Jemincare Announces 6 Approvals of Clinical Trials for its Innovative Drugs

27 December 2023 | Wednesday | News

Jemincare, a leading pharmaceutical company from China, announced that its wholly owned subsidiary company, Shanghai Jemincare Pharmaceutical Co., Ltd., recently received 6 approvals of clinical trials for its innovative drugs in the field of cancer, kidney and anti-infectious diseases, including 4 approvals from National Medical Products Administration (NMPA) and 2 approvals from the U.S. Food & Drug Administration (FDA).

On December 20, NMPA has approved a clinical trial for JMKX003801 to treat serious infection caused by Gram-negative bacteria. Drug resistance of antibiotics, especially carbapenem resistance, in Escherichia coli, Klebsiella pneumoniae, Acinetobacter baumannii and Pseudomonas aeruginosa has risen year by year. Preclinical studies on its mechanism show that JMKX003801 can overcome carbapenem resistance with very broad antibacterial spectrum.

On December 12, NMPA has approved a clinical trial for JMKX003142 to treat renal edema. There are about 120 million patients of chronic kidney disease (CKD) in China. The rise of proteinuria during the late stage of CKD will cause edema. Research has shown that JMKX003142 can improve patients' quality of life with minor side effects as a novel diuretic drug.

On November 28, NMPA has approved a clinical trial for JMKX003948 to treat renal cell carcinoma. In China, the number of newly diagnosed patients suffered from renal cell carcinoma is around 60 to 80 thousand each year. Since the failure of TKI and/or PD-1 immunotherapy, there is no other drug with new mechanism. Preclinical studies indicate that JMKX003948 show significant effect in animal models with a different mechanism of action.

On December 12, FDA has approved a clinical trial for JMKX000197 to treat BCG-unresponsive non-muscle-invasive bladder cancer, and earlier on October 19, NMPA has approved the clinical trial. Bladder cancer is the most common malignant tumor in bladder system and the number of newly diagnosed patients with bladder tumor is around 80 thousand each year in China. Preclinical studies indicate that JMKX000197 can regulate the immune system and show significant anti-tumor effect in BCG-unresponsive animal models.

Earlier on November 9, FDA has approved a clinical trial for JMKX003002 to treat hyperphosphatemia in end-stage kidney disease patients on dialysis. There are about 120 million patients of CKD in China and CKD causes hyperphosphatemia and CKD-mineral and bone disorder. As a novel drug to reduce phosphorus, JMKX003002 is expected to reduce phosphorus with a long-lasting effect and better oral compliance to improve the patients' quality of life.

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