Uni-Bio Science Group Receives BE Certification for PINUP® (Voriconazole Tablets) by the NMPA

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 PINUP® (Voriconazole Tablets) has
been successfully approved by the National Medical Products Administration
(“NMPA”) for Bioequivalence (“BE”) certification with the acceptance number of H20055751
(50mg). In order to meet the national requirements for improving the quality of
generic drugs, the Group launched the quality advancement and therapeutic
effect BE experiment in 2018. In August 2019, the Group had completed all the
BE experiments, and had submitted the results to the NMPA. The approval will facilitate
its hospital tenders and listings, especially in national procurement, to achieve
a larger market share in anti-fungal infection drug market. This approval is
very timely, Voriconazole has been included in the announcement for national
procurement in 8^th December 2020, and the Group’s PINUP ® will be
eligible to participate. Even though there are three manufactures that has
passed quality consistency evaluation for this product, there are only two
manufactures that has passed BE certification for the 50mg formulation, the
Group being one of them. Therefore, the Group is in a great position to quickly
expand its market share, supplying high quality Voriconazole without big
discounts in pricing.

PINUP ® (commonly known
as Voriconazole tablets) is a major drug for the treatment of severe fungal
infections. As the first line treatment recommended by clinical guidelines,
Voriconazole takes action by blocking the growth of the fungal cell wall, and
is widely used in oncology, hematology, respiratory, and ICUs patients who have
compromised immune systems.

According to IMS
statistics, the market size for China’s anti-fungal medicine in 2017 amounted
to RMB4.9 billion, of which Voriconazole accounted for the biggest share of
approximately 50%. The market value for anti-fungal medicines between 2014 and 2017
maintained a double-digit growth, a level that surpassed the growth of the
Chinese pharmaceutical market of 4%-9%. According to PDB and Menet, the percentage
of the orally-administered Voriconazole in all Voriconazole formulation is 37% in
2019 compared with 35% in 2017, representing an increasing trend in oral form
market. In recent years and foreseeable future, there is a continuing shift in
treatment paradigm towards oral Voriconazole due to its use as maintenance
therapy, as well as the convenient oral formulation against injection
formulation.