partneringNEWS™ recently spoke with Michael Yu, Co-Founder, President and CEO of Innovent Biologics Inc., a leading biopharmaceutical company based in Suzhou, China. The company is focused on providing in-demand drugs at affordable prices to patients in China by locally manufacturing products that meet international quality standards.
Michael Yu, Innovent Biologics
partneringNEWS (pN): In January, Innovent Biologics raised USD 100 million in series C funding to develop their pipeline of cancer and autoimmune indications. The round is the largest untranched private financing for a Chinese biotech. This is an incredible round. What do you think it means for Innovent and for the bigger sphere of China life sciences companies?
Michael Yu (MY): From day one, Innovent has defined its business model to achieve its goal. Our mission is that we want to be the best or leading biopharmaceutical company in China. To accomplish that, we decided to focus on quality. Our primary concern is to ensure the quality of the products we develop meet international standards. The same is true for our facility; we want to build a facility that meets international standards so that the products produced at our facility can be marketed not only in China, but also for the highly regulated markets outside of China. That is our business model and mission. This funding allows us to build our infrastructure, add more employees, and to progress our product pipeline in support of our high quality of operations.
pN: Regarding the USD 100 million round, what was the catalyst that made investors willing to invest so much money in the company? In addition to Innovent’s pipeline, did your manufacturing capabilities play a big role since you are the first manufacturer of high end biologicals to meet the rigorous quality standards set by the US Food and Drug Administration (FDA/cGMP) and the European Medicines Agency (EMEA)?
MY: To date, no Chinese biologic product has been approved for marketing in highly-regulated markets such as the US, and there is currently no facility that complies with international standards. Therefore, it would be imperative for anyone able to develop high-quality products to build an internationally compliant facility. I believe our investors have shared our vision and have seen this potential.
pN: What is important to know about establishing a manufacturing facility in terms of the importance of having it FDA compliant? Is this an essential part of a long-term commercialization strategy in China?
MY: China is significantly different from Europe and the US, as Chinese law dictates that any biologic company seeking to manufacture or market its product [in China as a domestic product] must own a manufacturing facility. It is essential for a company that wants to market products in the US to have an FDA compliant facility, but it is not essential for a company to have an FDA compliant facility that wants to just market products in China. However, having a facility that complies with international standards will provide any Chinese company a significant competitive advantage, as Chinese patients also deserve the highest-quality products available.
pN: China is ripe with potential for international companies who want to do business in China. Tell me about the opportunities for global partners.
MY: China is rapidly becoming a competitive force in the manufacturing of biologic drugs for worldwide sale. At present, no biologic products made in China have been approved for sale outside of the country, in part because no manufacturing facilities there have been capable of meeting the rigorous quality standards set by the US FDA and the European Medicines Agency. Innovent intends to be China’s first manufacturer of high-end biologics and the company is well on its way to achieving that vision.
A recent report issued by the Boston Consulting Group says that multinational companies need to think strategically about where they locate manufacturing and the extent to which pharmaceutical R&D is integrated into operations in China. I am hoping that Innovent’s emphasis on quality will attract partners and investors from around the globe. We would like to work together with big pharma to bring biologic products from highly regulated markets into China cost-effectively. To remain competitive, large pharma companies must change the way they have been doing business in China.
We anticipate the business environment in China becoming more difficult for global companies. For big pharmas to be successful at selling their products in China, they will have to work with local partners and localize product manufacturing. This is why we are structuring Innovent as a high-quality company that can be a good manufacturing partner in China for global firms.
pN: What are your thoughts on the biggest areas of unmet medical need in China?
MY: Compared to small molecule drugs, large molecule drugs are under-represented. For example, there are over 40 monoclonal antibodies approved in the US. However, China has only 21 marketable biologics, including 12 imported drugs, which means that less than one third of those innovative, truly effective therapeutics are currently available to Chinese patients. For autoimmune diseases and for diseases in oncology, I think these represent major unmet medical needs for biologic drugs.
pN: Innovent will be participating in ChinaBio® Partnering Forum this April 15–16. Why is this event important to you?
MY: I think EBD Group and ChinaBio® have been doing an excellent job of attracting a variety of interesting parties to the ChinaBio® Partnering Forum. I think the event has become the best partnering meeting in China. I encourage Western and Chinese companies to attend the meeting to revisit friends and potentially generate more business opportunities.
pN: Tell me about your pipeline and what would be appealing to investors.
MY: We have ten monoclonal antibodies in our pipeline: six novel complex biologics and four biosimilars. We work with an antibody discovery platform company from the US called Adimab and have quickly grown our innovative drug pipeline. We plan to move one or two products into clinical trials each year.
There is a lot of biological innovation coming from the field in China representing many collaboration opportunities, from small molecules to biologics. There are definitely some significant partnering opportunities in China.
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