SHANGHAI, March 1, 2024/PRNewswire/ -- Keji Pharmaceuticals (stock code: 2171.HK), an innovative CAR-T cell therapy company focused on treating hematologic malignancies and solid tumors, announced,National Drug Administration (“NMPA”) Has officially approved Saikaiser(Zewokie Orense injection, product number:CT053, a type aimed atBCMAThe itselfCAR-TNew drug marketing application (candidate product) (“NDA”), for the treatment of adult patients with recurrent or refractory multiple myeloma, with a history of at least3Progression after line therapy (at least one proteasome inhibitor and immunomodulator have been used).
SaikaizeIt is an autologous BCMA-targeted CAR-T cell product. It is produced by lentivirus transduction of T cells. The CAR encoded by lentivirus includes an all-human BCMA-specific single-chain variable fragment (“scFv”), a human CD8α hinge domain, a CD8α transmembrane domain, a 4-1 BB co-stimulation domain, and a CD3zeta activation domain. Self-developed new whole-human scFv has high binding affinity and stability.
SaikaizeThe approval was based on an open-label, single-arm, multi-center phase II clinical trial (LUMMICAR STUDY 1, NCT03975907) conducted in China. According to the test results announced by the American Society of Hematology (“ASH”) in 2022, CykeizerIt has shown encouraging efficacy and good safety.
Multiple myeloma is an intractable malignant plasmacytic disease that accounts for about 10% of all hematologic tumors.[1]As China's aging accelerates and the average life expectancy of the population increases, the number of cases of multiple myeloma will continue to increase. According to Frost and Sullivan estimates, the number of cases of multiple myeloma in China in 2023 is about 153,000, and the number of new cases is 23,200. The number of cases of multiple myeloma in China is expected to increase to 266,300 in 2030.[2]
SaikaizeProfessor Chen Wenming, the main researcher registered in clinical trials in China and chief physician of the Department of Hematology at Beijing Chaoyang Hospital, said:“Under traditional treatment, patients with recurrent or refractory multiple myeloma have poor prognosis and few treatment options. These patients have huge unmet clinical needs, and there is an urgent need for an effective, safe and convenient treatment. SaikaizeThe approval provided our clinicians with more choices and brought new hope to patients.”
SaikaizeProfessor Chengcheng, the main registered clinical trial researcher in China and chief physician of the Department of Hematology at the First Affiliated Hospital of Soochow University, said:“Judging from the published results of the LUMMICAR-1 study, Sekai ZeIt has shown deep and long-lasting efficacy in patients with recurrent or refractory multiple myeloma, and is generally well tolerated. I'm very happy to see SaikaiserIt has been successfully approved for listing, and we also expect it to benefit more patients in the future and help patients achieve high-quality long-term survival.”
Dr. Li Zonghai, founder, chairman of the board of directors, CEO and chief scientific officer of Keji Pharmaceuticals, said:“On the 10th anniversary of Koji's founding, I am very happy to announce Sekai Sekai ZeThe successful approval for listing is an important milestone in the company's development process and the best reward for our team's unremitting efforts. We sincerely thank the team members, researchers, patients and all sectors of society for their support and trust. We are looking forward to CykeizerIt can bring more hope to adult patients with recurrent or refractory multiple myeloma and improve their survival status. Adhering to the vision of 'science and technology to help the world', we will continue to explore new technologies, expand our product pipeline with global rights, solve the major challenges faced by CAR-T cell therapy, and bring innovative and differentiated cell therapies to cancer patients around the world.”
About Sekai Ze
SaikaizeIt is an all-human anti-autologous BCMA CAR-T cell product for the treatment of recurrent or refractory multiple myeloma. Keji Pharmaceutical received a notice from the State Drug Administration on March 1, 2024 to approve SaikaizeNew drug marketing application (approval date February 23, 2024) for the treatment of adult patients with recurrent or refractory multiple myeloma who have progressed after at least 3 lines of treatment (at least one proteasome inhibitor and immunomodulator has been used). Keji Pharmaceutical is advancing phase 1b/2 clinical trials (LUMMICAR STUDY 2) in North America to evaluate CykeizerSafety and efficacy for treating recurrent or refractory multiple myeloma.
SaikaizeIt received the title of Advanced Regenerative Medicine (RMAT) and Orphan Drug from the US FDA in 2019, and the European Medicines Agency (EMA) Priority Drug (PRIME) and Orphan Drug Product titles in 2019 and 2020, respectively. SaikaizeIt also received a breakthrough therapeutic drug from the State Drug Administration in 2020.
In January 2023, Keji Pharmaceutical and Huadong Pharmaceutical will compete with KaizeCommercial cooperation was reached in mainland China, and Keji Pharmaceutical awarded Huadong Pharmaceutical KaizeExclusive commercialization rights in mainland China.
About Keji Pharmaceutical
Keji Pharmaceutical (stock code: 2171.HK) is a biopharmaceutical company with operations in China and the US, focusing mainly on innovative CAR-T cell therapy for the treatment of hematologic malignancies and solid tumors. We have established a CAR-T cell research and development platform from target discovery, innovative CAR-T cell development, clinical trials to commercial-scale production. Through independent research and development of new technologies and a product pipeline with global rights, we solve the major challenges of CAR-T cell therapy, such as improving safety, improving the efficacy of treating solid tumors, and reducing treatment costs. Our mission is to be a global biopharmaceutical leader that brings innovation and differentiation to cancer patients around the world and makes cancer curable.
Forward-looking statements
All statements in this press release that are not historical facts or are unrelated to current facts or current conditions are forward-looking statements. Such forward-looking statements express the Group's current views, predictions, beliefs and expectations about future events as of the date of this press release. Such forward-looking statements are based on assumptions and factors beyond the Group's control. As a result, they are subject to material risks and uncertainties, actual events or results may differ materially from these forward-looking statements, and the forward-looking events discussed in this press release may not occur. These risks and uncertainties include, but are not limited to, details under the heading “Key Risks and Uncertainties” in our recent annual and interim reports and other announcements and reports posted on our corporate website. We make no representations or warranties about the fulfillment or reasonableness of any predictions, goals, estimates, or predictions in this press release, and should not rely on those predictions.
References
1. Kyle RA, Rajkumar SV. Multiple myeloma N Engl J Med. 2004; 351:1860-1873.
2. Frost and Sullivan Cellular Immunotherapy Market Independent Market Research version March, 2021. Data on file.
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