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[Pharmaceutical Network Industry News] On August 17, Xinlitai released two consecutive announcements about the clinical trial news of 2 drugs, namely, SAL0112 obtained the clinical trial approval notice, and S086 clinical trial made new progres.
The announcement shows that the company's SAL0112 tablets have been approved by the State Food and Drug Administration to carry out a phase I clinical trial for adult obese or overweight patients for weight management indication.
According to reports, SAL0112 tablet is an oral small molecule biased agonist of glucagon-like peptide-1 receptor (GLP-1R), which is an innovative drug independently developed by the compan.
The target indications include type 2 diabetes (T2DM), adult obesity Weight management for patients or overweight patient.
Among them, the indication of T2DM has obtained Phase I clinical license in early Augus.
At present, the GLP-1RAs that have been marketed in China are all peptide injections (such as liraglutide injection, semaglutide injection, dulaglutide injection, et.
), which are frequently injected for a long time or have poor patient complianc.
and so o.
SAL0112 tablets are for oral administratio.
If successfully developed and approved for marketing, it will effectively improve the route of administration for type 2 diabetes, improve the convenience of patients with medication, and enhance medication complianc.
In addition, as a small-molecule drug, SAL0112 tablets are expected to improve bioavailability more than oral peptide drugs, and are less affected by factors such as diet and concomitant drugs; they have great development potentia.
Another announcement shows that the company's self-developed S086 tablets for the treatment of mild to moderate essential hypertension have completed the enrollment of all patients according to the Phase III clinical pla.
S086 is an angiotensin II receptor-enkephalinase dual inhibitor, and its phase III clinical study aims to evaluate the efficacy and safety of different doses of S086 tablets in the treatment of mild to moderate essential hypertensio.
The company said that after the product is launched, it will further enrich the company's innovative product pipeline in the cardiovascular field, meet unmet clinical needs, and enhance the company's comprehensive competitiveness in the field of chronic disease.
In addition to the above-mentioned two drugs, Xinlitai has recently approved a number of drug clinical trial.
For example, on July 30, Xinlitai announced that the self-developed Class 1 new drug SAL0114 has completed the first clinical trial of Phase .
Enrolled; on July 14, the company and two subsidiaries announced that they received recombinant human neuregulin 1-anti-HER3 antibody fusion protein injection to carry out the phase I clinical trial of HFpEF (heart failure with preserved ejection fraction) and won the national FDA approve.
The 2021 annual report shows that the main business of Xinlitai and its subsidiaries involves the research and development, production and sales of drugs and medical device product.
The main products and projects under development include cardiovascular drugs and medical devices, cephalosporin antibiotics and raw materials, orthopedic.
Drugs, et.
, covering cardiovascular and cerebrovascular, hypoglycemic, orthopedic, anti-tumor, anti-infection and other therapeutic field.
As of the end of 2021, the company has 48 research projects, including 26 chemical drugs (including 21 innovative projects), 15 biological drugs (including 10 innovative projects), and 7 research projects in the field of medical device.
In addition, according to the information of Xinlitai's 2022 semi-annual report, the company currently has more than ten innovative drugs and key projects under research and developmen.
Behind the abundant research and development pipelines of Xinlitai, the company's continuous R&D investment is inseparabl.
In 2021, Xinlitai's R&D investment will reach 690 million yuan, and R&D investment will account for 261% of operating income in the same perio.
Up to now, the company has 639 R&D personnel, including 428 in the chemical medicine team and 127 in the biological medicine tea.
The announcement shows that the company's SAL0112 tablets have been approved by the State Food and Drug Administration to carry out a phase I clinical trial for adult obese or overweight patients for weight management indication.
According to reports, SAL0112 tablet is an oral small molecule biased agonist of glucagon-like peptide-1 receptor (GLP-1R), which is an innovative drug independently developed by the compan.
The target indications include type 2 diabetes (T2DM), adult obesity Weight management for patients or overweight patient.
Among them, the indication of T2DM has obtained Phase I clinical license in early Augus.
At present, the GLP-1RAs that have been marketed in China are all peptide injections (such as liraglutide injection, semaglutide injection, dulaglutide injection, et.
), which are frequently injected for a long time or have poor patient complianc.
and so o.
SAL0112 tablets are for oral administratio.
If successfully developed and approved for marketing, it will effectively improve the route of administration for type 2 diabetes, improve the convenience of patients with medication, and enhance medication complianc.
In addition, as a small-molecule drug, SAL0112 tablets are expected to improve bioavailability more than oral peptide drugs, and are less affected by factors such as diet and concomitant drugs; they have great development potentia.
Another announcement shows that the company's self-developed S086 tablets for the treatment of mild to moderate essential hypertension have completed the enrollment of all patients according to the Phase III clinical pla.
S086 is an angiotensin II receptor-enkephalinase dual inhibitor, and its phase III clinical study aims to evaluate the efficacy and safety of different doses of S086 tablets in the treatment of mild to moderate essential hypertensio.
The company said that after the product is launched, it will further enrich the company's innovative product pipeline in the cardiovascular field, meet unmet clinical needs, and enhance the company's comprehensive competitiveness in the field of chronic disease.
In addition to the above-mentioned two drugs, Xinlitai has recently approved a number of drug clinical trial.
For example, on July 30, Xinlitai announced that the self-developed Class 1 new drug SAL0114 has completed the first clinical trial of Phase .
Enrolled; on July 14, the company and two subsidiaries announced that they received recombinant human neuregulin 1-anti-HER3 antibody fusion protein injection to carry out the phase I clinical trial of HFpEF (heart failure with preserved ejection fraction) and won the national FDA approve.
The 2021 annual report shows that the main business of Xinlitai and its subsidiaries involves the research and development, production and sales of drugs and medical device product.
The main products and projects under development include cardiovascular drugs and medical devices, cephalosporin antibiotics and raw materials, orthopedic.
Drugs, et.
, covering cardiovascular and cerebrovascular, hypoglycemic, orthopedic, anti-tumor, anti-infection and other therapeutic field.
As of the end of 2021, the company has 48 research projects, including 26 chemical drugs (including 21 innovative projects), 15 biological drugs (including 10 innovative projects), and 7 research projects in the field of medical device.
In addition, according to the information of Xinlitai's 2022 semi-annual report, the company currently has more than ten innovative drugs and key projects under research and developmen.
Behind the abundant research and development pipelines of Xinlitai, the company's continuous R&D investment is inseparabl.
In 2021, Xinlitai's R&D investment will reach 690 million yuan, and R&D investment will account for 261% of operating income in the same perio.
Up to now, the company has 639 R&D personnel, including 428 in the chemical medicine team and 127 in the biological medicine tea.
