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Novo Nordisk’s Turoctocog Alfa Pegol for Hemophilia A Accepted for Review by China’s CDE
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The Center for Drug Evaluation (CDE) in China has indicated on its website that the market filing for turoctocog alfa pegol, developed by Denmark-based Novo Nordisk (NYSE: NVO), has been accepted for review. The drug is intended for the treatment of hemophilia A, a genetic bleeding disorder. Turoctocog Alfa Pegol:…
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AstraZeneca’s Eplontersen Gains Tacit Approval from CDE for ATTR-CM Clinical Study
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The Center for Drug Evaluation (CDE) website indicates that UK pharmaceutical major AstraZeneca’s (AZ, NASDAQ: AZN) injectable eplontersen has been tacitly approved for clinical study in hereditary and wild-type transthyretin-mediated amyloid cardiomyopathy (ATTR-CM), aiming to reduce cardiovascular mortality and cardiovascular-related hospitalizations. Eplontersen: An Antisense Oligonucleotide Therapy for ATTR-CMEplontersen, an antisense…
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Boehringer Ingelheim Gets NMPA Approval for Phase II Study of BI 764532 in SCLC
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Boehringer Ingelheim (BI) has announced that it has received approval from the National Medical Products Administration (NMPA) in China to conduct an open, multi-center Phase II dose-setting study. The study will assess the efficacy and safety of BI 764532 in patients with recurrent/refractory extensive-stage small cell lung cancer (ES-SCLC) and…
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HanchorBio’s HCB101 Receives WFDA Approval for Multi-Region Clinical Study
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Taiwan-based HanchorBio has announced that it has received approval from the Taiwan Food and Drug Administration (WFDA) to conduct a multi-region, multi-center clinical study for its innovative fusion protein, HCB101. HCB101: A Promising Fusion Protein for Cancer TreatmentHCB101 is an engineered SIRP linked to IgG4-Fc α fusion proteins that can…
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InnoCare Pharma’s ICP-723 Receives NMPA Approval for Pediatric Clinical Study
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Beijing InnoCare Pharma (HKG: 9969), a China-based biotech company specializing in cancer and autoimmune diseases, has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its second-generation pan-TRK inhibitor, ICP-723, in pediatric patients aged 2 to 12 years. This follows…
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Boehringer Ingelheim and Eli Lilly’s Jardiance Approved by EC for Chronic Kidney Disease
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Germany-based Boehringer Ingelheim and its US partner Eli Lilly & Co., (NYSE: LLY), have reported receiving European Commission (EC) approval for Jardiance (empagliflozin) as a treatment for adults with chronic kidney disease (CKD). This marks an expansion of Jardiance’s indications, which already include type 2 diabetes and heart failure. Expanding…
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FDA Approves Daiichi Sankyo’s Vanflyta for FLT3-ITD Positive AML Maintenance Treatment
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The US Food and Drug Administration (FDA) has granted clearance to Japan-based Daiichi Sankyo (TYO: 4568) for its type II FLT3 inhibitor, Vanflyta (quizartinib), as a maintenance treatment following consolidation chemotherapy for newly diagnosed acute myeloid leukemia (AML) that is FLT3-ITD positive in adult patients. Phase III Study Results and…
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Gilead Sciences Halts Development of Magrolimab for HR-MDS Following Phase III Trial Results
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Gilead Sciences (NASDAQ: GILD) has decided to stop pursuing the potential first-in-class immunotherapy, magrolimab, for higher-risk myelodysplastic syndromes (HR-MDS) after obtaining disappointing efficacy data from a Phase III trial. Although the company has not yet released the results, it has confirmed that the study’s primary endpoints included complete response (CR)…
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AbbVie’s Aquipta and Novartis’s Piqray Receive Regulatory Approvals in Mexico
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Mexico’s Federal Commission for Protection against Health Risks (COFEPRIS) has granted registration approvals to two innovative drugs: AbbVie’s (NYSE: ABBV) analgesic Aquipta (atogepant) and Novartis’ (NYSE: NVS) cancer therapy Piqray (alpelisib). This marks a significant milestone for both companies, expanding access to these treatments in the Mexican market. Aquipta: A…
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Ascletis Pharma’s ASC22 Combo Therapy Shows Promise in HIV Functional Cure Clinical Trial
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China-based Ascletis Pharma Inc., (HKG: 1672) has announced that the Shanghai Public Health Clinical Center presented clinical results of ASC22 (envafolimab) in combination with chidamide as a novel combination therapy aimed at achieving a functional cure for human immunodeficiency virus (HIV) infection. The findings were showcased at the 12th International…
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Jiangsu Hengrui Pharmaceuticals and Hansoh Pharmaceutical Group Get NMPA Approval for Solid Tumor Treatment
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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276) has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for a combination therapy involving its adebrelimab (SHR-1316) with Hansoh Pharmaceutical Group Co., Ltd’s (HKG: 3692) Ameile (almonertinib) or SHR-A2009, with or without chemotherapy, for the treatment…
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Eli Lilly’s Mirikizumab and Chia Tai Tianqing’s Lanifibranor Enter Breakthrough Therapy Review
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US pharmaceutical major Eli Lilly’s (NYSE: LLY) mirikizumab and China-based Chia Tai Tianqing’s lanifibranor have both entered into the breakthrough therapy review process, marking a significant step in advancing treatments for moderate to severe active Crohn’s disease (CD) and non-cirrhotic non-alcoholic steatohepatitis (NASH) with liver fibrosis, respectively. Mirikizumab: Anti-IL-23 Monoclonal…
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Vcanbio’s VUM02 Stem Cell Therapy Accepted for Review by China’s CDE for aGvHD Treatment
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China-based Vcanbio Cell & Gene Engineering Corp., Ltd (SHA: 600645) has announced that the Center for Drug Evaluation (CDE) has accepted another clinical trial filing for its VUM02 (human umbilical cord-derived mesenchymal stem cells) for review. The Category 1 therapeutic biologic product is under development as a treatment for acute…
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BeiGene’s Tislelizumab Receives Positive CHMP Opinion for Esophageal Cancer Treatment
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BeiGene (NASDAQ: BGNE) has announced that its programmed death-1 (PD-1) inhibitor, tislelizumab, has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), recommending a first market approval. The regulatory decision on whether to approve tislelizumab monotherapy for unresectable, locally…
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CanSino Biologics Granted Approval by Health Canada for Zoster Vaccine Candidate CS-2032
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China-based vaccines specialist CanSino Biologics Inc., (HKG: 6185) has announced receiving approval from Health Canada to conduct a Phase I clinical study assessing the safety and preliminary immunogenicity of CS-2032, a recombinant vaccine candidate for the zoster virus. This adenovirus vector-based vaccine is co-developed with UK firm Vaccitech Ltd under…
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Bavarian Nordic’s RSV Vaccine Candidate Fails Phase III Trial, Discontinues Program
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Denmark-based Bavarian Nordic A/S (CPH: BAVA) has revealed that its pipeline respiratory syncytial virus (RSV) vaccine candidate, MVA-BN RSV, did not achieve all primary endpoints in a Phase III trial. Consequently, the company has decided to discontinue its RSV program, including a co-development partnership with China-based Nuance Pharma for Greater…
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Antengene Corp. Receives FDA Fast-Track Designation for Xpovio in Myelofibrosis Treatment
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China-based biopharma Antengene Corp., Ltd (HKG: 6996) has announced receiving fast-track designation from the US Food and Drug Administration (FDA) for its drug Xpovio (selinexor) in the treatment of myelofibrosis (MF), an indication that covers primary myelofibrosis, myelofibrosis after primary thrombocytosis, and myelofibrosis after polycythemia vera. Background on Xpovio and…
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Hansoh Pharmaceutical’s Ibrexafungerp NDA Accepted for Review by China’s NMPA for VVC Treatment
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China-based Hansoh Pharmaceutical Group Co., Ltd (HKG: 3692) has announced that the National Medical Products Administration (NMPA) has accepted a New Drug Application (NDA) filing for its ibrexafungerp, intended for the treatment of vulvovaginal candidiasis (VVC) in adult and post-menarche females. Phase III Study Results and NDA FilingThe filing is…
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GenScript Biotech’s CAR-T Therapy Carvykti Reports USD 117 Million in Sales
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China-based Contract Research Organization (CRO) GenScript Biotech Corporation (HKG: 1548) has announced that its subsidiary, Legend Biotech Corporation (NASDAQ: LEGN), has reported sales of USD 117 million for its BCMA-directed chimeric antigen receptor T cell (CAR-T) therapy, Carvykti (ciltacabtagene autoleucel), as of June 30, 2023. The sales data, provided by…
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Ocumension Therapeutics’ OT-101-S Myopia Treatment Accepted for CDE Review
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Chinese ophthalmology specialist Ocumension Therapeutics (HKG: 1477) has announced that the Center for Drug Evaluation (CDE) has accepted the Phase III clinical filing for its in-house developed OT-101-S, a treatment aimed at delaying or arresting child myopia. This development marks a significant step forward in the advancement of this novel…
