Calliditas Therapeutics

Hansa Biopharma has appointed Dr. Richard Philipson as Chief Medical Officer effective July 14, bringing over 25 years of industry experience to the commercial-stage biopharmaceutical company.

• Renée Aguiar-Lucander has been appointed as the new CEO of Hansa Biopharma AB, effective immediately, replacing Søren Tulstrup who steps down after seven years with the company. • Aguiar-Lucander brings significant experience from her seven-year tenure as CEO of Calliditas Therapeutics, where she led a successful dual NASDAQ listing and launched the first approved drug for IgA nephropathy in the U.S. • The leadership change signals Hansa Biopharma's transition into a new growth phase, with the Board expressing confidence in Aguiar-Lucander's ability to advance the company's strategic positioning.

• Calliditas Therapeutics' Nefecon demonstrated significant efficacy in Phase 3 trial, showing 31% reduction in proteinuria compared to 5% in placebo for IgA nephropathy treatment. • The drug showed favorable safety profile consistent with budesonide, with key secondary endpoint demonstrating 7% treatment benefit in estimated glomerular filtration rate versus placebo. • Company plans FDA filing for accelerated approval in Q1 2021, followed by EMA submission in H2, targeting 130,000-150,000 potential patients in US market.

The Taiwan Food and Drug Administration (TFDA) has approved NEFECON® for treating primary immunoglobulin A nephropathy (IgAN) in adults at risk of disease progression.

Calliditas Therapeutics utilized a novel renal primary surrogate endpoint, proteinuria reduction, in a Phase III trial for IgA nephropathy (IgAN).

NADPH oxidase (NOX) inhibitors are emerging as potential treatments for fibrotic diseases and cancers by reducing reactive oxygen species (ROS) production.

The FDA granted full approval to Travere Therapeutics' Filspari (sparsentan) for IgA nephropathy, allowing broader use for patients at risk of disease progression.