Recently, Hengrui Pharmaceuticals' innovative drug fluazoparib (Errayi®) alone or in combination with apatinib (Etan®) for the treatment of HER2-negative breast cancer with mutations in the germline breast cancer susceptibility gene (gBRCA) has been included in the list of breakthrough therapeutic varieties by the Center for Drug Evaluation of the State Drug Administration (CDEA).

According to the data released by the International Agency for Research on Cancer (IARC) of the World Health Organization in 2020, breast cancer has become the world's number one malignant tumor and is one of the most common malignant tumors in women. Currently, the incidence of breast cancer in domestic patients is growing rapidly and has been ranked first on the spectrum of female tumor incidence, and recurrence and metastasis occur in nearly 50% of patients after treatment. Human breast cancer susceptibility genes (BRCA) are important oncogenes in the human body, including BRCA1 and BRCA2. Compared with the general population, carriers of BRCA1 and BRCA2 gene mutations have a 10- to 20-fold increased risk of breast cancer. And about 5% to 10% of breast cancer patients carry mutated BRCA genes, and BRCA mutated breast cancer patients tend to have higher stage and poorer prognosis. The treatment of BRCA gene mutated breast cancer in China is still dominated by platinum-based chemotherapy and lacks effective therapeutic means.

Fluzoparib is a new PARP inhibitor developed by Hengrui Pharmaceuticals with independent intellectual property rights, which can specifically kill tumor cells with BRCA mutation, and was approved to be listed in December 2020, and fluzoparib capsule has been approved for two indications, which are as follows: approved for platinum-sensitive breast cancer patients with germline BRCA mutation (gBRCAm) who have been previously treated with second-line and above chemotherapy in December 2020, and approved for platinum-sensitive breast cancer patients who have been treated with second-line and above chemotherapy in December 2020, and approved for platinum-sensitive breast cancer patients who have been treated with second-line and above chemotherapy. recurrent ovarian, fallopian tube, or primary peritoneal cancer; and approved in June 2021 for the maintenance treatment of adult patients with platinum-sensitive recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who have achieved complete or partial remission with platinum-containing chemotherapy. The application for marketing authorization of fluzoparib monotherapy for the maintenance treatment of patients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer after achieving complete remission or partial remission with first-line platinum-containing chemotherapy has been accepted by the State Administration of Pharmaceutical Affairs (SDPA) on 2023 August.

Apatinib, a small molecule tyrosine kinase inhibitor targeting vascular endothelial growth factor receptor (VEGFR) independently developed by Hengrui Pharmaceuticals, was approved for marketing in October 2014, and Apatinib mesylate tablets have been approved for three indications, which are: single-agent use for advanced gastric adenocarcinoma or gastroesophageal conjugation that has progressed or recurred after at least 2 prior systemic chemotherapies, which were approved for single-agent use in October 2014 adenocarcinoma; single-agent approval in December 2020 for the treatment of patients with advanced hepatocellular carcinoma who have failed or are intolerant to at least one prior line of systemic therapy; and approval in January 2023 for the first-line treatment of patients with unresectable or metastatic hepatocellular carcinoma in combination with injectable karelizumab.

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