Outlook | Building an Accelerator for Innovative Drug Development

Compared with manufacturing fields such as chemical engineering, new materials, and advanced equipment, the standards for innovation drug pilot-scale (in-between) production are more stringent, driven by the heightened regulatory attributes arising from the biological complexity of drugs and individual sensitivity.

Guide universities and research institutes, as well as pilot-scale production (in-between) platforms, to build industry-education integration bases and pilot-scale workshops; strengthen cooperation among industry, academia, and research; and cultivate a cohort of composite, skilled professionals who understand products, manufacturing, experiments, equipment, and safety, as well as an outstanding engineering team adept at solving complex engineering problems.

By |《Outlook》 News Weekly reporters Hu Yongshun, Luo Xin, Zhu Han

In 2025, China approved 76 innovative drugs, ranking first globally in terms of number. Innovation drug R&D faces high technical barriers, and large-scale launch depends on the key support of pilot-scale production platforms. Compared with manufacturing fields such as chemical engineering, new materials, and advanced equipment, the standards for innovation drug pilot-scale production are more stringent; this stems from the heightened regulatory attributes brought by the biological complexity of drugs and individual sensitivity.

The main role of innovation drug pilot-scale production is to simulate industrialized production conditions for trial-and-error, verifying the repeatability of laboratory technologies, the feasibility of mass production, and the stability of quality—thereby safeguarding the safety, efficacy, and economic value of medicines from the source.

It is difficult and costly for pharmaceutical companies to build their own pilot-scale platforms. By contrast, leveraging specialized pilot-scale platforms built by innovation drug CDMO (contract development and manufacturing organization) and CMO (contract manufacturing organization) enterprises can provide pilot-scale services in a more intensive and efficient manner, offering clear advantages over companies’ in-house platforms.

To meet the pilot-scale needs of more innovative drug small and medium-sized enterprises, the government has stimulated the willingness of pilot-scale platforms to provide public services through measures such as direct subsidies with fiscal funds and the layout of regional pilot-scale networks, thereby expanding the scope of services offered by pilot-scale platforms.

Experts interviewed, including Zhang Hailong, President of Crystal Easy Pharmaceutical Technology Co., Ltd., believe that, at present, innovation drug pilot-scale platforms still face challenges such as strengthening supply, improving adaptability, and enhancing service effectiveness. They suggest combining market mechanisms with government guidance in an organic way to push platforms to upgrade toward specialization, networking, and internationalization, while simultaneously improving the capabilities of hardware facilities and software services. They also call for creating a standardized and orderly development environment to avoid disorderly competition and low-level duplicate construction, and to turn pilot-scale platforms into an accelerator for new drug development and a source of momentum for industrial upgrading.

Wang Weitu / This publication

**　　Innovation drug pilot-scale platforms are developing rapidly**

Innovation drug pilot-scale platforms in China are in a period of rapid development. For example, in recent years, a group of CDMO and CMO companies capable of providing pilot-scale services for innovative drug achievements such as macromolecular biologics have emerged, strongly supporting the efficient transformation of innovation drug achievements and the pace toward上市.

Innovation drug pilot-scale production must pass GMP (Good Manufacturing Practice) certification. If you want to run clinical trials in foreign countries at the same time, you need to submit either an in-China-and-U.S. dual filing or an in-China-and-EU-and-U.S. triple filing; the pilot-scale data must meet local GMP requirements. With growth in demand for innovation drugs, more and more CDMO and CMO companies offering professional pilot-scale services for drug R&D have been created.

Jian Da Jiuzhou (Beijing) Biotechnology Co., Ltd. recently completed pilot-scale production of an adenovirus vector drug with domestic CDMO companies and initiated the dual filing process for in-China-and-U.S. submission. “A few years ago, it was difficult to find a pilot-scale platform in China that matched this type of drug. Now CDMO companies can complete pilot-scale sample production to a high standard. We submitted our clinical trial application to the National Medical Products Administration and the U.S. Food and Drug Administration, and we expect it will enter clinical trials this year.” Luo Minmin, the founder of the company, witnessed China’s rapid development of innovation drug pilot-scale platforms.

Some pilot-scale platforms originally built for a pharmaceutical company’s own use have also started to provide services to the industry. These companies typically use pilot-scale production lines in stages aligned with the new drug R&D timeline, but drug R&D takes a long time. Even if multiple drugs are developed at the same time, the pilot-scale production lines still have excess capacity.

Beijing Huafang Tian Shi Biopharmaceutical Co., Ltd. (hereinafter “Huafang Tian Shi”) is a CDMO enterprise spun off from its parent company Beijing Tian Guangshi Biotech Co., Ltd. “Tian Guangshi set up pilot-scale production line services for its own drug development. But once the drugs enter clinical trials, the pilot-scale production line does not need to run continuously. Many companies like ours have converted our pilot-scale workshops into CDMOs.” He Chuan, Chief Technical Officer of Scientific Production Technology at Huafang Tian Shi, told reporters. “This is like shared bicycles—by sharing resources, we solve the issue of excess capacity for part of the time on the pilot-scale production line.”

To meet the pilot-scale needs of more innovation drug small and medium-sized enterprises, multiple regions have introduced special policies to support pilot-scale platforms in expanding their service scope. For instance, Beijing supports large enterprises and universities/research institutes to open up internal pilot-scale capabilities, and explores incorporating pilot-scale platform services into support under the Capital’s Science and Technology Innovation Vouchers. For qualifying technology-based small and micro enterprises, the annual voucher limit is no more than 500k yuan.

Driven by cost control in R&D and production and improvements in efficiency and benefits, the global pharmaceutical outsourcing services market is accelerating its shift toward emerging markets, further pushing upgrades in service quality and expansion of market scale in China’s CDMO and CMO industries.

The China Business Industry Research Institute estimates that in 2025 China’s innovation drug CDMO market scale will reach 143.6 billion yuan, and in 2026 it will increase to 152.6 billion yuan. Five years ago, this figure was only 30 billion yuan, showing a clear upward growth trend.

**　　Gaps in platforms, a shortage of talent, and concerns about homogeneous development**

Along with the rapid growth of the innovation drug CDMO and CMO markets, supply of innovation drug pilot-scale production faces structural shortages. The standout issue is that high-end capacity is scarce while mid- and low-end capacity is excessive. In mature fields such as small-molecule chemical drugs, homogeneous competition is intensifying. In frontier fields such as cell therapy, nucleic acid drugs, and exosomes, supply gaps of pilot-scale platforms are prominent, and the overall pilot-scale platform sector faces the challenge of a shortage of specialized talent.

Frontier innovative drugs lack specialized pilot-scale platforms with precise matching. For example, exosomes can be used either as a drug delivery system or directly as therapeutic biologic products, and are generally considered an important development direction following small-molecule drugs, monoclonal antibodies, and cell and gene therapies. Despite promising prospects, pilot-scale processes for these drugs are complex and the equipment is highly specialized, and to date there has been no exosome drug approved worldwide.

Beijing Enze Kangkai Biotechnology Co., Ltd. (hereinafter “Enze Kangkai”) is among the first batch of companies globally to develop exosome drugs. Because there is no suitable pilot-scale platform in China, in 2022 the company built a GMP workshop and a 500-liter single-use cell fermentation device on its own. Company CEO Kong Guanyi said that the pilot-scale facilities can currently only meet the company’s own needs. Reporters learned that, even up to now, there is no exosome drug pilot-scale platform in China that has been scaled up in a substantial way.

Experts interviewed believe that to build competitive advantages in global frontier innovative drug markets, there is an urgent need for a forward-looking, precise pilot-scale platform layout to provide rapid process verification, GMP-grade scale-up, and coordinated support for registration and submissions for disruptive technologies in frontier drugs—thereby opening a crucial channel from lab breakthroughs to clinical application.

在 some more mature drug areas, CDMO and CMO construction models and operating methods have become increasingly homogeneous, and a clear trend of intense price competition has emerged. One CDMO company reported that in some project bidding, some peer companies even quoted prices lower than cost. Some quality-focused pharmaceutical companies have had no choice but to proactively withdraw from bidding.

“Simply cutting prices and compressing costs may damage drug quality and patients’ interests. We would rather connect with high-quality customers by providing high-standard services, support the standardized development of innovation drugs, and avoid getting trapped in a vicious low-price cycle.” He Chuan said.

Building and operating pilot-scale platforms requires a large number of composite engineering professionals. Innovation drug pilot-scale work involves many aspects such as process scale-up, quality control, and GMP compliance, and therefore has high requirements for personnel’s professional capabilities. Positions involving operations of hazardous chemicals, operation of high-pressure equipment, or handling of pathogenic microorganisms require obtaining the corresponding special qualifications in accordance with the law, such as certificates for hazardous chemical operations, pressure vessel operation certificates, or proof of successful completion of biosafety training. Training periods are long and talent loss rates are high.

Li Haoqiang, Chairman of Hangzhou Haoyang Biotechnology Co., Ltd., believes that the shortage of pilot-scale professional talent stems from a disconnect between school education and enterprise practice. “In undergraduate programs such as bioengineering, biotechnology, and pharmacy, there is little practical content. In master’s and PhD stages, the focus is more on basic theoretical research. As a result, newly graduated students lack engineering skills oriented toward industrial applications, making it difficult to meet hands-on pilot-scale operational needs.”

**　　Accelerate upgrading in quality and capability**

To meet China’s needs for industrializing innovation drug achievements, pilot-scale platforms must be upgraded in quality and capability.

Enterprises are the main entities for building and operating pilot-scale platforms. Experts interviewed suggest that relevant government competent departments strengthen compliance oversight and quality system evaluations of the operating entities of pilot-scale platforms. By improving service standards and establishing credit evaluation mechanisms, they can guide pilot-scale platforms to transition toward higher value-added and higher-technology-barrier fields. They should also encourage enterprises to target frontier areas of innovation drugs for differentiated competition, and help the industry shift from price competition to healthy development centered on quality, technology, and services.

For building pilot-scale platforms for frontier drugs, provide supporting policies such as tax incentives and talent recruitment support to reduce enterprise operating costs. Enze Kangkai, which engages in R&D of exosome drugs, has received numerous policy supports from relevant authorities in Beijing. “Our company has a postdoctoral workstation. In terms of professional title assessment and hiring, we have also received support from the Beijing Municipal Science and Technology Commission.” Kong Guanyi said. He added that talent policies from主管 departments play a key role in helping companies recruit and retain talent. He hopes relevant departments will continue to increase support for talent policies.

Address bottlenecks such as the disconnect between school education and enterprise practice. Focusing on frontier fields such as small-nucleic-acid delivery, cell and gene therapy, antibody-conjugated drugs, mRNA, and new nucleic-acid drug formulations, close the gaps in interdisciplinary program construction; improve incentive and promotion mechanisms for corporate mentors to participate in graduate student training, and enhance the willingness of corporate mentors to get involved in talent cultivation.

Guide universities and research institutes and pilot-scale platforms to build industry-education integration bases and pilot-scale workshops, strengthen cooperation among industry, academia, and research, and cultivate a group of composite talents who understand products, manufacturing, experiments, equipment, and safety, as well as an elite team of engineers skilled at solving complex engineering problems.

Experts from the Yangtze River Delta Smart Green Oasis Innovation Center at Zhejiang University suggest that the Ministry of Education and the Ministry of Industry and Information Technology jointly establish specialized master’s degree directions such as pilot-scale technology for nucleic acid drugs; pilot-scale platforms can co-build an enterprise mentor pool with leading enterprises, and provide corresponding points for the talent plan for mentors who participate in teaching and project mentoring; implement joint certification of vocational skill levels among platforms, enterprises, and universities, and allow national mutual recognition.

Enhance the capability of innovation drug pilot-scale platforms to connect with international standards. Luo Minmin told reporters that more and more innovation drugs in China are accelerating global launches; therefore, in the pilot-scale stage, it is necessary to simultaneously meet high-standard requirements from regulatory bodies in multiple regions worldwide regarding production compliance and data integrity. She suggests that each platform actively align with international standards and benchmarks for production facilities and equipment standards, quality control systems, personnel qualifications and training requirements, as well as environmental and safety requirements, so as to form capabilities that can support the in-China-and-U.S. dual filing and in-China-and-EU-and-U.S. triple filing processes.

Improve the digital and intelligent (数智化) level of pilot-scale platforms. Wang Youchun, Director of the Institute of Medical Biology at the Chinese Academy of Medical Sciences, said that currently, pilot-scale scale-up processes mainly rely on traditional manual operation and analysis, and the coverage rate of automated and intelligent equipment is still insufficient. He suggested that competent authorities introduce supporting policies to provide precise support for pilot-scale platforms to move toward digital and intelligent operations. For example, promote the application of digital technologies in process fixture testing, defect detection, predictive maintenance, and other links; and promote the use of machine vision, AI large models, big data, and other technologies in pilot-scale platforms to optimize process workflows, improve experiment efficiency, and promote upgrades of both the pilot-scale platform’s software and hardware, with independent controllability.

Zhang Hailong suggests that, by referring to the “Huiyan” system for national innovation drugs—which integrates end-to-end data across R&D, approval, market activity, and public opinion—efforts should be made to build an industry-level R&D and pilot-scale data platform covering stages such as R&D, clinical, and production. With safety guaranteed, promote the sharing of de-identified data. In accordance with laws and regulations, provide de-identified data services such as disease profiles and clinical needs to platforms and enterprises, and guide the directions of innovation drug R&D and pilot-scale layout.■