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Wyze Biotech’s RJMty19 Injection Accepted for CDE Review for r/r B-Cell NHL
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Wyze Biotech Co., Ltd, a Guangdong-based developer of off-the-shelf universal DNT cell therapies, has announced that an investigational new drug (IND) filing for its immune cell product RJMty19 injection has been accepted for review by China’s Center for Drug Evaluation (CDE). The therapy is intended for assessment as a treatment…
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GSK’s ViiV Healthcare Secures NMPA Approval for Vocabria in HIV-1 Treatment
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UK pharmaceutical giant GlaxoSmithKline (GSK, NYSE: GSK) has announced that its HIV joint venture, ViiV Healthcare, has received approval from China’s National Medical Products Administration (NMPA) for Vocabria (cabotegravir injection). The drug is approved for use in combination with Johnson & Johnson/Janssen Pharmaceutical’s (J&J, NYSE: JNJ) Rekambys (rilpivirine long-acting injection)…
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AbbVie’s Rinvoq Gains Two New Indications in China: AxSpA and Ankylosing Spondylitis
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US-based pharmaceutical company AbbVie (NYSE: ABBV) has announced the receipt of two additional indication approvals from China’s National Medical Products Administration (NMPA) for its drug Rinvoq (upadacitinib). The selective JAK inhibitor is now approved for treating adult patients with active radiologically negative axial spinal arthritis (axSpA) who show a poor…
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Eli Lilly’s Omvoh Receives FDA Approval for Ulcerative Colitis Treatment
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The US Food and Drug Administration (FDA) has granted regulatory approval to Eli Lilly (NYSE: LLY) for its interleukin-23p19 antagonist, Omvoh (mirikizumab), as a treatment for moderately to severely active ulcerative colitis (UC) in adults. This approval is a significant milestone for Eli Lilly, expanding its portfolio in the inflammatory…
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Abbisko Therapeutics Gets NMPA Approval for Phase I Study of ABSK112 in NSCLC
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Shanghai-based biotechnology firm Abbisko Therapeutics Co., Ltd (HKG: 2256) has announced that it has received approval from China’s National Medical Products Administration (NMPA) to initiate a Phase I clinical study for its investigational drug, ABSK112. This next-generation EGFR inhibitor, which targets the Exon20ins mutation, is set to be evaluated as…
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Biogen’s BIIB080 Shows Promise in Phase Ib Trial for Mild Alzheimer’s Disease
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Biogen (NASDAQ: BIIB) has released preliminary findings from a Phase Ib trial for BIIB080, a microtubule-associated protein tau (MAPT)-targeting antisense oligonucleotide (ASO) co-developed with Ionis Pharmaceuticals (NASDAQ: IONS). The trial focused on patients with mild Alzheimer’s disease (AD), showing that high doses of the spinal injection led to improvements in…
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Huadong Medicine’s Elahere Accepted for NMPA Review in China for Ovarian Cancer Treatment
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China-based Huadong Medicine Co., Ltd (SHE: 000963) has announced that the National Medical Products Administration (NMPA) has accepted the market filing for its antibody drug conjugate (ADC) Elahere (mirvetuximab soravtansine), targeting folate receptor α (FRα). This marks a significant step towards making the treatment available for patients in China. Acquisition…
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MSD Halts Phase II Trials for Glutamate Modulator MK-1942 in Alzheimer’s and Depression
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Merck, Sharp & Dohme (MSD; NYSE: MRK) has announced the discontinuation of two Phase II trials evaluating the efficacy of its glutamate modulator MK-1942 in patients with mild-to-moderate Alzheimer’s disease (AD) and treatment-resistant major depressive disorder (MDD). The decision comes after an unblinded data analysis indicated potential safety concerns. Trial…
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Novartis’ Pluvicto Demonstrates Positive Phase III Results in mCRPC Treatment
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Swiss pharmaceutical giant Novartis (NYSE: NVS) has released encouraging data from a Phase III study for its radioligand therapy (RLT) Pluvicto (177Lu vipivotide tetraxetan). The study focused on patients with prostate-specific membrane antigen (PSMA)-positive progressive metastatic castration-resistant prostate cancer (mCRPC), a challenging form of the disease. Primary Endpoint and Risk…
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Life Molecular Imaging and Sinotau Pharmaceutical Secure NMPA Approval for Neuraceq in China
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Germany-headquartered Life Molecular Imaging (LMI) and China-based Sinotau Pharmaceutical Group have announced that Neuraceq (florbetaben F-18 injection) has received regulatory approval from the National Medical Products Administration (NMPA) in China. This marks a significant milestone as Neuraceq becomes the first radiopharmaceutical targeting β-amyloid approved in China to support the diagnosis…
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Innovent Biologics’ GFH925 on Track for Priority Review Status for NSCLC Treatment
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The Center for Drug Evaluation (CDE) has indicated that Innovent Biologics’s (HKG: 1801) Category 1 chemical drug, GFH925, is set to receive priority review status for the treatment of advanced non-small cell lung cancer (NSCLC) with KRAS G12C mutation in patients who have received at least one systemic treatment. This…
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Zhejiang Jianfeng Receives FDA Approval for JFAN-1001 Clinical Trial in NSCLC
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Zhejiang Jianfeng Group Co., Ltd (SHA: 600668), a leading pharmaceutical company based in China, has announced that it has received clinical trial approval from the US Food and Drug Administration (FDA) for its Category 1 chemical drug, JFAN-1001. The drug is indicated for the treatment of locally advanced or metastatic…
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CSPC Pharmaceutical Gains NMPA Approval for Clinical Study of Bispecific Antibody NBL-028
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China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced that it has received approval from China’s National Medical Products Administration (NMPA) to conduct a clinical study for its investigational bispecific antibody (BsAb) NBL-028. The drug targets CLDN6 and CD137, focusing initially on advanced tumors with CLDN6 expression, such as testicular…
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Shanghai Henlius Initiates Global Phase III Study for HanSiZhuang in LS-SCLC
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China’s Shanghai Henlius Biotech, Inc. (HKG: 2696) has announced the milestone of the first patient dosing in the global multi-center Phase III clinical study for its anti-PD-1 monoclonal antibody (mAb) HanSiZhuang (serplulimab). The study is evaluating the drug in combination with chemotherapy and concurrent radiotherapy for patients with limited-stage small…
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Qilu Pharmaceutical Unveils Promising Data for QL1706 in Cervical Cancer Treatment at ESMO 2023
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China’s Qilu Pharmaceutical showcased compelling data for its combination drug QL1706 (iparomlimab and tuvonralimab) as a potential treatment for cervical cancer at the European Society for Medical Oncology (ESMO) Annual Congress 2023. The focus was on a multi-center, single-arm Phase II study conducted in China, evaluating QL1706 in combination with…
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EC Approves AstraZeneca and Daiichi Sankyo’s Enhertu for Advanced HER2+ NSCLC
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The European Commission (EC) has granted registration approval for the HER2-directed antibody-drug conjugate (ADC) Enhertu (trastuzumab deruxtecan) to AstraZeneca (AZ; NASDAQ: AZN) and Daiichi Sankyo (TYO: 4568). This approval is for the treatment of advanced HER2-positive non-small cell lung cancer (NSCLC) in adults who require systemic therapy following chemotherapy. The…
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Dizal’s Sunvozertinib Shows Promising Efficacy in Advanced NSCLC at ESMO 2023
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China-based Dizal Pharmaceutical Co., Ltd (SHA: 688192) presented compelling efficacy and safety data for its next-generation epidermal growth factor receptor (EGFR) inhibitor, sunvozertinib, at the European Society for Medical Oncology (ESMO) Congress 2023. The drug is being evaluated for first-line treatment in advanced non-small cell lung cancer (NSCLC) with EGFR…
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AbbVie Partners with Lupus Therapeutics to Advance Rinvoq in SLE Treatment
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AbbVie (NYSE: ABBV) announced this week a strategic collaboration with US-based Lupus Therapeutics aimed at accelerating the late-stage development of the JAK inhibitor Rinvoq (upadacitinib) for the treatment of systemic lupus erythematosus (SLE). This partnership marks a significant step in expanding the therapeutic applications of Rinvoq, which is already approved…
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BMS’s BMS-986278 Receives FDA Breakthrough Therapy Designation for Pulmonary Fibrosis
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Bristol-Myers Squibb (BMS; NYSE: BMY) announced this week that it has received breakthrough therapy designation from the US Food and Drug Administration (FDA) for BMS-986278, its potential first-in-class lysophosphatidic acid receptor 1 (LPA1) antagonist. This oral treatment for progressive pulmonary fibrosis (PPF) is now set for expedited development and review,…
