The FDA has lifted a partial clinical hold on MediLink Therapeutics’ Phase 1 trial for BNT326/YL202, a HER3-targeting antibody-drug conjugate (ADC), allowing the trial to resume with adjusted dose levels. The decision follows MediLink’s submission of a complete response addressing FDA concerns regarding potential safety risks at higher doses. The trial will focus on dose levels not exceeding 3 mg/kg, where the treatment has shown a manageable safety profile.
Hong Kong-based Hutchmed (China) Ltd. saw its US sales of the cancer drug Fruzaqla jump nearly 53% in the second quarter, driven by strong market uptake. While this boosted overall revenue, Hutchmed’s net profits fell due to a high base effect from a lucrative licensing deal the previous year. Despite this, the company is optimistic about its future, focusing on innovative drugs and considering divesting its traditional Chinese medicine business.
