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Click on the picture to register now [China, Shanghai] Fosun Kate Biotechnology Co.
, Ltd.
announced today that the National Medical Products Administration (NMPA) has officially approved the company's CD19 target autologous CAR-T cell therapy product Akilunsai injection (FKC876) ) New indication registration clinical trial application (IND) [Acceptance No.
CXSL2100098] for the treatment of relapsed or refractory indolent non-Hodgkin’s lymphoma (r/r iNHL) after second-line or above systemic treatment
.
"Fosun Kate CEO Mr.
Huang Hai said: "On March 5, 2021, the FDA accelerated the approval of Yescarta (axicabtagene ciloleucel) for the treatment of adult patients with relapsed/refractory follicular lymphoma.
We are very pleased to see FKC876 in China.
(Axicabtagene ciloleucel) The IND for this new indication has also been approved by the NMPA, which means that the second indication of Fosun Kate’s CAR-T cell therapy product has entered the clinical stage
.
We are very grateful to the regulatory authorities for their encouragement and support for innovative therapies.
We look forward to working with clinical experts in China to carry out relevant trials to provide an important basis for the registration and marketing of the product’s new indications in China, and to provide more non-Hodgkin’s lymph in China as soon as possible Tumor patients bring new hope and opportunities
.
""About indolent non-Hodgkin's lymphoma (iNHL) Indolent non-Hodgkin's lymphoma (iNHL) is a malignant tumor that has slow clinical progress but becomes more aggressive over time
.
Follicular lymphoma (FL) and marginal zone lymphoma (MZL) are common subtypes
.
FL is also the second most common type of lymphoma in the world, accounting for approximately 22% of confirmed cases of NHL worldwide
.
MZL is the third most common lymphoma, accounting for approximately 8% to 12% of all B-cell NHL1
.
Although with the progress of disease management, the long-term survival rate of FL patients has been greatly improved, but the prognosis is very different
.
At present, there is no standard treatment plan for the relapsed and refractory FL patients after second-line treatment and above, and the treatment options for the relapsed and refractory MZL patients are also very limited
.
About FKC876 FKC876 is a CAR-T cell therapy product that Fosun Kite introduced Yescarta (axicabtagene ciloleucel) technology from Kite (a subsidiary of Gilead) in the United States in early 2017 for industrialization in China
.
It is used to treat adult patients with relapsed or refractory large B-cell lymphoma (including diffuse large B-cell lymphoma, unspecified type, primary mediastinal large B-cell lymphoma, high-grade New drug marketing applications for B-cell lymphoma and diffuse large B-cell lymphoma transformed by follicular lymphoma have been included in the priority review by NMPA in March 2020
.
About Yescarta Yescarta was approved by the U.
S.
FDA on October 18, 2017 for the treatment of adult patients with relapsed and refractory large B-cell lymphoma, including diffuse large B-cell lymphoma (DLBCL), unspecified, primary mediastinum B-cell lymphoma (PMBCL), high-grade B-cell lymphoma, and follicular lymphoma transformed DLBCL is the first CAR-T cell drug approved by the US FDA for specific non-Hodgkin's lymphoma
.
On March 5, 2020, its application for extended indications for the treatment of adult patients with relapsed/refractory follicular lymphoma (FL) received accelerated approval from the U.
S.
FDA, becoming the world's first CAR- approved to be marketed for FL.
T cell therapy products
.
According to the results of the ZUMA-5 single-arm, open-label, multi-center trial, with a median follow-up of 17.
5 months, 92% of patients with relapsed/refractory indolent NHL (n=104) responded to Yescarta, and 76% achieved complete remission.
Neither DOR, PFS nor OS are achieved, and 64% of FL patients are still in continuous remission2
.
About Fosun Kite Fosun Kite Biotechnology Co.
, Ltd.
is a joint venture between Shanghai Fosun Pharmaceutical Group and Kite (a subsidiary of Gilead Sciences).
It is committed to the research and development of tumor immune cell therapy products and the standardized development of industrialization to benefit Chinese patients
.
The company is headquartered in Shanghai Zhangjiang Hi-Tech Park, and a CAR-T industrial production base of 10,000 square meters has been established and officially opened in Zhangjiang Innovative Medicine Industrial Base
.
In addition, the company also has a cell therapy R&D center of 2000 square meters and a team of innovative talents.
Through independent innovation and international cooperation, the company focuses on CAR-T/TCR-T early R&D and clinical evidence-based projects to create a sustainable innovative R&D pipeline
.
For more information about Fosun Kite, please visit Data sources: 1.
NCCN Guideline V1.
2020 B-cell Lymphomas 2.
Jacobson CA, et al.
2020 ASH Oral Abstract 700.
Yimike is always committed to bio-innovative drugs With original news reports on cutting-edge technologies, industry trends, industry insights, etc.
, all-media high-end matrix users reached 160,000+, of which industrial users accounted for more than 50%, scientific research and clinical users accounted for about 30%, and investment institutions accounted for more than 5%
.
In order to promote interactive exchanges in industry segments, we have established a number of professional WeChat groups, welcome to scan the QR code to add groups
.
, Ltd.
announced today that the National Medical Products Administration (NMPA) has officially approved the company's CD19 target autologous CAR-T cell therapy product Akilunsai injection (FKC876) ) New indication registration clinical trial application (IND) [Acceptance No.
CXSL2100098] for the treatment of relapsed or refractory indolent non-Hodgkin’s lymphoma (r/r iNHL) after second-line or above systemic treatment
.
"Fosun Kate CEO Mr.
Huang Hai said: "On March 5, 2021, the FDA accelerated the approval of Yescarta (axicabtagene ciloleucel) for the treatment of adult patients with relapsed/refractory follicular lymphoma.
We are very pleased to see FKC876 in China.
(Axicabtagene ciloleucel) The IND for this new indication has also been approved by the NMPA, which means that the second indication of Fosun Kate’s CAR-T cell therapy product has entered the clinical stage
.
We are very grateful to the regulatory authorities for their encouragement and support for innovative therapies.
We look forward to working with clinical experts in China to carry out relevant trials to provide an important basis for the registration and marketing of the product’s new indications in China, and to provide more non-Hodgkin’s lymph in China as soon as possible Tumor patients bring new hope and opportunities
.
""About indolent non-Hodgkin's lymphoma (iNHL) Indolent non-Hodgkin's lymphoma (iNHL) is a malignant tumor that has slow clinical progress but becomes more aggressive over time
.
Follicular lymphoma (FL) and marginal zone lymphoma (MZL) are common subtypes
.
FL is also the second most common type of lymphoma in the world, accounting for approximately 22% of confirmed cases of NHL worldwide
.
MZL is the third most common lymphoma, accounting for approximately 8% to 12% of all B-cell NHL1
.
Although with the progress of disease management, the long-term survival rate of FL patients has been greatly improved, but the prognosis is very different
.
At present, there is no standard treatment plan for the relapsed and refractory FL patients after second-line treatment and above, and the treatment options for the relapsed and refractory MZL patients are also very limited
.
About FKC876 FKC876 is a CAR-T cell therapy product that Fosun Kite introduced Yescarta (axicabtagene ciloleucel) technology from Kite (a subsidiary of Gilead) in the United States in early 2017 for industrialization in China
.
It is used to treat adult patients with relapsed or refractory large B-cell lymphoma (including diffuse large B-cell lymphoma, unspecified type, primary mediastinal large B-cell lymphoma, high-grade New drug marketing applications for B-cell lymphoma and diffuse large B-cell lymphoma transformed by follicular lymphoma have been included in the priority review by NMPA in March 2020
.
About Yescarta Yescarta was approved by the U.
S.
FDA on October 18, 2017 for the treatment of adult patients with relapsed and refractory large B-cell lymphoma, including diffuse large B-cell lymphoma (DLBCL), unspecified, primary mediastinum B-cell lymphoma (PMBCL), high-grade B-cell lymphoma, and follicular lymphoma transformed DLBCL is the first CAR-T cell drug approved by the US FDA for specific non-Hodgkin's lymphoma
.
On March 5, 2020, its application for extended indications for the treatment of adult patients with relapsed/refractory follicular lymphoma (FL) received accelerated approval from the U.
S.
FDA, becoming the world's first CAR- approved to be marketed for FL.
T cell therapy products
.
According to the results of the ZUMA-5 single-arm, open-label, multi-center trial, with a median follow-up of 17.
5 months, 92% of patients with relapsed/refractory indolent NHL (n=104) responded to Yescarta, and 76% achieved complete remission.
Neither DOR, PFS nor OS are achieved, and 64% of FL patients are still in continuous remission2
.
About Fosun Kite Fosun Kite Biotechnology Co.
, Ltd.
is a joint venture between Shanghai Fosun Pharmaceutical Group and Kite (a subsidiary of Gilead Sciences).
It is committed to the research and development of tumor immune cell therapy products and the standardized development of industrialization to benefit Chinese patients
.
The company is headquartered in Shanghai Zhangjiang Hi-Tech Park, and a CAR-T industrial production base of 10,000 square meters has been established and officially opened in Zhangjiang Innovative Medicine Industrial Base
.
In addition, the company also has a cell therapy R&D center of 2000 square meters and a team of innovative talents.
Through independent innovation and international cooperation, the company focuses on CAR-T/TCR-T early R&D and clinical evidence-based projects to create a sustainable innovative R&D pipeline
.
For more information about Fosun Kite, please visit Data sources: 1.
NCCN Guideline V1.
2020 B-cell Lymphomas 2.
Jacobson CA, et al.
2020 ASH Oral Abstract 700.
Yimike is always committed to bio-innovative drugs With original news reports on cutting-edge technologies, industry trends, industry insights, etc.
, all-media high-end matrix users reached 160,000+, of which industrial users accounted for more than 50%, scientific research and clinical users accounted for about 30%, and investment institutions accounted for more than 5%
.
In order to promote interactive exchanges in industry segments, we have established a number of professional WeChat groups, welcome to scan the QR code to add groups
.
