Hansoh Pharma's Class 1 New Drug HS-10529 Receives IND Approval in China for KRAS G12D-Mutant Solid Tumors

Apr 15, 2025 07:43 CST Updated 07:43

Hansoh Pharma

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On April 14, the official website of the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) announced the latest information,Hansoh Pharma's申报的1类新药HS-10529片获批临床，Proposed Development TreatmentKRAS G12DMutations in Advanced Solid Tumors (Pancreatic Cancer, Colorectal Cancer, Non-Small Cell Lung Cancer, etc.)According to the CDE official website and publicly available information, this is the first time the product has been approved for an IND in China.

Screenshot source:CDE Official Website

KRASIs a common driver gene mutation,KRAS G12DYesKRASThe main mutation subtype in approximately 34% ofPancreatic Ductal AdenocarcinomaDetected in 12% of colorectal cancers, 4% of non-small cell lung cancers, and various other types of cancer.KRAS G12DPatients with mutations have a poor prognosis, and currently, no targeted therapies have been approved for marketing.

According to public channel inquiries, dozens of new drugs targeting KRAS G12D have entered clinical research stages worldwide, with some leading products already advancing to Phase 2 clinical trials.These types of drugs under research cover small molecules, TCR-T cell therapies, siRNA drugs, protein degradation therapies, and more.

In clinical research, products targeting this site have also seen many advancements. For instance,In October 2024, Revolution Medicines announced its KRAS G12D-targeted covalent inhibitorRMC-9805Preliminary positive data in treated pancreatic ductal adenocarcinoma (PDAC) patients who received the product treatmentThe disease control rate for PDAC patients is as high as 80%.。The product was also selected by the well-known industry media Drug Hunter in its 2024 annual release.Star Molecule List。In July 2024, a subsidiary of *Cell*Cancer CellLaunched a Specific Inhibitor for KRAS G12DHRS-4642A latest advancement in development,Two patients with advanced non-small cell lung cancer who had received multiple lines of standard anti-tumor therapy achieved partial response (PR) with target lesion reductions of 53% and 31%, respectively.

We look forward to more products achieving breakthroughs in clinical applications, so that cutting-edge technologies can benefit patients as soon as possible.

References:

[1]Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China.Retrieved Apr 14，2025, From https://www.cde.org.cn/main/xxgk/listpage/4b5255eb0a84820cef4ca3e8b6bbe20c

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