Uni-Bio Group (HK690)’s Uni-PTH (Teriparatide) High-Precision Industrialization Project Was Successfully Approved

Focus on the Transformation of Major Frontier Achievements Targeting the Tens of Billions Osteoporosis Market

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.