Shanghai, China, April 23, 2026 — ImmuneOnco Biopharmaceuticals (Shanghai) Inc. ("ImmuneOnco", HKEX Stock Code: 01541.HK) today announced that the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) has officially accepted the Investigational New Drug (IND) application for IMM2510S, the subcutaneous formulation of its self-developed VEGF×PD-L1 bispecific drug, palverafusp alfa (IMM2510). This milestone marks a critical step in the formulation optimization of the IMM2510 program, promising a superior treatment option for patients with advanced solid tumors through a more convenient and safer route of administration.

PD-(L)1/VEGF Bispecifics: A Core Direction in Oncology Immunotherapy

Bispecific drugs targeting PD-(L)1 and VEGF have emerged as a pivotal research direction in tumor immunotherapy, leveraging the synergistic mechanism of "one drug, dual targets." According to incomplete statistics, 14 similar drugs globally have entered clinical stages. Notably, Akeso's ivonescimab (AK112), a PD-1/VEGF bispecific antibody, has been approved in China for the treatment of non-small cell lung cancer (NSCLC). The sector's robust market potential and clinical value are further underscored by high transaction volumes, exemplified by Akeso's licensing deal with Summit Therapeutics valued at over $5 billion.

Core Advantage: Differentiated Bispecific IMM2510 Powered by mAb-Trap Platform

IMM2510 is a VEGF×PD-L1 bispecific drug developed on ImmuneOnco's proprietary "mAb-Trap" technology platform. It exerts anti-tumor effects through multiple mechanisms: activating T cells by blocking the PD-1/PD-L1 pathway, remodeling the tumor microenvironment by inhibiting VEGF signaling, and inducing antibody-dependent cellular cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP).

Since the initial IND submission in 2020, IMM2510's clinical development has progressed steadily. Its innovative trial design has enabled a differentiated positioning among similar agents. IMM2510 monotherapy demonstrated promising efficacy in previously treated squamous lung cancer, and IND approvals have been granted for Phase II studies combining IMM2510 with chemotherapy for perioperative treatment of resectable squamous NSCLC and esophageal squamous cell carcinoma, as well as for advanced or recurrent endometrial cancer. Positive early clinical results confirm IMM2510's significant anti-tumor efficacy and manageable safety profile in advanced solid tumors.

IMM2510 has already shown exceptional potential in IO-resistant NSCLC: a Phase I study in 17 previously treated patients with advanced squamous NSCLC reported an objective response rate (ORR) of 35.3%, a disease control rate (DCR) of 76.5%, and a median progression-free survival (PFS) of 9.4 months. Updated results will be presented as a poster at ASCO 2026.

Formulation Upgrade: Subcutaneous Administration Addresses Clinical Pain Points of Intravenous Delivery

While intravenous IMM2510 has demonstrated robust efficacy, its clinical application faces limitations: patients require hospitalization for infusion, long-term treatment consumes substantial healthcare resources, and limited convenience imposes significant time and financial burdens on patients.

To address these unmet clinical needs, ImmuneOnco developed IMM2510S, a subcutaneous formulation optimized based on scientific rationale. Compared to intravenous administration, subcutaneous injection offers multiple advantages: it significantly enhances patient compliance (studies show over 85% preference for subcutaneous delivery), optimizes healthcare resource allocation by reducing system costs, and improves pharmacokinetic profiles by lowering peak drug concentration and prolonging exposure time, holding potential for further enhanced safety and efficacy. The acceptance of the IMM2510S IND application reflects ImmuneOnco's patient-centric commitment to continuous treatment optimization.

Executive Commentary

Dr. Tian Wenzhi, Founder, Chairman, CEO, and CSO of ImmuneOnco, stated: "The acceptance of the IMM2510S IND application is a key achievement in our formulation innovation driven by clinical needs. The rapid development of PD-(L)1/VEGF bispecifics validates the clinical value of this target combination, while formulation optimization is a critical step toward enhancing patient experience and expanding drug accessibility. Moving forward, we will accelerate the clinical development of both IMM2510 and IMM2510S, advancing multiple indications in parallel, with the goal of bringing new hope to advanced solid tumor patients through a more convenient and safer delivery method."

Dr. Wu Zhuli, Chief Medical Officer of ImmuneOnco, added: "Early clinical studies of IMM2510 have shown encouraging anti-tumor potential with intravenous administration. In the current competitive landscape, drug development demands not only efficacy breakthroughs but also a focus on the real-world patient experience. Formulation optimization embodies this philosophy. By transitioning from intravenous to subcutaneous delivery, we aim to deliver triple benefits for patients: reducing the burden of frequent hospital visits, lowering the risk of infusion-related adverse reactions, and further enhancing safety through a more stable drug exposure curve. These seemingly 'small' changes translate to tangible improvements in quality of life for cancer patients requiring long-term treatment."

"We look forward to creating a new treatment paradigm that balances efficacy and quality of life for advanced solid tumor patients through the innovative combination of a potent bispecific drug and a convenient formulation."