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Hansoh Pharma Submits NDA for GLP-1/GIP Dual Agonist Olezpeptide Injection for Chronic Weight Management

Jun 04, 2026 10:46 CST Updated 10:46
Hansoh Pharma

Pharmaceutical Research, Production, and Sales

Hansoh Pharma’s GLP-1/GIP dual receptor agonist, olepatide injection (HS-20094), had its New Drug Application (NDA) formally accepted by the National Medical Products Administration (NMPA) on June 3, 2026. It is proposed for long-term weight management in adults with obesity or overweight.
Drug Name:Olepatide Injection (development code HS-20094), a GLP-1/GIP dual-target agonist administered via once-weekly subcutaneous injection.
Indications:Long-term Weight Management in Adults with Obesity or Overweight (Application within China).
Receiving Institution:National Medical Products Administration (NMPA) of China.
Date of Acceptance:June 3, 2026 (Announcement posted on the Hong Kong Stock Exchange on June 4, 2026).
R&D Phase:The pivotal Phase III clinical trial in China (HS-20094-301) has been completed, with the mean weight reduction at the 48-week primary endpoint reaching 19.3%, and demonstrating good tolerability (nausea <10%, vomiting <5%).
Overseas Rights:On June 2, 2025, Hansoh Pharma announced that it had entered into a license agreement with Regeneron, granting Regeneron the exclusive global rights (excluding mainland China, Hong Kong, and Macau) to develop, manufacture, and commercialize HS-20094. Hansoh Pharma will receive an upfront payment of $80 million and is eligible to receive up to $1.93 billion in milestone payments based on progress in product development, regulatory approval, and commercialization.

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The following table lists GLP-1 drugs approved for marketing in China (once-daily dosing):

Drug Ingredients

Trade Name (English/Chinese)
Dosing Frequency
Approved Indications
Original Developer/Major Companies
Remarks
Liraglutide
Victoza (NovoLog)
Once daily
Type 2 Diabetes
Novo Nordisk
In China, multiple biosimilars, including those from Huadong Medicine (Liluping) and Tonghua Dongbao, have been approved, with some covering weight-loss indications.

Saxenda
Once Daily
Obesity/Overweight (Weight Loss)
Novo Nordisk
Products with Clear Indications for Weight Loss
Exenatide
Byetta (Baimida)
Twice daily
Type 2 Diabetes
AstraZeneca/Eli Lilly

Lixisenatide
Lyxumia (Lishimin)
Once daily
Type 2 Diabetes
Sanofi

Benaglutide
Yishengtai
Three times daily
Type 2 Diabetes
Renhui Bio
Domestic Original Research

Fillerme
Three times daily
Obesity/Overweight (Weight Loss)
Renhui Biopharma
Domestically Developed Original Drug: The First Domestic GLP-1 for Weight Loss

The following table lists GLP-1 drugs approved for marketing in China (administered once weekly):

Drug Ingredients

Product Name (English/Chinese)
Dosing Frequency
Approved Indications
Originator / Key Companies
Remarks
Semaglutide
Ozempic (NovoTherapy)
Once weekly
Type 2 Diabetes
Novo Nordisk
Injectable

Wegovy (Novo Nordisk)
Once weekly
Obesity/Overweight (Weight Loss)
Novo Nordisk
Injectable drug with a clear indication for weight loss

Rybelsus (NovoThrive)
Once daily
Type 2 Diabetes
Novo Nordisk
Oral tablet, the first approved oral GLP-1 drug
EnoglurideXianweiyingOnce weeklyObesity/Overweight (Weight Loss)Xianweida

Polyethylene Glycol Loxenatide
Fulaimi
Once weekly
Type 2 Diabetes
Hansoh Pharmaceutical
Domestic Original Research
Ebenatide
(Product Name TBD)
Once Weekly
Type 2 Diabetes
Changshan Pharmaceutical and others
Long-acting domestically developed new drug, approved and soon to be officially launched

The following table lists GLP-1 drugs (dual-target) that have been approved for marketing in China:

Drug Ingredients

Product Name (English/Chinese)
Target
Dosing Frequency
Approved Indications
Enterprise
Tirzepatide
Mounjaro (Mufengda)
GIP/GLP-1
Once weekly
Type 2 Diabetes
Eli Lilly

Zepbound
GIP/GLP-1
Once Weekly
Obesity/Overweight (Weight Loss)
Eli Lilly
Mazdutide
Xin Er Mei
GLP-1/GCGR
Once weekly
2Type 2 Diabetes, Weight Loss
Innovent/Eli Lilly

The semaglutide drugs for which marketing applications have been submitted in China are listed in the table below:
Serial Number
Company Name
Declaration Date
Registration Category
Indications for Application
1
Jiuyuan Gene
2024/4/3
3.3 Class (Biosimilar)
Type 2 Diabetes
2
Xinbeijiang Pharmaceutical (Livzon Group)
2024/6/13
3.3 Category (Biosimilar)
Type 2 Diabetes
3
Qilu Pharmaceutical
2024/9/15
Class 2.2 (Improved New Drugs)
Type 2 Diabetes
4
Federal Biopharma
2025/1/24
3.3 Class (Biosimilars)
Type 2 Diabetes
5
Huadong Medicine
2025/4/3
3.3 Class (Biosimilars)
Type 2 Diabetes
6
Baike Biologics
2025/8/5
Class 2.2 (Improved New Drug)
Type 2 Diabetes
2025/12/6
Class 2.2 (Improved New Drug)
Weight Loss (Obesity/Overweight)
7
Huisheng Biopharma
2025/8/16
3.3 Class (Biosimilars)
Type 2 Diabetes
8
Chengdu Better Biotech
2025/9/3
3.3 Class (Biosimilars)
Type 2 Diabetes
9
Fosun Wanbang
2025/11/7
3.3 Class (Biosimilar)
Type 2 Diabetes
10
Chia Tai Tianqing
2025/12/11
3.3 Class (Biosimilars)
Type 2 Diabetes
11
CSPC Pharmaceutical Group
December 2025
2.2 Class (Improved New Drug)
Weight Loss (Previously Submitted for Diabetes)
12
China Resources Double-Crane
2026/5/8
Class 2.2 (Improved New Drugs)
Type 2 Diabetes
Note: The above information is compiled from publicly available sources.

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