According to incomplete statistics from the People's Daily health client, as of March 23, 2022, 315 clinical trials have applied for "implied permission" since the beginning of the year. It is worth noting that in this context, many pharmaceutical companies have recently made new progress in the research and development and listing of class 1 new drugs.
A key clinical trial of JMT103, a new class 1 drug of CSPC Group, reached a preset endpoint
On March 22, CSPC Pharmaceutical Group announced that the key clinical trial of JMT103, a new class 1 drug of the company's subsidiary, Shanghai Jinmante Biotechnology Co., Ltd., for the treatment of non-resectable or surgically difficult osteopenytoma, reached a preset endpoint.
According to reports, JMT103 is an innovative fully human-derived LANKAL monoclonal antibody, which simplifies the production process by optimizing the structure of the same target drug disulumab, while enhancing affinity. The Group conducted two clinical studies in China (JMT103CN03 and JMT103CN03-1) as key clinical trials for JMT103 for the treatment of unresectable or surgically difficult osteojublastomas to support the marketing of this product. At present, the Group has submitted an application for pre-market communication to the State Drug Administration of the People's Republic of China.
According to the official website of Luye Pharmaceutical
Luye Pharmaceutical's new drug class 1 under research was approved to carry out phase III clinical trials
On March 21, Luye Pharmaceutical announced that the group's new compound (NCE) and China's class 1 chemical new drug "LY03005" has been approved by the Drug Evaluation Center (CDE) of the State Drug Administration of China to carry out Phase III clinical trials for the treatment of generalized anxiety disorder.
LY03005 is a novel molecular-solid therapeutic agent with a completely new mechanism of action, a triple reuptake inhibitor (SNDRI/TRI) of serotonin (5-HT), norepinephrine (NE), and dopamine (DA). 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 had completed Phase I to III clinical trials for the treatment of depression in China, and its marketing application was accepted by the CDE in June 2021.
Yichang Renfu Pharmaceutical Co., Ltd. class 1 new drug new indications were approved for listing
On March 17, Yichang Renfu Pharmaceutical also announced that it had received the "Drug Registration Certificate" on ramazolam for injection approved and issued by the State Drug Administration, and approved the company's remazolam for injection to increase the indications for listing, and the new indications were "induction and maintenance of general anesthesia".
It is understood that ramazolam besylate is a new type of benzodiazepine, which is an ultra-short-acting sedative/anesthetic drug, with the characteristics of water solubility and short elimination half-life. Ramazolam for injection is the first Class 1 innovative drug approved by Yichang Renfu Pharmaceutical in China in July 2020, and the first approved indication is "sedation for colonoscopy".
A number of new drugs of the first class in Howson have been approved for clinical trials
Recently, Haosen Pharmaceutical's class 1 new drugs HS-10380 and HS-10370 have been approved for clinical trials. Specifically, on March 8, the CDE website showed that Howson Pharmaceutical's class 1 new drug HS-10380 tablets obtained tacit permission for clinical trials and was intended to be used to treat schizophrenia. The industry believes that at the moment when innovative drugs for cancer are popular, HS-10380 tablets are rare psychiatric innovative drugs in the innovative research and development pipeline of local pharmaceutical companies.
Prior to this, the new class 1 drug "HS-10370 tablets" independently developed by Howson Pharmaceutical has also obtained a clinical trial notice approved by NMPA and is intended to be used for the treatment of advanced solid tumors, and the specific indications are to be determined after clinical trials. (Liu Yingqi)
