Hengrui Pharma arrives at ESMO 2026 in Madrid with 64 accepted research findings, six of them in the coveted Proffered Paper or Rapid Oral slots that draw the most floor traffic at the congress. The number matters because the prior three-year block, 2023 through 2025, produced 119 total acceptances combined. Hitting 64 in a single year signals the company’s late-stage pipeline is maturing fast, and two of those high-profile presentations carry regulatory weight that stretches beyond the conference hall.
The clearest near-term read will come from HERON-Lung01, a Phase 3 trial of the HER3-targeted ADC ruzaltatug rezetecan versus platinum-based chemotherapy in EGFR-mutated NSCLC after TKI failure. The trial already met its primary progression-free survival endpoint, and China’s NMPA accepted the marketing application in July 2026. The interim analysis at ESMO will be the dataset that oncologists and regulators in other markets study closely, particularly given the FDA’s Fast Track designation for the drug in a closely related post-third-generation-TKI setting. A parallel Phase 3 combining ruzaltatug rezetecan with an EGFR TKI as first-line therapy is already running, so what Madrid reveals about depth of response will shape enrollment assumptions for that successor study.
The second Proffered Paper centers on trastuzumab rezetecan (SHR-A1811) in HORIZON-Breast06, a randomized Phase 3 trial in HER2-low advanced breast cancer. Earlier Phase 2 data in hormone receptor-positive, HER2-low disease showed promising activity, but HORIZON-Breast06 is the confirmatory, randomized evidence that would support a regulatory filing. HER2-low is a contested space, and the trial’s design and patient selection criteria will draw scrutiny from investigators managing post-approval access decisions in that segment.
The pancreatic cancer data may be the program most trial designers watch. A Rapid Oral slot covers preliminary Phase 2 results for HRS-4642, a KRAS G12D inhibitor, combined with gemcitabine and nab-paclitaxel, with or without the PD-L1 inhibitor adebrelimab, as perioperative therapy. Phase 1b/2 data in 30 treatment-naive patients met the primary endpoint in advanced KRAS G12D-mutant pancreatic ductal adenocarcinoma, a result that earned NMPA breakthrough therapy designation for the combination. The perioperative framing is the design choice worth watching: it positions the drug not just as a palliative option but as a potential bridge to resection, which would open a meaningfully different patient population than advanced-disease studies alone.
Hengrui Pharma: the facts in one place
- Also written: Hengrui Pharmaceuticals, Jiangsu Hengrui Medicine
- Sponsor: Hengrui Pharma
- Indication studied: Multiple oncology indications including breast cancer, non-small-cell lung cancer, cervical cancer, and thymic epithelial tumors
- Registry identifier: not publicly listed
- Current status: Presenting 64 research findings at ESMO Congress 2026 in Madrid, with six in Proffered Paper or Rapid Oral slots.
- ESMO Congress 2026 preview press release 1: October 20, 2026
- ESMO Congress 2026 preview press release 2: October 21, 2026
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
