Oct 13, 2021 (Shanghai, China) – Jiangsu Hengrui Pharmaceuticals Co., Ltd. and its subsidiary Suzhou Suncadia Biopharmaceutical Co., Ltd. announced that NMPA approved an IND application for fuzuloparib in combination with bevacizumab to initiate a Phase Ib/III study as first-line maintenance treatment for unresectable or metastatic colorectal cancer.  

About the Study

SHR3162-III-308 consists of 2 parts:

* Part 1 (Phase Ib): to determine recommended Phase 3 dose (RP3D)

* Part 2 (Phase III): a multi-center, randomized, open-label, active-controlled study to evaluate the efficacy and safety of fuzuloparib in combination with bevacizumab as first-line maintenance treatment for unresectable or metastatic colorectal cancer, compared with capecitabine in combination with bevacizumab

The primary endpoint is progression-free survival (PFS) assessed by blinded independent central review (BICR). The secondary endpoints include overall survival (OS), time to second objective disease progression (PFS-2), time to first subsequent therapy (TFST), objective response rate (ORR), and disease control rate (DCR).

About Colorectal Cancer

Colorectal cancer is the third most common type of cancer and is the second leading cause of cancer mortality worldwide. Approximately 40% of all colorectal cancer patients are at Stage IV at the time of diagnosis, and 75-90% of these patients with unresectable cancer. The current treatment option for advanced or metastatic colorectal cancer is mainly chemotherapy in combination with targeted therapy. However, toxicity could accumulate with long-term chemotherapy and is difficult to recover. Therefore, a new drug or combination is urgently needed to prolong the PFS, reduce the occurrence of adverse events, and improve the quality of life.

About Fuzuloparib

Fuzuloparib is a novel, potent, and orally active PARP inhibitor developed by Hengrui, which has been marketed in China for the treatment of ovarian cancer. Fuzuloparib received its first marketing authorization in Dec 2020 in China for the treatment of platinum-sensitive recurrent ovarian cancer, fallopian tube cancer, or primary peritoneal cancer in patients with germline BRCA mutation who have undergone second-line or above chemotherapy, and then received its second marketing authorization in Jun 2021 for the ≥2-line maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube cancer, or primary peritoneal cancer who are in complete or partial response to platinum-based chemotherapy. Consistent with high bioavailability observed in non-clinical studies, clinical data demonstrated a steady serum concentration, few gastrointestinal AEs in the severity of ≥Grade 3, and a low discontinuation rate due to AEs in patients receiving fuzuloparib. Of note, a large-scale non-interventional registry study is currently ongoing to evaluate the effectiveness and safety of fuzuloparib for the treatment of ovarian cancer in the real-world setting.

In addition, fuzuloparib is being evaluated for the treatment of other tumors, such as breast cancer, pancreatic cancer, triple-negative breast cancer (TNBC), and small cell lung cancer (SCLC).

About Bevacizumab

Bevacizumab is a humanized anti-VEGF monoclonal antibody. Hengrui’s bevacizumab biosimilar has received marketing authorization for the treatment of metastatic colorectal cancer, advanced, metastatic, or recurrent NSCLC, and recurrent glioblastoma (GBM).

About Jiangsu Hengrui Pharmaceuticals Co., Ltd.

Hengrui is a leading global pharmaceutical company headquartered in China with a focus on research, development, manufacturing, and commercialization of innovative and high-quality healthcare products. Innovation is the core development strategy. Hengrui ranked the 21st among the top 1,000 global pharma companies in 2020. Hengrui has been on the Pharma Exec’s annual listing of the top global pharmaceutical companies for the third consecutive year, rising from the 47th in 2019 to the 38th in 2021.

BD Contact

Email: bd@hengrui.com

Phone: +86-21-61053532