Remegen: Vera’s TRUTAKNA approval validates BAFF/APRIL class and positive for ReMeGen

研报英文原文证据摘录

Remegen: Vera’s TRUTAKNA approval validates BAFF/APRIL class and positive for ReMeGen

Asia Pacific Equity Research

09 July 2026

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Remegen

Vera’s TRUTAKNA approval validates BAFF/APRIL

class and positive for RemeGen

Vera Therapeutics’ TRUTAKNA approval marks the first US regulatory Healthcare

validation of dual BAFF/APRIL inhibition (see our US biotech analyst AC Yang Huang

Anupam Rama's note here). Despite intensifying competition, we think it (852) 2800 3812

is a net positive read-through for RemeGen. The FDA granted accelerated yang.huang@jpmorgan.com

approval to TRUTAKNA (atacicept) on July 7 for reducing proteinuria in J.P. Morgan Securities (Asia Pacific) Limited/

J.P. Morgan Broking (Hong Kong) Limited

adults with primary IgA nephropathy (IgAN) at risk of disease

progression. RemeGen’s telitacicept was the world’s first approved dual 688331.SS, 688331 CH

BAFF/APRIL-targeting therapy, initially approved in China in 2021 with Overweight

IgAN indication approval in June 2026, while TRUTAKNA is the first Price: Rmb132.01

such therapy approved in the US and the second approved globally. 09 Jul 2026

Competition is set to increase further: Vertex completed the rolling BLA PricePT EndTarget:Date: Rmb151.0031 Dec 2026

for its dual BAFF/APRIL inhibitor povetacicept in March 2026, with an

FDA PDUFA date of November 30, 2026. Zai Lab holds its exclusive

development and commercialization rights in Greater China and 9995.HK, 9995 HK

Singapore.