Harbour Biomed Ltd. and Sichuan Kelun-Biotech Biopharmaceutical Co. Ltd. have announced IND approval by China’s National Medical Products Administration (NMPA) for HBM-7575 (SKB-575) for the treatment of atopic dermatitis.

The OX40-targeting mechanism pursued by drug developers around the world found itself shadowed March 3 when Kyowa Kirin Co. Ltd. gave up work with rocatinlimab, a monoclonal antibody for which hopes had risen in moderate to severe atopic dermatitis, prurigo nodularis and moderate to severe asthma.

Shortly after Amgen Inc. walked away from its partnership with Kyowa Kirin Co. Ltd., the Tokyo-based company said it is discontinuing all ongoing clinical trials for rocatinlimab due to safety concerns.

The U.S. FDA clearance Feb. 20 of East Windsor, N.J.-based Acrotech Biopharma Inc.’s PDE4 inhibitor Adquey (difamilast ointment 1%) for mild to moderate atopic dermatitis brought renewed focus on the mechanism, where other drugs are already approved and more are stocking developers’ pipelines across indications.

After 118 years as a private company, dermatology specialist Leo Pharma A/S is poised to complete an IPO after reporting a full-year net profit for the first time since 2018.

Marking an important day for those with atopic dermatitis, shares of two biopharmas surged on clinical data suggesting new biologics are on their way to help address 40% of patients with uncontrolled disease.

Almirall SA has submitted a CTA filing for a bispecific antibody targeting IL-13 and OX-40L for the treatment of atopic dermatitis. The company expects to initiate a first-in-human phase I trial during the first half of this year.

Citing the “totality of data,” Sanofi SA plans to file global regulatory submissions this year for amlitelimab in atopic dermatitis, despite mixed results from two additional phase III trials testing the OX40-ligand (OX40L) inhibitor the pharma firm has been positioning as a potential successor to its Regeneron Pharmaceuticals Inc.-partnered blockbuster, Dupixent (dupilumab).