Hansoh Pharma Secures IND Approvals for Eight Novel Class 1 Drugs in 2025

Jul 11, 2025 08:18 CST Updated 08:18

Hansoh Pharma

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Insight The database shows,2025 Since the year, Hansoh Pharma has 8 First Approval for Clinical Trials of a Class 1 New Drug。

In terms of drug types, it includes 2 PaymentADC、6 PaymentChemical Drugs. From the perspective of indications,3 This drug is used to treat tumors, 3 A drug used to treat immune system diseases,1 Cardiovascular system drugs,1 PaymentForEndocrine System and Metabolic Drugs.

Source: Insight Database

This article will specifically introduce five products with disclosed targets for reference.

HS-10561: BTK Inhibitor

February 25,HS-10561 Granted Clinical Approval for the First Time in China, for the Treatment of Chronic SpontaneousUrticaria.

Source: CDE Official Website

HS-10561 is a small molecule BTK inhibitor developed by Lu Peng Pharmaceutical. In August 2024, Hansoh Pharma and Lu Peng Pharmaceutical reached a strategic cooperation, through which Hansoh Pharma obtained the product.All Non-Oncology IndicationsIn China(Including Hong Kong, Macao and Taiwan)The rights to the research and development, registration, production, and commercialization. This time isHS-10561 capsule formulation has been approved for clinical use for the first time, while the tablet form of this product was already approved for clinical use as early as 2021.

HS-10501-2: GLP-1R Agonist Sustained-Release Tablets

February 26,HS-10501-2 Granted Clinical Approval in China for the First Time, Intended for Development to Treat Adult Type 2 Diabetes and Adult Obesity.

Source: CDE Official Website

HS-10501-2 isSustained-release tablet formulation of GLP-1R agonistIn May this year, Hansoh Pharma successively registered for the evaluation in overweight and obese subjects.Once daily oral administration of HS-10501/HS-10501-2A multicenter, randomized, double-blind, placebo-controlled Phase II clinical trial for efficacy and safety, as well asA Randomized, Double-blind, Placebo-controlled, Dose-escalation Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Dosing of HS-10501-2 in Healthy Participants.

HS-20122: EGFR/c-Met Bispecific Antibody ADC

On April 8, HS-20122 was approved for clinical use in China, intended for the treatment of advanced solid tumors.(Including non-small cell lung cancer, head and neck squamous cell carcinoma, or colorectal cancer, etc.)。

Source: CDE Official Website

According to public information,HS-20122 is aTargetToEGFR/c-Met Bispecific ADC, derived from the EGFR/cMet bispecific antibody PM1080 introduced by Promab.（HS-20117）. The product is currently in the Phase I dose escalation stage.

HS-10529: KRAS G12D Inhibitor

On April 15, HS-10529 received approval from the NMPA to commence clinical trials for the treatment of advanced solid tumors with KRAS G12D mutations.(Pancreatic cancer, colorectal cancer, non-small cell lung cancer, etc.)。

Source: CDE Official Website

KRAS is one of the most widely mutated oncogenes in tumors, with KRAS mutations present in approximately 30% of tumors. KRAS mutations include various point mutations, the most common of which are G12C, G12D, and others.Currently, there are no KRAS G12D inhibitors approved for marketing globally.

HS-10529 Is a self-developed product by Hansoh PharmaTargetedSmall Molecule Inhibitors of KRAS G12D, with high selectivity. Preclinical efficacy studies have shown that HS-10529 has good preclinical efficacy activity, pharmacokinetic properties, and safety.

HS-10510: PCSK9 Inhibitor

May 19,HS-10510 Approved for Clinical Use in China for the First Time, for the Treatment ofPrimary Hypercholesterolemia and Mixed Dyslipidemia。

Source: CDE Official Website

This MayOn the 30th day of the month, Hansoh Pharma registered a clinical drug trial on the Drug Clinical Trial Registration and Information Disclosure Platform in China.A Randomized, Double-blind, Placebo-controlled, Dose-escalation Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Oral Doses of HS-10510 Tablets in Healthy Subjects/Hyperlipidemic Subjects.

Based on the registration information and acceptance number, it is speculated thatHS-10510 is a small moleculePCSK9 Inhibitors。

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