On August 17, 2021, Fosun Kate Biotechnology Co., Ltd. reported that the National Medical Products Administration (NMPA) has officially designated the company’s CD19 target autologous CAR-T cell therapy product Akilunsai injection for new indications Included in the breakthrough treatment drug program, the proposed indication is the treatment of relapsed or refractory indolent non-Hodgkin’s lymphoma (r/r iNHL) after receiving second-line or above systemic treatment, including follicular lymphoma (FL) and Marginal zone lymphoma (MZL) (Press release, Gilead Sciences, AUG 17, 2021, View Source [SID1234633500]).
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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 NHL. 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.
Akilunza injection is Fosun Kate’s introduction of Yescarta (axicabtagene ciloleucel) from Kite (a company of Gilead) in the United States in early 2017 for technology transfer in China, and is authorized to locally produce the human CD19 autologous CAR- T cell therapy products. 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 applications for B-cell lymphoma and diffuse large B-cell lymphoma transformed by follicular lymphoma have been approved by the NMPA for marketing in June 2021.
In the United States, Yescarta was approved by the 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) non-specific, primary Mediastinal B-cell lymphoma (PMBCL), high-grade B-cell lymphoma and DLBCL transformed from follicular lymphoma are the first CAR-T cell drugs approved by the US FDA for specific non-Hodgkin lymphoma. On March 5, 2021, its application for extended indications for the treatment of adult patients with relapsed/refractory follicular lymphoma (FL) received accelerated approval from the US FDA, becoming the world’s first CAR- approved to be marketed for FL. T cell therapy products.
Fosun Kite Biotechnology Co., Ltd. is a joint venture between Shanghai Fosun Pharmaceutical Group and Kite of the United States. It is committed to the R&D, innovation, industrialization, commercialization, and standardized development of tumor cell therapy products for the benefit of 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 2000 square meter cell therapy R&D center and a team of innovative talents. Through independent innovation and international cooperation, the company focuses on CAR-T early R&D and clinical evidence-based projects to create a sustainable innovative R&D pipeline.
Mr. Huang Hai, CEO of Fosun Kate, said: "The inclusion of Akirensai injection in the breakthrough therapeutic drug program demonstrates NMPA’s support for clinical value-oriented drug innovation, and also shows that this drug is effective in treating relapsed or refractory drugs. The clinical advantages and potential of sexually inert non-Hodgkin’s lymphoma. The company will accelerate the clinical stage of the drug’s new indications, actively communicate and communicate with the drug review center, and provide more non-Hodgkin’s lymphoma in China as soon as possible. Tumor patients bring new hope and opportunities."