Innovative pharmaceutical companies entering the next stage of development need to take into account the living space and profit margins, deploy differentiated strategic directions, and have the blessing of R&D strength, rich product echelon, overseas development and marketing teams, and mergers and acquisitions integration capabilities
BeiGene Guangzhou biopharmaceutical production base
The Sci-Tech Board welcomed the first biotech company to be listed on the NASDAQ, the Hong Kong Stock Exchange and the Shanghai Stock Exchange. In December 2021, BeiGene will be listed on the Star Market.
The huge domestic market has always been a unique soil for the growth of enterprises, whether for local or multinational companies. Specific to the pharmaceutical industry, settling in the domestic market used to be a good choice, but now it is not the optimal solution.
A global biotechnology company that started in China is a position that BeiGene has established since its inception. Since its inception in 2010, BeiGene has naturally had a background of international research talent, a company that originated as a group of scientists and developers to discover new anti-cancer therapies and help improve patient access in China and around the world.
In the past ten years, BeiGene has successively established functional teams in clinical development, pharmacy registration, production and supply, and commercial operation around the world, with a view to bringing its rich product pipelines to more affordable prices through efficient and high-quality development, registration, production, and supply chains, so as to change the industry situation that innovative drugs have long been affordable to a few rich people in developed countries and regions.
In the past, in the field of medicine, based on cost advantages and manufacturing levels, Chinese pharmaceuticals mainly focused on the mass production of intermediates and bulk APIs. The industry often talks about the pharmaceutical industry being "big but not strong", and when it can run out of a world-class pharmaceutical company, BeiGene has assumed some expectations. Original research and innovative drugs are the pyramid tip of the pharmaceutical industry, and the R&D capabilities, manufacturing capabilities and global commercialization capabilities matched by them have been built step by step and are being accelerated.
Correspondingly, the COVID-19 pandemic is still spreading around the world, and issues such as the safety, accessibility, quality assurance and scale production of medicines have become the focus of attention. Some insiders judge that the pharmaceutical industry will also form a "new normal" after the epidemic, multi-center clinical research and international research and development cooperation will be more active; the patent protection system will be adjusted, sharing patent pools, active authorization, etc. will be common; the review and approval procedures of pharmaceutical products will tend to be simplified, and the listing cycle will continue to be shortened.
This opens up new possibilities for the growth of innovative companies and opens up new boundaries. In this round of opportunities, BeiGene has received capital assistance and landed on the Science and Technology Innovation Board, adding more imagination to the picture of world-class pharmaceutical companies.
A piece of the global market
If China's new drugs want to cut a piece of cake in the global market, they rely on several elements: first-class R&D capabilities, cost advantages, global R&D layout and supply chain capabilities, and overseas sales teams must have a full understanding of the local area.
The above conditions are fully satisfied, which requires a process for domestic pharmaceutical companies, and BeiGene's solution is to walk on two legs with self-reliance and external cooperation. On the one hand, through the self-built team to promote independent research and development of new drugs overseas, such as the first locally developed new drug zebutinib approved for listing by the US FDA, the company's self-built teams in Europe and the United States are commercialized. At the same time, it also has independently developed products, carry out external licensing cooperation, and expand overseas markets with the help of mature commercial teams of overseas large pharmaceutical companies, and the company can obtain income from technology licensing and R&D services at the same time. In China, in addition to independently developed products, it also adopts a certain cooperation introduction model and complements its own product line.
In February 2021, BeiGene partnered with global pharmaceutical giant Novartis to authorize Novartis to develop, produce and commercialize terelizumab in the United States, Canada, Mexico, EU member states, the United Kingdom, Norway, Switzerland, Iceland, Liechtenstein, Russia and Japan. The two companies will jointly develop the drug, and Novartis will be responsible for the registration application and commercialization activities after the transition period.
Based on this partnership, BeiGene can jointly sell products in North America, with part of the operating capital provided by Novartis. BeiGene received a down payment of $650 million for the licensing of this drug, and is eligible for broader benefits as clinical development and market development develop.
So far, this is still the cooperation with the highest down payment amount of domestic drug single products authorized to trade, and the new drugs involved, under the cooperation of both parties, have also submitted the first overseas listing application for terelizumab to the US FDA this year.
With the successive listing of drugs under development at home and abroad, as well as cooperation with more global pharmaceutical companies, BeiGene's product sales are expected to cover more regions around the world.
In recent years, with the changes in the internal and external environment, the transformation and upgrading of the pharmaceutical industry and internal differentiation have accelerated. Coupled with the impact of the epidemic, the situation facing Chinese pharmaceutical companies at this stage is becoming more and more severe, such as weak market growth, price reduction of medical insurance control drugs, stricter supervision, low profits of generic drugs, and the elimination tournament has begun.
The pressure faced by pharmaceutical companies in the domestic market means that the industry needs to change its business model. In this context, opening up the international market is one of the future upgrading directions of Chinese pharmaceutical companies.
Since it was first approved in the United States in 2019, BeiGene's first self-developed drug on the market, zebutinib, has been approved for marketing in many countries and regions. In addition to the United States and China, it also includes mainstream markets such as Australia, Russia and Canada, as well as emerging markets such as Chile, Brazil and Israel.
Recently, the drug has also been approved in the European Union for the treatment of adults with Fahrenheit macroglobulinemia (WM) who have previously received at least one therapy, or as a first-line therapy for the treatment of patients who are not candidates for chemotherapy immunotherapy.
In just two years, including the above approved news, the commercial footprint of zebutinib has traveled to 40 countries or regions around the world, as China's first local original anti-cancer new drug, which is relatively rare in China's pharmaceutical industry. Through the layout of multiple Phase 3 clinical trials in the early stage, the company will further develop to obtain more clinical evidence and further establish the potential "best in class" status of this drug.
However, the desire to carry out global research and development is very good, but the reality is difficult. It is easy to deal with regulatory agencies and clinical institutions in dozens of countries at the same time, and to strive to speed up and reduce costs for clinical development. Policy, cultural, legal and religious differences across markets pose great challenges to cross-border and time-zone team work. Ms. Yan Xiaojun, senior vice president of BeiGene and head of global pharmaceutical affairs, once mentioned in an interview that gelatin, a raw material used in zebutinib capsules, cannot be used in Islamic countries due to cultural and religious reasons, and the team needs to consider alternatives and has met the registration requirements for these regions.
R&D capabilities underpin the global landscape
In the new drug industry, if the global market can be used as a strategy, then the support of the company's research and development capabilities is crucial.
Since its inception 11 years ago, BeiGene has advanced 11 self-developed preclinical drug candidates into clinical trials or commercialization. As of November this year, the company has more than 2,800 R&D personnel, accounting for more than 36% of the total number of employees.
BeiGene's layout in research and development capabilities also has strong global characteristics. The clinical development team is distributed in China, the United States, Australia and Europe, and belongs to the leading company in the global clinical layout and operation of the domestic biotechnology industry.
BeiGene R&D Center
As of November this year, the company has conducted or plans to conduct more than 95 clinical trials in more than 40 countries and regions, including 38 phase III or potentially registered clinical trials, with a total enrollment of more than 14,000 patients and healthy subjects, of which more than half of the overseas enrollments.
Based on the above global layout, BeiGene is able to operate its global research and clinical trials with its own capabilities and efficiently promote them.
Currently, in addition to commercialized drugs and declared drug candidates, BeiGene has 36 drug candidates in clinical research, including HPK1 inhibitors with first-in-class potential, and many anti-tumor drug candidates with unique and differentiated designs. In the preclinical phase, more than 50 preclinical research projects are already being advanced by in-house teams, more than half of which have first-in-class potential.
The usual R&D path of innovative biotechnology companies is that researchers complete early research in the laboratory, and then entrust the new drug project to the CRO, which leads the clinical trial and market approval process, and each party has its own division of labor.
BeiGene's approach is not the same as most businesses. With the increase of new drug pipelines, the company's research and development scale is also increasing. At present, BeiGene's internal R&D team is performing nearly 100 clinical trials in 40 countries or regions around the world, including a number of large-scale, multi-center global clinical Phase 3 studies, and clinical trials basically do not rely on CRO, but carry out clinical trials through self-built teams, which greatly improves development efficiency and data quality. At present, BeiGene's global clinical development team has exceeded 2,100 people. Such a large internal clinical team can basically take care of all the links by itself, and such a capability is extremely rare in China.
At present, the company has established a variety of anti-tumor targets and drug technology platforms, R & D system covers molecular targeted drugs, immuno-oncology therapy, combination therapy, etc., R & D engine can be seamlessly connected with production and clinical development. Based on the mastered multiple drug technology platforms that can be applied to oncology and other fields, the company has built a complete set of full-process technology system from early detection of anti-tumor drugs to commercialization.
At the same time, in the research and development of small molecules, antibody drugs and the production of new drugs, as well as the transformation of research and development results, the company has established 4 core technology platforms.
The next stop in BeiGene
Although salesence-out is the fastest means for Chinese new drug companies to go to sea to pan for gold, overseas commercialization capabilities cannot be missing for a long time, which is one of the core competitiveness of international enterprises and a constraint for Chinese pharmaceutical companies to go directly to sea.
For its part, BeiGene has established commercialization teams in China, the United States, and Europe, with more than 3,100 commercial teams in China and more than 190 in the United States and Europe as of November.
In the future, BeiGene plans to create a new model of global growth by designing targeted market access strategies to enter the global market in stages at more affordable drug prices, and become a global biotechnology company with global strength and local wisdom.
In BeiGene's view, for innovative drugs, it has been aimed at the global stage since its inception. Only pipeline products that have been scientifically proven to have the potential for global competition can become candidates for commercialization in the future.
In the biomedical sector, BeiGene is the first company to complete the listing of NASDAQ, the Hong Kong Stock Exchange and the Science and Technology Innovation Board. Biotechnology has only had more than 30 years of development history so far, and compared with other mature industries, there are many development models that need to be explored and understood in this industry; at the same time, the knowledge threshold of this industry is also higher.
BeiGene said that being able to become the first N+H+A company means recognition and affirmation for the company by the world's major stock exchange market regulators and investors. At the same time, this also brings new challenges to BeiGene, and we hope to actively communicate with regulators and investors, and make progress with various stakeholders in China to deepen our understanding and awareness of the industry.
From the internationalization process of pharmaceutical companies around the world, it can be seen that those companies that have grown into multinational pharmaceutical giants have a long-term strategic vision, such as Pfizer in the middle of the last century has proposed an annual overseas sales target of 60 million US dollars. Crises and opportunities coexist in the international market, and Chinese pharmaceutical companies need to deploy in the strategic direction of both living space and profit margins as early as possible, and at the same time have the strength of research and development, the ability of mergers and acquisitions, the rich product echelon, overseas certification capabilities and the blessing of overseas marketing teams.
For a long time, BeiGene has an international perspective on being a global leader in the discovery, development and commercialization of innovative therapeutics, providing patients around the world with effective, accessible and affordable quality medicines.
After the listing on the Sci-Tech Innovation Board, BeiGene's next stop will continue to invest in the field of global innovative drug research and development, production and commercialization, efficiently promote the global clinical trials of innovative drugs under development, promote the construction of modern R&D centers and production bases, and expand domestic and foreign marketing teams to enhance the market share of the company's products, consolidate its leading position in the biotechnology industry, and become a global biotechnology company with global strength and local wisdom.