[Exciting News] Haibu Pharmaceutical's Ibrutinib Capsules have received the second domestic drug registration approval.
Classification:
Company News
Recent Events
Release time:
2024-12-18
Recently, the Ibrutinib capsules (140mg) independently developed by Haibu Pharmaceutical have obtained production approval, making it the second company in China to receive approval for this product after Xiansheng Pharmaceutical.
Both the raw material and formulation of Ibrutinib are projects independently initiated, researched, developed, and registered by Haibu. Currently, the Ibrutinib raw material has been filed with the FDA DMF in the United States, and the domestic CDE has approved the transfer to "A"; the MAH qualification for Ibrutinib capsules has been successfully transferred.
01. Overview of Ibrutinib
Ibrutinib (Ibrutinib) is the world's first approved BTK inhibitor. It covalently binds to the cysteine residue at the active site of BTK, inhibiting the activation of the B cell signaling pathway, thereby significantly suppressing B cell activity. In clinical applications, Ibrutinib has shown outstanding efficacy in patients with B cell lymphoma, especially those with refractory and relapsed advanced lymphoma.
According to public information, the global BTK inhibitor market is enormous, expected to reach $21.9 billion by 2025, and the Chinese market is projected to grow from 4.3 billion RMB in 2022 to 22.5 billion RMB by 2030. Among them, Ibrutinib is the best-selling product and is classified as a Category B product in China's 2022 National Medical Insurance Negotiation Directory.
· Approved by the US FDA in 2013
· Approved by the European Commission (EC) in 2014
·Approved for import by China's NMPA in 2018, marketed under the name "Yike"
02. Indications
This product is indicated as a monotherapy for the treatment of patients with mantle cell lymphoma (MCL) who have received at least one prior therapy.
This product is indicated as a monotherapy for the treatment of patients with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL).
This product is indicated as a monotherapy for the treatment of patients with Waldenström's macroglobulinemia (WM) who have received at least one prior therapy, or as first-line treatment for WM patients who are not suitable for chemotherapy or immunotherapy.
This product, in combination with Rituximab, is indicated for the treatment of patients with Waldenström's macroglobulinemia (WM).
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