Recently, Zhejiang Doer Biologics Co., Ltd. (hereinafter referred to as “Doer Biologics”) received the “Drug Clinical Trial Approval Notice” (Notice No.: 2026LP00516) approved and issued by the National Medical Products Administration (NMPA). The clinical trial application for DR30206 Injection submitted by Doer Biologics has been approved. The indicated usage is: This product in combination with standard chemotherapy is intended for patients with locally advanced or metastatic non-small cell lung cancer.
DR30206 Injection is a Class 1 therapeutic biological product independently developed by Doer Biologics and possessing global intellectual property rights. DR30206 is an antibody fusion protein targeting PD-L1, VEGF, and TGF-β. It works by blocking the PD-1/PD-L1 signaling pathway to restore the proliferation of exhausted CD8+ T cells, and by specifically binding to free VEGF and TGF-β to reduce tumor neovascularization while alleviating immunosuppression, thereby achieving the goal of tumor treatment. Results from completed non-clinical studies and the ongoing Phase I clinical trial indicate that DR30206 has a clear mechanism of action and exhibits tumor growth inhibition effects with a favorable safety profile, supporting the initiation of clinical trials for DR30206 combined with standard chemotherapy in patients with locally advanced or metastatic non-small cell lung cancer.
The first clinical trial of DR30206 Injection in China was approved by the NMPA in June 2023 for advanced solid tumors, and in April 2025, it received approval for clinical research "in combination with standard chemotherapy for advanced or metastatic digestive tract tumors."
In December 2025, Doer Biologics submitted a clinical trial application to the NMPA for DR30206 Injection combined with standard chemotherapy in the treatment of patients with locally advanced or metastatic non-small cell lung cancer. The application was accepted and has recently been approved, granting permission to conduct clinical trials for this product.
To date, there is no antibody fusion protein drug simultaneously targeting PD-L1, VEGF, and TGF-β marketed globally. The recent approval of the clinical trial in China for DR30206 Injection combined with standard chemotherapy in patients with locally advanced or metastatic non-small cell lung cancer represents another significant advancement in the R&D process of this new drug. In the future, the company will continue to fully advance the clinical development and registration work of this product, striving to provide more treatment options for a broader patient population.