In a series exploring trends across the APAC region, Norstella’s subject matter experts from key biopharma hubs delve into this year’s standout developments and share their outlook for 2025. China’s booming clinical trial landscape continues to grow and diversify with greater investment from Big Pharma in addition to new promising modalities at play. In our first spotlight on China, Janelle Hart, Managing Editor, Custom Content at Citeline, a Norstella company, sits down with Xu Hu and Dexter Yan, senior APAC reporters at Citeline, to discuss key trends and ongoing barriers impacting drug development in China and the future Chinese pharma market.
How would you describe the current clinical trial landscape in China? What major trends have you noticed in the last year?
Xu Hu: China has started appearing as the key player in the clinical trial landscape globally in terms of the growing number of global clinical trials initiated in the country, comprised of industry-sponsored trials (ISTs) and investigator-initiated trials. According to Citeline’s recent white paper, 31% of the world’s clinical trials initiated between 2019 and 2023 were conducted in China, with a compound annual growth rate of 8%.1
Among these trials, multi-specific antibodies and antibody-drug conjugates were the key drug modalities that drove growth for China. Regarding therapeutic areas, most of the trials were for oncology (46%), followed by cardiovascular (39%), metabolic/endocrinology (32%), and genitourinary (31%).1 Innovative treatments and domestic industry sponsors are the main driving factors for China’s growing activities in clinical trials.
Dexter Yan: The above Citeline report also points out that since 2020, China has claimed the world’s top location for clinical trials. Roughly 39% of all trials that started globally in 2023 had at least one site in China, up from 25% in 2019 when the country finished second behind the US. Globally, while the number of initiated trials fell by 7% from 2019 to 2023, China’s such trials rose by 46% over the same period.1
Also, in terms of ISTs, domestic companies with headquarters in China continue to initiate an overwhelming majority of their clinical trials in China. On the other hand, foreign industry sponsors and the world’s Top 20 Pharma still had Chinese sites only for a small part of their clinical trials.
Notably, China’s clinical trials for innovative therapies and vaccines have been moving closer to the center stage. In 2023, China’s Center for Drug Evaluation (CDE) accepted a total of 2,244 investigational new drug applications for innovative drug and vaccine candidates from domestic and foreign applicants, up 32% from 2022, according to an annual drug review report published by the CDE in February.2
What were the most significant Chinese drug approvals or milestones reached in 2024?
Xu Hu: My pick would be BeiGene’s tislelizumab, a PD-1 monoclonal antibody. China’s National Medical and Products Administration (NMPA) approved four additional indications of the drug this year, including first-line monotherapy for unresectable or metastatic hepatocellular carcinoma, first-line treatment in combination with chemotherapy for locally advanced unresectable or metastatic adenocarcinoma of the stomach or gastroesophageal junction, first-line for extensive-stage small cell lung cancer, as well as perioperative treatment for resectable non-small cell lung cancer (NSCLC).
Overseas, in March this year, tislelizumab (as a monotherapy) received approval from the FDA for unresectable or metastatic esophageal squamous cell carcinoma after prior systemic chemotherapy that did not include a PD-(L)1 inhibitor. In April, the EMA approved it for first- and second-line treatment of NSCLC.
Dexter Yan: I’d also mention that in April, Beijing Avistone Biotechnology won China’s full approval for its vebreltinib (also known as bozitinib) in a rare subtype of glioblastoma, making the molecule the world’s first c-Met inhibitor greenlighted for the treatment of the central nervous system tumor with c-Met alterations.
In May, China also approved ivonescimab from Akeso, a first-in-class PD-1/VEGF-targeting bispecific antibody used in combination with chemotherapy for the treatment of epidermal growth factor receptor (EGFR)-mutated locally advanced or metastatic non-squamous NSCLC after progression on EGFR inhibitor treatment.
Another noteworthy approval happened in June. Dizal grabbed the world’s first approval in China for a Janus kinase 1 (JAK1) inhibitor, in this case golidocitinib, for the treatment of relapsed or refractory (r/r) peripheral T-Cell lymphoma.
How does China differentiate itself from other APAC regions in the clinical trial space?
Xu Hu: The number of Phase I-IV trials initiated in China was the highest between 2019 and 2023, compared with other countries in APAC, including Japan, South Korea, India, Australia, and the rest of the region. Particularly, the majority of trials conducted among treatment-naïve patients with cancer in the region were in China (73%).1
What also differentiates China from the other APAC countries is the proportion of trials sponsored by the domestic industry versus foreign industry, especially for the Top 20 Pharma. Between 2019 and 2023, domestic companies tended to initiate trials locally in China (95%), foreign industry sponsors and the Top 20 Pharma only initiated 19% and 15% of their trials, respectively, in China. By comparison, 42% of trials initiated in Japan, for instance, were sponsored by the Top 20 Pharma; the domestic industry was also more willing to initiate their trials overseas (44%).1
Dexter Yan: In mid-October, Chinese authorities raised a red flag on clinical studies that could serve as a conduit for commercial bribes from pharmaceutical firms. The warnings, included in a set of proposed wide-ranging compliance guidelines for pharma firms, were the first major measures floated by the central government to stave off corruption around the country’s burgeoning clinical trials.
What new or ongoing drug development challenges will Chinese pharma and biotech companies face in 2025?
Xu Hu: Domestically, apart from the challenges naturally associated with developing innovative medicines, other ongoing challenges are further improving accessibility and affordability of innovative drugs for Chinese people. Globally, the challenge would be staying open to global collaborations and, at the same time, trying to engage more with the local market.
Dexter Yan: It remains to be seen if the NMPA would enforce a proposed amendment to the current accelerated approval pilot program, which took effect in July 2020. In August 2023, the regulator proposed new rules to tighten the grant of conditional approval, the equivalent of the FDA’s accelerated approval program. The stricter requirements on the application for conditional approval-oriented clinical trials underscored the regulator’s intention to turn fast-follower drugs away from competing with the products’ same-class frontrunners.
What Chinese M&A deals is the industry most anticipating in the year ahead?
Xu Hu: Chinese companies will potentially continue making deals with domestic peers. In 2025, M&A deals that the industry anticipates the most would still be cross-border ones for antibody-drug conjugates and cell therapies. Hopefully, we will also see some breakthroughs and deals happening in gene therapies.
Dexter Yan: M&A between Chinese biotechs and major pharma companies are expected to pick up despite a challenging fund-raising environment.
The first signs have appeared, although most of the deals to date in 2024 were focused on traditional Chinese medicine companies. In August, Northeast Pharmaceutical Group, a Chinese producer of active pharmaceutical ingredients and generic drugs, emerged as an unlikely player to outpace its better-funded domestic peers to cut the first biotech buyout deal for 2024. As of November, Northeast closed the deal to acquire a 70% stake in Beijing DCTY Biotech, a little-known cell therapy developer struggling with insolvency.
How do you see the Chinese pharma market growing over the next year? What would you say is the top priority for this sector?
Xu Hu: With the policies announced this year that support the development of the China pharma industry and market – for instance, accepting direct foreign investment in cell and gene therapies (CGTs) and increasing manufacturing flexibilities by allowing non-end-to-end manufacturing of biologics – the market is open to grow over the next year.
I also see domestic and international endeavors bringing and expediting innovative drugs developed in China to late-stage development. For example, in Chengdu, China, the Tianfu Jincheng Laboratory is exploring the model of medicine plus industry for several industrial areas, such as stem cell therapy, brain science, and digital diagnosis and treatment. Another example is Bayer’s incubator Bayer Co.Lab, which in October this year launched one site in Shanghai focusing on CGT and oncology. Hopefully, we will see some new biotech companies supported by those efforts emerge in the coming year.
I would say growth in the CGT sector is the top priority for the market.
Dexter Yan: The commercial market will remain challenging for Chinese drug developers in 2025, due to the residual effects from the government’s anti-corruption campaign launched in the summer of 2023. Also, Chinese drug developers have been lamenting the deep price cuts imposed on the novel drugs qualified for public medical insurance reimbursement, which is blamed for greatly dragging down the sector’s sales growth. The discounts, averaging more than 50% in the past years, are required in exchange for drug listings in the annually updated National Reimbursement Drug List, which can produce sales volume growth.
How can partnering with Norstella help organizations gain a competitive edge in the Chinese market?
Xu Hu: Our English-language content is unrivaled in the Chinese market. The insights business and our publications, including Scrip and Pink Sheet, focus on providing subscribers with unique and original content designed to enhance understanding of developments across the spectrum of the biopharma industry, from discovery through R&D, clinical trials, commercialization and post-marketing, and policies and regulations.
Dexter Yan: We go behind the headlines to add high-value perspective and context, building on the contacts and knowledge of our team, and where appropriate, leveraging the resources of our other products to add data and expert comment. This helps our readers gain a deeper understanding of the Chinese market, enabling them to compete better.
Is there anything we haven’t touched on that you’d like to highlight or add about the drug development landscape in China?
Dexter Yan: The importance of government policies and moves cannot be overestimated for China’s drug development landscape. In November, the Chinese government kickstarted a new round of the national drug-hunting campaign involving academia and industry, with the first two programs in lung and breast cancers launched in the same month. The government-funded drug development effort, running through 2030, will be primarily focused on four major chronic conditions with high prevalence in China: cardiovascular, respiratory, and metabolic disorders, as well as malignant tumors.
References:
To gain deeper insights into the APAC drug development landscape, read Citeline’s 2025 Scrip Asia 100 issue.
Managing Editor | Citeline
Senior Reporter, APAC | Citeline
Senior Editor, APAC | Citeline
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