Recently, BeBetter Med’s application of clinical trials for "BEBT-109 combined with BEBT-908 for the treatment of advanced NSCLC that is resistant to third-generation EGFR inhibitor therapy" and "BEBT-209 combined with BEBT-908 for the treatment of ER+/HER2- advanced breast cancer that is resistant to CDK4/6 inhibitors therapy and endocrine therapy” received CDE approval. 

Lung cancer and breast cancer are the two most common malignant tumors in China and around the world. Non-small cell lung cancer (NSCLC) accounts for approximately 80% of all lung cancers, and epidermal growth factor receptor (EGFR) tyrosine kinase embryogenic and activating mutations are present in approximately 15% of Caucasians and nearly 50% of Asians in patients with advanced NSCLC. First- and second-generation tyrosine kinase inhibitors (TKIs) in the treatment of advanced NSCLC with activating EGFR mutations can prolong progression-free survival (PFS) by about 9-15 months. The third-generation TKI, Osimertinib, as first-line therapy, can prolong PFS for up to about 18.9 months, PFS was prolonged by about 5.7 months as a second-line treatment for T790M acquired resistance mutation. Although the third-generation TKIs represented by Osimertinib have significant efficacy in the first- and second-line treatment of EGFR-mutated advanced NSCLC, patients will inevitably develop resistance. Except for chemotherapy and local therapy for some individuals, there are no effective treatment options so far. Disease progression after first- and second-line TKI therapy is a key cause of death in NSCLC patients, and overcoming TKI resistance is an unmet clinical need.

About 50-60% of breast cancer patients are hormone receptor (ER) positive and human epidermal growth factor receptor-2 (HER2) negative. In recent years, the biggest progress in breast cancer treatment is undoubtedly the application of CDK4/6 inhibitor combined with endocrine therapy in HR-positive and HER2-negative advanced breast cancer. CDK4/6 inhibitor combined with endocrine therapy in first- or second-line treatment of advanced metastatic ER-positive and HER2-negative breast cancer prolongs PFS by 10-11 months and 5-6 months, respectively. Disease progression or recurrence after CDK4/6 inhibitors and endocrine therapy is a new cause of breast cancer-related death, and overcoming CDK4/6 resistance is another urgent issue.

BeBetter Med Inc. focuses on the research and development of innovative drugs that treat unmet clinical needs. Taking advantage of its own pipeline and chemical entity differentiation, the company will launch "BEBT-109 combined with BEBT-908 in the treatment of advanced NSCLC that has been treated with third-generation EGFR inhibitors" and "BEBT-209 combined with BEBT-908 in the treatment of ER+/HER2- advanced breast cancer that developed resistance after treatment of CDK4/6 inhibitors and endocrine therapy”. The two clinical trials are expected to make a breakthrough to the problem that no effective treatment are present for the two major malignant tumors that develop resistance after first- and second-line therapies.