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...
Breakthrough therapy
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...
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...