Luye Pharma Group announced today that its synthetic class one new drug LPM4870108 tablets (LY01018), a small-molecule inhibitor of NTRK with independent intellectual property right, has received formal acceptance of clinical trial application from the Center for Drug Evaluation of the National Medical Products Administration in China, and will begin clinical trials soon. The drug is designed for the treatment of NTRK fusion-positive cancer patients with different tumor types and patients who have developed drug resistance to first-generation NTRK inhibitor.
Distributed in different types of cancer, NTRK gene fusion is a carcinogenic agent, which is discovered in over 20 types of solid tumors in adults and children, including lung cancer, colorectal cancer, thyroid tumor and fibrosarcoma. The currently available first-generation NTRK inhibitor with the same target has been regarded as a broad-spectrum anticancer drug with a precise target. It treats cancer based on genetics rather than targeting the primary cancer site, providing more treatment options for patients with solid tumors, especially those who are already at an advanced stage, have metastasis, or have no other effective treatments available.
Unfortunately, after being treated with the first-generation NTRK inhibitor with the same target for a period of time, most patients are observed in succession with acquired resistance mutations including NTRK1-G595R, NTRK2-G639R, and NTRK3-G623R. Currently there is no second-generation inhibitor targeting above-mentioned mutations available in the market.
LPM4870108 is the synthetic and highly selective second-generation NTRK inhibitor discovered by Luye Pharma, which is effective to wild type and acquired resistance type mutant. The drug is intended to be used for treatment of NTRK gene fusion and solid tumor patients with positive resistance mutations. It is expected to cover all indications relating to the currently available first-generation inhibitors with the same target, and be used for the treatment of patients with inherent resistance to the first-generation inhibitors as well as patients with acquired resistance, including first-line and second-line treatments of patients with NTRK gene fusion solid tumors.
A spokesperson of Luye Pharma Group said: "Cancer treatment is evolving by the day, and developments and breakthroughs in various innovative therapies could bring more novel treatment options for patients, helping them to achieve longer and better quality of lives. Luye Pharma has a long-term commitment to oncology therapeutics, aiming to provide more innovative drugs to cancer patients targeting these urgent needs and helping them to gain better clinical benefits."
Oncology is one of the key therapeutic areas for Luye Pharma. The company has a strong pipeline in this field including Bevacizumab Injection, Denosumab Injection, the innovative formulation Goserelin Acetate Extended-release Microspheres for Injection, Triptorelin Acetate Extended-release Microspheres for Injection, a collaborative project for an innovative drug Lurbinectedin, as well as other investigational innovative antibodies. More upcoming products will reinforce the company's leading position in oncology, and lay a solid foundation for its rapid expansion across the globe.
Luye Pharma Group announced today that its synthetic class one new drug LPM4870108 tablets (LY01018), a small-molecule inhibitor of NTRK with independent intellectual property right, has received formal acceptance of clinical trial application from the Center for Drug Evaluation of the National Medical Products Administration in China, and will begin clinical trials soon. The drug is designed for the treatment of NTRK fusion-positive cancer patients with different tumor types and patients who have developed drug resistance to first-generation NTRK inhibitor.
Distributed in different types of cancer, NTRK gene fusion is a carcinogenic agent, which is discovered in over 20 types of solid tumors in adults and children, including lung cancer, colorectal cancer, thyroid tumor and fibrosarcoma. The currently available first-generation NTRK inhibitor with the same target has been regarded as a broad-spectrum anticancer drug with a precise target. It treats cancer based on genetics rather than targeting the primary cancer site, providing more treatment options for patients with solid tumors, especially those who are already at an advanced stage, have metastasis, or have no other effective treatments available.
Unfortunately, after being treated with the first-generation NTRK inhibitor with the same target for a period of time, most patients are observed in succession with acquired resistance mutations including NTRK1-G595R, NTRK2-G639R, and NTRK3-G623R. Currently there is no second-generation inhibitor targeting above-mentioned mutations available in the market.
LPM4870108 is the synthetic and highly selective second-generation NTRK inhibitor discovered by Luye Pharma, which is effective to wild type and acquired resistance type mutant. The drug is intended to be used for treatment of NTRK gene fusion and solid tumor patients with positive resistance mutations. It is expected to cover all indications relating to the currently available first-generation inhibitors with the same target, and be used for the treatment of patients with inherent resistance to the first-generation inhibitors as well as patients with acquired resistance, including first-line and second-line treatments of patients with NTRK gene fusion solid tumors.
A spokesperson of Luye Pharma Group said: "Cancer treatment is evolving by the day, and developments and breakthroughs in various innovative therapies could bring more novel treatment options for patients, helping them to achieve longer and better quality of lives. Luye Pharma has a long-term commitment to oncology therapeutics, aiming to provide more innovative drugs to cancer patients targeting these urgent needs and helping them to gain better clinical benefits."
Oncology is one of the key therapeutic areas for Luye Pharma. The company has a strong pipeline in this field including Bevacizumab Injection, Denosumab Injection, the innovative formulation Goserelin Acetate Extended-release Microspheres for Injection, Triptorelin Acetate Extended-release Microspheres for Injection, a collaborative project for an innovative drug Lurbinectedin, as well as other investigational innovative antibodies. More upcoming products will reinforce the company's leading position in oncology, and lay a solid foundation for its rapid expansion across the globe.
