CDE of China NMPA clears I-Mab’s application for lemzoparlimab
Category: #health  By Pankaj Singh  Date: 2020-09-23
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CDE of China NMPA clears I-Mab’s application for lemzoparlimab

Clinical stage biopharmaceutical major, I-Mab, has reportedly announced that it has received the clearance of the Center for Drug Evaluation of the China National Medical Products Administration for its IND application for lemzoparlimab. The application reportedly deals with the initiation of a phase 1 clinical trial in patients who have been diagnosed with refractory or relapsed advanced lymphoma as part of a current IMCT that is also being conducted in the U.S.

According to Joan Shen, the CEO of I-Mab, the company firmly believes that lemzoparlimab has the potential to create a remarkable difference in the treatment of numerous cancers, especially hematologic malignancies in China. The company looks ahead toward advancing this initiative via close cooperation between the U.S. and China teams and furnishing a potentially life-changing drug to patients in need, added Shen.

The preliminary results of the latest phase 1 clinical trial in the United States depict differentiation of lemzoparlimab in terms of pharmacokinetics and safety profiles in cancer patients, cite sources. Reports state that Lemzoparlimab was well stood as a single agent at a dosage of up to 30 mg/kg/week without the introduction of any priming dosage strategy. In addition, no severe hematologic adverse events or dose-limiting toxicities were observed amongst all DLT-evaluable patients.

The complete data of the study will be presented at a suitable scientific conference later this year, state reports adding that the combination therapy of pembrolizumab with lemzoparlimab in patients with classical Hodgkin’s lymphoma and solid tumors are also underway in the U.S.

As per sources, Lemzoparlimab is an extremely differentiated anti-CD47 monoclonal antibody that was initially discovered and advanced by I-Mab. The candidate has been effectively designed for the minimization of inherent pinioning to normal RBCs while maintaining its robust anti-tumor activity, that forms an inherent attribute in the potential differentiation of lemzoparlimab from additional antibodies belonging to the same class.

 

Source Credits:

https://www.prnewswire.com/news-releases/i-mab-announces-china-nmpa-clearance-for-phase-1-clinical-trial-of-lemzoparlimab-in-relapsed-or-refractory-advanced-lymphoma-301134587.html



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Pankaj Singh

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Pankaj Singh

Pankaj Singh Develops content for Market Size Forecasters, Algosonline, and a couple of other platforms. A Post Graduate in Management by qualification, he worked as an underwriter in the UK insurance domain before deciding to switch his field of profession. With exp...

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