Home Novartis' Atrasentan (Noruida®) Becomes First High-Selectivity Endothelin A (ETA) Receptor Antagonist Approved in China for IgA Nephropathy

Novartis' Atrasentan (Noruida®) Becomes First High-Selectivity Endothelin A (ETA) Receptor Antagonist Approved in China for IgA Nephropathy

Aug 28, 2025 17:51 CST Updated 17:51
Novartis

Drug Development and Manufacturing

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PharmaCircleMonitoring shows:Recently, Novartis' innovative product Noruida®(Nepatrostat Hydrochloride Tablets) Approved by the National Medical Products Administration for Reducing Proteinuria in Adult Patients with Primary Immunoglobulin A Nephropathy (IgA Nephropathy) at Risk of Rapid Disease Progression.This product was first developed byDeveloped by Chinook and later acquired by Novartis

Generally, the Urine Protein-to-Creatinine Ratio (UPCR) of such patients is ≥ 1.5 g/g. Novartis®Is the first non-immunological therapy approved in China for the treatment of IgA nephropathy (IgAN), and is currently the only one specifically targeting this indication in China.Highly Selective Endothelin A (ETA) Receptor Antagonist, which is expected to reshape the cornerstone of IgA nephropathy treatment. This follows Fei Heda®(Ipocapam Hydrochloride Capsules) is the second nephrology product approved by Novartis in China after receiving approval for its nephrology indication.

Novartis China President and Managing Director Li Yao said, "We are very pleased to usher in the field of kidney disease treatment.Another ProductApproved in China. This is the first non-immunological basic treatment for the disease in China, offering a new therapeutic option for patients with IgA nephropathy. This approval will also benefit a wider patient population. This year, Novartis has had two products successively approved in the field of kidney disease treatment, fully demonstrating our firm commitment to accelerating the introduction of innovative drugs and achieving synchronization with the rest of the world. In the future, Novartis will continue to leverage its profound accumulation of over 40 years in the field of kidney disease treatment, advance the innovation pipeline layout in this field more quickly, and provide patients with more precise, effective, and safer treatment options.




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Meeting Information



Meeting Time:October 23-24, 2025

Hosted by:Clinical Research Professionals, Pharmaceutical Circle

Meeting Location:Nanjing

Participants:

1. Pharmaceutical and Medical Device R&D and Manufacturing Enterprises

2. Clinical CRO/SMO

3. Clinical Trial Parties and Supplier Enterprises (Systems, AuditsSearch, PharmaceuticalsSupply, BioassayTest, PV, translation, etc.)




Agenda



01
Opening Ceremony & Main Forum

1. A 40-Year Report on Clinical Trials in China

2. Award Ceremony for Outstanding Contributors to 40 Years of Clinical Trials in China

3. 2025 Clinical Trial Industry Development Survey Report

4. 2025 Annual Excellence in Clinical Research Supplier Awards

5. 2025 Clinical Research Professionals Employment Status Survey Report

6. 2025 Annual Excellence in Clinical Research Awards


02
9 Major Sub-Forums


Forum I



· New Trends and Clinical Trial Development

1. Latest Policies on Innovative Drug Research, Development and Commercialization

2. Latest Developments and Trends in International Pharmaceutical Regulation

3. Jiangsu Province Policies to Promote the Development of the Biopharmaceutical Industry and Clinical Trials

4. New Trends in the Development of the Biomedical Industry Abroad

5. Going Global and International Innovation: Overseas Expansion and Phase III Clinical Development Strategies for Innovative Drugs

6. NEWCOAuthorized Transactions




Forum II



· New Technologies and Clinical Trial Transformation

1. AIEmpower Clinical Trials

2. DCTPractice and Application

3. Digital Management of Clinical Trial Institutions

4. Remote Intelligent Clinical Trial Operations Practice

5. Informatization Management of Clinical Trials

6. Integrated Management System for Clinical Trials




Forum III



· New Regulations and Clinical Trial Management

1. Interpretation of the Latest Policies on Clinical Trial Management

2. Latest Verification Standards and Trends

3. FDA/EMAInspection Standards and Common Issues

4. Construction of Institutional Quality Management System

5. Safety Event Verification Standards and Quality Management

6. Challenges and Responses in Clinical Trial Quality Management Brought by New Technologies




Forum Four



· Clinical Trials of Innovative Drugs

1. ADC

2. RDC

3. Gene and Cell Therapy

4. Nucleic Acid Drugs and Delivery Technologies

5. Peptide Drugs

6. Innovative Traditional Chinese Medicine/Natural Medicines




Forum V



· Modified New Drug/Generic Drug Clinical Trials

1. Clinical Value and Development Strategies of Modified New Drugs

2. Development Opportunities and Challenges for Modified New Drug Clinical Trials

3. Challenges and Reflections in Clinical Research of Complex Formulations

4. Development Challenges and Application of New Technologies in Modified Compound Formulations

5. Development and Clinical Trials of Transdermal Preparations

6. Design and Analysis of Clinical Trials for Bioequivalence Evaluation




Forum VI



· Medical Device/IVDRegistration and Clinical Trials

1. Current Status and Trends in Innovative Device Registration

2. Medical Device Export and International Registration

3. IVDInnovation in R&D and Clinical Trials

4. Clinical Trials of Orthopedic Innovative Devices

5. Clinical Trials of Surgical Robots

6. AIEmpower Device R&D and Clinical Trials



Forum VII



· Clinical Trial Medical Affairs and Statistics

1. Medical Strategy

2. Medical Monitoring

3. Pharmacovigilance

4. Medical Writing

5. Data Management

6. Statistical Analysis



Forum VIII



· Clinical Trial Supply Chain and Central Laboratory Management

1. Pharmaceutical Supply Chain Management

2. Central Laboratory

3. Biological Sample Management

4. Equipment Rental

5. Logistics and Warehousing

6. Digitalization andAIEmpower Supply Chain Management




Forum IX



· Clinical Research and Achievement Transformation in Medical Institutions

1. Construction and Management of Biobanks

2. Investigator-Initiated Study Management

3. Hospital Diagnosis and Treatment Database Applied in Clinical Research

4. Application of Hospital Diagnostic Databases in Drug Development

5. Compliance and Ethical Issues in Clinical Research and Technology Transfer in Medical Institutions

6. Analysis of Medical Institution Achievement Transformation Examples







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