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

December 16, 2020 - 05:31
Uni-Bio Science Group Receives BE Certification for PINUP® (Voriconazole Tablets) by the NMPA

HONG KONG SAR - EQSNewswire - 16 December 2020 -  A fully integrated biopharmaceuticalcompany -- Uni-Bio Science GroupLimited (the "Company", together with its subsidiaries, the "Group"; Stockcode: 00690.HK) is pleased to announce that PINUP® (Voriconazole Tablets) hasbeen 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 ofgeneric drugs, the Group launched the quality advancement and therapeuticeffect BE experiment in 2018. In August 2019, the Group had completed all theBE experiments, and had submitted the results to the NMPA. The approval will facilitateits hospital tenders and listings, especially in national procurement, to achievea larger market share in anti-fungal infection drug market. This approval isvery timely, Voriconazole has been included in the announcement for nationalprocurement in 8th December 2020, and the Group's PINUP ® will beeligible to participate. Even though there are three manufactures that haspassed quality consistency evaluation for this product, there are only twomanufactures that has passed BE certification for the 50mg formulation, theGroup being one of them. Therefore, the Group is in a great position to quicklyexpand its market share, supplying high quality Voriconazole without bigdiscounts in pricing.


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


According to IMSstatistics, the market size for China's anti-fungal medicine in 2017 amountedto RMB4.9 billion, of which Voriconazole accounted for the biggest share ofapproximately 50%. The market value for anti-fungal medicines between 2014 and 2017maintained a double-digit growth, a level that surpassed the growth of theChinese pharmaceutical market of 4%-9%. According to PDB and Menet, the percentageof the orally-administered Voriconazole in all Voriconazole formulation is 37% in2019 compared with 35% in 2017, representing an increasing trend in oral formmarket. In recent years and foreseeable future, there is a continuing shift intreatment paradigm towards oral Voriconazole due to its use as maintenancetherapy, as well as the convenient oral formulation against injectionformulation. 


About PINUP® (Voriconazole Tablets)

PINUP ®(commonly known as Voriconazole tablets) is a major drug for the treatment ofsevere fungal infections. As the first line treatment recommended by clinicalguidelines, Voriconazole takes action by blocking the growth of the fungal cellwall, and is widely used in oncology, hematology, respiratory, and ICUspatients who have compromised immune systems.


About Uni-Bio Science Group

Uni-Bio Science Group Limited is principally engaged inthe research and development, manufacture and distribution of biopharmaceuticalproducts. The research and development center is fully equipped with a completesystem for the development of genetically-engineered products with a pilotplant test base which is in line with NMPA requirements. The Group has two GMPmanufacturing bases in Beijing and Shenzhen. The Group also has a highlyefficient commercialization platform and marketing network. The Group focuseson the development of novel treatments and innovative drugs addressing thetherapeutic areas of endocrine as diabetes and osteoporosis, ophthalmology anddermatology. Please visit the official website of Uni-Bio Science Group formore information: www.uni-bioscience.com/

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