Anke Biological Growth Hormone Approved for New Indication for Treatment of Idiopathic Short Stature

Text|Pharmaceutical Mission Hills

On September 13, China's National Food and Drug Administration (NMPA) announced that Anke Biotech's newly-declared application for the marketing authorization of recombinant human growth hormone for injection for the treatment of idiopathic short stature (ISS) indications has been officially approved
.

Screenshot source: NMPA official website

According to the announcement issued by Anke Biology earlier, short stature refers to an individual whose height is lower than the 3rd percentile of a normal population of the same race, age, and sex in a similar living environment or 2 standards below the average height of a normal population Poor (-2SD)
.

It is worth mentioning that growth hormone for the treatment of idiopathic short stature has been included in the Chinese Medical Association Pediatrics Journal "Guidelines for the diagnosis and treatment of children with short stature" and "Consensus Statement on the Diagnosis and Treatment of Children with Idiopathic Short Stature" and other industry guidelines
.

Public information shows that this recombinant human growth hormone for injection has been approved for marketing in 6 indications: 1) used for slow growth of children caused by endogenous growth hormone deficiency; 2) used for Noonan syndrome Children with short stature; 3) for children with short stature or growth disorders caused by SHOX gene defects; 4) for severe burn treatment; 5) for children with short stature caused by achondroplasia; 6) for Adult short bowel syndrome receiving nutritional support
.

This time the product has been approved for ISS indications, which is an enrichment and supplement to the approved indications
.

Reference materials:

[1] September 13, 2021 Drug Approval Documents Pending Information Release-1.