BeiGene, a global, science-driven biotechnology company, announced the opening of a new site for global developing & manufacturing of small molecule innovative medicines in Suzhou, East China’s Jiangsu Province on November 16. In an exclusive interview, SVP and Global Head of Technical Operations and Manufacturing of BeiGene Dr. Kyu-Sung Lee shared with Global Times his personal stories and elaborated his passion about benefiting patients around the world with innovative medicines, with BeiGene expanding its global manufacturing footprint starting in China.
“The new campus, as part of BeiGene’s commitment in Suzhou, China, represents a major strategic initiative in expanding the company’s global manufacturing footprint, and ensuring innovative medicines benefit patients around the world,” said Dr. Lee.
In Lee’s eyes, Suzhou campus has the greatest potential of any of its kind in China. The newly built plant, covering an area of nearly 50,000 square meters, is expected to produce 1 billion solid dosage form unit formulations annually upon completion.
BeiGene Small Molecule Global Developing & Manufacturing Campus for Innovative Medicines
The city of “Suzhou, known as a hub of science, attracts talents, existing biotech and then government infrastructure. BeiGene’s Suzhou Campus is now a center of excellence for new product introduction, where we are doing both clinical and commercial manufacturing for all the small and large molecules products. Suzhou has a unique position for our global manufacturing footprint,” Lee said.
Lee forged his career in biotechnology research and development engineering since 1990. Two positions stood out in his career development. He switched from R&D to manufacturing while working at Merck & Co. and further enhanced his leadership during his work at Samsung Biologics, which took his career to a higher level. Right after that, he joined BeiGene.
It seems that Lee always made the right choice at the critical moment. “It’s important to always try to do new things. Troubles and difficulties are inevitable when you start a facility or make the products. But at the end of the day, it’s all worth it,” he said.
“There’s a saying in BeiGene, that ‘Cancer has no borders. Neither do we.’ That’s why BeiGene attracted me.” Lee explained in his current job with plain words, that is, to make innovative drug available to as many patients as possible with affordable prices.
“In order to do that, we need to ensure cost-effective manufacturing, well calibrated capacity, and a shared approach to different patients. That’s why we build manufacturing facility in different countries, starting from China and then US. We are expanding our pipeline with different capacity, which will help us reach out to different patient groups. It’s exciting to be a part of this (groundbreaking work).”
As one person who is interested in applying his knowledge and experiences to the real world, Lee feels he is on the right track to realize his career dream by joining BeiGene – contribute to turn innovative drugs into new opportunities for patients in need around the world.
Even after joining BeiGene, Lee was impressed by how much practical effort it puts into realizing this mission: To transcend borders, time zones, and especially the status quo to develop therapies that are more accessible to people around the world. BeiGene Suzhou campus is an important step in approaching this mission practically and strategically.
Lee, who believes that working with excellent people plays a critical role to move forward, noted that China has been among one of the top players in the world and always has significant potential in almost every industry, not just in the pharmaceutical areas, thanks to the large talent pool and the work ethic in the country.
“People matter. Without them, I cannot achieve so much. We have more than 1,000 people in the organization now. Those people are essential to ensuring we can convert our mission to innovative medicine to help patients’ lives,” Lee said.
“I believe the reason why people chose the pharmaceutical industry – to help patients with their expertise. That’s where I resonate with BeiGene’s vision and feel ownership. Working at BeiGene would be a great way to contribute my career in this field. For that reason, I am grateful and look forward to collaborating with colleagues, partners and clients for many more years.”
Lee said that the opportunities to work globally were another critical factor for working at BeiGene. “I saw the possibilities of the company growing and expanding beyond China, the US and the EU and its ability to help people in need around the world.”
BeiGene is now striving its way to be self-sufficient on developing and manufacturing materials for both clinical and commercial purposes, which will give it a competitive advantage, he noted, who believes the opening of new campus in Suzhou better commercialize its pipeline products and boost its global expansion. Improving our in-house capabilities will give us a competitive advantage in terms of speed, cost and flexibility as we work to commercialize our pipeline products. These capabilities can also boost our global expansion from Suzhou, he said.
With the mission of providing high-quality innovative therapies for patients in China and globally, the Suzhou campus has been designed to be a state-of-the-art facility that accords with current Good Manufacturing Practice standards adopted by China, the US and the EU. It also has an advanced quality assurance system that meets the requirements for supplying products globally, including BRUKINSA.
BRUKINSA is the first BeiGene developed innovative medicine to gain US Food and Drug Administration (FDA) approval and which to date has been approved in more than 65 markets. It took the medicine only four years to go from molecules into commercial products in BeiGene Suzhou campus.
In July 2023, the Suzhou campus was subject to an on-site Current Good Manufacturing Practice inspection by the FDA, subsequently gaining its official approval in September and thereby enabling the medicine to be supplied to the US market.
Lee said, the FDA approval demonstrates international acknowledgement in the sustainability and reliability of the campus’ quality control system and solidifies the foundation upon which BeiGene can bring innovative, impactful, accessible and affordable medicines to more patients globally.
By harnessing key technology operations and developing in-house manufacturing capabilities, BeiGene has built a diverse global supply network. With its production sites in Suzhou and Guangzhou in China, and Hopewell and New Jersey in the US, the company effectively caters to the global demand for pharmaceutical commercialization and clinical trial supplies. This has powered the rapid advancement of the company’s highly differentiated value chain across the global industry.
Speaking of his plan for the company’s future development in the coming years, Lee said to make innovative medicine available to as many as patients with the affordable prices, “we need to make sure that all manufacturing is cost effective, to increase the capacitance and to shape approach to different patients with a different capacity.”
“The key to success is converting those ideas to clinical, converting those ideas to manufacturing,” Lee said, only by building the inhouse ability to new product introduction, may BeiGene ensure sustainable ability to strong pipelines and commercial products, which may help patients lives.
(Global Times)
