Good news | Haibu Pharmaceutical, Ibrutinib capsules accepted by CDE

　    On January 11, 2023, the National Medical Products Administration (CDE) accepted the registration application for the marketing license of Ibrutinib capsules from Beijing Haibu Pharmaceutical Technology Co., Ltd. (Acceptance No.: CYHS2300103).

Project Introduction

　　Ibrutinib is the world's first marketed BTK inhibitor used for the treatment of mantle cell lymphoma and chronic lymphocytic leukemia. Pharmacyclics LLC's Ibrutinib capsules, branded as 'Imbruvica', were approved by the FDA in November 2013, with global sales reaching approximately $9.8 billion in 2021. The original formulation 'Imbruvica' was approved for marketing in China in August 2017, with domestic sales of about 900 million RMB in 2021, showing a growing trend and a large market share.

　　The Ibrutinib active pharmaceutical ingredient developed by Haibu Pharmaceutical is produced by Chongqing Boten Pharmaceutical Technology Co., Ltd. The CDE registration was completed on January 10, 2022, and FDA DMF registration was completed on March 25, 2022. The product quality meets domestic and international standards.

　　The Ibrutinib capsules developed by Haibu Pharmaceutical are consistent in quality and efficacy with the reference formulation 'Imbruvica', and the registration application for marketing license was accepted by CDE on January 11, 2023.

Contact Information for Chemical Drug CROMs. Zhang 18611388630

Contact Information for PI AssociationMr. Yang 13611125266