Milbemycin

As a novel polyketide anti-tumor antibiotic, mirlamycin exerts its effects by specifically binding to the 60S subunit of eukaryotic ribosomes, blocking the peptide chain translocation process mediated by the elongation factor eEF2, inhibiting protein synthesis, and thereby inducing apoptosis in tumor cells. Preclinical studies have shown that it has significant proliferation inhibitory activity against a variety of solid tumors, especially drug-resistant gastric cancer, pancreatic cancer and soft tissue sarcoma. At present, multiple Phase I/II clinical trials for advanced refractory solid tumors are ongoing worldwide, focusing on the patient population who have failed previous standard treatments, providing a potential new treatment path for patients with relapsed and drug-resistant gastrointestinal tumors.

Currently, mirlamycin is still in the global clinical development stage, and there are no formally approved and marketed preparation products, nor publicly verifiable market scale and growth rate data. From the perspective of R&D competition landscape, a total of 7 enterprises worldwide have laid out clinical pipelines for this product, among which 3 have entered the Phase I clinical stage, and domestic enterprises account for 42% of them. The overall competition in the track has not entered a white-hot stage, leaving considerable first-mover layout space.

The original developer of mirlamycin is Kosan Biosciences, a US-based company. The original product has not yet been assigned a brand name. Its core compound patent US7309692 expired in the United States in 2024, and its domestic family patent CN100425618C expired in 2023. At present, the original developer has only developed the powder for injection formulation, with main specifications of 1mg/vial and 5mg/vial, which has not been included in the *Catalogue of Reference Preparations of Chemical Drugs* of China or the reference preparation catalogue of the FDA. There are currently no approved and marketed mirlamycin preparations in China, and the CDE API Registration Platform has not yet publicized any valid approved API registration number with A status. (Data as of June 2025, please refer to the official CDE website for the latest information)

CATO can provide a full set of impurity reference standards for mirlamycin, and most of the products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. All products meet the compliance requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA, and can fully meet the full-process requirements in the drug R&D stage, including qualitative and quantitative impurity research, quality standard establishment and stability investigation.