Over the last decade, China has become a key destination for oncology clinical trials, with Chinese sites increasingly incorporated within multinational studies. This shift reflects a significant evolution of China’s regulatory environment, integrating it into the larger global framework due to closer alignment with international standards. China’s implementation of ICH E6 (R3) as of March 31 2026 is a key example, enabling drug sponsors to run their trials in China simultaneously with other regions.

In parallel with this, China has now become a leading biopharma innovator, accounting for approximately one quarter of global drug development programs in 2023.[i]

China’s key advantages for oncology trials

One of China’s key advantages is its vast patient population, providing a deep and diverse pool of participants for oncology research. This strength has translated into notably faster recruitment timelines for clinical studies, helping CROs and sponsors bring drugs to market more quickly. In addition, the sophistication of China’s oncology clinical trial network has increased markedly over the past decade, evidenced by its growing leadership in early-phase cancer trials[ii], increasing representation at ASCO and ESMO[iii], and rising contributions to international multicenter studies. This evolution aligns with broader efforts by organizations such as ASCO and ESMO to globalize oncology research and expand clinical investigation opportunities beyond traditional US and European centers.

Early discovery‑to‑investigational new drug (IND) cycles are estimated to be 50–70% faster in China than in other regions[iv], driven by parallel workflows, a dense contract research organisation (CRO) ecosystem, and an execution‑focused culture. Meanwhile, patient enrollment is typically two to five times faster than benchmarks in the US and EU[v] in certain disease areas.

Lower operational costs further bolster China’s appeal. Compared to the US and Europe, China offers a more cost-effective environment for conducting trials, helping to maximize research budgets and support larger, more comprehensive studies. However, there are nuances across specific indications and disease prevalence data. So, both need to be assessed as the decision to go into China is not one-size-fits-all.

Nevertheless, multinational sponsors still face logistical, regulatory, and commercialization challenges that can impact study start‑up timelines if companies are unprepared or unguided. Sponsors need to prepare carefully from the outset, with robust advance planning to address requirements from the Chinese national regulator and local operational needs.

The National Medical Products Administration’s new 30-working day and 60-working day IND pathway

Following a successful pilot in 2024[vi], the National Medical Products Administration (NMPA) now offers a 30‑working day IND ‘no-objection’ pathway (versus the standard 60 days), broadly analogous to the FDA’s review period. According to the NMPA, this new pathway is intended for innovative products , i.e., products with new active substances that have not been approved anywhere in the world, that either have a globally synchronized clinical development program, or have received NMPA designations such as the Pediatric SPARK Plan, the Rare Disease Care Plan, or innovative traditional Chinese medicine, or are qualified as Priority Innovative Drugs with Significant Clinical Value and National Full-Chain Policy Support.

Currently, the vast majority of products that have applied for and been approved for the 30-working day IND pathway are globally synchronized development products (e.g., drug candidates that are being developed under a coordinated global strategy so they can achieve regulatory approvals and commercial launches in multiple major markets at roughly the same time).

With the NMPA now offering a more predictable and efficient regulatory review pathway, China is becoming an increasingly attractive location for global drug development strategies. However, oncology sponsors using this 30‑day route must be genuinely ‘China‑ready’, utilize contract research partners with proven regulatory insight, and have operational depth and strong relationships at leading cancer centers in China.

Caidya’s ‘China‑ready’ checklist for oncology sponsors using NMPA’s 30-working‑day pathway[vii]

1. Confirm your asset is eligible: Be sure it is a Class I innovative drug (including oncology biologics and targeted therapies). Prioritize programs with clear clinical value or urgent unmet need in Chinese cancer populations.

2. Decide if the 30‑working day timeline is appropriate: Use the pathway for oncology INDs where earlier Chinese data will materially influence global strategy (for example, pivotal design, sequence of indications, or launch timing), or where China is included in the global development plan.

3. Select and prepare a lead site and PI: Choose an oncology center(s) and investigator(s) with strong ethics review capacity, clean inspection history, and experience in global studies. Align early with the principal investigator so project set‑up and ethics review run in parallel with IND preparation.

4. Tighten risk management for your oncology trial: Put in place robust risk assessments covering safety (for example, cytokine release, immune‑related events), operational feasibility, and data quality. Document clear mitigation plans for high‑risk elements such as complex biomarker testing, companion diagnostics, or advanced therapies.

5. Commit to rapid start‑up in China: Ensure budget, contracts, import licences, laboratories and imaging vendors can support first patient in within 12 weeks of approval. Confirm that timelines are integrated into the development plan rather than treated as an ‘add‑on.’

6. Prepare and submit a ‘30‑working day ready’ IND: Compile the IND dossier to current NMPA and Centre for Drug Evaluation (CDE) standards, including oncology‑specific justifications (dose, regimen, patient selection, endpoints). Mark the application clearly for the ‘30‑day pathway’ and include all required supporting documents.

7. Track acceptance and any shift to 60 days: Plan for the possibility that complex technical questions, CMC, non-clinical data, or expert consultation may move the application to a 60‑day review and build this into your timeline.

Capturing China’s full value

With an established infrastructure and a long track record in China, Caidya can help interpret and navigate evolving NMPA requirements, make effective use of the 30‑working day pathway where applicable, and design high-quality ‘China‑ready’ trials from the start.

As China becomes an increasingly attractive destination for foreign‑sponsored studies, those who integrate it early into global plans and partner with a CRO such as Caidya will be best placed to capture the full benefits.

[i] https://www.citeline.com/en/resources/growing-pains-of-chinese-biotech [ii] https://dailyreporter.esmo.org/esmo-targeted-anticancer-therapies-asia-congress-2025/opinions/technology-integration-and-access-to-eligible-patients-underpin-the-growth-of-early-phase-trials-in-asia-pacific? [iii] https://www.nbd.com.cn/articles/2026-04-23/4354427 [iv] https://www.mckinsey.com/industries/life-sciences/our-insights/the-emerging-epicenter-asias-role-in-biopharmas-future#/ [v] https://www.mckinsey.com/industries/life-sciences/our-insights/the-emerging-epicenter-asias-role-in-biopharmas-future [vi] https://english.nmpa.gov.cn/2025-10/14/c_1132761.htm [vii] Taken from: https://english.nmpa.gov.cn/2025-10/14/c_1138494.htm

Caidya is the trade name of dMedClinical Co. Ltd. (Cayman Islands) and its global holdings. Clinipace, Inc. is one company in the Caidya group of companies. Clinipace, Inc. is owned, operated, managed, and controlled by dMedClinical Co. Ltd., a privately held company, whose investors include entities located in the People’s Republic of China (PRC), and which may be subject to PRC laws and regulations that differ from those of the United States.