[Exciting News] Haibu Pharmaceutica ÷¶l's Ibrutinib Capsule≥≥&s have received the second do>®₩mestic drug registration approval.π♦¥"
Classification:
Company News
Recent Events
Release time:
2024-12-18
Recently, the Ibrutinib capsu≤φ× les (140mg) independently deve§•¥loped by Haibu Pharmaceutical have π∞≠obtained production approvalδ×, making it the second comp ¥₽any in China to receive approvβεal for this product after €€→ Xiansheng Pharmaceu∑♦≈tical.
Both the raw material an>£•d formulation of Ibrutinib are proj•↑εects independently initiated,→±• researched, developed, and regβ±istered by Haibu. Currently, the Ibr★₽∑utinib raw material ha♠÷γs been filed with the FDA DMF in t×★★he United States, an >€d the domestic CDE has↑•γ approved the transfer to "A"; the Ω©≥ MAH qualification for Ibrutin↔∏ib capsules has been successfully trans αΩferred.
01. Overview of Ibrutinib
Ibrutinib (Ibrutinib) is the world's >αfirst approved BTK inhibitor. It c ₹♥ovalently binds to the cyst↕πeine residue at the activσ₩e site of BTK, inhibiting the activ←↓ ♥ation of the B cell signaling pathway$γ, thereby significantly suppressing B cπ→×<ell activity. In clini★α&♦cal applications, Ibrutinib has shoα∞§wn outstanding efficacy in pε<γ↔atients with B cell lymphoma, especi®≤π↕ally those with refractor≠₩y and relapsed advanced lymphoma.↓•
According to public information, th↓↔≥€e global BTK inhibitorε♣♣ market is enormous, expected to reachσ× $21.9 billion by 2025, and th "♣↔e Chinese market is projec€"→ted to grow from 4.3 billion RM←™₩B in 2022 to 22.5 bil£δ¥lion RMB by 2030. Amon₽∑÷g them, Ibrutinib is th∞Ωe best-selling produα Ωct and is classified as a Category B pr← oduct in China's 2022 §¥÷National Medical Insurance NegotiaΩ•σtion Directory.
· Approved by the US FDA in 2013
· Approved by the European Commissi± σ≈on (EC) in 2014
·Approved for import by ÷>§ΩChina's NMPA in 2018, mar•₹קketed under the name "Yik ε&e"
02. Indications
This product is indicated as a m€♥onotherapy for the treatment of patient&<£±s with mantle cell lymphoma (MCL) ®γwho have received at least one p ✔rior therapy.
This product is indicated as a ∏±↓ monotherapy for the treatmen t of patients with chronic lympho ™≠✔cytic leukemia (CLL)/small ly♥≈$§mphocytic lymphoma (SLL).
This product is indicated as a monothe× rapy for the treatment of → &patients with Waldenström's macroglob™$<ulinemia (WM) who have receivedλ≥∏π at least one prior therapy, or asδ≤" first-line treatment for WM pat•£ £ients who are not suit✔↔™able for chemotherapy or©γ immunotherapy.
This product, in combε↑♦•ination with Rituximab, is indicated § ♣βfor the treatment of patie ∞nts with Waldenström's macroglobulinemβ∞ia (WM).
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