Accelerating the Progress of 2nd Generation Uni-PTH Launch

HONG KONG, 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."