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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…
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Cutia Therapeutics’ CU-10201 Enters Priority Review for Acne Treatment in China
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Dermatology therapy developer Cutia Therapeutics (HKG: 2487) has announced that its CU-10201, a 4% minocycline foam agent for external use, has entered into priority review for the treatment of non-nodular moderate to severe acne vulgaris in individuals aged 9 and above in China. CU-10201: A Novel Pediatric Dosage Form for…
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NMPA Greenlights Oricell Therapeutics’ OriCAR-017 for Clinical Trials in Multiple Myeloma
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The National Medical Products Administration (NMPA) has indicated on its website that Oricell Therapeutics Co., Ltd’s GPRC5D-targeted chimeric antigen receptor (CAR)-T cell therapy, OriCAR-017, has been granted approval for clinical trials. The therapy is intended for the treatment of recurrent refractory multiple myeloma (R/R MM). GPRC5D as a Therapeutic Target…
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Lee’s Pharmaceutical’s Subsidiary Completes Phase III Study for Myopia Treatment NVK002
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China-based Lee’s Pharmaceutical Holdings Ltd (HKG: 0950) subsidiary, Zhaoke Ophthalmology Ltd (HKG: 6622), has announced the completion of the last patient visit in the one-year Phase III bridging study, Mini-CHAMP, for its NVK002—an atropine external use eye solution for myopia progression. Parallel Phase III Clinical Trials for NVK002In addition to…
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Novartis Reports Positive Phase III Results for Remibrutinib in Chronic Spontaneous Urticaria
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Swiss pharmaceutical giant Novartis AG (NYSE: NVS) has announced positive data from the Phase III trials for remibrutinib, an oral Bruton’s tyrosine kinase (BTK) inhibitor, which is under development to treat chronic spontaneous urticaria (CSU). The Phase III REMIX-1 and REMIX-2 studies successfully met all primary and secondary endpoints, showing…
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Novo Nordisk’s Wegovy Demonstrates 20% Reduction in Cardiovascular Events in SELECT Trial
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Denmark-based pharmaceutical giant Novo Nordisk A/S (NYSE: NVO) has released topline data supporting the use of its anti-obesity drug Wegovy (semaglutide). The data originates from the SELECT cardiovascular outcomes trial, which enrolled an extensive cohort of 17,604 adults suffering from obesity and established cardiovascular disease (CVD), but without diabetes. This…
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Lynk Pharmaceuticals’ LNK01001 Shows Positive Results in Atopic Dermatitis Phase II Study
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China-based Lynk Pharmaceuticals Co., Ltd has announced that its Phase II clinical study for LNK01001 in atopic dermatitis (AD) has yielded positive major results. The study, a randomized, double-blinded, placebo-controlled, multi-center trial, enrolled 150 patients and included high-dose and low-dose groups of LNK01001 alongside a placebo group. Study Design and…
