CSCO 2019: Chinese Innovative Biopharma Enters the Second Half — Global Expansion as the Key to Success
On September 18, 2019, the 22nd Congress of the Chinese Society of Clinical Oncology (CSCO) was held as scheduled in Xiamen. According to incomplete statistics, 28 domestic and international pharmaceutical companies presented clinical data at this year’s CSCO, with hundreds of satellite symposia of varying scales hosted. During the congress, BeiGene presented seven research findings via oral presentations, covering indications such as non-small cell lung cancer and nasopharyngeal carcinoma, making it the innovative pharmaceutical company with the highest number of oral presentations at this year’s CSCO.
A review of the development trajectory of China’s innovative drug industry reveals that by 2019, leading domestic innovators such as BeiGene had demonstrated widely recognized R&D capabilities after years of accumulation. Having cleared the R&D hurdle, these companies now face another critical challenge: successfully commercializing their innovative drugs and further transforming from “Biotech” to “BioPharma.”
Historically, the industry has commonly distinguished between two different business models of innovative pharmaceutical companies using the terms “Biotech” and “BioPharma.” Biotech, or biotechnology companies, are relatively small in scale and focus primarily on the research and development (R&D) of innovative drugs. They typically sell their drug candidates to large pharmaceutical companies or exit through acquisition once the drugs reach Phase II or III clinical trials, generally without assuming responsibility for post-approval manufacturing and commercialization. The United States is home to a large number of biotechnology companies, and in recent years, new drugs developed by biotech firms have accounted for more than half of the new drug approvals granted annually by the U.S. Food and Drug Administration (FDA).
“BioPharma” typically refers to biopharmaceutical companies—comprehensive enterprises that have grown from the R&D stage to possess a full industrial value chain, with business operations covering all segments from research and development and manufacturing to product sales.
For most Chinese innovative pharmaceutical companies, the ambition extends beyond being merely “small and beautiful” biotechnology firms; they harbor far greater aspirations. On one hand, they are striving to expand their R&D pipelines: in 2018, Chinese biotech companies filing for IPOs on the Hong Kong Stock Exchange had an average of 10 pipeline assets, whereas their counterparts listed on NASDAQ during the same period averaged only four. On the other hand, rather than following the path of many European and American biotech firms that ultimately sell their companies or products to large domestic or international pharmaceutical corporations, these Chinese enterprises are committed to building a complete industrial value chain, with the aim of growing into biopharmaceutical giants that command a significant presence on the global stage.
As we entered 2019, many companies saw their products approved for market launch, while numerous independently developed products also entered the review and approval pipeline, poised for imminent commercialization. These include BeiGene’s PD-1 inhibitor tislelizumab and the BTK inhibitor zanubrutinib, which are even expected to achieve their first regulatory approvals in overseas markets.
For leading Chinese innovative pharmaceutical companies such as BeiGene, Junshi Biosciences, and Innovent Biologics, achievements solely in the R&D phase do not guarantee commercial success; their sights are set on broader horizons.
As competition in the domestic market intensifies, an increasing number of innovative pharmaceutical companies are turning their attention overseas. Dr. Wu Xiaobin, General Manager of BeiGene’s China region and President of the company, has pointed out that the future of Chinese innovative pharmaceutical enterprises lies in the planning and implementation of globalization strategies. This path is essential for these companies to truly grow and strengthen, ultimately joining the ranks of the world’s pharmaceutical giants.
During the CSCO conference, Dr. Wu Xiaobin stated in an interview: “China’s innovative pharmaceutical industry is on the rise, yet sustained innovation demands substantial investment and requires access to broader markets and returns. Therefore, Chinese innovative pharmaceutical companies must not only compete in the domestic market but also achieve significant breakthroughs internationally to ensure sustainable R&D innovation and cultivate truly homegrown biopharmaceutical giants with global reach. Today, leveraging China’s position as the world’s second-largest pharmaceutical market, Chinese innovative drug companies have established the economic foundation necessary for international expansion. Meanwhile, under the impetus of the national ‘Belt and Road’ Initiative, stronger support will be provided for local innovative pharmaceutical enterprises to expand overseas and go global.”
As a flagship enterprise among China’s many innovative pharmaceutical companies that is vigorously pursuing a globalization strategy, global reach and internationalization have always been key hallmarks of BeiGene.
From an R&D perspective, BeiGene is the first domestic company to conduct clinical trials simultaneously in China and overseas. A review of the development history of its core products reveals that drugs in late-stage clinical development, including the PD-1 antibody tislelizumab, the BTK inhibitor zanubrutinib, and PARP inhibitors, all initially launched clinical trials concurrently in China and abroad. Currently, BeiGene is conducting more than 60 clinical trials worldwide, including 26 registrational or potentially registrational studies, with its clinical development footprint spanning five continents: Asia, Australia, North America, Europe, and South America.
This means that, in addition to the Chinese market, BeiGene is also capable of launching commercialization efforts in major overseas pharmaceutical markets, pointing to even broader future prospects. The BTK inhibitor zanubrutinib serves as a classic example: it previously secured four special designations from the U.S. Food and Drug Administration (FDA)—Fast Track, Accelerated Approval, Breakthrough Therapy, and Priority Review—and its New Drug Application for marketing approval in the United States was recently accepted by the FDA. If approved, it could become the first domestically developed and independently innovated new drug from China to gain FDA approval, marking a historic milestone for the Chinese pharmaceutical industry.
Dr. Wang Lai, Senior Vice President of BeiGene and Head of Global Research, Clinical Operations, and Biostatistics as well as Asia-Pacific Clinical Development, stated: “Globalization has been a steadfast goal for BeiGene since its inception. The drugs we develop are not intended solely for the Chinese market; rather, we seek opportunities in the global marketplace. As the company continues to mature, we are also expanding our exploratory efforts in preclinical research, aiming to develop first-in-class therapies that offer new hope and better treatment options for patients worldwide.”
In addition to its independent R&D efforts, BeiGene has repeatedly joined hands with major international pharmaceutical companies to actively establish global strategic collaborations. Following partnerships with Merck Serono and Celgene, BeiGene has continued to advance its global strategic cooperation by collaborating with multiple international pharmaceutical firms, including Mirati Therapeutics and SpringWorks Therapeutics, to develop promising innovative drugs such as sitravatinib, the RAF kinase inhibitor BGB-3245, and ZW25/ZW49, thereby further enriching its product pipeline.
It can be said that Chinese domestic innovative pharmaceutical companies, represented by BeiGene, entered the “second half” of development in 2019, with a cohort of leading firms poised to launch aggressive expansions into the global market. The next critical step for these Chinese innovators to evolve into major global pharmaceutical enterprises will likely hinge on building more comprehensive industrial chains and overall competitive strength, thereby advancing their globalization strategies.