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...
Breakthrough therapy
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...
CDE Grants Priority Review to Jiu An’s Adrenaline and AnHeart’s Taletrectinib; Two Others Earn Breakthrough Therapy Designation
The Center for Drug Evaluation (CDE) has announced that Jiu An Pharmaceutical’s adrenaline and AnHeart...
Bayer’s BAY 2927088 Receives FDA Breakthrough Therapy Designation for HER2-Mutated NSCLC
The US Food and Drug Administration (FDA) has granted Germany-based Bayer AG (ETR: BAYN) breakthrough...
J&J’s Gene Therapy for X-linked Retinitis Pigmentosa Receives CDE Nod for Breakthrough Designation
The Center for Drug Evaluation (CDE) website has indicated that Johnson & Johnson (J&J, NYSE:...
Allist Pharmaceuticals’ Furmonertinib and AstraZeneca’s Enhertu Earn Breakthrough Designations in China for NSCLC Treatments
The Center for Drug Evaluation (CDE) in China has indicated on its website that Allist...
Staidson Pharmaceutical’s BDB-001 Earns Breakthrough Therapy Designation in China for AAV Treatment
Staidson (Beijing) Pharmaceutical Co., Ltd (SHE: 300204), a China-based pharmaceutical company, has announced that its...
Shenzhen TargetRx’s TGRX-678 Set to Receive Breakthrough Therapy Designation for CML-AP
Shenzhen TargetRx, Inc., a China-based developer of small-molecule kinase inhibitors, is poised to receive breakthrough...
Simcere Pharmaceutical’s SIM0501 Receives FDA Approval for Advanced Solid Tumor Clinical Trial
Simcere Pharmaceutical Group (HKG: 2096) has announced that it has received clinical trial approval from...
Jiangxi Jemincare’s KRAS Inhibitor Earns Breakthrough Designation from China’s CDE for NSCLC
The China Center for Drug Evaluation (CDE) website has indicated that Jiangxi Jemincare Group’s proprietary...
JW Therapeutics Secures Priority Review for Carteyva in Relapsed/Refractory Mantle Cell Lymphoma
JW Therapeutics (HKG: 2126), based in China, has announced that its CAR-T cell therapy, Carteyva...
AbbVie’s Epcoritamab Earns EMA Review and FDA Breakthrough Designation for Follicular Lymphoma
AbbVie’s (NYSE: ABBV) bispecific antibody (BsAb) Tepkinly/Epkinly (epcoritamab) has been accepted for review by the...