China’s Rise in Innovative Drug Development: Regulatory Reforms, Cell and Gene Therapy Growth, and the CoJourney CDMO Spotlight
- Nicole Brooks
- May 7
- 10 min read
Updated: May 12
Contents
Introduction
Over the past decade, China has transformed its pharmaceutical sector, evolving from a generics-dominated market into a global engine for innovative drug development.
This shift has been driven by a combination of regulatory reforms, substantial increases in research and development (R&D) investment, and the rapid expansion of clinical research and manufacturing capabilities.
This article explores the key drivers behind China’s rise in innovative drug development and highlights how companies such as CoJourney act as a real-world example of the country’s growing influence in next-generation biopharmaceutical manufacturing.
China’s Pharmaceutical Regulatory Evolution
A review by Tan et al., 2025 [1] highlighted that in 2018, China’s regulatory authority, the State Drug Administration (SDA), was transformed into the National Medical Products Administration (NMPA) [2], [3].
With this transformation came significant regulatory advancements, modernising its regulatory systems to align China with international standards [4]. Notably, this alignment involved China joining the International Council for Harmonisation (ICH) [5], which is the organisation that brings together regulatory authorities and the pharmaceutical industry to develop unified, scientific, and technical guidelines for drug development and registration.
The NMPA also Improved its Drug Registration Classification System
Chemical drugs are now stratified into five categories, preventive or therapeutic biologics into three classes, and TCM into four classes.
Category 1 drugs in each classification represent innovative drugs and include chemical drugs, preventative biological products (vaccines) and therapeutic biological products [1].
Alongside its regulatory ecosystem, China’s progress has also been attributed to increased R&D investment, its rapidly increasing clinical trial efficiency, and significant advancements in biopharmaceutical manufacturing capabilities [1].
By leveraging its growing expertise in clinical trial efficiency, innovative drug manufacturing, and policy-driven support, China has the potential to contribute significantly to the development of life-saving therapies worldwide, particularly in areas such as cell-based therapies (e.g., CAR-T therapy for cancer) and gene therapy [1].
The overarching themes of China’s rapid pharmaceutical growth include [1]:
A surge in R&D investment and global pipeline share
Growth in drug applications
Surpassing Europe in the share of clinical trials
A shift toward highly complex, next-generation therapies
Accelerated regulatory efficiency
International expansion and out-licensing
1. A surge in R&D investment and global pipeline share
China's financial commitment to drug development has significantly increased in recent years, allowing it to capture a much larger share of the global pharmaceutical landscape.
R&D Spending: Internal R&D expenditures in China's pharmaceutical manufacturing industry grew by 54.59%, from 60.96 billion RMB (approx. $9.5B) in 2019 to 94.24 billion RMB (approx. $14.5B) in 2021 [1].
Global Pipeline Share: Over the past 15 years, China's share of global R&D pipelines dramatically increased from just 2% in 2007 to 15% in 2022 [1]. This growth is consistent with China accounting for ~30% of global clinical trials and up to 40% of out-licensing activity in 2024 [6].
2. Growth in drug applications
The volume of innovative drugs entering development and reaching the market has grown at an exceptionally high rate.
Investigational New Drugs (INDs): The number of accepted IND applications for innovative drugs surged from 688 in 2019 to 2,298 in 2023, representing a compound annual growth rate (CAGR) of 35.19% [1]. Recent data indicate that innovation activity remains high, with over 110 innovative drugs approved in China in 2024 (+11% YoY), alongside continued growth in regulatory submissions and a globally expanding clinical pipeline [6].
New Drug Applications (NDAs): Accepted NDA applications for innovative drugs increased from 30 in 2019 to 133 in 2023, achieving a CAGR of 45.11%. In 2023 alone, the regulatory authority approved 66 innovative drugs [1].
3. Surpassing Europe in the share of clinical trials
Driven by streamlined regulatory processes and an expanding ecosystem, China has overtaken Europe as a primary hub for clinical research (as of 2023).
Global Share: China's share of commercially sponsored clinical trials doubled from 9% in 2018 to 18% in 2023, while Europe's share plummeted from 22% to 12% over the same period [1].
Trial Volume: In 2023, the annual number of drug clinical trial registrations in China surpassed 4,000 for the first time, reaching 4,300 (a 26.1% increase compared to 2022). Over half of the new drug clinical trials initiated subject recruitment within a rapid six-month timeframe [1].
4. A shift toward highly complex, next-generation therapies
While historically reliant on "me-too" generic drugs, China's pipeline is increasingly dominated by "First-in-Class" (FIC) and next-generation products, particularly in oncology [1].
Pipeline Doubling: The number of innovative products in development by Chinese companies nearly doubled from 2,251 in 2021 to 4,391 in January 2024 [1], with AI predicted to save 40-60% of time costs during critical R&D phases [6].
Next-Generation Dominance: Between 2021 and 2024, next-generation therapies (such as cell and gene therapies, antibody-drug conjugates, and bispecific antibodies) grew by 179% (from 613 to 1,709 products), now making up 39% of China's total drug pipeline. First-in-Class drugs also saw a 100% growth rate during this timeframe [1].
5. Accelerated regulatory efficiency
China's NMPA has aggressively modernised its regulatory systems to align with international standards, slashing wait times.
Silent Approvals: The implementation of a 60-working-day "silent approval" mechanism for clinical trial applications means that trials are approved by default if no response is given, reducing wait times that previously took two to three years down to mere months [7].
High Approval Rates: In 2023, the NMPA approved 1,918 of the 2,298 innovative drug INDs submitted, an approval-to-submission ratio exceeding 80% [1].
6. International expansion and out-licensing
Chinese pharmaceutical and biotech companies are rapidly globalising their innovations, securing massive deals with international partners.
Out-Licensing Surge: In 2024, the number of out-licensing deals for Chinese innovative drugs reached 3.885, a 59% increase from 2020 [6].
Deal Value: The total transaction value for these out-licensing deals exceeded $46.5 billion in 2023, a 69% increase from $27.55 billion the previous year. Furthermore, between 2007 and 2023, Chinese companies conducted 691 clinical trials for 350 original innovative drugs within the United States [1].
Insights from Goldman Sachs
A 2025 report from Goldman Sachs suggested that about a quarter of innovative drug candidates now under active development originate from China. Additionally, 46% of new drug molecules that entered human trials in the first half of 2025 were from Chinese companies [8].
In terms of therapeutic areas of interest for China, Goldman Sachs also reported that oncology remains a major focus for China’s biopharmaceutical industry, with 54 oncology-related licensing deals completed year-to-date as of early November. Chinese companies also play a dominant role in key therapeutic modalities, accounting for around 70% of global development activity in antibody–drug conjugates (ADCs) and approximately 60% in bispecific antibodies, both important technologies in targeted cancer therapy [8].
The Goldman Sachs report echoed the themes of the Tan et al., 2025 [1] review about what attributed to China’s pharmaceutical growth, but it also described China’s highly concentrated ecosystems. Chinese research parks boast incredibly dense networks, sometimes housing up to 700 contract research organisations and biotech collaborators in a single location [8], fostering a rapid pace of drug development and strong fundamental research in a condensed area.
Chinese Contract Development and Manufacturing Organisation (CDMO) Spotlight: CoJourney
With the scene set on the evolution of China’s drug development landscape, we turn our attention to a specific CDMO spotlight, namely CoJourney.
We met Lijun Wang, the CEO of CoJourney, at ELRIG’s Cell and Gene Therapy 2026 conference and asked her about Chinese medicine regulations and how China can develop innovative therapies so quickly.
She explained a programme we had not heard about before, the dual-track pathway, which involves the Drug Track and the Medical Technology Track (Investigator Initiated Trials track, IIT track).
The Drug Track
The drug track involves the traditional Investigational New Drug (IND) and Biologics License Application (BLA) pathway established by the Food and Drug Administration (FDA). The drug track is governed by the NMPA in China.
The IIT Track
The IIT track is overseen by the National Health Commission (NHC), which regulates clinical trials conducted within hospital settings, whereby trial sponsors must coordinate with hospitals to identify principal investigators qualified to initiate clinical trials. Lijun explained that clinical trial enrolment via this pathway can be significantly more efficient and more cost-effective than the drug track. This allows researchers to rapidly collect preliminary safety and efficacy data for proof-of-concept—a critical step in assessing the potential of the drug product under investigation [9]. However, while IIT studies are primarily driven by clinical needs and researcher interests, poor design or execution can compromise data quality. Furthermore, these studies frequently contend with significant funding shortages, unclear policies and an incomplete regulatory system [9].
Lijun noted that under the traditional IIT track, patients cannot be charged for participation in clinical trials. However, under the new policy (NHC Decree 818, effective May 1, 2026), hospitals may charge patients for such medical technologies provided they obtain NHC approval. The approval criteria will be released and are subject to assessment and improvement. This shift enables sponsors to receive early reimbursement and ensures the continued viability of the IIT track. Alternatively, sponsors opting for the drug track must follow the IND/BLA pathway. According to Lijun, in this case, high-quality Real-World Evidence (RWE) generated under GCP standards from an IIT can be leveraged to support NMPA regulatory filings, facilitating a faster path toward marketing approval, different to FDA and EMA frameworks.
CoJourney has supported numerous clients with IND/IIT manufacturing and regulatory filings for both FDA and NMPA clearance. Lijun has observed a significant uptick in interest from US and EU CGT sponsors looking to leverage China’s manufacturing capabilities and the IIT track for early-phase development. Amidst this trend toward global collaboration, more companies are pursuing concurrent filings with the NMPA, EMA, and FDA. However, when asked about Europe’s response to China’s rapid expansion, Lijun noted that despite growing awareness and interest, there remains a fundamental lack of understanding regarding the Chinese regulatory "ground rules," compounded by a lack of urgency in decision-making. She further observed that both the EMA and FDA are proactively modernising their regulatory science frameworks and embracing AI-driven review process strategic shifts that will push more CGT commercialisation, likely catalysed by intensifying global competition.
Ongoing Challenges
Reimbursement remains a significant hurdle in China. Lijun explained that cost pressures are exceptionally high; if developers fail to build the cost efficiencies early in the development process, their therapies will lack viable reimbursement pathways by the time they reach approval. Driven by this intense pressure, Chinese developers are pioneering innovative strategies to rapidly reduce Cost of Goods (COGs). Ultimately, if a therapy is not affordable and accessible upon approval, it will quickly be outcompeted and replaced in the market.
What does CoJourney do?
CoJourney’s mission in Lijun’s words…
“We are the enablers.
We want to be the bridge for non-Chinese developers into China and the bridge for Chinese developers into global development. Globalisation is the key, and if you want next-generation manufacturing and on-the-ground support for IIT trials, talk to us.”
According to Lijun, CoJourney is a Contract Development and Manufacturing Organisation (CDMO) with primary operations in China and a strategic presence in the US. The company is dedicated to accelerating both time-to-clinic and time-to-market for gene therapy products. To achieve this, CoJourney delivers end-to-end, next-generation manufacturing solutions characterised by high yields, exceptional purity, unmatched speed, and cost-efficiency. Specifically, their capabilities encompass process development, manufacturing, analytical testing, and lot release for critical gene therapy raw materials, intermediates, and drug products.
Its primary service areas include:
Plasmids
Viral Vectors (such as AAV and Lentivirus)
sgRNA (for in vivo and ex-vivo gene editing)
Exosomes
How CoJourney Operates
CoJourney achieves its goals through a combination of proprietary technology, global regulatory compliance, and scalable infrastructure:
Proprietary Technology: It utilises an industry-leading Zero Chrom® Plasmid Platform, which is a column-free manufacturing process. This platform creates high-purity plasmids, eliminates cross-contamination risks, and significantly reduces production time and costs. In addition, they offer off-the-shelf, ready-to-use helper and packaging plasmids.
Cost Reduction: The company’s scalable manufacturing platform produces plasmids at 80% lower cost than competitors. For viral vectors, it achieves volumetric yields 5–10 times above the industry average, supported by robust and scalable platforms. Combined with other cost-reduction measures, these advantages lower the COGS per dose by one to two orders of magnitude (10–100x) compared to therapies that rely on legacy processes.
Global Regulatory Compliance: CoJourney operates state-of-the-art facilities with quality systems designed to meet rigorous FDA (US), EMA (Europe), and NMPA (China) standards. They have a proven track record of regulatory IND approvals in US and China.
Scalability: Their production can scale up to 30 litres for plasmids and 500 litres for viral vectors.
Global Footprint: CoJourney operates globally, maintaining two GMP facilities in Hangzhou, China, alongside a strategic US presence in Horsham, Pennsylvania. The company is expanding beyond its US and China base to aggressively scale business operations across Europe and the Asia-Pacific (APAC) region.
How CoJourney Mirrors China’s Drug Development Progress
CoJourney serves as a perfect real-world case study of China's biopharma evolution:
The Shift to Complex, Next-Generation Therapies: CoJourney is directly embedded in this era of China’s biopharma innovation, providing the specialised manufacturing (plasmids, viral vectors, sgRNA) required to bring these cutting-edge therapies to life.
Global Integration and Regulatory Harmonisation: CoJourney embodies global standards by explicitly designing its quality systems to comply with NMPA, FDA, and EMA standards and involvement in successful US FDA IND approvals. Furthermore, its physical expansion into the US market demonstrates the increasing globalisation of Chinese biotech firms.
Cost-Effective Innovation & Strategic Partnerships: As a dedicated ecosystem partner, CoJourney leverages proprietary platforms to reduce the COGS by 1 to 2 logs (10- to 100-fold), all while maintaining exceptional quality and rapid delivery speeds.
Summary
China’s pharmaceutical industry has experienced extraordinary growth, driven by rising R&D investment, regulatory modernisation, expanding clinical trial capacity, and the rapid development of next-generation therapeutics.
Regulatory reforms under the NMPA, including streamlined clinical trial approvals, alignment with ICH standards, and new drug classification systems, have significantly accelerated innovation and improved the efficiency of drug development.
At the same time, China’s share of the global R&D pipeline, clinical trials, and innovative drug applications has expanded dramatically, with a growing emphasis on advanced modalities such as cell and gene therapies, antibody–drug conjugates, and bispecific antibodies. The rise of biotech ecosystems increased global partnerships, and a surge in out-licensing deals further demonstrates China’s integration into the international biopharmaceutical landscape.
Companies such as CoJourney illustrate how these trends translate into real-world innovation, aiming to provide scalable, cost-efficient manufacturing solutions for gene therapy components while operating within globally harmonised regulatory standards.
References
[1] R. Tan et al., “Current landscape of innovative drug development and regulatory support in China,” Sig Transduct Target Ther, vol. 10, no. 1, p. 220, Jul. 2025, doi: 10.1038/s41392-025-02267-y.
[2] W. Tang et al., “Evolving drug regulatory landscape in China: A clinical pharmacology perspective,” Clinical and Translational Science, vol. 14, no. 4, pp. 1222–1230, 2021, doi: 10.1111/cts.12987.
[3] “National Medical Products Administration.” Accessed: Mar. 18, 2026. [Online]. Available: https://english.nmpa.gov.cn
[4] J. Lu, L. Xu, W. Wei, and W. He, “Advanced therapy medicinal products in China: Regulation and development,” MedComm, vol. 4, no. 3, p. e251, 2023, doi: 10.1002/mco2.251.
[5] “ICH Official web site : ICH.” Accessed: Mar. 18, 2026. [Online]. Available: https://www.ich.org
[6] “China Life Sciences Sector Overview and Outlook”. Accessed: Apr. 11, 2026. [Online] https://assets.kpmg.com/content/dam/kpmg/cn/pdf/en/2025/04/china-life-sciences-sector-overview-and-outlook.pdf
[7] Y. Liu et al., “Evolution of drug regulations and regulatory innovation for anticancer drugs in China,” Acta Pharmaceutica Sinica B, vol. 12, no. 12, pp. 4365–4377, Dec. 2022, doi: 10.1016/j.apsb.2022.08.004.
[8] “China Is Increasing Its Share of Global Drug Development.” Accessed: Mar. 18, 2026. [Online]. Available: https://www.goldmansachs.com/insights/articles/china-is-increasing-its-share-of-global-drug-development
[9] Y. Yang et al., “The Role and Challenges of Investigator‐Initiated Trials in the Cell and Gene Therapy Products Boom in Mainland China,” Clin Transl Sci, vol. 18, no. 2, p. e70148, Feb. 2025, doi: 10.1111/cts.70148.
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