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Gan & Lee Pharmaceuticals Gets FDA Approval for GZR18 Obesity/Overweight Phase II Study
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China-based Gan & Lee Pharmaceuticals (SHA: 603087) has announced that it has received approval from the US Food and Drug Administration (FDA) to initiate a Phase II study for its investigational drug GZR18 in treating obesity and overweight conditions, with and without type 2 diabetes (T2D). GZR18: A Promising GLP-1…
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HutchMed’s Orpathys Receives Breakthrough Therapy Designation in China for Advanced Lung Cancer
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HutchMed (China) Ltd (HKG: 0013, NASDAQ: HCM) has announced that its MET inhibitor, Orpathys (savolitinib), co-developed with AstraZeneca (AZ, NASDAQ: AZN), has been granted Breakthrough Therapy Designation (BTD) by China’s National Medical Products Administration (NMPA). The designation is for the use of Orpathys in combination with Tagrisso (osimertinib) for the…
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HutchMed to Receive Milestone Payment as Takeda’s Fruzaqla Gets Reimbursement Nod in Spain
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China-based HutchMed (China) Ltd (HKG: 0013, NASDAQ: HCM) is poised to receive another milestone payment from its partner Takeda (TYO: 4502, NYSE:TAK), following the Japanese firm’s achievement of a national reimbursement recommendation for Fruzaqla (fruquintinib) for patients with previously treated metastatic colorectal cancer (CRC) in Spain. This event marks the…
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HuidaGene Therapeutics Launches MUSCLE Study for CRISPR Therapy in Duchenne Muscular Dystrophy
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Shanghai-based genome medicines specialist HuidaGene Therapeutics has announced the initiation of the MUSCLE study for its CRISPR-based DNA-editing therapy, HG302, which targets Duchenne muscular dystrophy (DMD), with the first subject now dosed. Understanding Duchenne Muscular Dystrophy and HG302Duchenne muscular dystrophy is a severe X-linked recessive disorder and a prevalent form…
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Transcenta’s LIV-1 ADCs Show Promising Results in Pre-Clinical Breast Cancer Study
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China-based biotech company Transcenta Holdings Ltd (HKG: 6628) announced updated results from a pre-clinical study for its LIV-1 antibody-based antibody drug conjugates (ADCs) at the 2024 San Antonio Breast Cancer Symposium (SABCS). The study focuses on the potential of LIV-1 as a therapeutic target in metastatic breast cancer. LIV-1 as…
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ImmunoTech Biopharm’s CAR-T-19 Earns Breakthrough Therapy Designation for B-ALL Treatment
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China-based chimeric antigen receptor T-cell (CAR-T) specialist Immunotech Biopharm Ltd (HKG: 6978) has announced receiving Breakthrough Therapy Designation (BTD) from China’s National Medical Products Administration (NMPA) for its CAR-T-19 injection. This designation is awarded for the treatment of relapsed/refractory B-cell acute lymphoblastic leukemia (B-ALL) patients aged 25 and under, marking…
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Jiangsu Hengrui Pharmaceuticals Receives NMPA Clearance for HRS-4729 Peptide Drug
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Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) has announced the receipt of clinical clearance from China’s National Medical Products Administration (NMPA) for its peptide drug HRS-4729. This development marks a significant step forward in the company’s pipeline of innovative drugs. HRS-4729: A Triple Agonist for Diabetes TreatmentHRS-4729 is a triple…
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AstraZeneca’s Lynparza Shows Sustained Improvements in OlympiA Phase III Study
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UK pharmaceutical major AstraZeneca (AZ; NASDAQ: AZN) has updated data from the Phase III OlympiA study for its PARP inhibitor Lynparza (olaparib) at the San Antonio Breast Cancer Symposium 2024 (SABCS). The study provides significant insights into the efficacy and safety of Lynparza in patients with germline BRCA-mutated (gBRCAm) HER2-negative…
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Sanofi Receives FDA Fast-Track Designation for Influenza and COVID-19 Combo Vaccine Candidates
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Sanofi (NASDAQ: SNY) has announced that it has received Fast-Track Designations from the US Food and Drug Administration (FDA) for its combination vaccine candidates aimed at preventing influenza and COVID-19 infections in individuals aged 50 and older. Details of the Combination Vaccine CandidatesOne of the combination vaccine candidates (NCT06695117) pairs…
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Eli Lilly’s Imlunestrant Reduces Disease Progression in ER+/HER2- Advanced Breast Cancer: EMBER-3 Study
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US pharmaceutical major Eli Lilly and Company (NYSE: LLY) has published results from the Phase III EMBER-3 study for its drug imlunestrant in patients with estrogen receptor positive (ER+), human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer (ABC). The study focused on patients whose disease progressed on…
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Arvinas and Pfizer Present Positive TACTIVE-U Sub-Study Data at SABCS 2024
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Partners Arvinas, Inc. (NASDAQ: ARVN) and Pfizer Inc. (NYSE: PFE) have jointly presented preliminary data from the ongoing Phase Ib portion of the TACTIVE-U sub-study at the 2024 San Antonio Breast Cancer Symposium (SABCS) in San Antonio, Texas. The study assesses vepdegestrant in combination with Verzenios (abemaciclib) in patients with…
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Novartis’ Kisqali Shows Sustained Efficacy in NATALEE Study at SABCS 2024
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Swiss pharmaceutical giant Novartis (NYSE: NVS) presented updated results from the pivotal Phase III NATALEE study for its Kisqali (ribociclib) at the 2024 San Antonio Breast Cancer Symposium (SABCS). The study provides significant insights into the efficacy of Kisqali in combination with endocrine therapy (ET) for patients with receptor-positive/human epidermal…
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Legend Biotech’s Carvykti Demonstrates High MRD Negativity Rates in Phase III CARTITUDE-4 Trial
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China-based Legend Biotech Corporation (NASDAQ: LEGN) has released new data on minimal residual disease (MRD) negativity rates from the Phase III CARTITUDE-4 trial at the 66th Annual American Society of Hematology (ASH) Annual Meeting. The trial compared Carvykti (ciltacabtagene autoleucel; cilta-cel) with the standard of care (SoC) in treating multiple…
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Huadong Medicine’s Arcalyst Receives NMPA Approval for Recurrent Pericarditis Treatment
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China-based Huadong Medicine Co., Ltd (SHE: 000963) has announced receiving another indication approval from the National Medical Products Administration (NMPA) for its Arcalyst (rilonacept), a treatment for recurrent pericarditis (RP). This marks an expansion of the drug’s application in addressing autoimmune diseases. Rilonacept’s Mechanism and Global ApprovalsRilonacept is a recombinant…
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IMEIK Technology Receives NMPA Approval for Recombinant Human Hyaluronidase Clinical Study
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China-based IMEIK Technology Development Co., Ltd (SHE: 300896) has announced receiving approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its recombinant human hyaluronidase for injection. The study aims to explore the use of the drug to promote the diffusion of subcutaneous infusion as an…
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Patronus Biotech’s RSV Vaccine LYB005 Receives NMPA Approval for Clinical Study
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Guangzhou Patronus Biotech Co., Ltd., a vaccine start-up specializing in respiratory and infectious diseases, has received approval from China’s National Medical Products Administration (NMPA) to initiate a clinical study for its recombinant respiratory syncytial virus (RSV) vaccine (CHO cells), LYB005. LYB005’s U-VLP Technology and Clinical ProgressLYB005 is an RSV vaccine…
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Shanghai Pharmaceuticals’ SRD4610 Receives FDA Orphan Drug Designation for ALS Treatment
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China’s Shanghai Pharmaceuticals (SPH; HKG: 2607; SHA: 601607) has announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to its SRD4610, an in-house developed compound Chinese medicine, for the treatment of amyotrophic lateral sclerosis (ALS). This designation highlights the potential impact of SRD4610 in…
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Sperogenix Therapeutics’ Agamree Receives NMPA Approval for Duchenne Muscular Dystrophy Treatment
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China-based rare disease specialist Sperogenix Therapeutics Limited has announced receiving marketing approval from the National Medical Products Administration (NMPA) for its drug Agamree (vamorolone), which is used to treat patients with Duchenne muscular dystrophy (DMD). This marks a significant milestone as Agamree becomes the first DMD drug approved in China,…
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Jiangsu Hengrui Pharmaceuticals Secures NMPA Approvals for SHR-4394 and HRS-3802 Clinical Trials
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Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) has announced receiving separate clinical trial approvals from China’s National Medical Products Administration (NMPA) for its two drug candidates, SHR-4394 and HRS-3802. SHR-4394: A Novel Therapeutic Biologic for Prostate CancerSHR-4394 is an in-house developed therapeutic biologic product, with its target undisclosed, currently under…
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Merck’s PD-1 Inhibitor Keytruda Approved by NMPA for Cervical Cancer Treatment in China
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US-based Merck, Sharp & Dohme Inc., (MSD, NYSE: MRK) has announced receiving marketing approval from China’s National Medical Products Administration (NMPA) for its PD-1 inhibitor Keytruda (pembrolizumab). The approval allows the use of Keytruda in combination with chemotherapy for International Federation of Obstetrics and Gynecology (FIGO) 2014 stage III-IVA cervical…
