Shanghai, July 24, 2023
Bivision Pharmaceuticals, Inc. (Bivision) today announced receiving the approval (CXHL2300514) of its Investigational New Drug (IND) application for lutetium Lu 177 JH020002 injection, a novel drug for targeted radionuclide therapy (TRT), from the National Medical Products Administration (NMPA) of China. This was the latest milestone achieved by Bivision after obtaining an IND approval for the same drug from the US Food and Drug Administration (FDA) five weeks ago. As a result, Bivision became the first Chinese company to be allowed to carry out clinical trials for a TRT drug simultaneously in the United States and China, securing its leading position in TRT development in China and beyond.
Prostate cancer (PC) is the most common cancer in American and European men. In recent years, the incidence of PC has shown a rapid growth in Chinese men with more than half of the patients found that the cancer had metastasized when first diagnosed, making it more difficult to treat. Metastatic castration-resistant prostate cancer (mCRPC), an advanced and deadly form of PC currently with no effective treatment in China and only one approved drug (Pluvicto) in the US and Europe, is the cancer stopped responding to hormone treatment and spread to other parts of the body.
Lutetium Lu 177 JH020002 is intended to treat adults with prostate specific membrane antigen positive (PSMA+) mCRPC and expected to expand treatment to other forms of PC. The drug demonstrated better efficacy in animal models with both high and mid-to-low levels of PSMA comparing to Pluvicto while the latter appeared to work only with high PSMA-expressing models. This advantage leaves lutetium Lu 177 JH020002 a wide window to offer new treatment solutions to PC patients of other forms than mCRPC.
About Bivision
Bivision is an early clinical-stage biopharmaceutical company advancing a novel approach, targeted radionuclide therapy (TRT), to cancer treatment. TRTs are created to attack cancer more precisely and controllably by delivering DNA-breaking radiation directly to cancer cells to cause damage to targeted and nearby cells, a unique killing mechanism different from all other targeted therapies. Bivision believes that its approach can combine the benefits of targeted therapy, radiation therapy, immunotherapy, and companion diagnostic imaging and provide cancer patients with a new treatment option for better and fuller lives.
Founded by four scientists who brought in more than 50 combined years of experience in TRT development, Bivision is powered by its proprietary technology platforms to design, construct, assess, and optimize its TRT candidates. Its robust pipeline includes versatile programs evaluating several differentiated drug targets with the first program currently in Phase I/II clinical trials and the second one entering IND enabling studies. To learn more, visit https://www.bivisionpharma.com.
