A fully integrated biopharmaceutical company – Uni-Bio Science Group Limited, is pleased to announce its interim results for six months ended 30 June 2020 (the “Period”). During the Period, the Group recorded a turnover of HK$67.4 million, representing a decrease of approximately 30.7% year-on-year. It is mainly attributable to substantial decrease in sales recorded from February to April due to the limited hospital services and decrease patient flow during the COVID-19 pandemic. Nevertheless, the sales rebound significantly in May and June, which exceeded the monthly performance of the same period of last year, showing a V-curve market recovery, operating profit from marketed pharmaceutical products reached HK$1.7 million, representing an increase of 126.6%. Excluding the one-off gains of HK$65.9 million from the disposals of a subsidiary and material assets in the first half of 2019, there was a improvement of HK$9.5 million for the Period, from a loss of HK$21 million in first half of 2019 to a loss of HK$11.5 million in the first half of 2020.
The Group has numerous innovative biologic drugs and quality generic products undergoing late stage R&D. Amid the pandemic, many of these projects have not been significantly impacted.
High Quality Generic Products
Pinup® (voriconazole) has completed all Bioequivalence (“BE”) experiments, which will obtain BE certification in the second half of 2020. Pinup is expected to become the second BE approved voriconazole in China. With only a limited numbers of competitors in the market, passing BE will provide Pinup® solid competitive advantages. On the other hand, Bokangtai® (“Mitiglinide”), a first and/or second line of treatment for the Type 2 Diabetes, is currently undergoing BE studies in collaboration with Jiangsu Hansoh Pharmaceutical. The Group expects to submit the results to the National Medical Products Administration (“NMPA”) at the end of 2020 and obtain BE certification in the second half of 2021. Bokangtai® is expected to be the first Mitiglinide to be BE certified in the market, therefore enjoying enormous market potential.
The NMPA officially accepted the Group’s application for registering Boshutai® (“Acarbose”) as a Category IV chemical drug. Acarbose has completed its production evaluation in July 2020. It is expected that Acarbose will be launched into the market within the next three to six months. To compete with competitors in the national volume-based procurement program, the Group partnered with Sinopharm Weiqida and Suzhou Yingli to lower its manufacturing cost and optimize its cost structure. The management believes that cost leadership is the key for generic drugs to succeed in the PRC market.
Innovative Biologic Programs
Uni-PTH is the only class of anabolic agent which can actively increase bone density and reduce the chance of vertebral and hip and has very limited competition in the PRC market. Supplementary information of Uni-PTH lyophilised powder injection was submitted in December 2019, and is currently awaiting production evaluation from the NMPA, which was originally expected in the second half of 2020. However, due to the Pandemic and strict lockdown regulations in Beijing, the NMPA has pushed the evaluation to a later date. Based on updated timelines, the Group expects the registration approval of Uni-PTH lyophilised powder injection in the first half of 2021. Nevertheless, there has been significant progress in the 2nd generation liquid formulation Uni-PTH, advancing to a significant milestone where the application of clinical trial exemption was submitted in April 2020. If approved, development of liquid form Uni-PTH would be significantly accelerated.
Finally, the application for clinical trial of Recombinant GLP-1 Injection (“Uni-GLP”) has been approved by the NMPA on 14 July 2020. The Group is going to carry out bridging clinical research and phase III clinical trials directly in the second half of 2020. Uni-GLP is the first biologically expressed GLP-1 agent in the world. Due to its higher technical requirement, the product will not be easily copied and enjoy greater advantages in pricing as compared with chemically synthesized GLP-1. The product also enjoys the benefits from stable active pharmaceutical ingredients supply and costs as no external procurement is required. Coupled with clinical advantages such as an improved safety profile, Uni-GLP has the potential of becoming a leading product in the blue ocean GLP-1 market of China.
The resumption of regular hospital services and patient inflow in the second half of 2020 will continue to drive sales recovery of marketed products. As social distance may still be a concern in over-crowed top tier hospitals, the Group has been putting more resources to expand networks to lower-tier hospitals and cities. In addition, social distancing and travel limitations brought by the COVID-19 outbreak have greatly changed the behavior of patients and consumers. The demands for online medical consultation and pharmacies have increased. As a result, the Group has taken proactive steps to pioneer new online business models. This includes the Group’s recently formed collaboration with Medlink, which is expected to become another driver of GeneTime® sales as well as other products in the future.
Looking into the future, Mr. Kingsley Leung, Chairman of Uni-Bio Science Group said, “We are actively diversifying our product portfolio. Antibody drug market has been growing in recent years. the Group is investigating antibody drug opportunities in metabolic, dermatology and ophthalmology indications. By collaborating with strategic partners, the Group will create a network of new technologies, resources and pharmaceutical professionals, in order to co-develop next generation, best-in-class antibody drugs in the above fields. Besides, we are also planning to expand our production capacity by establishing a new production site for GeneTime® and GeneSoft® in Beijing, which is expected to launch production in 2023. All in all, we are planning the next phase of the company’s development, especially as most of our current self-developed products are about to enter the market.”
About Uni-Bio Science Group Limited
Uni-Bio Science Group Limited is principally engaged in the research and development, manufacture and distribution of pharmaceutical products. The research and development centre is fully equipped with a complete system for the development of genetically-engineered products with a pilot plant test base which is in line with NMPA requirements. The Group also has two GMP manufacturing bases in Beijing and Shenzhen. The Group is focused on the development of novel treatments and innovative drugs addressing the therapeutic areas of diabetes, ophthalmology and dermatology.