HaiHe Biopharma 
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 1 Product   17 Diseases   1 Product   2 Trials   44 News 


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  • ||||||||||  paclitaxel oral (DHP107) / Dae Hwa
    Preclinical, Journal:  Subacute toxicity and toxicokinetics study of DHP107, an oral paclitaxel formulation with once-weekly dosing in mice. (Pubmed Central) -  May 22, 2019   
    Systemic exposure to paclitaxel increased with DHP107 doses in single and multiple dosing with no marked differences between sexes. In conclusion, the target organs were determined to be the reproductive and hematopoietic organs in male mice, suggesting of sex difference and the NOAEL of DHP107 was established to be < 25 mg/kg for males and 50 mg/kg for females.
  • ||||||||||  Journal:  Aberrant FGFR signaling mediates resistance to CDK4/6 inhibitors in ER+ breast cancer. (Pubmed Central) -  Apr 23, 2019   
    Addition of the FGFR TKI erdafitinib to palbociclib/fulvestrant induced complete responses of FGFR1-amplified/ER+ patient-derived-xenografts...Finally, ctDNA from patients enrolled in MONALEESA-2, the registration trial of ribociclib, showed that patients with FGFR1 amplification exhibited a shorter progression-free survival compared to patients with wild type FGFR1. Thus, we propose breast cancers with FGFR pathway alterations should be considered for trials using combinations of ER, CDK4/6 and FGFR antagonists.
  • ||||||||||  Liporaxel (paclitaxel oral) / Dae Hwa, HaiHe Biopharma
    Enrollment open, Trial completion date, Trial initiation date, Trial primary completion date, Metastases:  OPERA: Oral Paclitaxel Efficacy Safety and PK in Recurrent and Metastatic Breast Cancer (clinicaltrials.gov) -  Aug 13, 2018   
    P2,  N=72, Recruiting, 
    Active, not recruiting --> Completed Not yet recruiting --> Recruiting | Trial completion date: Jan 2019 --> Sep 2019 | Initiation date: Dec 2017 --> Jul 2018 | Trial primary completion date: Sep 2018 --> May 2019
  • ||||||||||  Liporaxel (paclitaxel oral) / Dae Hwa, HaiHe Biopharma
    Enrollment open, Trial completion date, Trial primary completion date, Metastases:  OPTIMAL: Oral Paclitaxel Trial In Recurrent and Metastatic Breast Cancer As 1st Line Therapy (clinicaltrials.gov) -  Jun 6, 2018   
    P2/3,  N=476, Recruiting, 
    Not yet recruiting --> Recruiting | Trial completion date: Jan 2019 --> Sep 2019 | Initiation date: Dec 2017 --> Jul 2018 | Trial primary completion date: Sep 2018 --> May 2019 Not yet recruiting --> Recruiting | Trial completion date: Oct 2021 --> Mar 2022 | Trial primary completion date: Oct 2018 --> Jan 2019
  • ||||||||||  delpazolid (LCB01-0371) / LegoChem Biosci
    Trial completion date, Trial primary completion date:  A Phase II Clinical Study of LCB01-0371 to Evaluate the EBA, Safety and PK (clinicaltrials.gov) -  Apr 10, 2018   
    P2,  N=64, Recruiting, 
    Therefore, these tumors are endocrine resistant and should be candidates for treatment with combinations of ER and FGFR antagonists. Trial completion date: Feb 2018 --> Dec 2018 | Trial primary completion date: Feb 2018 --> Oct 2018
  • ||||||||||  delpazolid (LCB01-0371) / LegoChem Biosci
    Trial completion, Trial completion date:  IV Dosage Form of LCB01-0371 Phase I Study in Healthy Male Volunteers (clinicaltrials.gov) -  Apr 10, 2018   
    P1,  N=24, Completed, 
    Trial completion date: Feb 2018 --> Dec 2018 | Trial primary completion date: Feb 2018 --> Oct 2018 Recruiting --> Completed | Trial completion date: Dec 2017 --> Jul 2017
  • ||||||||||  delpazolid (LCB01-0371) / LegoChem Biosci
    Enrollment open, Enrollment change, Trial primary completion date:  A Phase II Clinical Study of LCB01-0371 to Evaluate the EBA, Safety and PK (clinicaltrials.gov) -  Aug 29, 2017   
    P2,  N=64, Recruiting, 
    Phase classification: P1a/1b --> P1 Not yet recruiting --> Recruiting | N=30 --> 64 | Trial primary completion date: May 2017 --> Feb 2018
  • ||||||||||  grapiprant (RQ-00000007) / AskAt, Ikena Oncology, Maruishi Pharma
    Enrollment change, Trial initiation date, Trial withdrawal, Metastases:  Phase II Trial of EP4 Receptor Antagonist, AAT-007 (RQ-07; CJ-023,423) in Advanced Solid Tumors (clinicaltrials.gov) -  Jun 7, 2017   
    P2,  N=0, Withdrawn, 
    N=158 --> 243 | Trial primary completion date: Oct 2018 --> Dec 2020 N=45 --> 0 | Initiation date: Jan 2017 --> Jun 2017 | Not yet recruiting --> Withdrawn
  • ||||||||||  delpazolid (LCB01-0371) / LegoChem Biosci
    Enrollment open, Trial primary completion date:  IV Dosage Form of LCB01-0371 Phase I Study in Healthy Male Volunteers (clinicaltrials.gov) -  Mar 13, 2017   
    P1,  N=24, Recruiting, 
    Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting | Trial primary completion date: Dec 2016 --> Sep 2017
  • ||||||||||  simmitecan / HaiHe Biopharma
    Trial completion, Metastases:  Study of Simmitecan Hydrochloride in the Treatment of Advanced Solid Tumor (clinicaltrials.gov) -  Dec 20, 2016   
    P1,  N=39, Completed, 
    Not yet recruiting --> Recruiting | Trial primary completion date: Dec 2016 --> Sep 2017 Active, not recruiting --> Completed
  • ||||||||||  lucitanib (E 3810) / Clovis, Servier
    Enrollment change, Trial initiation date, Trial withdrawal, Trial primary completion date, Pan tumor, Metastases:  Lucitanib (E3810) in Patients With Advanced Cancer and FGFR, VEGFR, or PDGFR Pathway Aberrations (clinicaltrials.gov) -  Nov 2, 2016   
    P2,  N=0, Withdrawn, 
    Active, not recruiting --> Completed | Trial primary completion date: Sep 2016 --> Apr 2016 N=180 --> 0 | Initiation date: Apr 2016 --> Apr 2017 | Not yet recruiting --> Withdrawn | Trial primary completion date: Apr 2020 --> Apr 2021
  • ||||||||||  grapiprant (RQ-00000007) / AskAt, Ikena Oncology, Maruishi Pharma
    Trial initiation date, Trial primary completion date, Metastases:  Phase II Trial of EP4 Receptor Antagonist, AAT-007 (RQ-07; CJ-023,423) in Advanced Solid Tumors (clinicaltrials.gov) -  May 23, 2016   
    P2,  N=45, Not yet recruiting, 
    Trial primary completion date: Jun 2016 --> Sep 2016 Initiation date: Dec 2015 --> Jan 2017 | Trial primary completion date: Dec 2017 --> Dec 2019
  • ||||||||||  delpazolid (LCB01-0371) / LegoChem Biosci
    Trial completion, Enrollment change, Trial primary completion date:  To Evaluate the Effect of Food on Pharmacokinetics(PK), Phase I Clinical Study of LCB01-0371 (clinicaltrials.gov) -  Mar 23, 2016   
    P1,  N=30, Completed, 
    Trial primary completion date: May 2016 --> Mar 2017 Not yet recruiting --> Completed | N=24 --> 30 | Trial primary completion date: Sep 2015 --> Dec 2015
  • ||||||||||  simmitecan / HaiHe Biopharma
    Enrollment closed, Enrollment change, Trial primary completion date, Metastases:  Study of Simmitecan Hydrochloride in the Treatment of Advanced Solid Tumor (clinicaltrials.gov) -  Mar 21, 2016   
    P1,  N=39, Active, not recruiting, 
    Not yet recruiting --> Completed | N=24 --> 30 | Trial primary completion date: Sep 2015 --> Dec 2015 Recruiting --> Active, not recruiting | N=51 --> 39 | Trial primary completion date: Jan 2014 --> Mar 2016