Compared to manufacturing fields such as chemicals, new materials, and high-end equipment, the pilot testing standards for innovative drugs are more stringent, which stems from the high regulatory attributes brought about by the biological complexity of drugs and individual sensitivity.
Guide universities and research institutions to build industry-education integration bases and pilot testing workshops with pilot testing platforms, strengthen industry-university-research cooperation, and cultivate a group of compound talents who understand products, manufacturing, testing, equipment, and safety, as well as an excellent engineering team skilled in solving complex engineering problems.
In 2025, China approved 76 innovative drugs, ranking first in the world. The technological barriers for innovative drug research and development are high, and large-scale market entry relies on the key support of pilot testing platforms—compared to manufacturing fields such as chemicals, new materials, and high-end equipment, the pilot testing standards for innovative drugs are more stringent, which stems from the high regulatory attributes brought about by the biological complexity of drugs and individual sensitivity.
The main role of pilot testing for innovative drugs is to simulate industrial production conditions for trial and error, verifying the repeatability of laboratory techniques, the feasibility of mass production, and the stability of quality, thereby ensuring the safety, effectiveness, and economy of drugs from the source.
Building pilot testing platforms by pharmaceutical companies is technically difficult and costly, while specialized pilot testing platforms built by relying on innovative drug CDMO (Contract Development and Manufacturing Organization) and CMO (Contract Manufacturing Organization) companies can efficiently provide pilot testing services, showing significant advantages over self-built platforms by pharmaceutical companies.
To meet the pilot testing needs of more small and medium-sized innovative drug enterprises, the government stimulates the enthusiasm of pilot testing platforms to provide public services through measures such as direct financial subsidies and the layout of regional pilot testing networks, expanding the service scope of pilot testing platforms.
Experts interviewed, including Zhang Hailong, president of Jingyi Pharmaceutical Technology Co., Ltd., believe that the current pilot testing platforms for innovative drugs still face challenges such as strengthening supply, enhancing adaptability, and improving service efficiency. They suggest that the organic combination of market mechanisms and government guidance should be promoted to upgrade the platforms towards specialization, networking, and internationalization, while simultaneously improving hardware facility capabilities and software service levels; creating a standardized and orderly development environment to avoid disorderly competition and low-level repeated construction, and turning pilot testing platforms into accelerators for new drug creation and sources for industrial upgrading.
<img src="https://imageproxy.pbkrs.com/https://inews.gtimg.com/om_bt/O5psb7rD1diXJfbAkV8W8s5U0mY960zisK-4UQ9ot66HkAA/641?x-oss-process=image/auto-orient,1/interlace,1/resize,w_1440,h_1440/quality,q_95/format,jpg" alt="" original-src="https://imageproxy.pbkrs.com/https://inews.gtimg.com/om_bt/O5psb7rD1diXJfbAkV8W8s5U0mY960zisK-4UQ9ot66HkAA/641"/> Wang Weitu / This Journal
Rapid Development of Innovative Drug Pilot Testing Platforms
China's innovative drug pilot testing platforms are in a period of rapid development. For example, in recent years, a number of CDMO and CMO companies capable of providing pilot testing services for innovative drug results such as macromolecular biological drugs have emerged, strongly supporting the efficient transformation and market entry process of innovative drug results.
Innovative drug pilot testing must pass GMP (Good Manufacturing Practice) certification. If clinical trials are to be conducted simultaneously abroad, dual reporting in China and the U.S. or triple reporting in China, the U.S., and Europe is required, and the pilot testing data must meet local GMP requirements. Driven by the growing demand for innovative drugs, more and more CDMO and CMO companies providing specialized pilot testing services for drug research and development have emerged.
JianDa JiuZhou (Beijing) Biotechnology Co., Ltd. recently completed pilot testing for an adenoviral vector drug relying on domestic CDMO companies and initiated the dual reporting process in China and the U.S. &#34;A few years ago, it was difficult to find a matching pilot testing platform for this drug in China, but now CDMO companies can complete the production of pilot testing samples to a high standard
&#34;We have submitted clinical trial applications to the National Medical Products Administration and the U.S. Food and Drug Administration, and we expect to enter clinical trials this year.&#34; The company's founder, Luo Minmin, witnessed the rapid development of China's innovative drug pilot testing platform.
Some pilot testing platforms originally used by pharmaceutical companies for their own purposes have begun to provide services to the industry. These pharmaceutical companies typically use pilot production lines periodically according to the progress of new drug development, but drug research and development takes a long time. Even if several drugs are developed simultaneously, the pilot production lines still have surplus capacity.
Beijing Huafangtianshi Biopharmaceutical Co., Ltd. (hereinafter referred to as Huafangtianshi) is a CDMO company that has been independent from its parent company, Beijing Tianguangshi Biotechnology Co., Ltd. &#34;Tianguangshi established pilot production lines to serve its own drug development, but once the drugs enter clinical trials, the pilot production lines do not need to operate continuously. Many companies like ours have transformed their pilot workshops into CDMOs,&#34; said He Chuan, the Director of Science and Technology at Huafangtianshi. &#34;It's like shared bicycles, solving the surplus capacity issue of pilot production lines during certain periods through resource sharing.&#34;
To meet the pilot testing needs of more innovative small and medium-sized pharmaceutical enterprises, various regions have introduced special policies to support pilot testing platforms in expanding their service scope. For example, Beijing supports large enterprises, universities, and research institutions in opening their internal pilot testing capabilities and explores promoting the inclusion of pilot testing platform services in the capital's technology innovation voucher support scope. Eligible technology-based small and micro enterprises can use up to 500,000 yuan of innovation voucher credits each year.
Driven by the control of R&amp;D production costs and the improvement of efficiency, the international pharmaceutical outsourcing service market is accelerating its shift to emerging markets, further promoting the upgrade of service levels and market scale expansion in China's CDMO and CMO industries.
According to the China Business Industry Research Institute, the market size of China's innovative drug CDMO is expected to reach 143.6 billion yuan by 2025 and increase to 152.6 billion yuan by 2026. This figure was only 30 billion yuan five years ago, showing a significant growth trend.
Platform Gaps, Talent Shortages, and Homogenization Concerns
While the innovative drug CDMO and CMO market is rapidly developing, the supply of pilot testing for innovative drugs faces structural shortages, particularly characterized by a shortage of high-end services and an oversupply of mid-to-low-end services. In mature fields such as small molecule chemical drugs, homogenization competition is intensifying, while in cutting-edge drug fields such as cell therapy, nucleic acid drugs, and exosomes, the supply gap for pilot testing platforms is prominent, and the overall pilot testing platforms face challenges of professional talent shortages.
Frontier innovative drugs lack specialized pilot testing platforms that match their needs precisely. For example, exosomes can serve as drug delivery systems or directly as therapeutic biological agents and are generally considered an important development direction following small molecule drugs, monoclonal antibodies, and cell and gene therapies. Despite the broad prospects for these drugs, the pilot testing process is complex, and the equipment is highly specialized, with no exosome drugs having been launched globally.
Beijing Enzekangtai Biotechnology Co., Ltd. (hereinafter referred to as Enzekangtai) is one of the first companies globally to focus on the research and development of exosome drugs. Due to the lack of suitable pilot testing platforms in China, the company built its own GMP workshop and a 500-liter disposable cell fermentation device in 2022. The company's CEO, Kong Guanyi, stated that this pilot testing facility can currently only meet its own needs. Reports indicate that there is still no large-scale pilot testing platform for exosome drugs in China
Experts interviewed believe that to build a competitive advantage in the global cutting-edge innovative drug field, it is urgent to establish a forward-looking and precise pilot testing platform, providing rapid process validation, GMP-level scaling, and collaborative registration services for disruptive technologies in innovative drugs, thereby opening up the critical channel from laboratory results to clinical applications.
In some more mature drug fields, the construction models and operational methods of CDMO and CMO are becoming increasingly homogenized, leading to a noticeable trend of fierce price competition. Some CDMO companies have reported that in certain project bids, some peers even quoted prices below cost, forcing some quality-focused pharmaceutical companies to voluntarily withdraw their bids.
&#34;Simply lowering prices and cutting costs may harm drug quality and patient interests. We prefer to connect with high-quality clients by providing high-level services, supporting the standardized development of innovative drugs, and avoiding falling into a vicious cycle of low prices,&#34; said He Chuan.
Building and operating a pilot testing platform requires a large number of multidisciplinary engineering talents. The pilot testing of innovative drugs encompasses various aspects such as process scaling, quality control, and GMP compliance, which demand high professional capabilities. Positions involving the operation of hazardous chemicals, high-pressure equipment, or pathogenic microorganisms require corresponding special qualifications, such as hazardous chemical operation certificates, pressure vessel operation certificates, or biosafety training certificates, with long training cycles and high talent turnover rates.
Li Haoqiang, chairman of Hangzhou Haoyang Biotechnology Co., Ltd., believes that the shortage of specialized pilot testing talents stems from the disconnect between school education and enterprise practice. &#34;There is little practical content in undergraduate education in bioengineering, biotechnology, and pharmacy, and master's and doctoral stages focus more on basic theoretical research. Fresh graduates lack engineering capabilities oriented towards industrial applications, making it difficult to meet the practical needs of pilot testing.&#34;
Accelerate Quality Improvement and Upgrading
To meet the industrialization needs of innovative drug results in China, it is necessary to promote the quality improvement and upgrading of pilot testing platforms.
Enterprises are the main bodies for the construction and operation of pilot testing platforms. Interviewed experts suggest that government authorities strengthen compliance supervision and quality system evaluation of pilot testing platform operators, guiding pilot testing platforms to transform towards high value-added and high technical barrier fields through improving service standards and establishing credit evaluation mechanisms, encouraging enterprises to aim for differentiated competition in cutting-edge innovative drug fields, and promoting the industry from price competition to a healthy development centered on quality, technology, and service.
For the construction of cutting-edge drug pilot testing platforms, supportive policies such as tax incentives and talent introduction should be provided to reduce enterprise operating costs. Enze Kangtai, engaged in exosome drug research and development, has received numerous policy supports from relevant departments in Beijing. &#34;Our company has a postdoctoral workstation and has also received support from the Beijing Science and Technology Commission in terms of professional title evaluation,&#34; said Kong Guanyi, noting that the talent policies of the authorities play a key role in attracting and retaining talent for enterprises, and hoping that relevant departments will continue to strengthen support for talent policies.
Addressing the disconnect between school education and enterprise practice and other bottlenecks. Focusing on cutting-edge fields such as small nucleic acid delivery, cell and gene therapy, antibody-drug conjugates, mRNA, and new nucleic acid drug formulations, it is necessary to fill the gaps in interdisciplinary construction; improve the incentives and professional title promotion mechanisms for enterprise mentors participating in graduate education, enhancing the enthusiasm of enterprise mentors in talent cultivation
Guide universities and research institutions to build industry-education integration bases and pilot test workshops with pilot test platforms, strengthen industry-university-research cooperation, and cultivate a group of compound talents who understand products, manufacturing, testing, equipment, and safety, as well as an excellent engineering team skilled in solving complex engineering problems.
Experts from the Yangtze River Delta Smart Oasis Innovation Center of Zhejiang University suggest that the Ministry of Education and the Ministry of Industry and Information Technology jointly establish master's programs in nucleic acid drug pilot test technology; create a pool of corporate mentors in collaboration with leading enterprises for the pilot test platform, providing corresponding talent plan points for mentors involved in teaching and project guidance; implement a tripartite joint certification of vocational skill levels among platforms, enterprises, and universities, with nationwide mutual recognition.
Enhance the pilot test platform's capability to align with international standards for innovative drugs. Luo Minmin told reporters that an increasing number of innovative drugs in China are accelerating their global market entry, thus the pilot test phase must simultaneously meet the high standard requirements of regulatory agencies in multiple regions worldwide for production specifications and data integrity. It is recommended that each platform actively connect with international standards, benchmark production facility and equipment standards, quality control systems, personnel qualifications and training requirements, as well as environmental protection and safety requirements, to form capabilities that support dual submissions in China and the U.S. and triple submissions in China, the U.S., and Europe.
Improve the digital intelligence level of pilot test platforms. Wang Youchun, director of the Institute of Medical Biology at the Chinese Academy of Medical Sciences, introduced that the current pilot test scaling process mainly relies on traditional manual operations and analysis, with insufficient coverage of automation and intelligent equipment. It is recommended that relevant authorities introduce supportive policies to provide precise support for the digital transformation of pilot test platforms. For example, promote the application of digital technologies in process tooling testing, defect detection, predictive maintenance, etc.; encourage the application of machine vision, AI large models, big data, etc., in pilot test platforms to optimize process flows, enhance testing efficiency, and promote the upgrade of pilot test hardware and software to be independently controllable.
Zhang Hailong suggests creating an industry-level research and pilot test data platform covering research and development, clinical, and production stages, referencing the national innovative drug &#34;Huiyan&#34; system that integrates data across the entire chain of research and development, approval, market, and public opinion. Under the premise of ensuring safety, promote the sharing of de-identified data, and legally provide de-identified data services such as disease spectrum and clinical needs to platforms and enterprises, guiding the direction of innovative drug research and pilot test layout.■

This article discusses the current development status and challenges of China's innovative drug pilot testing platforms. Compared to other manufacturing sectors, the standards for innovative drug pilot testing are stricter and must meet high regulatory requirements. The government incentivizes pilot testing platforms to provide public services through financial subsidies and regional pilot testing networks. Experts suggest combining market mechanisms with government guidance to promote the specialization, networking, and internationalization of pilot testing platforms, in order to enhance service efficiency and facilitate new drug research and development as well as industrial upgrades

Outlook | Building an Accelerator for Innovative Drug Development