In 2020, Bristol-Myers Squibb used the "China 2030 Strategy" to string together its 10-year plan for China's development. Now, Chen Siyuan, vice president of Bristol-Myers Squibb, general manager of China and Asia regional market, and president of China, predicts that in the next seven years, the pace of Bristol-Myers Squibb's development in China will be "acceleration".
In 2020, Bristol-Myers Squibb (BMS) officially released its "China 2030 Strategy", one of the key indicators of which is to introduce more "first-in-class" and "best-in-class" new drugs to China.
Three years later, looking back, this 10-year strategy, which is based on the certainty of BMS's global pipeline and full confidence in the potential of China's pharmaceutical market to be unleashed in the future, has gone far and wide.
With the arrival of the world's first and only approved tyrosine kinase 2 (TYK2) allosteric inhibitor deuterium colecitinib (Sondido), BMS China has been approved in the past three years to four, the first three are the "Y drug" ipilimumab approved in 2021 (the world's first approved in Yiwonian, and the first in China** Thalassemia innovative drug for injection (libroze) in more than ten years, and the innovative drug approved for marketing in China in January 2023 for *** Multiple sclerosis of ozanimod hydrochloride capsules (Thermo Percia).
In addition, in 2024, BMS China will also have a new drug for the treatment of **obstructive hypertrophic cardiomyopathy, M**Acamten, which is expected to be approved for marketing, "M**Acamten has obtained breakthrough designation in China." At present, China's National Medical Products Administration (NMPA) has included it in the priority review and approval process. Chen Siyuan said to the manager of e-medicine.
Chen Siyuan, Vice President, General Manager of China and Asia Regional Markets, and President of Bristol-Myers Squibb China.
In four years, five pioneering and representative drugs in their respective fields have been launched, providing a footnote to the sustainability of BMS's "China 2030 Strategy".
Of course, as a strategic guide for the development of BMS in China over the past 10 years, Chen Siyuan believes that it is essential to look back on the strategy every year, "We are evaluating every year whether several important key points of the strategy set at that time are in line with expectations and achieve our set milestones."
The conclusion is positive, "We are rapidly bringing innovative products in our global pipeline to China and making every effort to enter the medical insurance payment as soon as possible, and at the same time, cooperation with Chinese innovative pharmaceutical companies is also being implemented."
More importantly, in addition to continuously consolidating the confidence in the implementation of BMS's "China 2030 Strategy", Chen Siyuan believes that with the increase in product portfolio in the past three years, as well as the lean organizational strength cultivated by the approval and commercialization of new drugs, under the guidance of the "China 2030 Strategy", BMS will usher in a new round of development "acceleration" in the future.
A continuously expanding product portfolio
The formulation and implementation of any long-term strategy requires the right time, place, and people.
In the "China 2030 Strategy", BMS will introduce more "first-in-class" and "best-in-class" new drugs to China, which is a key indicator, which is inseparable from the two "days" of the strategy.
The first is the well-known 60-day acquiescence system for clinical trials driven by the drug review reform, as well as various systems that have accelerated the approval of new drugs, including but not limited to rapid review, breakthrough designation, conditional approval, and even the "first and first trial" of approved new drugs overseas.
The second is the blessing of BMS's strong and rich global pipeline. In a sense, this factor is even more critical in the implementation of BMS's "China 2030 Strategy". The favorable policy is a public resource that can be shared by all multinational pharmaceutical companies, while the global pipeline is unique.
Of course, the establishment of BMS's current global pipeline stems from the transformation of BMS earlier than other multinational pharmaceutical companies. Since 2007, BMS Global has launched the "String of Pearls Project" to transform into an innovative biopharmaceutical company that solves "incurable diseases" through a series of initiatives such as divestiture, aggregation and mergers and acquisitions.
Among the 37 new drugs approved by the FDA in 2022, BMS is the biggest winner, namely nivolumab + relatlimab in combination with **, M**acamten and deuterocolitinib. In addition, at the 2023 JPMorgan conference, BMS global management revealed that it has $50 billion of disposable resources for future small and medium-sized mergers and acquisitions to expand the pipeline.
The task left to BMS China is how to anchor the unmet needs of Chinese patients and accelerate the process. "What is needed by Chinese patients is a dimension of assessment. In addition, we need to speed up our entry into China, how to speed it up, and whether it is really accelerated, which is another dimension. Chen Siyuan said.
Focusing on these two dimensions, BMS China continues to expand its product line, "BMS currently has more than 30 clinical studies in immuno-oncology in China, 16 clinical studies in the field of hematology and 21 clinical studies in different stages in the field of immunology. In BMS's China 2030 Strategy, we will ensure that Phase III clinical studies of innovative drugs are carried out in sync with the worldIn the areas of urgent and unmet diseases in China, the goal of BMS is to 'gradually participate in the early development of the world', achieve faster filing, and let Chinese patients use it as soon as possible."
Since the launch of the "China 2030 Strategy", BMS China has successively deployed new products in the fields of hematology, immunology and cardiovascular, and has continued to add new indications for the already marketed immuno-oncology products "O drug" and "Y drug".
The newly approved Sundido is BMS' representative product in the field of immunology. As a "new star" in the field of autoimmune diseases that has received widespread attention in the industry before approval, this oral TYK2 allosteric inhibitor is considered a blockbuster new drug in the immunology track of BMS because of its precise target and unique "allosteric inhibition" mechanism, which has shown robust efficacy, as well as good safety and tolerability in moderate to severe plaque psoriasis. "The arrival of Sonodido can effectively meet the urgent need for long-acting, safe and convenient oral** regimens for psoriasis patients. Chen Siyuan said.
As we all know, with the increase in the number of new drugs listed in the field of immunology, this field has become another "battleground" for pharmaceutical companies after the tumor track, and the existing targeted ** program is mainly concentrated in the field of macromolecules, injection administration is the main route of administration, in addition to the efficacy, the convenience of clinical application brought by innovative oral small molecule drugs is bound to become a significant advantage for BMS in the field of autoimmunity.
Approved for marketing in 2022** Rottercept (Libloze), which is thalassaemia, is a son of BMS in the field of hematological diseases. - Thalassemia is a rare disease worldwide, but in China, according to epidemiological statistics, Guangxi, Guangdong, Fujian, Hunan, Yunnan, Guizhou, Sichuan and other places are all areas with a high incidence of -thalassemia. "There has been no drug for the cause in this field, and Rotercept is the drug for the cause of the disease.
The upcoming new drug M**Acamten focuses on the field of cardiovascular diseases, and BMS China has high hopes for this field.
In 2020, BMS acquired M**Acamten through the acquisition of Myokardia, which licensed exclusive rights to M**Acamten in China and certain other Asian markets to LianBio a few months prior to the acquisition. In October 2023, BMS China will price the above interests as 3$500 million recovered.
It is reported that M**Acamten has been approved for marketing in the United States in 2022 for **obstructive hypertrophic cardiomyopathy, and is the first and only cardiac myosin inhibitor approved by the US FDA. It is worth mentioning that M**Acamten won the Galen Prize, which is considered by the industry to be the "Nobel Prize in the pharmaceutical industry" this year, which is the second time that BMS has won this award in recent years, and before that, there were O drugs and Y drugs in the field of immuno-oncology.
In China, we hope to enter the cardiovascular field through M**Acamten, and build a pipeline or team in the cardiovascular field of BMS China on this basis. Chen Siyuan said, "In fact, the field of cardiovascular disease has always been the advantage of BMS, and we will have more blockbuster products in the future."
In the BMS "China 2030 Strategy", in addition to bringing in, there is also going out, and the landmark action is to cooperate with Chinese innovative pharmaceutical companies to build a bridge to bring Chinese innovation to other markets around the world.
In this regard, BMS is a big move as soon as it makes a move. On December 11, BMS entered into a licensing cooperation with Systimmune, a subsidiary of Baili Tianheng Pharmaceutical, to obtain the development and commercialization rights of a first-in-class HER3 EGFR bispecific antibody ADC product in addition to Chinese mainland China for an upfront payment of US$800 million and a potential total transaction value of US$8.4 billion.
Lift the patient's reach to "multiple legs" synchronously forward
If the richness of the product portfolio depends on the "time of day", then improving the accessibility of new products depends more on grasping the "geographical advantage".
From the establishment of the National Medical Security Administration in 2018, to the normalization of the annual drug price negotiation in the medical insurance catalogue in 2019, and then to the gradual improvement of the medical insurance negotiation rules after 2020, the certainty of the medical insurance policy for the inclusion of new drugs in the reimbursement catalogue, coupled with the sustainability of the medical insurance coverage of more than 95%, has made it a common choice for all pharmaceutical companies to quickly introduce new drugs into China with the help of review and approval policies, and quickly improve the accessibility of new drugs through medical insurance coverage through negotiations.
In fact, rapidly improving access to new drugs is also an important part of BMS's "China 2030 Strategy". Chen Siyuan concluded that in terms of improving the accessibility and affordability of drugs, BMS China is moving forward with "multiple legs".
The first is to enter the medical insurance coverage "with the greatest sincerity and the greatest efforts". "All new products will be included in the possibility of medical insurance together with China as soon as they are launched. It's not about doing it selectively, it's about all the products because it's the most widespread payment system." Of course, "we will also explore innovative patient access models, such as Huimin Insurance, patient assistance programs, the Greater Bay Area Hong Kong-Macao Medicine-Device Connect policy, the Boao Lecheng International Medical Plan, and differentiated patient support and services."
At present, the innovative drug for thalassemia, which was approved for marketing in 2022, has completed the drug price negotiation within 7 months after its launch, entered the medical insurance, and will be implemented from March 1, 2023Ozanimod (Reposia), which was approved for marketing in 2023 for multiple sclerosis, has also been included in the medical insurance and will be implemented from January 1, 2024.
Of course, due to the positioning of China's medical security system to "protect the basics", there are also "products that have not yet entered the medical insurance for various reasons" in BMS's pipeline in China, such as the immuno-oncology drug "Immune Gemini". To improve the accessibility of such drugs, BMS China has adopted an innovative payment method. According to Chen Siyuan, at present, BMS China's "O Medicine" and "Y Medicine" have been included in 149 Huimin Insurance products across the country, covering more than 10.8 billion policyholders, "only by making it accessible and affordable for patients, realizing survival benefits and improving the quality of life, can innovative drugs truly exert their value".
In addition to the coverage of the payment side, BMS China will also fully consider the "first to try" policy. "Through the 'pilot and pilot' projects in Boao, the Greater Bay Area and other places, new drugs that have been approved overseas can be used by Chinese patients more quickly. At the same time, after the approval of new drugs and before they are included in the "window period", BMS will also carry out patient assistance and patient support programs to ensure that patients can use new drugs as soon as possible at a relatively reasonable cost.
However, the clear results of improving patient access to new drugs require a lot of pioneering work on new drugs by BMS China, which may be the most challenging for BMS China. "In some areas where there were no first-class drugs or traditional first-class drugs that could not meet the needs of patients, once our first-in-class or best-in-class products are approved for marketing, we are the first or the only one", "Maybe many fields have formed a set of mechanisms and methods over the years, but in new fields, we need to create".
No matter how big or small, every aspect. From market education, expert consensus to clinical guidelines, etc., all need to be "created". This is the honor of becoming a leader in the subdivision, and it is also the ability transformation that needs to be completed as a leader in the subdivision.
It is common knowledge that capacity improvement is a process that goes from the inside out, and from the outside in, and goes on and on. Although Chen Siyuan believes that "different fields and different majors will have different methods", all different processes and results can be summarized into a key word, "insight".
From the executive level, this is an "emergence of crowds" with "new drugs accessible to patients" as the clear target, which requires the cooperation of clinical experts in various segments, the BMS China team, the BMS Asia-Pacific regional market, and even the global management of BMS.
If you don't have a replicable experience, you will go to other markets around the world. "If the U.S. is the first to go public, communicate with the U.S. In addition, there may be lessons to be learned from many clinical practices in Japan in the Asia-Pacific region."
In the absence of clinical application guidelines, we will continue to communicate with KOLs to reach a consensus on the clinical-related data of new drugs constructed by BMS, help BMS R&D and medical teams build a set of knowledge graphs of new drugs, and transmit disease knowledge, drug information, clinical application, patient benefits and other information to clinicians in an appropriate way to help improve the level of clinical diagnosis and treatment.
When the team "first arrived" in a new field, it combined practical experience with targeted training, constantly consolidated its ability base, expanded its ability boundary, and "the ability to be more international and global needs to be strengthened in any field".
And this is the "people" needed for the implementation of the "China 2030 Strategy".
Build organizational strength with actual combat
A long-term strategy with clear goals can block out the noise when the team executes, and the lean organizational force built up in actual combat is the "people" that any long-term strategy must have to continue to produce results.
On January 1, 2023, after three years in the role of BMS China, Chen Siyuan was promoted to Vice President and General Manager of China and Asia Regional Market of BMS, responsible for the Asian regional markets including Taiwan, South Korea and Southeast Asia, in addition to Chinese mainland and Hong Kong.
In the past few years, the market environment, policy environment and competition ecology of China's pharmaceutical industry have undergone tremendous changes. In the midst of this, along the way, Chen Siyuan concluded that as a regional market leader of a multinational pharmaceutical company, he needs to have three capabilities.
The first is the ability to launch new products in synergy with commercialization, which is not only related to the close cooperation between the strategic layout and R&D strategy of the global pipeline and the local pipeline, but also the construction of comprehensive commercial capabilities after the launch of new products. "The Chinese market is developing very fast, and new products are coming to market very quickly. Therefore, it is very important to see the opportunity and implement it quickly to bring new products to the Chinese market and benefit patients as soon as possible."
The second is the ability to shape and develop the market. Chen Siyuan said, "Before the iPhone, everyone didn't know that mobile phones could become like this." The same is true for new drugs, "innovative drugs, in addition to the clinical data that has been definitive, in fact, many things are unknown", which requires everyone in the middle of it to "learn and absorb quickly, so that all relevant parties in the ecosystem can participate earlier, create new ideas and create a market".
The third is the ability to embrace change. Change is the only constant certainty in the rapid iteration of the market, "changes in teams, changes in capabilities, changes in different areas, including changes in the way things are done." It's also important for leaders to lead the change and lead the whole team through that change, and to find a better way and a way to do it."
In the above context, the general managers of multinational pharmaceutical companies in China are like "wall breakers", and they need to work together to contribute their wisdom to the re-construction of the development logic of multinational pharmaceutical companies in China by solving one policy problem, market problem, access problem, and talent problem.
Chen Siyuan put the key to solving the problem on talent recruitment and ability training and improvement, "the implementation of all strategies ultimately depends on people", which is also one of the core contents of BMS's "China 2030 Strategy". The focus is two: quantity and quality.
In terms of the number of talents, the number of employees in BMS China's R&D and commercial teams increased by about 30% compared to 2020.
In terms of talent quality, we use "Double-Wing Advancement" as a tool to continuously carry out capacity improvement.
On the one hand, through technical training and leadership training, employees can build their ability to recognize and solve problems, "leadership is a very important part of the competency model", "there is no ready-made plan for many things, and there is a practice that can be used for reference, which requires employees to make self-breakthroughs and solve problems with creative methods".
On the one hand, through actual combat drills, the team's combat effectiveness is enhanced in the "artillery fire". Just like Chen Siyuan's summary of the capabilities of regional leaders of multinational pharmaceutical companies, she believes that "capabilities are developed through continuous experimentation, and you need to do these jobs, and you need to have these capabilities." Of course, BMS China's product layout in China also provides a platform for employees who want to continuously expand the boundaries of their capabilities, "through continuous experimentation, continuous trial and error, and continuous experience, to build their capabilities".
Three years ago, BMS used the "China 2030 Strategy" to string together its 10-year plan for China's development. Over the past three years, BMS China has been enriching its product portfolio, continuously improving patient accessibility, and using its team capabilities trained in actual combat to jointly gather the right time, place, and people for the subsequent development of the "China 2030 Strategy".
This is the basis for Chen Siyuan's prediction that the "China 2030 Strategy" will achieve "acceleration" in the future, "The outside world will see that we have more and more milestones, faster and faster, and even more innovative drugs will be approved in the world and China earlier and faster in the next few years." Because, "the work is done after the strategy is formulated, but the results are seen slowly."
Just like the BMS deal with LianBio, which was only announced in October 2023, in fact, "the work started three years ago."