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 Dongguan.

Uni-E4

Uni-E4, 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.

Clinical studies have shown that Uni-E4 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-E4 phase III trial demonstrate that, when compared to insulin glargine, Uni-E4 can effectively decrease the body weight of diabetes patients through suppressing the appetite and prolonging gastrointestinal emptying time.'  Furthermore, Uni-E4 has also been shown to lower the risk of hypoglycemia and promoting β-cell regeneration, an important clinical advantage in managing Type 2 diabetes complications in the long term.

Uni-E4's potential as a new treatment has been recognised through the selection of Uni-E4 as a '€˜New Key Drug Formulation'€ of the State's Major Science and Technology Project under the '€œEleventh Five-Year Plan'€. Uni-E4 was also awarded the '€œSpecialty Contract of the State's Major Science and Technology Project'€ by the Ministry of Science and Technology of the People's Republic of China.

Broadening Uni-E4'€™s potential

The Group is also in the process of developing innovative formulations and drug delivery devices for Uni-E4 to expand the value of the product offering by increasing compliance and convenience to users in both the short and long-term.

Our development team is also reviewing the potential to develop Uni-E4 in new indications where there are also significant unmet medical needs.

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Uni-Bio Science was awarded “Best Innovation” for Uni-E4 at the inaugural Hong Kong Business Listed Companies Award

• 

It is expected that 143 million people in China will have diabetes by 2035

• 

Uni-E4 is a cost-effective alternative for the growing diabetes burden in China

• 

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

Uni-PTH

Uni-PTH (Parathyroid hormone 1-34 analogue) 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. In clinical trials, Uni- PTH has been shown to be effective in stimulating new bone formation on quiescent bone surface. 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 China Food and Drug Administration in April 2015. 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

The Group is also in the process of developing innovative formulations and drug delivery devices for Uni-PTH to expand the value of the product offering by increasing compliance and convenience to users.

Our development team is also reviewing the potential to develop Uni-E4 in new indications where there are also significant unmet medical needs.

• 

China accounts for more than 37% of global Osteoporosis population

• 

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

• 

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

• 

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

Uni-E4-Fc

Uni-E4-Fc (rExendin-4 Fc) is a long-acting version of Uni-E4 as a next generation rExendin-4 treatment. Uni-E4's half-life in the body is significantly extended by attaching an Fc fragment. As a result, Uni- E4-Fc will only require injection once every 2 or 3 weeks, greatly improving the treatment convenience to patients.

Uni-E4-Fc is currently in preclinical development stage.

Uni-EPO-Fc

Uni-EPO-Fc (rhEPO-Fc) is a new Class I drug candidate for the treatment of anaemia associated with chronic renal diseases, cancer related therapies or surgical blood loss. Uni-EPO-Fc is a long-acting version of EPO, a currently marketed treatment for anaemia that induces erythropoiesis (red blood cell production) by binding to the erythropoietin receptor on the red cell progenitor surface and activating a JAK2 signalling cascade. The half-life of rhEPO in the body is significantly extended by attaching a Fc fragment and rhEPO-Fc's long-acting formulation positions it strongly as a potential once-fortnightly treatment, an important advantage over the daily administration that EPO often requires. Pre-clinical trials of Uni-EPO-Fc have been completed and Uni-Bio Science is now undertaking a phase I study in China. The clinical studies of Uni-EPO-Fc are supported by the People's Republic of China's Ministry of Science and Technology following its selection as a '€œNew Key Drug Formulation'€ of the State's Major Science and Technology Project under the '€œEleventh Five-Year Plan'€.

• 

Uni-Bio Science Fc Fragment technology overcomes shortcoming of traditional IgG1 Fc technology

• 

Global rhEPO market is expected to reach USD11.9B in 2020*

• 

China rhEPO market is expected to reach USD477M by 2018, growing at 18.5% per year*

• 

Long-acting EPOs (once-weekly) are expected to demonstrate the highest growth globally*

• 

Increases patient compliance and convenience in an under-treated, growing patient population

*Frost and Sullivan (2015)

Second generation synthetic corticosteroid

Rhinex is a second generation synthetic corticosteroid for treatment of seasonal and perennial rhinitis with less than 0.1% systemic absorption. Rhinex is believed to be more efficient than oral anti-histamines.

• 

37% of people in the world suffer from seasonal and perennial rhinitis (WHO)

• 

Prevalence of allergic rhinitis in China: total prevalence is 34.3%, increasing with age below 30 years old (9.8% for children)

• 

Seasonal and perennial rhinitis

Anti-cholinergic agent for mydriasis and cycloplegia

Ocucyclo is an anti-cholinergic agent for mydriasis (dilation of pupil) and cycloplegia (paralysis of ciliary muscle for use in eyesight examination). It blocks the sphincter muscle of iris and the accommodative muscle of the ciliary body to cholinergic stimulation.

• 

Prevalence rate of uveitis: 0.15%

• 

2M patients with active and inactive uveitis in China

• 

Mydriasis and cycloplegia

Uni-E4

Uni-E4, 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.

Clinical studies have shown that Uni-E4 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-E4 phase III trial demonstrate that, when compared to insulin glargine, Uni-E4 can effectively decrease the body weight of diabetes patients through suppressing the appetite and prolonging gastrointestinal emptying time.'  Furthermore, Uni-E4 has also been shown to lower the risk of hypoglycemia and promoting β-cell regeneration, an important clinical advantage in managing Type 2 diabetes complications in the long term.

Uni-E4's potential as a new treatment has been recognised through the selection of Uni-E4 as a "€˜New Key Drug Formulation" of the State's Major Science and Technology Project under the '€œEleventh Five-Year Plan'€. Uni-E4 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.

Broadening Uni-E4'€™s potential

The Group is also in the process of developing innovative formulations and drug delivery devices for Uni-E4 to expand the value of the product offering by increasing compliance and convenience to users in both the short and long-term.

Our development team is also reviewing the potential to develop Uni-E4 in new indications where there are also significant unmet medical needs.

• 

Uni-Bio Science was awarded “Best Innovation” for Uni-E4 at the inaugural Hong Kong Business Listed Companies Award

• 

It is expected that 143 million people in China will have diabetes by 2035

• 

Uni-E4 is a cost-effective alternative for the growing diabetes burden in China

• 

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

Uni-PTH

Uni-PTH (Parathyroid hormone 1-34 analogue) 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. In clinical trials, Uni- PTH has been shown to be effective in stimulating new bone formation on quiescent bone surface. 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 China Food and Drug Administration in April 2015. 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

The Group is also in the process of developing innovative formulations and drug delivery devices for Uni-PTH to expand the value of the product offering by increasing compliance and convenience to users.

Our development team is also reviewing the potential to develop Uni-PTH in new indications where there are also significant unmet medical needs.

• 

China accounts for more than 37% of global Osteoporosis population

• 

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

• 

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

• 

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

Uni-E4-Fc

Uni-E4-Fc (rExendin-4 Fc) is a long-acting version of Uni-E4 as a next generation rExendin-4 treatment. Uni-E4'€™s half-life in the body is significantly extended by attaching an Fc fragment. As a result, Uni- E4-Fc will only require injection once every 2 or 3 weeks, greatly improving the treatment convenience to patients.

Uni-E4-Fc is currently in preclinical development stage.

Uni-EPO-Fc

Uni-EPO-Fc (rhEPO-Fc) is a new Class I drug candidate for the treatment of anaemia associated with chronic renal diseases, cancer related therapies or surgical blood loss. Uni-EPO-Fc is a long-acting version of EPO, a currently marketed treatment for anaemia that induces erythropoiesis (red blood cell production) by binding to the erythropoietin receptor on the red cell progenitor surface and activating a JAK2 signalling cascade. The half-life of rhEPO in the body is significantly extended by attaching a Fc fragment and rhEPO-Fc'€™s long-acting formulation positions it strongly as a potential once-fortnightly treatment, an important advantage over the daily administration that EPO often requires. Pre-clinical trials of Uni-EPO-Fc have been completed and Uni-Bio Science is now undertaking a phase I study in China. The clinical studies of Uni-EPO-Fc are supported by the People'€™s Republic of China'€™s Ministry of Science and Technology following its selection as a '€œNew Key Drug Formulation'€ of the State'€™s Major Science and Technology Project under the '€œEleventh Five-Year Plan'€.

• 

Uni-Bio Science Fc Fragment technology overcomes shortcoming of traditional IgG1 Fc technology

• 

Global rhEPO market is expected to reach USD11.9B in 2020*

• 

China rhEPO market is expected to reach USD477M by 2018, growing at 18.5% per year*

• 

Long-acting EPOs (once-weekly) are expected to demonstrate the highest growth globally*

• 

Increases patient compliance and convenience in an under-treated, growing patient population

*Frost and Sullivan (2015)

Second generation synthetic corticosteroid

Rhinex is a second generation synthetic corticosteroid for treatment of seasonal and perennial rhinitis with less than 0.1% systemic absorption. Rhinex is believed to be more efficient than oral anti-histamines.

• 

37% of people in the world suffer from seasonal and perennial rhinitis (WHO)

• 

Prevalence of allergic rhinitis in China: total prevalence is 34.3%, increasing with age below 30 years old (9.8% for children)

• 

Seasonal and perennial rhinitis

Anti-cholinergic agent for mydriasis and cycloplegia

Ocucyclo is an anti-cholinergic agent for mydriasis (dilation of pupil) and cycloplegia (paralysis of ciliary muscle for use in eyesight examination). It blocks the sphincter muscle of iris and the accommodative muscle of the ciliary body to cholinergic stimulation.

• 

Prevalence rate of uveitis: 0.15%

• 

2M patients with active and inactive uveitis in China

• 

Mydriasis and cycloplegia