HOME ABOUT CONTACT AVAILABLE ISSUES SUBSCRIBE MEDIA & ADS
LATEST UPDATES » Vol 26, Nos. 11 & 12, November & December 2022 – Worlds Within Worlds – Viruses, Humanity, and the Environment       » Pinpointing How This Key Protein Facilitates Viral Transmission From Insects to Plants       » A New Approach to Treating Organic Wastewater       » Using Old Plants for New Tricks?       » Using Gas Bubbles as Lenses to View Tissues More Deeply       » Seawater as a Renewable Energy Source       » Generating Oxygen Within Cells
Vol 26, Nos. 11 & 12, November & December 2022   |   Issue PDF view/purchase
INSIDE INDUSTRY
RemeGen Receives Orphan Drug Designation from FDA for Telitacicept for the Treatment of Myasthenia Gravis
This will address the large unmet need on a global scale for Myasthenia Gravis.

RemeGen Co., Ltd., a commercial-stage biotechnology company, announced that the U.S. Food and Drug Administration (FDA) has granted orphan-drug designation (ODD) for its proprietary novel fusion protein Telitacicept (RC18) for the treatment of myasthenia gravis (MG).

Myasthenia gravis (MG) is a chronic autoimmune neuromuscular disease that causes patients to be prone to fluctuating muscle weakness. It can affect eye movements, swallowing, speech, and respiratory functions to varying degrees and can even be life-threatening in severe cases. The disease, although rare, is a long-term condition that currently is difficult to cure. In 2018, it was added to the National Rare Diseases Registry System of China, the first national list of rare diseases to be issued in the country.

At present, the most common treatment options to alleviate symptoms for MG include cholinesterase inhibitors, glucocorticoids, immunosuppressants, intravenous immunoglobulin, plasma exchange, anti-CD20 monoclonal antibodies (mAbs), and thymectomy. These treatments can have certain side effects, while fast-acting treatments such as plasma replacement may have an impact on the immune system due to the removal of other macromolecules and poor accessibility. Therefore, a large unmet clinical need is currently being addressed by RemeGen.

“We’re delighted that the FDA has granted ODD for the RemeGencreated proprietary novel fusion protein Telitacicept,” said Dr. Jianmin Fang, CEO and Chief Scientific Officer of RemeGen. “This is an important step in our quest to address the large unmet need on a global scale for myasthenia gravis, and follows on from our successful Phase II clinical study on patients in China earlier this year.

In the first quarter of this year, the company announced the completion of a Phase II clinical study of Telitacicept for the treatment of generalised myasthenia gravis (gMG) in Chinese patients, which showed positive results.protein


Source: RemeGen Co., Ltd.

NEWS CRUNCH  
news analytica Vietnam Exhibition Returns to Reunite the Industry After Its 4-Year Hiatus
news 2022 PDA Aseptic Processing of Biopharmaceuticals Conference
news Thailand LAB INTERNATIONAL, Bio Asia Pacific, and FutureCHEM INTERNATIONAL are ready to offer the Science and Technology Industry complete solutions this September!
news Better together: registration opens for Vitafoods Asia 2022 co-located with Fi Asia in October
SPOTLIGHT  

MAGAZINE TAGS
About Us
Events
Available issues
Editorial Board
Letters to Editor
Contribute to APBN
Advertise with Us
CONTACT
World Scientific Publishing Co. Pte. Ltd.
5 Toh Tuck Link, Singapore 596224
Tel: 65-6466-5775
Fax: 65-6467-7667
» For Editorial Enquiries:
   [email protected] or Ms Carmen Chan
» For Subscriptions, Advertisements &
   Media Partnerships Enquiries:
   [email protected]
Copyright© 2022 World Scientific Publishing Co Pte Ltd  •  Privacy Policy