Boan Biotech Announces CDE Acceptance of Phase Ⅱ Clinical Trial Application for BA1106 in Combination with BA1104 for NSCLC

Yantai, April 4th, 2026 –- Boan Biotech announced today that the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) has accepted the application for a Phase Ⅱ clinical trial of its proprietary anti-CD25 antibody BA1106 in combination with its PD-1 inhibitor (a nivolumab biosimilar injection coded BA1104)  as first-line or second-line regimens for non-small cell lung cancer (NSCLC). 

The Phase Ⅱ clinical trial is a multicenter, single-arm, open-label study designed to evaluate the efficacy, safety, and pharmacokinetic (PK) profile of BA1106 in combination with BA1104 in patients with driver gene-negative NSCLC.

Lung cancer remains one of the most prevalent malignancies in the world, and NSCLC accounts for 85% to 90% of all cases¹.  Among patients with NSCLC, approximately 40% to 50% are driver gene-negative, and their number is steadily increasing². Although the advent of immune checkpoint inhibitors (ICIs) has significantly improved patient outcomes, most patients will eventually develop drug resistance. For them, the lack of effective treatment options following disease progression is a critical unmet need.¹

Present across various solid tumors, regulatory T cells (Tregs) are critical immunosuppressive components of the tumor microenvironment, where high infiltration typically correlates with poor clinical outcomes. As such, targeting Tregs has become a focal point of next-generation cancer immunotherapy. BA1106 is the first investigational non-IL-2-blocking anti-CD25 (IL-2Rα) antibody in China to initiate clinical trials for the treatment of solid tumors. With “moderate” ADCC activity and a unique binding epitope design, BA1106 selectively targets CD25-overexpressing Tregs. While depleting Tregs, it expands effector T cell(Teff) populations and preserves IL-2 signaling, thereby enhancing anti-tumor immune responses and demonstrating potential for the treatment of multiple solid tumors. 

In the Phase Ⅰ clinical trial, the combination of BA1106 and BA1104 showed encouraging efficacy signals in patients with lung adenocarcinoma, squamous cell lung cancer, and gastric cancer, and all of them had previously experienced disease progression on ICIs. Furthermore, BA1106 demonstrated a favorable safety and tolerability profile as a monotherapy or in combination with BA1104. Most treatment-related adverse events were mild (Grades 1–2). During dose escalation, no dose-limiting toxicities (DLTs) were observed, and the maximum tolerated dose (MTD) was not reached at dose level up to 1.2 mg/kg. These results are encouraging for subsequent clinical studies. 

“The unique design of BA1106 enables precise Treg modulation and efficacy-safety balance with an enhanced anti-tumor immune response.” said Jiang Hua, Chairlady and Chief Executive Officer of Boan Biotech. “The Phase Ⅰ clinical trial already demonstrated the potential of BA1106 used in combination with a PD-1 inhibitor, as encouraging signals were observed across multiple tumor types. We are now speeding up the Phase Ⅱ clinical trial of the combination therapy for treating NSCLC, targeting both treatment-naive patients and those who have experienced disease progression following prior immunotherapy. We will also explore this combination therapy in other high-incidence solid tumors, including gastric cancer, in an effort to deliver better outcomes for patients.”

References：
1. Expert Committee on Non-small Cell Lung Cancer, the Chinese Society of Clinical Oncology: Chinese Expert Consensus on Second-line Treatment for Non-small Cell Lung Cancer with Negative Driver Gene Mutations. Chin J Lung Cancer, February 2024, Vol.27, No.2. DOI: 10.3779/j.issn.1009-3419.2024.102.10.
2. Liu H, Lao M, Cai X, et al., Research Progress in Radiotherapy for Brain Metastases of Driver-Gene Negative Non-Small Cell Lung Cancer. Chinese Journal of Radiation Oncology, 2024, 33(8): 766-771. DOI: 10.3760/cma.j.cn113030-20231125-00178.