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On December 25, Shenzhen Microcore Biotech Co., Ltd. ("Microcore Biotech") in the study of anti-tumor original innovative drug Chiauranib capsule by the State Drug Administration Drug Review Center (CDE) officially included in the "breakthrough treatment drug varieties", into the adaptation of the market approval as the target of confirmed Phase III clinical trials for the treatment of patients with progression or recurrence of small cell lung cancer (SCLC) after a 2-line system chemotherapy program.
Isoroni is a new chemical structure designed and developed by Microcore Bio with global patent protection, belonging to the multi-target protein kinase inhibitor for anti-tumor treatment, as a class 1 original innovative drug.
Theo Ronnie selectively inhibits multiple kinase targets such as Aurora B, CSF1R and VEGFR/PDGFR/c-Kit, thereby inhibiting tumor cell proliferation, enhancing anti-tumor immunity, and inhibiting tumor angiogenesty to achieve multi-pathentic anti-tumor effects.
the molecular mechanism associated with the Aurora B pathland, which inhibits potentially abnormal activity in small cell lung cancer, has the basis for the efficacy of single-drug treatment SCLC, which is an important marker of Theuroni's differentiation from other anti-angiogenesic therapist drugs.
Theroni was approved for Phase I clinical trials issued by the former State Food and Drug Administration (CFDA) in August 2013 and has completed a number of phase II clinical trials in China for different types of malignant tumors with single-drug or combined therapy, demonstrating positive clinical efficacy and good human safety tolerance.
, Theroni has completed preIND communication with the FDA on clinical development of small cell lung cancer.
small cell lung cancer accounts for about 15-20% of the total lung cancer patients, compared to non-small cell lung cancer, small cell lung cancer lack of clear tumor-driven genes and the corresponding targeted treatment drugs, clinically based on chemotherapy, although there is short-term efficacy but very easy to relapse, the long-term survival of patients far worse than non-small cell lung cancer, the urgent need for new mechanisms of treatment drugs.
trials, Theo Ronnie achieved very positive results in single-drug treatment compared to historical control data for patients who failed multi-line therapy, potentially providing better treatment options for patients with small cell lung cancer.
source: Shenzhen Microcore Biotech Co., Ltd. Note: The original text has been reduced