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 8th 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. 


About PINUP® (Voriconazole Tablets)

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.


About Uni-Bio Science Group
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/

SOURCE:

Uni-Bio Science Group Limited

CATEGORY:

Medical

 
PUBLISHED ON:

16 Dec 2020

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