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On January 12, NMPA's official website showed that fosun Kate CAR-T product "Aquilonsai Injection" market application (acceptance number: CXSS2000006) entered the administrative approval stage, is expected to be approved in the nearth.
this means that the first CAR-T therapeutic products are about to be approved for sale!From NMPA's official website, Aquilonsai Injection, codentag FKC876, Fosun Kate introduced YESCARTA (Axicabtagene Ciloleucel) technology from Kite Pharma in the United States and is authorized to localize the production of targeted CD19 self-contained CAR-T cell therapy products in China.
October 18, 2017, Yescarta was approved by the FDA to treat patients with recurring and incurable large B-cell lymphoma, the first FDA-approved CAR-T cell drug for specific non-Hodgkin's lymphoma.
27 August 2018, it was approved for listing in Europe for the treatment of relapsed or resecurable DLBCL and PMBCL.
currently has three approved CAR-T cell immunotherapy products on the market worldwide, including Kite Pharmaceuticals' Yescarta and Tecartus and Novarma's Kymriah, all targeting CD19.
details of its approval time and adaptation are as follows: According to Gilead and Novartic's published financial reports, Yescarta and Kymriah's global sales for fiscal 2019 were approximately $456 million and $278 million, respectively.
Fosun Kate introduced Yescarta from Kite Pharma in the United States in early 2017 to gain technical and commercial rights in Chinese mainland, the Hong Kong Special Administrative Region and the Macao Special Administrative Region, and intends to localize production in China.
august 2018, the CDE approved its IND application, and in February 2020 Fosun Kate submitted a listing application, which took just over a year.
February 21, 2020, Fosun Kate Aquilonsai's application for the market for injections was accepted by the National Drug Administration (NMPA).
's listing application is based on a one-arm, open, multi-center bridging clinical trial (FKC876-2018-001) conducted in China to assess the safety and efficacy of this product in chinese patients with refratic invasive NHL (Large B cell lymphoma).
10, 2020, the listing application was formally approved by the CDE for priority review.
the drug entered the administrative approval stage today.
to be approved by the company in less than a year.
Aquilonsai Injection Review Time Axis from the Insight database () Insight database shows that, in addition to Fosun Kate, only the CAR-T products of the Pharmaceutical Ming Juno family are currently on the market.
car-T products in the clinical phase, Novart's Kymriah® (tisagenlecleucel) is the fastest-growing, with Phase III clinical start-ups and seven domestic CAR-T products already in Phase II clinical.
, it is worth mentioning that nanjing's legendary BCMA Targeted CAR-T was incorporated into the breakthrough therapy program by CDE in August 2020.