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Innovent Biologics’ IBI354 Earns Breakthrough Therapy Designation for Ovarian Cancer Treatment
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The Center for Drug Evaluation (CDE) website has indicated that China-based Innovent Biologics, Inc. (HKG: 1801) is set to obtain breakthrough therapy designation (BTD) for its antibody drug conjugate (ADC) IBI354, which targets HER2, for the treatment of platinum-resistant ovarian cancer. Phase I/II Clinical Study ResultsThe Phase I/II clinical study…
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Huahui Health’s Libevitug Earns FDA Breakthrough Designation for Chronic Hepatitis Delta Virus
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Beijing-based biotech company Huahui Health, specializing in viral hepatitis, hepatology, and oncology, has announced that it has received Breakthrough Therapy Designation (BTD) from the U.S. Food and Drug Administration (FDA) for its libevitug (HH-003), an anti-PreS1 human monoclonal antibody (mAb), for the treatment of patients with chronic hepatitis delta virus…
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J&J’s Nipocalimab Receives FDA Breakthrough Therapy Designation for Sjögren’s Disease
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US-based pharmaceutical giant Johnson & Johnson (J&J, NYSE: JNJ) has announced that it has received Breakthrough Therapy Designation (BTD) from the US Food and Drug Administration (FDA) for its investigational drug nipocalimab. The designation is for the treatment of moderate-to-severe Sjögren’s disease (SjD), a chronic autoantibody disease with a high…
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Ascentage Pharma’s Lisaftoclax and AceLink Therapeutics’ AL01211 Receive FDA Designations
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The Center for Drug Evaluation (CDE) website has indicated that China-based Ascentage Pharma’s (HKG: 6855) lisaftoclax (APG-2575) and AceLink Therapeutics(Suzhou)’s AL01211 are on track to receive priority review and breakthrough therapy designation (BTD) statuses respectively from the US Food and Drug Administration (FDA). Lisaftoclax, an oral BCL-2 inhibitor, is indicated…
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Chinese ADCs from Escugen, Hansoh, and MediLink Therapeutics Eye Breakthrough Designations in China
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The Center for Drug Evaluation of the National Medical Products Administration (NMPA) has indicated on its website that three antibody drug conjugates (ADCs) from Chinese pharmaceutical companies are on track to receive breakthrough therapy designations (BTDs) in China. These include Shanghai Escugen’s ESG401, Jiangsu Hansoh Pharmaceutical Co., Ltd (HKG: 3692)’s…
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Jiangsu Hengrui’s HR19042 Earns Breakthrough Designation for Autoimmune Hepatitis Treatment in China
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Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a leading pharmaceutical company in China, has announced that it has received Breakthrough Therapy Designation (BTD) from the National Medical Products Administration (NMPA) for its modified drug HR19042, which targets active autoimmune hepatitis (AIH). AIH is a rare liver disease that, if untreated,…
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3D Medicines’ Envafolimab Earns NMPA Breakthrough Designation for TMB-H Solid Tumors
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3D Medicines (HKG: 1244), a biopharmaceutical company based in China, has announced that its envafolimab has been granted Breakthrough Therapy Designation (BTD) by China’s National Medical Products Administration (NMPA) for an additional indication. The PD-L1 monoclonal antibody (mAb) is now indicated for the treatment of unresectable or metastatic solid tumors…
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Dizal Pharmaceutical’s Sunvozertinib Earns Breakthrough Designation for NSCLC from China’s NMPA
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Dizal Pharmaceutical Co., Ltd (SHA: 688192), a biopharmaceutical company based in China, has announced that it has received Breakthrough Therapy Designation (BTD) from China’s National Medical Products Administration (NMPA) for its next-generation epidermal growth factor receptor (EGFR) inhibitor, sunvozertinib. This designation is in relation to the drug’s potential use as…
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Ascletis Pharma’s ASC40 Earns FDA Breakthrough Therapy Designation for Fibrotic MASH
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China-based Ascletis Pharma Inc. (HKG: 1672) has announced that ASC40 (denifanstat), a fatty acid synthase (FASN) inhibitor co-developed with US partner Sagimet Biosciences Inc. (NASDAQ: SGMT), has received a breakthrough therapy designation (BTD) from the US Food and Drug Administration (FDA). The designation is for the treatment of patients with…
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Sichuan Biokin’s BL-B01D1 Earns Breakthrough Therapy Designation for Esophageal Cancer from China’s CDE
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Sichuan Biokin Pharmaceutical Co., Ltd (SHA: 688506) has announced that its bispecific antibody drug conjugate (ADC), BL-B01D1, has received breakthrough therapy designation (BTD) from the Center for Drug Evaluation (CDE) in China. The designation is for the treatment of patients with recurrent or metastatic esophageal squamous cell carcinoma (ESCC) who…
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Boehringer Ingelheim’s Survodutide Earns FDA Breakthrough Therapy Designation for MASH Treatment
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German pharmaceutical company Boehringer Ingelheim has received breakthrough therapy designation (BTD) from the US Food and Drug Administration (FDA) for its drug candidate survodutide (BI 456906), a dual glucagon/GLP-1 receptor agonist, for the treatment of non-cirrhotic metabolic dysfunction-associated steatohepatitis (MASH) in adults with moderate or advanced fibrosis (stages 2 or…
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Dizal Pharmaceutical’s Surufatinib Earns CDE Consideration for Breakthrough Therapy in EGFR exon20ins NSCLC
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Dizal Pharmaceutical, a biopharmaceutical company based in China, has announced that the Center for Drug Evaluation (CDE) in China is considering its drug candidate DZD9008 for breakthrough therapy status. The drug is designed to treat patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have not received…
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Hengrui Medicine’s HR19042 Capsules Designated as Breakthrough Therapy for Autoimmune Hepatitis by China NMPA
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The Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has recently announced that Hengrui Medicine (SHA: 600276)’s Class 2.2 improved drug, HR19042 capsule, is planned to be included in the breakthrough therapy category, targeting active autoimmune hepatitis. According to previous announcements by Hengrui Medicine, HR19042 is…
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CDE’s BL-B01D1 on Track for Breakthrough Therapy Designations for EGFR Wild-Type and Mutant NSCLC
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The Center for Drug Evaluation (CDE) has indicated on its website that two indications for its in-house developed bispecific antibody drug conjugate (ADC), BL-B01D1, are on track to receive breakthrough therapy designations (BTDs). The first indication is for patients with locally advanced or metastatic EGFR wild-type non-small cell lung cancer…
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I-Mab’s Plonmarlimab Receives Breakthrough Therapy Designation in China for R/R MAS Treatment
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China-based biopharmaceutical company I-Mab (NASDAQ: IMAB) has announced that its proprietary human granulocyte-macrophage colony-stimulating factor (GM-CSF) neutralizing antibody, plonmarlimab, is poised to receive breakthrough therapy designation (BTD) from the National Medical Products Administration (NMPA) for the treatment of recurrent/refractory hemophagocytic lymphohistiocytosis (R/R MAS), a severe and life-threatening condition. Plonmarlimab is…
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Jiangsu Hengrui’s ANGPTL3 Inhibitor SHR-1918 Earns Breakthrough Designation for HoFH Treatment
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Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a leading pharmaceutical company in China, has announced that it has received Breakthrough Therapy Designation (BTD) from China’s Center for Drug Evaluation (CDE) for its drug candidate SHR-1918. This in-house developed monoclonal antibody (mAb) targeting angiopoietin-like protein 3 (ANGPTL3) is intended for the…
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Jiangsu Simcere’s Edaravone, Borneol Sublingual Tablet Earns FDA Breakthrough Therapy Designation for Stroke Treatment
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HONG KONG—Jiangsu Simcere Pharmaceutical Co., Ltd (HKG: 2096) has announced that it has received Breakthrough Therapy Designation (BTD) from the US Food and Drug Administration (FDA) for its edaravone, borneol sublingual tablet, intended for the treatment of acute ischemic stroke (AIS). The edaravone, borneol sublingual tablet is a solid oral…
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China’s Sinovent and UK’s GSK Eye Breakthrough Therapy Designations for Cancer Therapies
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BEIJING/LONDON—The Center for Drug Evaluation (CDE) in China has indicated that Sinovent Inc.’s EZH2 inhibitor XNW5004 and GlaxoSmithKline’s (GSK) antibody drug conjugate (ADC) belantamab mafodotin are on track to receive breakthrough therapy designations (BTDs). Sinovent’s XNW5004 is targeting the recurrent or refractory peripheral T-cell lymphoma indication and has demonstrated potential…
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Jiangsu Hansoh and GSK Receive FDA Breakthrough Designation for B7-H3 Targeted ADC in Small-Cell Lung Cancer
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Jiangsu Hansoh Pharmaceutical Co., Ltd (HKG: 3692), a prominent Chinese pharmaceutical company, and its UK counterpart GSK plc (NYSE: GSK) have jointly announced that they have received the prestigious Breakthrough Therapy Designation (BTD) from the US FDA for their candidate HS-20093, also known as GSK5764227. This B7-H3-targeted antibody-drug conjugate (ADC)…
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Jiangsu Hansoh Pharmaceutical and GSK Win FDA Breakthrough Therapy Designation for B7-H3 Targeted ADC in Small-Cell Lung Cancer
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LONDON/HONG KONG—Jiangsu Hansoh Pharmaceutical Co., Ltd (HKG: 3692), in collaboration with UK-based GSK plc (NYSE: GSK), has been awarded the Breakthrough Therapy Designation (BTD) by the US FDA for their jointly developed antibody-drug conjugate (ADC) HS-20093, also known as GSK5764227. The therapy is intended for the treatment of patients with…
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Boehringer Ingelheim’s Zongertinib Earns Breakthrough Designation in China for HER2-Mutated NSCLC
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Boehringer Ingelheim, a leading German pharmaceutical company, has received a significant endorsement from China’s Center for Drug Evaluation (CDE) with the breakthrough therapy designation (BTD) for its investigational HER2-targeted tyrosine kinase inhibitor (TKI), zongertinib (BI 1810631). This designation underscores the potential of zongertinib in treating adult patients with HER2-mutated advanced,…
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Mabwell’s Nectin-4 Targeting ADC 9MW2821 on Path to Breakthrough Designation in China for Urothelial Carcinoma
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Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062), a biopharmaceutical company based in China, has announced that its antibody drug conjugate (ADC), 9MW2821, which targets Nectin-4, is on track to receive breakthrough therapy designation (BTD) from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) for the…
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Chongqing Genrix’s GR1803 Earns Breakthrough Therapy Designation in China for RRMM Treatment
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The Center for Drug Evaluation (CDE) of China has indicated that Chongqing Genrix Bio Pharmaceutical Co., Ltd (SHA: 688443) is on track to receive Breakthrough Therapy Designation (BTD) for its bispecific antibody GR1803. This designation is for the treatment of recurrent refractory multiple myeloma (RRMM) in patients who have previously…
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Lepu Biotechnology’s MRG003 Earns FDA Breakthrough Therapy Designation for Nasopharyngeal Carcinoma
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Lepu Biotechnology Co., Ltd (HKG: 2157), a biopharmaceutical company based in China, has announced that it has received Breakthrough Therapy Designation (BTD) from the US Food and Drug Administration (FDA) for its pipeline candidate, MRG003. This designation highlights the drug’s potential in treating recurrent/metastatic nasopharyngeal carcinoma (R/M NPC), a significant…
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Belief BioMed’s Hemophilia B Gene Therapy BBM-H901 Slated for Priority Review in China
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The Center for Drug Evaluation (CDE) has indicated on its website that the market application for BBM-H901, a gene therapy treatment for hemophilia B developed by Belief BioMed Group (BBM), a Shanghai-based specialist in gene therapy, is on track for priority review. BBM-H901, co-developed with Japan’s Takeda, is an adeno-associated…
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Jiangsu Suzhong Pharma’s Sutetinib Earns Breakthrough Designation for NSCLC from China’s NMPA
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Jiangsu Suzhong Pharma Group Co., Ltd, a leading pharmaceutical company based in China, has received a breakthrough therapy designation from the National Medical Products Administration (NMPA) for its drug candidate sutetinib, which is under development for locally advanced or metastatic non-small cell lung cancer (NSCLC) with specific non-resistant rare EGFR…
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China’s NMPA Considers Breakthrough Designations for Xiangxue and Innostellar’s Therapies
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Xiangxue Pharmaceutical Co., Ltd (SHE: 300147) and Innostellar Biotherapeutics Co., Ltd have both been noted by the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) as potential candidates for breakthrough therapy designations (BTDs). Xiangxue’s TAEST16001, a T-cell receptor TCR affinity-enhanced specific T-cell (TAEST) therapy, and Innostellar’s…
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Alebund Pharmaceuticals’ AP306 Earns Breakthrough Designation for Chronic Kidney Disease
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Alebund Pharmaceuticals, based in Shanghai, has announced that its drug candidate AP306 (EOS789), a pan-inhibitor of phosphate transporter proteins NaPi-IIb, PiT-1, and PiT-2, has been granted breakthrough therapy designation (BTD) by the Center for Drug Evaluation. The drug is intended for the treatment of chronic kidney disease hyperphosphatemia. As the…
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Boehringer Ingelheim’s Survodutide Earns Breakthrough Designation for MASH Treatment in China
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Boehringer Ingelheim (BI), the German pharmaceutical colossus, has declared that it has been granted Breakthrough Therapy Designation (BTD) by China’s Center for Drug Evaluation (CDE) for its experimental drug candidate, survodutide (BI 456906). This designation underscores the drug’s promising therapeutic potential for patients suffering from metabolic dysfunction-associated steatohepatitis (MASH). Derived…
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Sino Biopharmaceutical’s KRAS Inhibitor Garsorasib Earns Breakthrough Designation in China
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Sino Biopharmaceutical Ltd (HKG: 1177), a prominent biopharmaceutical company in China, has announced that its candidate garsorasib (D-1553), a KRAS G12C inhibitor co-developed with InventisBio (Shanghai) Co., Ltd, has been granted Breakthrough Therapy Designation (BTD) by China’s Center for Drug Evaluation (CDE). The designation covers two indications: the treatment of…
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Bayer’s HER2 Targeting Drug BAY 2927088 Earns Breakthrough Designation in China
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The Center for Drug Evaluation (CDE) in China has granted Breakthrough Therapy Designation (BTD) to German pharmaceutical giant Bayer (ETR: BAYN)’s drug candidate BAY 2927088 for the treatment of HER2 mutant non-small cell lung cancer (NSCLC), as indicated on the CDE’s official website. This marks a significant regulatory milestone for…
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AbbVie’s Telisotuzumab Vedotin Earns Breakthrough Therapy Designation in China for c-Met Positive NSCLC
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AbbVie Inc. (NYSE: ABBV), a leading pharmaceutical company based in the U.S., has announced that its cutting-edge antibody-drug conjugate (ADC) telisotuzumab vedotin has been granted breakthrough therapy designation (BTD) in China. This designation is for the treatment of advanced or metastatic epidermal growth factor receptor (EGFR) wild-type (WT) non-squamous (NSq)…
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Jiangsu Hengrui’s HER2 Targeted ADC SHR-A1811 Poised to Earn Breakthrough Designation in China
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Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a leading pharmaceutical company in China, has announced that its HER2 targeted antibody-drug conjugate (ADC), SHR-A1811, is on track to receive breakthrough therapy designation (BTD) status from the Center for Drug Evaluation (CDE) in China. This designation is for the treatment of HER2…
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Chipscreen’s Chidamide in Sight of Breakthrough Therapy Designation in China for MSS/pMMR Colorectal Cancer
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Shenzhen Chipscreen Pharmaceutical Co., Ltd (SHA: 688321), a biopharmaceutical company based in China, has announced that its drug Epidaza (chidamide) is on track to receive a breakthrough therapy designation (BTD) in China. The potential designation is for the use of chidamide in combination with PD-1 inhibitor sintilimab and bevacizumab for…
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Jiangsu Hengrui’s SHR-A1921 Anticipated to Gain NMPA Breakthrough Designation for Ovarian Cancer
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Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276) has announced that its drug candidate SHR-A1921 is on track to receive breakthrough therapy designation (BTD) from the National Medical Products Administration (NMPA) for the treatment of platinum-resistant recurrent epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer. SHR-A1921 is an antibody…
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RemeGen’s Disitamab Vedotin on Track for Breakthrough Designation in Muscle Invasive Bladder Cancer
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RemeGen Ltd (HKG: 9995), a biopharmaceutical company based in China, has announced that its antibody-drug conjugate (ADC) candidate, disitamab vedotin (RC48), is poised to receive breakthrough therapy designation (BTD) in China. This designation underscores the molecule’s potential in treating perioperative treatment of muscle invasive bladder cancer (MIBC) with HER2 expression,…
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MicroPort CardioFlow Medtech’s AltaValve Receives FDA Breakthrough Designation for Mitral Regurgitation Treatment
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MicroPort Scientific Corp (HKG: 0853), a leading medical device company based in China, has announced that its spin-off, MicroPort CardioFlow Medtech Co., Ltd (HKG: 2160), has received Breakthrough Devices status from the US Food and Drug Administration (FDA) for its AltaValve transcatheter mitral valve replacement device. This product, co-developed with…
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Innovent Biologics’ CLDN18.2 ADC IBI343 Receives Breakthrough Designation in China
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Innovent Biologics Inc. (HKG: 1801), a leading biopharmaceutical company based in China, has announced that its antibody-drug conjugate (ADC), IBI343, targeting CLDN18.2, has been granted breakthrough therapy designation (BTD) status in China. This designation highlights the potential of IBI343 as a third-line treatment option for patients with advanced gastric or…
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Sichuan Biokin’s BL-B01D1 Earns Breakthrough Designation for Nasopharyngeal Carcinoma Treatment
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Sichuan Biokin Pharmaceutical Co., Ltd (SHA: 688506), a biopharmaceutical company based in China, has announced that it has received Breakthrough Therapy Designation (BTD) from the National Medical Products Administration for its antibody-drug conjugate (ADC), BL-B01D1. This designation is for the treatment of patients with late-stage locally advanced or metastatic nasopharyngeal…
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Dizal Pharmaceutical’s Sunvozertinib Earns FDA Breakthrough Therapy Designation for NSCLC
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Dizal Pharmaceutical Co., Ltd (SHA: 688192), a leading Chinese pharmaceutical company, has announced that its next-generation epidermal growth factor receptor (EGFR) inhibitor, sunvozertinib, has received breakthrough therapy designation (BTD) from the US Food and Drug Administration (FDA). This designation is in recognition of sunvozertinib’s potential as a first-line treatment for…
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Jiangsu Hengrui’s Fluzoparib Receives Breakthrough Therapy Designation for HER2-Negative Breast Cancer
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Jiangsu Hengrui Medicine Co., Ltd. (SHA: 600276), a China-based pharmaceutical company, has announced that its indication approval filing for fluzoparib—a poly (ADP-ribose) polymerase (PARP) inhibitor—has been awarded breakthrough therapy designation (BTD) by China’s Center for Drug Evaluation (CDE). The designation applies to fluzoparib, both as a monotherapy and in combination…
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Teruisi Pharma’s TRS005 Receives Support for Breakthrough Designation in China for CD20-Positive Lymphoma
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The Center for Drug Evaluation (CDE) in China has signaled that Teruisi Pharma’s antibody drug conjugate (ADC), TRS005, which targets CD20, is on track to receive breakthrough therapy designation (BTD) for the treatment of recurrent or refractory CD20-positive diffuse large B-cell lymphoma (DLBCL). The drug is being developed specifically for…
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Duality Biologics’ DB-1303 on Track for Breakthrough Designation for HER2+ Endometrial Cancer
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The Center for Drug Evaluation (CDE) website has indicated that DB-1303, a HER2 targeted antibody drug conjugate (ADC) developed by Duality Biologics, a biotech company with operations in both the United States and China, is poised to receive breakthrough therapy designation (BTD). The proposed use for the treatment is for…
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CDE Grants Priority Review to Jiu An’s Adrenaline and AnHeart’s Taletrectinib; Two Others Earn Breakthrough Therapy Designation
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The Center for Drug Evaluation (CDE) has announced that Jiu An Pharmaceutical’s adrenaline and AnHeart Therapeutics’ taletrectinib are set for priority review, while Biotheus Inc.’s PM8002 and Sichuan Kelun Pharmaceutical Co., Ltd. (SHE: 002422)’s SKB264 have been designated as breakthrough therapies (BTDs). Adrenaline is gaining priority status due to new…
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Bayer’s BAY 2927088 Receives FDA Breakthrough Therapy Designation for HER2-Mutated NSCLC
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The US Food and Drug Administration (FDA) has granted Germany-based Bayer AG (ETR: BAYN) breakthrough therapy designation for its tyrosine kinase inhibitor (TKI) BAY 2927088. The drug is under review as a potential treatment for unresectable or metastatic non-small cell lung cancer (NSCLC) with activating HER2 (ERBB2) mutations that have…
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J&J’s Gene Therapy for X-linked Retinitis Pigmentosa Receives CDE Nod for Breakthrough Designation
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The Center for Drug Evaluation (CDE) website has indicated that Johnson & Johnson (J&J, NYSE: JNJ)’s AAV5-hRKp.RPGR (JNJ-5340, botaretigene sparoparvovec) intraocular injectable solution is on track to receive breakthrough therapy designation (BTD). This product, an adeno-associated virus vector (AAV) based gene therapy co-developed with MeiraGTx Holdings plc, is aimed at…
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Allist Pharmaceuticals’ Furmonertinib and AstraZeneca’s Enhertu Earn Breakthrough Designations in China for NSCLC Treatments
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The Center for Drug Evaluation (CDE) in China has indicated on its website that Allist Pharmaceuticals Co., Ltd, a Shanghai-based biotech firm, has received breakthrough therapy designations (BTDs) for its epidermal growth factor receptor (EGFR) tyrosine-kinase inhibitor (TKI) furmonertinib and for Enhertu (trastuzumab deruxtecan), a HER2-targeted antibody drug conjugate (ADC)…
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Staidson Pharmaceutical’s BDB-001 Earns Breakthrough Therapy Designation in China for AAV Treatment
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Staidson (Beijing) Pharmaceutical Co., Ltd (SHE: 300204), a China-based pharmaceutical company, has announced that its drug candidate BDB-001 has been granted breakthrough therapy designation (BTD) status in China for the treatment of anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV). Research indicates that the downstream activation of C5a, a product of the…
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Shenzhen TargetRx’s TGRX-678 Set to Receive Breakthrough Therapy Designation for CML-AP
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Shenzhen TargetRx, Inc., a China-based developer of small-molecule kinase inhibitors, is poised to receive breakthrough therapy designation (BTD) for its Bcr-Abl inhibitor, TGRX-678, according to the China Center for Drug Evaluation (CDE) website. This designation recognizes the molecule’s promising potential for treating accelerated chronic myeloid leukemia (CML-AP) in patients who…
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Simcere Pharmaceutical’s SIM0501 Receives FDA Approval for Advanced Solid Tumor Clinical Trial
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Simcere Pharmaceutical Group (HKG: 2096) has announced that it has received clinical trial approval from the US Food and Drug Administration (FDA) for its cancer drug candidate SIM0501, which targets advanced solid tumors. The company’s clinical filing was previously accepted for review by China’s National Medical Products Administration (NMPA) in…
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Jiangxi Jemincare’s KRAS Inhibitor Earns Breakthrough Designation from China’s CDE for NSCLC
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The China Center for Drug Evaluation (CDE) website has indicated that Jiangxi Jemincare Group’s proprietary small-molecule KRAS inhibitor, JMKX001899, has been granted breakthrough therapy designation (BTD) status for the treatment of advanced or metastatic non-small cell lung cancer (NSCLC) with a KRAS G12C mutation in patients who have previously received…
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JW Therapeutics Secures Priority Review for Carteyva in Relapsed/Refractory Mantle Cell Lymphoma
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JW Therapeutics (HKG: 2126), based in China, has announced that its CAR-T cell therapy, Carteyva (relmacabtagene autoleucel injection), has received priority review status for the treatment of relapsed or refractory mantle cell lymphoma (r/r MCL). This designation recognizes the drug’s status as a breakthrough therapy. Relmacabtagene autoleucel is an autologous…
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AbbVie’s Epcoritamab Earns EMA Review and FDA Breakthrough Designation for Follicular Lymphoma
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AbbVie’s (NYSE: ABBV) bispecific antibody (BsAb) Tepkinly/Epkinly (epcoritamab) has been accepted for review by the European Medicines Agency (EMA) and granted breakthrough therapy designation (BTD) by the US Food and Drug Administration (FDA) for the treatment of relapsed or refractory (r/r) follicular lymphoma (FL). These regulatory decisions are backed by…
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CSPC Pharmaceutical’s Glumetinib Earns Breakthrough Therapy Designation in China
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Glumetinib, a MET targeted tyrosine kinase inhibitor (TKI) co-developed by CSPC Pharmaceutical Group Ltd (HKG: 1093) and Shanghai Haihe Pharmaceutical Co., Ltd, has been granted breakthrough therapy designation (BTD) by the Center for Drug Evaluation (CDE) in China. The drug is indicated for locally advanced or metastatic non-small cell lung…
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I-Mab and HI-Bio’s Felzartamab Earns Breakthrough Therapy Designation from US FDA
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China-based I-Mab (NASDAQ: IMAB) and its US partner HI-Bio have announced that they have received breakthrough therapy designation (BTD) from the US Food and Drug Administration (FDA) for their CD38 monoclonal antibody (mAb), felzartamab. This designation highlights the drug’s potential as a treatment for primary membranous nephropathy (PMN), a rare…
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Chongqing Precision Biotechnology’s PCAR-19B Receives CDE Nod for Breakthrough Therapy Designation
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The China’s Center for Drug Evaluation (CDE) website has indicated that Chongqing Precision Biotechnology Co., Ltd’s PCAR-19B cell autologous reinfusion preparation is on track to receive breakthrough therapy designation (BTD). This designation recognizes the potential of PCAR-19B as a treatment for patients aged 3 to 21 years old with CD19-positive…
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Allist Pharmaceuticals’ Furmonertinib Receives FDA Breakthrough Therapy Designation for NSCLC
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Shanghai-based biotech Allist Pharmaceuticals Co., Ltd (SHA: 688578) has announced that it has received breakthrough therapy designation (BTD) from the US FDA for its drug candidate furmonertinib. This designation underscores the drug’s potential as a treatment for previously untreated, locally advanced, or metastatic non-small cell lung cancer (NSCLC) with epidermal…
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CDE Grants Priority Review to LaNova’s LM-302, Roche’s Alectinib, and Alphamab’s KN026
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China’s Center for Drug Evaluation (CDE) has indicated that LaNova Medicines’ LM-302, Roche’s (SWX: ROG) alectinib, and Alphamab Oncology’s HER2-targeted bispecific antibody (BsAb) KN026 (anbenitamab) are set for priority reviews. This designation is a significant step that could expedite the availability of these drugs to patients in need. LM-302: A…
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AcornMed Receives FDA Breakthrough Device Designation for Urothelial Carcinoma Liquid Biopsy
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Beijing-based tumor precision medicine specialist, AcornMed, has been granted Breakthrough Device Designation (BDD) by the US FDA for its early screening liquid biopsy product, AcornMed utLIFE-UC, designed for detecting urothelial carcinoma. Innovative Liquid Biopsy Technology for Urothelial Carcinoma DetectionThe AcornMed utLIFE-UC product leverages the company’s proprietary database and algorithms to…
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CDE Indicates BTD Status for Visirna’s VSA001, Sperogenix’s Vamorolone, and Zai Lab’s Efgartigimod
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The Center for Drug Evaluation (CDE) website has indicated that Visirna Therapeutics’ novel siRNA therapy VSA001, Sperogenix Therapeutics’ vamorolone, and Zai Lab’s (HKG: 9688) efgartigimod are on track for breakthrough therapy designation (BTD) status awards in China. VSA001 for Familial Chylomicronemia Syndrome (FCS)VSA001 is designed to reduce triglyceride levels in…
