Shisi Pharmaceutical Group (02005) has obtained drug production registration approval from the State Drug Administration for gadobutol injection (7.5ml: 4.5354g)

Zhitong Finance App News, Shisi Pharmaceutical Group (02005) issued an announcement. The group has obtained a drug production registration approval from the China State Drug Administration for gadobutol injection (7.5ml: 4.5354g), which is a Class 4 chemical drug, and is deemed to have passed the consistency evaluation. Gadobutrol injection is mainly used for diagnosis, for intravenous administration only. It is suitable for adults and children of all ages (including full-term neonates). It is mainly used for contrast-enhanced magnetic resonance imaging (CE-MRI) examination of all parts of the body (including head and spinal cord), and contrast-enhanced magnetic resonance angiography (CE-MRA) examination of all parts of the body.

The Group's gadobutrol API has been approved by the State Drug Administration and registered as an API for use in marketed formulations. As a next-generation macrocyclic structural magnetic resonance imaging contrast agent, gadobutol further enriches the Group's diagnostic and therapeutic drug product matrix. Gadolinium is a rare earth metal. This injection was approved to implement an integrated business layout for gadolinium APIs and injectable formulations to help expand the clinical medical imaging market and form business collaboration with the Group's existing formulations.

The Group has obtained indocyanine green (25mg) for injection from the State Drug Administration, which is a Class 3 chemical, and is deemed to have passed the consistency evaluation. Injectable indocyanine green is mainly used to diagnose various liver diseases such as cirrhosis, hepatic fibrosis, tenacious hepatitis, and occupational and drug-toxic liver disease, to understand the extent of liver damage and reserve function; it can also be used for choroidal angiography to determine the location of choroidal diseases.

The Group's indoline green APIs have been approved by the State Drug Administration and registered as APIs for use in marketed formulations. This time, injectable powders were approved to further improve the product layout during the perioperative period and ICU intensive care departments. Relying on the advantages of integrated APIs and formulations, they help expand the top three surgical and critical care markets, and form a synergy effect with existing critical care preparations.