The third anniversary of the newly revised Drug Management Law, Jinan CDMO enterprise grows up

In August 2019, the twelfth meeting of the Standing Committee of the 13th National People's Congress voted to pass the newly revised "Drug Administration Law of the People's Republic of China" (2019), which was implemented on December 1, 2019. Among them, the system of drug listing permits (MAH) system involved in the Management Law has attracted much attention. In addition to the main content of the MAH system, in addition to the responsibility of drug listing licensed holders in response to the non -clinical research, clinical trials, production and operation, etc. "Business)". Under the MAH system, the production, research, and sales of drugs are separated, and this system has also prompted custom R & D production institutions (CDMO) to obtain more cooperation opportunities. The scale of the CDMO industry is ushered in explosive growth and development opportunities. Today, the "Drug Administration of the People's Republic of China" has passed the third anniversary. The reporter visited some CDMO companies in Jinan to experience the new changes in the field of pharmaceuticals through their development.

Jinan's CDMO enterprise research and development is "hard core"

What is CDMO? Generally speaking, it is a customized R & D and production in the field of pharmaceuticals. It is a brand new outsourcing organization. It is mainly research and development and production. The service target is the product of pharmaceutical companies and biotechnology companies, especially for innovative products. Provide process development and commercialized customized R & D and production services.

It is understood that the CDMO custom R & D and production includes the in -depth penetration of the entire industrial chain such as raw materials and preparations for small trials of raw materials and preparations, large -scale research release, commercial approval production, clinical trials, registration, and pharmaceutical production after listing. Process research and development and production services, with high value -added technology output.

Jinan, which is based on the biomedical industry as a strong development field, also gathers many companies specializing in CDMO. Hua Po Kaisheng, located in the High -tech Zone Life Science City, is an enterprise with CDMO and related pharmaceutical business. The person in charge of the company told reporters that since its establishment, the company has focused on creating several R & D -drive -type technology platforms. After years of specialized research and accumulation, various technical platforms are exporting results in an orderly manner. In recent years Cooperating the development of an anti -tumor drug has now entered the clinical stage.

There are no shortage of "invisible champions" in the industry with R & D companies. In the production workshop of Tonglu Pharmaceutical Company in Jinan, Yu Lun, chairman of Tonglu Pharmaceutical, pointed to the functional partition of the scene, "This is a research and development laboratory, this is a production workshop." At present CDMO, a MAH center was established to carry out related businesses. In the past five years, the company has obtained 20 varieties of drug registration and approval. Orally, there are 6 varieties in the country, and 4 varieties are third in the country.

CDMO market size continues to grow

Throughout the development of CDMO over the years, its scale has always been expanding, and at the same time, the global CDMO business has gradually shifted to China.

In the memory of a person in the field of biomedicine for many years, CDMO has experienced many rapid opportunities. In the late 1990s, some foreign companies began to lead and run the CDMO model. In 2008, the world financial situation changed at any time, and the medical innovation model began to change. Some enterprises have begun to provide research and development technical services for foreign companies. This business grows on a large scale in China. After the state issued by the state in November 2015 allows trial MAH listing license holders system in some regions of China, this policy is also Become an important opportunity to encourage domestic enterprises to quickly develop the CDMO business. After the implementation of the newly revised Drug Management Law of the People's Republic of China in 2019, on July 1, 2020, the State Administration of Market Supervision Order 27 "Measures for Drug Registration Management" and the "Measures for the Supervision and Management of Drug Production Supervision" No. 28 were announced. Comprehensively implement the system of drug listing permit holders. At this point, in the business model or legal level, my country's CDMO companies have gradually matured.

In response, Sheng Zuntian, chairman of Shandong Shengzhiyuan Biotechnology Co., Ltd., felt deeply. His company has 5 platforms including research and development, production platforms, testing, sales, and holders. As of the end of 2021, there have been more than 50 sets of pharmaceutical research materials for drug research and development and consistency evaluation projects. Among them, many varieties have achieved annual sales of more than 100 million yuan, creating rich value for customers. According to the relevant data of China Business Information Network, the Chinese biopharmaceutical CDMO market increased from 2.5 billion yuan in 2016 to 9.1 billion yuan in 2020, and the compound annual growth rate from 2016 to 2020 was 38.3%. In the future, the market will maintain rapid growth, and it is expected to reach 45.8 billion yuan by 2025. The compound annual growth rate from 2020 to 2025 is 38.1%, and the industry scale will continue to expand.

CDMO model promotes new drug research and development, optimized resource allocation

Under the MAH system incentive, CDOM grows rapidly, providing favorable conditions for the development of new drugs and optimizing resource allocation.

"New drug R & D investment and high cost", Yu Lun told reporters that whether it is innovative or generic drugs, the medicine must be produced in the workshop that meets the GMP specifications. Essence Generally speaking, the most common production workshop investment starts tens of millions. The CDMO model can reduce the investment of the enterprise, allow R & D enterprises to focus on research and development, and manufacturers provide production. Develop to higher levels. "

"In today's market environment, if companies want to go long -term, whether it is R & D, production, or sales, all parties must hold groups to warm up." Sheng Zuntian vividly met the company's metaphor to become the "iron triangle", targeting different different differentials, targeting different different things, and targeting different different things, targeting differently Products jointly realized the three -party cooperation of R & D -production -sales, broke through the regional barriers, and changed the "group" cooperation with "single -solo".

Improve talent and technical level to promote the industry faster development

Although the development of CDMO enterprises in Jinan has entered a "fast track", compared with the rapid development of the biomedical industry such as the Yangtze River Delta, the Bohai Rim, the Pearl River Delta, and Sichuan and Chongqing, there is still a certain distance.

The person in charge of some enterprises told reporters that compared with the long triangle and other places, Jinan's CDMO started later, and it would take some time to form a large -scale industrial cluster. For enterprises, what currently needs is talent, such as some related majors, especially graduates related to pharmacy such as 985 and 211. Although Shandong has it, most of them work in large enterprises. province.

In addition, "we need to further enhance service capabilities before" excellent CDMO companies, "said a person in charge of an enterprise. Although Shandong is a major pharmaceutical production province, it lacks professional and high -level CDMO companies. This type of enterprise is based on providing CDMO. It can establish and determine to establish professional management, service teams and business processes. "I believe that through continuous development, our CDMO industry will definitely develop faster and better."

Reporter: Zhang Shuai

Edit: Wang Jing

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