{"id":9116,"date":"2025-08-25T17:18:16","date_gmt":"2025-08-25T09:18:16","guid":{"rendered":"https:\/\/chimebiologics.com\/?p=9116"},"modified":"2025-12-09T16:48:49","modified_gmt":"2025-12-09T08:48:49","slug":"chime-biologics-supports-the-bla-filing-of-polaris-group-in-u-s-fda-in-entering-the-substantive-review-stage","status":"publish","type":"post","link":"https:\/\/chimebiologics.com\/ja\/chime-biologics-supports-the-bla-filing-of-polaris-group-in-u-s-fda-in-entering-the-substantive-review-stage\/","title":{"rendered":"(English) Chime Biologics Supports the BLA Filing of Polaris Group in U.S. FDA in Entering the Substantive Review Stage"},"content":{"rendered":"

\u7533\u3057\u8a33\u3042\u308a\u307e\u305b\u3093\u3001\u3053\u306e\u30b3\u30f3\u30c6\u30f3\u30c4\u306f\u305f\u3060\u4eca\u3000English<\/a>\u3068 \u4e2d\u6587<\/a>\u3000\u306e\u307f\u3067\u3059\u3002 For the sake of viewer convenience, the content is shown below in this site default language. You may click one of the links to switch the site language to another available language.<\/p>

<\/p>\n

Chime Biologics Supports the BLA Filing of Polaris Group in U.S. FDA in Entering the Substantive Review Stage<\/strong><\/h1>\n

\"\"<\/p>\n

August<\/b><\/strong>\u00a0<\/b><\/strong>25<\/b><\/strong>, 2025, <\/b><\/strong>Wuhan<\/b><\/strong>, <\/b><\/strong>China<\/b><\/strong>\u00a0-\u00a0Chime Biologics<\/u><\/a>, a leading global CDMO that enables its partners' success in biologics, is proud to congratulate our valued partner, Polaris Group<\/u><\/a>\u00a0(TWSE:6550), on the progression of its Biologics License Application (BLA) with the U.S. Food and Drug Administration (FDA) into the substantive review stage.<\/p>\n

As the CDMO partner, Chime Biologics prepared the CMC CTD dossier and addressed the queries from U.S. FDA to support the rolling submission of Polaris Group\u2019s BLA to meet the stringent regulatory requirements in U.S. Chime Biologics is honored to receive a Certificate of Platinum Partnership (images below) from Polaris Group, acknowledging our critical role in supporting their BLA submission. This milestone further reinforces our position as a trusted partner of choice for global biopharmaceutical companies.<\/p>\n

\u201cWe are honored to support Polaris Group in reaching this critical milestone with the FDA,\u201d said Dr. <\/b><\/strong>Jimmy Wei, President of Chime Biologics<\/b><\/strong>. \u201cThis is not only an important moment for Polaris Group, but also a landmark achievement for Chime Biologics as we advance our mission to accelerate biologics development and manufacturing on a global scale.\u201d<\/p>\n

\"\"

Certificate of Platinum Partnership presented by Polaris Group to Chime Biologics for our contribution to their BLA submission milestone.<\/p><\/div>\n

A<\/b><\/strong>bout Polaris Group<\/b><\/strong><\/p>\n

Polaris Group is a multinational biotechnology company focused on developing novel anti-cancer therapies involved in every stage of the drug development process. The family companies in the Group harness structure-based drug design technology to create novel oncology therapies, conduct clinical studies at top-tier cancer centers worldwide and operate cGMP production facilities in Northern California, U.S. and China.\u00a0For more information, please visit\u00a0https:\/\/polarispharma.com\/<\/u><\/a>.<\/p>\n

About Chime Biologics<\/b><\/strong><\/p>\n

Chime Biologics is a leading global CDMO, focused on ensuring our customers' success in delivering innovative biologic medicines to patients across the world. Chime Biologics can support customers end to end, from pre-clinical support and cell line development through to clinical and commercial manufacturing of drug substance and drug product. Employing our innovative and state-of-the-art development and manufacturing capabilities and proven success in supporting our clients with their clinical and commercial authorizations across the globe, Chime Biologics is a true end-to-end solution provider for the biologics industry. With over 500 skilled employees, we share a common goal to make cutting-edge biomedicines affordable and accessible to patients worldwide, fulfilling our commitment to improving human health globally. For more information, please visit www.chimebiologics.com<\/u><\/a>.<\/p>\n

<\/p>\n<\/div><\/section><\/div>\n