Newsletter: December 2022

A message of “thanks” from Chris Chen, CEO – WuXi Biologics

Dear valued partners,

As we approach the holiday season and the start of new year, I would like to share how proud I am of the relentless commitment by our entire organization to our vision that “every drug can be made and every disease can be treated” for the benefit of patients worldwide. An endeavor of this magnitude requires the help and support of the entire global healthcare community, from our vendors supplying critical research materials when we need them, to the scientists and pharma companies that continue to bring novel and improved mechanisms to fight the many diseases that impact our daily lives. Our pledge to this effort is to provide the tools, technologies and drug discovery, development and manufacturing platforms to bring critical biotherapeutics and vaccines to the clinic and to provide a robust global network of commercial manufacturing sites of the highest quality.

Evidence that we are meeting our commitment to this goal is the fact that we have enabled our clients to bring an astonishing 315 products into the clinic with over 80 of those currently in late-stage clinical trials. In 2022 alone we helped our clients get over 100 INDs approved which included a novel RNA product. Our commercial manufacturing network is currently supporting 14 commercial biologics and vaccines with capacity to support more across our 13 drug substance (DS) manufacturing facilities and 11 drug product (DP) fill sites. To support our clients goals into the future we plan to have over 580,000 L of bioreactor capacity in 2026, and in 2022 we continued to expand our Global Dual Sourcing strategy as we began GMP operations at our 48,000 L bioreactor capacity site in the Hebei province of China, released our first drug substance GMP manufacturing suites in the United States, new GMP drug product fill suites in Hangzhou, China, and we announced the start of a 120,000 L capacity site in Singapore and a commercial-scale prefilled syringe fill site in Wuxi, China.

The company’s operational commitment to quality has continued as evidenced by passing multiple global regulatory agency inspections this year in our China and Ireland GMP manufacturing and testing facilities. Our global quality system has now passed a total of 26 quality inspections from the U.S. FDA, EMA, PMDA, NMPA, MFDS, HSA, HPRA, Health Canada, ANVISA and the WHO resulting in multiple commercial licenses granted to our manufacturing partners. Our outstanding late-stage development and manufacturing teams conducted 11 DS and 8 DP process performance qualifications (PPQs) at a 100% success rate. I am also pleased to announce that after significant delays to conduct inspections due to the pandemic, in the second half of the year, we successfully completed on-site end-use checks and were removed from the UVL list by the U.S. Department of Commerce.

Our clients want to not only work with an organization with world-class quality systems and state-of-the-art facilities, but they need to know they work with a quality organization dedicated to sustainability initiatives. I am so pleased with our entire global organization’s promise to further Environmental, Social and Governance (ESG) and Corporate Social Responsibility (CSR) programs at all levels of the organization. For the second consecutive year we were a Sustainalytics’ “ESG Top Rated Company” and we achieved a high ranking in the FTSE4Good Index Series and this year we were the only healthcare-sector company among the top 10 constituents in the Emerging Markets category. In addition, each site across our U.S., Germany, Ireland and China footprint works with charities and philanthropic groups to support and better the lives of the people that live and work in the local communities.

I cannot conclude my sentiments on the year that has passed without expressing my deep appreciation to the over 10,000 employees that came to work every day, often under extreme circumstances and under the threat of the continued global pandemic, to push our client’s programs forward and to meet critical project deliverables, milestones and timelines. The extraordinary efforts of each scientist and engineer at WuXi Biologics and within our subsidiaries WuXi XDC and WuXi Vaccines allowed us to enable over 400 clients and support over 560 projects around the world. I am thankful for their relentless energy and time and also the trust our clients put in us to deliver life-changing and life-saving medicines where and when they are needed most.

Therefore, on behalf of everyone at WuXi Biologics, we would like to extend our sincerest gratitude for your continued partnership and the commitment to make this world a healthier place. And above all, we wish you and your loved ones a wonderful and safe holiday season and a happy new year!

Sincerely,

Chris Chen CEO, WuXi Biologics

Other Significant Highlights in 2022

Most of All

Thank you to the global healthcare community, critical research materials vendors, scientists and pharma companies that continue to bring novel and improved mechanisms to fight the many diseases that impact our daily lives