Return to site
Return to site

RemeGen's Telitacicept Granted Conditional Marketing Approval to Treat Systemic Lupus Erythematosus (SLE) in China

March 12, 2021
broken image

RemeGen Co., Ltd. (RemeGen, 9995.HK) announces that telitacicept (RC18, Brand Name: 泰爱®), the dual targeted TACI-Fc fusion protein independently developed in-house by the Company, has been granted conditional marketing approval by the National Medical Products Administration of China (NMPA) for the treatment of patients with Systemic Lupus Erythematosus (SLE).

SLE has one of the highest mortality and disability rates among autoimmune rheumatic diseases. According to Frost & Sullivan, the global SLE prevalence was approximately 7.7 million in 2019, estimated to reach 8.6 million by 2030. In China, there were approximately 1.0 million SLE patients in 2019, and the prevalence is estimated to grow to approximately 1.1 million by 2030. According to Frost & Sullivan, the market size of global SLE biological therapeutics is estimated to grow at a CAGR of 26.8% from US$0.8 billion in 2019 to US$10.8 billion by 2030.

Telitacicept is the second innovative biologics drug approved to treat SLE in China over the past 60 years. It is constructed with the extracellular domain of the human transmembrane activator and calcium modulator and cyclophilin ligand interactor (TACI) receptor and the fragment crystallizable (Fc) domain of human immunoglobulin G (IgG). Telitacicept targets two cell-signaling molecules critical for B-lymphocyte development: B-cell lymphocyte stimulator (BLyS) and a proliferation inducing ligand (APRIL), which allows it to effectively reduce B-cell mediated autoimmune responses that are implicated in several autoimmune diseases. RemeGen is currently conducting a number of phase II or III clinical studies for telitacicept to treat other indications within the autoimmune disease area, in an attempt to address the significant unmet or underserved medical needs in this therapeutic area.

Source: RemeGen Co.

Related News:

RemeGen Debuts on Hong Kong Stock Exchange (2020/11/09)

RemeGen Completes USD $100 Million Plus in Funding (2020/04/02)

Previous
Allist's Third Generation EGFR-TKI Receives Marketing...
Next
Connect Biopharma Holdings Limited announces pricing of...
 Return to site
Cookie Use
We use cookies to improve browsing experience, security, and data collection. By accepting, you agree to the use of cookies for advertising and analytics. You can change your cookie settings at any time. Learn More
Accept all
Settings
Decline All
Cookie Settings
Necessary Cookies
These cookies enable core functionality such as security, network management, and accessibility. These cookies can’t be switched off.
Analytics Cookies
These cookies help us better understand how visitors interact with our website and help us discover errors.
Preferences Cookies
These cookies allow the website to remember choices you've made to provide enhanced functionality and personalization.
Save