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HONG KONG, CHINA - Media
OutReach - 18 April 2019 – A fully integrated
biopharmaceutical company — Uni-Bio Science Group Limited (“Uni-Bio
Science”, together with its subsidiaries, referred to as the “Group”; Stock
code: 0690.HK), is pleased to announce that a wholly-owned
subsidiary of the Company, Beijing Genetech Pharmaceutical Co., (“Beijing
Genetech Pharm”), its high-precision industrialization project of rhPTH1-34 for injection has been successful certified and approved by
Zhongguancun Science Park Management Committee (“the Committee”), which has
undertaken the establishment and declaration of major frontier original technological
achievements transformation and industrialization projects, according to The Announcement on
High-precision Industrial Cultivation Project in Zhongguancun Demonstration
Zone Park (2nd batch) in 2018. After
the project was launched, the first batch of government support funds were
received in April 2019. Based on The
Circular on the Collection of high-precision Industry Cultivation Projects in
Zhongguancun National Independent Innovation Demonstration Zone Branches in
2018 issued by the
Committee in May 2018, the declaring units selected for this project can
receive financial support with a total amount of not more than 10 million yuan,
and can support for up to three consecutive years.
http://zgcgw.beijing.gov.cn/zgc/zwgk/tzgg/180307/index.html
The company has signed with the Committee
the Agreement of
Support Fund Use for Zone Major Frontier Original Technical Achievements
Transformation and Industrialization Project in Zhongguancun National
Independent Innovation Demonstration, and will accept the phased supervision and performance assessment by
the Committee for the project in strict accordance with the provisions of the
agreement.
The special Cultivation Project is derived
from the Several
Measures for Accurately Supporting the Construction of Major Frontier Projects
and Innovation Platforms in the National Independent Innovation Demonstration
Zone of Zhongguancun
(ZKYF[2017] No.13) and Implementation Measures (ZKYF [2018] No. 17), the Committee and the
district governments (sub-parks) jointly search and support for around 10
high-tech industries and key industries in the Zhongguancun demonstration area,
specifically supporting key core technology breakthroughs, industrial
innovation development and agglomeration in such segments as artificial
intelligence, 5th-generation communication technology, biomedicine, and
high-end medical equipment in Beijing.
Our project of recombinant human parathyroid
hormone (Teriparatide) rhPTH (1-34) for injection and its industrialization,
which is constructed by genetic recombination technology and registered the
class VII new drug for the treatment of osteoporosis, having major core
technologies and owning independent intellectual property rights, belongs to
the biomedical industry. This time it is capable to stand out by the following
points:
1) Rediscovering the mechanism of
traditional osteoporosis treatment drugs to form its unique clinical efficacy
2) Breakthrough of soluble protein’s low
expression technology
3) High-density fermentation core technology
innovation and its process establishment
4) Beyond the Polypeptide chemical synthesis
process, establishing genetic engineering biosynthetic method
5) The core technologies of reconstitution
and injection integration
All aspects mentioned above and many other
ones are at the leading international level. Uni-PTH is one of the few wholly
biological expression preparations among the same kind of domestic products.
Compared with the chemical synthesis dosage form introduced by most of the
other brands, it has made a qualitative leap in technology and scientific
research. This is also true compared to the original drug. It is expected that
the launch of this product will have a strong driving effect on related
industrial development and filled domestic gaps.
It is noted that rhPTH (1-34) is the only known biological agent which
can effectively promote bone formation, increase bone mineral density, improve
bone structure and reduce the incidence of vertebral and extra-vertebral
fractures. Our group has funded the development and research of this product
for more than 10 years from the project establishment to the completion of
clinical trials with investment of hundreds of millions. It is the first
government-led industrialized production and listing project of our company.
Moreover, considering the convenience and advanced methods of medication for
patients, it has a cluster of innovative products portfolio outputs, namely its
2nd generation Uni-PTH in injection formulation and the 3rd generation of Uni-PTH
oral dosage form which will provide more comfortable choices for patients in
PRC.
Nowadays, the competition for innovative
pharmaceuticals in the world is becoming increasingly fierce. The new round of
drug regulatory reforms continues to deepen and the series of policies further
encourage companies to develop innovative drugs. The company actively responds
to relevant national reform policies and deeply cultivates biopharmaceutical
R&D technologies and capabilities on Platform construction, especially Uni-PTH’s
innovative dosage form combination will be the biggest support point for the
project to be industrialized and marketed as soon as possible, helping Uni-PTH
to firmly occupy the treatment market share of osteoporosis
in the future with effective, safe, convenient and non-invasive advantages. In
the first place. From the perspectives of pharmacology, formulation innovation,
and clinical indications, it is aimed at the increasing aging of Chinese
society, especially the elderly and postmenopausal women, and the widespread
osteoporosis caused by the modern society’s diet and work schedule. As always,
the Group will be committed to the development of bio-innovative drug solutions
that are minimally invasive, cost-effective, and easy to handle, and benefit
the livelihood of the vast patient population.
This approval and supporting indicates that
the industrialization project has important clinical significance and great
commercial potential. For the high-tech industry financing grants, the Group
will focus on the optimization and upgrading of the production line of the
product, the protection of independent intellectual property rights and major
core technologies, and the market promotion to drive its official launch and
realize its social value in time.
Uni-Bio Science Group Limited is principally
engaged in the research and development, manufacture and distribution of
pharmaceutical 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
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.
Uni-Bio Science Group Limited
was listed on the Main Board of the Hong Kong Stock Exchange on November 12,
2001. Stock code: 0690.
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