"The whole pharmaceutical R&D and industry market has actually become more interesting." In March 2022, Shi Dongmei, head of Merck's China R&D Center, told Jianzhi Bureau.
Shi Dongmei, head of Merck China R&D Center
In 2021, Merck China adjusted its research and development strategy to accelerate investment in immunity, neurological and other fields on the basis of its previous layout. Many varieties that are still in the early stages of Merck's global research and development have been introduced to China for research.
Overall, Merck avoided China's current "target fever", which actually requires a lot of determination. As a multinational enterprise, Merck Group needs to have a full understanding of the Chinese pharmaceutical market and policy environment when formulating R&D and promotion strategies for different markets.
Merck's transformation is actually a microcosm of the transformation of research and development in China's pharmaceutical industry.
The turning point has come
In 2019, on the first day of her appointment to Merck China, Shi Dongmei felt the importance that the headquarters attached to the research and development work in China - allowing China to achieve global synchronous research and development and enter the early stage of research and development of new products is the core assessment of her just joining the company as the head of Global Clinical Development china of Merck China.
This year, one of Merck's star products was developed in the first batch of 5 indications, and China was simultaneously included in it. Previously, multinational pharmaceutical companies, even if they set up clinical trial sites in Asia, often preferred Japan or South Korea.
This change means that the importance of the Chinese market and the high incidence and unique disease spectrum of Chinese patients have become a key focus in the development of new drugs.
Merck China R&D Center was established in 2009, when the headquarters of multinational pharmaceutical companies did not pay enough attention to China, and there were many concerns about China's local R&D capabilities and R&D environment.
Similar to its peers at that time, Merck China's R&D department at that time only undertook some of the very marginal tasks in the headquarters R&D system, such as participating in international multi-center registered clinical trials or conducting regional/Chinese bridging clinical registration trials to qualify for earlier marketing of drugs.
At that time, there were very few multinational pharmaceutical companies that really brought early clinical development to China.
In 2015, China's pharmaceutical market underwent a fundamental transformation. In August of that year, the State Council issued the Opinions on Reforming the Review and Approval System for Drugs and Medical Devices, allowing new drugs that have not been listed overseas to carry out clinical trials simultaneously in China after approval, and experimental data that meets the requirements "can be used when applying for registration".
The reform of drug review allows multinational pharmaceutical companies to gradually achieve synchronous global development and enter China faster. The strategies of multinational pharmaceutical companies have shifted.
Shi Dongmei introduced that at present, Merck China's R & D team has a total of about 200 people, because of the clinical trial outsourcing model, the number is not much, but the establishment is very complete, registration, clinical, operation, translational medicine, digital system, drug safety, project management and medical department and other positions are readily available, is a "full-functional R&D hub" - improve the functional departments of R & D center.
In 2018, Merck China joined only 4 global and local clinical programs. By the beginning of 2022, that number had increased to 18. In addition, a number of newer projects have been identified as underway next year.
The R&D stage in China has moved forward, which is a distinctive feature of Merck China at present.
Shi Dongmei introduced to the Health Bureau: The China team will communicate the Chinese disease spectrum, disease characteristics, biomarkers, current diagnosis and treatment standards, and preclinical and clinical research data requirements for clinical development and registration of drugs in China in advance to the global R&D team. The Chinese R&D team has moved from late clinical R&D to early clinical development and preclinical R&D.
This development model allows for earlier consideration of unmet clinical needs in global and key market regions, more effective investigation of product mechanisms, and whether there are potential geographical differences and different treatment practices in the patient population of the target indications.
For example, there are differences between the West and the commonly used clinical regimens such as gastric cancer, and it is difficult to use a treatment plan data to meet the global review of registered cancer species, and some combination therapies may require clinical trials in different regions. "The clinical development of the drug is extremely time-consuming, so the disease spectrum, clinical practice and registration requirements of different regions are fully considered in the preclinical data and early clinical development stage, which can better and seamlessly connect our research and development needs in the later clinical development stage." Shi Dongmei explains.
Mission of China
The Health Bureau learned that in the past two years, the management of the entire Merck Pharmaceutical and Health Business has been continuously adding new blood, "they come from different types of pharmaceutical companies, have a broader vision, and have a deeper understanding of the Chinese pharmaceutical environment."
To this end, Shi Dongmei proposed: The China-led clinical trials that are specifically carried out for patients with high incidence or characteristic diseases in China are made into global clinical trials, not only the "in China for China" advocated by Merck, but also the research and development results in China can feed back to the international market.
In June 2021, the plan was submitted to Merck's headquarters, and the Team in China also proposed a complete implementation plan for multiple indications of the three products and conducted a detailed demonstration on a global scale, "The company is very supportive from top to bottom and is currently evaluating which product to use as an example to carry out this project." ”
Quantity will not be the whole pursuit of an R&D department. Simply introducing products cannot grasp the Chinese market in the fierce competition. Only by differentiating in product positioning and R&D strategies can we truly find and meet the clinical needs of Chinese patients.
"Oncology drugs have been a global R&D hotspot in the past 10-15 years, and the competition has entered a white-hot situation," Shi Dongmei admitted: "Many tumor species have entered the relative platform stage of treatment, and even if investment is increased in the short term, the products produced may not have significant advantages in prolonging patient life or improving quality of life." ”
In September 2021, data released at the annual meeting of the Chinese Society of Clinical Oncology showed that of the 1640 clinical approvals approved by the State Food and Drug Administration of China that year, 795 were related to the development of tumor drugs. Shi Dongmei and his team found that there are still blank spots in tumor treatment, such as pancreatic cancer, colorectal cancer, stomach cancer and other cancers, there are still huge unmet clinical needs.
These potential needs are the development direction that enterprises can grasp in the future.
In addition, Merck has also continuously shifted its attention to some diseases with high incidence in China and unmet clinical needs. In the past year, the company's layout focus has also fallen on the two areas where the market gap in immunity and nerves is still relatively large.
On March 8, the official website of the State Food and Drug Administration announced that a potential first-in-class product for the treatment of systemic lupus erythematosus by Merck has been approved for clinical trials in China. Systemic lupus erythematosus is a typical autoimmune disease, with about half of the world's patients in China. Some institutions predict that the domestic systemic lupus erythematosus drug market is expected to exceed $4 billion in 2025.
To raise the bar for such drug candidates, Merck is now "focusing on first-in-class and best-in-class."
The Health Bureau learned that Merck China was basically not involved in the advanced clinical trials of immune drugs before. Shi Dongmei believes that in the current market environment, drugs that want to continue to be listed must invest higher research and development costs, and have higher requirements for the safety and effectiveness of products. Merck China will continue to increase its R&D investment in the field of immunity and neurology to meet more clinical needs for the benefit of patients.
Undoubtedly, competitors will soon catch up, and then, the world's best innovative drugs can be listed in China faster, patients will use innovative drugs faster, and companies with "follow" capabilities can ensure that patients can buy more affordable drugs within a few years, and multiple participants can benefit from them.
Shi Dongmei feels that it is this competitive environment that has created "a very good era, both for patients and for the pharmaceutical industry."
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