Marketing application of BOGUTAI® (teriparatide injection) has been officially accepted by the China National Medical Products Administration (NMPA)
- Written by The Bulletin
HONG KONG SAR - EQS Newswire - 29 June 2022 - A fully integrated biopharmaceutical company – Uni-Bio Science Group Limited (the "Company", together with its subsidiaries, the "Group"; Stock code: 00690.HK) is pleased to announce that t the marketing application submitted by the Group's self-developed BOGUTAI® (teriparatide injection) has been accepted by the China National Medical Products Administration ("NMPA") on 28 June 2022, with the acceptance number "CXSS2200062国".
If BOGUTAI® is approved for marketing, it will provide patients with better drug choices, which is a major milestone for the company in the field of orthopedic diseases.
BOGUTAI® (teriparatide injection) is the Group's fifth marketed product following GENETIME® , GENESOFT® , PINUP® , BOKANGTAI®, and it is also the first domestic manufactured PTH Liquid in China to use a disposable injection pen. Developed in collaboration with Swiss self-care giant Ypsomed, this product has an extremely thin injection needle and high dose accuracy, which can greatly reduce the pain of injections for patients. The Group strongly believe BOGUTAI® will be a future blockbuster for the Group by virtue of the product's strong cost advantage, better therapeutic effect and convenient administration method.
Teriparatide injection adopts biological expression technology, and is a recombinant human parathyroid hormone analog (PTH1-34), which has the same sequence as the 34-amino acid N-terminal amino acid (biologically active region) of human parathyroid hormone of 84 amino acids. For the treatment of osteoporosis in postmenopausal women with a high risk of fractures, it is the only osteogenesis-promoting anti-osteoporosis drug approved for marketing at home and abroad, which can effectively improve bone microstructure, increase bone strength, promote bone healing, and significantly reduce the risk of vertebral and nonvertebral fractures in postmenopausal women.
China is the country with the largest number of osteoporosis in the world. According to the data of the seventh census in 2021, there are currently 264.02 million people aged 60 and above in my country, accounting for 18.70%. Epidemiological surveys show that the prevalence of osteoporosis among people over 50 years old in China is 20.7% for women and 14.4% for men; the prevalence of osteoporosis among people over 60 years old is significantly higher, and women are particularly prominent, as high as 51.6%. Hence, there are currently about 90 million osteoporosis patients in China, and the osteoporosis market size is about 15 billion to 20 billion yuan. The current market share of teriparatide is only about 1% of the PRC osteoporosis market, which is significantly lower than that of foreign countries. The main reason is that it is expensive and not covered by medical insurance. However, in the long run, with the aging of Chinese's population, the gradual improvement of the coverage of the medical insurance system and the improvement of residents' purchasing power, the market size of teriparatide will accelerate significant. Moreover, BOGUTAI's product positioning of being more cost-effective and safe fits the needs of target demographic better, ensuring faster growth compared to other teriparatide competitors.
About Uni-Bio Science Group
Uni-Bio Science Group Limited is principally engaged in the research and development, manufacture and distribution of biopharmaceutical products. The research and development center is fully equipped with a complete system for the development of genetically-engineered products with a pilot plant test base which is in line with NMPA requirements. The Group has two GMP manufacturing bases in Beijing and Shenzhen. The Group also has a highly efficient commercialization platform and marketing network. The Group focuses on the development of novel treatments and innovative drugs addressing the therapeutic areas of endocrine as diabetes and osteoporosis, ophthalmology and dermatology. Please visit the official website of Uni-Bio Science Group for more information: www.uni-bioscience.com/
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