The China’s Center for Drug Evaluation (CDE) website has indicated that several drugs, including German giant Boehringer Ingelheim’s (BI) zongertinib, Visirna Therapeutics’ plozasiran, Chia Tai Tianqing’s anlotinib, and HutchMed (China) Ltd’s (HKG: 0013, NASDAQ: HCM) Orpathys (savolitinib), are on course to obtain priority review statuses.
Boehringer Ingelheim’s Zongertinib for HER2-Mutated NSCLC
BI’s zongertinib, a small molecule HER2 inhibitor, is poised for priority review status for the treatment of adult patients with unresectable or metastatic non-small cell lung cancer (NSCLC) carrying HER2 (ERBB2) activating mutations who have previously received systemic therapy. This development highlights the potential for improved treatment options in the fight against lung cancer.
Visirna Therapeutics’ Plozasiran for Familial Chylomicron Syndrome (FCS)
Visirna Therapeutics’ plozasiran, an APOC3-targeted siNRA therapy co-developed by US firm Arrowhead Pharmaceuticals, is seeking approval for use in reducing triglyceride levels in adult patients with familial chylomicron syndrome (FCS), thereby reducing the risk of acute pancreatitis. The therapy aims to provide a dietary control-based solution for managing this rare condition.
Chia Tai Tianqing’s Anlotinib for Acinar Soft Tissue Sarcoma
Chia Tai Tianqing’s anlotinib, a multi-target kinase inhibitor with existing indications for various cancers, is expected to win approval for the treatment of advanced or unresectable acinar soft tissue sarcoma. This further expands the drug’s potential applications in oncology.
HutchMed’s Savolitinib for NSCLC with MET Exon 14 Skipping Alterations
HutchMed’s savolitinib, an oral mesenchymal-epithelial transformation factor (MET) inhibitor, was conditionally approved in China in June 2021 for the treatment of NSCLC with MET exon 14 skipping alterations that has progressed after chemotherapy or is unsuited to systemic therapy. The drug, co-developed by AstraZeneca, is now indicated, when combined with osimertinib, for the treatment of locally advanced or metastatic NSCLC with failed EGFR-TKI treatment and MET amplification.-Fineline Info & Tech
