Core Insights - The company Vera has reported positive Phase III data for its treatment targeting IgA nephropathy, a type of kidney disease, which was presented at the ASN meeting and published in the New England Journal of Medicine [2] Group 1: Clinical Development - Vera has completed Phase III trials that yielded compelling results in the treatment of glomerulonephritis, specifically IgA nephropathy [2] - The company submitted its Biologics License Application (BLA) on November 7, with a review timeline of 2 months plus an additional 6 months [2] Group 2: Regulatory Milestones - Vera has received breakthrough designation for its treatment, which is expected to expedite the review process [2] - A PDUFA date is anticipated in early January, with a potential final decision expected in July [2]

Core Viewpoint - The company Fuhong Hanlin (02696) has announced the completion of the first patient dosing in a Phase II clinical trial for HLX79 injection combined with Hanlikang (Rituximab injection) for the treatment of active glomerulonephritis in China, excluding Hong Kong, Macau, and Taiwan [1] Group 1 - The study is a double-blind, randomized, controlled, multi-center Phase II clinical trial aimed at evaluating the efficacy, safety, and tolerability of HLX79 combined with Hanlikang compared to placebo in patients with active glomerulonephritis, specifically lupus nephritis (LN) and membranous nephropathy (MN) [2] - The trial consists of two phases: the first phase is a dose-escalation period where eligible participants will receive weekly doses of HLX79 (10 mg/kg, 20 mg/kg, or 30 mg/kg) combined with Hanlikang or Hanlikang placebo (375 mg/m²) [2] - The primary objective of the first phase is to assess the safety and tolerability of HLX79 combined with Hanlikang compared to placebo combined with Hanlikang in treating active glomerulonephritis [2] Group 2 - The second phase is an exploratory efficacy phase where eligible participants will receive weekly doses of HLX79 (high dose/low dose) combined with Hanlikang (375 mg/m²), HLX79 placebo combined with Hanlikang, or HLX79 placebo combined with Hanlikang placebo in a 2:2:1:1 ratio [2] - The primary objective of the second phase is to evaluate the clinical efficacy of HLX79 combined with Hanlikang, placebo combined with Hanlikang, and placebo treatment for active glomerulonephritis on top of standard treatment [2] - Secondary objectives include assessing other clinical efficacy, safety, tolerability, pharmacokinetic characteristics, and immunogenicity, while exploratory objectives aim to evaluate the dynamic changes of potential biomarkers [2] - As of the date of the announcement, there are no similar combination therapies approved for marketing globally [2]