Merck's Centennial Art of War: Seeking innovation within the regulations to promote China's pharmaceutical "global voyage" stable and far-reaching

A grand strategy, a new vision

In recent years, China's pharmaceutical industry has developed rapidly, especially in 2017, when China announced its participation in the International Human Medicines Technical Coordination Council (ICH), China's pharmaceutical industry has officially placed itself in an international competitive environment

This is a historical leap in which China's outlook is upgraded to global outlook, and policy outlook is connected to scientific outlook; it is also a transformational revolution from imitation to innovation

Under the continuous improvement of the international drug approval and review system;

In the increasingly synchronized global drug R&D and registration environment;

In the context of market competition where innovative ideas and technology continue to break through;

In the ever-changing Internet, artificial intelligence and other new technology application scenarios.

How can my country's pharmaceutical industry seize the opportunity to create an "international new drug" of "equal quality and high efficiency"?

In the opinion of Mr.

One is: Have a global vision of policies and regulations, keep abreast of the latest policy and regulation trends, and ensure the development of drug innovation, research and development, production and operation in line with international regulatory standards;

The second is: complete technological iteration, build a fast and efficient drug research and development platform, establish a modern biopharmaceutical process production system that meets the latest quality requirements, and realize commercial scale production

In this regard, as a provider with 353 years of experience in the world’s leading process solutions, and as a behind-the-scenes supporter who has been committed to promoting the high-quality global development of Chinese biopharmaceutical companies, how will Merck help Chinese pharmaceutical companies solve the above "problems" ? Mr.

Rooted in China to understand the needs of the local market

Mr.

During this period of time, he was shocked by the rapid development of China's pharmaceutical industry, especially the rapid rise of China's major pharmaceutical companies

From the performance point of view, according to MedTrend medical trend report data, in 2020, seven multinational pharmaceutical companies, led by AstraZeneca, Roche, Eli Lilly, etc.

Multinational pharmaceutical companies have always been big players in the Chinese market, but it can be seen that the role of Chinese pharmaceutical companies in the Chinese market has become more and more important

In this regard, Mr.

In his view, major changes in the policy environment such as China’s accession to ICH and the implementation of centralized mass procurement are also a great opportunity for Chinese pharmaceutical companies to achieve "qualitative change" from "quantitative change".

1) Pay more attention to the whole life cycle management of drugs

2) Pay more attention to the scientific and fine management of drug quality and cost

3) Pursue the independent innovation and quality improvement of pharmaceutical companies

Regulatory guidance, innovation-driven deepening service in the Chinese market

The rapid changes in the environment of China's pharmaceutical industry have made Chinese pharmaceutical companies more urgent for an upstream supplier that can support the entire life cycle from drug research and development, marketing registration and approval to production
.

Under such demand, the advantages of Merck's many years of advanced experience have emerged:

The first advantage is quality and regulatory services
.
According to Mr.
Mai Xuankai, after years of experience accumulation and global development, Merck already has a very advanced regulatory experience and a team of experts around the world
.
After taking root in the Chinese market, Merck has also brought these experience and expert teams to China, and has been committed to providing Chinese biopharmaceutical companies with training and consulting services related to the quality of the life cycle of drugs to meet the increasingly stringent regulatory requirements and International industry standards
.

In this regard, Mr.
Mai Xuankai also mentioned that Merck’s existing Emprove® project can include Merck’s quality management system, product safety data, product and production continuous stability data and monitoring reports, and upstream supplier management.
Information such as supply chain and supply chain is directly and transparently disclosed to drug companies, fully supporting the supplier management, drug registration, quality risk assessment, and GMP production of drug companies, and providing reliable regulations and quality assurance for the development of the company
.

In addition, during its many years of entering the Chinese market, Merck has been actively involved in the writing of relevant guidelines for the pharmaceutical industry in China, including "Guidelines for Sterilization and Filtration Technology and Application", "Key Points for Virus Contamination Risk Control of Biological Products for Therapeutic Use", "International pharmaceutical single-use system application and technical guidance "and so on
.

It is worth mentioning that in January 2021, the new book "The Essentials of Virus Contamination Risk Control for Therapeutic Biological Products", which was organized by the National Pharmacopoeia Commission, China Food and Drug International Exchange Center, Merck and related institutions and experts in the industry, was officially released.
, Widely acclaimed in the industry
.

This is the first book in China to systematically interpret the virus contamination risk control of biological products.
It summarizes and summarizes the technical requirements and regulations related to the virus safety of biological products at home and abroad, and provides Chinese pharmaceutical companies with virus contamination risk control strategies and technologies.
Advanced guidance
.

"Future quality and regulations are still the foundation and focus of Merck's service to the Chinese pharmaceutical industry
.
" Mr.
Mai Xuankai said
.

Another advantage is advanced technical support: German craftsmanship has always been known for its rigor, and has a jaw-dropping pursuit of innovation and optimization of details and quality control.
It has always been synonymous with precision and high-end
.

Adhering to this tradition, over the years, Merck has provided China with a reputation for advanced production process technology solutions, and has created many such as: cooperation with Taibang Biological in the field of blood products, and Transcenta in the continuous stream downstream precision Sample cases of pure system cooperation (leading the world) and strategic cooperation with Genscript in the field of cell gene therapy
.

In addition, in order to strengthen China's innovation, in 2020, Merck opened the Merck Life Science Technology and Training Center (M Lab Collaboration Center) in Shanghai
.
It is reported that this is Merck's largest laboratory among the nine global innovation centers
.

M Lab™ includes laboratory scale and process development support laboratories, providing non-GMP (Good Manufacturing Practice) laboratory space, where pharmaceutical and biopharmaceutical manufacturers can explore ideas, learn innovative technologies, and interact with Merck scientists Work side by side with engineers to solve key process development and production challenges
.

In addition, customers can also participate in product demonstrations, practical training, formal biopharmaceutical education courses and experiments, and use best-practice new methods to develop, optimize and scale up processes and simplify global technology transfer
.

According to Mr.
Mai Xuankai, now Merck has also launched a new biopharmaceutical dedicated automation management platform at M Lab, corresponding to Control, Connect, Collect, and Collaborate, aiming to actively use the digital platform to introduce more foreign technologies and support China The pharmaceutical industry enters the Industry 4.
0 era more and faster, and participates in the process of internationalization and globalization
.

Witnessing changes to boost the global voyage of China Pharmaceuticals

It is worth mentioning that, in addition to supporting the development of China’s pharmaceutical industry over the years, Merck has also witnessed China’s pharmaceutical industry becoming a global leader in some segments, such as gene and cell therapy, monoclonal antibodies, vaccines and other fields
.

As a company that emphasizes "curiosity" and "innovative" genes, in the future selection of Merck's Chinese partners, Mr.
Mai Xuankai said that he is inclined to choose life science and technology with a very strong curiosity and willingness An enterprise that makes efforts to innovate and make breakthroughs
.

Combining with Merck’s years of cultivating China’s pharmaceutical industry, we can see that pharmaceutical innovation is no longer a single innovation invention.
Only by making good use of global forces and working together can we truly create a global product, a global product.
A chemical industry has truly achieved the ambitious goal of benefiting patients around the world
.

Reference data:

MedTrend Medical Trends: "7 Multinational Pharmaceutical Companies' 2020 China Performance Released! With a total income of 147.
6 billion yuan, AstraZeneca is the king.
"

Mi Nei.
com: "367 pharmaceutical companies posted 2020 transcripts! Shanghai Pharmaceuticals, Jointown, Baiyunshan.
.
.
45 companies have revenues of over 10 billion, and 10 have net profits of over 3 billion.
"