Hengrui's ESMO Push Runs Through State Regulators

In July 2026, China’s National Medical Products Administration accepted Hengrui Pharma’s marketing application for ruzaltatug rezetecan, an experimental treatment for some adults with advanced non-small-cell lung cancer. Now, the company is bringing interim trial analyses and 63 other research findings to the European Society for Medical Oncology Congress in Madrid, where medicines, regulators and corporate claims of innovation will share the stage.

The corporate pitch

Hengrui will present 64 findings at the congress, which runs from October 23 to 27. The programme includes three Proffered Paper presentations, three Rapid Oral presentations, 32 posters and 26 e-posters, spanning more than ten cancer areas and oncology supportive care. The company says it has attended ESMO for 11 consecutive years since 2016, and that 119 of its research findings were accepted between 2023 and 2025.

The congress also serves as a commercial showcase: Hengrui will host an exhibition booth for the second consecutive year, after opening its first booth in 2025. Jo Feng, the company’s president and COO, called the 64 presentations “a new record for Hengrui.” She said Hengrui wants to share clinical evidence and bring Chinese innovation to patients worldwide. The presentations and booth put the company’s research—and its own account of that work—in front of oncology specialists.

Two independently developed antibody-drug conjugates feature in Proffered Paper presentations. Trastuzumab rezetecan (SHR-A1811) will be discussed in HORIZON-Breast06, a randomized phase 3 study in HER2-low advanced breast cancer. Ruzaltatug rezetecan (SHR-A2009) will feature in interim analyses from HERON-Lung01, a phase 3 trial comparing the drug with platinum-based chemotherapy in patients with EGFR-mutated advanced non-small-cell lung cancer whose disease progressed after EGFR-TKI treatment.

Regulators and trial evidence

Professor Yi-Long Wu of Guangdong Provincial People's Hospital leads HERON-Lung01. Chongrui Xu, also of Guangdong Provincial People's Hospital, is scheduled to present the interim analyses on October 26. Hengrui says the NMPA accepted its marketing application for ruzaltatug rezetecan in July 2026, following positive trial results. The application covers adults with EGFR-mutated locally advanced or metastatic non-squamous NSCLC whose disease progressed after EGFR-TKI therapy.

A separate Phase III trial is underway in China, evaluating ruzaltatug rezetecan with an EGFR TKI as first-line treatment for locally advanced or metastatic NSCLC with EGFR mutations. Outside China, the U.S. Food and Drug Administration granted the drug Fast Track designation for patients whose metastatic disease progressed after treatment with a third-generation EGFR-TKI and platinum-based chemotherapy. These decisions mark the drug’s regulatory path; the congress presentation will report interim analyses, not final results.

Hengrui’s other listed research includes abstract LBA13 on trastuzumab rezetecan in HER2-low advanced breast cancer. Ying Fan of the Cancer Hospital, Chinese Academy of Medical Sciences, is scheduled to present on October 23. The company says it is developing trastuzumab rezetecan for more than ten indications, including breast, lung, gastric, colorectal and cervical cancers. Hengrui also says the drug ranks among the innovative medicines with the highest number of breakthrough therapy designations in China.

A portfolio on display

The programme includes preliminary results from a phase 2 study of HRS-4642, Hengrui’s independently developed KRAS G12D inhibitor, with chemotherapy, with or without adebrelimab, as perioperative therapy for KRAS G12D-mutant pancreatic cancer. HRS-4642 injection with gemcitabine and nab-paclitaxel received breakthrough therapy designation from the CDE of the NMPA for first-line treatment of advanced or metastatic pancreatic cancer with a KRAS G12D mutation.

Other scheduled presentations cover a phase 3 trial of short-course radiotherapy followed by camrelizumab and chemotherapy in locally advanced rectal cancer, and a phase 2 study of SHR-A2102 in recurrent or metastatic cervical cancer. Another study concerns rivoceranib in pretreated metastatic thymic epithelial tumors. Hengrui describes oncology as one of its core strategic business areas. As of June 2026, it said 14 independently developed Class 1 innovative medicines had launched in China. The company’s ESMO programme puts its research before specialists. It also makes the case for the next products in that portfolio.