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PRODUCTS IN DEVELOPMENT

Uni-Bio Science is developing four new patent protected Class I and Class VII prescription drugs in its 3,000m2 research institute in PRC.

Uni-GLP

Uni-GLP, a GLP-1 agonist, is a non-insulin treatment candidate that stimulates the incretin pathway and is effective in the treatment of Type 2 diabetes.

GLP-1 agonist is also one of the only classes of diabetic drugs shown to also cause weight loss. As obesity is a common comorbidity of T2DM, this class is effective in T2DM patients who are overweight, accounting for at least 30% of all diabetes patients in the PRC according to IMS primary research. Moreover, this class of drugs also has other beneficial effects that are expected to drive physician prescription, such as lowering the risk of hypoglycemia and promoting β-cell regeneration, an important clinical advantage in managing Type 2 diabetes complications in the long term.

Clinical studies have shown that Uni-GLP effectively regulates blood glucose levels through multiple mechanisms including stimulating insulin secretion, inhibiting glucagon release, decreasing appetite and decreasing gastric emptying. It is positioned as a major second-line treatment option. The results from the Uni-GLP phase III trial demonstrate that, when compared to insulin glargine, Uni-GLP can effectively decrease the body weight of diabetes patients through suppressing the appetite and prolonging gastrointestinal emptying time.

It has to be mentioned that Uni-GLP is biologically expressed, with much closer physical structure to naturally produced GLP-1, giving it a stronger affinity to GLP-1 receptor and better stability profile; in clinical studies, Uni-GLP is shown to have better bioactivity and potential hypoglycemic effect with much lower immunogenicity. In addition, biological-expressed GLP-1 has a greener and lower production cost than the chemical synthetic one. Uni-GLP as short acting GLP-1 has more advantages against long-acting one, it has a much stronger efficacy on decreasing postprandial glucose, which accounts for >47% of newly diagnosed diabetes patient. Short-acting GLP-1 has a flexible administration regimen, which is also advantageous to newly diagnosed patient where time is needed to find a suitable dosage.

To offer a more patient-friendly product, Uni-GLP utilizes Un-Bio Science’s R&D platform to develop next generation innovative formulations. Uni-GLP’s 1nd generation product is a next-generation liquid pre-filled injection pen, expected to be launched in 2022. The Group is also in the process of developing innovative formulations and drug delivery devices for Uni-GLP to expand the value of the product offering by increasing compliance and convenience to users in both the short and long-term.

Our clinical development team is also reviewing the potential to develop Uni-GLP in new indications and explore the other reported treatment targets, such as obesity and Alzheimer's disease, where there are also significant unmet medical needs.

Uni-GLP's potential as a new treatment has been recognised through the selection of Uni-GLP as a "New Key Drug Formulation" of the“State’s Major Science and Technology Project under the 'Eleventh Five-Year Plan”. Uni-GLP was also awarded the "Specialty Contract of the State's Major Science and Technology Project" by the Ministry of Science and Technology of the People's Republic of China.

Uni-GLP Highlights:

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Effective in control HbA1c whilst offering better safety profile compared to insulin, with added benefit of weight loss

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Uni-GLP is a cost-effective alternative for the growing diabetes burden in China

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GLP-1 T2D market is growing at 51% (5yr CAGR)

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Uni-GLP has higher bioavailability, less immunogenicity and cheaper manufacturing cost

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Uni-Bio Science was awarded “Best Innovation” for Uni-GLP at the inaugural Hong Kong Business Listed Companies Award

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.

Uni-Bio Science's New Drug Application analogue was accepted for review by the NMPA in September 2018. The application for Uni-PTH is currently under review for the treatment of post-menopausal women with osteoporosis, a disease affecting an estimated 70-100 million patients in China according to industry reports.

Broadening Uni-PTH's potential

Uni-PTH powder formulation is expected to launch in 2020, the prefilled injection pen formulation for PTH is also in development and is expected to require a bridging clinical trial before launching in 2022.

The Group is also working on development for innovative formulations of Uni-PTH and drug delivery devices to extend the value of the product by increasing compliance and convenience to users. At the same time, the clinical development team is also reviewing the potential to develop Uni-PTH in new indications where there are also significant unmet medical needs.

Uni-PTH Highlights:

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Uni-PTH has been shown to increase bone mass density and potentially reduce fracture incidence

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China accounts for more than 37% of global Osteoporosis population

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Physicians believe that Uni-PTH is more effective in managing ostealgia when compared to current treatments such as calcitonin

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Uni-Bio Science will potentially be the 3rd domestic company in China to launch this anabolic agent