Thirteen Class 1 new drugs have been approved for clinical trials! Innovent, Hansoh, Gan & Lee, and Health-One, among others, have entered the fray

April 28, 2026  Source: drugdu 30

"/In the past week, China has seen a number of new developments in clinical trial applications for innovative drugs . Data shows that from April 20th to April 26th, 2026, 13 Class 1 new drugs were approved for clinical trials, linked to 19 application numbers. These drugs cover chemical drugs, therapeutic biological products, and traditional Chinese medicine, involving multiple areas such as ADCs, bispecific antibodies, siRNA, small molecule inhibitors, anti-infective drugs, and innovative traditional Chinese medicines.
This batch of products includes projects from companies such as Innovent Biologics, Hansoh Pharmaceutical, Gan & Lee Pharmaceuticals, Health-One, and Qilu Pharmaceutical, as well as new developments in innovative traditional Chinese medicine and anti-infective drugs. More noteworthy than the approval of individual products for clinical trials is the simultaneous advancement of different technological approaches to the clinical stage.
Antibody drugs remained one of the most active areas last week.
Last week, therapeutic biologics projects saw progress in ADC, bispecific antibodies, and monoclonal antibodies. Gan & Lee Pharmaceuticals' GLR1059 for injection received clinical trial approval. Public information shows that this product is an ADC drug targeting Nectin-4. Nectin-4 is one of the most promising targets in the ADC field in recent years, and the clinical trial of GLR1059 signifies Gan & Lee Pharmaceuticals' continued progress in innovative oncology drugs. Innovent Biologics received clinical trial approval for two products last week: IBI3031 and IBI115 . Public information shows that IBI3031 is an IGF-1R/TSHR bispecific antibody intended for thyroid eye disease; IBI115 is a DLL3/CD3 bispecific antibody intended for advanced small cell lung cancer. In addition, CVL006 injection and SG301SC injection also received clinical trial approval. The former involves VEGF/PD-L1, and the latter is a monoclonal antibody-related project. Overall, antibody drugs remain one of the most noteworthy sectors among the clinical trial approvals last week.
siRNA, small molecules, and anti-infective drugs also hold promise.
Qilu Pharmaceutical's QLS7320 injection is a noteworthy siRNA product. QLS7320 achieves liver-targeted delivery via GalNAc conjugation and is intended for the treatment of paroxysmal nocturnal hemoglobinuria (PNH). In recent years, small nucleic acid drugs have seen increasing interest in delivery technologies, rare diseases, and autoimmune diseases. QLS7320's entry into the clinical stage adds a new observational sample to the domestic siRNA pipeline. Fushi Biosciences' FS-207 tablets represent a new advancement in small molecule drugs. Public information shows that this product is a small molecule inhibitor of WRN helicase, intended for the treatment of MSI-H advanced solid tumors. WRN is one of the important targets for synthetic lethality; after related domestic projects enter clinical trials, the subsequent efficacy and safety data deserve continuous monitoring. Health Yuan's JKN2502 for injection falls under the anti-infective field. JKN2502 is a novel lipopeptide polymyxin antibiotic intended for the treatment of severe infections. Compared to popular fields like oncology and metabolism, innovative anti-infective drugs are not always in the spotlight, but the clinical need for multidrug-resistant bacterial infections has always existed.
Metabolic diseases and innovative traditional Chinese medicines have also been included in the list.
Hansoh Pharmaceutical's HS-20136 injection received clinical trial approval last week, linked to six other drug application numbers. This product is intended for the treatment of type 2 diabetes and weight management. With the continued rise in popularity of GLP-1 and other metabolic disease-related drugs, weight management has become a key area of focus for pharmaceutical companies both domestically and internationally. Two innovative traditional Chinese medicine drugs also appeared on last week's list: Dihuang Baoyuan Granules and Fuling Yunhua Granules . Both are from Jingyi and Shengyi Pharmaceutical-related entities, with Dihuang Baoyuan Granules linked to two application numbers.

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