Hengrui Pharmaceuticals’ HR19042 Capsules Designated as Breakthrough Therapy for Autoimmune Hepatitis by China NMPA
The Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has recently...
Breakthrough therapy
CDE’s BL-B01D1 on Track for Breakthrough Therapy Designations for EGFR Wild-Type and Mutant NSCLC
The Center for Drug Evaluation (CDE) has indicated on its website that two indications for...
I-Mab’s Plonmarlimab Receives Breakthrough Therapy Designation in China for R/R MAS Treatment
China-based biopharmaceutical company I-Mab (NASDAQ: IMAB) has announced that its proprietary human granulocyte-macrophage colony-stimulating factor...
Jiangsu Hengrui’s ANGPTL3 Inhibitor SHR-1918 Earns Breakthrough Designation for HoFH Treatment
Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276), a leading pharmaceutical company in China, has announced...
Jiangsu Simcere’s Edaravone, Borneol Sublingual Tablet Earns FDA Breakthrough Therapy Designation for Stroke Treatment
HONG KONG—Jiangsu Simcere Pharmaceutical Co., Ltd (HKG: 2096) has announced that it has received Breakthrough...
China’s Evopoint Biosciences and UK’s GSK Eye Breakthrough Therapy Designations for Cancer Therapies
BEIJING/LONDON—The Center for Drug Evaluation (CDE) in China has indicated that Evopoint Biosciences’ EZH2 inhibitor...
Jiangsu Hansoh and GSK Receive FDA Breakthrough Designation for B7-H3 Targeted ADC in Small-Cell Lung Cancer
Jiangsu Hansoh Pharmaceutical Co., Ltd (HKG: 3692), a prominent Chinese pharmaceutical company, and its UK...
Jiangsu Hansoh Pharmaceutical and GSK Win FDA Breakthrough Therapy Designation for B7-H3 Targeted ADC in Small-Cell Lung Cancer
LONDON/HONG KONG—Jiangsu Hansoh Pharmaceutical Co., Ltd (HKG: 3692), in collaboration with UK-based GSK plc (NYSE:...
Boehringer Ingelheim’s Zongertinib Earns Breakthrough Designation in China for HER2-Mutated NSCLC
Boehringer Ingelheim, a leading German pharmaceutical company, has received a significant endorsement from China’s Center...
Mabwell’s Nectin-4 Targeting ADC 9MW2821 on Path to Breakthrough Designation in China for Urothelial Carcinoma
Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062), a biopharmaceutical company based in China, has announced...
Chongqing Genrix’s GR1803 Earns Breakthrough Therapy Designation in China for RRMM Treatment
The Center for Drug Evaluation (CDE) of China has indicated that Chongqing Genrix Biopharmaceutical Co.,...
Lepu Biotechnology’s MRG003 Earns FDA Breakthrough Therapy Designation for Nasopharyngeal Carcinoma
Lepu Biotechnology Co., Ltd (HKG: 2157), a biopharmaceutical company based in China, has announced that...
Belief BioMed’s Hemophilia B Gene Therapy BBM-H901 Slated for Priority Review in China
The Center for Drug Evaluation (CDE) has indicated on its website that the market application...
Jiangsu Suzhong Pharma’s Sutetinib Earns Breakthrough Designation for NSCLC from China’s NMPA
Jiangsu Suzhong Pharma Group Co., Ltd, a leading pharmaceutical company based in China, has received...
China’s NMPA Considers Breakthrough Designations for Xiangxue and Innostellar’s Therapies
Xiangxue Pharmaceutical Co., Ltd (SHE: 300147) and Innostellar Biotherapeutics Co., Ltd have both been noted...
AusperBio’s AHB-137 Antiviral Candidate on Path to Breakthrough Designation for Chronic Hepatitis B in China
AusperBio, a sino-American developer specializing in liver therapies, has announced that its drug candidate AHB-137...
Alebund Pharmaceuticals’ AP306 Earns Breakthrough Designation for Chronic Kidney Disease
Alebund Pharmaceuticals, based in Shanghai, has announced that its drug candidate AP306 (EOS789), a pan-inhibitor...
Boehringer Ingelheim’s Survodutide Earns Breakthrough Designation for MASH Treatment in China
Boehringer Ingelheim (BI), the German pharmaceutical colossus, has declared that it has been granted Breakthrough...
Sino Biopharmaceutical’s KRAS Inhibitor Garsorasib Earns Breakthrough Designation in China
Sino Biopharmaceutical Ltd (HKG: 1177), a prominent biopharmaceutical company in China, has announced that its...
Bayer’s HER2 Targeting Drug BAY 2927088 Earns Breakthrough Designation in China
The Center for Drug Evaluation (CDE) in China has granted Breakthrough Therapy Designation (BTD) to...