YS Biopharma Co. Ltd. has received clinical trial approval by the Philippine Food and Drug Administration to begin a phase I trial of its YS-HBV-002 immunotherapeutic vaccine, designed to treat chronic hepatitis B virus (HBV) infection. The trial will begin in the Philippines in June.

Having addressed the manufacturing issues that resulted in a few complete response letters, Alvotech Holdings SA and Teva Pharmaceutical Industries Ltd.’s biosimilars partnership is now on a roll, with the U.S. FDA approving the team’s second biosimilar, Selarsdi, less than two months after approving the first one, Simlandi, as an adalimumab interchangeable.

The timing is ripe for a robust biosimilar market in China, given the rapid increase of novel biologics approved to treat cancer and inflammatory diseases in the country over the past decade and the looming patent cliffs for several established biologics. As of December, the NMPA had approved more than 20 biosimilars that were developed in China. Most of those referenced just two biologics – Roche AG’s cancer drug Avastin (bevacizumab) and Abbvie Inc.’s immunology drug Humira (adalimumab). In 2022, the oncology and immunology biosimilar market in China garnered sales of about $2 billion, according to Clarivate estimates. To reach their full potential in China though, biosimilars must win over prescribers and patients.

The FDA has granted orphan drug designation to the active ingredient in Soligenix Inc.’s Marvax, a heat stable subunit protein vaccine of recombinantly expressed Marburg marburgvirus (MARV) glycoprotein, for the prevention and post-exposure prophylaxis against MARV infection.

SARS-CoV-2 could proliferate in the lungs causing severe COVID-19 through a special type of immune cell. A group of scientists from Stanford University observed how this coronavirus infected interstitial macrophages through a CD209 receptor, triggering the inflammatory response observed in hospitalized patients.

Following decisions in 2023 to back away from its lead neurological therapies and conserve cash, Eliem Therapeutics Inc. found a vote of investor confidence and a new direction through its acquisition of privately held Tenet Medicines Inc. and its anti-CD19 antibody for autoimmune disease.

The U.S. FDA has cleared Tr1x Inc.’s IND application for TRX-103 for the prevention of graft-vs.-host disease (GVHD) in patients undergoing HLA-mismatched hematopoietic stem cell transplantation (HSCT).

Sitryx Therapeutics Ltd. has nominated SYX-5219 as the first candidate from its proprietary pipeline to progress to regulatory nonclinical studies to support a clinical trial authorization (CTA). SYX-5219 has the potential to address a broad range of inflammatory diseases and will advance into the clinic for the treatment of atopic dermatitis.