In this section, you check the frequently asked questions that investors often ask for Uni-Bio Science Group.
Check our answer to solve all your curiosity.
Uni-Bio Science Group is a leading Chinese biopharmaceutical healthcare company engaged in the research, development, production and commercialisation of biopharmaceuticals for the Chinese healthcare market. The Company is headquartered in Hong Kong and is listed on the main board of the Stock Exchange of Hong Kong Limited (HKEx stock code: 0690). Uni-Bio Science has developed a strong competitive portfolio of market-leading products in diabetes, ophthalmology and dermatology across China. Our products are manufactured at our state-of-the-art cGMP certified plants in Beijing and Shenzhen.
The Company is also committed to developing next-generation innovative therapies and have a growing pipeline of drug candidates that with “blockbuster” potential that are complementary to its existing portfolio.
Uni-Bio Science is a leading Chinese biopharmaceutical healthcare company engaged in the research, development, production and commercialisation of biopharmaceuticals for the Chinese healthcare market. We are committed to the research and development, commercialisation and manufacturing of innovative drugs to address the unmet medical needs in China. We currently manufacture and commercialise four marketed drugs:
1. GeneTime® (recombinant human epidermal growth factor liquid for external use), a dermatology drug, mainly used for burns and wound healing, and is one of the leading products in the China. The drug is on the national reimbursement drug list (NRDL);
2. GeneSoft® (recombinant human epidermal growth factor derivative eye drops), an ophthalmology drug, mainly used for ophthalmic surgeries and ophthalmic wound healing. We are in the process of applying for NRDL listing;
3. Pinapu® (Voriconazole), an anti-infective drug, mainly used for treating fungal infection, which is also a national reimbursement drug; and
4. Mitiglinide is a best-in-class prescription oral drug for the treatment of type 2 diabetes by premise of lowering blood glucose content. The drug was recently included into the 2017 NRDL.
GeneTime® and GeneSoft® are both biologics manufactured by Shenzhen Watsin, while Pinapu® is a chemical drug manufactured by Beijing Genetech.
In addition, Uni-Bio Science has a growing pipeline of drug candidates that with “blockbuster” potential that are complementary to its existing portfolio of marketed therapies.
The Company’s lead programmes in development include Uni-PTH (Recombinant Human Parathyroid Hormone 1-34) for the treatment of osteoporosis and Uni-E4 - a next-generation drug for the treatment of Type 2 diabetes.
Uni-PTH is the only drug class which has been shown to increase bone mass density, reduce bone fracture and effectively manage ostealgia (bone pain). It has completed phase III clinical trials, and its New Drug Application was accepted by the China Food and Drug Administration (CFDA) in April 2015. It is expected to be registered by mid-2017.
In clinical studies, Uni-E4 has been shown to be an effective treatment for Type-2 diabetes in addition to relieving obesity in overweight patients, lowering the risk of hypoglycemia and promoting β-cell regeneration. It has completed phase III clinical trials and Uni-Bio Science expects to submit a New Drug Application through the accelerated “green channel” shortly and for the product to be registered by mid-2017.
Given the large number of patients suffering from osteoporosis and diabetes in China, the Company has full confidence in the potential of these two new drugs.
According to the Stock Exchange Industry Classification System, the Company belongs to pharmaceutical sector under Health & Personal Care. Under Wind’s classification, the Company belongs to the biotechnology sector.
As at 31 December 2015, Mr. TONG Kit Shing, Chairman of the Board, holds approximately 21.14% (included issued ordinary shares and underlying shares) of the shares of the Company (calculation basis of 5,049,030,129 shares in issue as at the date) registered in the name of and beneficially owned by him or Automatic Result Limited; Mr. Kingsley LEUNG, Executive Director, holds approximately 21.03% (included issued ordinary shares and underlying shares) of the shares of the Company (same as above) registered in the name of and beneficially owned by him or Lord Profit Limited, and Overseas Capital Assets Limited, an institutional investor, holds approximately 15.19% (included issued ordinary shares and underlying shares) of the shares of the Company(same as above). The remaining shares of the Company are held by institutional and retail investors.
Overseas Capital Assets Limited is an investment company. Its stake in Uni-Bio Science is categorized as financial investment and is not involved in the daily operations of our business.
As of 31 December 2016, the Company employed 311 staff, including 76 staff in the PRC R&D department, 137 staff in the PRC commercial offices, 88 staff in the PRC production department, and 10 staff in Hong Kong. Apart from the full-time employees in the PRC sales offices, the Company also has 171 regional distributors.
The Board of directors of the Company (the “Board”) is comprised of two Executive Directors and three Independent Non-executive Directors.
Uni-Bio Science currently commercialises its products in Mainland China, with presence in all 22 provinces, four municipalities and five autonomous regions. Domestic sales currently account for 100% of our revenue from pharmaceutical products and the Company aim to expand into the international market in the future.
The Company focuses on the research and development of innovative treatments in diabetes (including other metabolic diseases), ophthalmology and dermatology , with priority in developing Class I & VII prescription drugs. Uni-Bio Science’s Class I prescription new drugs in development include Uni-E4 for treating of Type 2 diabetes and rhEPO-Fc (Recombinant Human Erythropoietin-Fc) for the treatment of anemia, and the Class VII prescription new drug includes Uni-PTH used for treating osteoporosis.
GeneTime® (recombinant human epidermal growth factor, an external-use spray) can be applied for burn wounds (including superficial or deep second-degree burns), small residual wounds, different kinds of chronic ulcer wounds (including vascular, radiation, diabetes ulcers), surgical wounds and new skin donor site wounds etc. At present, it is the only epidermal growth factor spray in China. Its aseptic packaging allows easy and convenient usage, reducing the possible repercussions from misuse.
GeneSoft® (recombinant human epidermal growth factor derivative eye drop) is used for corneal epithelium defect caused by different reasons, including corneal mechanical injury, various corneal surgery treatments, mild dry eye with superficial punctate keratopathy, and minor chemical burns etc. Our patented formula with three additional amino acids at the amino terminal in the epidermal growth factor derivative substantially enhances its molecular stability, allowing the drug to be stored in room temperature.
Pinapu® (Voriconazole), a broad-spectrum triazole anti-fungus drug used for treating invasive aspergillosis, severe invasive infections caused by fluconazole-resistant yeasts (including candida krusei), and severe infections caused by scedosporium species and fusarium species. The drug can be used to treat ongoing and possibly life-threating infections among immunosuppressive patients.
Mitiglinide is an insulintropic, glinide class drug used for treating type 2 diabetes. It has a fast onset of action, as well as a reduced risk of post-prandial hypoglycemia and dyslipidemia compared to other glinides in the market. These makes it suitable for elderlies, which account for 63% of the type 2 diabetic patients. The drug is currently sold under brand name Bokangtai® in China.
Uni-PTH is a Class VII prescription new drug used to treat osteoporosis, stimulate bone growth, improve bone density and lower fracture risk. The China osteoporosis drug market is estimated to reach RMB15.5 billion in 2015, approximately one fifth of the global market.
Uni-E4 is for treating Type 2 diabetes. Apart from effectively controlling the blood glucose level, it is also effective for diabetes affiliated obesity to ease the patients’ overweight condition. According to IMS, it is estimated that 30% of the diabetes patients are overweight, and the domestic diabetes drug market will reach RMB26 billion in 2017. Currently, 11.6% of the Chinese adults suffer from diabetes, costing the government RMB173 billion per year, creating a tremendous strain on the country’s public health system and a pressing need for effective treatment solutions.
The Company has its own sales team and engages more than 150 sales representatives. Our sales network covers 1,000 hospitals. We plan to expand our own sales team and seek opportunities to collaborate with major pharmaceutical companies to market our products, with the aim to expand our coverage to 3,000 hospitals.
Yes. Currently, Uni-Bio Science is working with two partners to commercialize their drug products. In 2015, Uni-Bio Science signed a partnership to acquire a new oral anti-diabetes drug called Mitiglinide from Jiangsu Hansoh. Mitiglinide has been approved by the CFDA to treat type 2 diabetes in a first- and second- line setting. Uni-Bio Science owns all rights to the product, and Jiangsu Hansoh will continue supplying drug to Uni-Bio Science till technology transfer is complete. In 2014, Uni-Bio Science signed a cooperative partnership agreement with a Korean company, Samil Pharmaceuticals, and has become an exclusive distributor for the company’s four drug products. The term of the agreement is 8 years. The agreement is renewable upon maturity for another 4 years .
1) Rhinex nasal spray: second generation anabolic steroids indicated for seasonal rhinitis and perennial rhinitis treatment
2) Ocucyclo: a drug indicated for mydriasis and cycloplegia
3) Lantanoprost: indicated for treating primary open angle glaucoma and ocular hypertension
4) Allenol eye drop: indicated for treating allergic conjunctivitis
For the twelve months ended 31 December 2016, the Company recorded an overall revenue of approximately HK$146.5 million, representing a strong increase of 18.7% (normalized growth: 25.8%) as compared with approximately HK$123.4 million recorded in the twelve months ended 31 December 2015. In particular, the sales of in-house chemical pharmaceutical product Pinapu® reached HK$60.5 million, representing a 46.3% (normalized growth: 54.4%) year-on-year growth. The sales of in-house biological pharmaceutical products increased by 4.9% (normalized growth: 10.7%) from last corresponding year to HK$86.0 million, representing approximately 58.7% of total consolidated sales. Gross profit margins remains constant at around 84.6%.
Total Research & Development costs charged for 2016, included capitalization to intangible assets of HK$7.9 million, was approximately HK$26.7 million. This cost represents 46.3% of total revenue of the corresponding year, an increase from 29.6% in the previous year. Most of which was related to the final phase III clinical trial payments and industrialization cost before commercialization. As the Group develops new technology and its pipeline, R&D costs may fluctuate year-to-year due to the cost stage of the respective development project..
During the year, the Company’s losses narrowed from HK$59.7 million in the last corresponding year to HK$55.7 million, representing a decrease of 6.8% between both years. The magnitude of decrease is very significant, mainly attributed from the growth of sales and reduction of general and administrative expenses. The Group is still showing a loss from operations mostly due to depreciation on fixed assets and amortization of intangible assets and prepaid lease payment, totaling HK$28.7 million, a 12.0% decreased from last year’s loss. The majority of these expenses relate to the Group’s heavy investment in plant and machinery to adhere to the new China Good Manufacturing Practice standards, and development in advance of the commercialization of its pipeline products (Uni-PTH and Uni-E4).
As of 31 December 2016, the Company’s bank balance and cash amounted to approximately HK$78.1 million. The Company’s financing need depends on the cooperation forms and progress of our projects. Specifically, we may cooperate with our partners in different ways. For example, we may consider acquiring the patents for self-operation, or otherwise adopting a profit-sharing model for certain products, the need for cash flow of which may vary from case to case. Overall, the Company enjoys sound operations at present and our financing need depends on future funding requirement. We will closely monitor the market conditions and explore the best alternative when needs arise.