据悉，近日，公司公告公司原创1类新药、FAK/ALK/ROS1三联酪氨酸激酶抑制剂(TKI)APG-2449获国家药监局批准，将开展针对二代ALK TKI耐药或不耐受的非小细胞肺癌(NSCLC)或初治ALK阳性晚期NSCLC的两项注册III期临床研究。Recently, the company announced that the original innovative drug, FAK/ALK/ROS1 triple tyrosine kinase inhibitor (TKI) APG-2449, has been approved by the National Medical Products Administration to conduct two Phase III clinical trials for second-generation ALK TKI-resistant or intolerant non-small cell lung cancer (NSCLC) or first-line ALK-positive advanced NSCLC.
Zhongtong Finance and Economics APP learned that China International Capital Corporation released research reports stating that it basically maintains AstraZeneca Pharmaceuticals-B (06855) 2024/2025 net income forecast loss of 0.389 billion yuan / loss of 0.935 billion yuan unchanged and maintains the company's 'outperforming the industry' rating. Taking into account the company's initiation of registration clinical trials for APG-2449, continuous progress in international registration clinical trials for APG-2575, the potential continuous opening of new indications space, combined with the enhancement of Hong Kong stock innovative drug liquidity, the bank has raised the company's target price by 48.6% to 55 Hong Kong dollars.
Company Status
Recently, the company announced that the original innovative drug, FAK/ALK/ROS1 triple tyrosine kinase inhibitor (TKI) APG-2449, has been approved by the National Medical Products Administration to conduct two Phase III clinical trials for second-generation ALK TKI-resistant or intolerant non-small cell lung cancer (NSCLC) or first-line ALK-positive advanced NSCLC.
CICC's main points are as follows:
Second-generation ALK TKI-resistant NSCLC has significant unmet clinical needs.
According to the company's announcement, ALK-positive NSCLC accounts for about 3%-5% of lung cancer patients, who are often younger and have a higher risk of brain metastasis. Although there are multiple ALK targeted drugs on the market, over half of NSCLC patients develop secondary resistance after receiving treatment with second-generation ALK TKIs. The subsequent treatment regimen for patients who fail second-generation ALK TKI treatment is currently chemotherapy, and the exploration of non-chemotherapy targeted treatment regimens remains a major trend in current innovative drug research and development.
APG-2449 is the third-generation ALK/ROS1 TKI independently developed by Ascentage, and also the first domestically approved FAK inhibitor to enter clinical trials.
According to the company's announcement, in previous clinical trials, APG-2449 has demonstrated good safety and preliminary clinical benefit signals, with a strong inhibitory effect on brain metastases. In the upcoming registration Phase III clinical research, the company plans to explore the safety and effectiveness of APG-2449 compared to platinum-containing chemotherapy in second-generation ALK TKI-resistant or intolerant NSCLC patients, as well as compared to crizotinib in first-line ALK-positive advanced NSCLC patients. The bank believes this marks the company's exploration in the solid tumor field approaching maturity.
The company is a pioneer and forerunner in the domestic innovative small molecule drugs in the field of hematologic malignancies.
In the field of hematologic malignancies, the company's orelabrutinib has been approved for marketing in China, and the company has signed an exclusive option agreement with Takeda Pharmaceutical for up to approximately $1.2 billion, which is expected to provide support for the international commercialization of orelabrutinib; multiple global multicenter Phase III clinical trials of APG-2575 are ongoing, and the company is expected to become the first domestically approved Bcl-2 inhibitor. The bank believes that the early clinical data of the company's APG-2449 are excellent, and the initiation of registration Phase III clinical research in the NSCLC field is expected to further solidify the foundation for the company's expansion into the solid tumor field.
