Relying on the efficient platform technology, IMMUNEONCO-B (01541) is promoting the upgrade of the IMM2510 formulation, improving the convenience and compliance of cancer patient treatment.

In recent years, with the publication of the guidance principle that the research and development of new anti-tumor drugs should be "patient-oriented", improving patient treatment experience and enhancing treatment convenience has become an important direction of clinical research and development. Subcutaneous injection formulations, with their advantages of convenience and efficiency, have gradually become an important upgrade direction for the administration of large molecule targeted immunotherapy drugs. On July 2nd, IMMUNEONCO-B (01541) announced that the company's independently developed VEGFPD-L1 dual-target drug, Perivrafip (IMM2510) subcutaneous injection formulation (IMM2510S) has officially obtained approval from the National Medical Products Administration (NMPA) for its Investigational New Drug (IND) application, marking that IMM2510 is expected to provide more convenient and safer administration to advanced solid tumor patients, offering them a better quality treatment choice. Relying on an efficient platform technology to promote the upgrade of core formulations Compared to traditional intravenous administration, subcutaneous injection has multiple advantages: it can significantly improve patient compliance, with studies showing a preference rate of over 85% for subcutaneous administration; it can optimize the allocation of medical resources, reducing healthcare system costs; it can optimize the pharmacokinetic behavior in the body, lowering peak drug concentrations, prolonging drug exposure time, and potentially further enhancing treatment safety and efficacy. IMM2510S switching from intravenous to subcutaneous injection is achieved by the introduction of the recombinant human hyaluronidase (rHuPH20) as a core excipient. This enzyme can temporarily reduce the viscosity of subcutaneous tissue, opening up absorption pathways for large molecule antibody drugs, achieving rapid, high-capacity, and efficient subcutaneous delivery, with the hyaluronic acid barrier usually self-recovering within 24-48 hours after administration. By the end of 2025, nine subcutaneous formulations containing rHuPH20 have been approved for marketing globally, fully confirming the maturity and clinical value of this technology. Leveraging its independent R&D and manufacturing platform, IMMUNEONCO successfully developed and registered the recombinant human hyaluronidase (rHuPH20) excipient for pharmaceutical use, which has significant advantages in terms of high enzyme activity, high purity, and high yield. Based on this core excipient, the company has constructed an efficient subcutaneous formulation technology platform. Supported by the subcutaneous formulation technology platform, the IMM2510S project successfully achieved formulation upgrades using this excipient, not only confirming the stability and effectiveness of the enzyme in complex biologic formulations but also demonstrating its "combat capabilities" as a key excipient, supporting the subcutaneous administration requirements of monoclonal antibodies and providing a solid guarantee for the safety and efficacy of drugs. Additionally, the subcutaneous formulation technology platform, as an independently developed hyaluronidase and related technical platform by IMMUNEONCO, will also provide solid technical support for the development of subcutaneous injection formulations for multiple large molecule drugs in the company's future independently developed product pipeline. Filling the treatment gap in squamous cell lung cancer and improving market accessibility In fact, the approval of the IND application for IMM2510S and its clinical application is not simply a matter of "changing the route of administration", but a thorough change in the diagnosis and treatment mode of squamous cell lung cancer from the perspectives of patient experience, clinical processes, healthcare resources, and grassroots accessibility. It aims to fill the treatment gap in advanced squamous cell lung cancer and improve market accessibility. In the field of later-line treatment, patients with squamous cell lung cancer who have progressed after receiving PD-1 inhibitors and platinum-based chemotherapy have a very poor prognosis. Docetaxel, as the standard treatment for this population, has limited efficacy and significant toxicity. At this year's ASCO annual meeting, IMMUNEONCO's IMM2510, with its excellent data in later-line squamous cell cancer, is expected to become a key drug in filling the clinical gap for immunotherapy-resistant squamous cell lung cancer. From the disclosed research data, IMM2510 shows advantages over other drugs in terms of Disease Control Rate (DCR) and Progression-Free Survival (PFS) in the same indication, as well as a differentiated positioning of "non-chemotherapy, low toxicity, single-agent convenience". In terms of safety data, IMM2510 demonstrates a noticeable rarity: a permanent discontinuation rate of only 3.1% due to Adverse Events (AE); a Grade 3 or higher treatment-related AE rate of 53.1% and a Grade 3 or higher treatment-related Serious Adverse Event (TRAE) rate of 37.5%. The main toxicity observed is hematological, and no Grade 3 or higher immune-related Adverse Events (irAEs) were observed. Comparatively, other drugs in the same indication pathway undergoing Phase III clinical trials, such as ONC-392 (anti-CTLA-4 antibody), have an irAE rate as high as 60%, and a discontinuation rate due to AE of 22.2%; while another drug, IBI363, also has a discontinuation rate due to AE of 22.2%, and exhibits high irAE toxicities like joint pain and rashes. It is worth mentioning that the aforementioned two competitors' drugs are administered intravenously, while IMM2510 with subcutaneous administration undoubtedly demonstrates a more significant advantage. From a market perspective, lung cancer, as one of the most common and deadliest malignant tumors globally, has always been a focus in the field of oncology. Squamous cell lung cancer accounts for about 25-30% of non-small cell lung cancer cases, and patients with later-stage squamous cell lung cancer are often elderly, with multiple comorbidities, have failed platinum-based + immunotherapy, have poor physical conditions, and have very limited tolerance to toxicity. By advancing the administration mode of IMM2510 from "intravenous infusion-based" to a diversified selection of "intravenous + subcutaneous", it is expected to significantly improve patient compliance, promote the treatment of later-stage squamous cell lung cancer at the grassroots level, and further enhance market accessibility.