On September 8, 2021, Jiangsu Hengrui Pharmaceutical Co., Ltd. and its subsidiary Suzhou Sundia Biotechnology Co., Ltd. received the Notice of Approval for Drug Clinical Trials issued by the National Medical Products Administration (NMPA) for Fuzuloparib Capsules and Bevacizumab Injection. The NMPA approved the initiation of a Phase Ib/III clinical trial comparing Fuzuloparib plus Bevacizumab versus Capecitabine plus Bevacizumab as first-line maintenance treatment for patients with unresectable or metastatic colorectal cancer.
About Colorectal Cancer
Colorectal cancer is a common malignant tumor, ranking 3rd in incidence and 2nd in mortality worldwide. Approximately 40% of patients are diagnosed at Stage IV, and 75%–90% of these cases are unresectable.
Current treatments for advanced or metastatic colorectal cancer rely mainly on combined chemotherapy and targeted therapy. However, toxicities from long-term chemotherapy accumulate over time and are often irreversible. There is an urgent clinical need for novel drugs or combination regimens to address this unmet medical need—prolonging patients’ progression-free survival, reducing adverse reactions, and improving quality of life.
About Fuzuloparib
Fuzuloparib is a Class 1.1 innovative drug developed by Hengrui Medicine, and the first domestically invented poly(ADP-ribose) polymerase (PARP) inhibitor with independent intellectual property rights in China. As a PARP inhibitor, it selectively induces cytotoxicity in tumor cells harboring BRCA mutations.
Hengrui Medicine obtained clinical trial approval in August 2013 and launched clinical development. In December 2020, Fuzuloparib Capsules were approved for the treatment of platinum-sensitive recurrent ovarian cancer, fallopian tube cancer, or primary peritoneal cancer in patients with germline BRCA mutations (gBRCAm) who had received two or more prior lines of chemotherapy.
In June 2021, its second indication was approved by the NMPA: maintenance treatment for platinum-sensitive recurrent epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer in patients who achieved complete or partial response to platinum-based chemotherapy.
About Bevacizumab
Bevacizumab is a humanized anti-VEGF monoclonal antibody. Hengrui’s Bevacizumab Injection is an independently developed biosimilar, developed and approved via the biosimilar regulatory pathway with reference to the originator product.
Following a rigorous biosimilar development program, it underwent comprehensive similarity assessments covering quality, non-clinical, and clinical comparative studies. These investigations confirmed high pharmacokinetic (PK) similarity to the reference product, as well as equivalent efficacy and a favorable benefit-risk profile. This approval improves clinical accessibility while maximizing therapeutic benefits for patients. The product was approved by the NMPA in June 2021.
Fuzuloparib combined with chemotherapy or targeted agents is being investigated across multiple tumor types, including breast cancer, ovarian cancer, and gastrointestinal malignancies, with numerous ongoing studies. Synergistic antitumor activity has been established for PARP inhibitors combined with anti-angiogenic agents.
It is anticipated that this novel combination of Fuzuloparib and Bevacizumab Injection will deliver greater clinical benefits to more patients with unresectable or metastatic colorectal cancer, potentially offering a new treatment option for this patient population.
