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Gilead’s Livdelzi Receives Conditional EC Approval for Primary Biliary Cholangitis
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US-based Gilead Sciences Inc. (NASDAQ: GILD) announced that it has received conditional approval from the European Commission (EC) for its liver disease drug Livdelzi (seladelpar). The drug is approved for use in combination with ursodeoxycholic acid (UDCA) to treat primary biliary cholangitis (PBC) in adults who have an inadequate response…
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Boehringer Ingelheim Launches LENTICLAIR Study for CF Gene Therapy BI 3720931
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German pharmaceutical company Boehringer Ingelheim announced the initiation of the Phase I/II LENTICLAIR study for its gene therapy candidate BI 3720931 in cystic fibrosis (CF). The study is being conducted in collaboration with IP Group, the UK Respiratory Gene Therapy Consortium (GTC), and OXB. Study DetailsBI 3720931 is an inhaled…
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Huadong Medicine’s Biosimilar Tresiba Accepted by NMPA for Review
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China-based Huadong Medicine Co., Ltd (SHE: 000963) announced that its market filing for a biosimilar version of Denmark-based Novo Nordisk A/S’s (NYSE: NVO) Tresiba (insulin degludec) has been accepted for review by the National Medical Products Administration (NMPA). The targeted indication is adult type 2 diabetes. Drug ProfileInsulin degludec, a…
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Innogen Pharmaceutical Launches Efsubaglutide Alfa for Type 2 Diabetes in China
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China-based Guangzhou Innogen Pharmaceutical Group Co., Ltd, a biopharma focused on metabolic diseases, announced the global launch of its efsubaglutide alfa, a next-generation ultra-long-acting glucagon-like peptide 1 (GLP-1) receptor agonist for the treatment of type 2 diabetes (T2D), in Changshu, Jiangsu province. Drug ProfileEfsubaglutide alfa, with an average half-life of…
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Bayer’s AskBio Receives RMAT Designation for AB-1005 in Parkinson’s Disease
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German pharmaceutical giant Bayer (ETR: BAYN) announced that its gene therapy subsidiary AskBio Inc. has received Regenerative Medicine Advanced Therapy (RMAT) designation from the US Food and Drug Administration (FDA) for its investigational gene therapy AB-1005 as a treatment for Parkinson’s disease (PD). Drug ProfileAB-1005 is an investigational gene therapy…
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Phanes Therapeutics Doses First Patient in Peluntamig Study for SCLC and NEC
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Sino-US biotech Phanes Therapeutics Inc. announced that the first patient has been dosed in a clinical study evaluating peluntamig (PT217) in combination with chemotherapy. The trial focuses on patients with small cell lung cancer (SCLC) and neuroendocrine carcinoma (NEC). Drug ProfilePeluntamig is a bispecific antibody (BsAb) targeting DLL3 and CD47.…
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Boehringer Ingelheim’s Zongertinib NDA Accepted by FDA for HER2-Mutated NSCLC
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Germany-based Boehringer Ingelheim announced that the US Food and Drug Administration (FDA) has accepted its new drug application (NDA) for zongertinib (BI 1810631). The drug is indicated for adult patients with unresectable or metastatic non-small cell lung cancer (NSCLC) with HER2 (ERBB2) mutations who have received prior systemic therapy. The…
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Hepalink Pharmaceutical’s H1710 Heparanase Inhibitor Approved for Phase I Study
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China-based Shenzhen Hepalink Pharmaceutical Group Co., Ltd (SHE: 002399) announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a Phase I clinical study of its proprietary drug candidate H1710, a heparanase (HPA) inhibitor, for the treatment of advanced solid tumors. Drug ProfileH1710 is designed…
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Henlius Biotech’s Avastin Biosimilar Hanbeitai Approved in Bolivia
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Shanghai Henlius Biotech Inc. (HKG: 2696) announced that its biosimilar of Roche’s Avastin (bevacizumab), Hanbeitai, has received marketing approval in Bolivia. This marks the first approval for the drug outside of China. The product will be marketed under the trade name Longiva in the Latin American country. Licensing DealHenlius entered…
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Astellas Pharma’s Xospata Wins Regular NMPA Approval for FLT3-Mutated AML
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Japan-based Astellas Pharma Inc. (TYO: 4503, OTCMKTS: ALPMY ) announced that the National Medical Products Administration (NMPA) has converted the conditional approval for its Xospata (gilteritinib) into regular approval. The decision is based on data from the COMMODORE study, a Phase III trial comparing gilteritinib to salvage chemotherapy in patients…
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Hanx Biopharmaceuticals’ HX009 Receives NMPA Clearance for TNBC Study
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Hanx Biopharmaceuticals (Wuhan) Co., Ltd. announced that it has received clearance from the National Medical Products Administration (NMPA) for its HX009, a bifunctional macromolecule targeting PD-1 and CD47. The company plans to test the investigational cancer immunotherapy in combination with an antibody drug conjugate (ADC) for triple-negative breast cancer (TNBC)…
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Biogen Licenses Stoke Therapeutics’ Zorevunersen for Dravet Syndrome Outside Americas
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US-based Biogen Inc. (NASDAQ: BIIB) has entered into a licensing agreement with Stoke Therapeutics, Inc. (NASDAQ: STOK), securing exclusive commercialization rights to zorevunersen, a drug for Dravet syndrome, in all territories outside the United States, Canada, and Mexico. Drug ProfileZorevunersen is an antisense oligonucleotide (ASO) targeting the SCN1A gene, the…
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TAHO Pharma’s TAH3311 Oral Film Shows Bioequivalence to Eliquis in Study
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Taiwan-based TAHO Pharmaceuticals announced positive preliminary results from a pivotal study for its TAH3311 oral dissolving films, a generic version of Bristol-Myers Squibb/Pfizer’s Eliquis (apixaban). The study demonstrated that TAH3311 was bioequivalent to the reference drug under fasting conditions. Study ResultsThe trial involved 60 healthy subjects, with 48 completing the…
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Sanofi’s Dupixent Receives Priority Review from FDA for Bullous Pemphigoid Treatment
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Sanofi (EPA: SAN, NASDAQ: SNY) announced that the US Food and Drug Administration (FDA) has accepted the supplemental biologics license application (sBLA) for Dupixent (dupilumab) for the treatment of adults with bullous pemphigoid (BP) and granted it priority review status. The FDA is expected to make its decision by June…
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Biokin Pharmaceutical’s BL-M07D1 Receives NMPA Approval for Phase II/III Study in HER2+ Breast Cancer
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China-based Sichuan Biokin Pharmaceutical Co., Ltd (SHA: 688506) announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a Phase II/III clinical study of its antibody drug conjugate (ADC), BL-M07D1, for the treatment of HER2 positive breast cancer. The trial will evaluate BL-M07D1 in combination…
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Gilead Sciences’ Lenacapavir NDA for HIV Prevention Accepted by FDA for Priority Review
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US-based Gilead Sciences Inc. (NASDAQ: GILD) announced that the New Drug Application (NDA) for its lenacapavir, a twice-yearly injectable HIV-1 capsid inhibitor for pre-exposure prophylaxis (PrEP), has been accepted by the US Food and Drug Administration (FDA) for priority review. The Prescription Drug User Fee Act (PDUFA) target action date…
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Merck’s Welireg Wins Conditional EU Approval for VHL Disease and Advanced RCC
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US pharmaceutical giant Merck, Sharp & Dohme (MSD, NYSE: MRK) announced that it has received conditional approval from the European Commission (EC) for its oral drug Welireg (belzutifan) for the treatment of von Hippel-Lindau (VHL) disease and advanced clear cell renal cell carcinoma (RCC). Drug ProfileWelireg is a hypoxia-inducible factor-2…
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InnoCare Pharma Receives NMPA Approval for Mesutoclax Phase III Study in CLL/SLL
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Beijing-based biotech InnoCare Pharma (HKG: 9969, SHA: 688428) announced that it has received approval from the National Medical Products Administration (NMPA) to initiate a regulatory Phase III clinical study for its B-cell lymphoma-2 (BCL2) inhibitor mesutoclax (ICP-248) in combination with its Bruton’s tyrosine kinase (BTK) inhibitor orelabrutinib. The study will…
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Hengrui Pharma’s HR19034 Eye Drops for Myopia Delay Accepted by NMPA
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Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) announced that its market filing for HR19034 eye drops, designed to delay myopia progression in children aged 6-12, has been accepted by the National Medical Products Administration (NMPA). The product targets children with spherical diopters ranging from -0.50D to -4.00D and astigmatism/anisometropia ≤…
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Gan & Lee Pharmaceuticals Doses First Patient in GZR4 Phase III Study for Diabetes
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China-based Gan & Lee Pharmaceuticals (SHA: 603087) announced that the first patient has been dosed in a Phase III clinical study for GZR4, its Category 1 therapeutic biologic product. GZR4 is an investigational ultra-long-acting insulin designed for once-per-week subcutaneous injection to treat diabetes. Drug ProfileGZR4 aims to provide a convenient…
