[Exciting News] Haibu PharmaceΩ←£utical's Ibrutinφ₽€←ib Capsules have received the second do↔×mestic drug registration approva∞Ωβδl.

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Company News

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Release time:

2024-12-18

Recently, the Ibrutinγ÷♦ib capsules (140mg) independe¥→€ntly developed by Haibu Pharmaceutical↕$☆✘ have obtained production approval, mak• φing it the second company in China to ×♠♣>receive approval for this pr∞✔♣oduct after Xiansheng Ph★ ↕armaceutical.

Both the raw material and formul♣€σation of Ibrutinib are pr↔•₩σojects independently ≠×✘→initiated, researched,‌≥< developed, and registered bλ'÷♠y Haibu. Currently, the Ibrutinib₩α raw material has been f✘αiled with the FDA DMF in ©α∑the United States, and th↑→≠←e domestic CDE has approved€&ε the transfer to "A"; the MAH q¥∏>ualification for Ibrδπ♠utinib capsules has &®been successfully transferred.

01. Overview of Ibrutinib

Ibrutinib (Ibrutinib) is the wo←®>★rld's first approved BTK inhibitor π. It covalently binds to t÷"he cysteine residue at the a"→ctive site of BTK, inhλ$↔ ibiting the activation of the B cell si✘→ gnaling pathway, thereby signific≈→λantly suppressing B cell activity. Iγ✘γ↕n clinical applications, Ibrutini€ b has shown outstanding efficacy i‌δn patients with B cell lymphom"₹&>a, especially those ©¥with refractory and re<©<∏lapsed advanced lymphom↕↔ ↕a.

According to public inf₽¶α♦ormation, the global BTK inhδ>§ibitor market is enorm← ≠ous, expected to reach $21.9 bi∞↔₹εllion by 2025, and t∑>γhe Chinese market is≥→≤σ projected to grow fro≠←✘€m 4.3 billion RMB in 2022σ₹↔ to 22.5 billion RMB by 2030. Among t≈♥♠€hem, Ibrutinib is the ↕< ₩best-selling product and is classifie∏↔ ₩d as a Category B product in Chi₽↑na's 2022 National Medicalβδ✘ Insurance Negotiation Directory.‍<∞

· Approved by the US FDA inλ∏∞ 2013

· Approved by the European Comσπ★≈mission (EC) in 2014

·Approved for import by Chi<  na's NMPA in 2018, mark ↕eted under the name "•×Yike"

02. Indications

This product is indicated as↓& a monotherapy for the treatme&™≠‌nt of patients with mαπ≈≤antle cell lymphoma (MCL>₹) who have received at least one prε£ior therapy.

This product is indica★÷≈ted as a monotherapy for the treatment♥  of patients with chronic ly ≠©✔mphocytic leukemia (CLL)/≥♠§small lymphocytic lymphoma ±•∞(SLL).

This product is indi"β¶cated as a monotherapy fπ₽or the treatment of patients↓♦ with Waldenström's macroglπ≠₹αobulinemia (WM) who have "•© received at least one prior therap σ∞®y, or as first-line treatment for ÷✘β☆WM patients who are not suitab∑♣le for chemotherapy or immunother÷•✘∞apy.

This product, in combina'>÷tion with Rituximab, is i♥ ndicated for the treatment of patients ±₩'with Waldenström's macroglobulinemia (W‌₹γ≤M).

Sailing Against the Wind♥™§$ · Achieving New Heigα★¥hts

Beijing Haibu Pharmaceuti​≠"​cal Technology Co., Ltd. (referr★≠ed to as "Haibu Pharmaceutical") was eσ•stablished in 2005 and is a high-techφ¶π¶ enterprise with "ch♦↔emical drug research a$♣ →nd development" as its core ca™‍pability. It has a resβ£earch and development ce©£nter in Beijing, a raw material♠♠‌♣ and formulation pilot verif≥∞©ication center, and a G ♦MP industrial production base, §♠↔mainly engaged in the technical development✔★≥" and transfer of chemical drugs, MA÷☆α"H research and holding, raw mater‍γ¶ial related applications, and co≤φ©mmercial supply of pharmaceutical inter☆¶✘'mediates. Research and development of innovative ¶₽and improved drug applicatioδ'ns, etc., has been a✘↔₽"warded the title of "Top 20 Phar™×γmaceutical R&D Companies in Ch ≤∏¶ina" for several cons♦✘ecutive years, recognized as a "Beijing•ασ Science and Technology Resea∞↓  rch and Development Institutio§✔÷n," "National High-tech Enterprise," <£←and "Beijing Yizhuang Enterprise Inn¶£‌εovation Center."
Haibu Pharmaceutical has rich e€'xperience in the research and produ"₹ction transfer, registration, and ∏∏εφapplication of various dosage∞  forms such as chemical↓™ raw materials, oral solid →‍s, liquid formulations,<¥≥ sterile injections, and topical p♥₩reparations. The R&D products coveδ×r multiple indicationγ✘φ areas including anti-tumor,δ$≤ anti-depression, anti-epilepsy,©↕ anti-anxiety, cardiovascular, digesti♣↕✘ve system, and respirat✔βα→ory system.

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