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Public information shows that Yida Fang was approved by NMPA for marketing in May 2024 for the treatment of locally advanced or metastatic non squamous NSCLC with EGFR mutations that have progressed after EGFR TKI therapy. At present, there is one indication for Ivosi in the final review stage of the NDA, and a total of 12 phase III clinical studies are being efficiently promoted, including 3 international multicenter phase III clinical studies and 6 phase III clinical studies using PD - (L) monoclonal antibody as a positive control drug.

 

 

 

In addition to lung cancer, Ivosi has more than 10 clinical trials under way for biliary tract cancer, head and neck squamous cell cancer, triple negative breast cancer, colorectal cancer, pancreatic cancer, hepatocellular carcinoma and other indications.

 

 

 

Lung cancer is a malignant tumor originating from the bronchial mucosa or glands of the lungs, with a very high incidence rate in China. From a classification perspective, non-small cell lung cancer (NSCLC) is relatively common, with a slower growth rate and later metastasis. Patients have a significant unmet need for treatment.

 

 

 

In recent years, with the continuous improvement of China's innovative drug research and development capabilities, more and more local pharmaceutical companies have achieved breakthroughs in the field of lung cancer treatment, showing a trend of diversified development from traditional treatment to precision treatment, immunotherapy, and other directions. Targeted therapy drugs, PD-1/PD-L1 inhibitors, and bispecific drugs have emerged in the market one after another.

 

 

 

Among them, Beta Pharmaceuticals' Ecatinib Hydrochloride (Kemena), as the first independently developed small molecule EGFR-TKI targeted drug in China, has benefited more than 700000 lung cancer patients nationwide since its launch in June 2011, and has been a cornerstone of Beta's revenue for many years. From 2011 to 2021, Kemena's market sales have exceeded 10 billion yuan in the past ten years since its launch, and it has achieved a total sales revenue of over 14.5 billion yuan so far.

 

 

 

Ensatinib hydrochloride (Bemena), as a new generation ALK inhibitor, was approved for market by the US Food and Drug Administration (FDA) in December 2024, becoming the first innovative drug of Betta Pharmaceuticals to go global. In February 2025, its European Medicines Agency (EMA) market application process was officially launched, which is expected to expand into the international market. At the same time, the company is constantly expanding into new therapeutic areas and has launched the large molecule biopharmaceutical Bevacizumab (Bevacizumab), which is bioequivalent to Avastin. The company actively promotes its commercialization and continues to enrich lung cancer treatment options.

 

 

 

It is worth mentioning that the third-generation EGFR-TKI market has become saturated. At present, the country