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Sanofi’s Sarclisa Meets Co-Primary Endpoints in Phase III IRAKLIA Study for Multiple Myeloma
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French pharmaceutical giant Sanofi (NASDAQ: SNY, EPA: SAN) has announced that the Phase III IRAKLIA study for its Sarclisa (isatuximab) met its co-primary endpoints when administered subcutaneously (SC) via an on-body delivery system (OBDS) in patients with multiple myeloma (MM). This marks a significant step forward in the treatment of…
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FDA Grants Priority Review to Johnson & Johnson’s Nipocalimab for Myasthenia Gravis
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US-based Johnson & Johnson (J&J, NYSE: JNJ) has announced that the US FDA has granted priority review status to the Biologics License Application (BLA) for its portfolio drug nipocalimab. This priority status is based on results from the Phase III Vivacity-MG3 study and is awarded for the product’s potential use…
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Bayer’s Elinzanetant Meets All Primary Endpoints in Phase III OASIS 4 Study
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Germany-based Bayer AG (ETR: BAYN) has announced that the Phase III OASIS 4 study for its non-hormonal treatment elinzanetant has reached all primary endpoints. The study focused on moderate to severe vasomotor symptoms (VMS) caused by adjuvant endocrine therapy in women with breast cancer or at high risk of developing…
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Inmagene Biopharmaceuticals Posts Positive Results for IMG-007 in Atopic Dermatitis
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Inmagene Biopharmaceuticals, a Sino-US biotech that recently merged with US-based Ikena Oncology, Inc. (NASDAQ: IKNA), has posted additional positive topline results from the Phase IIa study for IMG-007 in patients with moderate-to-severe atopic dermatitis (AD). The company also released results from a Phase I trial of IMG-007’s subcutaneous (SC) formulation.…
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GSK Launches Cabotegravir Injection in China for HIV Pre-Exposure Prophylaxis
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UK-based GlaxoSmithKline (GSK; NYSE: GSK) has announced the official commercial launch of its cabotegravir injection in China. The integrase strand transfer inhibitor (INSTI) was approved in May of last year for pre-exposure prophylaxis (PrEP) of HIV-1 in adults and adolescents (weighing ≥ 35kg) at risk of infection, to reduce the…
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NHSA Revises 2024 NRDL Drug Information Based on Public Feedback
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China’s National Healthcare Security Administration (NHSA) has announced revisions to the information about certain drugs on the 2024 National Reimbursement Drug List (NRDL) following public feedback. These changes reflect the NHSA’s commitment to transparency and responsiveness in managing the country’s drug reimbursement policies. Specific Drug UpdatesThe NHSA has confirmed that…
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Astellas’ Padcev and Keytruda Combo Cleared by NMPA for Urothelial Cancer
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Japan-based Astellas Pharma Inc. (TYO: 4503) has announced marketing clearance by China’s National Medical Products Administration (NMPA) for its Padcev (enfortumab vedotin) in combination with Keytruda (pembrolizumab) to treat adult patients with locally advanced or metastatic urothelial cancer (la/mUC). This combination offers a new therapeutic option to patients in China,…
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HuidaGene Therapeutics Receives EMA Orphan Designation for HG004 Gene Therapy
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Shanghai-based genome medicines specialist HuidaGene Therapeutics has announced a positive opinion from the European Medicines Agency (EMA) for the Committee for Orphan Medicinal Products (COMP) on the orphan designation filing for its HG004. The gene therapy is designed for the treatment of inherited retinal dystrophy caused by dysfunction in the…
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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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Kelun Pharmaceutical’s Generic Mulpleta Gains NMPA Approval in China
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China-based Sichuan Kelun Pharmaceutical Co., Ltd (SHE: 002422) has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its generic version of Japan-based Shionogi’s Mulpleta (lusutrombopag). This Category 4 chemical drug becomes the first generic Mulpleta in China, marking a significant milestone in the…
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Sanofi’s Sarclisa Gains NMPA Approval for Multiple Myeloma Treatment in China
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French pharmaceutical giant Sanofi (NASDAQ: SNY) has announced that it has received marketing approval from China’s National Medical Products Administration (NMPA) for its Sarclisa (isatuximab) in combination with pomalidomide plus dexamethasone. This approval is for the treatment of adult patients with multiple myeloma who have previously received at least first-line…
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Mirror Biologics and Merck KGaA Collaborate on Phase II Trial for Colorectal Cancer Immunotherapy
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US-based Mirror Biologics, Inc., an off-the-shelf immunotherapy developer, has announced a clinical trial collaboration and supply agreement with German major Merck KGaA (ETR: MRK). The collaboration aims to jointly conduct a Phase II clinical study assessing the efficacy and safety of Mirror’s immunotherapy AlloStim combined with Merck’s Bavencio (avelumab), an…
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Johnson & Johnson’s Posdinemab Receives FDA Fast Track Designation for Alzheimer’s Disease
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US giant Johnson & Johnson (J&J, NYSE: JNJ) has announced that it has received Fast Track designation from the US FDA for its posdinemab, a phosphorylated tau-directed monoclonal antibody (mAb) targeting Alzheimer’s disease (AD). This designation is a significant milestone in the development of posdinemab, which is designed to slow…
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MSD’s Gardasil Vaccine Gains NMPA Approval for Use in Males Aged 9 to 26
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US major Merck, Sharp & Dohme (MSD; NYSE: MRK) has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its recombinant human papillomavirus (HPV) quadrivalent vaccine, Gardasil, for use in males aged 9 to 26. This approval expands the vaccine’s application to include prevention…
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Bayer’s Nubeqa Seeks NMPA Approval for New Prostate Cancer Indication
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Bayer AG (ETR: BAYN) has announced the submission of a supplemental new drug application (sNDA) for its Nubeqa (darolutamide) to the National Medical Products Administration (NMPA) in China. The German pharmaceutical giant is seeking approval for its androgen receptor inhibitor (ARi) combined with androgen deprivation therapy (ADT) for the treatment…
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Avenzo Therapeutics Licenses Duality Biologics’ EGFR/HER3 Bispecific ADC AVZO-1418/DB-1418
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US-based oncology-focused biotech Avenzo Therapeutics, Inc. has signed a licensing agreement with Duality Biologics, an antibody conjugate drug (ADC) developer operating out of the United States and China, for AVZO-1418/DB-1418, a potential best-in-class EGFR/HER3 bispecific ADC. Drug Profile and DevelopmentAVZO-1418/DB-1418 is an EGFR/HER3 dual-targeting ADC based on a topoisomerase-1 inhibitor.…
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Insilico Medicine’s ISM5411 Shows Positive Results in Phase I Studies for Inflammatory Bowel Disease
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China’s generative artificial intelligence (AI)-driven biotech, Insilico Medicine, has announced positive preliminary results from two concluded Phase I studies for its candidate drug ISM5411 in Australia and China. The drug is being developed to treat inflammatory bowel disease (IBD). Study Details and ResultsISM5411 is an intestinal restriction oral PHD inhibitor.…
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Yiling Pharmaceutical Withdraws Clinical Filing for G201-Na in Assisted Reproduction
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China-based Yiling Pharmaceutical Co., Ltd (SHE: 002603) has announced the withdrawal of its clinical filing for the Category 1 chemical drug G201-Na in assisted reproduction from the National Medical Products Administration (NMPA). The decision was made citing drug approval policies and program progress. Drug Profile and MechanismG201-Na is a small…
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Dizal’s Sunvozertinib Receives Priority Review from FDA for EGFR Exon 20 NSCLC
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China-based Dizal Pharmaceutical Co., Ltd (SHA: 688192) has announced that its New Drug Application (NDA) for sunvozertinib has been accepted for review by the US FDA with priority review status. The EGFR inhibitor is targeting approval to treat locally advanced or metastatic non-small cell lung cancer (NSCLC) patients with epidermal…
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CSPC Pharmaceutical Group Receives NMPA Approvals for ADC SYS6045 and PDE4B Inhibitor SYH2059
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China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced that it has received separate clinical trial approvals from the National Medical Products Administration (NMPA) for its antibody drug conjugate (ADC) SYS6045 and small molecule inhibitor SYH2059. These approvals mark significant milestones in the development of both drug candidates. SYS6045: Antibody…
