Recently, Zhejiang Doer Biologics Co., Ltd. (hereinafter referred to as "Doer Biologics") , Huadong Medicine Co., Ltd. 's controlled subsidiary, received the Drug Clinical Trial Approval Notice (Notice No.: 2026LP03146) 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, as consolidation therapy, is intended for patients with locally advanced/unresectable (Stage III) non-small cell lung cancer who have not progressed after concurrent/sequential chemoradiotherapy.
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 as consolidation therapy in patients with locally advanced/unresectable (Stage III) non-small cell lung cancer who have not progressed after concurrent/sequential chemoradiotherapy.
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"; in October 2026, it was approved for the clinical study of "in combination with standard chemotherapy for recurrent or metastatic head and neck squamous cell carcinoma."
In August 2026, Doer Biologics submitted to the NMPA a clinical trial application for DR30206 for Injection as consolidation therapy, intended for the treatment of patients with locally advanced/unresectable (Stage III) non-small cell lung cancer who have not progressed after concurrent/sequential chemoradiotherapy, 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 as consolidation therapy, intended for patients with locally advanced/unresectable (Stage III) non-small cell lung cancer who have not progressed after concurrent/sequential chemoradiotherapy, marks another major 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.