China NMPA has granted conditional approval for conditional approval for RemeGen’s Telitacicept (RC-18) with theraputic indiction of Systemic Lupus Erythematosus(SLE) on Mar 10, 2021. This is the RemeGen’s first product approved for marketing.
Telitacicept is a kind of TACI-Fc fusion protein and a dual-targeting drug that inhibits the two cytokines of BLyS(B-cell lymphocyte stimulator) and APRIL at the same time.[1]Di Wu, Jing Li, Dong Xu, etc. A Human Recombinant Fusion Protein Targeting B Lymphocyte Stimulator (BlyS) and a Proliferation-Inducing Ligand (APRIL), Telitacicept (RC18), in Systemic Lupus … Continue reading Telitacicept can be used for the treatment of autoimmune diseases such as moderate to severe SLE, rheumatoid arthritis, and neuromyelitis optica spectrum disorder (NMOSD).
China NMPA accepted RemeGen’s NDA for telitacicept for the treatment of SLE in November 2019 and granted us priority review in December 2019. FDA grants fast track designation to RemeGen’s telitacicept as a treatment for SLE in Apr, 2019. Phase II New Drug Clinical Trial starts in the US at the same year.
The published data showed that there was a statistically significant difference in the clinical response rate (SLE responder index, SRI-4) between the telitacicept group (79.2%) and the placebo group (32%) in clinical trial. [2] Bingyi Yang,† Ming Zhao,† Haijing Wu,A Comprehensive Review of Biological Agents for Lupus: Beyond Single Target, Front. Immunol., 02 October 2020
Except for the indication of SLE ,phase III clinical trials for rheumatoid arthritis, and phase II clinical trials for IgA nephritis, Sjogren’s syndrome, multiple sclerosis and myasthenia gravis are all under process for telitacicept by RemeGen.
Although price of Telitacicept is not reveal yet, it is estimated by professional investorss that sales volume will be nearly 3 billion in the future.
About RemeGen Co Ltd
RemeGen, a leading biopharmaceutical company in China , was founded in Yantai, Shandong Province of China in 2008. RemeGen has research labs and offices throughout China and the United States. RemeGen is committed to the discovery, development and commercialization of innovative and differentiated biologic drugs of significant clinical value in the key therapeutic areas of autoimmune, oncology and ophthalmic diseases.
References
| ↑1 | Di Wu, Jing Li, Dong Xu, etc. A Human Recombinant Fusion Protein Targeting B Lymphocyte Stimulator (BlyS) and a Proliferation-Inducing Ligand (APRIL), Telitacicept (RC18), in Systemic Lupus Erythematosus (SLE): Results of a Phase 2b Study, Meeting: 2019 ACR/ARP Annual Meeting |
| ↑2 | Bingyi Yang,† Ming Zhao,† Haijing Wu,A Comprehensive Review of Biological Agents for Lupus: Beyond Single Target, Front. Immunol., 02 October 2020 |
