On August 29, Boehringer Ingelheim and Sino Biopharmaceutical (01177.HK) jointly announced that their jointly promoted drug, Zongertinib (Chinese generic name: Zongertinib tablets, English generic name: zongertinib), has been officially approved by the China National Medical Products Administration for the treatment of adult patients with unresectable locally advanced or metastatic non-small cell lung cancer (NSCLC) who have activating HER2 (ERBB2) mutations and have received at least one previous systemic therapy.
Sanhetu® is the world's first and currently only approved oral HER2 tyrosine kinase inhibitor. Its conditional approval in China is based on positive results from the Beamion-LUNG 1 study, which evaluated the efficacy and safety of zonectinib in patients with advanced non-small cell lung cancer (NSCLC) harboring a HER2 (ERBB2) mutation. Data from cohort 1 (N=75) of previously treated patients demonstrated an objective response rate (ORR) of 71% (95% CI: 60-80), including 7% complete responses, and a disease control rate (DCR) of 96%. The median duration of response (DoR) was 14.1 months, and the median progression-free survival (PFS) was 12.4 months. These data were presented at the 2025 American Association for Cancer Research (AACR) Annual Meeting and simultaneously published in the New England Journal of Medicine. Furthermore, zonectinib demonstrated a manageable safety profile, with a treatment discontinuation rate of only 2.9%.
Professor Wu Yilong, Chairman of the Chinese Thoracic Oncology Research Group (CTONG) and Guangdong Provincial People's Hospital, said: "The treatment of non-small cell lung cancer has long faced a key challenge: there has been no oral drug targeting HER2 that is well tolerated. The approval of Zonectinib will change this situation and establish a new treatment benchmark for HER2-mutated advanced non-small cell lung cancer. This innovative drugThis drug provides a highly effective, targeted, oral treatment option for this patient population with a very poor prognosis and limited treatment options. Furthermore, with its highly selective design, Zonectinib effectively avoids the severe skin and gastrointestinal adverse reactions associated with EGFR inhibition in traditional therapies, significantly improving patients' treatment tolerance and quality of life."
Xie Chengrun, Chief Executive Officer of Sino Biopharmaceuticals, said: "Lung cancer is the world's leading cancer, and there is still a huge unmet need for treatment in the clinic. The approval of Sanhetu® in China will provide a more effective and more compliant treatment option for the numerous domestic patients with HER2-mutated non-small cell lung cancer, and will further enrich Sino Biopharmaceuticals ' product line in the field of oncology, especially lung cancer. Sino Biopharmaceuticals adheres to clinical needs and will continue to enrich our pipeline, striving to bring therapeutic benefits to more patients and using 'health technology to warm more lives'."
"Zonatinib has been awarded Breakthrough Therapy Designation and Priority Review, and has been granted accelerated approval, which fully demonstrates the high recognition of the clinical value of this innovative drug by the national drug regulatory authorities. As the world's first oral targeted therapy for patients with HER2-mutated non-small cell lung cancer, the launch of Sanhetu® will fill the treatment gap in this field and bring groundbreaking new treatment options and new hope to patients."Adhering to our patient-centric philosophy, Boehringer Ingelheim will continue to focus on high-unmet clinical needs in oncology, accelerating the introduction of world-leading treatments, and enabling more Chinese patients to benefit from cutting-edge medical advances sooner rather than later," said Chen Wenhan, General Manager of Human Pharmaceuticals, Greater China, Boehringer Ingelheim.
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