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首頁/最新消息/最新消息/3.5億預付款!南京傳奇生物與楊森簽署全球合作協議,共同開發CAR-T細胞療法

3.5億預付款!南京傳奇生物與楊森簽署全球合作協議,共同開發CAR-T細胞療法

發佈日期 : 2017/12/22

2017年12月11日中國南京傳奇生技公司向中國食品藥品監督管理總局(CFDA)遞交中國第一個CAR-T臨床試驗申請,並且獲得CFDA受理,編號為CXSL1700201。就在此申請10天後(21日),Janssen Biotech(強生旗下楊森公司)宣布與南京傳奇生物科技簽署一項全球合作和許可協議,獲得其CAR-T細胞產品LCAR-B38M的開發,生產,以及商業化許可。在此協議下,Janssen將與南京傳奇以30/70的比例工同承擔在大中華地區的成本與分享利益。在全球其他地區,比例為50/50。在合作之初,Janssen將支付3.5億美金的前金,隨著開發與監管等里程碑的到來,Janssen將提供額外資金。

來源: FierceBiotech 

Dark horse Nanjing Legend Biotech was one of the surprising stars of ASCO this summer with its CAR-T data, and now Johnson & Johnson is paying $350 million upfront to join forces with the company and look for a working “cure” for certain blood cancers.

Back in June, Chinese firm Nanjing Legend Biotech, which many had never heard of, grabbed attention at the American Society of Clinical Oncology (ASCO) annual meeting, showing that its CAR-T candidate could be a safe and effective way to treat relapsed or refractory multiple myeloma.

Researchers reported that in an ongoing early-phase clinical trial in China, 33 out of 35 (94%) patients whose multiple myeloma had relapsed on previous treatments had clinical remission within two months of receiving Legend’s experimental anti-BCMA CAR-T cell product, dubbed LCAR-B38M, and the objective response rate was 100%.

Now J&J wants in, doing a deal with its U.S. and European subsidiaries to develop, manufacture and sell LCAR-B38M; it’s already been accepted for review by the China Food and Drug Administration (CFDA) and in “the planning phase of clinical studies in the United States for multiple myeloma,” according to the U.S. giant’s statement.

It will be competing with the likes of Bluebird Bio and Juno to get the next-gen therapy on the market for this disease, and comes in the same year that the first CAR-T therapies from Novartis and Gilead/Kite saw approval.

Under the deal, Legend gives Janssen, J&J’s biotech unit, a worldwide license to jointly develop and commercialize LCAR-B38M in multiple myeloma with the Legend team. Janssen will record worldwide net trade sales, except for sales made in Greater China. The companies have entered into a 50-50 cost-sharing/profit-split arrangement, except in Greater China, where Janssen and Legend have a 30-70 cost-sharing/profit-split arrangement. The biotech gains $350 million straightaway, with biobucks and royalties coming down the line, although details on exact figures were not shared.

 

“Despite significant advances, multiple myeloma remains an incurable disease for most patients, creating the need for additional, highly active options,” said Peter Lebowitz, M.D., Ph.D., global therapeutic area head, oncology, Janssen Research & Development. “LCAR-B38M provides an innovative approach with the potential to transform the treatment of myeloma. We look forward to collaborating with the pioneering scientific team at Legend and applying our expertise to the development of this cell therapy, with the goal of building regimens aiming for a cure.”