May 15, 2023 Bivision Pharmaceuticals(Shanghai),Inc.(hereinafter referred to as "Bivision”), a biopharmaceutical company focused on discovery , development and commercialization of novel theranostic medicine, announced that the IND application for its proprietary drug candidate "Lutetium [177Lu]JH020002 injection" (pipeline code: JH02) was officially accepted by the Center for Drug Evaluation (CDE) of the State Drug Administration of China (Acceptance number: CXHL2300514).
The indication of this product is primarily for prostate cancer, the most common cancer in Chinese men. As a novel PSMA targeted radiopharmaceutical, JH02 is expected to fulfill the domestic gap of lack of novel treatment for prostate cancer patients. The preclinical studies revealed that JH02 shows significant advantages over marketed drug in the same class. This IND application also marks that R&D process for the novel targeted radiopharmaceuticals in China has been accelerated towards clinical stage.
New breakthrough in targeted radionuclide therapy，Bivision’s JH02 gives patients more feasibility
Differentiated from the most of current existing radiopharmaceuticals on the market, which are mostly not “paired” drugs which means the diagnosis and treatment must use different drugs. Bivision focuses on developing targeted theranostic drugs for clinical application which can significantly improve the treatment efficiency for cancer patients. The concept of "theranostics" is the integration of "diagnosis" and "treatment". Imaging and treatment can be carried out by using the same molecule with different nuclides respectively. The paired theranostics can not only achieve systemic dynamics, non-invasive early imaging and rating, as well as evaluating treatment efficiency, but also solve the current clinical issues in the aspects of drug dosage, safety and overcoming drug resistance, and maximize the benefits of personalized treatment.
As the first echelon enterprise in the development of targeted radiopharmaceuticals in China, Bivision has developed a novel targeted radionuclide therapeutic drug JH02 based on J-Linker platform, one of the core proprietary technologies independently developed by Bivision. This variety has the characteristics of high selectivity, high specificity, high tumor uptake, and can bind and stay in the tumor site for a long time. JH02 is expected to fulfill the domestic gap of lack of novel treatment for prostate cancer patients. The preclinical studies revealed that JH02 shows significant advantages over marketed drug in term of safety margin, efficacy, and manufacture process. Apparently, JH02 may provide a new treatment regime for prostate cancer patients.
Meantime, Bivision is simultaneously filing the IND application of JH02 in the United States. Previously, Bivision raised 40 millions yuan in seed round led by Kaitai Capital in 2021, and again raised nearly 100 million yuan in angel round led by Gaorong Capital in 2022 to fund its targeted radiopharmaceutical programs.
About Bivision
Founded in 2021, Bivision is an innovative biotechnology company dedicated to develop the next generation of targeted radionuclide therapy (TRT). Bivision was founded by a group of biotech veterans who have extensive experience and expertise in the field of targeted radionuclide therapy. Since inception, Bivision has built a key proprietary technology platform for its drug development which enables its programs to be advanced to clinical stage quickly. Bivision will strive to become a patient-oriented innovative biotech committed to provide patients with better radiopharmaceuticals allowing more patients to have a better quality of life style.
