On September 23, the CDE website announced that two indications of the injectable BL-B01D1 submitted by Baili Pharmaceutical are proposed to be included in the breakthrough therapy category. These indications are: locally advanced or metastatic EGFR wild-type non-small cell lung cancer patients who have previously failed anti-PD-1/PD-L1 monoclonal antibody treatment and platinum-based chemotherapy; and locally advanced or metastatic non-squamous non-small cell lung cancer patients with EGFR-sensitive mutations who have failed EGFR-TKI treatment. BL-B01D1 is an EGFR×HER3 bispecific antibody-drug conjugate (ADC).On September 23, UCB announced that the FDA had approved Bimzelx (bimekizumab-bkzx), an IL-17A/IL-17F monoclonal antibody, for the treatment of adult patients with active psoriatic arthritis (PsA), adult patients with active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation, and adult patients with active ankylosing spondylitis (AS).On September 23, the CDE website announced that the marketing application for HSK21542 Injection submitted by Haisco has been accepted. According to Haisco's announcement, this marketing application had already been granted priority review by the CDE for the indication of treating moderate to severe pruritus associated with chronic kidney disease in adult patients on maintenance hemodialysis. HSK21542 is a potent peripheral kappa opioid receptor (KOR) selective agonist developed by Haisco.Recently, Johnson & Johnson announced that the U.S. FDA has approved its bispecific antibody Rybrevant (amivantamab) in combination with standard chemotherapy (carboplatin and pemetrexed) for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) exon 19 deletion (ex19del) or L858R substitution mutations, whose disease has progressed after receiving EGFR tyrosine kinase inhibitor (TKI) therapy.Investment and Financing in PharmaceuticalsRecently, LongBio, a biotechnology company focusing on the development of innovative antibody drugs in the fields of allergy and complement, announced the successful completion of a nearly 100-million-yuan B2 round of financing. This round of financing was led by Qiming Venture Partners, with existing shareholders adding further investments. The proceeds will be used to advance LongBio's core projects in clinical research in China, accelerate the product launch process, and support the company’s international market expansion, further strengthening its competitiveness in the global biopharmaceuticals field.Technology-Driven Drug Research
Pathogenic hypothalamic extracellular matrix promotes metabolic disease[1]Beddows, C.A., Shi, F., Horton, A.L. et al. Pathogenic hypothalamic extracellular matrix promotes metabolic disease. Nature (2024). https://doi.org/10.1038/s41586-024-07922-y
