Shanghai, China – July 2, 2026 – ImmuneOnco Biopharmaceuticals (Shanghai) Inc. (“ImmuneOnco” or the “Company”; HKEX Stock Code: 01541.HK) today announced that the Investigational New Drug (IND) application for IMM2510S, a subcutaneous injection formulation of palverafusp alfa (IMM2510), the Company’s proprietary VEGF×PD-L1 dual-targeted therapy, has been officially approved by the National Medical Products Administration (NMPA). This milestone marks a significant step forward in providing patients with advanced solid tumors a more convenient and safer treatment option through optimized drug delivery.

Core Advantages: A Differentiated Dual-Targeted Therapy Built on the mAb-Trap Platform

Palverafusp alfa (IMM2510) is a VEGF×PD-L1 dual-targeted therapy developed on ImmuneOnco’s proprietary “mAb-Trap” technology platform. It exerts its anti-tumor effects through multiple mechanisms, including activating T cells by blocking the PD-1/PD-L1 signaling pathway, reshaping the tumor microenvironment by inhibiting VEGF signaling, and inducing antibody-dependent cellular cytotoxicity (ADCC) and phagocytosis (ADCP).

Since its first IND submission in 2020, the clinical development of IMM2510 has progressed steadily. Through innovative trial designs, the Company has achieved a differentiated development strategy among its peers. IMM2510 monotherapy has demonstrated promising efficacy in previously treated squamous cell lung cancer. Furthermore, IND applications for Phase II trials have been approved for IMM2510 combined with chemotherapy as perioperative treatment for resectable squamous non-small cell lung cancer (NSCLC) and esophageal squamous cell carcinoma (ESCC), as well as for the treatment of advanced or recurrent endometrial cancer.

Additionally, the combination of IMM2510 and IMM27M has shown exceptional potential. The Phase Ib clinical trial of this combination for advanced solid tumors has identified a recommended Phase II dose. Dose-expansion studies are currently underway in ESCC and squamous NSCLC patients who have previously failed immunotherapy. Preliminary clinical data indicate that the combination regimen is well-tolerated and has demonstrated promising anti-tumor efficacy: among six ESCC patients evaluated for efficacy during the dose-escalation phase, three achieved partial response (PR), two achieved stable disease (SD), and one experienced unconfirmed progressive disease (iuPD), resulting in an overall objective response rate (ORR) of 50%.

Positive early clinical study results confirm that IMM2510 possesses significant anti-tumor efficacy and a manageable safety profile in the treatment of advanced solid tumors.

Latest ASCO Data: Overcoming Immunotherapy Resistance with Superior Efficacy and Safety

The clinical value of IMM2510 has been further validated on premier international academic platforms. At the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting, ImmuneOnco presented the latest Phase I clinical data of IMM2510 in patients with advanced squamous NSCLC who had progressed on prior immunotherapy (IO) as a poster presentation (Abstract No.: 8580). This marks the fourth consecutive year that IMM2510 has been featured at ASCO, one of the world’s most prestigious oncology conferences.

Among 22 efficacy-evaluable subjects, IMM2510 demonstrated significant anti-tumor activity with an ORR of 27.3% and a disease control rate (DCR) of 81.8%. In the cohort receiving the recommended Phase II dose (RP2D) of 20 mg/kg, the DCR further increased to 88.2%. The median progression-free survival (mPFS) was 9.4 months, and the median duration of response (DoR) was 11.1 months.

In terms of safety, IMM2510 exhibited excellent tolerability. The rate of permanent discontinuation due to adverse events was only 3.1%, and no Grade ≥3 immune-related adverse events (irAEs) were observed. This safety profile effectively aligns with the clinical need for low-toxicity treatments in IO-resistant squamous NSCLC patients. Based on these positive data, 20 mg/kg Q2W has been established as the recommended Phase II dose, and subsequent Phase III clinical studies are currently being planned.

Technological Moat and Formulation Upgrade: Empowering Subcutaneous Development via the Hyaluronidase Technology Platform

Intravenous (IV) administration has certain limitations, including the need for hospitalization, significant consumption of healthcare resources over long-term treatment, and poor convenience, which impose both time and financial burdens on patients. To address these unmet clinical needs based on scientific rationale, ImmuneOnco has optimized the formulation of IMM2510 and successfully developed the subcutaneous injection formulation, IMM2510S.

As the Company’s first subcutaneous pipeline candidate developed on its recombinant human hyaluronidase (rHuPH20) technology platform, IMM2510S leverages rHuPH20 to effectively promote the dispersion and absorption of the drug in subcutaneous tissue. This not only provides robust technical support for the formulation upgrade but also highlights the Company’s differentiated innovation capabilities in subcutaneous drug delivery.

rHuPH20 is an enzyme capable of specifically and rapidly degrading hyaluronic acid (HA) in subcutaneous tissue. By temporarily reducing tissue viscosity and diffusion resistance, rHuPH20 enables rapid, large-volume subcutaneous administration of macromolecular drugs. The hyaluronic acid barrier typically recovers within 24 to 48 hours post-administration. As of the end of 2025, nine subcutaneous formulations containing rHuPH20 have been approved globally, fully validating the maturity and clinical value of this technology. Relying on its proprietary R&D and manufacturing platform, ImmuneOnco has successfully developed and filed an rHuPH20 pharmaceutical excipient (Filing No.: F20250000188), which features significant advantages including high enzymatic activity, high purity, and high yield. Based on this core excipient, the Company has built an efficient subcutaneous formulation technology platform, providing solid support for the formulation upgrade of innovative drugs.

Compared to traditional IV administration, subcutaneous injection offers multiple advantages: it significantly improves patient compliance, with studies showing a patient preference rate of over 85% for subcutaneous delivery; it optimizes healthcare resource allocation and reduces healthcare system costs; and it optimizes in vivo pharmacokinetics by lowering peak drug concentrations and extending drug exposure time, thereby holding the potential to further enhance treatment safety and efficacy. The approval of the IMM2510S IND application is a vital practice of ImmuneOnco’s patient-centric approach to continuously optimizing treatment regimens.

Dr. Wenzhi Tian, Chairman, Chief Executive Officer, and Chief Scientific Officer of ImmuneOnco, commented:

“The approval of the IMM2510S subcutaneous IND application is a significant milestone in our efforts to drive formulation innovation based on clinical needs. Globally, several hyaluronidase-based subcutaneous antibody drugs have already been approved. ImmuneOnco’s proprietary rHuPH20 and its associated technology platform will provide robust technical support for the future subcutaneous development of multiple proprietary macromolecular drug pipelines. Previous IV clinical trials have demonstrated that IMM2510 has significant advantages in overcoming immunotherapy resistance and maintaining a favorable safety profile. The development of the subcutaneous formulation, through the innovative combination of a highly efficacious dual-targeted therapy and a convenient delivery method, will greatly enhance patient convenience and compliance, bringing new hope to patients with advanced solid tumors.”

Dr. Zhuli Wu, Chief Medical Officer of ImmuneOnco, stated:

“In the current competitive landscape, drug development not only pursues breakthroughs in efficacy but also focuses on the real-world patient experience during treatment. By transitioning from IV to subcutaneous administration, we aim to deliver a triple benefit to patients: reducing the burden of frequent hospital visits, lowering the risk of infusion-related adverse reactions, and further enhancing treatment safety through a more stable drug exposure profile. We look forward to providing patients with advanced solid tumors a new treatment option that balances therapeutic efficacy with quality of life.”