The Center for Drug Evaluation (CDE) has indicated on its website that five investigational drugs and one companion diagnostic (CDx) are on track to receive priority review status. The drugs include:
Novartis’ Fabhalta (iptacopan) for C3 glomerulopathy (C3G), a best-in-class specific complement factor B oral inhibitor that comprehensively controls intravascular and extravascular hemolysis. It was approved in China in April this year for the treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH) who have not previously received complement inhibitor therapy.
Novartis’ lutetium (177Lu) vipivotide tetraxetan, a radioactive drug targeting prostate-specific membrane antigen (PSMA) for the treatment of adult patients with PSMA positive metastatic castration-resistant prostate cancer (mCRPC) who have received androgen receptor pathway inhibition and paclitaxel chemotherapy. The CDx, 68Ga gozetotide preparation kit, is suitable for identifying PSMA positive lesions in adult prostate cancer patients through PET-CT.
Ji Xing Pharmaceuticals’ aficamten (CK-3773274) for symptomatic obstructive hypertrophic cardiomyopathy (HCM). The cardiac myosin inhibitor was the subject of a licensing deal with Cytokinetics Inc (CYTK) in July 2020, granting Jixing exclusive development and commercialization rights in Greater China.
CANbridge Pharmaceuticals’ velaglucerase β for long-term enzyme replacement therapy (ERT) in patients diagnosed with Gaucher’s disease types I (GD1) and III (GD3). Takeda’s Vpriv (velaglucerase alfa) was previously approved for marketing in China.
Lepu Biotechnology Co., Ltd’s (2157.HK) MRG003, an antibody-drug conjugate (ADC) targeting epidermal growth factor receptor (EGFR) for the treatment of recurrent/metastatic nasopharyngeal carcinoma (R/M NPC) in patients who have previously failed at least second-line systemic chemotherapy and PD-1/PD-L1 inhibitor treatment. It has previously obtained breakthrough therapy designation (BTD) status in the US.- Flcube.com
