BeiGene's Guangzhou Biologics Manufacturing Facility Phase I Completed with 8,000-Liter Capacity and $325 Million Investment

Guangzhou, September 27, 2019 – Today, Phase I of BeOne Medicines’ Guangzhou Biologics Manufacturing Facility (hereinafter referred to as the “Guangzhou Facility”) was officially completed. VCBeat attended the completion ceremony.

According to our understanding, the total investment in this base is expected to exceed RMB 2.3 billion, covering an area of 100,000 square meters, with a focus on process development and manufacturing of large-molecule biologics at commercial scale. Phase I achieved an 8,000-liter production capacity in just two years, outpacing similar projects worldwide with “China speed.” Tislelizumab, a PD-1 antibody independently developed by BeOne Medicines, will be manufactured at this facility, benefiting not only patients in China but also those abroad.

Mr. John Oyler, Chairman, Founder, and CEO of BeOne Medicines, delivers remarks on-site (Photo by VCBeat)

Mr. John Oyler, Chairman, Founder, and CEO of BeOne Medicines, stated that the company is committed to building a complete industrial value chain spanning R&D, manufacturing, and commercialization, making substantial investments to establish world-leading capabilities. Dr. Xiaodong Wang, Founder and Chair of the Scientific Advisory Committee at BeOne Medicines, remarked, “We aim to develop the best anticancer drugs for the Chinese people, and we, as Chinese innovators, strive to deliver the best anticancer drugs to the world.” Over the past nine years, we have progressed step by step from a single laboratory bench and a single pipette to where we are today. Cancer knows no borders, and neither does BeOne; together, our strength is greatest. Dr. Liu Jian, Senior Vice President and Head of Biologics Manufacturing at BeOne Medicines, pointed out that the Guangzhou biologics manufacturing facility has consistently adhered to the principles of high quality, high speed, and advanced technology. Since its establishment, the site has achieved 2.7 million safe work hours, complies with GMP standards in China, the United States, and the European Union, and collaborates with world-class partner Boehringer Ingelheim to build a robust quality management system. Government leaders have highly recognized the facility’s construction, stating that the Guangzhou project has become a hallmark of high-end manufacturing in Guangzhou and set an industry benchmark that surpasses international standards for the biopharmaceutical sector.

BeOne Medicines’ Guangzhou Biologics Manufacturing Base Phase I Project Completed (Photo by VCBeat)

The Guangzhou manufacturing base is built in compliance with GMP standards of China, the United States, and the European Union, setting an industry benchmark in both software and hardware aspects, and is committed to accelerating patient access to high-quality innovative medicines.

In terms of hardware, construction of the base commenced in 2017. Throughout the building process, advanced management principles and a rigorous work ethic were consistently upheld, achieving 2.7 million safe working hours and ensuring high-quality engineering standards. The base adopts the globally leading KUBio™ integrated solution to enhance overall operational efficiency, reduce construction costs, improve conversion rates, and streamline operational procedures.

In terms of software, the Guangzhou facility strives to achieve full intelligence—from underlying architecture and process control to data management—by leveraging technologies ranging from paperless and digital systems to artificial intelligence, thereby fundamentally ensuring the integrity of real-time data. The management team at the Guangzhou facility consists entirely of professionals from leading multinational corporations, with extensive experience in biopharmaceutical production both domestically and internationally. Furthermore, the Guangzhou facility implements and adheres to a globally unified quality management system, fostering a culture that prioritizes quality above all else through a comprehensive set of regulations and training programs.

Furthermore, the Guangzhou base rigorously selects business partners across engineering, processes, and production facilities to ensure the high quality of its pharmaceutical products. For instance, it has fully adopted the manufacturing processes of Boehringer Ingelheim, a top-tier global biologics producer; engaged Kockremont, a world-leading enterprise, for project engineering management; and utilized imported filling linkage production lines from Bosch, which also handles commissioning and qualification.

Over the past four decades of reform and opening-up, China’s manufacturing sector has become the largest in the world, yet it must continue to advance from the low-to-mid end toward the mid-to-high end of the industrial value chain. In particular, given the relatively weak foundation of China’s biopharmaceutical manufacturing processes, whether “Made in China” can keep pace with the booming “R&D in China” for innovative drugs will determine whether innovation can be translated into industrial competitiveness, and even global leadership.

Biologic drug manufacturing is inherently complex, with biologic agents typically having structures hundreds of times larger than those of small-molecule drugs. The consistent production of high-quality biologics depends on rigorous process management (Quality by Process), advanced manufacturing facilities, sophisticated production processes, and the extensive expertise of skilled personnel. According to Liu Jian, Senior Vice President and Head of Biologics Manufacturing at BeOne Medicines, Phase I of the Guangzhou facility exclusively employs 2,000-liter single-use bioreactors, aligning with international advanced standards and ensuring stable production quality. Meanwhile, the Guangzhou site emphasizes process development and patent innovation. Leveraging its talent advantages, the facility has the potential and capability to further enhance production efficiency, surpassing existing international experience and standards.

According to IQVIA data, biologics are capturing an increasingly larger share of the global market; eight of the top 10 best-selling drugs worldwide in 2018 were biologics. China has also become one of the most promising markets for biologics, with the market size reaching nearly RMB 100 billion in 2018, among which anti-tumor biologics demonstrated the most significant growth rate.

BeOne Medicines, a leading enterprise in China’s innovative biopharmaceutical industry, is dedicated to the development and commercialization of novel molecularly targeted and immuno-oncology therapies for cancer treatment. The Guangzhou facility will be responsible for manufacturing large-molecule monoclonal antibody anticancer drugs, including tislelizumab, a PD-1 inhibitor independently developed by the company. Tislelizumab is a novel, structurally optimized PD-1 monoclonal antibody; clinical data demonstrate that it offers renewed hope for patients in indications such as classical Hodgkin lymphoma.

The completion of Phase I of the Guangzhou manufacturing base once again demonstrates BeOne Medicines’ full industrial value chain, sets industry standards for anticancer drug manufacturing, boosts the global competitiveness of China’s biopharmaceutical sector, showcases the innovative strength of China’s high-end manufacturing as a “model performer,” and contributes to the realization of the “Two Centenary Goals” by advancing innovation in anticancer therapies.