Today (March 2), Shanghai Fosun Pharmaceutical (Group) Co.Ltd(600196) ( Shanghai Fosun Pharmaceutical (Group) Co.Ltd(600196) , SH) announced that, Fosun Kate Biotechnology Co., Ltd. ( Shanghai Fosun Pharmaceutical (Group) Co.Ltd(600196) whose holding subsidiary holds 50% of its equity, hereinafter referred to as Fosun Kate) invested by it recently received the approval from the State Drug Administration on its CD19 target autologous car-t cell treatment product fkc889 for the treatment of recurrent or refractory mantle cell lymphoma (R / R MCL) after receiving second-line or above treatment Approval of clinical trials in adult patients.
The reporter of the daily economic news noted that fkc889 is Shanghai Fosun Pharmaceutical (Group) Co.Ltd(600196) another cell therapy product. Last year, Fosun Kate’s application for listing and registration was approved by the State Food and drug administration.
So far, two CD19 target autologous car-t cell therapy products have been approved in China, and the other product is benoda of Shanghai Yaoming junuo Biotechnology Co., Ltd.
another cell therapy product approved
According to Shanghai Fosun Pharmaceutical (Group) Co.Ltd(600196) announcement, fkc889 is a car-t cell therapy product localized by Fosun Kate through technology transfer according to brexucabtagene autoleucel (trade name tecartus) of kit Pharma, Inc. (hereinafter referred to as kit, a holding subsidiary of Gilead Sciences, Inc.).
In July 2020, tecartus was approved to be listed in the United States by the U.S. FDA (i.e. the U.S. Food and Drug Administration). In December 2020, tecartus was approved by the European EMA (i.e. the European Drug Administration) for listing in Europe.
The reporter of the daily economic news noted that yikaida, which attracted extensive attention in the market last year, was also produced locally through technology transfer of kit based anti-human CD19 car-t cell injection (trade name yescarta). Last June, Fosun Kate’s yikaida was approved for listingp align=”center” style=”text-align:center;”> Source: screenshot of the official website of the State Drug Administration
It is worth noting that although both ekida and fkc889 are CD19 target autologous car-t cell therapy products, their indication ranges are different.
According to Shanghai Fosun Pharmaceutical (Group) Co.Ltd(600196) previous announcement, the approved indications of yikaida are for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after previous second-line or more systematic treatment, including diffuse large B-cell lymphoma (DLBCL), nonspecific type (NOS), primary mediastinal large B-cell lymphoma (pmbcl), high-grade B-cell lymphoma and DLBCL transformed from follicular lymphoma Fkc889 approved this time is intended to be mainly used to treat adult patients with recurrent or refractory mantle cell lymphoma (R / R MCL) after receiving second-line and above treatment.
As of January 2022, Fosun Kate’s cumulative R & D investment for fkc889 at this stage is about 11.92 million yuan. Compared with yikaida, the R & D investment of fkc889 is relatively low. According to Shanghai Fosun Pharmaceutical (Group) Co.Ltd(600196) previous announcement, as of May 2021, that is, before the listing of yikaida, Fosun Kate has invested about 675 million yuan in R & D.
\u3000\u3000 “According to the requirements of relevant laws and regulations in China, the product can only be put on the market after a series of clinical studies are carried out in China and approved by the national drug evaluation department. According to the research and development experience, there are certain risks in the research and development of new drugs, such as the termination of clinical trials due to safety and / or effectiveness. The research and development of new drugs and their listing are a long-term work and there are many problems There are many uncertain factors. Please pay attention to the investment risk. ” Shanghai Fosun Pharmaceutical (Group) Co.Ltd(600196) indicates.
original drug sales of about 176 million US dollars in 2021
Shanghai Fosun Pharmaceutical (Group) Co.Ltd(600196) said that as of March 2, the same target autologous car-t cell therapy products that have been listed in China include yikaida of Fosun Kate (akirensai injection, approved for listing in June 2021) and benoda of Shanghai Yaoming junuo Biotechnology Co., Ltd. (Ricky orenzai injection, approved for listing in September 2021).
According to the announcement of yaomingjunuo (02126, HK), benoda (Reggio arenaceous injection) is an autologous car-t cell immunotherapy product targeting CD19 independently developed by yaomingjunuo on the basis of the car-t cell process platform of junuo medical (a company of Bristol Myers Squibb). As the first product of mingjunuo, benoda was approved by the State Drug Administration in September 2021 for the treatment of R / R large B-cell lymphoma (lbcl) in adult patients after second-line or more systematic treatment.
According to Shanghai Fosun Pharmaceutical (Group) Co.Ltd(600196) previous announcement, as of June last year, in addition to yescarta, the listed CD19 target autologous car-t cell therapy products mainly include kymriah of Novartis Pharma Schweiz Ag (approved for listing in August 2017), It is mainly used for the treatment of acute lymphoblastic leukemia in children and young adults (2 to 25 years old) and adult recurrent / refractory large B-cell lymphoma (including diffuse large B-cell lymphoma, transformed follicular lymphoma and primary mediastinal B-cell lymphoma); Tecartus of kite Pharma (approved for marketing in July 2020) is mainly used to treat adult recurrent / refractory mantle cell lymphoma; Breyanzi of Bristol Myers Squibb Company (approved for marketing in February 2021) is used to treat adult recurrent or refractory large B-cell lymphoma.
According to Shanghai Fosun Pharmaceutical (Group) Co.Ltd(600196) citing the financial reports published by Gilead Sciences, Inc. and Novartis Pharma Schweiz AG, the global sales of yescarta, kymriah and tecartus in 2020 were about 563 million US dollars, 474 million US dollars and 44 million US dollars respectively.
According to the announcement of Gilead Sciences, Inc., the global sales of tecartus and yescarta in 2021 were 176 million US dollars and 695 million US dollars respectively.
