Wed, April 03, 2024 at 03:24

• 

  Kang-hoon

  • Good day, Annie.

  • I have some news about RemeGen Co. Ltd., a commercial-stage biotechnology company.

  • They recently obtained Fast Track Designation (FTD) from the United States Food and Drug Administration (FDA) for their innovative BLyS/APRIL dual-target fusion protein drug, Telitacicept (RC18).

  • This drug is being developed for the treatment of patients with primary Sjgren's syndrome (pSS).

  • 
• Annie

  • Oh, really?😮 What exactly is this Fast Track Designation?

  
• 

  Kang-hoon

  • Fast Track Designation is a process designed by the FDA to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need.

• Annie

  • I see, so it's like a fast pass for drugs that could potentially save lives or address unmet needs.

  • But what is this primary Sjgren's syndrome (pSS)?

  
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• 

  Kang-hoon

  • Primary Sjgren's syndrome is a common rheumatic disease.

  • It's characterized by autoimmune exocrinopathy that clinically manifests as dry eyes and mouth caused by glandular dysfunction as a result of autoimmune damage.

  • Multiple organ systems are also at risk of being affected.

• Annie

  • That sounds pretty serious...😢 How does Telitacicept work to treat this condition?

  
• 

  Kang-hoon

  • Telitacicept is an innovative BLyS/APRIL dual-target fusion protein drug that simultaneously inhibits the overexpression of two cytokines, B-cell lymphocyte stimulator (BLyS) and a proliferation-inducing ligand (APRIL).

  • It prevents abnormal differentiation and maturation of B-cells, thereby treating various autoimmune diseases mediated by B-cells.

• Annie

  • Wow, that sounds very advanced!😲 So, when did they start developing this drug?

  
• 

  Kang-hoon

  • In December 2023, Telitacicept was granted Investigational New Drug (IND) by the FDA for the treatment of active pSS in adults.

  • 

  • A phase III clinical trial for this indication is currently underway in China.

• Annie

  • I see.

  • So it's still in the trial phase.

  • What does the CEO of RemeGen say about this?

  
• 

  Kang-hoon

  • Dr. Jianmin Fang, CEO of RemeGen, expressed delight at the FDA's recognition of Telitacicept for fast track designation.

  • He mentioned that it has performed well in clinical studies for multiple indications that have been marketed in China.

  • They are accelerating global development of multiple indications of Telitacicept and are confident of cementing a leadership position in B-cell-mediated autoimmunity drugs.

• Annie

  • That's great!👍 So, do you think this news is good or bad?

  • How will it affect the market?

  
• 

  Kang-hoon

  • This news is definitely positive.

  • The Fast Track Designation will accelerate the development and review process of Telitacicept.

  • If successful, it could potentially bring significant benefits to patients with primary Sjgren's syndrome and other autoimmune diseases.

  • This could also boost RemeGen's reputation and position in the biotechnology market.

  • Upon comprehensive consideration, this news is perceived as a 😍Bullish.