On May 22, 2026 Boehringer Ingelheim reported HERNEXEOS (zongertinib tablets) has been conditionally approved as monotherapy by China’s National Medical Products Administration (NMPA) as an initial treatment for adult patients with unresectable, locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) tyrosine kinase domain (TKD) mutations.1 The approval is based on data demonstrating a 75.7% objective response rate, with full approval contingent on confirmation of clinical benefit in an ongoing trial. It represents another major milestone following the Breakthrough Therapy Designation (BTD) from the Center for Drug Evaluation (CDE) of China’s NMPA for first-line treatment.4 The therapy is also approved for patients in China who have received prior treatment.

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"In the past, patients with HER2‑mutant advanced non-small cell lung cancer faced significant diagnostic and treatment challenges in clinical practice. These challenges not only placed considerable physical and psychological burdens on patients but also limited the delivery of precise lung cancer treatment," said Professor Yi-Long Wu from Guangdong Provincial People’s Hospital, Chairman of the Chinese Thoracic Oncology Group (CTONG). "This advancement directly addresses patients’ core clinical needs for quality care."

The approval is based on data from a cohort of treatment-naïve patients (N=74) in the Phase Ib Beamion LUNG-1 trial, which demonstrated an objective response rate (ORR) of 75.7%, including 10.8% achieving complete response (CR) and 64.9% achieving partial response (PR). The median duration of response (mDoR) was 15.2 months. Treatment-related adverse events (AEs) were predominantly low-grade. In a pooled safety population, which included 177 patients with HER2 (ERBB2)-mutant NSCLC in Beamion LUNG-1, AEs led to dose reductions in 9% of patients and dose discontinuations in 6% of patients. Data for treatment-naive patients were presented at the European Lung Cancer Congress 2026 (ELCC 2026) and published in The New England Journal of Medicine.

"The first-line approval of HERNEXEOS in China marks an important step forward in our ambition to redefine the treatment of HER2-driven cancers," said Shashank Deshpande, Chairman of the Board of Managing Directors at Boehringer Ingelheim. "Building on strong global momentum, including approvals in the U.S., and supported by compelling clinical evidence, we are advancing this therapy across various stages of disease and tumor types. This milestone reflects not only the progress we have made, but the broader opportunity ahead – to deliver unprecedented impact for people living with cancer, now and for generations to come."

About HER2 (ERBB2)-mutant non-small cell lung cancer (NSCLC)
Lung cancer claims more lives than any other cancer type7 and the incidence is set to increase to over 3 million cases worldwide by 2040.8 NSCLC is the most common type of lung cancer.7 The condition is often diagnosed at a late stage9, and fewer than 3 in 10 patients are alive five years after diagnosis.9,10 People living with advanced NSCLC can experience a detrimental physical, psychological, and emotional impact on their daily lives.8,11,12

Up to 4% of lung cancers are driven by HER2 (ERBB2) mutations (or gene alterations).7 Mutations in HER2 can lead to overexpression and overactivation, which can in turn result in uncontrolled cell production, inhibition of cell death and promotion of tumor growth and spread.13

About HERNEXEOS (zongertinib tablets)
HERNEXEOS (zongertinib tablets) is an irreversible tyrosine kinase inhibitor (TKI) that selectively inhibits HER2 while sparing wild-type EGFR, thereby minimizing associated toxicities. HERNEXEOS is approved in the U.S., China, Hong Kong and Japan as the first orally administered targeted therapy for adult patients with HER2 (ERBB2)-mutant advanced non-small cell lung cancer. Zongertinib is not approved in other markets.

The treatment is being evaluated in ongoing trials across a range of earlier stages and advanced solid tumors with HER2 alterations. Beamion LUNG-2 is an ongoing Phase III controlled study evaluating zongertinib as an initial treatment for patients with advanced NSCLC that has HER2 tyrosine kinase domain mutations (NCT06151574). Beamion LUNG-3 is a Phase III clinical trial investigating zongertinib as an adjuvant monotherapy in patients with early-stage, resectable NSCLC (Stage II-IIIB) with HER2 (ERBB2)-mutations (NCT07195695).

(Press release, Boehringer Ingelheim, MAY 22, 2026, View Source [SID1234666017])