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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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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 (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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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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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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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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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 (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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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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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 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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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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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 (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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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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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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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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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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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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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…