Doer Biologics Announces First Patient Dosed in Ib/IIa Clinical Trial of DR30206 in Combination with Standard Chemotherapy for Advanced or Metastatic Gastrointestinal Cancers

DR30206 for Injection is a Class 1 therapeutic biologic independently developed by Doer Biologics with global intellectual property rights. DR30206 is an antibody fusion protein targeting PD-L1, VEGF, and TGF-β. By blocking the PD-1/PD-L1 signaling pathway, it restores the proliferation of exhausted CD8+T cells; by specifically binding to free VEGF and TGF-β, it reduces the formation of tumor neovascularization while relieving immunosuppression, thereby achieving the purpose of killing tumors.

On June 28, 2023, Doer Biologics received the "Clinical Trial Approval Notice" issued by the National Medical Products Administration (NMPA). The clinical trial application for injectable DR30206 was approved, allowing DR30206 to proceed with clinical trials for the treatment of patients with advanced solid tumors. On April 16, 2025, the first subject was dosed in the Phase Ib clinical trial for non-small cell lung cancer treatment. On April 3, 2025, Doer Biologics received another "Clinical Trial Approval Notice" from the NMPA, approving DR30206 to conduct clinical trials in combination with standard chemotherapy for the treatment of patients with advanced or metastatic gastrointestinal tumors.

The completed non-clinical studies have demonstrated that DR30206 has a clear mechanism of action and activity in inhibiting tumor growth. The ongoing Phase Ia dose-escalation and Phase Ib expansion clinical trials have both observed good safety and preliminary anti-tumor efficacy signals for DR30206.

The Phase Ib clinical study of DR30206 in combination with standard chemotherapy for the treatment of patients with advanced or metastatic gastrointestinal tumors plans to enroll patients with histologically or cytologically confirmed unresectable locally advanced or metastatic colorectal cancer, or who have progressed after receiving first-line chemotherapy with or without targeted therapy or immunotherapy. The Phase IIa clinical study plans to enroll colorectal cancer patients who have not previously received systemic chemotherapy or who have progressed after receiving first-line chemotherapy with or without targeted therapy or immunotherapy, as well as other patients with gastrointestinal tumors.