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Lee’s Pharmaceutical’s Subsidiary Announces Positive Results for Myopia Treatment NVK002
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China-based Lee’s Pharmaceutical Holdings Ltd (HKG: 0950), through its subsidiary Zhaoke Ophthalmology Ltd (HKG: 6622), has announced positive topline results from the Phase III mini CHAMP study for NVK002, an atropine external use eye solution developed to address myopia progression. Study Design and ParticipantsThe Phase III mini CHAMP study was…
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J&J’s Cetrelimab and TAR-200 Gain Tacit Approvals for Bladder Cancer Trials
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The Center for Drug Evaluation (CDE) website has indicated that Johnson & Johnson (J&J; NYSE: JNJ) has received two tacit clinical trial approvals for its Category 1 drug cetrelimab combined with TAR-200. The approvals are for the treatment of high-risk non-muscle-invasive bladder cancer (NMIBC) patients not receiving BCG treatment, and…
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RemeGen Secures NMPA Approval for Phase II Study of Disitamab Vedotin in Breast Cancer
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China-based biopharma RemeGen Ltd (HKG: 9995) has announced that it has received approval from the National Medical Products Administration (NMPA) to initiate a Phase II clinical study for its antibody-drug conjugate (ADC) candidate, disitamab vedotin (RC48), in patients with breast cancer. First Home-Grown ADC with Conditional Approvals Disitamab vedotin stands…
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Ascentage Pharma Initiates Phase III Study for APG-2575 and Calquence in CLL/SLL
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Suzhou-based Ascentage Pharma (HKG: 6855) has announced the approval to commence a global multi-center, randomized, open-label pivotal Phase III clinical trial evaluating the efficacy and safety of APG-2575 combined with Calquence (acalabrutinib) in untreated chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) patients. Earlier this year, the drug received clearance for a…
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Betta Pharmaceuticals Secures NMPA Approval for Befotertinib in NSCLC Treatment
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China-based Betta Pharmaceuticals Co., Ltd. (SHE: 300558) has officially announced its receipt of market approval from the National Medical Products Administration (NMPA) for befotertinib, a third-generation epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI). This critical approval allows befotertinib to be used as a first-line treatment for locally advanced or…
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KPC Pharmaceuticals Secures WHO Prequalification for Dihydroartemisinin/Piperaquine
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Yunnan-based KPC Pharmaceuticals Inc. (SHA: 600422) has announced that its dihydroartemisinin/piperaquine 40mg/320mg formulation has received Prequalification (PQ) status from the World Health Organization (WHO). This critical milestone allows the anti-malaria drug to be included in the procurement scope of international organizations and public health institutions, enhancing its accessibility in malaria-affected…
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MSD’s Keytruda Achieves Primary Endpoint in Late-Stage NSCLC Trial
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Merck, Sharp & Dohme (MSD; NYSE: MRK) has announced that a late-stage trial for its anti-PD-1 drug Keytruda (pembrolizumab) has successfully met the primary endpoint of statistically significant and clinically meaningful improvement in overall survival (OS) in patients with resectable non-small cell lung cancer (NSCLC). The trial evaluated Keytruda as…
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Novo Nordisk Halts Phase III Ozempic Study on Renal Impairment in Diabetes Patients
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Denmark-based pharmaceutical giant Novo Nordisk (NYSE: NVO) has decided to discontinue a Phase III global study evaluating the impact of the GLP-1 receptor agonist Ozempic (semaglutide) on the progression of renal impairment in individuals with type 2 diabetes (T2D) and chronic kidney disease (CKD). The decision was recommended by an…
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Henlius Pharmaceutical Secures GMP Compliance for PD-1 Inhibitor Serplulimab in Indonesia
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Shanghai Henlius Pharmaceutical Co., Ltd (HKG: 2696) has announced that its partner, PT Kalbe Genexine Biologics (KGbio), through its subsidiary PT Kalbio Global Medika, has received a GMP inspection completion letter from the Badan Pengawas Obat dan Makanan (BPOM), a member of the Pharmaceutical Inspection Co-operation Scheme (PIC/S) in Indonesia.…
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Yiling Pharmaceutical Secures NMPA Approval for Phase I Study of G201-Na in Premenopausal Women
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China-based Yiling Pharmaceutical Co., Ltd (SHE: 002603) has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a single-center, randomized, double-blind, placebo-controlled Phase I clinical study. This trial will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of G201-Na in premenopausal healthy adult women. G201-Na:…
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GenFleet Therapeutics’ CDK9 Inhibitor SLS009 Earns Orphan Drug Status for AML
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Shanghai-based biotechnology company GenFleet Therapeutics has announced that its CDK9 inhibitor, SLS009 (GFH009), has received orphan drug designation (ODD) from the US Food and Drug Administration (FDA) for the treatment of acute myeloid leukemia (AML). This designation is a significant milestone, recognizing the drug’s potential to address a rare and…
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Roche’s Forimtamig Receives Tacit Approval for Multiple Myeloma Clinical Trials
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The Center for Drug Evaluation (CDE) has indicated that Swiss pharmaceutical giant Roche (SWX: ROG) has secured tacit clinical trial approval for its Category 1 biologic product, forimtamig (RG6234), in the treatment of multiple myeloma (MM). Promising Efficacy in Phase I Trials Forimtamig is a bispecific antibody (BsAb) designed to…
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Janssen Unveils Promising Clinical Data on IL-23 Blockers for Psoriasis
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The Janssen unit of Johnson & Johnson (J&J; NYSE: JNJ) is showcasing new clinical data this week from trials assessing the efficacy of IL-23 blockers, Tremfya (guselkumab) and JNJ-2113, in the treatment of psoriasis. The findings, derived from a late-stage study, reveal that Tremfya facilitated clear skin within 28 weeks…
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AstraZeneca Seeks Approval for Capivasertib in Combination with Faslodex for Breast Cancer Treatment
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AstraZeneca (AZ, NASDAQ: AZN) has submitted a market approval filing for its Category 1 drug candidate, capivasertib, in combination with Faslodex (fulvestrant), according to the China Center for Drug Evaluation (CDE) website. The filing has been accepted for review, marking a significant step forward in the treatment of hormone receptor…
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Jiangsu Hengrui Pharmaceuticals Gets NMPA Approval for Anti-Tumor Drug Candidate SHR-2022
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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276), a leading pharmaceutical company based in China, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its investigational drug candidate, SHR-2022 injection. This marks a significant step forward in the development of a new approach…
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Atom Bioscience Initiates Global Phase III Clinical Study for Gout Drug ABP-671
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China-based Atom Bioscience (Jiangsu Atom Bioscience and Pharmaceutical Co., Ltd) has announced the enrollment of the first patient in a global pivotal clinical study for its pipeline candidate, ABP-671. This small molecule inhibitor of the urate transporter 1 (URAT1) protein plays a crucial role in the reabsorption of uric acid…
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GluBio Pharmaceutical’s GLB-002 Receives NMPA Approval for Clinical Trials in Hematological Tumors
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GluBio Pharmaceutical Co., Ltd, a specialist in molecular glue targeted protein degradation (TPD) based in Zhejiang, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its molecular glue degrading agent, GLB-002. The drug is indicated for the treatment of non-Hodgkin’s lymphoma (NHL)…
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Luye Pharma Files NDA for Paliperidone Palmitate Injectable Suspension with US FDA
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China-based Luye Pharma Group (HKG: 2186) has announced the submission of a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for its product, paliperidone palmitate extended-release injectable suspension (LY03010), via the 505(b)(2) regulatory pathway. The drug is under consideration for approval as a treatment for schizophrenia…
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Shanghai BDgene’s BD112 Earns Orphan Drug Designation from US FDA for Huntington’s Disease
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Shanghai BDgene Technology Co., Ltd, a specialist in gene therapy, has announced that its drug candidate BD112, which utilizes virus-like particle (VLP) delivery technology for in vivo gene editing, has received orphan drug designation (ODD) from the US Food and Drug Administration (FDA). This follows a previous ODD granted by…
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J&J’s Janssen Reports Favorable Spravato Data in Late-Stage TRD Trial
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Johnson & Johnson’s (J&J; NYSE: JNJ) subsidiary, Janssen, has presented tolerability and efficacy data from a late-stage trial comparing its antidepressant Spravato (esketamine nasal spray) with oral quetiapine in the treatment of treatment-resistant major depressive disorder (TRD). The trial evaluated both drugs in combination with serotonin reuptake inhibitors (SRIs). Trial…
