CHANGCHUN—Changchun High & New Technology Industries (Group) Inc., (SHE: 000661), a leading biopharmaceutical company in China, has announced that it has received additional indication approval from the National Medical Products Administration (NMPA) for its polyethylene glycol recombinant human somatropin. This long-acting somatropin is now approved for use in growth disorders in girls with gonadal hypoplasia, commonly known as Turner syndrome.
Turner syndrome, a genetic condition resulting from the absence or partial loss of one X chromosome, presents with a range of symptoms including short stature, gonadal dysplasia, and characteristic physical features. It can also be associated with autoimmune diseases and cognitive impairments, significantly affecting the quality of life for affected children.
The approval of this long-acting somatropin marks a significant advancement in the treatment landscape for Turner syndrome. Unlike existing short-acting somatropin preparations that require daily administration, this product offers a more convenient treatment option. Clinical trials have demonstrated that it can substantially improve height standard deviation scores and growth rates in children with Turner syndrome, while maintaining a favorable safety and tolerability profile.
Previously approved in China in 2014 for the treatment of slow growth due to endogenous growth hormone deficiency, this new indication expands the product’s potential to support a broader patient population. The approval underscores Changchun High & New Technology’s commitment to addressing unmet medical needs and enhancing patient care in the field of pediatric endocrinology.- Flcube.com
