-
Sandoz Achieves Primary Endpoint in Phase III Trial for Biosimilar Aflibercept
•
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…
-
Everest Medicines’ Partner Venatorx Pharmaceuticals Receives FDA Priority Review for Cefepime-Taniborbactam
•
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…
-
Simcere Pharmaceutical’s Cosela Receives NMPA Review for ES-SCLC Indication
•
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…
-
SinoMab BioScience Receives NMPA Approval for Phase I Clinical Study of SM17 Asthma Therapy
•
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…
-
J&J Subsidiary Janssen Wins FDA Approval for Akeega in BRCA-Positive mCRPC Treatment
•
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).…
-
Medivir’s Fostrox in Combination with Lenvima Shows Promise in Phase IIa HCC Trial
•
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…
-
Pfizer’s Elrexfio Earns Accelerated FDA Approval for Relapsed/Refractory Multiple Myeloma
•
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…
-
Janssen’s Talvey Receives FDA Accelerated Approval for Relapsed/Refractory Multiple Myeloma
•
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…
-
Telix Pharmaceuticals and Grand Pharma Initiate Phase III Trial for Illucix in China
•
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,…
-
Bio-Thera Solutions’ BAT8006 Shows Positive Phase I Results in Solid Tumor Treatment
•
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…
-
Vcanbio Receives Orphan Drug Designation for VUM02 in Idiopathic Pulmonary Fibrosis Treatment
•
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…
-
Asieris Pharmaceuticals’ Hexvix Meets Primary Endpoint in Phase III Bladder Cancer Study
•
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…
-
Sichuan Kelun-Biotech’s SKB264 Achieves Primary Endpoint in Phase III TNBC Study
•
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,…
-
Huadong Medicine’s HDM3001, a Biosimilar to Stelara, Accepted for Review by NMPA
•
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,…
-
CanSino BiologicsLaunches Phase III Trial for DTcP Vaccine in Infants and Young Children
•
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…
-
Cutia Therapeutics’ CU-10201 Enters Priority Review for Acne Treatment in China
•
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…
-
NMPA Greenlights Oricell Therapeutics’ OriCAR-017 for Clinical Trials in Multiple Myeloma
•
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…
-
Lee’s Pharmaceutical’s Subsidiary Completes Phase III Study for Myopia Treatment NVK002
•
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…
