From “No Treatment Options” to “Effective Oral Therapy”: Sanhetu® First-Line Indication Approved in China, Filling the Gap in First-Line Targeted Therapy for HER2-Mutant Lung Cancer

ShanghaiMay 21, 2026 /PRNewswire/ — On May 21, 2026, Boehringer Ingelheim and China Biopharmaceuticals jointly announced today that Shenghutu^® (Chinese generic name: Zongertinib Tablets, English generic name: zongertinib), promoted jointly by both parties in mainland China, has been approved by the China National Medical Products Administration (NMPA) as a monotherapy for the first-line treatment of adult patients with unresectable locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring activating mutations in the HER2 (ERBB2) tyrosine kinase domain. This approval marks another major milestone following the breakthrough therapy designation granted by the Center for Drug Evaluation (CDE) of the NMPA for the first-line indication of Shenghutu^®, and its previous approval by the NMPA in August 2025 for the treatment of previously treated patients.

As the first globally approved oral HER2 tyrosine kinase inhibitor, the approval of Shenghutu^® for the first-line indication signifies that China has officially entered a new era of precision targeted first-line therapy for HER2-mutant advanced NSCLC, ending the long-standing lack of highly effective and precise targeted drugs for first-line treatment in this patient population. Additionally, its oral administration offers greater convenience for patients.

The conditional approval of Shenghutu^® for the first-line indication in China is based on clinical trial results from Cohort 2 of the Phase 1b Beamion-LUNG 1 study^[1], which evaluated the efficacy and safety of zongertinib in treatment-naïve patients with advanced NSCLC harboring HER2 (ERBB2) activating mutations. Data showed that in the treated Cohort 1 treatment-naïve patients (N=74), the confirmed objective response rate (ORR) was 76%, with 11% of patients achieving complete response and 65% achieving partial response. The median duration of response (mDoR) was 15.2 months, and the median progression-free survival (mPFS) was 14.4 months. These data were reported at the 2026 European Lung Cancer Congress (ELCC 2026) and simultaneously published in the New England Journal of Medicine. Additionally, the article reported data from 30 patients with HER2-mutant advanced NSCLC and active brain metastases, of whom 47% achieved confirmed intracranial objective response (iORR) per the Response Assessment in Neuro-Oncology Brain Metastases (RANO-BM) criteria.

The incidence of HER2 mutations in NSCLC is approximately 2%-4%^[2]. These mutations are more common in women, non-smokers, patients with lung adenocarcinoma, and younger individuals, and are associated with high tumor aggressiveness, high risk of brain metastases, and extremely poor prognosis^[3],[4]. They have long been considered one of the “refractory subtypes” among known driver genes^[5]. In clinical practice, these patients face particularly prominent core challenges: a long-standing lack of targeted oral drugs, limited efficacy of traditional chemotherapy regimens^[6] with significant toxicities, low response rates to immunotherapy, and difficulty achieving effective tumor control. Moreover, existing treatments often involve inconvenient administration, poor treatment adherence, and inadequate control of brain metastases, failing to effectively delay disease progression, leading to poor quality of life and shortened survival. Their urgent clinical treatment needs have long remained unmet.

Professor Yi-Long Wu, Chairman of the Chinese Thoracic Oncology Group (CTONG) and Guangdong Provincial People’s Hospital, stated: “From a clinical practice perspective, the multiple diagnostic and treatment challenges previously faced by patients with HER2-mutant advanced NSCLC not only imposed dual physical and psychological burdens but also became a key bottleneck hindering the development of precision lung cancer therapy. The successful approval of zongertinib for the first-line indication provides crucial support to break this deadlock. It completely overcomes the treatment dilemma in the initial treatment phase for these patients, allowing them to escape the limitations of traditional treatment regimens and access more targeted, convenient, and safer precision treatment options early on. This not only helps effectively extend survival but also significantly alleviates the physical discomfort and psychological burden of treatment, enabling patients to maintain a good quality of life during therapy. It truly achieves a leap from ‘having drugs available’ to ‘accessing good drugs,’ precisely addressing the core clinical demands of patients for high-quality treatment and long-term survival.”

Wenhan Chen, General Manager of Boehringer Ingelheim’s Human Pharma Business in Greater China, stated: “From the outset of its development, Shenghutu^® has focused on the most urgent clinical gaps in HER2-mutant NSCLC, aiming to fill treatment voids and meet patient needs. As the world’s first oral HER2-TKI, the successful approval of this first-line indication effectively addresses the long-standing clinical pain point of lacking first-line oral targeted drugs in the HER2-mutant NSCLC field, providing patients with more convenient and targeted treatment options. Boehringer Ingelheim remains committed to the core principle of ‘patient-centricity,’ and will continue to focus on highly unmet clinical needs in oncology, collaborate with various stakeholders, accelerate the accessibility of innovative drugs, and promote the faster and broader benefit of cutting-edge medical achievements to Chinese patients.”

Chengyun Xie, CEO of China Biopharmaceuticals, stated: “The smooth approval of Shenghutu^® for the first-line indication is a significant milestone in our strategic partnership with Boehringer Ingelheim. It breaks through the long-standing bottleneck of lacking precision targeted drugs for these patients and marks the official entry of China into a new era of precision targeted first-line therapy for HER2-mutant advanced NSCLC. China Biopharmaceuticals will continue to leverage its deep expertise and unique resources in the oncology field, fully enhance the accessibility of innovative and effective drugs, and contribute to the high-quality upgrade of lung cancer diagnosis and treatment standards in China.”

About HER2 (ERBB2) Mutant Non-Small Cell Lung Cancer (NSCLC)

Lung cancer is one of the most lethal types of malignant tumors globally^[7], with non-small cell lung cancer (NSCLC) being the most common type^[8]. HER2 (ERBB2) mutations account for approximately 2–4% of NSCLC cases and are typically associated with poor prognosis and a higher incidence of brain metastases^[8],[9]. Abnormal alterations in HER2 (ERBB2), including mutations, amplifications, and overexpression, can lead to abnormal cell proliferation, inhibit apoptosis, and promote tumor growth and spread^[9,10]. Traditional chemotherapy and immunotherapy have shown limited efficacy in the HER2-mutant population^[7]. Antibody-drug conjugates (ADCs) have demonstrated some efficacy in this area but require intravenous administration and carry risks of potential adverse events such as myelosuppression and interstitial lung disease^[6,10]. Therefore, patients with HER2-mutant advanced NSCLC still face significant and unmet treatment needs, urgently requiring a highly effective, safe, and orally convenient precision targeted therapy.

About Shenghutu^® (Zongertinib Tablets)

Shenghutu^® (zongertinib tablets) is an irreversible tyrosine kinase inhibitor (TKI) that selectively inhibits HER2 (ERBB2) while sparing wild-type EGFR, thereby helping to reduce associated toxicities^[10],[11]. Genetic testing can identify patients with advanced NSCLC harboring HER2 (ERBB2) mutations, thereby determining their suitability for treatment with Shenghutu^®[8,11].

About the Beamion Clinical Trial

About Boehringer Ingelheim in Oncology

Boehringer Ingelheim is committed to driving meaningful scientific advancements that transform the lives of cancer patients, ultimately aiming to cure all types of cancer. The company’s generational commitment to scientific innovation is vividly reflected in its robust pipeline of cancer cell-targeting and immuno-oncology therapies, as well as its clever combination therapy strategies. In oncology, Boehringer Ingelheim is steadfast in building a broad collaborative research network and actively seeking diverse innovative ideas, which is crucial for tackling highly challenging and impactful cancer research areas. In short, for Boehringer Ingelheim, conquering cancer is about current and future generations.

About the Strategic Collaboration between Boehringer Ingelheim and China Biopharmaceuticals

Boehringer Ingelheim and China Biopharmaceuticals have established a strategic partnership dedicated to bringing innovative oncology therapies to the mainland China market. This collaboration leverages the complementary strengths of both parties to provide more and better treatment options for cancer patients in China. The two parties will collaborate on several of Boehringer Ingelheim’s innovative oncology products in late-stage clinical development. Zongertinib is one of the strategic collaboration products between Boehringer Ingelheim and China Biopharmaceuticals in mainland China.