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[Pharmaceutical Network Industry News] With the continuous improvement of the research and development capabilities of domestic pharmaceutical companies, the research and development of domestic new drugs has begun to show an explosive trend in recent years
.
According to data on the website of the Center for Drug Evaluation (CDE) of China's State Food and Drug Administration, since 2022, 315 clinical trial applications have passed "implicit licenses"
.
It is worth noting that under this background, many pharmaceutical companies have recently made new progress in the R&D and listing of Class 1 new drugs
.
A key clinical trial of CSPC’s new class 1 drug JMT103 reached the preset endpoint A few days ago, CSPC announced that the company’s subsidiary Shanghai Jinmante Biotechnology Co.
, Ltd.
’s class 1 new drug JMT103 is used for the treatment of unresectable or difficult surgery The pivotal clinical trial in GCTs met prespecified endpoints
.
According to reports, JMT103 is an innovative fully human RANKL monoclonal antibody.
By optimizing the structure of the same target drug denosumab, the production process is simplified while enhancing the affinity
.
The Group has conducted two clinical studies (JMT103CN03 and JMT103CN03-1) in China as pivotal clinical trials of JMT103 in the treatment of unresectable or difficult-to-operate GCTs to support the marketing application of the product
.
At present, the Group has submitted an application for pre-market communication to the State Drug Administration of China
.
Luye Pharma's Class 1 New Drug Under Development Approved for Phase III Clinical Trials Recently, Luye Pharma announced that the group's new product under development (NCE) and China's Class 1 new chemical drug "LY03005" has been approved by the Center for Drug Evaluation of the State Drug Administration of China (CDE) approved a Phase III clinical trial for the treatment of generalized anxiety disorder
.
LY03005 is a novel molecular entity therapeutic with a novel mechanism of action, a serotonin (5-HT), norepinephrine (NE) and dopamine (DA) triple reuptake inhibitor (SNDRI/TRI)
.
The approved clinical trial is a Phase III clinical trial evaluating the efficacy and safety of LY03005 in patients with generalized anxiety disorder
.
Previously, the drug has completed Phase I to Phase III clinical trials for the treatment of depression in China, and its marketing application was accepted by CDE in June 2021
.
Not long before Yichang Renfu Pharmaceutical was approved for the market with new indications of Category 1 new drugs, Yichang Renfu Pharmaceutical also announced that it had received the "Drug Registration Certificate" approved and issued by the State Drug Administration for Remazolam Besylate for Injection , approved the company to increase the indication of remazolam besylate for injection, and the new indication is "general anesthesia induction and maintenance"
.
It is understood that remazolam besylate is a new type of benzodiazepine drug, which is an ultra-short-acting sedative/anesthetic drug with the characteristics of water solubility and short elimination half-life
.
Remazolam besylate for injection is the first Class 1 innovative drug approved for marketing in China by Yichang Renfu Pharmaceutical in July 2020.
The first approved indication is "sedation for colonoscopy"
.
Many of Hansoh's Class 1 New Drugs Approved for Clinical
Trials
Specifically, on March 8, the CDE website showed that Hansoh Pharmaceutical's Class 1 new drug HS-10380 tablets obtained an implied license for clinical trials and was intended to be used for the treatment of schizophrenia
.
The industry believes that HS-10380 tablets are a rare psychiatric innovative drug in the innovative R&D pipeline of local pharmaceutical companies when innovative oncology drugs are popular
.
Prior to this, Hansoh Pharmaceutical's self-developed Class 1 new drug "HS-10370 Tablets" has also obtained a clinical trial notice approved and issued by the NMPA, and is intended to be used for the treatment of advanced solid tumors.
The specific indications will be determined after clinical trials
.
Disclaimer: Under no circumstances does the information or opinions expressed in this article constitute investment advice to anyone
.
.
According to data on the website of the Center for Drug Evaluation (CDE) of China's State Food and Drug Administration, since 2022, 315 clinical trial applications have passed "implicit licenses"
.
It is worth noting that under this background, many pharmaceutical companies have recently made new progress in the R&D and listing of Class 1 new drugs
.
A key clinical trial of CSPC’s new class 1 drug JMT103 reached the preset endpoint A few days ago, CSPC announced that the company’s subsidiary Shanghai Jinmante Biotechnology Co.
, Ltd.
’s class 1 new drug JMT103 is used for the treatment of unresectable or difficult surgery The pivotal clinical trial in GCTs met prespecified endpoints
.
According to reports, JMT103 is an innovative fully human RANKL monoclonal antibody.
By optimizing the structure of the same target drug denosumab, the production process is simplified while enhancing the affinity
.
The Group has conducted two clinical studies (JMT103CN03 and JMT103CN03-1) in China as pivotal clinical trials of JMT103 in the treatment of unresectable or difficult-to-operate GCTs to support the marketing application of the product
.
At present, the Group has submitted an application for pre-market communication to the State Drug Administration of China
.
Luye Pharma's Class 1 New Drug Under Development Approved for Phase III Clinical Trials Recently, Luye Pharma announced that the group's new product under development (NCE) and China's Class 1 new chemical drug "LY03005" has been approved by the Center for Drug Evaluation of the State Drug Administration of China (CDE) approved a Phase III clinical trial for the treatment of generalized anxiety disorder
.
LY03005 is a novel molecular entity therapeutic with a novel mechanism of action, a serotonin (5-HT), norepinephrine (NE) and dopamine (DA) triple reuptake inhibitor (SNDRI/TRI)
.
The approved clinical trial is a Phase III clinical trial evaluating the efficacy and safety of LY03005 in patients with generalized anxiety disorder
.
Previously, the drug has completed Phase I to Phase III clinical trials for the treatment of depression in China, and its marketing application was accepted by CDE in June 2021
.
Not long before Yichang Renfu Pharmaceutical was approved for the market with new indications of Category 1 new drugs, Yichang Renfu Pharmaceutical also announced that it had received the "Drug Registration Certificate" approved and issued by the State Drug Administration for Remazolam Besylate for Injection , approved the company to increase the indication of remazolam besylate for injection, and the new indication is "general anesthesia induction and maintenance"
.
It is understood that remazolam besylate is a new type of benzodiazepine drug, which is an ultra-short-acting sedative/anesthetic drug with the characteristics of water solubility and short elimination half-life
.
Remazolam besylate for injection is the first Class 1 innovative drug approved for marketing in China by Yichang Renfu Pharmaceutical in July 2020.
The first approved indication is "sedation for colonoscopy"
.
Many of Hansoh's Class 1 New Drugs Approved for Clinical
Trials
Specifically, on March 8, the CDE website showed that Hansoh Pharmaceutical's Class 1 new drug HS-10380 tablets obtained an implied license for clinical trials and was intended to be used for the treatment of schizophrenia
.
The industry believes that HS-10380 tablets are a rare psychiatric innovative drug in the innovative R&D pipeline of local pharmaceutical companies when innovative oncology drugs are popular
.
Prior to this, Hansoh Pharmaceutical's self-developed Class 1 new drug "HS-10370 Tablets" has also obtained a clinical trial notice approved and issued by the NMPA, and is intended to be used for the treatment of advanced solid tumors.
The specific indications will be determined after clinical trials
.
Disclaimer: Under no circumstances does the information or opinions expressed in this article constitute investment advice to anyone
.
