Hong Kong-listed biopharmaceutical company Uni-Bio Science Group Ltd (HKG: 0690) has announced that it has received marketing approval from China’s National Medical Products Administration (NMPA) for its generic version of Eli Lilly Inc (NYSE: LLY)’s Forteo (teriparatide) injection, indicated for the treatment of osteoporosis in postmenopausal women who are at a high risk of fractures. This marks the first domestically developed disposable pre-filled pen injection of teriparatide in China.
Teriparatide, a recombinant human parathyroid hormone analogue (PTH1-34), has been demonstrated to effectively promote new bone formation, increase bone density, enhance bone quality, and reduce the risk of vertebral and non-vertebral fractures as well as recurrent fractures. It is considered the preferred medication for patients with an extremely high risk of fractures. Preclinical and non-clinical trials have shown that Uni-Bio’s version of the drug exhibits high similarity in biological activity to the original product, with superior drug stability. Clinical pharmacokinetic (PK) equivalence studies also indicate that Uni-Bio’s teriparatide is fully equivalent to Forteo, with a higher safety profile.- Flcube.com
