On August 26, 2021 Boan Biotech reported that Boyounuo (Bevacizumab Injection), an self-developed anticancer biologic, has been approved by China’s National Medical Products Administration for the treatment of hepatocellular carcinoma (HCC) (Press release, Boan Biotech, AUG 26, 2021, View Source [SID1234595077]). It is the fourth indication approved for Boyounuo, with the first three indications being for advanced, metastatic or recurrent non-small-cell lung cancer, metastatic colorectal cancer, and recurrent glioblastoma. The latest approval gives liver cancer patients a new treatment option and will enable Boyounuo to serve a broader patient population.
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Liver cancer is a common malignancy in China, and the disease has a high morbidity and a high mortality rate. HCC is the most common form of liver cancer, accounting for around 90% of all cases . According to data from the World Health Organization’s International Agency for Research, 910,000 new cases of liver cancer were reported worldwide in 2020, of which 410,000 occurred in China, accounting for over 45% of the world total. In China, liver cancer has become the second most deadly form of cancer: 390,000 deaths were reported in 2020, close to the number of new cases the same year . The 5-year survival rate for liver cancer patients in China was only 12.1% , indicating high incidence and low survival. The disease severely affects life and health of China’s population and places a significant healthcare burden on society and patient’s families.
Due to its insidious onset, most liver cancer patients have already reached the middle to late stage of the disease at the time of initial diagnosis, when radical surgery is no longer a treatment option. The prognosis, especially for patients with unresectable HCC, is poor: patients have few options for systemic treatment and the 1-year survival rate after diagnosis is less than 50% . Bevacizumab in combination with atezolizumab is the first first-line treatment for advanced HCC to achieve positive results in more than a decade. The combination therapy overcomes common factors which lead to poor prognosis of HCC by leveraging a unique mechanism of immunotherapy together with the regulatory effects of anti-angiogenic therapy on the immune microenvironment. Compared to first-line therapies for HCC prior to this combination, patients with advanced unresectable HCC who receive the combination therapy are able to live longer and enjoy better quality of life. Bevacizumab in combination with atezolizumab is also the first approved first-line immune combination therapy for unresectable HCC and has been listed as a first-line treatment option for liver cancer by several authoritative guidelines in China and around the world with the best level of evidence and the highest level of recommendation.
Boyounuo is an anti-VEGF humanized monoclonal antibody injection developed 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, efficacy, safety and immunogenicity.
Dr. Dou Changlin, R&D President and COO of Boan Biotech, said, "We are delighted to see the approval of another indication for Boyounuo. Bevacizumab is one of the standard therapies used in the treatment of malignant tumors. We anticipate that Boyounuo will help serve more patients and contribute to the better management of cancers in China."