BeiGene announces phase 1 completion of Guangzhou Bio-manufacturing Base

Sept 27, 2019, Guangzhou, China—BeiGene, Ltd, a commercial-stage biopharmaceutical company focused on developing and commercializing innovative molecularly-targeted and immuno-oncology drugs for the treatment of cancer, today announced the Phase 1 completion of its Guangzhou Bio-manufacturing Base.

Covering an area of 100,000 square meters, the base focuses on commercial-scale manufacturing of macromolecular pharmaceutical solutions, and has a total expected investment of more than 2.3 billion yuan ($323 million).

Over the two years of Phase 1 construction, the Guangzhou base has achieved a capacity of 8,000 liters at China speed, far surpassing other global projects of the same type. It will be responsible for manufacturing tislelizumab, BeiGene's internally developed anti-PD-1 antibody, which will serve not only Chinese patients, but also be exported to emerging markets as the first innovative anti-cancer drug developed and manufactured in China.

John V. Oyler, BeiGene chairman, co-founder and CEO, said that BeiGene set out to build a full value chain operation, including R&D, manufacturing, and commercialization to establish great power in the biopharmaceutical market.

Dr. Wang Xiaodong, chairman of the scientific advisory board and co-founder of BeiGene, said that BeiGene aims at manufacturing the best anti-cancer drug for Chinese patients and is confident that it is capable of delivering the best quality drug for patients around the world. BeiGene started with a small team of scientists and has grown into a true global company. He said there is a saying at BeiGene that cancer has no borders; neither does the company. Its dedication to patients has attracted talents from different parts of the world, a team that shares the company's vision and drives the company forward to conquer all challenges in growth and development.  

Dr. Jonathan Liu, BeiGene senior vice president of bio-manufacturing, noted that BeiGene has always adhered to the principles of high quality, high speed and high technology. Since the construction of the bio-manufacturing base, BeiGene has accomplished 2.7 million safe working hours, compliant with GMP standards of China, the US and the EU. By partnering with world first-class bio-manufacturer Boehringer-Ingelheim, BeiGene realized a solid quality management system. The local government recognizes BeiGene's achievements and considers the company a pioneer in high-end manufacturing and a benchmark for the Chinese biopharmaceutical industry.

Integrating world-class resources to establish a benchmark for biopharma

The Guangzhou base is aligned with the design criteria of the US, the EU, and China, which set benchmarks for both software and hardware systems to quickly improve patient benefits. [Photo provided to chinadaily.com.cn]

From a hardware perspective, the Guangzhou base began installation in 2017 and was constructed to follow an advanced management philosophy with meticulous working practices. The approach paved the way for 2.7 million safe working hours of quality engineering.

Meanwhile, world-leading KUBio™ modular facilities were adopted to enhance overall operational efficiency, lower construction costs, increase rates of conversion and streamline processes.

From a software perspective, the Guangzhou base strives for complete intelligence through its underlying structure, process control and data management to guarantee integrity of real-time data. The members of the executive team at the Guangzhou base have strong work experience from world-class multinational biopharma enterprises.

The Guangzhou base develops and implements a globally unified quality management system and has built a culture of “quality first” through a combination of rules, regulations and training.

BeiGene Guangzhou Bio-manufacturing Base [Photo provided to chinadaily.com.cn]

The Guangzhou base has established collaboration with reputable partners in construction, manufacturing and facilities management to ensure sound product quality. For instance, the base introduced the process control system of world-leading bio-manufacturer Boehringer Ingelheim, while Cockram, a time-honored global construction company, is in charge of engineering management.

In addition, Bosch provides imported filling and linkage production lines and commissioning verification for the base.

Targeting manufacturing pain points in pursuit of innovation and quality

Over 40 years of reform and opening up, China has become a worldwide leader in terms of the scale of its manufacturing industry. However, in terms of industry value chains, China still has a long way to go in developing from the low end to the mid-to-high end.

The advancement of innovative biologic R&D capability in China has been nonetheless remarkable, especially at a time when the manufacturing process environment in China is relatively disadvantageous. Whether "Made in China" can stand out in this context determines the extent to which innovation can be transformed to commercial competence, or even global leadership.

The molecular weight of biologics is a hundred times larger than chemical drugs, which means that the manufacturing process of biologics is more complicated. Biological manufacture of consistent quality relies on rigorous process management and high-level facilities, as well as processing technologies and experienced biopharma talents.

According to Dr. Jonathan Liu, BeiGene senior vice president in bio-manufacturing, the Guangzhou base has adopted a single tank of 2,000 liters system in compliance with global standards to ensure a stable level of quality.

With the Guangzhou base devoted to craftsmanship, patent and talent attraction, it shows great potential to enhance efficiency and further surpass global requirements.

BeiGene Guangzhou Bio-manufacturing Base Phase 1 Completion Ceremony [Photo provided to chinadaily.com.cn]

Focusing on biopharmaceuticals to facilitate China's anti-cancer therapy

According to IQVIA, biologics account for an increasingly large share of the global pharmaceutical market, with biologics making up to 80 percent of the top ten drugs in terms of global sales in 2018.

Over the past several years, China has become one of the largest potential biologics markets. The scale of its biological market is now at 1 billion yuan, in which anti-cancer drugs are experiencing the highest growth rate.

As a leading player among China's biopharma companies, BeiGene focuses on developing and commercializing innovative molecularly-targeted and immuno-oncology drugs for the treatment of cancer.

The Guangzhou base will be responsible for manufacturing macromolecular monoclonal antibodies, including BeiGene's self-developed PD-1 tislelizumab. After a brand-new structural optimization, data from clinical trials reveal that tislelizumab can potentially bring better treatment options and hope of survival to patients with classical Hodgkin's lymphoma.

The Phase 1 completion of the Guangzhou base demonstrates BeiGene's efforts to enhance its full industrial value chain, and the innovative power of China's high-end manufacturing to outperform global competition.

While aiming high, BeiGene demonstrates not only China's confidence in high-end manufacturing, but also the mission of benefiting Chinese patients while helping others around the world.

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