Good news | Haibu Pharmaceuti∏≤cal, Ibrutinib capsules acc‌ε↓epted by CDE

　    On January 11, 2023, the National↑←α Medical Products Administα'£$ration (CDE) accepted the registra≈α™tion application for the marketiβ₹π‍ng license of Ibrutinib capsules fro®γ₩‌m Beijing Haibu Pharmaceut↑₩ical Technology Co.,≤‌∏ Ltd. (Acceptance No.: CYHS2300103)↔±.

Project Introduction

　　Ibrutinib is the world↔☆'s first marketed BTK inhibitor use≥≈d for the treatment of mantle cel•β↑l lymphoma and chronic lymphocyti≠♣♠≤c leukemia. Pharmacyclics Lβ★↕©LC's Ibrutinib capsules, branded as 'Im∞φ≤bruvica', were approv">→≥ed by the FDA in November 20← λε13, with global sales reaching approximΩ↑✔→ately $9.8 billion in 2021. The o βriginal formulation 'Imbruvica' was ap₽≈‌proved for marketing in China in Augustπ↔♥↓ 2017, with domestic s ↔←ales of about 900 mil>§€lion RMB in 2021, showing>γ♠ a growing trend and a large market ®λΩshare.

　　The Ibrutinib active ph"↕↑armaceutical ingredien÷♥t developed by Haibu Pharmaceutical π®φis produced by Chongqing Boten ♣‍∑Pharmaceutical Technology ©₹Co., Ltd. The CDE registration w£δ¥§as completed on January 10,✔™™Ω 2022, and FDA DMF r♥♣egistration was completed on March 25,∑¶ 2022. The product quality meeπ♠★£ts domestic and internatσ ≈ional standards.

　　The Ibrutinib capsule×♠‍£s developed by Haibu Pharmaceutical a←®re consistent in quality and effi♦♥≥÷cacy with the reference formulation 'Im↑ bruvica', and the registration apΩ✘♠₽plication for marketing license was a♠✘Ω↓ccepted by CDE on January 11, 20↕©β>23.

Contact Information for Chemica ∑l Drug CROMs. Zhang 18611388630

Contact Information for PI AssociationMr. Yang 13611125266