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CASI獲得抗CD19 T細胞治療產品全球獨家商業權益

CASI Pharmaceuticals, Inc. (納斯達克股票代碼:CASI) 是一家美國納斯達克上市的生物醫藥公司,在中國、美國及世界其他地區擁有藥物開發、產品加速上市和創新療法探索平臺。CASI宣布與合源生物科技(天津)有限公司(以下簡稱“合源生物”)正式簽署許可協議,獲得其CNCT19項目全球獨家商業權益。CNCT19 是自體抗CD19 T細胞治療產品,由合源生物開發。此后,合源生物將繼續開展CNCT19項目的研發工作,CASI將加入項目指導委員會。在未來,CASI將根據協議,在項目研發進展到重大里程碑階段后,向合源生物支付相關費用;進入商業化階段后根據約定向合源生物支付銷售分紅。與此協議相關聯的凱信遠達醫藥(無錫)有限公司是一家CASI占股80%的合資公司將通過旗下一家全資子公司向合源生物投資人民幣八千萬圓(約合一千一百六十萬美圓)作為預付款。

CNCT19針對的CD19靶點是一種廣泛表達于 B 細胞活化與增殖的重要膜抗原之一,是所有B細胞共有的表面標志物,也是 B 淋巴細胞系統惡性血液病的有效靶點。來自不同科研機構的以CD19為靶點的嵌合抗原受體(CAR)在兒童及成人復發型B 細胞急性淋巴細胞白血?。?B-ALL )、慢性淋巴細胞白血?。?CLL )和 B 細胞非霍奇金淋巴瘤( B-NHL )中表現出持續有效的抗腫瘤療效。CD19在 CAR-T 治療白血病、淋巴瘤等血液惡性腫瘤的臨床試驗中是最常用的生物標志物。合源生物已經向 國家藥品監督管理局提交了兩個 IND,分別用于急性淋巴細胞白血?。?ALL )和非霍奇金淋巴瘤( NHL )適應癥;預計將于2019年底獲得批準。

CASI中國區總裁張煒博士表示“與合源生物的合作令人振奮,初步的數據似乎預示著CNCT19將會是NHL和ALL T細胞治療領域療效最好的產品。能夠推動細胞治療的創新和發展,為惡性血液腫瘤患者提供解決方案,我們為此項投資感到興奮!我們期待與合源生物的專家一起推進臨床研發,CASI也將做好項目商業化的準備工作?!?/span>

CASI首席醫學官Alexander Zukiwski表示“合源生物在臨床注冊方面已經完成了大量的工作,已經遞交了ALL和NHL兩個IND申請,并且已經確認了一期和二期臨床試驗參與的中心。一旦獲得臨床試驗批準,臨床項目可立即開展?!?/span>

關于CASI

CASI Pharmaceuticals is a U.S. biopharmaceutical company focused on developing and accelerating the launch of pharmaceutical products and innovative therapeutics in China, the U.S., and throughout the world. CASI’s product pipeline features (i) an autologous anti-CD19 t-cell therapy product (CNCT19) being developed for the treatment of B-ALL and NHL; (ii) an anti-CD38 monoclonal antibody being developed for the treatment of multiple myeloma and other CD38 positive hematological cancers (CID-103); (iii) China rights to three U.S. Food and Drug Administration (FDA)-approved drugs (EVOMELA? (melphalan hydrochloride for injection) approved by China’s National Medical Products Administration (NMPA) for marketing, ZEVALIN?(ibritumomab tiuxetan) and MARQIBO? (vincristine sulfate LIPOSOME injection) approved by NMPA for registration confirmatory trials in China; and (iv) a portfolio of FDA-approved and pending abbreviated new drug applications (ANDAs). CASI has offices in Rockville, Maryland and a wholly owned subsidiary in Beijing, China. More information on CASI is available at?www.casipharmaceuticals.com.


關于合源生物(Juvantas)

Juventas Cell Therapy is a China-based domestic company located in Tianjin City, China engaged in cell therapy. The company’s lead product, CNCT19, devolved from the CD19 CAR-T, was originally created at the Institute of Hematology, Chinese Academy of Medical Sciences, one of the top hematology centers in China. CD19 CAR-T is used to treat cancer patients with acute lymphoblastic leukemia and relapsed non-Hodgkin lymphoma. Through its commercial collaboration with CASI, Juventas intends to be the first domestic company to launch a CD19 CAR-T in China. Wei-Wu He Ph.D. is the chairman and a founding shareholder of Juventas. A committee of independent directors of CASI negotiated the terms of the investment and license agreements and recommended that the board of directors approve the transaction. Dr. He did not participate in the committee’s deliberations or the board of directors’ approval of the transaction.

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