Everest Medicines Announces CTA Approval by China NMPA for Phase 3 Trial of Sacituzumab Govitecan-Hziy for Metastatic Urothelial Cancer
Everest Medicines Announces CTA Approval by China NMPA for Phase 3 Trial of Sacituzumab Govitecan-Hziy for Metastatic Urothelial Cancer
Everest to initiate trial in China as part of global Phase 3 TROPiCS-04
珠穆朗瑪峰將在中國開始試驗作為全球三期熱帶的一部分 -04
SHANGHAI, Jan. 6, 2021 /PRNewswire/ -- Everest Medicines (HKEX 1952.HK), a biopharmaceutical company focused on developing and commercializing transformative pharmaceutical products that address critical unmet medical needs for patients in Greater China and other parts of Asia, today announced that the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of the People's Republic of China has approved a Clinical Trial Application (CTA) for sacituzumab govitecan-hziy for the treatment of patients with metastatic urothelial cancer (mUC).
上海, 二零二一年一月六日 /PRNewswire/-珠峰醫藥（HKEX 1952.HK），一家生物製藥公司，致力於開發和商業化轉型藥品，以滿足患者未滿足的關鍵醫療需求 大中華 和其他部分 亞洲今天宣布，國家醫療產品監督管理局（NMPA）的藥物評估中心（CDE） 中華人民共和國 已經批准了一項臨床試驗申請（CTA）用於治療轉移性泌尿上皮癌（MUC）患者的薩基珠單抗戈維替康-hziy。
With this CTA, Everest Medicines plans to enroll patients in China as part of the Phase 3, global, multicenter, open-label randomized controlled TROPiCS-04 trial. The trial will evaluate sacituzumab govitecan-hziy compared with standard of care chemotherapeutic options in subjects with metastatic or locally advanced unresectable urothelial cancer who have progressed after prior therapy with a platinum-based regimen and anti-programmed cell death protein 1 (PD-1)/programmed death-ligand 1 (PD-L1) therapy. Subjects will be randomized to receive either sacituzumab govitecan-hziy or Treatment of Physician's Choice (TPC), including paclitaxel, docetaxel, and vinflunine.
有了這個 CTA，珠穆朗瑪峰藥品計劃將患者註冊 中國 作為第三階段，全球，多中心，開放標籤隨機對照熱帶 -04 試驗的一部分。該試驗將評估薩基珠單抗戈維替康-hziy 與護理化學治療選項的標準相比，轉移性或局部晚期不可切除的泌尿上皮癌，該癌症在以鉑為基礎的治療方案和抗程序細胞死亡蛋白 1（PD-1）/編程死亡配體 1（PD-L1）治療後進行治療。受試者將隨機接收甘草單抗戈維替康或醫師選擇治療 (TPC), 包括紫杉醇, 多西他賽, 和長春氟寧.
Positive results from the pivotal Phase 2 TROPHY U-01 study of sacituzumab govitecan-hziy in 113 mUC patients, presented at the ESMO 2020 annual conference, confirmed earlier study results showing sacituzumab govitecan-hziy has significant activity and is safe in patients with heavily pretreated mUC who progressed on both platinum-based chemotherapy and checkpoint inhibitors (CPI). Results from the study showed that sacituzumab govitecan-hziy achieved a 27% overall response rate (ORR) and a median duration of response (DOR) of 5.9 months in heavily pre-treated patients with mUC. Sacituzumab govitecan-hziy has received Fast Track Designation from the U.S. Food and Drug Administration (FDA) in this indication.
ESMO 2020 年會議上發表的關鍵階段 TRIUM U-01 研究結果顯示，在 ESMO 2020 年會議上，證實早期研究結果顯示薩基珠單抗戈維替可達-hziy 具有顯著活性，並且在經過嚴重預處理的 MUC 患者中是安全的，他們在基於鉑的化療和檢查點抑制劑（CPI）上進行了重度預處理的 MUC 患者中是安全的。從研究結果表明，薩基珠單抗戈維替康-hziy 實現了 27% 整體響應率 (ORR) 和反應的中位持續時間 (DOR) 5.9 在重度預治療患者的 MUC 個月.糖果單抗食品藥物管理局（FDA）在此適應症中獲得了美國食品和藥物管理局（FDA）的快速通道指定。
"Based on the compelling results generated to date, we believe that sacituzumab govitecan-hziy has the potential to offer patients with mUC a new treatment option, which may advance current standards of care and treatment," said Yang Shi, Chief Medical Officer for Oncology at Everest Medicines. "Urothelial cancer is one of the most common urologic malignancies in China, with both incidence and mortality rates gradually increasing in recent years. We look forward to working with investigators and patients to initiate this study in China."
「根據迄今為止產生的令人信服的結果，我們認為，sacituzumab 戈維替康-hziy 有可能為患有 MUC 的患者提供新的治療選擇，這可能會提高當前的護理和治療標準，」說 楊石珠穆朗瑪峰藥物腫瘤科首席醫學官「泌尿上皮癌是最常見的泌尿外科惡性腫瘤之一 中國，近年來發病率和死亡率都逐漸增加。我們期待與調查人員和患者合作開始這項研究 中國。」
About Urothelial Cancer
關於泌尿上皮癌
Urothelial cancer is a type of cancer that begins in urothelial cells that line the urethra, bladder, ureters, renal pelvis, and some other organs that make up the urinary system. According to Frost & Sullivan, in 2019, the incidence of urothelial cancer reached 76.4 thousand in China.
泌尿上皮癌是一種癌症，開始於泌尿道、膀胱、輸尿管、腎盆和其他一些構成泌尿系統的器官的泌尿上皮細胞。根據弗羅斯特與沙利文的數據，2019 年，泌尿上皮癌的發病率在中國達到 76.4 萬。
About Sacituzumab Govitecan-Hziy
關於薩基祖單布·戈維捷卡-赫濟伊
Sacituzumab govitecan-hziy is a first-in-class, antibody-drug conjugate (ADC) directed at TROP-2, a membrane antigen that is over-expressed in many common epithelial cancers. Under a licensing agreement with Gilead Sciences, Inc., Everest Medicines has exclusive rights to develop, register, and commercialize sacituzumab govitecan-hziy for all cancer indications in Greater China, South Korea, and certain Southeast Asian countries.
薩基珠單抗是一種一流的抗體藥物結合物（ADC），用於 TROP-2，這是一種在許多常見的上皮癌中過度表達的膜抗原。根據與吉列德科學有限公司的許可協議，珠穆朗瑪峰藥品擁有開發，註冊和商業化的獨家權利，用於所有癌症適應症 大中華, 大韓民國，以及某些東南亞國家。
About Everest Medicines
關於珠峰藥品
Everest Medicines is a biopharmaceutical company focused on developing and commercializing transformative pharmaceutical products that address critical unmet medical needs for patients in Greater China and other Asian markets. The management team of Everest Medicines has deep expertise and an extensive track record of high-quality clinical development, regulatory affairs, CMC, business development and operations both in China and with leading global pharmaceutical companies. Everest Medicines has built a portfolio of eight potentially global first-in-class or best-in-class molecules, many of which are in late-stage clinical development. The Company's therapeutic areas of interest include oncology, autoimmune disorders, cardio-renal diseases and infectious diseases. For more information, please visit its website at .
珠穆朗瑪峰藥品是一家生物製藥公司，專注於開發和商業化轉型藥品，以滿足患者未滿足的關鍵醫療需求 大中華 及其他亞洲市場。珠峰藥業的管理團隊擁有深厚的專業知識，並在高質量的臨床開發，監管事務，CMC，業務發展和運營方面擁有廣泛的記錄 中國 並與全球領先的製藥公司合作。珠峰藥業已建立了由八個潛在的全球一流或一流的分子組成的產品組合，其中許多分子處於後期臨床開發階段。該公司的治療領域包括腫瘤學，自身免疫性疾病，心臟腎病和傳染病。有關更多信息，請訪問其網站。
For further information, please contact:
欲了解更多信息，請聯繫：
Everest Medicines
Media in US and Europe:
Darcie Robinson
Vice President
Westwicke PR
(203) 919-7905
珠穆朗瑪峰藥品
美國和媒體 歐洲:
达西·罗宾逊
副總統
韋斯特維克 PR
(203) 919-7905
Media in China:
Edmond Lococo
Managing Director
媒體在 中國:
艾德蒙·洛可可
董事總經理
ICR Asia
+86 (10) 6583-7510
ICR 亞洲
+86 (10) 6583-7510
譯文內容由第三人軟體翻譯。