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, 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 agnoist 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 hypoglycaemia and promoting ß-cell regeneration, an important clinical advantage in managing Type 2 diabetes complications in the long term.

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.

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

In response to increasing number of formulation choice to the market, the Group is now reviewing the competitive advantage of its powder formulation as well as speeding up the research progress for a next-generation liquid formulation of Uni-E4. 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 and explore the other reported treatment targets such as obesity and Alzheimer's disease, where there are also significant unmet medical needs.


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


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


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


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


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. 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. 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. We have also evaluated all ongoing clinical studies and the application will be transferred to China's Centre for Drug Evaluation for technical review by the end of 2017.

Broadening Uni-PTH'€s potential

Similar to Uni-E4’s development strategy, we are working on a liquid formulation, offering more choices to the clinicians and patients in China. 

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.


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


China accounts for more than 37% of global Osteoporosis population


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 (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 (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'€.


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


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


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*


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

*Frost and Sullivan (2015)


Acarbose is a small molecule drug used to treat diabetes mellitus type 2 and, in some countries, prediabetes. Acarbose inhibits a class of enzymes, known as glycoside hydrolases, required for digesting carbohydrates into glucoses. With the inhibition of enzyme, the patient would effectively absorb less glucose because the carbohydrates are not broken down into glucose molecules. For patients with Type II Diabetes, the therapeutic effect of Acarbose decreases blood glucose levels, achieving a reduction in HbA1c level.

Reimbursed under the NRDL, Acarbose is a lucrative drug with limited competitors in China with a market size of RMB 3.2B. Currently, small molecule drugs represent 49.4% market share of diabetes market in China, RMB23B in 2014, growing at 17.2% (2015-2035E). Diabetes one of the fastest growing disease in China due to sedentary lifestyle and aging population. And Acarbose’s unique mechanism is effective towards Asian patients because of their high-carbohydrate diet.

The Group's partner, Sun-Novo, has strong development track record in China. They currently hold 65 IND approvals, 2 NDA approvals for API, 2 NDA approvals for finished drugs. They are also the partner with a number of leading pharmaceutical companies (including Shanghai Pharma, CR).

The joint-research on Acarbose tablets' manufacturing process and development has begun in 2017.


Reimbursed under the NRDL with a market size of RMB 3.2B


Effective towards Asian patients' high-carbohydrate diet