{"id":10224,"date":"2020-12-16T04:40:00","date_gmt":"2020-12-16T04:40:00","guid":{"rendered":"https:\/\/eodishasamachar.com\/en\/2020\/12\/16\/uni-bio-science-group-receives-be-certification-for-pinup-voriconazole-tablets-by-the-nmpa\/"},"modified":"2020-12-16T04:40:00","modified_gmt":"2020-12-16T04:40:00","slug":"uni-bio-science-group-receives-be-certification-for-pinup-voriconazole-tablets-by-the-nmpa","status":"publish","type":"post","link":"https:\/\/eodishasamachar.com\/en\/2020\/12\/16\/uni-bio-science-group-receives-be-certification-for-pinup-voriconazole-tablets-by-the-nmpa\/","title":{"rendered":"Uni-Bio Science Group Receives BE Certification for PINUP\u00ae (Voriconazole Tablets) by the NMPA"},"content":{"rendered":"<p> \n<\/p>\n<div id=\"\">\n                            <!--<a class=\"format-txt\" href=\"{baseURL}\/View\/{release.id}?_download=1\">View this article in .txt format<\/a>--><\/p>\n<p class=\"Default\">HONG KONG SAR &#8211; EQS<br \/>\nNewswire &#8211; 16 December 2020 &#8211;\u00a0 A fully integrated biopharmaceutical<br \/>\ncompany &#8212; <a href=\"http:\/\/www.uni-bioscience.com\/\">Uni-Bio Science Group<br \/>\nLimited<\/a> (the &#8220;Company&#8221;, together with its subsidiaries, the &#8220;Group&#8221;; Stock<br \/>\ncode: 00690.HK) is pleased to announce that PINUP\u00ae (Voriconazole Tablets) has<br \/>\nbeen successfully approved by the National Medical Products Administration<br \/>\n(&#8220;NMPA&#8221;) for Bioequivalence (&#8220;BE&#8221;) certification with the acceptance number of H20055751<br \/>\n(50mg). In order to meet the national requirements for improving the quality of<br \/>\ngeneric drugs, the Group launched the quality advancement and therapeutic<br \/>\neffect BE experiment in 2018. In August 2019, the Group had completed all the<br \/>\nBE experiments, and had submitted the results to the NMPA. The approval will facilitate<br \/>\nits hospital tenders and listings, especially in national procurement, to achieve<br \/>\na larger market share in anti-fungal infection drug market. This approval is<br \/>\nvery timely, Voriconazole has been included in the announcement for national<br \/>\nprocurement in 8<sup>th<\/sup> December 2020, and the Group&#8217;s PINUP \u00ae will be<br \/>\neligible to participate. Even though there are three manufactures that has<br \/>\npassed quality consistency evaluation for this product, there are only two<br \/>\nmanufactures that has passed BE certification for the 50mg formulation, the<br \/>\nGroup being one of them. Therefore, the Group is in a great position to quickly<br \/>\nexpand its market share, supplying high quality Voriconazole without big<br \/>\ndiscounts in pricing.<\/p>\n<p class=\"Default\">PINUP \u00ae (commonly known<br \/>\nas Voriconazole tablets) is a major drug for the treatment of severe fungal<br \/>\ninfections. As the first line treatment recommended by clinical guidelines,<br \/>\nVoriconazole takes action by blocking the growth of the fungal cell wall, and<br \/>\nis widely used in oncology, hematology, respiratory, and ICUs patients who have<br \/>\ncompromised immune systems.<\/p>\n<p class=\"Default\">According to IMS<br \/>\nstatistics, the market size for China&#8217;s anti-fungal medicine in 2017 amounted<br \/>\nto RMB4.9 billion, of which Voriconazole accounted for the biggest share of<br \/>\napproximately 50%. The market value for anti-fungal medicines between 2014 and 2017<br \/>\nmaintained a double-digit growth, a level that surpassed the growth of the<br \/>\nChinese pharmaceutical market of 4%-9%. According to PDB and Menet, the percentage<br \/>\nof the orally-administered Voriconazole in all Voriconazole formulation is 37% in<br \/>\n2019 compared with 35% in 2017, representing an increasing trend in oral form<br \/>\nmarket. In recent years and foreseeable future, there is a continuing shift in<br \/>\ntreatment paradigm towards oral Voriconazole due to its use as maintenance<br \/>\ntherapy, as well as the convenient oral formulation against injection<br \/>\nformulation.\u00a0 <\/p>\n<\/p><\/div>\n\n<br \/><a href=\"https:\/\/www.media-outreach.com\/release.php\/View\/58478#Contact\">Source link <\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>HONG KONG SAR &#8211; EQS Newswire &#8211; 16 December 2020 &#8211;\u00a0 A fully integrated biopharmaceutical company &#8212; Uni-Bio Science Group Limited (the &#8220;Company&#8221;, together with its subsidiaries, the &#8220;Group&#8221;; Stock code: 00690.HK) is pleased to announce that PINUP\u00ae (Voriconazole Tablets) has been successfully approved by the National Medical Products Administration (&#8220;NMPA&#8221;) for Bioequivalence (&#8220;BE&#8221;) certification &hellip;<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[60],"tags":[],"_links":{"self":[{"href":"https:\/\/eodishasamachar.com\/en\/wp-json\/wp\/v2\/posts\/10224"}],"collection":[{"href":"https:\/\/eodishasamachar.com\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/eodishasamachar.com\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/eodishasamachar.com\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/eodishasamachar.com\/en\/wp-json\/wp\/v2\/comments?post=10224"}],"version-history":[{"count":0,"href":"https:\/\/eodishasamachar.com\/en\/wp-json\/wp\/v2\/posts\/10224\/revisions"}],"wp:attachment":[{"href":"https:\/\/eodishasamachar.com\/en\/wp-json\/wp\/v2\/media?parent=10224"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/eodishasamachar.com\/en\/wp-json\/wp\/v2\/categories?post=10224"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/eodishasamachar.com\/en\/wp-json\/wp\/v2\/tags?post=10224"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}