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Innovent Biologics’ IBI363 Granted Breakthrough Therapy Designation for Melanoma
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China-based Innovent Biologics, Inc. (HKG: 1801) announced that it has received breakthrough therapy designation (BTD) from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) for its investigational drug IBI363. The designation is for the treatment of unresectable locally advanced or metastatic mucosal or acral melanoma…
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Hengrui’s HRS-5965 Granted Breakthrough Therapy Designation for IgA Nephropathy
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China-based Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) announced that it has received breakthrough therapy designation (BTD) from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) for its investigational drug HRS-5965. The designation is for the treatment of primary IgA nephropathy, the most common primary…
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Oriomics’ Liver Cancer Screening Reagent Earns FDA Breakthrough Device Designation
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Hangzhou-based Oriomics, a cancer screening specialist backed by Hotgen Biotech Co., Ltd (SHA: 688068), has obtained Breakthrough Device Designation (BDD) from the US Food and Drug Administration (FDA) for its liver cancer multi-gene methylation + protein multi-omics screening reagent and supporting analysis software. This recognition highlights the innovative nature of…
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Hengrui’s Trastuzumab Rezetecan Nears 8th Breakthrough Therapy Designation
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China-based Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) announced that its trastuzumab rezetecan (SHR-A1811), an HER2-targeted antibody-drug conjugate (ADC), is on course to receive its 8th Breakthrough Therapy Designation (BTD) from the Center for Drug Evaluation of the National Medical Products Administration (NMPA). The targeted indication is recurrent or metastatic…
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Alphamab Oncology’s JSKN033 Receives Breakthrough Therapy Designation for Platinum Resistant Ovarian Cancer
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China-based Alphamab Oncology (HKG: 9966) announced receiving Breakthrough Therapy Designation (BTD) from the National Medical Products Administration (NMPA) for its JSKN033, a HER2-targeted antibody drug conjugate (ADC) for the treatment of platinum-resistant recurrent epithelial ovarian cancer (PROC), primary peritoneal cancer, or fallopian tube cancer, regardless of HER2 expression levels. Drug…
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Ascentage Pharma’s Olverembatinib Receives Third BTD in China for Ph+ ALL Treatment
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China-based Ascentage Pharma (HKG: 6855) has announced that the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) has awarded Breakthrough Therapy Designation (BTD) to its olverembatinib, a novel BCR-ABL1 tyrosine kinase inhibitor (TKI). The designation is for the drug’s use in combination with low-intensity chemotherapy as…
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CARsgen’s CT041 Awarded Breakthrough Therapy Designation for Gastric Cancer
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CARsgen Therapeutics Holdings Ltd (HKG: 2171) announced that its chimeric antigen receptor (CAR) T-cell therapy, Satricabtagene autoleucel (CT041), has been awarded Breakthrough Therapy Designation (BTD) by the Center for Drug Evaluation of the National Medical Products Administration (NMPA). The targeted indication is Claudin18.2-positive advanced gastric / gastroesophageal junction cancer (G…
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CSPC Pharmaceutical’s Sirolimus Receives BTD for Malignant PEComa Treatment
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China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) announced that it has received Breakthrough Therapy Designation (BTD) from China’s National Medical Products Administration (NMPA) for its sirolimus (albumin-bound) as a monotherapy for malignant perivascular epithelioid cell tumor (PEComa). Drug ProfileSirolimus, also known as rapamycin, is a commonly used specific mTOR inhibitor.…
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MediLink’s YL201 Receives Breakthrough Therapy Designation for Nasopharyngeal Carcinoma
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Suzhou-based biotech MediLink Therapeutics (Suzhou) Co., Ltd has announced receiving another breakthrough therapy designation (BTD) from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) for its antibody drug conjugate (ADC) YL201. The designation is for the treatment of recurrent/metastatic nasopharyngeal carcinoma (R/M NPC), following the…
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Innovent’s IBI343 Receives Breakthrough Therapy Designation for Pancreatic Cancer
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China-based biopharma Innovent Biologics, Inc. (HKG: 1801) has announced receiving another Breakthrough Therapy Designation (BTD) from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) for its IBI343. The latest designation was granted for the TOPO1i anti-CLDN18.2 antibody drug conjugate (ADC) as monotherapy for the treatment…
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JW Therapeutics’ Carteyva Granted Breakthrough Therapy Designation by CDE
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China-based JW Therapeutics (HKG: 2126) has announced that its Carteyva (relmacabtagene autoleucel injection) has been granted Breakthrough Therapy Designation by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA). This designation recognizes the potential of Carteyva as a second-line treatment for adults with relapsed or refractory…
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Mabwell’s 9MW2821 Granted Breakthrough Therapy Designation by CDE for Urothelial Carcinoma
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China-based Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062) has announced that the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) has granted Breakthrough Therapy Designation (BTD) to its 9MW2821, an antibody drug conjugate (ADC) targeting Nectin-4. The designation is for the use of 9MW2821 in combination…
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Hansoh and GSK’s HS-20093 Receives FDA Breakthrough Therapy Designation for Osteosarcoma
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China-based Jiangsu Hansoh Pharmaceutical Co., Ltd (HKG: 3692) and its UK partner GSK plc (LON: GSK, NYSE: GSK) have announced that they have received another breakthrough therapy designation (BTD) from the US FDA for their B7-H3-targeted antibody drug conjugate (ADC), HS-20093 (GSK5764227). The indication this time is for the drug’s…
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Sichuan Biokin’s BL-M08D1 and CSPC’s SYS6010 Eye Breakthrough Therapy Designations in China
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The China’s Center for Drug Evaluation (CDE) website has indicated that China-based Sichuan Biokin Pharmaceutical Co., Ltd’s (SHA: 688506) BL-M08D1 and CSPC Pharmaceutical Group Ltd’s (HKG: 1093) SYS6010 are on track to obtain Breakthrough Therapy Designations (BTDs) from the agency. These designations are for the treatment of recurrent small cell…
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BioNova Pharmaceuticals’ BN104 Receives Breakthrough Therapy Designation in China
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The China’s Center for Drug Evaluation (CDE) website has indicated that BioNova Pharmaceuticals (Shanghai) Ltd.’s novel small molecule, BN104, is on track to obtain Breakthrough Therapy Designation (BTD). This development marks a significant milestone for the treatment of relapsed/refractory acute leukemia patients carrying KMT2A rearrangement and/or NPM1 mutation in China.…
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Jiangsu Hengrui’s Trastuzumab Rezetecan on Track for NMPA’s Breakthrough Therapy Designation
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Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276), a leading pharmaceutical company based in China, has announced that its trastuzumab rezetecan (SHR-A1811), an HER2 targeted antibody-drug conjugate (ADC), is on course to receive Breakthrough Therapy Designation (BTD) from the Center for Drug Evaluation of the National Medical Products Administration (NMPA). The…
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GSK’s Jemperli Receives FDA Breakthrough Therapy Designation for Rectal Cancer Treatment
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UK-based pharmaceutical giant GSK (NYSE: GSK) has announced that it has received Breakthrough Therapy Designation (BTD) from the US Food and Drug Administration (FDA) for its drug Jemperli (dostarlimab). The designation is for the treatment of patients with locally advanced mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) rectal cancer. Jemperli’s Background…
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Sanofi’s Tolebrutinib Earns FDA Breakthrough Designation for Non-Relapsing Secondary Progressive MS
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Sanofi (NASDAQ: SNY) has announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to its Bruton’s tyrosine kinase (BTK) inhibitor, Tolebrutinib, for the treatment of adults with non-relapsing secondary progressive multiple sclerosis (nrSPMS). Phase III HERCULES Study Results Influence FDA DecisionThe FDA’s decision is supported…
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Fujian Cosunter Pharmaceutical’s GST-HG141 Earns Breakthrough Designation for Chronic Hepatitis B
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Fujian Cosunter Pharmaceutical Co., Ltd (SHE: 300436), a China-based pharmaceutical company, has announced that it has received breakthrough therapy designation (BTD) from the Center for Drug Evaluation of the National Medical Products Administration (NMPA) for its drug neracorvir (GST-HG141), which is intended to treat chronic hepatitis B virus (HBV). GST-HG141:…
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HutchMed’s Orpathys Receives Breakthrough Therapy Designation in China for Advanced Lung Cancer
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HutchMed (China) Ltd (HKG: 0013, NASDAQ: HCM) has announced that its MET inhibitor, Orpathys (savolitinib), co-developed with AstraZeneca (AZ, NASDAQ: AZN), has been granted Breakthrough Therapy Designation (BTD) by China’s National Medical Products Administration (NMPA). The designation is for the use of Orpathys in combination with Tagrisso (osimertinib) for the…
