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Bayer's breakthrough small molecule lung cancer drug is launched in China


Time:2025-07-24 14:28:13  Source:  Author:

 

 Lung cancer has always occupied a heavy proportion in the global cancer burden. According to data, there will be 2.48 million new cases of lung cancer in 2022, accounting for 12.4% of the total number of new cancer cases worldwide. Non small cell lung cancer (NSCLC) is a common type of lung cancer. For a long time, there has been a lack of fully approved effective therapies for metastatic or advanced NSCLC patients carrying HER2 activating mutations. However, this dilemma is expected to be broken by Bayer's BAY 2927088 tablets. ​

 
BAY 2927088 is an oral reversible tyrosine kinase inhibitor under development by Bayer, with clear research and development goals aimed at treating non-small cell lung cancer patients carrying HER2 activating mutations. The activation mutation of HER2 gene plays a key role in the occurrence and development of NSCLC, and BAY 2927088 can accurately inhibit the mutated human epidermal growth factor receptor 2 (HER2), including HER2 exon 20 insertion and HER2 point mutation. At the same time, it has high selectivity for mutant epidermal growth factor receptor (EGFR) compared to wild-type, and exerts anti-tumor effects through dual regulation of EGFR/HER2 signaling pathway. This precise targeted therapy strategy is like finding precise navigation for attacking cancer cells in the dark, greatly improving the targeting and effectiveness of treatment while reducing damage to normal cells. ​
 
The value of drugs ultimately lies in their clinical efficacy. The safety, pharmacokinetics, and preliminary efficacy of BAY 2927088 in adult patients with advanced NSCLC carrying HER2 or EGFR were evaluated in a phase I/II, open label, multicenter first in person study (NCT05099172). The data proves the effectiveness of BAY 2927088 in clinical treatment.
 
BAY 2927088 has received high recognition from regulatory agencies in both China and the United States during the research and development process. In February 2024, it obtained breakthrough therapy recognition from the US FDA, and in June of the same year, the Center for Drug Evaluation (CDE) of the China National Medical Products Administration also granted it breakthrough therapy variety recognition. The indication is for the treatment of adult patients with HER2 activating mutations who have previously received systemic treatment for unresectable or metastatic non-small cell lung cancer (NSCLC).
 
The breakthrough therapy certification aims to accelerate the development and approval of innovative drugs for the prevention and treatment of diseases that seriously endanger life or seriously affect quality of life, for which there are no effective prevention and treatment methods, or for which there are significant clinical advantages compared to existing treatment methods. These two determinations not only affirm the clinical value of BAY 2927088, but also open up a green channel for its subsequent research and approval processes.
 
It is reported that on July 23, 2025, the website of the Center for Drug Evaluation (CDE) of the China National Medical Products Administration announced that Bayer's application for the marketing of Class 1 new drug BAY 2927088 tablets has been accepted. Although the specific indications have not yet been announced, this news undoubtedly brings good news to many lung cancer patients. ​
 
At present, Bayer has not stopped exploring. The global Phase III SOHO-02 trial has completed the first patient enrollment. This is an open label, randomized, multicenter clinical trial aimed at evaluating the efficacy and safety of BAY 2927088 as a first-line treatment in advanced non-small cell lung cancer patients carrying HER2 activating mutations. I believe that with the continuous deepening of research, BAY 2927088 will bring more surprises and breakthroughs to the treatment of lung cancer, further improve the prognosis of HER2 mutant NSCLC patients, enhance their quality of life, and write a new chapter in the field of lung cancer treatment. ​

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