On February 1, 2021, Shanghai Longyao Biotechnology Co., Ltd.'s partner, GenScript's subsidiary, Legend Bio's CAR-T therapy, received accelerated review by the European Medicines Agency. Shanghai Longyao Biotechnology Co., Ltd. would like to express its warm congratulations.
Legend Bio is a clinical-stage global biopharmaceutical company focusing on the development of innovative cell therapy products for oncology and other indications. first stock. Cedarquiorenza is a new class 1 drug of Legend Bio's therapeutic biological products. It is a chimeric antigen receptor T cell (CAR-T) therapy and is currently conducting multiple clinical studies for the treatment of relapsed or refractory disease. It is a CAR-T with a differentiated structure composed of two single-domain antibodies targeting BCMA. In December 2017, Legend Bio entered into an exclusive global license and collaboration agreement with Janssen Bio, a subsidiary of Johnson & Johnson, for the development and commercialization of Cidaki Orenza.
cilta-cel is scheduled to submit a marketing authorization application in the first half of 2021 based on the results of the pivotal 1b/2 CARTITUDE-1 study evaluating the product in the treatment of relapsed or refractory multiple myeloid efficacy and safety in cancer patients. Results of the study were presented at the 62nd Annual Meeting of the American Society of Hematology in December 2020.
"CHMP's request for accelerated review strongly demonstrates the potential of cilta-cel for the treatment of multiple myeloma disease," said Dr. Ying Huang, CEO and CFO of Legend Biotechnology. "Our collaboration with our partner Janssen The companies look forward to working with EMA to bring this treatment to market and bring new hope to patients."
CHMP's request for accelerated review is another milestone following Legend Bio's rolling submission of cilta-cel's Biologics License Application to the U.S. Food and Drug Administration (FDA) in December 2020. Previously, Cedarquiorenza was granted breakthrough therapy designation in the United States in December 2019, priority drug designation by the European Commission in April 2019, and breakthrough therapy designation in China in August 2020. In addition, the U.S. FDA in February 2019, and the European Commission in February 2020 successively granted orphan drug designation for Cedarquiorenza.
In addition to Sidaki Orenza products, Legend Bio's innovative product pipeline has been further expanded, and it is moving towards becoming a platform-based CAR-T company. Its investigational autologous chimeric antigen receptor T-cell (CAR-T) therapy for the treatment of adults with relapsed or refractory T-cell lymphoma (TCL) was also approved by the U.S. FDA for new drug clinical trials on December 14, 2020 ( IND) application, becoming the second IND application approved by Legend Bio in the United States.
On February 15, 2019, GenScript and Shanghai Longyao Biotechnology Co., Ltd. signed a strategic cooperation agreement. GenScript provides one-stop preclinical pharmacy with a complete plasmid and virus CMC development and GMP production platform Research services will help Longyao Biotech's innovative CAR-T immune cell therapy technology successfully complete the clinical application, and the two parties are also cooperating on a new generation of CAR-T technology based on novel costimulatory signals and third signals, which can effectively overcome The immunosuppressive microenvironment of solid tumors and metastatic tumors enhances the efficacy of CAR-T on hematological and solid tumors.
"We warmly congratulate our partner GenScript's Legend Bio's CAR-T therapy for its accelerated review by the European Medicines Agency. If it is finally approved, it is expected to become the first Chinese-made CAR-T innovative drug to receive accelerated review. We will continue to Focus on the progress of accelerated review, and wish GenScript Legend Biothe first to receive accelerated review of China-made CAR-T innovative drugs. In the future cooperation, GenScript and Shanghai Longyao Bio will continue to Adhering to the principle of strong alliances and complementary advantages, we will promote the industrialization of its CAR-T cell therapy project and benefit tumor patients as soon as possible."
About Shanghai Longyao Biological
Longyao Bio is committed to the research and development, technology transformation, product declaration, clinical application research and application promotion of tumor immune cell counting. The company is led by a team of scientists led by Professor Yang Xuanming of Shanghai Jiaotong University, and Dr. Yao Yi, a former senior FDA review expert, serves as the chief medical officer. Malignant hematological tumor, solid tumor technology and products have laid out 14 product pipelines, accumulated many original achievements, and applied for a number of patents for key technologies. In July 2018, China Biotechnology Services Holdings Co., Ltd. (stock code 8037.HK) signed a contract to acquire 67% of the equity of Longyao Bio. The listed company has laid out precise detection and precise treatment, and is committed to building a future biotechnology platform. In terms of resources and resources, the development of Longyao Biology is fully guaranteed.
On January 21, 2021, the clinical trial application of Shanghai Longyao’s CD20-targeted CAR-T product was officially approved, and the National Medical Products Administration approved the clinical trial application of Shanghai Longyao’s LY007 cell injection, which is classified as a Class I new drug. , which reflects Shanghai Longyao's research and development capabilities in the field of immune cell drugs; on January 27, 2021, Eastern Time, an article on CD20-CART-OX40 was successfully published in Science Translational Medicine, with authors including China Shanghai Longyao Biotechnology Co., Ltd. (“Longyao”), a subsidiary of Biotechnology Services (08037), and Professor Yang Xuanming, the chief scientist of Longyao. Under the leadership of the team of scientists headed by Yang Xuanming, Longyao Biotechnology has stronger tumor killing efficiency and longer-lasting self-amplification ability in building an improved CAR-T laboratory preparation technology.