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EMA’s CHMP Recommends Approval of Keytruda as Adjuvant NSCLC Treatment
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The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the approval of Merck, Sharp & Dohme’s (MSD; NYSE: MRK) anti-PD-1 therapy, Keytruda (pembrolizumab), as an adjuvant treatment for non-small cell lung cancer (NSCLC) in adults who are at a high risk of…
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Novartis’s Kisqali Reduces Cancer Recurrence Risk in HR+/HER2- Early Breast Cancer: Phase III Results
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Swiss pharmaceutical giant Novartis (NYSE: NVS) has published results from a Phase III study of its CDK4/6 inhibitor Kisqali (ribociclib) in combination with endocrine therapy (ET) as an adjuvant treatment for HR+/HER2- early breast cancer (EBC). The data, recorded for up to three years, indicated that Kisqali reduced the risk…
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Akeso Biopharma’s AK132 Receives Green Light for Clinical Trial in Advanced Solid Tumors
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Akeso Biopharma’s (HKG: 9926) AK132, a bispecific antibody (BsAb) targeting Claudin18.2 and CD47, has received approval from China’s Center for Drug Evaluation to proceed with a clinical study in patients with advanced malignant solid tumors. This marks the sixth in-house developed BsAb from the Chinese firm to enter clinical development.…
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CSPC Pharmaceutical Group Receives NMPA Approval for Irinotecan Liposome Injection
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China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced that it has received market approval from the National Medical Products Administration (NMPA) in China for its irinotecan liposome injection. The drug is indicated for the treatment of metastatic pancreatic cancer in patients after gemcitabine treatment and is also used in…
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Japan’s MHLW Reviews GSK’s Momelotinib for Myelofibrosis Treatment
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The Ministry of Health, Labour and Welfare (MHLW) in Japan has accepted for review a filing by UK-based GlaxoSmithKline (GSK; NYSE: GSK) for its first-in-class candidate, momelotinib, as a potential treatment for the blood cancer myelofibrosis. The submission is supported by Phase III clinical trial results that show significant improvements…
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AstraZeneca and Daiichi Sankyo Report Positive Results for Datopotamab Deruxtecan Combo in NSCLC
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UK-based pharmaceutical company AstraZeneca (AZ; NASDAQ: AZN) has announced positive data from a Phase Ib study for the antibody-drug conjugate (ADC) datopotamab deruxtecan in combination with checkpoint inhibitor Imfinzi (durvalumab). The study, conducted in partnership with Daiichi Sankyo (TYO: 4568), focused on first-line advanced or metastatic non-small cell lung cancer…
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Chongqing Lummy Pharmaceutical’s Subsidiary Receives NMPA Approval for CUD002 mRNA Vaccine
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Chongqing Lummy Pharmaceutical Co., Ltd (SHE: 300006), through its subsidiary Sichuan Cunde Therapeutics Co., Ltd, has received clinical trial approval from the National Medical Products Administration (NMPA) for the CUD002 injection. This mRNA-edited DC (dendritic cell) tumor therapeutic vaccine product is based on patient tumor neoantigens, marking a significant step…
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Dizal Pharmaceutical’s Golidocitinib NDA Accepted for Review by NMPA
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China-based Dizal Pharmaceutical Co., Ltd (SHA: 688192) has announced that the National Medical Products Administration (NMPA) has accepted for review its New Drug Application (NDA) for golidocitinib, a first-in-class JAK1 inhibitor. The drug candidate is filed for the initial indication of treating recurrent refractory peripheral T-cell lymphoma (r/r PTCL). Supporting…
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Grand Pharmaceutical’s GSP301 NS Meets Primary Endpoint in Phase III SAR Study
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China-based Grand Pharmaceutical Group Limited (HKG: 0512) has announced that its Phase III study (GSP 301-308) for the Ryaltris compound nasal spray (GSP301 NS) in seasonal allergic rhinitis (SAR) has successfully reached its primary endpoint in China. Study Design and Patient EnrollmentThe randomized, double-blind, double-simulation, three-arm, multi-center, parallel-controlled Phase III…
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Haisco Pharmaceutical’s HSK16149 for Post-Herpes Neuralgia Accepted for NMPA Review
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China-based Haisco Pharmaceutical Group Co., Ltd (SHE: 002653) has announced that the National Medical Products Administration (NMPA) has accepted for review a market approval filing for its drug candidate HSK16149 as a treatment for post-herpes neuralgia (PHN). This in-house Category 1 drug, an oral gamma-aminobutyric acid (GABA) analogue, is under…
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Asieris Pharmaceuticals’ APL-1202 Shows Positive Interim Analysis in MIBC Trial with BeiGene’s Tislelizumab
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China-based urogenital cancer specialist Asieris Pharmaceuticals (SHA: 688176) has revealed positive results from a Phase II interim analysis of its drug candidate APL-1202, combined with BeiGene Ltd’s (NASDAQ: BGNE; HKG: 6160) programmed death-1 (PD-1) inhibitor tislelizumab, as neoadjuvant chemotherapy (NAC) in muscular invasive bladder cancer (MIBC). The trial has demonstrated…
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AstraZeneca’s Fasenra Shows Non-Inferior Efficacy to Nucala in EGPA: Phase III Results
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UK-based pharmaceutical giant AstraZeneca (AZ; NASDAQ: AZN) has unveiled the results of a Phase III study, demonstrating the non-inferiority of its IL-5 antagonist Fasenra (benralizumab) compared to GlaxoSmithKline’s (GSK; NYSE: GSK) Nucala (mepolizumab) in the treatment of relapsing or refractory eosinophilic granulomatosis with polyangiitis (EGPA). The study highlights that Fasenra…
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InnoCare Pharma and ArriVent Biopharma Partner on Clinical Study for Advanced NSCLC Treatment
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China-based InnoCare Pharma (HKG: 9969; SHA: 688428) has announced that it has received the green light to conduct a clinical study in China for its drug candidate ICP-189, in combination with ArriVent Biopharma Inc.’s furmonertinib, for the treatment of advanced non-small cell lung cancer (NSCLC). The collaboration between InnoCare and…
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EMA Approves Astellas’ Xtandi for Non-Metastatic Hormone-Sensitive Prostate Cancer
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The European Medicines Agency (EMA) has granted Japan-based Astellas (TYO: 4503) an indication extension approval for its androgen receptor inhibitor Xtandi (enzalutamide). This approval expands the use of Xtandi as a treatment for non-metastatic hormone-sensitive prostate cancer (nmHSPC) in patients with high-risk biochemical recurrence (BCR) who are unsuitable for salvage-radiotherapy.…
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FDA Accepts Takeda’s Filing for Subcutaneous Entyvio as Maintenance Therapy for Crohn’s Disease
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The US Food and Drug Administration (FDA) has accepted a filing from Japan-based Takeda (TYO: 4502) for a subcutaneous version of the alpha4beta7 integrin inhibitor Entyvio (vedolizumab). This new formulation is intended as a maintenance therapy for adult patients with moderately to severely active Crohn’s disease (CD) who have been…
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AbbVie’s Skyrizi Outperforms Janssen’s Stelara in Phase III Crohn’s Disease Trial
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AbbVie (NYSE: ABBV) has announced early data from a Phase III trial that compared the IL-23 inhibitor Skyrizi (risankizumab) with Johnson & Johnson (J&J; NYSE: JNJ) subsidiary Janssen’s Stelara (ustekinumab) in patients with moderate-to-severe Crohn’s disease (CD) unresponsive to anti-TNF therapy. The blinded efficacy assessment revealed that Skyrizi achieved clinical…
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Boehringer Ingelheim Gets NMPA Approval for Brigimadlin Safety and Efficacy Study in China
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Germany-based Boehringer Ingelheim (BI) has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct the Brightline-2 study in China. The study will assess the safety and efficacy of the company’s MDM2-p53 antagonist, brigimadlin (BI 907828), in patients with locally advanced/metastatic, MDM2 amplification, TP53 wild-type…
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MSD’s Sotatercept Demonstrates Positive Interim Results in Phase III PAH Studies
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Merck, Sharp & Dohme (MSD; NYSE: MRK) has presented interim data from Phase III and extension studies for its potential first-in-class biologic sotatercept, which is being investigated for the treatment of pulmonary arterial hypertension (PAH). The late-stage trial indicated that the activin signaling inhibitor led to a reduction in right…
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AstraZeneca’s Tagrisso Combination Therapy Shows Improved Efficacy in EGFR-mutated NSCLC
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UK-headquartered AstraZeneca (AZ; NASDAQ: AZN) has announced interim Phase III data demonstrating that the addition of pemetrexed plus cisplatin/carboplatin chemotherapy to tyrosine kinase inhibitor (TKI) Tagrisso (osimertinib) improves therapeutic effects in patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC). The combination therapy reduced the risk of…
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Janssen Reports Positive Results from Phase Ib/II Study of Rybrevant Combo in EGFR-mutated NSCLC
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Johnson & Johnson (J&J; NYSE: JNJ) subsidiary Janssen has provided an update on an ongoing Phase Ib/II study cohort assessing the safety and pharmacokinetics of the bispecific antibody (BsAb) Rybrevant (amivantamab) in combination with tyrosine kinase inhibitor (TKI) lazertinib and chemotherapy for the treatment of relapsed/refractory EGFR-mutated non-small cell lung…
