Over 10 Class 1 Innovative Drugs Receive First-in-China IND Approvals from Companies Including Innovent Biologics and AstraZeneca

　　【Pharmaceutical Network Industry DynamicsFrom January 13 to January 18, 11 Class 1 innovative drugs received Investigational New Drug (IND) approval for the first time in China, from pharmaceutical companies such as Qilu Pharmaceutical, GenSci, Innovent Bio, and AstraZeneca.
 

Last week, Qilu Pharmaceutical's申报的化药1类新药QLS1304片获得了临床试验默示许可，用于既往标准治疗失败的晚期实体瘤患者。有数据显示，2023年在中国三大终端六大市场抗肿瘤化药销售额超过800亿元。在该治疗领域，Qilu Pharmaceutical有10款1类新药在中国处于获批临床及以上阶段。
 

GenSci's Class 1 New Drug, GenSci120 Injection, Approved for Clinical Trials for Two Indications, Aiming to Develop Treatments for Systemic Lupus Erythematosus and Primary Sjögren's Syndrome. Data shows that GenSci120 is a humanized anti-PD-1 monoclonal antibody developed by GenSci, with an antibody type of IgG1. By binding to PD-1 and activating the PD-1 inhibitory signaling pathway as well as ADCC effects, it inhibits or kills pathogenic T cells, exerting relatively specific targeted immunosuppressive effects.
 

Innovent Bio's Class 1 New Drug IBI3014 Approved for Clinical Trials, Intended for Development to Treat Advanced Solid Tumors. Additionally, it is expected that Innovent Bio will have three major drugs potentially launched by 2025, including: Mastytide (GCG/GLP-1), a dual-target GLP-1 drug co-developed by Innovent Bio and Eli Lilly; Teprotumumab, intended for the treatment of Thyroid Eye Disease (TED); and Picankibart, an IL-23p19 monoclonal antibody independently developed by the company.
 

In addition to the above products, according to the review, several domestically produced innovative drugs were approved for clinical trials last week. These include the approval of the Class 1 new drug DF-003 capsule, developed by Shanghai Yaoyuan Biotechnology Co., Ltd., for the treatment of chronic kidney disease. The Class 1 new drug CVI-2742 capsule, submitted by Civeo Pharmaceuticals, was approved for clinical trials to treat non-alcoholic steatohepatitis (also known as metabolic dysfunction-associated steatohepatitis, MASH). RGL-2201 injection, a Class 1 new drug from Ruihong Di Pharmaceuticals, was approved for clinical trials to treat neovascular age-related macular degeneration. APL-2302 (ASN-3186 capsule), a Class 1 new drug from Asia-Pacific Pharmaceuticals, was approved for clinical trials to treat advanced solid tumors. GH56 capsule, a Class 1 new drug from Qinhou Pharmaceuticals, was approved for clinical trials for the treatment of advanced solid tumors with MTAP gene deletion. NSP-1047A tablets, a Class 1 new drug submitted by Novostar Pharmaceuticals, were approved for clinical trials to treat relapsed or refractory acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS). The Class 1 new drug KY-0301 injection, developed by Keyi Pharmaceuticals, was approved for clinical trials to treat advanced solid tumors.
 

In addition, last week, one imported product was approved for clinical trials — AZD0022, a Class 1 new drug submitted by AstraZeneca. This drug is under development for the treatment of advanced solid tumors carrying the KRAS G12D mutation. Reports indicate that this is a KRAS G12D inhibitor, currently in Phase 1/2 clinical trials internationally.
 

KRAS is a commonly mutated driver gene, and KRAS G12D is the predominant mutation subtype among KRAS mutations. It can be detected in approximately 34% of pancreatic ductal adenocarcinomas, 12% of colorectal cancers, 4% of non-small cell lung cancers, and various other types of cancers. Patients with the KRAS G12D mutation have a poor prognosis, and currently, no targeted therapies have been approved for this mutation. AZD0022 is a small-molecule KRAS G12D inhibitor. According to available information, AstraZeneca initiated a Phase 1/2a study (ALAFOSS-01) in October 2024 to evaluate the safety, tolerability, pharmacokinetics, and efficacy of AZD0022 as a monotherapy or in combination with anticancer drugs for adult patients with KRAS G12D-mutated tumors. This is an international multicenter study planned to be conducted in China, the United States, Australia, Canada, and other countries, with an enrollment target of 430 participants, including those with advanced solid tumors, non-small cell lung cancer, colorectal cancer, and pancreatic ductal carcinoma. The study is expected to reach preliminary completion by January 2028.
 

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