RemeGen's RC88 Obtained FDA Fast Track Designation, Heralds New Hope for Ovarian Cancer Patients
RemeGen's RC88 Obtained FDA Fast Track Designation, Heralds New Hope for Ovarian Cancer Patients
YANTAI, China, Jan. 12, 2024 /PRNewswire/ -- RemeGen Co. Ltd. ("RemeGen" or "the Company") (9995.HK, 688331.SH), a commercial-stage biotechnology company, announced recently that its independently developed mesothelin (MSLN)-targeting antibody-drug conjugate (ADC), RC88, has been granted Fast Track Designation (FTD) by the U.S. Food and Drug Administration (FDA) for the treatment of platinum-resistant recurrent epithelial ovarian, fallopian tube, and primary peritoneal cancers. This marks another significant development following the FDA's approval to RC88's international multicenter Phase II clinical trials last month.
中國煙臺，2024 年 1 月 12 日 /PRNewswire/ — RemeGen Co.商業階段生物技術公司有限公司（“RemeGen” 或 “公司”）（9995.HK，688331.SH）最近宣佈，其獨立開發的間皮素（MSLN）靶向抗體藥物偶聯物（ADC）RC88已獲得美國食品藥品監督管理局（FDA）的快速通道稱號（FTD），用於治療耐鉑複發性上皮卵巢，輸卵管癌和原發性腹膜癌。這標誌着繼上個月美國食品藥品管理局批准RC88的國際多中心II期臨床試驗之後的又一項重大進展。
RC88 consists of a recombinant humanized anti-MSLN monoclonal antibody linked to the microtubule inhibitor monomethyl auristatin E (MMAE), which acts as a microtubule inhibitor. It has a high affinity for MSLN, which can specifically bind to overexpressing MSLN tissues, and has clearly displayed a terminating effect on tumor cells with various expression levels of MSLN.
RC88 由一種重組人源化抗 MSLN 單克隆抗體組成，該抗體與微管抑制劑單甲基奧利司汀E（MMAE）相連，後者起到微管抑制劑的作用。它對MSLN具有很高的親和力，MSLN可以特異性地與過表達的MSLN組織結合，並且對不同表達水平的MSLN的腫瘤細胞明顯顯示出終止作用。
Epithelial ovarian cancer (EOC) is the leading cause of cancer-related deaths in women, often diagnosed late and prone to relapse within two years, with their disease evolving from platinum-sensitive to resistant. The later the stage and the more aggressive the ovarian cancer, the higher the expression rate of MSLN, and current treatment options are limited. RC88 uniquely targets MSLN, offering a novel approach to this challenging medical condition.
上皮性卵巢癌（EOC）是女性癌症相關死亡的主要原因，通常被診斷爲晚期，並且容易在兩年內復發，她們的疾病從鉑敏感性演變爲耐藥性。階段越晚，卵巢癌的侵襲性越強，MSLN的表達率越高，目前的治療選擇有限。RC88 以獨特的方式針對 MSLN，爲這種具有挑戰性的疾病提供了一種新方法。
FTD is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill unmet medical needs. The purpose behind this is to get important new drugs to the patient earlier.
FTD是一個旨在促進藥物開發和加快審查的流程，以治療嚴重疾病和滿足未滿足的醫療需求。這背後的目的是儘早爲患者提供重要的新藥。
Reflecting on this process, Dr. Jianmin Fang, CEO of RemeGen, said, "The FDA's FTD accelerates the development and review process of RC88, which affirms our commitment to pioneering treatments that address the urgent needs of those facing challenging disease. Moving forward, RemeGen will continue to accelerate the development of its ADC products, with the aim of bringing more and better solutions to patients globally."
在回顧這一過程時，RemeGen首席執行官方建敏博士說：“FDA的FDD加快了RC88的開發和審查過程，這證實了我們對開創性治療的承諾，以滿足面臨挑戰性疾病的人的迫切需求。展望未來，RemeGen將繼續加快其ADC產品的開發，旨在爲全球患者提供更多更好的解決方案。”
The Company is poised to initiate international multicenter phase II clinical studies across the United States, China, the European Union, and other regions, aiming to further clarify the optimal dosage, effectiveness, and safety of RC88 monotherapy.
該公司準備在美國、中國、歐盟和其他地區啓動國際多中心二期臨床研究，旨在進一步闡明RC88單一療法的最佳劑量、有效性和安全性。
About RemeGen Co. Ltd.
關於 RemeGen Co.有限公司
Founded in 2008, RemeGen (9995.HK, SHA: 688331) is a leading biopharmaceutical company in China committed to providing solutions to the unmet clinical needs of patients suffering from life-threatening illnesses. RemeGen has research laboratories and offices throughout China and the United States. The company is committed to discovering, developing, and commercializing innovative and differentiated biologic drugs of significant clinical value in the key therapeutic areas of autoimmune, oncology, and ophthalmic diseases. For more details, please visit:
RemeGen（9995.HK，股票代碼：688331）成立於2008年，是中國領先的生物製藥公司，致力於爲患有危及生命的疾病的患者未得到滿足的臨床需求提供解決方案。RemeGen在中國和美國設有研究實驗室和辦公室。該公司致力於發現、開發和商業化在自身免疫疾病、腫瘤學和眼科疾病等關鍵治療領域具有重大臨床價值的創新和差異化生物藥物。欲了解更多詳情，請訪問：
About RC88
關於 RC88
RC88 is a novel antibody drug conjugate (ADC) independently developed by RemeGen targeting mesothelin (MSLN). It uses the company's independently developed innovative bridging technology to connect antibodies and drugs. The structure includes MSLN-targeting antibodies, cleavable connections and a small fraction of cytotoxins (MMAE) can mediate the endocytosis of antibodies by binding to MSLN-positive tumor cells, thereby effectively delivering cytotoxins to cancer cells and achieving improved tumor killing effects.
RC88是由瑞茂生物自主開發的靶向間皮素（MSLN）的新型抗體藥物偶聯物（ADC）。它使用公司自主開發的創新橋接技術來連接抗體和藥物。該結構包括靶向MSLN的抗體、可分解的連接和一小部分細胞毒素（MMAE）可以通過與MSLN陽性腫瘤細胞結合來介導抗體的內吞作用，從而有效地將細胞毒素輸送到癌細胞並提高腫瘤殺滅效果。
SOURCE RemeGen Co., Ltd
來源 RemeGen 有限公司