Luye Pharma Group today announced that Boyounuo (Bevacizumab Injection), an oncology biologic developed in-house by its subsidiary Boan Biotech, has been approved by China’s National Medical Products Administration for the treatment of recurrent glioblastoma. It is the third indication approved for Boyounuo in China, the first two being advanced, metastatic or recurrent non-small cell lung cancer and metastatic colorectal cancer. The approval of this new indication will enable the product serve a broader patient population.
Glioblastoma is the most common malignant primary brain tumor, representing approximately 57% of all gliomas and 48% of all primary malignant central nervous system (CNS) tumors1. Characterized by high morbidity, high recurrence rate, high mortality rate and low cure rate, glioblastoma is regarded as one of the most difficult tumors to treat in the field of neurosurgery. Bevacizumab is one of the most important therapeutic agents in the treatment of glioblastoma after temozolomide, and has been listed as a recommended therapy for recurrent glioblastoma in multiple authoritative guidelines and consensus in China and around the world.
Boyounuo is an anti-VEGF humanized monoclonal antibody injection developed in-house by Boan Biotech. It is a biosimilar to Avastin®. Comparative clinical studies have shown that Boyounuo is highly similar to Avastin® in terms of PK characteristics, clinical efficacy, safety and immunogenicity. According to the Guidelines on Similarity Evaluation and Indication Extrapolation of Biosimilars, all indications for Avastin® approved in China can also be gradually applied to Boyounuo.
A signature anti-angiogenic oncology drug, bevacizumab is one of the standard therapies in the treatment of malignant tumors. Avastin® has been approved worldwide for the treatment of non-small cell lung cancer, colorectal cancer, glioblastoma, renal cell carcinoma, cervical cancer, ovarian cancer and other solid tumors, while in China it has been approved for treating advanced, metastatic or recurrent non-small cell lung cancer , metastatic colorectal cancer, recurrent glioblastoma and hepatocellular carcinoma.
Dr. Dou Changlin, R&D President and COO of Boan Biotech, said, “We are delighted to see the approval of the third indication for Boyounuo within three months of the Group’s announcement of marketing authorization for the product on May 7. Bevacizumab injection is the gold standard for the treatment of several malignant tumors. Its efficacy and safety have been widely recognized by doctors and patients in clinical applications. Given the large unmet treatment needs in these disease areas, we hope that Boyounuo will bring benefits to more patients, helping them live longer lives while improving their quality of life.”
Boan Biotech is accelerating growth in core market coverage via its own business team, commercial resources and networks to improve the accessibility of Boyounuo. Meanwhile, the company has granted AstraZeneca exclusive promotional rights in county markets across 21 provinces, municipalities and autonomous regions of China’s mainland to serve a broader patient base.
About Boan Biotech
As a subsidiary of Luye Pharma Group, Boan Biotech is a fully integrated biopharmaceutical company that specializes in therapeutic antibody development, manufacturing and commercialization with a focus on oncology, immunology, pain, and endocrine diseases. Boan Biotech's antibody discovery work is based on three technology platforms: Human Antibody Transgenic Mouse and Phage Display Technology Platform, Bispecific T-cell Engager Technology Platform and ADC Technology Platform. The company has developed more than 10 innovative antibody product candidates with international intellectual property protection, and 8 biosimilar product candidates, one of which – Boyounuo (Bevacizumab Injection) – has been launched in China.
Boan Biotech has expertise in the full industry chain: antibody generation, lead optimization, cell line development, process development, technology transfer, pilot and commercial scale production. The company is also actively exploring other cutting-edge technologies. Outside of China, Boan Biotech also pursues biopharmaceutical products development in the US and EU markets.