Yiming Angke Reports Breakthrough Phase Ib/IIa Results for IMM0306 Combination Therapy in Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma

Yiming Angke Biomedical Technology (Shanghai) Co., Ltd. announced breakthrough results from its Phase Ib/IIa clinical study of amulirafusp alfa (IMM0306), a first-in-class myeloid cell engager molecule targeting both CD47 and CD20, in combination with lenalidomide for relapsed/refractory CD20-positive B-cell non-Hodgkin lymphoma.

The Hong Kong-listed biopharmaceutical company (stock code: 01541.HK) reported that in patients with relapsed/refractory marginal zone lymphoma, the combination achieved an objective response rate of 92.3% and a complete response rate of 53.8%. As of September 20, 2026, the study had enrolled 13 patients with relapsed/refractory CD20-positive marginal zone lymphoma.

These results represent a substantial improvement over approved BTK inhibitors, which have demonstrated objective response rates of 57.8% and complete response rates of 12% in comparable patient populations. The Phase II study continues to enroll patients.

Follicular Lymphoma Data Show Dual-Drug Advantage

In the follicular lymphoma cohort, 44 evaluable patients with relapsed/refractory CD20-positive disease achieved an objective response rate of 88.6% and a complete response rate of 70.5%. The dual-drug combination outperformed historical Phase II data for obinutuzumab plus lenalidomide, which showed a complete response rate of 38.0%—more than 30 percentage points lower.

Compared with the classic R2 regimen of rituximab plus lenalidomide, which achieved a complete response rate of 34.7% and objective response rate of 80.3%, IMM0306 plus lenalidomide doubled the complete response rate while improving overall response. Even against the three-drug regimen of tafasitamab plus R2, presented at the 2024 American Society of Hematology meeting with an objective response rate of 83.5% and complete response rate of 52.0%, the two-drug combination demonstrated superior efficacy in both metrics while offering treatment economy advantages.

Safety Profile Distinguishes IMM0306

Unlike bispecific T-cell engagers currently gaining traction, the study observed no cytokine release syndrome-related toxicity, no severe adverse effects associated with cytokine storms, and no neurotoxicity. The toxicity profile consisted primarily of hematologic events that are clinically known and manageable. Patient discontinuation rates remained extremely low, with no treatment-related deaths reported.

This favorable safety profile stems from IMM0306's differentiated design, which exhibits higher affinity for CD20 than CD47. The molecule preferentially binds CD20 on tumor cell surfaces, avoiding damage to normal CD47-expressing cells while dually activating macrophage-mediated phagocytosis and the immune system against tumor cells, enabling deeper tumor clearance.

Executive Commentary

"IMM0306 is a flagship product in our CD47 target portfolio, and these data validate our differentiated innovation strategy across multiple dimensions," said Dr. Tian Wenzhi, Chairman, CEO, and CSO of Yiming Angke. "The therapeutic window of high efficacy and low toxicity positions us to accelerate global clinical development and bring benefits to more patients with hematologic malignancies and solid tumors."

Dr. Wu Zhuli, Chief Medical Officer, noted that IMM0306 can simultaneously bind CD47 and CD20 on B cells. "Through its triple mechanism of action, it enables more thorough B-cell clearance," she said. "The combination therapy has achieved deeper and more durable responses, which holds significant clinical importance for patients with relapsed/refractory indolent lymphoma who have limited treatment options."

Company Background and Pipeline

Founded in 2015 and headquartered in Shanghai's Zhangjiang district, Yiming Angke is among the few global biotechnology companies capable of systematically harnessing both innate and adaptive immune systems. The company, which listed on the Hong Kong Stock Exchange Main Board in September 2023, has built a robust pipeline of eight core innovative drugs across nine clinical-stage projects under its "Drug-by-Design" philosophy.

The company has been recognized as a National-Level Specialized, Refined, Differential, and Innovation "Little Giant" enterprise and was named to the "2025 Zhangjiang Innovative Pharmaceutical Enterprise Global Competitiveness TOP 15." Market observers note that with dual validation of efficacy and safety in indolent lymphoma, IMM0306's commercialization potential and global licensing opportunities are expanding, positioning Yiming Angke for renewed capital market attention as a leader in the CD47 therapeutic space.