Macroren's non-clinical DMPK research services helped Agomelatine transdermal patch gain clinical approval

On May 14, according to the official media of Xinwen Biology, its clinical application for Agomelatine transdermal patch was successfully approved. This is the world's first Agomelatine transdermal patch for the treatment of adult depression, and will be the first to enter the clinic in China.

This variety is declared as a class 2.2 improved new drug, and its non-clinical DMPK research work is completed by Wuhan Hongren Biomedical Co., LTD. (referred to as: Hongren Pharmaceutical), and its non-clinical PK research content includes:

• 1) A comparative study of PK in Bama miniature pigs (percutaneous versus oral administration)

• 2) Study on skin tissue distribution of Bama miniature pigs
• 3) Study on tissue distribution in rats

The DMPK team of Hongren Pharmaceutical has rich experience in the study of PK of transdermal drug delivery preparations, and can provide gels, creams, patches, micronedles and other preparations for the skin administration of large and small animals (rats, guinea pigs, Bama miniature pigs, etc.). In addition, the platform has rich project experience in the collection of skin tissues (cuticle, epidermis, dermis and subcutaneous tissue) and the separation, homogenization and detection of each layer of tissue.

Research platform on macrotoughness pharmacokinetics

Macro Drug nonclinical Evaluation Center