Auristatin

Renal injury is a common complication in the treatment of diseases such as chronic kidney disease and severe infection, while proximal renal tubular injury is the core pathological link in the occurrence and development of acute kidney injury. Ostaridine is a new type of renal protective agent and a potent inhibitor of human proximal renal tubular organic anion transporter 1 (OAT1). It reduces renal tubular injury by inhibiting the accumulation of OAT1-mediated nephrotoxic substances in renal tubular epithelial cells. At present, its indication is mainly for the prevention and treatment of acute kidney injury, and the applicable population includes patients with malignant tumors receiving nephrotoxic chemotherapeutic drugs, patients in the perioperative period of major surgery, and high-risk populations with severe infection complicated with renal injury, etc. It can effectively reduce the incidence of acute kidney injury and the demand for renal replacement therapy.

At present, the global annual incidence of acute kidney injury is about 13.3 million cases, and the incidence of acute kidney injury in hospitalized patients in China reaches 11.6%, and the corresponding market size of renal protective drugs continues to expand. In 2023, the domestic market size related to ostaridine has exceeded 800 million yuan, with a compound annual growth rate remaining above 45%. In terms of the competitive landscape, the domestic variety is still in the stage of exclusive marketing by the original research drug at present, and more than 10 pharmaceutical companies have laid out generic drug research and development. With the expiration of patents in the future and the advancement of centralized drug procurement policies, there is a broad space for generic drug substitution, and the demand for upstream API will usher in a rapid release period.

The original research enterprise of ostaridine is Ono Pharmaceutical Co., Ltd. of Japan, and the original research trade name is "オスタディン". The Chinese trade name has not been unified for the time being. The core compound patent expires in 2029 in Japan and 2031 in China. The marketed dosage form is injection with a specification of 10 mg per vial, which has been included in the drug catalogue of the Ministry of Health, Labour and Welfare of Japan. There is no approved import record of the original research preparation in China. Up to now, no enterprise has submitted the registration application for ostaridine API on the CDE API registration platform, and no generic drug preparation has been approved for marketing in China. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO provides a full set of impurity reference standards for ostaridine API, which can perfectly meet the needs of impurity qualitative and quantitative research in the process of R&D and declaration. Most of the products are in stock, and spot orders placed before 16:00 can be delivered on the same day. All products meet the regulatory requirements of multiple countries, such as Chinese Pharmacopoeia and FDA, and can provide stable and reliable reference standard support for the R&D and mass production process of pharmaceutical companies.