Beigene Ltd. has received approval from China’s NMPA to market Sylvant (siltuximab) for the treatment of patients with multicentric Castleman disease, including HIV-negative and human herpes virus-8-negative disease. The green light comes at a good time as the Beijing-headquartered company is preparing for a $3.5 billion listing on Shanghai’s STAR Market, its third listing. The monoclonal antibody siltuximab previously received regulatory approval in the U.S. and Europe.
PERTH, Australia – Cynata Therapeutics Ltd. has regained rights to its Cymerus mesenchymal stem cell (MSC) product, CYP-001, for graft-vs.-host disease (GVHD) from former licensee Fujifilm Corp., with the two companies negotiating a new partnership under which Fujifilm will manufacture the product.
Harbour Biomed Therapeutics Ltd. said its anti-FcRn monoclonal antibody, batoclimab, generated top-line phase II data in generalized myasthenia gravis, and the company expects to move into a phase III study by the end of this year, with final data reported in April 2022.
Having created a profitable preclinical services business, Biocytogen Pharmaceuticals Co. Ltd. is now working to develop its own pipeline of antibody therapeutics, recently inking a partnership with China Resources Biopharmaceutical Co. Ltd. to develop drugs for oncology and immunology indications and raising “tens of millions of dollars” in a new financing round to support the development of its antibody drugs.
Keymed Biosciences Inc. debuted on the Hong Kong Stock Exchange (HKSE) on July 8, raising HK$2.94 billion (US$378.48 million) in the process. The company will use the funds raised for the R&D and commercialization of key pipeline candidates.
Just days after Hifibio Therapeutics Inc. closed a $75 million series D financing, Fibrogen Inc. has agreed to pay the antibody specialist $25 million up front and as much as $1.1 billion in milestones for rights to multiple preclinical programs for autoimmune diseases and cancer. The deal includes exclusive rights to Galectin-9 programs, in which the lead asset is expected to enter clinical development in the first quarter of 2023, and options to license all assets in Hifibio's CXCR5 and CCR8 programs.
Inmagene Biopharmaceuticals Co. Ltd. has raised $100 million in a series C financing to move its IL-17 inhibitor to phase II trials in the U.S. and China.
Takeda Pharmaceutical Co. Ltd. said findings from its phase III Solstice study testing oral antiviral TAK-620 (maribavir) in treating solid organ transplant recipients with cytomegalovirus infections resistant or refractory to prior therapy (R/R CMV), showed twice the rate of confirmed CMV viremia clearance compared to other conventional therapies.
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.
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