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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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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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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 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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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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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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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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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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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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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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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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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 (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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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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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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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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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…
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AstraZeneca (AZ; NASDAQ: AZN) has released early data from a Phase II trial investigating the antibody-drug conjugate (ADC) Enhertu (trastuzumab deruxtecan) in patients with HER2-mutant unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC). The trial assessed the efficacy and safety of different dosages of Enhertu, revealing that while a…
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Gan & Lee Pharmaceuticals (SHA: 603087), a China-based pharmaceutical company, has announced the dosing of the first patient in a Phase II clinical study for its Category 1 therapeutic biologic product, GZR4. GZR4 is an investigational ultra-long-acting insulin designed for once-per-week subcutaneous injection to treat diabetes. Design and Objectives of…
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China-based Grand Pharmaceutical Group Limited (HKG: 0512) has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its generic version of Italy’s Recordati’s Carbaglu (carglumic acid). This marks the first approval of such a generic drug in China, offering a treatment for hyperammoniaemia caused…