Hong Kong-based Uni-Bio Science said that the China National Medical Products Administration (NMPA) has approved the marketing application for Bogutai (teriparatide injection).
Bogutai is intended for osteoporosis treatment in postmenopausal women at high risk of fractures.
It is claimed as the first domestically produced disposable pre-filled pen teriparatide injection.
Uni-Bio said that the injection matches Forteo treatment in effectiveness and is superior in terms of safety profile.
Bogutai, created in partnership with the Swiss self-care company Ypsomed, features a pre-filled structural design with ultra-fine needles that ensure more dosage precision.
The design is said to reduce the patient’s discomfort and improve compliance. Additionally, its cost is claimed to be more patient-friendly than Forteo’s.
Uni-Bio chairman Kingsley Leung said: “Our experience with the successful sales of Genetime in the bone department has provided us with invaluable insights and resources that we can leverage for the commercialization of Bogutai.
“We are confident that our preparation, combined with our expanded sales teams and academic promotions, will ensure Bogutai’s successful launch and acceptance in the market.”
Uni-Bio has planned extensive academic pre-marketing activities aimed at possible target clients and increased the size of its sales staff to introduce Bogutai to the osteoporosis industry.
The pharmaceutical firm has also invested in an advanced pre-filled sterile injection production machine located in Beijing. The machine is built by German-based Bausch+Ströbel.
The production line has an hourly capacity of 3,000 – 8,000 cartridge units and up to 11,000 pre-filled syringe units.
Uni-Bio anticipates meeting the long-term supply demands of Bogutai using such a large manufacturing capacity.
Leung added: “We’re incredibly proud of the investments we’ve made in our production facilities. These investments are a testament to our commitment to delivering high-quality and innovative products to patients in need.
“Our production capabilities, combined with our expanded sales teams and academic promotions, position us to successfully commercialise Bogutai and meet the demanding needs of the market.”
