On June 19, Gelunhui announced that the self-developed Class 1 innovative drug, Envonalkib (TQ-B3139) (trade name: Anloqing capsule), has been approved for listing by the China National Medical Products Administration. It is used for the treatment of ALK-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) patients who have not undergone therapy with ALK inhibitors. In terms of product structure, the operating income of 10-30 billion yuan products was 401/1288/60 million yuan respectively.
Envonalkib is a new type of ALK inhibitor independently developed by the group, and this first-line treatment indication for ALK-positive NSCLC approval is based on the results of a multicenter, randomized, controlled Phase III clinical study (NCT04009317) of Envonalkib compared with crizotinib for first-line treatment of ALK-positive advanced NSCLC. The study results were published in Signal Transduction and Targeted Therapy (IF: 39.3) on August 14, 2023.
Clinical data shows that it is significantly more effective than crizotinib, and patients with brain metastases benefit significantly.
As of August 31, 2022, the results of the primary endpoint of this Phase III study evaluated by the Independent Review Committee (IRC) showed that the median progression-free survival (mPFS) of Enfalkib and crizotinib were 24.87 months and 11.60 months, respectively, HR=0.47(P<0.0001), the risk of tumor recurrence was reduced by 53%, and the difference between the two groups was statistically significant. At the same time, Enfalkib showed significant advantages in all key subgroup analyses, especially in patients with baseline brain metastases, showing a significant benefit (HR=0.36). The total objective response rate (ORR) of the two groups of patients with baseline evaluable brain metastases was 78.95% vs. 23.81%, and the duration of response (DoR) was 25.82 months vs. 7.39 months (HR=0.12); the time to disease progression to patients with baseline brain metastases in the two groups was 30.32 months vs. 8.28 months (HR=0.31). The results showed that Enfalkib could significantly delay disease progression in patients with brain metastases or reduce the risk of new brain metastases. The safety results of this study showed that the adverse events related to the experimental drug were basically similar to those of similar drugs in the past, and the overall safety was controllable without new safety signals.
Market situation: high incidence rate of lung cancer in China, unmet needs for patients with brain metastases.
Non-small cell lung cancer (NSCLC) is a malignant tumor with high incidence and mortality rates in China and globally. According to the research report "Cancer incidence and mortality in China, 2016" published by the National Cancer Center in 2022, there are about 828,000 new cases of lung cancer and 657,000 deaths each year in China, and the incidence and mortality rates are the highest of all types of cancer. Among NSCLC patients, the incidence of ALK mutations is 3% to 7%. With the aging of the population and the popularization of molecular diagnosis and treatment technology in China, the diagnostic rate of newly diagnosed ALK-positive NSCLC patients has shown an upward trend year by year. Crizotinib is the first generation ALK inhibitor. Its efficacy is significantly better than that of chemotherapy, but almost half of the patients experience disease progression after about one year of treatment, and crizotinib has weak penetration into the central nervous system, making it ineffective in controlling the occurrence and development of brain metastases, and the clinical needs are still unmet.
After saltanib, famitinib, and bevacizumab injection, Enfalkib is another Class 1 innovative drug approved by the group, indicating that the group's innovation and product layout in the field of lung cancer continue to enrich, which is of great significance to the group's innovative development.