Hangzhou, China – November 20, 2025 – Zhejiang Doer Biologics Co., Ltd. ("Doer Biologics"), a clinical-stage biopharmaceutical company focused on developing innovative biotherapeutics for metabolic diseases and cancer, and a controlled subsidiary of Huadong Medicine Co., Ltd., today announced that the first patient has been successfully dosed in the monotherapy expansion – head and neck squamous cell carcinoma (HNSCC) cohort of the Phase Ib clinical trial for its innovative tri-specific drug candidate, DR30206. The dosing was conducted at West China Hospital of Sichuan University.
DR30206 for Injection is a Class 1 therapeutic biologic product independently developed by Doer Biologics with global intellectual property rights. DR30206 is an antibody fusion protein targeting PD-L1, VEGF, and TGF-β. It is designed to kill tumors 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 angiogenesis and alleviate immune suppression.
On June 28, 2023, Doer Biologics received a Drug Clinical Trial Approval Notice from the National Medical Products Administration (NMPA) approving the Investigational New Drug (IND) application for DR30206 for Injection to conduct clinical trials for the treatment of patients with advanced solid tumors. Subsequently, on April 16, 2025, the first patient was dosed in the Phase Ib trial cohort for non-small cell lung cancer (NSCLC). On April 3, 2025, Doer Biologics received another NMPA approval for a clinical trial of DR30206 in combination with standard chemotherapy for the treatment of patients with advanced or metastatic gastrointestinal tumors, and the first patient for this combination therapy was dosed on June 11, 2025.
Completed non-clinical studies have demonstrated that DR30206 has a clear mechanism of action and exhibits tumor growth inhibition activity. The ongoing Phase Ia dose-escalation and Phase Ib expansion stage clinical trials have observed a favorable safety profile and preliminary anti-tumor efficacy signals for DR30206.
The Phase Ib monotherapy expansion HNSCC cohort plans to enroll patients with histologically and/or cytologically confirmed recurrent or metastatic HNSCC (according to the UICC/AJCC 8th edition staging system) that is not curable by local therapy. Primary tumors must be located in the oral cavity, oropharynx, hypopharynx, or larynx. Patients must have received no more than one prior line of systemic anti-tumor therapy for the recurrent or metastatic disease. (For patients who have not received prior systemic anti-tumor therapy, tumor tissue samples must be confirmed by a central laboratory to have a PD-L1 Combined Positive Score (CPS) ≥1).
Dr. Yanshan Huang, Founder and CEO of Doer Biologics, commented, "DR30206 is an innovative tri-specific biologic drug designed, engineered, and developed using Doer Biologics' proprietary SMART-VHHBody and MultipleBody® platform technologies. It demonstrates high affinity and good specificity for all three targets: PD-L1, VEGF, and TGF-β. Non-clinical studies have shown that DR30206 exhibits potent anti-tumor activity across multiple different solid tumor-related models."
Dr. Yongliang Fang, Chief Operating Officer of Doer Biologics, remarked, "We are encouraged by the progress of the ongoing Phase Ib clinical study of DR30206. The ongoing Phase Ia dose-escalation and Phase Ib expansion trials have demonstrated favorable tolerability in humans and preliminary anti-tumor efficacy signals in patients with various types of solid tumors. The enrollment and dosing of the first patient in this Phase Ib HNSCC expansion cohort at West China Hospital of Sichuan University represents another significant milestone in the clinical development of DR30206. Recent scientific advances globally also highlight the importance of targeting TGF-β in the treatment of recurrent or metastatic HNSCC. We look forward to the potential of DR30206 to provide a new treatment option for HNSCC patients in the future."
For more information on the Phase I clinical trials of DR30206 in China, please refer to the Drug Clinical Trial Registration and Information (Registration Numbers: CTR20233502, CTR20251945).