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    Home > Medical News > Medical Science News > Late lymphoma TJC4 has been approved for clinical trials by NMPA

    Late lymphoma TJC4 has been approved for clinical trials by NMPA

    • Last Update: 2021-03-02
    • Source: Internet
    • Author: User
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    Heavenly Creatures (the "Company") is a clinical biopharmaceian company dedicated to the target discovery, clinical development and commercialization of innovative biopharmaceers to provide new and effective treatments for cancer treatments that are in urgent need worldwide. The company announced today that its new drug lemzoparlimab (also known as TJC4) for the treatment of patients with relapsed or resuscable advanced lymphoma has been approved by the China National Drug Administration (NMPA) Drug Review Center (CDE) for Phase 1 clinical trials (CXSL2000206). This is the first international multi-center clinical trial approved by Lemzoparlimab in China and the second new drug application to be approved for clinical research in China. Currently, a Phase 1/2a clinical trial (CXSL1900039; NCT04202003) in China for the treatment of patients with relapsed or resuscable acute myeloid leukemia (r/r AML) is also under way and clinical results are expected in early 2021.Lemzoparlimab is a highly differentiated CD47 monoclonal antibody developed by Heavenly Life. The innovation is that lemzoparlimab's ability to minimize binding to normal red blood cells while retaining strong anti-tumor activity reduces the occurrence of clinically severe anemia, a unique advantage that makes it unique in the global CD47 antibody research and development queue.
    Preliminary results from Lemzoparlimab's Phase 1 cancer clinical study in the United States showed differentiated advantages in safety and better pharmacological dynamics. The results showed that lemzoparlimab showed good tolerance in the dose range of 1 mg/kg to 30 mg/kg per week, without any pre-exciting administration, and that dose-limiting toxicity or severe hematological adverse events were not observed in assessable patients. The results of the trials will be presented at relevant international academic conferences later this year. At the same time, Tianbi is conducting a clinical study in the United States of lemzoparlimab in patients with pym monoantigens for the treatment of solid and classic Hodgkin's lymphoma."We firmly believe that lemzoparlimab has great potential in treating a wide range of cancers, particularly malignant tumors in the blood system," said Dr. Hsin Huajun, Chief Executive Officer of Tiantian Bio. We look forward to accelerating clinical research through close cooperation between the U.S. and Chinese teams to reach patients faster with this innovative, life-saving drug. Earlier, Tiantian Bio established a broad global strategic partnership with AbbVie on the development and commercialization of lemzoparlimab. Under the cooperation agreement, the two sides will work together to design and further conduct clinical trials around the world to assess the potential of lemzoparlimab for treatment in a variety of cancers. Heavenly Creatures reserves all rights Chinese mainland the development and commercialization of Lemzoparlimab in Hong Kong, China, Macau, China and Hong Kong, China. In the future, the two sides may expand their cooperation to jointly develop other CD47 joint treatment options.Guan
    in CD47 and Lemzoparlimab CD47 is a glycoprotein widely expressed on the surface of a variety of cancer cells, which releases a "don't eat me" signal by connecting with SIRP alpha on the surface of tumor-eating cells to stop macrophages from devouring. CD47 antibody has become one of the most promising tumor immune targets because it can block this signal and make macrophages attack tumor cells. But CD47 antibodies attack tumor cells while binding to normal red blood cells, causing hematological side effects, such as severe anemia, which hinders the development and clinical application of CD47 antibodies as a cancer treatment. Scientists at Heavenly Life have made a breakthrough discovery of a unique CD47 antibody, lemzoparlimab, that effectively targets tumor cells while minimizeing the adverse effects on red blood cells to avoid severe anemia.A series of preclinical studies have fully demonstrated the hematological safety benefits and superior anti-tumor activity of lemzoparlimab. Now, the results of Phase 1 clinical trials in cancer patients provide further clinical validation for this differentiation. In addition to the ongoing clinical trials in patients with acute myeloid leukemia (AML) in China, Tianbi will continue to advance research in the United States on the joint treatment of solid tumors with Lemzoparlimab and Keytruda® (Pim monoanti) and in the joint treatment of lymphoma with Rithuxan®

    about the life ofTiantian Bio is a dynamic international biotechnology company, focusing on the field of tumor immunity and autoimmune diseases in the field of differentiated innovative biopharmaceers research and development, with the mission of "continuous development of innovative biological drugs, truly change the lives of patients." Driven by a two-wheel strategy of "fast product launch" and "fast proof of concept", Tiantian Bio has rapidly established more than a dozen innovative drug research and development pipelines with global competitiveness through diversified models such as independent research and development and global cooperation. Tiantian Bio is rapidly growing into an integrated global biopharmaceutical company covering the entire industry chain, thanks to its excellent pharmaceutical research and development team, recognized preclinical and clinical development capabilities, and world-class GMP production capacity. Tiantian Life has offices in Beijing, Shanghai, Hong Kong and Maryland, USA.
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