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Immunofoco’s IMC008 Earns Orphan Drug Designation for Gastric Cancer from FDA
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Suzhou-based cell therapy developer Immunofoco has announced that it has received orphan drug designation (ODD) from the US Food and Drug Administration (FDA) for its next-generation autologous CAR-T therapy, IMC008, which is being developed to treat gastric cancer. IMC008: A Next-Generation CAR-T Therapy Utilizing SNR TechnologyIMC008 is grounded in Immunofoco’s…
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Seagen’s Tukysa Meets Primary Endpoint in Phase III Study for HER2+ Breast Cancer
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Seagen (NASDAQ: SGEN), currently in the process of being acquired by Pfizer (NYSE: PFE), has announced an update on an ongoing Phase III oncology study involving a combination therapy that includes the HER2 inhibitor Tukysa (tucatinib), one of Seagen’s four marketed drugs that attracted Pfizer’s interest. The trial successfully met…
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Inmagene Biopharmaceuticals Initiates Global Study for IMG-007 in Atopic Dermatitis
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China-based Inmagene Biopharmaceuticals has announced the first patient dosing in a global, multi-center, proof-of-concept study assessing the safety, pharmacokinetics, and efficacy of its pipeline candidate IMG-007. The molecule is being evaluated as a treatment for moderate-to-severe atopic dermatitis (AD), a condition that affects a significant patient population worldwide. IMG-007: An…
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Sandoz Achieves Primary Endpoint in Phase III Trial for Biosimilar Aflibercept
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Switzerland-based Novartis (NYSE: NVS) subsidiary Sandoz (SWX: SDZ) has announced that a Phase III confirmatory trial for its biosimilar version of Bayer’s (ETR: BAYN) Eylea/Wetlia (aflibercept) has successfully reached its primary efficacy endpoint in neovascular (wet) age-related macular degeneration (nAMD). The study demonstrated that Sandoz’s biosimilar product showed no clinically…
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Everest Medicines’ Partner Venatorx Pharmaceuticals Receives FDA Priority Review for Cefepime-Taniborbactam
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China-based Everest Medicines (HKG: 1952) announced that its partner, Venatorx Pharmaceuticals, has received acceptance from the US Food and Drug Administration (FDA) for a New Drug Application (NDA) for cefepime-taniborbactam, an investigational beta-lactam/beta-lactamase inhibitor (BL/BLI) antibiotic. The drug is intended for the potential treatment of adult patients with complicated urinary…
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Simcere Pharmaceutical’s Cosela Receives NMPA Review for ES-SCLC Indication
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China-based Simcere Pharmaceutical Group (HKG: 2096) has announced that the National Medical Products Administration (NMPA) has accepted an indication approval filing for its drug Cosela (trilaciclib). The CDK4/6 inhibitor is under development to treat extensive-stage small-cell lung cancer (ES-SCLC), with the aim of reducing the incidence of chemotherapy-induced bone marrow…
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SinoMab BioScience Receives NMPA Approval for Phase I Clinical Study of SM17 Asthma Therapy
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Hong Kong-based biotech company SinoMab BioScience Ltd (HKG: 3681) has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a Phase I clinical study assessing the safety of SM17, a first-in-class asthma therapy, in the Chinese population. The study will also explore the clinical…
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J&J Subsidiary Janssen Wins FDA Approval for Akeega in BRCA-Positive mCRPC Treatment
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The US Food & Drug Administration (FDA) has granted marketing approval to Johnson & Johnson (J&J; NYSE: JNJ) subsidiary Janssen for its oral drug Akeega (niraparib + abiraterone) in combination with prednisone. This treatment is designated for adult patients with deleterious or suspected deleterious BRCA-positive metastatic castration-resistant prostate cancer (mCRPC).…
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Medivir’s Fostrox in Combination with Lenvima Shows Promise in Phase IIa HCC Trial
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Sweden-based Medivir (STO: MVIR) has released interim data from a Phase IIa trial evaluating the combination of its experimental drug fostrox with Japan partner Eisai’s (TYO: 4523) kinase inhibitor Lenvima (Lenvatinib) for the treatment of advanced hepatocellular carcinoma (HCC). The trial focuses on patients for whom current first- or second-line…
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Pfizer’s Elrexfio Earns Accelerated FDA Approval for Relapsed/Refractory Multiple Myeloma
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This week, Pfizer (NYSE: PFE) received an accelerated approval from the US Food and Drug Administration (FDA) for its bispecific antibody (BsAb) Elrexfio (elranatamab) as a treatment for relapsed or refractory multiple myeloma (r/rMM) in adults who have received at least four prior lines of therapy. The decision was based…
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Janssen’s Talvey Receives FDA Accelerated Approval for Relapsed/Refractory Multiple Myeloma
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The Janssen unit of Johnson & Johnson (J&J; NYSE: JNJ) announced last week that it received accelerated approval from the US Food and Drug Administration (FDA) for its first-in-class GPRC5D/CD3 bispecific antibody (BsAb), Talvey (talquetamab). This treatment is designated for adults with relapsed or refractory multiple myeloma (r/rMM) who have…
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Telix Pharmaceuticals and Grand Pharma Initiate Phase III Trial for Illucix in China
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Australian biotechnology company Telix Pharmaceuticals Ltd (ASX: TLX) and its China market partner, Grand Pharmaceutical Group Limited (HKG: 0512), have announced the dosing of the first patient in a pivotal Phase III trial for TLX591-CDx (Illucix) in China. TLX591-CDx is a kit for the preparation of Gallium 68 (68Ga) PSMA-11,…
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Bio-Thera Solutions’ BAT8006 Shows Positive Phase I Results in Solid Tumor Treatment
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China-based Bio-Thera Solutions, Ltd (SHA: 688177) has announced positive Phase I clinical data for BAT8006 (Folate-Receptor-α-ADC) at the Bethune Obstetrics and Gynecology Forum in China. The study evaluated the safety and efficacy of the antibody-drug conjugate (ADC) in a dose escalation trial. BAT8006: A Promising ADC for Solid TumorsBAT8006 is…
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Vcanbio Receives Orphan Drug Designation for VUM02 in Idiopathic Pulmonary Fibrosis Treatment
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China-based Vcanbio Cell & Gene Engineering Corp., Ltd (SHA: 600645) has announced that it has received orphan drug designation (ODD) from the US FDA for its VUM02 (human umbilical cord-derived mesenchymal stem cells), a Category 1 therapeutic biologic product for the treatment of idiopathic pulmonary fibrosis (IPF). VUM02: An Innovative…
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Asieris Pharmaceuticals’ Hexvix Meets Primary Endpoint in Phase III Bladder Cancer Study
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China-based urogenital cancer specialist Asieris Pharmaceuticals (SHA: 688176) has revealed that a Phase III study for Hexvix (APL-1706) in bladder cancer diagnosis has successfully reached its primary endpoint. Study Design and OutcomesThe prospective, subject-controlled, multi-center Phase III study compared the detection rates of APL-1706 combined with blue light cystoscopy and…
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Sichuan Kelun-Biotech’s SKB264 Achieves Primary Endpoint in Phase III TNBC Study
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Sichuan Kelun Pharmaceutical Co., Ltd’s innovative drug development subsidiary, Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (HKG: 6990), has announced that its Phase III clinical study for SKB264 (MK-2870) has reached its primary endpoint. The study, which is a randomized, controlled, open, multi-center trial, evaluated SKB264 in patients with irresectable local advanced,…
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Huadong Medicine’s HDM3001, a Biosimilar to Stelara, Accepted for Review by NMPA
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China-based Huadong Medicine Co., Ltd (SHE: 000963) has announced that the National Medical Products Administration (NMPA) has accepted a market filing for HDM3001 (QX001S), a biosimilar version of Johnson & Johnson’s Stelara (ustekinumab), for the treatment of moderate to severe plaque psoriasis. Market Potential and Clinical ProgressThe originator drug, Stelara,…
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CanSino BiologicsLaunches Phase III Trial for DTcP Vaccine in Infants and Young Children
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CanSino Biologics Inc. a leading China-based vaccines specialist (HKG: 6185), has announced the initiation of a Phase III clinical study for its DTcP vaccine, targeting infants and young children under 2 years old. This development is accompanied by the enrollment of the first subjects in the trial. Quality Consistency and…
