Recently, Zhejiang Doer Biologics Co., Ltd. (hereinafter referred to as "Doer Biologics"), a controlled subsidiary of Huadong Medicine Co., Ltd., received the Drug Clinical Trial Approval Notice (Notice No.: 2026LP03086) approved and issued by the National Medical Products Administration (NMPA). The clinical trial application for DR30206 for Injection submitted by Doer Biologics has been approved, with the indication: this product, in combination with standard chemotherapy, is intended for the treatment of patients with 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 free VEGF and TGF-β, it reduces tumor neovascularization while relieving immunosuppression, thereby achieving the purpose of treating tumors. Completed non-clinical studies and ongoing Phase I clinical trials have shown that DR30206 has a well-defined mechanism of action and tumor growth inhibitory effects, with a favorable safety profile, supporting the conduct of clinical trials of DR30206 in combination with standard chemotherapy in patients with locally advanced or metastatic non-small cell lung cancer.
The first clinical trial of DR30206 for Injection in China was approved by the NMPA in June 2023, with the indication of advanced solid tumors; in April 2025, it was approved for the clinical study of "in combination with standard chemotherapy for advanced or metastatic gastrointestinal tumors"; in February 2026, it was approved for the clinical study of "in combination with standard chemotherapy for patients with locally advanced or metastatic non-small cell lung cancer."
DR30206 has completed the Phase Ib dose expansion enrollment for first-line non-small cell lung cancer and is currently advancing subsequent expansion or combination therapy studies. Concurrently, a Phase Ib clinical study of monotherapy for head and neck squamous cell carcinoma, a Phase Ib/IIa clinical study of combination therapy for advanced or metastatic gastrointestinal tumors, and a Phase Ib/II clinical study of combination therapy for locally advanced or metastatic non-small cell lung cancer are being actively conducted.
In July 2026, Doer Biologics submitted to the NMPA a clinical trial application for DR30206 for Injection in combination with standard chemotherapy for the treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma, which was accepted and recently approved, agreeing to the conduct of clinical trials of this product.
As of now, there is no antibody fusion protein drug simultaneously targeting PD-L1, VEGF, and TGF-β approved for marketing worldwide. The approval of the clinical trial in China for DR30206 for Injection in combination with standard chemotherapy for patients with recurrent or metastatic head and neck squamous cell carcinoma marks another important milestone in the development process of this novel drug and will further enhance the company's core competitiveness in the field of oncology treatment. In the future, the company will continue to fully advance the clinical development and registration of this product, striving to provide more treatment options for patients in need!