Wu Xiaobin of BeiGene: Reshaping China's and Global Pharmaceutical Industries Amid Pandemic-Driven Transformation

Amid the shadow of the pandemic, China's healthcare industry is surging forward at an accelerated paceIt has further earned recognition for its robust testing capabilities and vaccine R&D strengths.AllGlobal Recognition. At the 8th Huaxing held last weekCapitalMedAt the Therapy and Life Sciences Leaders Summit, Wu Xiaobin, General Manager and President of BeOne Medicines China, delivered a keynote address，He stated that the robust technological and biotechnological capabilities demonstrated by China during the pandemic have truly instilled great confidence in its people, while the momentum behind the iterative innovation of Chinese-style medicine has also been strong. Furthermore, Wu Xiaobin believes“The Belt and Road Initiative”will become the new direction for the future international development of domestic pharmaceutical companies.

Below is an excerpt from the speech, which we hope will inspire you. Stay tuned for more highlights from the summit.

Speaker: Wu Xiaobin, General Manager and President of BeOne Medicines China

2020 was a turbulent year, as the global COVID-19 pandemic posed severe challenges to countries worldwide. During the outbreak, test kits and nucleic acid testing played a crucial role in epidemic prevention and control. During the 2003 SARS outbreak, it took us a considerable amount of time to identify the pathogen; however, this time we completed viral genome sequencing immediately. This step was critical, as only after sequencing could we develop test kits and carry out large-scale nucleic acid testing and other related measures.

The recent resurgence of the epidemic in Europe has left many countries with insufficient testing capacity, forcing them to reserve testing resources solely for high-risk frontline populations. This stands in stark contrast to the situation in China. For instance, Qingdao completed nucleic acid testing for ten million people within five days, demonstrating a testing capability that is simply incomparable. China was able to bring the epidemic under control rapidly, largely due to its ample supply of test kits and robust testing capacity.

In terms of therapeutic agents, referencing the primary treatment protocols for some patients after contracting COVID-19, regimens have included neutralizing antibodies, remdesivir, and the corticosteroid dexamethasone. China possesses domestic capabilities for several of these medications. For instance, in the research, development, and manufacturing of neutralizing antibodies, China is by no means lagging behind other countries. At least five or six pharmaceutical companies in China, including BeOne Medicines, are developing neutralizing antibodies. I am confident that China’s neutralizing antibodies are in no way inferior to those from the United States and may even be superior.

Additionally, zanubrutinib, a BTK inhibitor and an independently developed novel anticancer drug by BeOne Medicines, has previously been approved in the United States for the treatment of a type of lymphoma. It has now been found that this class of inhibitors may exhibit certain efficacy in COVID-19 patients who develop cytokine storm symptoms in the later stages of the disease. Zanubrutinib is currently undergoing Phase II clinical trials in the United States.

Overall, during the pandemic, the robust technological and biotechnological capabilities demonstrated by China have significantly bolstered national confidence, as we truly had “food in hand and calm in heart.”

Historically, China’s innovative drugs have relied heavily on imports, with the majority of domestically produced medicines being generics. Although many imported new drugs have been introduced into the Chinese market, their accessibility and affordability have become severe issues due to high prices. As a country with a population exceeding 1.4 billion, China cannot perpetually depend on imported innovative drugs to meet the healthcare needs of its citizens. In the past, innovative drugs in China were often affordable only to high-income groups, creating an unsustainable situation; human life should not come at the cost of driving people back into poverty or causing new impoverishment. Since 2015, the National Medical Products Administration has implemented sweeping reforms, greatly unleashing the potential of privately developed biopharmaceuticals and innovative drugs.

The momentum of China-style iterative innovation is particularly robust. The way domestically produced home appliances once reshaped the global landscape is now unfolding in the pharmaceutical industry. Taking PD-1 inhibitors as an example, without locally developed innovative drugs, Opdivo and Keytruda would have likely dominated the global market, or at least the Chinese market, for many years. However, with Chinese companies conducting parallel R&D, dozens of PD-1/PD-L1 antibody drugs were rapidly developed. Currently, four domestically developed PD-1 inhibitors have been launched in China, significantly altering the market landscape.

Keytruda, the best-selling PD-1 inhibitor, has been surging in the global market; however, its market share in China has dropped below 30%, and this downward trend continues. Conversely, domestically produced PD-1 inhibitors in China are gaining momentum. These agents offer not only competitive pricing and robust efficacy but also comparable safety profiles. Thus, disruption has already taken place in China and will inevitably drive similar changes in other parts of the world.

Take KRAS, for example. It has recently emerged as a hot new target globally, with no drugs yet approved for market launch worldwide. In China, several companies, including BeOne Medicines, have already initiated clinical trials, demonstrating rapid progress. The traditional logic of the global pharmaceutical industry held that an innovative drug could secure a company’s competitive advantage and peace of mind for a decade. However, this paradigm has been overturned in China. We are not only capable of developing novel drugs with independent intellectual property rights, but we can also do so at a faster pace and on a larger scale. Referring to BeOne Medicines’ target portfolio map, the company has strategically positioned itself across numerous tumor types and diverse oncology targets. This is not only characteristic of BeOne Medicines but also representative of Chinese innovative pharmaceutical companies as a whole.

This progress is also attributable to policy-level support, as the Chinese government has continuously encouraged the development of major innovative projects in the pharmaceutical industry in recent years, driving overall sectoral prosperity. Since the second half of 2018, within the first year and a half following the introduction of Chapter 18A by the Hong Kong Stock Exchange, domestic biotechnology companies raised net proceeds exceeding RMB 35 billion through initial public offerings. Furthermore, since the launch of China’s STAR Market, biotechnology firms have raised more than RMB 27 billion. It is evident that regulatory liberalization and supportive policies have significantly accelerated the development of the pharmaceutical industry, while also attracting substantial inflows of global capital and talent.

Finally, I would like to share two key figures with you. First, in January of this year, Amgen completed a partial equity investment in BeOne Medicines for $2.7 billion, marking the largest equity transaction in the global biopharmaceutical sector. Second, in July, BeOne Medicines closed a new equity financing round amounting to $2.07 billion, setting a record as the largest new equity issuance by a biotechnology company in the history of the global biopharmaceutical industry. These developments underscore that global capital remains bullish on the future growth of China’s biopharmaceutical industry and recognizes BeOne Medicines’ leading position in the field of innovative drugs in China.

So, what lies ahead? In the past, we often spoke of Chinese pharmaceutical companies going global and entering European and American markets. Now, we are indeed making this a reality. For instance, BeOne Medicines’ BTK inhibitor zanubrutinib has already entered the U.S. market and has filed for marketing approval in Europe, Australia, Canada, Israel, and other countries. Some U.S. pharmaceutical companies are now willing to accept and introduce innovative drugs from China, collaborating with Chinese enterprises, as they recognize that the global landscape needs disruption.

However, there is another direction for internationalization that I wish to highlight: the Belt and Road Initiative (BRI) countries. The BRI nations encompass billions of people worldwide. Historically, these countries have lacked the capacity to develop independently innovative drugs and have been unable to afford innovative or patented medicines from Europe and the United States. As a result, access to such medications was limited to the extremely wealthy—a scenario that previously mirrored the situation in China. While the emergence of innovative drugs in China has changed this landscape, conditions in BRI countries remain largely unchanged. Why, then, do we not expand our innovative drugs into these markets?

Here lies a monumental logical conundrum. Currently, the global community exclusively recognizes innovative drugs and regulatory approvals originating from Europe and the United States. While this paradigm was valid in the past, it is no longer tenable, given the emergence of numerous innovative drugs stemming from China’s intelligent manufacturing sector. China has now joined the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). If mutual recognition of regulatory oversight can be achieved within the ICH framework, the approval of innovative drugs will no longer hinge solely on endorsements from the United States and Europe. Instead, China will become an integral part of the certification system, fostering a diversified approval landscape. This shift will enable China’s pharmaceutical industry, in collaboration with testing companies, to implement the Belt and Road Initiative by delivering more medications for cancer, cardiovascular diseases, chronic conditions, and rare diseases to developing nations. As a livelihood-focused endeavor, this initiative stands to benefit billions of people across the Belt and Road regions.