Yiming Oncology Gets NMPA Approval for IMM2510 Subcutaneous Injection on July 2

On July 2, Yiming Oncology-B (01541) announced that its independently developed dual-target VEGF×PD-L1 antibody IMM2510 subcutaneous injection formulation (IMM2510S) has received official approval from China's National Medical Products Administration (NMPA) for its Investigational New Drug (IND) application.

The subcutaneous formulation leverages recombinant human hyaluronidase (rHuPH20) as a key excipient to facilitate large-molecule antibody delivery. Studies show patient preference for subcutaneous administration exceeds 85%, while the approach optimizes pharmacokinetics and reduces peak drug concentrations. The hyaluronic acid barrier typically restores within 24-48 hours post-injection. Globally, nine subcutaneous formulations containing rHuPH20 have been approved as of end-2025, validating the technology's maturity. Yiming independently developed and registered its rHuPH20 excipient with high enzymatic activity and purity, enabling the subcutaneous formulation platform to support large-molecule drug delivery for future pipeline products.