Recombinant Human Coagulation Factor Ⅷ
- Generic Name
- Recombinant Human Coagulation Factor Ⅷ
- Indication
用于血浆凝血因子Ⅷ（FⅧ）缺乏的甲型血友病（罕见病）治疗。在纠正或预防出血、急诊或择期手术中，本品起到暂时代替缺失的凝血因子的作用。
Gensaic and Novo Nordisk Partner to Develop Novel Precision Therapeutics Platform
• Gensaic and Novo Nordisk have formed a strategic collaboration to develop next-generation precision therapeutics, combining Gensaic's innovative delivery platform with Novo's therapeutic expertise.
• The partnership aims to advance novel treatment approaches across multiple therapeutic areas, leveraging advanced drug delivery technologies to enhance therapeutic efficacy and patient outcomes.
• This collaboration represents a significant step forward in precision medicine development, with potential applications in metabolic disorders and other chronic diseases.
Hemophilia Treatment Advances: Gene Therapy, Prophylaxis, and On-Demand Therapies Highlighted at ASH 2024
• ASH 2024 highlighted significant progress in hemophilia care since Hemlibra's approval, including gene therapies for hemophilia A and B, offering curative potential.
• Despite advances, unmet needs persist, including spontaneous bleeds in prophylaxis patients, limited gene therapy access, and concerns about long-term risks like liver toxicity.
• Emerging therapies like Pfizer's giroctocogene fitelparvovec and Sanofi's fitusiran show promise, with ongoing trials and regulatory reviews potentially expanding treatment options.
• Novel on-demand treatments like Staidson's bemiltenase alfa offer alternatives, particularly in price-sensitive markets, demonstrating a 12-hour bleed clearance rate of 83%.
Hemophilia A and B Pipeline Advances with Novel Therapies in Clinical Trials
• Several companies are actively developing novel therapies for Hemophilia A and B, with many in various phases of clinical trials, showing promise for improving treatment options.
• TiumBio Co., Ltd. has submitted a Clinical Trial Application to initiate a Phase 1b investigation of TU7710, a new recombinant activated factor VII for hemophilia patients with inhibitors.
• The FDA approved ALTUVIIIO (efanesoctocog alfa) in February 2023, a factor VIII replacement therapy for adults and children with Hemophilia A, for routine prophylaxis and on-demand treatment.
• BioMarin received FDA approval for Roctavian in June 2023, a single-dose gene therapy for severe Hemophilia A, marking a significant advancement in treatment.
Drug Development Updates
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