Luye Pharma Group today announced that the clinical trials application for the company's self-developed innovative oncology product, Hydrochloride Irinotecan Floxurudine Liposome Injection (LY01616), has received formal acceptance from the China Center for Drug Evaluation of National Medical Products Administration and will soon enter the clinical trials phase. The Investigational New Drug application is the first in China to cover a combinational liposome treatment, representing a breakthrough for the company in terms of combinational liposome R&D and manufacturing ability. The method of preparation for the drug is significantly complex, with a high-tech production process.
Irinotecan combined with fluorouracil is one of the first choices in chemotherapy treatment for advanced colorectal cancer. LY01616 is an innovative combinational liposome formulation loaded with irinotecan and floxurudine, indicated for the treatment of advanced colorectal cancer. Currently there is no same drug product available on the global market.
LY01616 was independently developed by Luye Pharma through its Laboratory for Long-acting and Targeting Drug Delivery Systems. The company has reached an advanced international standard in the development of liposomes and other novel drug delivery technologies and has the critical technical ability to encapsulate two drugs in a single liposome. With developments in R&D and manufacturing, the company has built a variety of new technology platforms, including new liposome platforms, advanced carrier material platforms, and industrialized research platforms. These encompass the pre-clinical research phase through to the commercialization phase, a point of key importance to the Laboratory for Long-acting and Targeted Drug Delivery Systems.
LY01616 is designed to achieve better synergistic effects of combined chemotherapy
Compared with single drug chemotherapy, combined chemotherapy can leverage the various mechanisms of different drugs to achieve a synergistic effect, thereby reducing the incidence of drug resistance and improving the effect of chemotherapy, and is now the global standard for clinical treatment for cancerous tumors. The effect of combined chemotherapy however depends strongly on the ratio of drugs in the combination, with specific synergistic ratios achieving the best therapeutic effect.
In traditional combined chemotherapy, due to the differences in drug properties and metabolic pathways in vivo, along with other factors, it is difficult to maintain the desired drug ratio after the combined chemotherapy mixture has entered the body, negatively influencing efficacy. LY01616 is developed to solve these clinical problems by wrapping the combined chemotherapy drugs with a certain synergistic ratio inside a single liposome. This allows for the several advantages when compared with traditional combined chemotherapy. Firstly, loading drugs at a specific ratio and delivering them to target tissues can better achieve combined chemotherapy’s synergistic effects. Furthermore, a single liposome with a combined chemotherapy formula can reduce the volume and frequency of drug administration, and required administration time. Finally, total dosage of certain chemotherapy drugs can be reduced, so as to decrease the chance of adverse reactions.
Luye Pharma strengthens leading advantages in liposome technology
A liposome is a complicated structure composed of a phospholipid bilayer made of cholesterol and other lipid components, surrounding a micro vesicle. Liposomes can be used as drug carriers to increase drug solubility and stability, to prolong blood circulation times and to improve tumor targeting and efficacy.
Luye Pharma has developed core competitive advantages in liposome and targeted drug delivery technology, and has made a leading breakthrough in the commercialization of liposome drugs in China. The company has established a highly intelligent liposome production line to further enhance its industrialization capabilities. One of its key products, Paclitaxel Liposome for Injection, has been widely recognized by doctors and patients for its proven efficacy and improved safety in long-term clinical use. The company is also in the process of developing other drug candidates with this technology platform, including Doxorubicin Hydrochloride Liposome Injection and Irinotecan Hydrochloride Liposome Injection, now both in the clinical stage.
Luye Pharma continues to focus on a strategic approach to oncology therapeutics
The therapeutic field of colorectal cancer, where LY01616 is applied, has one of the highest incidence of malignant tumor types. It is the third most prevalent type of cancerous tumor in China, with over 429,000 new cases and 281,000 related deaths in 2018. The growing number of patients with this condition means that there is a significant unmet demand for medication.
Luye Pharma believes that LY01616 will provide a new treatment option to patients with colorectal cancer, and will further enrich its oncology product pipeline. The company’s existing resources and strengths in the field of oncology will also create synergetic support for upcoming products.
Luye Pharma has a number of new drug projects planned in its oncology product pipeline, 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 CAR-T therapy and other R&D projects. More upcoming products will serve to reinforce the company's leading position in oncology, and will help to lay a solid foundation for its rapid expansion around the globe.
Luye Pharma Group today announced that the clinical trials application for the company's self-developed innovative oncology product, Hydrochloride Irinotecan Floxurudine Liposome Injection (LY01616), has received formal acceptance from the China Center for Drug Evaluation of National Medical Products Administration and will soon enter the clinical trials phase. The Investigational New Drug application is the first in China to cover a combinational liposome treatment, representing a breakthrough for the company in terms of combinational liposome R&D and manufacturing ability. The method of preparation for the drug is significantly complex, with a high-tech production process.
Irinotecan combined with fluorouracil is one of the first choices in chemotherapy treatment for advanced colorectal cancer. LY01616 is an innovative combinational liposome formulation loaded with irinotecan and floxurudine, indicated for the treatment of advanced colorectal cancer. Currently there is no same drug product available on the global market.
LY01616 was independently developed by Luye Pharma through its Laboratory for Long-acting and Targeting Drug Delivery Systems. The company has reached an advanced international standard in the development of liposomes and other novel drug delivery technologies and has the critical technical ability to encapsulate two drugs in a single liposome. With developments in R&D and manufacturing, the company has built a variety of new technology platforms, including new liposome platforms, advanced carrier material platforms, and industrialized research platforms. These encompass the pre-clinical research phase through to the commercialization phase, a point of key importance to the Laboratory for Long-acting and Targeted Drug Delivery Systems.
LY01616 is designed to achieve better synergistic effects of combined chemotherapy
Compared with single drug chemotherapy, combined chemotherapy can leverage the various mechanisms of different drugs to achieve a synergistic effect, thereby reducing the incidence of drug resistance and improving the effect of chemotherapy, and is now the global standard for clinical treatment for cancerous tumors. The effect of combined chemotherapy however depends strongly on the ratio of drugs in the combination, with specific synergistic ratios achieving the best therapeutic effect.
In traditional combined chemotherapy, due to the differences in drug properties and metabolic pathways in vivo, along with other factors, it is difficult to maintain the desired drug ratio after the combined chemotherapy mixture has entered the body, negatively influencing efficacy. LY01616 is developed to solve these clinical problems by wrapping the combined chemotherapy drugs with a certain synergistic ratio inside a single liposome. This allows for the several advantages when compared with traditional combined chemotherapy. Firstly, loading drugs at a specific ratio and delivering them to target tissues can better achieve combined chemotherapy’s synergistic effects. Furthermore, a single liposome with a combined chemotherapy formula can reduce the volume and frequency of drug administration, and required administration time. Finally, total dosage of certain chemotherapy drugs can be reduced, so as to decrease the chance of adverse reactions.
Luye Pharma strengthens leading advantages in liposome technology
A liposome is a complicated structure composed of a phospholipid bilayer made of cholesterol and other lipid components, surrounding a micro vesicle. Liposomes can be used as drug carriers to increase drug solubility and stability, to prolong blood circulation times and to improve tumor targeting and efficacy.
Luye Pharma has developed core competitive advantages in liposome and targeted drug delivery technology, and has made a leading breakthrough in the commercialization of liposome drugs in China. The company has established a highly intelligent liposome production line to further enhance its industrialization capabilities. One of its key products, Paclitaxel Liposome for Injection, has been widely recognized by doctors and patients for its proven efficacy and improved safety in long-term clinical use. The company is also in the process of developing other drug candidates with this technology platform, including Doxorubicin Hydrochloride Liposome Injection and Irinotecan Hydrochloride Liposome Injection, now both in the clinical stage.
Luye Pharma continues to focus on a strategic approach to oncology therapeutics
The therapeutic field of colorectal cancer, where LY01616 is applied, has one of the highest incidence of malignant tumor types. It is the third most prevalent type of cancerous tumor in China, with over 429,000 new cases and 281,000 related deaths in 2018. The growing number of patients with this condition means that there is a significant unmet demand for medication.
Luye Pharma believes that LY01616 will provide a new treatment option to patients with colorectal cancer, and will further enrich its oncology product pipeline. The company’s existing resources and strengths in the field of oncology will also create synergetic support for upcoming products.
Luye Pharma has a number of new drug projects planned in its oncology product pipeline, 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 CAR-T therapy and other R&D projects. More upcoming products will serve to reinforce the company's leading position in oncology, and will help to lay a solid foundation for its rapid expansion around the globe.
