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NMPA Approves J&J’s FGFR Kinase Inhibitor Balversa for Urothelial Carcinoma
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China’s National Medical Products Administration (NMPA) has approved Johnson & Johnson’s (J&J; NYSE: JNJ) FGFR kinase inhibitor Balversa (erdafitinib) for the treatment of adult patients with unresectable locally advanced or metastatic urothelial carcinoma (UC). The drug is indicated for patients who carry susceptible FGFR3 gene mutations and have undergone at…
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Doma Biopharma Receives FDA Clearance for DM002 Phase I Study-Fineline Info & Tech
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China-based Doma Biopharmaceutical (Suzhou) Co., Ltd has announced that it has received clearance from the US Food and Drug Administration (FDA) to initiate a Phase I clinical study. The study will assess the safety, tolerability, and preliminary anti-tumor activity of its Category 1 drug DM002 in multiple solid tumors. This…
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GSK’s Shingrix Prefilled Syringe Accepted for FDA Review
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UK-headquartered GlaxoSmithKline (GSK; NYSE: GSK) has announced that a market filing for a prefilled syringe presentation of its recombinant zoster vaccine Shingrix has been accepted for review by the US Food and Drug Administration (FDA). This development marks a significant step towards enhancing the convenience and efficiency of vaccine administration.…
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Fosun Pharmaceutical’s FCN-437c Accepted for NMPA Review for Breast Cancer Treatment
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Fosun Pharmaceutical (Group) Co., Ltd (HKG: 2196, SHA: 600196) has announced that another market approval filing for its FCN-437c has been accepted for review by the National Medical Products Administration (NMPA). This marks a significant step in the development of a new treatment option for patients with hormone receptor (HR)…
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Hengrui’s SHR4640 Accepted for NMPA Review for Gout and Hyperuricemia Treatment
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China-based Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) has announced that a market filing for its SHR4640 as a long-term treatment for primary gout with hyperuricemia has been accepted for review by the National Medical Products Administration (NMPA). This marks a significant step in the development of a new treatment…
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Sinogen’s SalMet-Vec Receives FDA Orphan Drug Designation for Pancreatic Cancer
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China’s oncology specialist Guangzhou Sinogen Pharmaceutical Co., Ltd. has announced receiving Orphan Drug Designation (ODD) from the US FDA for its SalMet-Vec in pancreatic cancer. This oncolytic bacteria drug has previously earned ODD statuses from the agency for osteosarcoma, hepatocellular carcinoma, and small cell lung cancer. Drug Profile and MechanismSalMet-Vec…
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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…
