RemeGen Enters a Licensing Agreement with Santen Pharmaceutical for RC28-E to Treat Eye Diseases

Shots:RemeGen has granted Santen exclusive rights to develop, manufacture, & commercialize RC28-E in Greater China (incl. Mainland China, Hong Kong, Macau, & Taiwan), South Korea, Thailand, Vietnam, Singapore, Philippines, Indonesia, & Malaysia, while RemeGen will retain its rights in other territoriesAs per the deal, RemeGen will receive $38.9M (¥250M) upfront, ~$72.3M (¥520M) in…

ByRidhi RastogiAugust 19, 2025

NEWS

Remegen Reports P-III Trial Data of Telitacicept for Sjögren’s Syndrome in China

Shots:Remegen has reported P-III trial data assessing telitacicept vs PBO in pts with primary Sjögren's syndromeTrial met its 1EP of reduced EULAR Sjögren’s syndrome disease activity index (ESSDAI), showing improved disease activity at Wk. 24; NMPA’s BLA submission is planned, along with presentation of detailed data at an upcoming conferenceTelitacicept is a…

ByRidhi RastogiAugust 13, 2025

NEWS

Vor Bio Enters a ~$4.12B Exclusive Global License Agreement with RemeGen to Develop and Commercialize Telitacicept

Shots:Vor Bio and RemeGen have entered an exclusive licensing agreement, giving Vor Bio rights outside China, Hong Kong, Macau, and Taiwan to develop & commercialize telitaciceptAs per the Deal, RemeGen will receive $125M ($45M upfront and $80M in stock warrants). RemeGen is eligible for more than $4B in regulatory & commercial milestones + tiered…

ByDipanshu DixitJune 27, 2025

NEWS

RemeGen’s Telitacicept Receives the NMPA’s Approval for Generalized Myasthenia Gravis (gMG)

Shots:The NMPA has approved telitacicept for the treatment of AChR antibody-positive gMG in combination with standard therapiesIn P-III trial for gMG, telitacicept demonstrated favorable efficacy vs PBO, with 98.1% vs 12% pts achieving ≥3-point MG-ADL reduction (-5.74 vs -0.91) as well as 87% vs 16% pts having ≥5-point QMG reduction (-8.66 vs -2.27) at…

ByRidhi RastogiMay 27, 2025

NEWS

Remegen Reports P-III Trial Data of Telitacicept for Generalized Myasthenia Gravis (gMG)

Shots:Remegen has reported P-III trial data assessing Telitacicept (RC18; 240mg; n=57) vs PBO (n=57) in 114 chinese gMG pts, with baseline MG-ADL score ≥6 & QMG score ≥8; trial incl. 24wk. double-blind phase followed by an open-label phase. BLA is under the NMPA’s review, with decision expected in Q2’25Trial showed 98.1% vs 12% pts achieved…

ByRidhi RastogiApril 9, 2025

INSIGHTS+

Insights+: Breakthrough Therapy Designation by the US FDA in 2020

Breakthrough Therapy (BT) Designation is an expedited review program introduced in Section 902 of the Food and Drug Safety and Innovation Act of 2012The Breakthrough Designation is granted to the drug candidates as monotherapy or in combination with other drugs intended to treat serious or life-threatening diseases and has shown substantial improvement over available…

BySenior EditorMarch 11, 2021

Remegen Reports P-III Trial Data of Telitacicept for Sjögren’s Syndrome in China

Vor Bio Enters a ~$4.12B Exclusive Global License Agreement with RemeGen to Develop and Commercialize Telitacicept

RemeGen’s Telitacicept Receives the NMPA’s Approval for Generalized Myasthenia Gravis (gMG)

Remegen Reports P-III Trial Data of Telitacicept for Generalized Myasthenia Gravis (gMG)

Insights+: Breakthrough Therapy Designation by the US FDA in 2020

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