The U.S. FDA approved 22 drugs in June, tying with March for the highest number of approvals and a jump from 15 approvals in May. The FDA approved 107 drugs in the first half (H1) of 2025, making it the third-highest total for this period in BioWorld’s records, trailing 118 approvals in 2024 and 108 in 2020.
Livzon Mabpharm Inc.’s anti-IL-17A/F monoclonal antibody, LZM-012, met the primary endpoint in a phase III trial in moderate to severe plaque psoriasis. Conducted at Fudan University’s Huashan Hospital, the phase III multicenter, randomized, double-blind, active-controlled (secukinumab) trial enrolled 926 patients with moderate to severe plaque psoriasis.
Regulatory snapshots, including drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations in Asia-Pacific: Biocon, Bio-Thera, Daiichi, GC Biopharma.
Biopharma happenings in Asia-Pacific including deals and partnerships, grants, preclinical data and other news in brief: 365mc, Acumen, Biogen, Bridge Health, Centargia, Harrow, Hekabio, I-Mab, JCR, Kadimastem, Kowa, Nicox, Nkgen, NLS, Otsuka, Raziel, Samsung.
China has proved to be a fertile ground for innovation as evidenced by some big deals in the antibody-drug conjugate (ADC) space, and the number of candidates entering clinical trials in China or being advanced in the U.S. by Chinese companies.
Under a new licensing deal announced July 8, JCR Pharmaceuticals Co. Ltd. granted Alexion Pharmaceuticals Inc. rights to its adeno-associated virus (AAV) capsids for use in up to five of Alexion’s genomic medicines programs.
Historically, Q2 has often been one of the strongest quarters for biopharma financing, but 2025’s figures suggest a more cautious investment climate. Biopharma companies raised $16.02 billion in the second quarter (Q2) of 2025, a modest increase from the $13.11 billion brought during Q1. While the uptick signals some recovery from Q1, the sector is still pacing well behind the highs of recent years.
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