The Center for Drug Evaluation (CDE) website has indicated that Chia Tai Tianqing’s TQB3454, Henlius Bio’s HLX208, and LianBio’s infigratinib are all set to be awarded priority review status as Category 1 chemical drugs.
TQB3454: A Promising IDH1 Mutase Inhibitor
TQB3454 is an in-house developed IDH1 mutase inhibitor intended for the treatment of locally advanced, recurrent, and/or metastatic cholangiocarcinoma with IDH1 mutations. IDH1, a rate-limiting enzyme, plays a crucial role in various tumor types, including acute myeloid leukemia, cholangiocarcinoma, and glioma. The potential priority review status underscores the importance of TQB3454 in addressing unmet medical needs for these cancer types.
HLX208: A BRAF V600E Inhibitor for LCH and ECD
HLX208, a small molecule BRAF V600E inhibitor licensed from NeuPharma in May 2021, is on track for priority review status for use in adult Langerhans cell histiocytosis (LCH) and Erdheim Chester disease (ECD) with BRAF V600E mutations. This priority status reflects the urgency in providing effective treatments for these rare diseases.
Infigratinib: An Oral FGFR Inhibitor with Broad Potential
LianBio secured the development and commercialization rights to infigratinib, an oral FGFR1-3 inhibitor, through a licensing deal with BridgeBio in 2020 for the Chinese mainland, Hong Kong, and Macau. The potential priority review status is indicated for the treatment of locally advanced or metastatic gastric cancer or gastroesophageal junction adenocarcinoma with FGFR2 gene amplification that has previously received at least two lines of systemic treatment. Infigratinib was fast-tracked in the US in May 2021 to treat locally advanced or metastatic cholangiocarcinoma with FGFR2 fusion or rearrangement after treatment, highlighting its potential impact on patient outcomes.-Fineline Info & Tech
