Chinese drugmakers struggle to recruit for EU

Key Takeaways

• Reuters (15–16 July 2026) reports Hengrui and CanSino executives citing shortages in global development, regulatory, and cross-cultural management talent.
• Hengrui’s 22 June 2026 HKEX filing says EMA accepted an MAA for rezvilutamide in high-volume mHSPC—its first innovative EU filing.
• CHART (NCT03520478) enrolled 654 patients at 72 China and Europe sites; Lancet Oncology published primary results in 2022.
• EMA-authorised Hetronifly (serplulimab) shows Chinese-origin oncology products are already in EU care pathways, increasing local ops demand.

Talent gap and EU expansion at a glance

Signal	Detail	Source type
Hiring bottleneck	Shortage of staff for overseas trials, multi-jurisdiction filings, international marketing	Reuters interviews (Hengrui, CanSino)
Hengrui EU filing	EMA accepted rezvilutamide MAA for high-volume mHSPC (announced 22 June 2026)	HKEX overseas regulatory announcement
Supporting trial	CHART / SHR-3680-III-HSPC, NCT03520478, 654 patients, 72 China+Europe sites	Company filing + ClinicalTrials.gov
EU marketed example	Hetronifly (serplulimab) authorised in EU for ES-SCLC and other indications	EMA EPAR
EU angle	Expansion needs EU clinical ops, regulatory affairs, PV, and launch teams	Primary synthesis

What did Reuters report about the talent shortage?

In Reuters’ 15 July 2026 analysis on Chinese drugmakers’ global hiring struggles, executives said rapid growth in China-based experimental medicine has outpaced the workforce needed to take products abroad. Hengrui chairman Sun Piaoyang cited needs in global multicentre trials, overseas registration, and commercialisation, and a shortage of people with international regulatory and cross-cultural management experience.

CanSino CEO Yu Xuefeng told Reuters that specialists for overseas trials, multi-jurisdiction submissions, and international marketing remain scarce. The piece notes China-headquartered sponsors still run most of their trials only in China, while Western regulators increasingly expect multiregional data—raising the bar for EU and US hiring.

How does Hengrui’s EMA filing illustrate the EU talent demand?

Hengrui’s 22 June 2026 Hong Kong exchange overseas regulatory announcement states that EMA formally accepted a marketing authorisation application for rezvilutamide tablets with androgen-deprivation therapy for adult men with high-volume metastatic hormone-sensitive prostate cancer (mHSPC). The company called it its first self-developed innovative drug filed with the EU.

The filing rests on the CHART Phase 3 study (SHR-3680-III-HSPC), run at 72 centres in China and Europe with 654 randomised patients. Primary endpoints were IRC-assessed radiographic progression-free survival and overall survival versus bicalutamide plus ADT. Filing an EU MAA after a China–Europe programme requires teams who can answer EMA questions, manage EU sites, and prepare Module 2/5 narratives—the exact skill set Reuters says is hard to hire.

What do CHART data show for European reviewers?

ClinicalTrials.gov study NCT03520478 documents the international CHART programme supporting rezvilutamide. Hengrui’s exchange notice summarises earlier cutoffs: as of 28 February 2022, radiographic progression or death risk fell 54% versus control (median rPFS not reached vs 23.5 months; HR 0.46, 95% CI 0.36–0.60), with OS HR 0.58 (95% CI 0.44–0.77). Those results were published in The Lancet Oncology in 2022.

A later OS update cited in the HKEX notice (cutoff 6 June 2025; median follow-up 72.8 months) reported median OS 78.8 vs 44.8 months (HR 0.59, 95% CI 0.47–0.73). EMA acceptance does not equal approval; Hengrui’s filing itself warns review outcome and timing remain uncertain.

Where is Chinese biopharma already operating in the EU?

Talent pressure is not only about future filings. EMA’s Hetronifly (serplulimab) EPAR describes an authorised EU medicine used with chemotherapy in extensive-stage small-cell lung cancer and in additional non-small-cell lung and oesophageal squamous cell carcinoma settings. Maintaining EU authorisations requires pharmacovigilance systems, quality oversight, and medical information capacity inside Europe—roles that compete for the same scarce internationally experienced pool Reuters describes.

Recruiters quoted by Reuters said talent gaps more often slow execution or push companies toward partners than cancel overseas programmes outright. For EU employers and CROs, that implies more partner-dependent Chinese-sponsored trials and rising competition for bilingual regulatory and clinical project managers.

What does this mean for EU hiring and trial execution?

Sponsors expanding from China into the EU need people who can run GCP sites under Regulation (EU) No 536/2014, prepare CTIS submissions, and answer CHMP/EMA questions in English under European assessment clocks. When those hires lag, companies lean on CROs and local MAH partners—raising cost and coordination risk on programmes like CHART-style China–Europe designs.

Related NovaPharmaNews EU coverage includes PRAC June 2026 highlights, the 2026 EU drugs agency report, and Zealand Pharma’s EU-relevant clinical update.

What remains unproven?

Reuters’ talent findings are interview-based industry reporting, not a regulator census of EU vacancies. IQVIA and ICON statistics cited in secondary reprints of the Reuters piece are not independently verified here from those vendors’ primary pages. EMA acceptance of rezvilutamide is not approval, and Hetronifly’s EU presence does not by itself quantify Henlius or peers’ hiring shortfalls in Europe.

Frequently Asked Questions

Primary Sources

1. Reuters: Chinese drugmakers struggle to recruit staff for global expansion
2. HKEX: Hengrui overseas regulatory announcement on EMA MAA acceptance (22 June 2026)
3. ClinicalTrials.gov: CHART / NCT03520478
4. The Lancet Oncology: CHART Phase 3 rezvilutamide results (2022)
5. EMA: Hetronifly (serplulimab) EPAR