According to incomplete statistics from the People’s Daily Health Client, as of March 23, 2022, 315 clinical trial applications have passed the “implicit license” since the beginning of the year. 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 class 1 new drug JMT103 reached the preset endpoint
On March 22, CSPC announced that, The pivotal clinical trial of JMT103, a new class 1 drug for the treatment of unresectable or difficult-to-operate GCTs, reached the pre-specified endpoint.
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.
According to Luye Pharma’s official website
Luye Pharma’s Class 1 new drug under development is approved for development Phase III Clinical Trials
On March 21, Luye Pharma announced that the group’s new compound (NCE) and China’s Class 1 new chemical drug “LY03005” has been approved by the National Medical Products Administration of China The Centers for Drug Evaluation (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.
Yichang Renfu Pharmaceutical’s Class 1 new drug and new indications were approved for listing
On March 17, Yichang Renfu Pharmaceutical also announced that it received the national The “Drug Registration Certificate” for Remazolam Besylate for Injection, approved and issued by the Drug Administration, approved the company’s listing of additional indications for Remazolam Besylate for injection. The new indication is “general anesthesia induction and maintain”.
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 category 1 innovative drug approved by Yichang Renfu Pharmaceutical in China in July 2020. The first approved indication is “sedation for colonoscopy”.
Many of Hansoh’s Class I new drugs have been approved for clinical trials one after another
Recently, Hansoh Pharmaceutical’s Class I new drugs HS-10380 and HS-10370 Approved for clinical trials one after another. 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.
Before 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, with specific indications. To be determined after clinical trials. (Liu Yingqi)