Uni-Bio Science Group: The National Medical Products Administration Granted Marketing Approval for BOSHUTAI® (Acarbose Tablets) in China
HONG KONG SAR – EQS Newswire – 16 December 2020 – A fully integrated biopharmaceutical company — Uni-Bio Science Group Limited (the “Company”, together with its subsidiaries, the “Group”; Stock code: 00690.HK) is pleased to announce that BOSHUTAI® (Acarbose Tablets) has been granted approval for marketing in China by the National Medical Products Administration (“NMPA”) on 10 Nov 2020. The company has also passed GMP manufacturing inspection and is allowed to begin manufacturing of BOSHUTAI® on 10 December 2020. The approvals mean that the Company is qualified to produce and launch BOSHUTAI® as newly approved generic drug, which marks another milestone for the Company in the metabolic industry.
Uni-bio Science Group CEO Mr. Frank Zhao(left) and
Suzhou Yingli Executive Director Mr. Xu Honglei(right)
Uni-bio Science Group Head of sales and marketing Mr. An Wen Du given presentation on the commercialization strategy of BOSHUTAI®
BOSHUTAI® (Acarbose Tablets) is the Group’s fifth marketed product following GENETIME®, GENESOFT®, PINUP®, BOKANGTAI®. Next step, the Company will focus on the launch and successful commercialization of BOSHUTAI®. As manufacturing cost leadership is essential for the success of the product, the company is already working with a number of strategic partnerships across the supply chain to ensure BOSHUTAI® is manufactured at the lowest cost possible. Additionally, the Company successfully held the BOSHUTAI® launch conference on 11 December 2020, where more than 60 commercial partners attended the event.
Acarbose was first developed by Bayer in 1975 and launched in Switzerland in 1986 (trade name: Glucobay®). As the first FDA-approved alpha-glucosidase inhibitor in the world, it entered China in 1994 and is now recommended as a first-line drug for T2D. Acarbose is sold far better in China and Asia than in other western countries due to the high carbohydrate content in Asian cuisine.
Although BOSHUTAI® is the fifth Acarbose launched in China, the Group is still confident in taking market share for two reasons. Firstly, Acarbose has been marketed in China for more than 20 years, China’s Acarbose market is dominated by Glucobay®. Nevertheless, in recent years, the market share of Glucobay® is rapidly declining, while the market share of domestic-made counterparts is rising due to more affordable pricing. Moreover, BOSHUTAI® is expected to be included in the next national drug volume-based procurement, the stable supply of API and Acarbose Market Authorization Holder (“MAH”) strategy of the Group enables Acarbose cost leadership and decreases supply chain risk in the future. It is expected that at least three companies can potentially win the national procurement, where each winner enjoys approximately 30% market share of the whole centralized procurement market. According to the Chinese public healthcare institute sales data, Acarbose reached RMB 8.4 billion in sales in 2018, growing at double-digit CAGR in the past five years. If the Group successfully implements its strategy and win the national procurement, BOSHUTAI® will significantly and positively impact revenue in the coming few years.
About BOSHUTAI® (Acarbose Tablets)
BOSHUTAI® is the trade name of the acarbose tablets developed by Uni-Bio Science Group, which comes in two dosage strengths, 50mg/tablet and 100mg/tablet. Acarbose is clinically indicated for impaired glucose tolerance and diabetes type 2 patients to decrease post-prandial glucose level, listed as a first line therapeutic drug in the China Diabetes Prevention and Therapy Guide 2017, and listed as one of drugs in the National Essential Medicine List and National Basic Medical Insurance. Acarbose inhibits alpha glucosidase in the intestine to decrease glucose absorption, which is particularly suitable for Asian patients whom have high carbohydrate diets. According to International Diabetes Federation data, Diabetes population in China reached 114 million. The PRC diabetes drug market is expected to continue to grow quickly in the coming ten years due to drivers such as aging population, increasing diagnosis and treatment rate, and growing importance of chronic disease drug by the medical insurance policy in China. Acarbose already has the largest market share among oral hypoglycemic agents in China; In addition, Acarbose was listed in the 2nd round of China National Drug Centralized Procurement Scheme in the end in 2019, indicating high clinical value and large market size of Acarbose.
About Uni-Bio Science Group
Uni-Bio Science Group Limited is principally engaged in the research and development, manufacture and distribution of biopharmaceutical products. The research and development center 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 has two GMP manufacturing bases in Beijing and Shenzhen. The Group also has a highly efficient commercialization platform and marketing network. The Group focuses on the development of novel treatments and innovative drugs addressing the therapeutic areas of endocrine as diabetes and osteoporosis, ophthalmology and dermatology. Please visit the official website of Uni-Bio Science Group for more information: www.uni-bioscience.com/