World's First Venom-Derived Hemophilia Drug Pimotase Alfa Approved in China

Note: The data cutoff for this week's statistics is set to Friday, with any subsequent data carried over to the following week.

On June 4 this week, the NMPA granted conditional approval to four innovative drugs on the same day.Otsuka Pharmaceutical's nephrology drug, sparsentan injection,Guangzhou Lupeng Pharmaceutical'sBTK InhibitorsLobutinib Tablets,Jiangsu Vcare's tumor-agnostic drug, Anruqutinib Capsules, andStaidson's Subsidiary Beijietaipomitase alfa for injection for hemophilia treatment.

Three of these four drugs are domestically produced and all are pioneering, among whichBomitase Alfa for Injection is derived fromIts active ingredient is purified from the venom of Russell’s viper. As the world’s first factor X activator, it provides an innovative therapy for hemophilia with inhibitors.

Lobutinib Tablets areThe world's first fourth-generation covalent and non-covalent BTK inhibitor,Since the launch of Johnson & Johnson’s ibrutinib, this target has yielded three blockbuster drugs, collectively achieving global annual sales exceeding $10 billion.

Otsuka Pharmaceutical'sBelimumab Injection Approved forAdult Patients with Primary Immunoglobulin A Nephropathy (IgAN),Can be self-administered once every four weeks,Another Strong Contender Emerges in the IgA Nephropathy Field.

This WeekHansoh Pharma'sGLP-1 Innovative DrugThe Marketing Authorization Application for Orforglipron Injection Has Been Accepted; It Is Indicated for Long-Term Weight Management in Adults with Obesity or Overweight and Is a GLP-1/GIP Receptor Agonist.

In comparison, no major generic drug varieties were approved this week; it is noted that competitors have emerged in volume for two exclusive varieties.Two Manufacturers Report Weekly Production of Sivelestat Sodium for Injection，Chongqing Huapont andShandong Haorui'en, Phase III clinical trials not conducted;

Landiolol Hydrochloride for Injection: Three Companies Have Submitted Marketing Applications, namely Yichang Humanwell,Sichuan Aobang Gude Pharmaceutical and Hubei Langtian,None have undergone Phase III clinical trials. At such a rapid pace, competition in this product category has truly intensified. See our analysis for details:China’s First Truly Class III Medical Device Exempt from Clinical Trials Emerges?!