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 1 Product   17 Diseases   1 Product   2 Trials   44 News 


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  • ||||||||||  Management of Refractory Nontuberculous Mycobacterial Pulmonary Disease (CRYSTAL 2; 3F) -  Oct 21, 2024 - Abstract #KATRDIC2024KATRDIC_140;    
    When bacterial conversion is difficult, the treatment goal may shift to improving quality of life through appropriate antibiotic therapy. This presentation will comprehensively address the causes of treatment-refractory NTM-PD and outline appropriate management strategies.
  • ||||||||||  Haiyitan (gumarontinib) / HaiHe Biopharma
    Trial completion, Enrollment change, Metastases:  A Phase I Study of SCC244 in Patients with Advanced MET Alterations Solid Tumors (clinicaltrials.gov) -  Oct 9, 2024   
    P1,  N=177, Completed, 
    This presentation will comprehensively address the causes of treatment-refractory NTM-PD and outline appropriate management strategies. Unknown status --> Completed | N=75 --> 177
  • ||||||||||  Haiyitan (gumarontinib) / HaiHe Biopharma
    Trial completion, Enrollment change, Metastases:  Study to Evaluate the Safety and Anti-tumor Activity of SCC244 (clinicaltrials.gov) -  Oct 8, 2024   
    P1,  N=56, Completed, 
    Unknown status --> Completed | N=75 --> 177 Unknown status --> Completed | N=113 --> 56
  • ||||||||||  Halaven (eribulin mesylate) / Eisai, grapiprant (RQ-00000007) / AskAt, Ikena Oncology, Maruishi Pharma
    Enrollment change, Trial completion date, Trial termination, Trial primary completion date, Metastases:  Grapiprant and Eribulin for the Treatment of Metastatic Inflammatory Breast Cancer (clinicaltrials.gov) -  Sep 19, 2024   
    P1/2,  N=6, Terminated, 
    Study Group: [Organizing Committee] N=25 --> 6 | Trial completion date: Dec 2025 --> Sep 2024 | Active, not recruiting --> Terminated | Trial primary completion date: Dec 2025 --> Sep 2024; The sponsor terminated support for this study
  • ||||||||||  HH2853 / HaiHe Biopharma, Shanghai Inst. of Materia Medica
    Review, Journal, PARP Biomarker:  Dual-target EZH2 inhibitor: latest advances in medicinal chemistry. (Pubmed Central) -  Sep 2, 2024   
    Dual-target inhibitors, exemplified by EZH1/2 inhibitor HH-2853(28), offer enhanced efficacy and reduced adverse effects. This review highlights recent advancements in dual inhibitors targeting EZH2 and other proteins like BRD4, PARP1, and EHMT2, emphasizing rational design, structure-activity relationships, and safety profiles, suggesting their potential in clinical applications.
  • ||||||||||  HH185 / CSPC Pharma, HaiHe Biopharma
    Trial completion date, Trial primary completion date, Monotherapy, Metastases:  A Monotherapy in Subjects With Advanced Solid Tumors (clinicaltrials.gov) -  Aug 22, 2024   
    P1,  N=42, Active, not recruiting, 
    No abstract available Trial completion date: Jun 2024 --> Dec 2024 | Trial primary completion date: Jun 2024 --> Dec 2024
  • ||||||||||  Liporaxel (paclitaxel oral) / Dae Hwa, HaiHe Biopharma
    Trial completion, Metastases:  Food Effect on Pharmacokinetics and Safety of DHP107 (Liporaxel (clinicaltrials.gov) -  Jul 25, 2024   
    P1,  N=25, Completed, 
    ClinicalTrials.gov identifier: NCT03457532; NCT04270591. Not yet recruiting --> Completed
  • ||||||||||  Review, Journal:  Pyrazolopyridine-based kinase inhibitors for anti-cancer targeted therapy. (Pubmed Central) -  May 24, 2024   
    Notably, selpercatinib, glumetinib, camonsertib and olverembatinib have either received approval or are in late-phase clinical studies. This review presents the success stories employing pyrazolopyridine scaffolds as hinge-binding cores to address various challenges in kinase-targeted drug discovery research.
  • ||||||||||  delpazolid (LCB01-0371) / LegoChem Biosci
    Enrollment change, Trial completion date, Trial termination, Trial primary completion date, Monotherapy:  A Phase 2a Study, Effect of Vancomycin With vs Without Delpazolid (LCB01-0371) in Patients With MRSA Bacteremia (clinicaltrials.gov) -  May 15, 2024   
    P2,  N=40, Terminated, 
    This review presents the success stories employing pyrazolopyridine scaffolds as hinge-binding cores to address various challenges in kinase-targeted drug discovery research. N=100 --> 40 | Trial completion date: Nov 2024 --> Feb 2024 | Recruiting --> Terminated | Trial primary completion date: Nov 2024 --> Feb 2024; Early termination; Difficulties in enrolling subjects due to the decrease in patients with MRSA bacteremia
  • ||||||||||  HH2853 / HaiHe Biopharma, Shanghai Inst. of Materia Medica
    Enrollment change, Metastases:  Evaluate the Safety and Clinical Activity of HH2853 (clinicaltrials.gov) -  May 8, 2024   
    P1/2,  N=254, Recruiting, 
    N=100 --> 40 | Trial completion date: Nov 2024 --> Feb 2024 | Recruiting --> Terminated | Trial primary completion date: Nov 2024 --> Feb 2024; Early termination; Difficulties in enrolling subjects due to the decrease in patients with MRSA bacteremia N=168 --> 254
  • ||||||||||  Liporaxel (paclitaxel oral) / Dae Hwa, HaiHe Biopharma
    Paclitaxel oral solution versus paclitaxel injection as second-line therapy in advanced gastric cancer: A randomized, open-label, non-inferiority phase 3 trial. (Hall A; Poster Bd #: 31) -  Apr 24, 2024 - Abstract #ASCO2024ASCO_3784;    
    Safer and more convenient paclitaxel oral solution (Liporaxel), the world's first oral formulation, has been initially approved in Korea for treatment of gastric cancer. The study showed statistical non-inferiority of paclitaxel oral solution in PFS and statistically significant and clinically meaningful improvement in OS as compared to paclitaxel IV, with clinically manageable safety profile, supporting paclitaxel oral solution as second-line treatment option for patients with gastric cancer.
  • ||||||||||  Liporaxel (paclitaxel oral) / Dae Hwa, HaiHe Biopharma, Stivarga (regorafenib) / Bayer
    New P2 trial:  GIST Oral Paclitaxel(Liporaxel) (clinicaltrials.gov) -  Mar 22, 2024   
    P2,  N=28, Not yet recruiting, 
  • ||||||||||  HH2853 / HaiHe Biopharma, Shanghai Inst. of Materia Medica
    Trial completion date, Trial primary completion date, Metastases:  Evaluate the Safety and Clinical Activity of HH2853 (clinicaltrials.gov) -  Mar 13, 2024   
    P1/2,  N=168, Recruiting, 
    N=350 --> 24 | Recruiting --> Terminated; Business decision Trial completion date: Dec 2024 --> Dec 2025 | Trial primary completion date: Dec 2023 --> Dec 2025
  • ||||||||||  lucitanib (E 3810) / Clovis, Servier
    Targeting angiogenesis for improved survival in mantle cell lymphoma (Section 22) -  Mar 5, 2024 - Abstract #AACR2024AACR_5270;    
    Lucitanib treatment significantly prolonged median overall survival significantly in the systemic MCL model. Our data demonstrates that targeting angiogenesis in MCL can provide therapeutic benefits, as demonstrated in preclinical MCL models.
  • ||||||||||  delpazolid (LCB01-0371) / LegoChem Biosci
    Trial completion, Phase classification, Trial completion date, Combination therapy:  PanACEA DElpazolid Dose-finding and COmbination DEvelopment (DECODE) (clinicaltrials.gov) -  Feb 22, 2024   
    P2,  N=76, Completed, 
    Abstract is embargoed at this time. Active, not recruiting --> Completed | Phase classification: P2b --> P2 | Trial completion date: Mar 2024 --> Sep 2023
  • ||||||||||  Liporaxel (paclitaxel oral) / Dae Hwa, HaiHe Biopharma
    Trial completion, Metastases:  OPERA: Oral Paclitaxel Efficacy Safety and PK in Recurrent and Metastatic Breast Cancer (clinicaltrials.gov) -  Feb 16, 2024   
    P2,  N=72, Completed, 
    Active, not recruiting --> Completed | Phase classification: P2b --> P2 | Trial completion date: Mar 2024 --> Sep 2023 Unknown status --> Completed
  • ||||||||||  HH185 / CSPC Pharma, HaiHe Biopharma
    Enrollment closed, Trial primary completion date, Monotherapy, Metastases:  A Monotherapy in Subjects With Advanced Solid Tumors (clinicaltrials.gov) -  Jan 31, 2024   
    P1,  N=42, Active, not recruiting, 
    Unknown status --> Completed Recruiting --> Active, not recruiting | Trial primary completion date: Dec 2023 --> Jun 2024
  • ||||||||||  delpazolid (LCB01-0371) / LegoChem Biosci
    Phase classification, Trial completion date, Trial primary completion date, Monotherapy:  A Phase 2a Study, Effect of Vancomycin With vs Without Delpazolid (LCB01-0371) in Patients With MRSA Bacteremia (clinicaltrials.gov) -  Jan 25, 2024   
    P2,  N=100, Recruiting, 
    Not yet recruiting --> Active, not recruiting | Phase classification: P2a --> P2 Phase classification: P2a --> P2 | Trial completion date: Nov 2023 --> Nov 2024 | Trial primary completion date: Nov 2023 --> Nov 2024
  • ||||||||||  Liporaxel (paclitaxel oral) / Dae Hwa, HaiHe Biopharma
    Enrollment closed, Trial completion date, Trial primary completion date, Metastases:  OPTIMAL: Oral Paclitaxel Trial In Recurrent and Metastatic Breast Cancer As 1st Line Therapy (clinicaltrials.gov) -  Dec 27, 2023   
    P2/3,  N=549, Active, not recruiting, 
    This study could provide a novel approach to treat CMGC. Unknown status --> Active, not recruiting | Trial completion date: Mar 2022 --> Mar 2024 | Trial primary completion date: Dec 2020 --> Jan 2024
  • ||||||||||  delpazolid (LCB01-0371) / LegoChem Biosci
    Preclinical, Journal:  Intracellular and in vivo activities of oxazolidinone drugs against Mycobacterium avium complex infection. (Pubmed Central) -  Nov 28, 2023   
    The prevalence of Mycobacterium avium complex-pulmonary disease (MAC-PD) has become a growing concern worldwide, and current treatments involving macrolides (clarithromycin [CLR] or azithromycin), ethambutol, and rifampicin have limited success, highlighting the need for better therapeutic strategies...Here, we first evaluated the intracellular anti-MAC activities of two oxazolidinone drugs, linezolid (LZD) and delpazolid (DZD), against 10 macrolide-susceptible MAC strains and one macrolide-resistant M. avium strain in murine bone marrow-derived macrophages (BMDMs) and found that both drugs demonstrated similar potential...Upon assessment of bacterial burdens and inflamed lesions, oxazolidinone drugs exhibited no anti-MAC effect, and there was no significant difference in the synergistic effect of CLR between LZD and DZD. These findings suggest that oxazolidinone drugs inhibit intracellular bacterial growth, even against macrolide-resistant MAC, but their clinical application requires further consideration.
  • ||||||||||  CYH33 / HaiHe Biopharma, Avastin (bevacizumab) / Roche
    Journal, PARP Biomarker:  An Attempt to Develop a New Treatment Strategy for Rare Refractory Gynecological Malignancies: The Japanese Gynecologic Oncology Group. (Pubmed Central) -  Nov 9, 2023   
    Through C-CAT database analysis, we estimated that approximately 40% of the patients with OCCC harbored at least 1 of the 17 PIK3CA hotspot mutations designated in the CYH33-G201 trial. JGOG will continue the challenge of establishing novel treatment strategies for rare refractory cancers that will benefit patients suffering from gynecological malignancies, especially those who do not receive satisfactory standard treatment and care.
  • ||||||||||  grapiprant (RQ-00000007) / AskAt, Ikena Oncology, Maruishi Pharma
    Trial completion date, Trial primary completion date, Combination therapy:  3D1002 in Combination With Oxycodone Hydrochloride Sustained-release Tablets in Patients With Moderate to Severe Cancer Pain (clinicaltrials.gov) -  Oct 25, 2023   
    P2a/2b,  N=177, Not yet recruiting, 
    Conclusions The selective EZH1/2 dual inhibitor HH2853 demonstrated good safety and promising efficacy in r/r PTCL patients, indicating its potential as a therapeutic option for this difficult to treat patient population. Trial completion date: Sep 2024 --> Sep 2025 | Trial primary completion date: Jun 2024 --> Jun 2025
  • ||||||||||  grapiprant (RQ-00000007) / AskAt, Ikena Oncology, Maruishi Pharma
    Trial completion, Trial completion date, Trial primary completion date, Combination therapy, Metastases:  KEYNOTE-878: Grapiprant and Pembrolizumab in Patients With Advanced or Progressive MSS Colorectal Cancer (clinicaltrials.gov) -  Oct 24, 2023   
    P1b,  N=54, Completed, 
    Trial completion date: Sep 2024 --> Sep 2025 | Trial primary completion date: Jun 2024 --> Jun 2025 Active, not recruiting --> Completed | Trial completion date: Sep 2022 --> Mar 2023 | Trial primary completion date: Jun 2022 --> Mar 2023