Accessibility Statement Skip Navigation
  • Resources
  • Data Privacy
  • Contact Us
  • Send a Release
Return to PR Newswire homepage
  • News
  • Products
    • Overview
    • Distribution by PR Newswire
    • Guaranteed Paid Placement
    • Cision Media Monitoring
    • Multichannel Amplification
    • All Products
  • Contact
    • General Inquiries
    • Request a Demo
    • Partnerships
    • Media Inquiries
When typing in this field, a list of search results will appear and be automatically updated as you type.

Searching for your content...

No results found. Please change your search terms and try again.
  • News in Focus
      • Browse News Releases

      • All News Releases
      • All Public Company
      • English-only
      • All Multimedia

      • All Multimedia
      • All Photos
      • All Videos
  • Business & Money
      • Auto & Transportation

      • Aerospace & Defense
      • Air Freight
      • Airlines & Aviation
      • Automotive
      • Maritime & Shipbuilding
      • Railroads & Intermodal Transportation
      • Supply Chain/Logistics
      • Transportation, Trucking & Railroad
      • Travel
      • Trucking & Road Transportation
      • View All Auto & Transportation

      • Business Technology

      • Blockchain
      • Broadcast Tech
      • Computer & Electronics
      • Computer Accessories
      • Computer Hardware
      • Computer Networks
      • Computer Software
      • Data Analytics
      • Electronic Commerce
      • Electronic Components
      • Electronic Design Automation
      • Financial Technology
      • High-Tech Security
      • Internet Technology
      • Nanotechnology
      • Semiconductors
      • View All Business Technology

      • Entertain­ment & Media

      • Advertising
      • Art, Culture & Design
      • Books
      • Entertainment
      • Film & Motion Picture
      • Magazines
      • Music
      • Publishing & Information Services
      • Radio & Podcast
      • Television
      • View All Entertain­ment & Media

      • Financial Services & Investing

      • Accounting News & Issues
      • Acquisitions, Mergers & Takeovers
      • Banking & Financial Services
      • Bankruptcy
      • Bond & Stock Ratings
      • Conference Call Announcements
      • Contracts
      • Cryptocurrency
      • Dividends
      • Earnings
      • Earnings Projections or Forecasts
      • Financing Agreements
      • Insurance
      • Investment Options
      • Joint Ventures
      • Mutual Funds
      • Offerings
      • Private Placement
      • Real Estate
      • Restructuring & Recapitalization
      • Sales Reports
      • Shareholder Activism
      • Shareholder Meetings
      • Venture Capital
      • View All Financial Services & Investing

      • General Business

      • Awards
      • Commercial Real Estate
      • Corporate Expansion
      • Earnings
      • Environmental, Social and Governance (ESG)
      • Human Resource & Workforce Management
      • Licensing/marketing agreements
      • New Products & Services
      • Obituary
      • Outsourcing Businesses
      • Overseas Real Estate (Non-US)
      • Personnel Announcements
      • Residential Real Estate
      • Small-Business Services
      • Socially Responsible Investing
      • Surveys, Polls & Research
      • Trade Show News
      • View All General Business

  • Science & Tech
      • Consumer Technology

      • Artificial Intelligence
      • Blockchain
      • Cloud Computing/Internet of Things
      • Computer Accessories
      • Computer Electronics
      • Computer Hardware
      • Computer Networks
      • Computer Software
      • Consumer Electronics
      • Cryptocurrency
      • Data Analytics
      • Electronic Commerce
      • Electronic Design Automation
      • Financial Technology
      • Mobile Devices/Apps
      • Social Media
      • STEM (Science, Tech, Engineering, Math)
      • Wireless Communications
      • View All Consumer Technology

      • Energy & Natural Resources

      • Alternative Energies
      • Chemical
      • Electrical Utilities
      • General Manufacturing
      • Mining
      • Mining & Metals
      • Natural Gas Utilities
      • Oil & Energy
      • Oil & Gas Discoveries
      • Utilities
      • Water Utilities
      • View All Energy & Natural Resources

      • Environ­ment

      • Conservation & Recycling
      • Environmental Issues
      • Environmental Policy
      • Environmental Products & Services
      • Green Technology
      • Natural Disasters
      • View All Environ­ment

      • Heavy Industry & Manufacturing

      • Aerospace & Defense
      • Agriculture
      • Chemical
      • Computer Accessories
      • Construction & Building
      • General Manufacturing
      • HVAC (Heating, Ventilation & Air-Conditioning)
      • Machinery
      • Machine Tools, Metalworking & Metallurgy
      • Mining
      • Mining & Metals
      • Paper, Forest Products & Containers
      • Precious Metals
      • Textiles
      • Tobacco
      • View All Heavy Industry & Manufacturing

      • Telecomm­unications

      • Computer Accessories
      • Computer Networks
      • Mobile Devices/Apps
      • Telecommunications
      • Telecommunications Carriers & Services
      • Telecommunications Equipment
      • VoIP (Voice over Internet Protocol)
      • Wireless Communications
      • View All Telecomm­unications

  • Lifestyle & Health
      • Consumer Products & Retail

      • Animals & Pets
      • Beers, Wine & Spirits
      • Beverages
      • Cannabis
      • Cosmetics and Personal Care
      • Fashion
      • Food
      • Furniture & Furnishings
      • Home Improvement
      • Household, Consumer & Cosmetics
      • Household Products
      • Jewelry
      • Non-Alcoholic Beverages
      • Office Products
      • Product Recalls
      • Restaurants
      • Retail
      • Supermarkets
      • Toys
      • View All Consumer Products & Retail

      • Entertain­ment & Media

      • Advertising
      • Art, Culture & Design
      • Books
      • Entertainment
      • Film & Motion Picture
      • Magazines
      • Music
      • Publishing & Information Services
      • Radio & Podcast
      • Television
      • View All Entertain­ment & Media

      • Health

      • Biometrics
      • Biotechnology
      • Clinical Trials & Medical Discoveries
      • Dentistry
      • FDA Approval
      • Fitness/Wellness
      • Health Care & Hospitals
      • Health Insurance
      • Infectious Disease Control
      • International Medical Approval
      • Medical Equipment
      • Medical Pharmaceuticals
      • Mental Health
      • Pharmaceuticals
      • Supplementary Medicine
      • View All Health

      • Sports

      • Outdoors, Camping & Hiking
      • Sporting Events
      • Sports
      • Sports Equipment & Accessories
      • View All Sports

      • Travel

      • Amusement Parks & Tourist Attractions
      • Gambling & Casinos
      • Hotels & Resorts
      • Outdoors, Camping & Hiking
      • Passenger Aviation
      • Travel
      • View All Travel

  • Policy & Public Interest
      • Policy & Public Interest

      • Animal Welfare
      • Corporate Social Responsibility
      • Economic News, Trends & Analysis
      • Education
      • Environmental Products & Services
      • European Government
      • Natural Disasters
      • Not-for-Profit
      • Public Safety
      • View All Policy & Public Interest

  • People & Culture
      • People & Culture

      • Children-related news
      • Disabled Persons
      • Diversity, Equity & Inclusion
      • Hispanic-oriented news
      • LGBTQ+
      • Religion
      • Senior Citizens
      • Veterans
      • Women-Related news
      • View All People & Culture

  • Overview
  • Distribution by PR Newswire
  • Guaranteed Paid Placement
  • Cision Media Monitoring
  • Multichannel Amplification
  • All Products
  • General Inquiries
  • Request a Demo
  • Partnerships
  • Media Inquiries
  • Hamburger menu
  • PR Newswire: news distribution, targeting and monitoring Home
  • Send a Release
    • Chat

    • ALL CONTACT INFO
    • Contact Us


  • News Releases
  • Send a Release
  • Data Privacy
  • News in Focus
    • Browse All News
    • Multimedia Gallery
    • Trending Topics
  • Business & Money
    • Auto & Transportation
    • Business Technology
    • Entertain­ment & Media
    • Financial Services & Investing
    • General Business
  • Science & Tech
    • Consumer Technology
    • Energy & Natural Resources
    • Environ­ment
    • Heavy Industry & Manufacturing
    • Telecomm­unications
  • Lifestyle & Health
    • Consumer Products & Retail
    • Entertain­ment & Media
    • Health
    • Sports
    • Travel
  • Policy & Public Interest
  • People & Culture
    • People & Culture
  • News Releases
  • Send a Release
  • Data Privacy
  • Overview
  • Distribution by PR Newswire
  • Guaranteed Paid Placement
  • Cision Media Monitoring
  • Cision IR
  • SocialBoost
  • All Products
  • News Releases
  • Send a Release
  • Data Privacy
  • General Inquiries
  • Request a Demo
  • Editorial Bureaus
  • Partnerships
  • Media Inquiries
  • News Releases
  • Send a Release
  • Data Privacy

FDA Grants Fast Track Designation for AJ201, a First-in-Class Therapy for Kenndy's Disease
  • USA - español
  • Japan - Japanese
  • USA - English
  • USA - English
  • USA - Deutsch


News provided by

AnnJi Pharmaceutical Co., Ltd.

23 Oct, 2025, 11:24 CST

Share this article

Share toX

Share this article

Share toX

TAIPEI, Oct. 23, 2025 /PRNewswire/ -- AnnJi Pharmaceutical Co., Ltd. (AnnJi, TWSE: 7754) today announced that the U.S. Food & Drug Administration (FDA) has granted Fast Track Designation for AJ201, the first-in-class for therapy for spinal and bulbar muscular atrophy (SBMA, also known as Kennedy's disease).

"Receiving the Fast Track Designation for AJ201 marks a significant milestone for AnnJi," said Dr. Wendy Huang, CEO and Chairperson of the Board of AnnJi. "Alongside the Orphan Drug Designations granted by both the U.S. FDA and EMA, this recognition reinforces AJ201's potential to address the unmet needs of patients with SBMA. Backed by a strong global patent portfolio, we remain committed to advancing AJ201 into Phase 3 development and to working closely with the FDA to potentially deliver the first approved treatment for SBMA in more than two decades."

About SBMA and AJ201

SBMA, or Kennedy's disease, is a rare X-linked inherited neuromuscular disorder caused by CAG repeat expansion in the androgen receptor (AR) gene. The resulting mutant AR protein contributes to muscle and neuron degeneration through mechanisms involving cellular toxicity, oxidative stress, and neuroinflammation. SBMA affects ~1 in 40,000 males globally and currently has no FDA-approved treatment.

AJ201, also known as JM17, is a novel investigational compound that has shown potential in reducing mutant AR toxicity and improving motor function in preclinical SBMA models. At the molecular level, it promotes degradation of pathogenic mAR protein, induces expression of antioxidant enzymes, proteasome subunits, and heat shock proteins, all of which may slow disease progression (Bott et al., 2016).

About AnnJi Pharmaceutical

AnnJi Pharmaceutical Co., Ltd. (TWSE: 7754) is a clinical-stage drug development company focused on the development of innovative small molecules (NCEs). The company is dedicated to addressing high unmet medical needs in the fields of neurology, dermatology, and immune-inflammatory diseases, including rare diseases, such as Kennedy's disease (SBMA) and Idiopathic Pulmonary Fibrosis (IPF).

AnnJi is committed to develop innovative therapies that improve the quality of life for patients suffering from neglected chronic diseases. We focus on advancing high-quality, differentiated, and innovative drug candidates, and collaborating with global pharmaceutical partners. Upon achieving proof-of-concept in phase II clinical trials, we aim to out-license our products for further co-development and commercialization, with the goal of bringing them to global markets and driving sustainable growth for the company.

Contact:

Anne Yu; [email protected]

SOURCE AnnJi Pharmaceutical Co., Ltd.

Modal title

Also from this source

AnnJi Showcases Clinical Breakthrough of AJ201 at WMS 2025

AnnJi Showcases Clinical Breakthrough of AJ201 at WMS 2025

AnnJi Pharmaceutical Co., Ltd. (AnnJi, TWSE: 7754) announced that the Phase 2a clinical result of AJ201 for spinal and bulbar muscular atrophy (SBMA, ...

AnnJi Pharmaceutical Company Announces Positive Phase 1/2a Results for AJ201 in Spinal and Bulbar Muscular Atrophy (SBMA) Patients

AnnJi Pharmaceutical Co., Ltd., a clinical-stage Taiwanese biotechnology company focused on addressing unmet medical needs in dermatology, neurology, ...

More Releases From This Source

Explore

Health Care & Hospitals

Health Care & Hospitals

Medical Pharmaceuticals

Medical Pharmaceuticals

Pharmaceuticals

Pharmaceuticals

Biotechnology

Biotechnology

News Releases in Similar Topics

Contact Cision

  • General Inquiries
  • Request a Demo
  • Partnerships
  • Media Inquiries

Products

  • Cision Communication Cloud®
  • For Marketers
  • For Public Relations
  • For IR & Compliance
  • For Agency
  • For Small Business
  • All Products

About

  • About PR Newswire
  • About Cision
  • Become a Publishing Partner
  • Careers
  • Accessibility Statement
  • APAC – Simplified Chinese
  • APAC
  • APAC - Traditional Chinese
  • Arabic
  • Brazil
  • Canada
  • Czech
  • Denmark
  • Finland
  • France
  • Germany
  • India
  • Indonesia
  • Israel
  • Italy
  • Japan
  • Korea
  • Mexico
  • Middle East
  • Netherlands
  • Norway
  • Poland
  • Portugal
  • Russia
  • Slovakia
  • Spain
  • Sweden
  • United Kingdom
  • United States
  • Vietnam

My Services

  • All New Releases
  • Platform

Do not sell or share my personal information:

  • Submit via [email protected] 
  • Call Privacy toll-free: 877-297-8921

Contact Cision

Products

About

My Services
  • All News Releases
  • Platform
[email protected]
  • Terms of Use
  • Privacy Policy
  • Information Security Policy
  • Site Map
  • RSS
  • Cookie Settings
  • Accessibility
Copyright © 2025 Cision US Inc.