Harbour BioMed Announces Resubmission of Biologics License Application for Batoclimab to NMPA for Treatment of Generalized Myasthenia Gravis
Harbour BioMed Announces Resubmission of Biologics License Application for Batoclimab to NMPA for Treatment of Generalized Myasthenia Gravis
CAMBRIDGE, Mass., ROTTERDAM, Netherlands and SUZHOU, China, June 26, 2024 /PRNewswire/ -- Harbour BioMed (the "Company"; HKEX: 02142), a global biopharmaceutical company committed to the discovery, development, and commercialization of novel antibody therapeutics focusing on oncology and immunology, announces that it has resubmitted the Biologics License Application (BLA) of batoclimab (HBM9161) to the National Medical Products Administration (NMPA) of China for the treatment of generalized myasthenia gravis (gMG).
2024年6月26日，位於美國馬薩諸塞州劍橋、荷蘭鹿特丹和中國蘇州的全球生物醫藥公司Harbour BioMed（香港交易所：02142）宣佈，已重新提交受體結合型免疫球蛋白治療藥物batoclimab（HBM9161）用於治療全身性重症肌無力（gMG）的生物製品批准申請（BLA）給中國國家藥品監督管理局（NMPA）。該公司致力於發現、開發和商業化以腫瘤學和免疫學爲重點的新型抗體治療藥物。
Following the clinical trial protocol, the Company completed the extension period for the Phase III clinical trial to collect additional long-term safety data without enrolling new patients. As a result, the Company voluntarily included this additional safety data and resubmitted the BLA for batoclimab (HBM9161) as planned.
根據臨床試驗協議，公司完成了III期臨床試驗的延期階段，結果獲得了額外的長期安全數據，未招募新病人。因此，公司按計劃自願包含了這些額外的安全數據，重新提交了batoclimab（HBM9161）生物製品批准申請（BLA）。
"We are delighted to resubmit the BLA to the NMPA as scheduled and will continuously communicate closely with the NMPA to advance the review process of this innovative therapy. Based on the results of the Phase III clinical trial, which demonstrated the efficacy of batoclimab in both primary and secondary endpoints, we believe this innovative therapy will further enhance the treatment of generalized myasthenia gravis and benefit more patients," said Dr. Jingsong Wang, Founder, Chairman and CEO of Harbour BioMed.
Harbour BioMed的創始人、董事長和CEO王勁松博士表示，“我們很高興按計劃將BLA提交給NMPA，並將繼續與NMPA進行緊密溝通，推進這種創新療法的審評進程。基於III期臨床試驗的結果，該治療藥物在主要和次要終點上均表現出batoclimab的療效，我們相信這種創新療法將進一步增強全身性重症肌無力的治療效果並惠及更多患者。”
Batoclimab received the "Breakthrough Therapy Certificate" from the NMPA in 2021 and achieved a positive outcome in the proof-of-concept study for treating Chinese gMG patients in July 2021. The positive topline results of its Phase III clinical trial were announced in March 2023.
Batoclimab於2021年獲得中國國家藥品監督管理局頒發的“突破性療法證書”，並在2021年7月的針對中國gMG患者的概念驗證研究中取得了積極的結果。其III期臨床試驗的積極頂線結果在2023年3月公佈。
In October 2022, the Company entered into an agreement with NBP Pharma, a wholly owned subsidiary of the CSPC Group, to co-develop batoclimab in Greater China. Under this agreement, the Company is responsible for developing and conducting the full clinical trial of batoclimab for gMG in China and will receive tiered royalties based on annual net sales of batoclimab in Greater China.
2022年10月，公司與華僑城集團控股有限公司全資子公司標誌醫療科技（南京）有限公司（NBP Pharma）達成一項協議，共同在大中華地區開發batoclimab。根據協議，公司負責在中國開發和進行batoclimab治療gMG的完整臨床試驗，根據batoclimab在大中華地區的年淨銷售額，獲得分層版稅。
About Generalized Myasthenia Gravis (gMG)
關於全身性重症肌無力（gMG）
Myasthenia gravis (MG) is an acquired autoimmune disease mediated by antibodies such as anti-acetylcholine receptor (AChR) immunoglobulin G (IgG) and anti-muscle-specific tyrosine kinase (Anti-MuSK) IgG, which involves the postsynaptic membrane of the neuromuscular junction, causes impaired transmission at the neuromuscular junction, and presents with skeletal muscle contraction weakness. Patients often have ocular muscle manifestations such as eyelid ptosis and diplopia, and most patients will show symptoms other than ocular muscles and develop generalized myasthenia gravis (gMG) which significantly affects their working status and quality of life, and some patients even develop myasthenic crisis which will be life-threatening in severe cases.
重症肌無力（MG）是由抗乙酰膽鹼受體（AChR）免疫球蛋白G（IgG）和抗肌特異性酪氨酸激酶（Anti-MuSK）IgG等抗體介導的自身免疫性疾病，涉及神經肌肉接頭的postsynaptic膜，導致神經肌肉接頭傳輸受損，表現爲骨骼肌收縮無力。患者通常有眼肌表現，如眼瞼下垂和複視，大多數患者將表現出除眼肌外的其他症狀，發展爲全身性重症肌無力（gMG），嚴重影響了他們的工作狀態和生活質量，部分患者甚至可能發生重症肌無力危象，嚴重者可能會威脅生命。
Current main treatments for MG include cholinesterase inhibitors and glucocorticoids and other immunosuppressive drugs, but the efficacy and safety cannot meet the clinical needs of many patients. Targeting reduction of pathogenic IgG autoantibodies is one of the best solutions in MG treatment in terms of the pathophysiological mechanism, such as plasmapheresis and intravenous immunoglobulin, however, there still remains a significant unmet need for these treatment options, including the accessibility, safety and economic cost.
目前治療MG的主要方法包括膽鹼酯酶抑制劑和糖皮質激素和其他免疫抑制藥物，但其療效和安全性不能滿足許多患者的臨床需求。針對致病IgG自身抗體的降低是MG治療中最佳的解決方案之一，例如血漿置換和靜脈注射免疫球蛋白，然而，這些治療方案仍存在顯著的未滿足需求，包括可及性、安全性和經濟成本等。
About Batoclimab (HBM9161)
關於Batoclimab（HBM9161）
Batoclimab (HBM9161), a fully human anti-FcRn mAb, blocks FcRn-IgG interactions, accelerating the degradation of autoantibodies and leads to the treatment of pathogenic IgG-mediated autoimmune diseases. Phase III study in myasthenia gravis received positive results showing that batoclimab can quickly, significantly, and safely alleviate patients' symptoms and improve quality of life.
Batoclimab（HBM9161）是一種完全人源抗FcRn單克隆抗體，可阻斷FcRn與IgG的相互作用，加速自身抗體的降解，並導致治療致病的IgG介導的自身免疫疾病。針對重症肌無力的III期研究取得了積極結果，表明batoclimab可以快速、顯著、安全地緩解患者的症狀並改善生活質量。
About Harbour BioMed
關於Harbour BioMed
Harbour BioMed (HKEX: 02142) is a global biopharmaceutical company committed to the discovery, development, and commercialization of novel antibody therapeutics focusing on immunology and oncology. The Company is building its robust portfolio and differentiated pipeline through internal R&D capability, collaborations with co-discovery and co-development partners, and select acquisitions.
Harbour BioMed（香港交易所：02142）是一家全球性生物製藥公司，致力於發現、開發和商業化以免疫學和腫瘤學爲重點的新型抗體治療藥物。公司通過內部研發能力、與聯合發現和共同開發合作伙伴的合作以及有選擇的收購，構建其強大的組合產品線和差異化的管線。
The proprietary antibody technology platforms Harbour Mice generates fully human monoclonal antibodies in two heavy and two light chains (H2L2) format, as well as heavy chain only (HCAb) format. Building upon the HCAb antibodies, the HCAb-based immune cell engagers (HBICE) bispecific antibody technology is capable of delivering tumor-killing effects unachievable by traditional combination therapies. Integrating Harbour Mice, and HBICE with a single B cell cloning platform, our antibody discovery engine is highly unique and efficient for the development of next-generation therapeutic antibodies. For further information, please refer to .
專有抗體技術平台Harbour Mice可生成兩個重和兩個輕鏈（H2L2）格式的全人源單克隆抗體以及僅重鏈（HCAb）格式。在HCAb抗體的基礎上，基於HCAb的免疫細胞接合劑（HBICE）雙特異性抗體技術能夠通過傳統的聯合療法難以實現的方式提供腫瘤殺傷效應。將Harbour Mice，和HBICE與單個B細胞克隆平台相結合，我們的抗體發現引擎在開發下一代治療性抗體方面具有高度獨特性和效率。有關詳細信息，請參閱 。
SOURCE Harbour BioMed
來源：Harbour BioMed
譯文內容由第三人軟體翻譯。