Boan Biotech’s 博优诺® (Bevacizumab Injection) Launched along with Patient Assistance Program

博优诺® (Bevacizumab Injection), an anticancer drug developed by Boan Biotech, a subsidiary of Luye Pharma Group, was launched in China on June 5, 2021. The first product from Boan Biotech’s pipeline to hit the market, 博优诺® is indicated for the treatment of advanced, metastatic or recurrent non-small-cell lung cancer (NSCLC), and metastatic colorectal cancer (mCRC). At the new-product launch conference, the company also announced a patient assistance program in partnership with Beijing Health Alliance Charitable Foundation, designed to make the drug more accessible and affordable to patients.

博优诺® Launch Conference

Over one hundred experts, academics and distinguished guests attended the launch, including Academician Yu Jinming of Shandong Cancer Hospital & Institute, Professor Qin Shukui of Jinling Hospital Affiliated to Medical School of Nanjing University, Professor Ma Jun of Harbin Institute of Hematology and Oncology, Professor Shi Yuankai of Cancer Hospital of Chinese Academy of Medical Sciences, Professor Liang Jun of Peking University International Hospital, Professor Jiang Zefei of Chinese PLA General Hospital, Professor Hao Jihui of Tianjin Medical University Cancer Institute and Hospital, and Wu Xianfei, Vice Chairman of Beijing Health Alliance Charitable Foundation. They witnessed this milestone moment with company representatives from Luye Pharma and Boan Biotech, including Yang Rongbing, President of Luye Pharma Group, Xie Wenmin, President of Luye Pharma (China), Jiang Hua, Chief Executive Officer of Boan Biotech, and Dr. Dou Changlin, R&D President and Chief Operating Officer of Boan Biotech.

博优诺® is Equivalent in Efficacy to the Originator Drug - Bevacizumab is a Standard Therapy for the Treatment of Multiple Cancers

Bevacizumab injection is a signature anti-angiogenic oncology therapy. The originator bevacizumab is indicated worldwide for the treatment of various solid tumors such as NSCLC, colorectal cancer, glioblastoma, renal cell carcinoma, cervical cancer and ovarian cancer. Its value has been widely recognized by physicians and patients after long-term clinical use for its significant efficacy and good safety profile. 

As a biosimilar of bevacizumab, 博优诺® was compared head-to-head with the originator drug in two pivotal clinical studies. The first was a pharmacokinetic (PK) study among healthy subjects, and the second was a comparative study of efficacy and safety in metastatic or recurrent non-squamous NSCLC patients. Both studies met primary endpoints, demonstrating that the two drugs are equivalent in efficacy and highly similar in terms of PK characteristics, safety, and immunogenicity.

Professor Shi Yuankai of Cancer Hospital of Chinese Academy of Medical Sciences

“In clinical studies, 博优诺® demonstrated good efficacy and a sound safety profile. Both are highly similar to those of the originator drug,” said Professor Shi Yuankai of Cancer Hospital of Chinese Academy of Medical Sciences, Chairman of Cancer Foundation of China, the principal investigator of the phase III clinical trial of 博优诺®. “The development of bevacizumab biosimilars is an important step forward in meeting the clinical needs of patients. The launch of 博优诺® will bring a new treatment option to the many patients who need anti-angiogenic therapy.” 

Dr.Dou Changlin, R&D President and Chief Operating Officer of Boan Biotech

Dr. Dou Changlin, Project Head of 博优诺®, R&D President and Chief Operating Officer of Boan Biotech, reflected on the development path. “We rigorously followed the biosimilar development pathway in the R&D of 博优诺®. Its bioequivalence with the originator drug is demonstrated in various respects, including primary and higher-level structures, physicochemical properties, purity, biological activity, non-clinical PKPD profile, toxicological profile, clinical pharmacokinetic profile, and clinical efficacy and safety. We built a complete chain of evidence covering all stages of development, including CMC research, non-clinical study and clinical trial. Through the development of 博优诺®, we have further strengthened our R&D and manufacturing capability in biopharmaceuticals. We look forward to providing more high-quality and affordable biological drugs to patients through continuous innovation.”

Patient Assistance Program Launched to Alleviate Treatment Burden

In recent years, the number of new cancer patients in China has been rising. According to data from the World Health Organization’s International Agency for Research on Cancer, the number of new cancer cases reported in 2020 in China was 4.57 million, the highest country figure for the year and accounting for 23.7% of the world total. Lung cancer and colorectal cancer were the two cancers with the highest incidence rate in China in 2020, with approximately 820,000 and 560,000 new cases.

Anti-angiogenic drugs are one of the indispensable tools in the treatment of malignant tumors. Bevacizumab can be combined with chemotherapy, targeted therapy, or immunotherapy to treat NSCLC; and bevacizumab in combination with chemotherapy can be used as a first, second, third and cross-line treatment, and as a translational treatment of mCRC. In addition, the combination of bevacizumab with paclitaxel-based chemotherapeutic agents, including paclitaxel liposomes, has unique advantages. 

Professor Liang Jun of Peking University International Hospital

Professor Liang Jun of Peking University International Hospital said, “Bevacizumab can be used in combination with many other treatment regimens, and the combination treatments offer various advantages that play an important role in the treatment of NSCLC, colorectal cancer and other malignant tumors. Given the large unmet treatment needs in these disease areas, we expect that 博优诺® will bring the benefits of bevacizumab to more patients, improving their quality of life and extending their lives.” 

To further increase the drug’s accessibility and affordability, Boan Biotech and Beijing Health Alliance Charitable Foundation jointly launched the 博优诺® Patient Assistance Program, which will be carried out across China. Its goal is to alleviate the financial burden of patients who are in need of assistance by providing them with drugs. Boan Biotech will donate 博优诺® to Beijing Health Alliance Charitable Foundation, while the latter will take charge of the management and operation of the program and provide charitable drugs to applicants who qualify for the program.

博优诺® Patient Assistance Program Signing Ceremony
From left to right: Wu Xianfei, Vice Chairman of Beijing Health Alliance Charitable Foundation;
Chi Guangming, Vice President of Commercial Operation Center of Boan Biotech

Wu Xianfei, Vice Chairman of Beijing Health Alliance Charitable Foundation, said, “We are grateful for the generous support from Boan Biotech. By carrying out the Patient Assistance Program, we hope that more patients will benefit from standardized and continuous treatment, and that it will lower their financial burden, improve their quality of life, and help tide them over any difficulties.”

Working with Partners for Quicker Access, Serving Global Patients with Innovation 

博优诺® is the first antibody drug successfully developed by Boan Biotech. To make it available to patients as quickly as possible, the company arranged the delivery of the first batch of product within ten days of announcing official approval. Prescriptions have already been issued in many cities across the country. 

In terms of patient coverage, Boan Biotech is actively increasing the accessibility of 博优诺® in core markets via its own business team, and through commercial resources and networks. To serve patients in wider areas, the company has granted AstraZeneca exclusive promotion rights in county markets across 21 provinces, municipalities and autonomous regions of the Chinese mainland. 

Jiang Hua, Chief Executive Officer of Boan Biotech

“We have been active in preparing for the entry of 博优诺® into the market, in manufacturing, sales team building, market access channels, and other areas, while engaging in close collaboration with partners in order to better serve patients,” said Jiang Hua, Chief Executive Officer of Boan Biotech. “The launch of 博优诺® demonstrates that Boan Biotech has succeeded in building a complete full-industry value chain capability in the biopharmaceutical field from R&D, clinical study, and manufacturing to commercial operations. It will also serve as a solid foundation for the efficient development of other products in our pipeline.”

Currently, Boan Biotech has developed more than ten innovative antibody product candidates with international intellectual property protection, and eight biosimilar product candidates, including 博优诺®, which have been launched in the market. 

Yang Rongbing, President of Luye Pharma Group

“Biopharmaceutical is and will continue to be one of the strategic areas for Luye Pharma Group. We are accelerating the development of our biopharmaceutical business globally via Boan Biotech. We look forward to serving patients in China and around the world with more high-quality and innovative products,” concluded Yang Rongbing, President of Luye Pharma Group.