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.
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.
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.
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/
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