In recent years, the release of guidance principles stating that the development of novel anti-tumor drugs should be "patient-needs-oriented" has made improving the patient treatment experience and enhancing convenience a key direction in clinical R&D. Subcutaneous injection formulations, with their advantages of convenience and efficiency, are gradually becoming a significant upgrade path for the delivery of large-molecule targeted immunotherapies.

On July 2nd, IMMUNEONCO-B (01541) announced that the Investigational New Drug (IND) application for the subcutaneous injection formulation (IMM2510S) of its self-developed, dual VEGF×PD-L1 targeting drug, Perivalafup α (IMM2510), has been formally approved by the National Medical Products Administration (NMPA). This approval signifies that IMM2510 may in the future provide a superior treatment option for patients with advanced solid tumors through a more convenient and safer administration method.

Leveraging Platform Technology for Core Asset Formulation Advancement

Compared to traditional intravenous administration, subcutaneous injection offers multiple advantages: it can significantly improve patient compliance, with studies showing a patient preference rate for subcutaneous delivery exceeding 85%; it optimizes the allocation of medical resources and reduces healthcare system costs; and it can optimize the pharmacokinetic profile in vivo, lowering peak drug concentration and extending drug exposure time, with the potential to further enhance treatment safety and efficacy.

The key to converting IMM2510 from intravenous to subcutaneous injection lies in the introduction of the core excipient, recombinant human hyaluronidase (rHuPH20). This enzyme can temporarily reduce the viscosity of subcutaneous tissue, creating an absorption pathway for large-molecule antibody drugs, enabling rapid, high-volume, and efficient subcutaneous delivery. The hyaluronic acid barrier typically self-restores within 24-48 hours after administration. By the end of 2025, nine subcutaneous formulations containing rHuPH20 have been approved globally, fully demonstrating the maturity and clinical value of this technology.

Relying on its self-developed and self-controlled production platform, IMMUNEONCO-B successfully developed and registered the recombinant human hyaluronidase (rHuPH20) as a pharmaceutical excipient, which boasts significant advantages such as high enzyme activity, high purity, and high yield. Based on this core excipient, the company has established an efficient subcutaneous formulation technology platform.

Supported by this platform, the IMM2510S project successfully achieved the formulation upgrade using this excipient. This not only validates the stability and effectiveness of the enzyme in complex biologic formulations but also proves its "practical capability" as a key excipient, capable of supporting the subcutaneous delivery needs of large-molecule drugs like mono- and bispecific antibodies, providing solid assurance for drug safety and efficacy.

Furthermore, as a hyaluronidase and related technology platform self-developed and produced by IMMUNEONCO-B, this subcutaneous formulation technology platform will also provide robust technical support for the future development of subcutaneous injection formulations for multiple self-developed large-molecule drug product pipelines.

Addressing Unmet Needs in Later-Line Lung Squamous Cell Carcinoma and Enhancing Market Accessibility

In reality, the approval of the IND application for IMM2510S and its application in clinical practice is far from a simple "change in administration method." It represents a fundamental transformation in the diagnosis and treatment paradigm for lung squamous cell carcinoma across four dimensions: patient experience, clinical workflow, medical resources, and accessibility at the grassroots level. This addresses an unmet need in later-line treatment while improving market accessibility.

In the later-line treatment field, the prognosis is extremely poor for patients with lung squamous cell carcinoma who have progressed after receiving PD-1 inhibitors and platinum-based chemotherapy. Docetaxel, as the standard treatment regimen for this population, has limited efficacy and significant toxicity. At this year's ASCO annual meeting, IMMUNEONCO-B's IMM2510, with its outstanding data in later-line squamous cell carcinoma, demonstrated potential to become a key drug filling the clinical gap for IO-resistant lung squamous cell carcinoma.

Based on the disclosed research data, IMM2510 not only shows advantages in Disease Control Rate (DCR) and Progression-Free Survival (PFS) compared to drugs for the same indication but also adds a differentiated positioning of being "chemotherapy-free, low-toxicity, and convenient as a monotherapy."

Regarding safety data, IMM2510 demonstrates clear scarcity: the rate of permanent discontinuation due to Adverse Events (AEs) was only 3.1% (1/32); the rate of Grade ≥3 Treatment-Emergent Adverse Events (TEAEs) was 53.1% (17/32), and Grade ≥3 Treatment-Related Adverse Events (TRAEs) were 37.5% (12/32). The overall toxicity profile was primarily hematological, with no Grade ≥3 immune-related Adverse Events (irAEs) observed.

In a horizontal comparison with other candidates in the same indication pipeline undergoing Phase III clinical studies: ONC-392 (an anti-CTLA-4 antibody) had an irAE incidence rate as high as 60%, with a discontinuation rate due to AEs reaching 22.2%. Another candidate, IBI363, also had a discontinuation rate due to AEs of 22.2%, and exhibited high irAE toxicities such as arthralgia and rash.

It is worth noting that the administration methods for the two aforementioned investigational competitors are both intravenous injection. In contrast, IMM2510, with its subcutaneous formulation, undoubtedly demonstrates a more significant first-mover advantage.

From a market perspective, lung cancer, as one of the malignancies with the highest global incidence and mortality rates, has consistently been a focus in oncology. Among these, lung squamous cell carcinoma accounts for approximately 25%-30% of non-small cell lung cancer cases. Patients with later-line lung squamous cell carcinoma are often elderly, have multiple comorbidities, have failed platinum-based + immunotherapy, have poor performance status, and have extremely limited tolerance for toxicity.

Advancing the IMM2510 administration model from a "dominantly intravenous infusion" approach to a diversified choice of "intravenous + subcutaneous" has the potential to significantly improve patient medication compliance, promote the penetration of later-line lung squamous cell carcinoma treatment to the grassroots level, and further enhance market accessibility.