Boan Biotech's Boyounuo® (Bevacizumab Injection) Approved for Two New Indications: Ovarian Cancer and Cervical Cancer

February 25, 2022, Shanghai —Boan Biotech today announced that Boyounuo^® (Bevacizumab Injection), an anticancer biologic, has been approved by China’s National Medical Products Administration (NMPA) for two new indications, which are two gynecological cancers. Specifically, Boyounuo® is approved to be used in combination with carboplatin and paclitaxel as the first-line treatment for patients with Stage III or Stage IV epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer after the initial surgical resection, and is also approved to be used in combination with paclitaxel and cisplatin or paclitaxel and topotecan for the treatment of patients with persistent, recurrent or metastatic cervical cancer. 

Boyounuo^® is a recombinant anti-VEGF humanized monoclonal antibody injection developed by Boan Biotech. Comparative clinical studies have shown that Boyounuo^® is highly similar to the originator bevacizumab in terms of pharmacokinetics, efficacy, safety and immunogenicity. 

As a signature anti-angiogenic oncology drug, bevacizumab is one of the indispensable therapies for the treatment of malignant tumors. Neovascularization plays a crucial role in the progression, invasion and metastasis of tumors, and the interaction of vascular endothelial growth factor (VEGF) with its receptor leads to endothelial cell proliferation and neovascularization. Bevacizumab precisely targets VEGF and thus reduces microvascular growth and inhibits metastasis.

Cervical cancer and ovarian cancer are two common malignant gynecological cancers. The former has a high incidence and the latter a high mortality rate. According to the 2020 global cancer burden data by the International Agency for Research on Cancer (IARC) of the World Health Organization, in China, approximately 110,000 new cases of cervical cancer were reported that year with close to 60,000 deaths, and approximately 55,000 new cases of ovarian cancer with about 38,000 deaths . These two gynecological cancers seriously affect the lives and health of women.

When it comes to the treatment of ovarian cancer, multiple clinical studies have shown that bevacizumab in combination with chemotherapy as the first-line and maintenance treatment can significantly improve progression free survival (PFS) in patients with Stage III or Stage IV epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer who have received the initial surgical resection; and the combination therapy can also significantly improve the PFS and the objective response rate (ORR) in platinum-sensitive or platinum-resistant patients with recurrent epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer.

When it comes to the treatment of cervical cancer, clinical studies have shown that bevacizumab in combination with chemotherapy as the first-line treatment for patients with persistent, recurrent or metastatic cervical cancer can significantly improve their overall survival (OS), PFS, and ORR.

Given its clear efficacy and high safety demonstrated in clinical applications, bevacizumab has been recommended by some authoritative Chinese and international guidelines as a preferred treatment for ovarian cancer and cervical cancer. For example, bevacizumab in combination with chemotherapy is recommended as the first-line treatment for patients with recurrent and metastatic cervical cancer and as the first-line treatment and maintenance treatment for patients with ovarian cancer and as the treatment for recurrent ovarian cancer. The approval of the drug for the two new indications will provide another treatment option for patients with the two cancers.