The "2022 Survey on the Survival Status of ALK-positive Patients with Non-Small Cell Lung Cancer" published in 22 years shows that adverse reactions such as edema, diarrhea, vomiting and constipation in ALK-TKI drug targeting ** have a greater impact on the lives of patients.
The results of a pooled analysis of 409 large samples of 409 patients from four clinical studies showed that Iruaq had an excellent overall performance in terms of "somatosensory" related adverse reactions such as edema, gastrointestinal reactions (diarrhea, vomiting, constipation, nausea), fatigue, rash, visual disturbances, and emotional effects, and the incidence was lower than that of other types of ALK-TKI. This safety feature of Iruac will provide patients with a better medication experience.
Iluac can induce apoptosis in tumor cells by inhibiting the phosphorylation of ALK and ROS1 kinases and thereby blocking the activation of downstream signaling pathway proteins such as ERK, STAT5 and AKT. In patients with ROS1-positive NSCLC who have not previously received crizotinib prior crizotinib, Iluac was assessed by investigators to have an ORR of 74% and a DCR of 96%. Superior to the existing ROS1 standard** drug crizotinib.
Previously, based on the efficacy and safety data of Iluac, Iluak was successively written into the "2023 CSCO Guidelines for the Diagnosis and Treatment of Non-small Cell Lung Cancer" and the "Guidelines for the Diagnosis and Treatment of Primary Lung Cancer in China (2023 Edition)".
As a rare target, the number of patients with ALK is relatively small. All the patients in Iruak's Phase I-III clinical study are from China, with a total sample size of nearly 600 cases, far exceeding the sample size of similar ALK-TKI clinical studies conducted in the Chinese population. Therefore, the dosage, efficacy and safety data of Iruak can more directly reflect the situation of Chinese patients, and have greater and practical guiding significance for the clinical application of Chinese patients.
Qilu Pharmaceutical's 8 products have successfully entered the medical insurance
Every drug that can be covered by medical insurance is not simple.
In addition to Iluac tablets, Qilu Pharmaceutical's other 7 products that entered the medical insurance this time, aripiprazole oral dissolving film, montelukast sodium oral dissolving film, aprepitant injection, trifluridine tipiracil tablets, ceftazidime avibactam for injection, tedizolid phosphate for injection, and oseltamivir phosphate dry suspension, also have their own strengths.
For example, Qilu Pharmaceutical's montelukast sodium oral film is the first and only oral film dosage form of montelukast sodium in China, which belongs to 2Class 2 new drugs, special drugs for children, effectively make up for the shortcomings of children's drugs in the medical insurance catalog, compared with granules, the use of patented technology to solve the problem of instability of montelukast sodium, one paste instant dissolving, fast onset, high safety, better compliance, more suitable for pediatric patients.
Aripiprazole oral film is the world's first aripiprazole oral film dosage form, which is a new dosage form with improved and clear clinical value, which is used for **psychosis** and is a safe new generation of antipsychotic drugs. The "Chinese Expert Consensus on the Management of Metabolic Syndrome in Patients with Mental Disorders" clearly pointed out that the metabolic risk classification of antipsychotics, olanzapine is high-risk, aripiprazole is low-risk, compared with olanzapine, aripiprazole metabolic syndrome (weight gain, blood sugar and lipid elevation) has a low risk and better safety.
Aprepitant is the world's earliest central nervous system inhibitory antiemetic drug for the prevention of nausea and vomiting (CINV) caused by clinical chemotherapy. The problem of inability to directly administer intravenously can improve the dissolution speed and solubility of poorly soluble drugs, improve the stability of drugs in vitro and in vivo, ensure accurate dosage, easy to use, and improve patient compliance, which has been unanimously recommended by major authoritative guidelines (NCCN ASCO).
Trifluridine tepiracil tablets are indicated for patients with metastatic colorectal cancer (MCRC) who have received prior fluoropyrimidine, oxaliplatin and irinotecan-based chemotherapy, as well as those who have received or are not suitable for anti-vascular endothelial growth factor (EGF)** anti-epidermal growth factor receptor (EGFR)**RAS wild type).
Trifluridine tipiracil tablets are a new type of oral cytotoxic drugs with a triple mechanism of action to ensure anti-cancer efficacyTwo phase III studies (the International Recourse Study and the Asia-Pacific Terra Study) showed that the adverse reactions of perceived symptoms were low, and the patients' medication experience was goodCompared with fluorouracil, TAS-102 cardiotoxicity is rarer.
Benefiting Chinese patients, Qilu has more innovative drugs on the way
Today, Qilu Pharmaceutical's 8 drugs such as Iluac tablets have been successfully entered into the medical insurance, which will also more effectively benefit Chinese patients and improve drug accessibility. Judging from the adjustment of the medical insurance catalogue in the past few years, the vast majority of innovative drugs can achieve price for volume, ushering in a sales explosion.
Industry insiders said that China's medical insurance access model has been transformed into product and advantage-oriented, and high-quality drugs will have a greater competitive advantage in the future.
Li Yan, president of Qilu Pharmaceutical, previously said that the approval of Iluac tablets is the beginning of Qilu Pharmaceutical's innovative research and development into the harvest period, and during the "14th Five-Year Plan" period, Qilu will successively launch a number of innovative drugs to provide more new options for major diseases.
As a leading pharmaceutical company in China, Qilu Pharmaceutical is guided by solving the current unmet clinical needs, spares no effort to carry out the layout of innovative drugs, closely follows the development trend of international innovative drugs, and continues to develop "global new" and "global good" drugs in the fields of unmet major diseases such as anti-tumor, anti-infection, liver disease, autoimmunity, and metabolic diseases. At present, Qilu has more than 80 innovative drug projects under development, 18 Class 1 new drugs are in different clinical research stages, and 7 Class 1 new drugs have been approved for clinical trials this year.
In addition, focusing on the field of major multi-incidence diseases, Qilu Pharmaceutical is committed to the research and development of generic drugs with high clinical value, continuously providing more high-quality drug options for clinical use, and improving drug accessibility. Up to now, Qilu Pharmaceutical has a total of 150 products that have passed the consistency evaluation, of which 54 are the first in China.