On April 15, 2026, Bayer announced that the National Medical Products Administration (NMPA) of China had approved the novel targeted therapy drug for lung cancer, Sevabertinib Tablets (brand name: HYRNUO®), for the monotherapy treatment of adult patients with unresectable locally advanced or metastatic non-small cell lung cancer (NSCLC) who have HER2 (ERBB2) activating mutations and have previously received at least one systemic treatment. Sevabertinib Tablets are an oral small molecule tyrosine kinase inhibitor (TKI), which had previously been included as a breakthrough therapy by the NMPA’s Center for Drug Evaluation (CDE), and its marketing application was included in the priority review.

Public data reveals that NSCLC is the most prevalent type of lung cancer, accounting for over 85% of lung cancer cases. Approximately 2% to 4% of patients with advanced NSCLC possess activating HER2 mutations. Currently, treatment options for patients with HER2-mutated NSCLC, which include chemotherapy and antibody-drug conjugates (ADCs), are limited. Oral small molecule targeted therapies hold promise for providing improved efficacy and safety for patients with HER2-mutated NSCLC.

Sevabertinib is an orally administered reversible TKI that effectively inhibits mutant human epidermal growth factor receptor 2 (HER2), including HER2 exon 20 insertions and HER2 point mutations, as well as epidermal growth factor receptor (EGFR). It exhibits high selectivity for mutant EGFR compared to wild-type EGFR. In November 2025, the FDA accelerated the approval of Sevabertinib for the treatment of adult patients with late-stage or metastatic non-squamous NSCLC who carry HER2 activating mutations and have previously received one systemic treatment.

The US FDA and China’s NMPA approved the marketing of Sevabertinib based on the positive results from the open-label, multicenter Phase I/II SOHO-01 trial. This trial targeted patients with advanced NSCLC carrying HER2 activating mutations, who had disease progression after receiving ≥1 systemic treatment and had not previously received HER2-targeted TKI therapy. The primary efficacy endpoints were the confirmed objective response rate (ORR) and duration of response (DOR), as assessed by an independent central review committee (BICR).

The research results showed that among patients who had not previously received HER2-targeted antibody-drug conjugates (ADCs), the objective response rate was 64%, with 2.5% of patients achieving complete response and 62% achieving partial response. The median duration of response was 9.2 months (95% CI 6.3-15.0, N=52). Furthermore, among patients who had previously received HER2-targeted ADC treatment, the objective response rate was 38%, with 5.5% achieving complete response and 33% achieving partial response. The median duration of response was 7 months. Sevabertinib was safe and well-tolerated, consistent with previous reports.

Sevabertinib is registered in the US FDA drug database with one patent “US 10428063B2”. This US patent claims protection for compounds covering sevabertinib, their preparation methods, and their pharmaceutical compositions, with an expiration date of 2036-01-25. Currently, there is one Chinese patent family for this patent, “CN107406417B”. This CN patent claims protection for compounds covering sevabertinib, their preparation methods, their pharmaceutical compositions, and their therapeutic uses, with an expiration date of 2036-01-25.

Reference materials:

1. https://mp.weixin.qq.com/s/4pZMgDB9NFFs8yYxboey8Q

2. https://zhuanlan.zhihu.com/p/2028136167787303273#

3. https://finance.sina.com.cn/roll/2026-04-16/doc-inhusraa2831552.shtml