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Uni-Bio Science Group Receives IND Approval for Uni-PTH Liquid Injection by the National Medical Products Administration


Redaksi | Jumat,04 September 2020 - 23:51:06 WIB
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Uni-Bio Science Group Receives IND Approval for Uni-PTH Liquid Injection by the National Medical Products Administration

Accelerating the Progress of 2nd Generation Uni-PTH Launch

CHINA - EQS Newswire - 4 September 2020 - 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 Uni-PTH (pre-filled injection pen) or "2nd Generation Uni-PTH" has been successfully approved by the National Medical Products Administration ("NMPA") for clinical trial with the acceptance number of CXSL2000138. The approval allows the Company to begin conducting bridging clinical trials, which will accelerate the launch of 2nd Generation Uni-PTH, expected as soon as 2022.

Uni-PTH is the world's only anabolic (bone growing) agent for osteoporosis and ostealgia treatment. Its treatment mechanism is quite different from products already existing in the market. Rather than inhibiting bone absorption, Uni-PTH has been shown to be effective in stimulating new bone formation on quiescent bone surface. By stimulating new bone formation, Uni-PTH can quickly improve bone quality and increase bone density within 6 months of treatment, therefore reducing fracture incidence and bone pain, especially helpful in treating patients with moderate-to-severe osteoporosis and ostealgia

Furthermore, 2nd Generation Uni-PTH improves upon the formulation of 1st Generation Uni-PTH in terms of patient convenience. On 5th May 2020, the Company announced a strategic collaboration with Swiss self-care giant Yposmed to develop 2nd Generation Uni-PTH alongside YpsoPen®, a state-of-the-art pen injector with unparalleled dosing accuracy and minimized injection pain. Together with YpsoPen®, 2nd Generation Uni-PTH is designed to provide safer long-term self-care solution for osteoporosis and ostealgia patients.

Mr. Kingsley Leung, the Chairman of Uni-Bio Science Group, said, "The approval of clinical trial application was faster than we expected. Moreover, the NMPA has been very open to new clinical trial strategies, our proposed development strategy was accepted after preparing detailed data supporting our rationale. Overall, the outcome will greatly decrease the time and resources needed to bring our 2nd Generation Uni-PTH to market! The change in attitude of the NMPA's review process is highly encouraging for the Group to focus its R&D in innovative drugs. Leveraging on our development and regulatory experience with Uni-PTH and Uni-GLP, we hope to kick start our next phase of pipeline development, most likely focused on next-generation best-in-class biologics."

About Uni-PTH
Uni-PTH (Parathyroid hormone 1-34 analogue or rhPTH (1-34)) is an effective agent treating osteoporosis and ostealgia. It is a Class VII prescription new drug and is the world's only anabolic (bone growing) agent. Uni-PTH has the potential to offer patients in China an affordable and effective treatment option for osteoporosis and ostealgia compared to current treatment options. Currently, the PRC osteoporosis market is expected to be worth RMB15.5 billion (approximately one fifth of the global osteoporosis market) and will continue to grow quickly largely due to increasing prevalence of osteoporosis among the female and elderly population, rising standards of living and increasing awareness and education in bone health.

In clinical trials, Uni- PTH has been shown to be effective in stimulating new bone formation on quiescent bone surface, which is treatment mechanism rarely seen in the market filled with products to inhibit bone absorption. By stimulating bone formation, Uni-PTH has the potential to reduce fracture incidence by improving bone qualities and increasing bone density.

Currently, the Company is developing two formulations; 1st Generation Uni-PTH is a lyophilized powder, currently in market approval registration, and 2nd Generation Uni-PTH is a pre-filled injection pen, currently conducting bridging studies. Both products are expected to launch within the next 24 months. As high-tech innovative drug, 1st Generation Uni-PTH (powder) was granted high-precision industrialization project by Beijing Zhongguancun Science Park Management Committee ("the Committee") in 2018.

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.


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