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...
Breakthrough therapy
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...
AbbVie’s Telisotuzumab Vedotin Earns Breakthrough Therapy Designation in China for c-Met Positive NSCLC
AbbVie Inc. (NYSE: ABBV), a leading pharmaceutical company based in the U.S., has announced that...
Jiangsu Hengrui’s HER2 Targeted ADC SHR-A1811 Poised to Earn Breakthrough Designation in China
Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276), a leading pharmaceutical company in China, has announced...
Chipscreen’s Chidamide in Sight of Breakthrough Therapy Designation in China for MSS/pMMR Colorectal Cancer
Shenzhen Chipscreen Biosciences Co., Ltd (SHA: 688321), a biopharmaceutical company based in China, has announced...
Jiangsu Hengrui’s SHR-A1921 Anticipated to Gain NMPA Breakthrough Designation for Ovarian Cancer
Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276) has announced that its drug candidate SHR-A1921 is...
RemeGen’s Disitamab Vedotin on Track for Breakthrough Designation in Muscle Invasive Bladder Cancer
RemeGen Ltd (HKG: 9995), a biopharmaceutical company based in China, has announced that its antibody-drug...
MicroPort CardioFlow Medtech’s AltaValve Receives FDA Breakthrough Designation for Mitral Regurgitation Treatment
MicroPort Scientific Corp (HKG: 0853), a leading medical device company based in China, has announced...
Brii Biosciences’ BRII-835 Aims for Breakthrough Therapy Status in China for Chronic Hepatitis B
The Center for Drug Evaluation (CDE) website has indicated that Brii Biosciences Ltd (HKG: 2137),...
Innovent Biologics’ CLDN18.2 ADC IBI343 Receives Breakthrough Designation in China
Innovent Biologics Inc. (HKG: 1801), a leading biopharmaceutical company based in China, has announced that...
Sichuan Biokin’s BL-B01D1 Earns Breakthrough Designation for Nasopharyngeal Carcinoma Treatment
Sichuan Biokin Pharmaceutical Co., Ltd (SHA: 688506), a biopharmaceutical company based in China, has announced...
Dizal Pharmaceutical’s Sunvozertinib Earns FDA Breakthrough Therapy Designation for NSCLC
Dizal Pharmaceutical Co., Ltd (SHA: 688192), a leading Chinese pharmaceutical company, has announced that its...
Jiangsu Hengrui’s Fluzoparib Receives Breakthrough Therapy Designation for HER2-Negative Breast Cancer
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276), a China-based pharmaceutical company, has announced that its...
Teruisi Pharma’s TRS005 Receives Support for Breakthrough Designation in China for CD20-Positive Lymphoma
The Center for Drug Evaluation (CDE) in China has signaled that Teruisi Pharma’s antibody drug...
Duality Biologics’ DB-1303 on Track for Breakthrough Designation for HER2+ Endometrial Cancer
The Center for Drug Evaluation (CDE) website has indicated that DB-1303, a HER2 targeted antibody...