Zenas Biopharma LLC launched on March 23 as a U.S. funded cross-border biotech company targeting autoimmune diseases in China. The company, headquartered in Miromar Lakes, Fla., is founded and funded by Tellus Bioventures LLC and Fairmount Funds Management LLC.

Remegen Co. Ltd.’s RC-18 (telitacicept) was granted conditional approval for systemic lupus erythematosus (SLE), marking the first NDA approval for the company that launched the world’s biggest biotech IPO last year. A self-developed dual targeted TACI-Fc fusion protein, telitacicept is the second innovative biologic to treat SLE approved in China.

Clinical-stage biopharma HBM Holdings Ltd. (also known as Harbour Biomed) debuted on the Hong Kong Stock Exchange on Dec. 10, raising HK$1.71 billion (US$220.7 million) to advance its autoimmune candidates to commercial launches in 2023.

Preclinical startup Tavotek Biotherapeutics Ltd., with operations in Pennsylvania and Suzhou, China, boasts two technology platforms for discovering and developing molecular-targeted biologics for cancers and autoimmune diseases and is working to push its candidates, including a bispecific antibody, to the clinic next year.

PERTH, Australia – Regenerative medicine company Mesoblast Ltd. saw its stock drop 37% on the news that it received an FDA complete response letter to its BLA for Ryoncil (remestemcel-L) for the treatment of pediatric steroid-refractory acute graft-vs.-host disease.

HONG KONG – Looking to boost its R&D capacity, China’s Sunshine Guojian Pharmaceutical (Shanghai) Co. Ltd. launched an IPO on July 22 that raised ¥1.7 billion (US$240 million) on Shanghai’s STAR market. Shares (SSE:688336) almost doubled in value on the first day of trading, closing at ¥54.10, for a gain of 92%.

PERTH, Australia – CSL Ltd. said its subsidiary, CSL Behring, has agreed to exercise an option to acquire Canadian biotech Vitaeris Inc. for its lead phase III asset for rejection in solid organ kidney transplant patients.