Doer Biologics, a Subsidiary of Huadong Medicine, Announces First Patient Dosed in Phase Ib Trial of DR30206 for Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

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 "Drug 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 patient was dosed in the Phase Ib clinical trial for the treatment of non-small cell lung cancer. On April 3, 2025, Doer Biologics received another "Drug 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. On June 11, 2025, the first patient was dosed in this trial.

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.

DR30206 Ib Phase Single-Agent Expansion Cohort of Head and Neck Squamous Cell Carcinoma (HNSCC) plans to enroll patients with histologically and/or cytologically confirmed recurrent or metastatic HNSCC (according to the 8th edition staging system of the Union for International Cancer Control and the American Joint Committee on Cancer) that is not curable by local treatment. The primary tumors are located in the oral cavity, oropharynx, hypopharynx, or larynx; patients should have received no more than one prior line of systemic anti-tumor therapy at the recurrent or metastatic stage (patients who have not received systemic anti-tumor therapy are required to have a tumor tissue sample confirmed by the central laboratory with a PD-L1 CPS ≥1).

More information about the Phase I clinical trial of DR30206 in China can be found on the Drug Clinical Trial Registry and Information Disclosure Platform (Registration numbers: CTR20233502, CTR20251945).