In July of 2012, Dr. Dou Changlin, an expert in antibody technology who has worked in the U.S. and Singapore for over 20 years returned to China to participate in the establishment of Boan Biotech. In November of the same year, Boan Biotech kicked off the Avastin^® biosimilar project. With years of efforts, Boyounuo^®(Bevacizumab Injection) was granted with marketing authorization. Boyounuo^® is the third biosimilar of Avastin^® to enter the market in China, as well as the first product from Boan Biotech's pipeline to receive marketing authorization. Through the development of Boyounuo^®,  Boan has further proved its R&D and manufacturing capability in biopharmaceuticals. As one of the important strategic directions for the current and future development of Luye Pharma, the biopharmaceuticals represented by Boyounuo^® will help the company accelerate the global planning of its biopharmaceutical business. We invited the head of this project, Dr. Dou Changlin, R & D President and COO of Boan Biotech to share with us the background story of Boyounuo^®.

 

Q: Hello, Dr. Dou, thank you very much for accepting this interview. We have read a number of good news about Boyounuo^® (Bevacizumab Injection) recently: the successful product launch in China, the first prescription written in multiple Chinese hospitals, and Boan Biotech grants AstraZeneca exclusive rights in specific county markets of China. As the head of this project, could you please start with a brief introduction on the progress of this project and its background?

D: Important milestones during the development include: IND submission, clinical trial approval, clinical study, manufacturing process validation, BLA submission, on-site inspection, on-site inspection on clinical research, registration of samples, and marketing authorization.We used scientific methods to arrange schedule, we had comprehensive communication and swift actions during the whole process. The overall development progress was quite smooth, we were able to launch the product ahead of timeline, which is also shorter than average development period of antibody drugs.

 

Q:  Boyounuo^®  is the third biosimilar of Avastin^® to enter the Chinese market, in order to achieve that, in addition to use innovative methods to get ahead of competitors during application process, Boan's R & D capabilities also play a vital role, what do you think the core competitiveness of Boan's R & D platform?

D: It is not accidentally to accelerate product development and registration. The success of this project is due to the solid technology foundation we have laid since the establishment of Boan. Our core competitiveness lies in high level of R & D capabilities and practical CMC. We have consistent process development to ensure the consistency of product quality. The team is equipped with strong execution and extensive practical experience in process scale-up and tech transfer.

The launch of Boyounuo^® proved our solid capability in pharmacology research. In terms of technology innovation, Boan has established platforms including human antibody transgenic mouse, bispecific T-cell engager, ADC. The combination of efficient innovation and practical CMC have enabled Boan’s core competitiveness.

 

Q: The success of Boyounuo^®  is due to the project team's hard work, what is your view on teamwork to a successful project?

D: This is a very good question. The process of antibody drug development is very difficult. We need both team members' expertise and good collaboration for efficient operation. We have different roles including antibody screening, cell line development, lab-scale process development, pilot-scale process development, manufacturing scale-up, analysis, pharmacology, toxicology, PK, clinical, quality, registration and sales to work together as a team. We conducted smooth communication and strictly execute the work plans we have made., because collaboration is the key to a successful project.

Since the establishment of Luye Pharma in 1994, the company has built up excellent expert team and valuable experience in R & D, manufacturing, quality, workshop construction, government affair and others. Boan is able to achieve efficient operation with the strong support of Luye Pharma.

 

Q: Do you have any memorable stories about teamwork to share with us?

D: I have two stories to share with you. When we were working with CMO on the manufacturing of clinical samples in the summer of 2017, everything went quite well with stock solution, but we discovered deviation during filling, and is in the risk of delay clinical progress. I took my team to visit CMO immediately and started in-depth communication to find a solution. After a series of research, we managed to close the deviation and secured the progress of clinical trials.

The second story happened after we started Phase III clinical studies. President Yang attended R & D's quarterly meeting in September, he discussed with the team on how to accelerate this project through cross-functional collaboration. With the great support from the Group, we were able to speed up clinical studies.

 

Q: Boyounuo^® is the first product that obtained marketing approval in Boan Biotech's product pipeline, what does this mean to Boan and future pipeline?

D: The success of this project proves that Boan Biotech is a comprehensive company equipped with capabilities in biopharmaceutical R & D and commercialization that covers the whole life cycle of drugs. Boan is at forefront of the competition among hundreds of biopharmaceutical companies in China.

The review and approval standards of NMPA are very high, especially the approval of biosimilar drugs is required to achieve a high degree of consistency in pharmacology, non-clinical, clinical with the originator, and the regulations have been aligned with Europe and the United States. This is a challenge but also an opportunity to Boan, because we have the capability and strength to launch more products.

 

Q: What is the future plan and expectation on Boyounuo^® and research pipeline? What is Boan Biotech's global strategy?

D: Pharmaceutical companies need global strategic planning, and so does Boan. We are currently doing research on Boyounuo^®'s market potential in emerging countries and we are already in conversation with some countries. We have over half of innovative antibodies in Boan's research pipeline. The internationalization of biosimilar and innovative antibodies is based on forecast of each product in target market. During the application in China and oversea market, we also constantly make improvement plans.

 

Q: what is your expectations for the future of the company?

D: I always say biopharmaceutical is an important direction of pharmaceutical companies. Aside from our pillar products, Boan has started to make strategic plans in new areas in the recent years, including cell therapy, ADC drug and some other new technologies. We hope these new technologies and development can bring diversified development and abundant return. Luye Pharma has set a vision to become global top 50 pharmaceutical company by 2025, I hope Boan can make its own contribution to support the company to achieve this vision, and I hope Luye can have splendid future.