commercialization of sugemalimab outside of Greater China.