Iruplak (Qixinke), the 7th ALK Inhibitor for NSCLC, Launches with New Indication Demonstrating 66% Reduction in Risk of Death or Disease Progression

Reporter Lin Zichen from Every Day Economic News Editor Yang Xia from Every Day Economic News

On February 25, the press conference for the marketing of the first-line indication of Yilu Ak tablet (trade name: Qixinke), a major achievement of the national "Major New Drug Creation" science and technology project, was held in Jinan. Data show that Yilu Ak tablet is the first small molecule Class 1 innovative drug with independent intellectual property rights developed by Qilu Pharmaceutical Co., Ltd. On January 16, it was approved for the new indication, which can be used for the first-line treatment of anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC). Currently, it has covered all patients with ALK-positive locally advanced or metastatic NSCLC.

On the 26th, Dr. Zheng Shansong from Qilu Pharmaceutical Co., Ltd. told reporters from The Economic Information Daily that in 2013, crizotinib was the only treatment for ALK-positive non-small cell lung cancer in clinical practice. However, after about one year of use, crizotinib is prone to drug resistance and brain metastasis; safety issues are prominent with high incidences of adverse reactions such as nausea, vomiting, diarrhea, constipation, gastrointestinal toxicity, muscle pain, edema, and visual disturbances, seriously affecting patients' medication experience. Currently, there are seven first-line treatments for ALK-positive non-small cell lung cancer: in addition to the newly launched Iruac, there are also Crizotinib, Ceritinib, Alectinib, Brigatinib, Lorlatinib, and Ensartinib.

Compared with similar drugs, Iruak has lower incidence rates of adverse reactions related to patients' intuitive feelings, such as muscle pain (5.6%), edema (4.4%), and constipation (3.2%). A Phase III head-to-head randomized controlled clinical trial on the efficacy and safety of Iruak as a first-line treatment for ALK-positive advanced NSCLC showed that the median progression-free survival (PFS) was 27.7 months in the Iruak group and 14.6 months in the Crizotinib group. Compared with Crizotinib, Iruak can reduce the risk of death or progression by 66% in the first-line treatment of ALK-positive NSCLC patients. Among similar drugs evaluated for PFS by IRC in Asian populations, Iruak demonstrated the highest reduction in the risk of death and progression.

Reporters learned from Qilu Pharmaceutical that in 2023, the group's R&D investment reached 4.43 billion yuan, a year-on-year increase of 13.9%. The proportion of R&D investment to sales revenue in the past two years was 11% and 15%, respectively. The total R&D investment over the past five years has been nearly 15 billion yuan, and it is expected to exceed 20 billion yuan during the "14th Five-Year Plan" period. With the rapid progress of over 80 innovative drug pipelines, including more than 80 new Class I drugs, as well as the swift advancement of a series of high-end novel formulations for generic drugs, R&D investment is expected to continue to increase.

Zheng Shansong stated that the company's current innovative product portfolio includes monoclonal antibodies, combination antibodies, bispecific antibodies, ADCs, PROTACs, and more. At this stage, the most anticipated product is the combination antibody QL1706 (Ipalolisib Tosvorilen, "Qibean"), which submitted its first marketing application last year. Reports indicate that this is the world’s first PD-1/CTLA-4 targeted combination antibody to have entered the application process for market approval.

Editor: He Songlin