Thirteen Class 1 New Drugs Receive First-in-China IND Approvals, Including Innovations from Innovent, Humanwell and More
Hansoh Pharma
Pharmaceutical Research, Production, and Sales
Hengrui Pharma
Innovative and High-Quality Pharmaceutical Developer
According to the Mose Pharm China Drug Evaluation Database, last week(February 24 ~ March 02)Thirteen novel Class 1 drugs have received Investigational New Drug (IND) approval for the first time in China, including six chemical drugs, five biologics, and two traditional Chinese medicines. This article will highlight selected products and introduce the basic information of these new drugs.
Screenshot source: Mosentropy China Drug Evaluation Database
Hansoh PharmaAnnounced that its self-developed Class 1 new chemical drugHS-10501-2Has successfully obtained clinical trial approval, aiming to explore its potential in treating adult obesity and type 2 diabetes. According to the application number information, this new drug falls under the category of chemical drugs, but so far, its specific mechanism of action has not been disclosed through public channels.
Screenshot source: Mesentech Global Drug R&D Database
In addition, Hansoh Pharma is also actively promoting another R&D project - oral GLP-1 receptor.（GLP-1R）Agonist DrugsHS-10501 Tablets, the drug has officially entered the clinical research stage in China, also targeting the treatment areas of adult obesity and type 2 diabetes.
Renfu PharmaSelf-developed Class 1 New DrugCXJM-66 InjectionClinically approved for application in surgical anesthesia and acute pain management. As a new molecular entity drug,CXJM-66Classified as Chemical Drug Class 1 according to the registration classification.
Screenshot source:Moxie Pharma Global Drug Research and Development Database
This drug has an innovative structure and acts as a sodium channel blocker, effectively preventing sodium ions from entering the cell membrane, inhibiting the transmission of neuronal excitation signals, and demonstrating a characteristic that is difficult to be washed off, thereby providing long-lasting anesthesia effects. Non-clinical study results show,CXJM-66 InjectionA single use can quickly exhibit significant analgesic effects, with no significant toxic reactions observed, demonstrating excellent safety.CXJM-66 InjectionThe successful development marks an important step for Yichang Renfu in the field of anesthetic and analgesic drug research and development.
February 26,Hengrui PharmaOfficially announced that its subsidiaryShandong Shengdi PharmaceuticalThe declared Class 1 new chemical drugHRS-1301 Tablets, has been approved by the National Medical Products Administration and has officially entered the clinical trial stage for the treatment of hyperlipidemia.
Screenshot source:Moxie Pharma Global Drug R&D Database
HRS-1301 TabletsIt is an innovative drug independently developed by Hengrui Pharma. Although its specific mechanism of action has not been disclosed, preclinical studies have confirmed its effectiveness in improving symptoms of hyperlipidemia. Currently, no similar drugs are available on the market worldwide.As of the time of the announcement,Hengrui PharmaInHRS-1301 TabletsThe project has cumulatively invested approximately 18.36 million RMB in research and development funds.
On February 24, the CDE of China's National Medical Products Administration (NMPA) announced,Innovent BiologicsSelf-developed Class 1 New DrugIBI3002Approved for clinical trials, intended to treat asthma.
Screenshot source:Moxie Pharma Global Drug Research and Development Database
IBI3002Is a bispecific antibody against IL-4Rα/TSLP, currently undergoing Phase 1 clinical trials in Australia, marking the first IND approval in China. The drug targets IL-4Rα and TSLP, aiming to treat inflammatory diseases including asthma. By blocking these two cytokine signaling pathways,IBI3002Can inhibit type 2 and non-type 2 inflammation, and in vitro experiments show its effect is superior to similar monoclonal antibodies already on the market, with the potential to demonstrate superiority in the treatment of type 2 inflammatory diseases.
On February 25, according to the announcement on the CDE official website,Lingnuo PharmaClass 1 New Drug ApplicationInjectable SLN12140（LIN-2102）Received clinical approval aimed at treating primary IgA nephropathy.SLN12140It is a new generation of complement-targeting drug developed by Linnovation Pharma, featuring a single-domain antibody VHH-Fc structure that effectively inhibits abnormal complement activation in the pathology of IgAN.
Screenshot source:Moxie Pharma Global Drug R&D Database
Compared with other complement-targeted drugs,SLN12140With more stable pharmacokinetic properties, excellent target specificity and activity, and a convenient subcutaneous administration method. Its mechanism of selective inhibition of complement activation ensures higher safety, making it suitable for long-term treatment of IgA nephropathy and other complement-related diseases. Currently, the product has been approved to conduct clinical trials in China, Australia, and the United States.
Last week, 13 Class 1 new drugs were approved in China, covering multiple therapeutic areas and bringing new hope to patients. Hansoh Pharma's HS-10501 series targets obesity and diabetes, Renfu Pharmaceutical's CXJM-66 injection innovates in the field of anesthesia and pain relief, and Hengrui Pharma's HRS-1301 tablets are expected to fill the gap in hyperlipidemia drugs. These new drugs demonstrate the enhancement of China's new drug R&D capabilities, providing patients with more treatment options.
END
This article is original. Please leave a message to obtain authorization for reprint.
Blue Paper on the Current Status and Future Trends of the CGT Industry - 202406
White Paper on the Current Status and Future Trends of the Traditional Chinese Medicine Industry - 202407
2023 Pharmaceutical Enterprise Comprehensive Strength Ranking - 202408
Crossing Borders, Leading Innovation: The Practice of Chinese Pharmaceutical Companies Expanding Overseas - 202408
Five Major Small Molecule Drugs with Patents About to Expire: How Intense is the Competition for Generic Drugs in China? - 202409
Analysis Report on the Current Status of China's Radiopharmaceuticals Market - 202410
Development Prospects of Synthetic Biology Industry and Analysis of Upstream, Midstream, and Downstream Enterprises in China's Synthetic Biology Industry Chain - 202410
China Synthetic Biology Venture Capital Market Analysis Report - 202410
China Diabetes Clinical Diagnosis and Treatment and Drug Multi-Channel Market Data Analysis - 202411
Analysis of Complex Injectable Formulations Based on Dosage Form Modification -- Microspheres Chapter - 202411
2024 Analysis Report on the Development of the Medical Aesthetics Injection Materials Market - 20241213
National Drug Centralized Procurement Tracking Report - Review and Outlook of the First 9 Batches - 202411
More RecentlyMoxie ConsultingPopular Report, Scan the QR Code Below to Claim
Contact us to experience more professional services from Mosen Pharma. | ||||
WillDiscussion CombinedWork | GardenDistrict TakeWu | Database Consultation | Customization Service | Media Cooperation |
???ClickImage Above, you can start the Mosan Chemical Data Query
