Jiangsu Hengrui Pharma 
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  • ||||||||||  AiTan (rivoceranib) / HLB Bio Group, AiRuiKa (camrelizumab) / Incyte
    [VIRTUAL] Genomic profiling of advanced cervical cancer to predict response to PD-1 inhibitor combination therapy: A secondary analysis of the CLAP trial () -  Jan 29, 2021 - Abstract #SGO2021SGO_791;    
    P2
    Objectives: The CLAP trial (NCT03816553) is a multicenter, single-arm, phase II study in patients with metastatic, recurrent, or persistent cervical cancer who were treated with PD-1 inhibitor camrelizumab plus a VEGFR2 inhibitor apatinib. In this study, we uncovered PIK3CA, PTEN, ERBB3, PI3K pathway genes mutations and TMB as novel predictive biomarkers in cervical cancer patients treated with PD-1 inhibitor combination therapy, which might be of great clinical relevance in patient Stratification.
  • ||||||||||  SHR7280 / Jiangsu Hengrui Pharma
    Enrollment open:  The Pharmacokinetic(PK)/Pharmacodynamics(PD) Study of SHR7280 Tablets in Premenopausal Subjects With Endometriosis. (clinicaltrials.gov) -  Jan 28, 2021   
    P1/2,  N=166, Recruiting, 
    In this study, we uncovered PIK3CA, PTEN, ERBB3, PI3K pathway genes mutations and TMB as novel predictive biomarkers in cervical cancer patients treated with PD-1 inhibitor combination therapy, which might be of great clinical relevance in patient Stratification. Not yet recruiting --> Recruiting
  • ||||||||||  Irene (pyrotinib) / Jiangsu Hengrui Pharma
    Enrollment open:  Pyrotinib Plus Thalidomide in Advanced NSCLC Patients Harboring HER2 Exon 20 Insertions (clinicaltrials.gov) -  Jan 27, 2021   
    P2,  N=39, Recruiting, 
    Moreover, it will also evaluate the feasibility of endocrine therapy as an alternative to chemotherapy in providing de-escalation therapy with less toxicity for advanced HR+/HER2+ patients. Not yet recruiting --> Recruiting
  • ||||||||||  AiTan (rivoceranib) / HLB Bio Group
    Trial completion, Trial completion date, Trial primary completion date:  Multicenter Phase II Study of Apatinib in Patients With Advanced Breast Cancer(CABC006) (clinicaltrials.gov) -  Jan 27, 2021   
    P2,  N=30, Completed, 
    Not yet recruiting --> Recruiting Active, not recruiting --> Completed | Trial completion date: May 2017 --> Sep 2020 | Trial primary completion date: May 2017 --> Sep 2020
  • ||||||||||  Retrospective data, Journal:  HER2-targeted regimens after prior trastuzumab for patients with HER2-positive unresectable, locally advanced or metastatic breast cancer: a network meta-analysis of randomized controlled trials. (Pubmed Central) -  Jan 26, 2021   
    For HER2 positive unresectable, locally advanced or metastatic patients progressed after trastuzumab therapy pyrotinib plus capecitabine ranked the highest surface under the cumulative ranking area (SUCRA) in PFS, ORR and its SUCRA in OS was higher than Trastuzumab emtansine (T-DM1)...Six of included studies reported any grade ≥3 adverse events, the prevalence of any grade ≥3 adverse events in lapatinib plus capecitabine (353/683), T-DM1 (213/558), trastuzumab plus capecitabine (130/218), pertuzumab plus trastuzumab plus capecitabine (118/228), pyrotinib plus capecitabine (220/384), T-DM1 plus atezolizumab (43/132) and capecitabine (24/94) were 51.7%, 38.2%, 59.6%, 51.8%, 57.3%, 32.6% and 25.5%, respectively...T-DM1 plus atezolizumab, pyrotinib plus capecitabine and pertuzumab plus trastuzumab plus capecitabine have comparable effect on OS improvement and all of them were likely better than T-DM1. The risk of grade ≥3 adverse events for specific treatment regimens were also provided.
  • ||||||||||  AiTan (rivoceranib) / HLB Bio Group
    Clinical, Journal:  Evaluation of IgG, IgM, CD4+ and CD8+ T cells during neoadjuvant chemotherapy with Tezio and Apatinib in gastric cancer patients. (Pubmed Central) -  Jan 23, 2021   
    Wilcoxon rank-sum test and chi-square test found that the chemotherapy effect of the new chemotherapy group was better than that of the traditional chemotherapy group, and the results of repeated measures analysis of variance showed that the IgG, IgM and CD4+/CD8+ T cell ratios of the patients in the new chemotherapy group were higher than that of traditional chemotherapy group (all P <0.05). Apatinib combined with Tezio's preoperative neoadjuvant chemotherapy can improve the chemotherapy effect of advanced gastric cancer, increase the rate of surgical R0 resection, and reduce the patient's immunosuppressive status during treatment.
  • ||||||||||  Cabometyx (cabozantinib tablet) / Takeda, Exelixis, Ipsen
    Clinical, Retrospective data, Review, Journal:  Bleeding with vascular endothelial growth factor tyrosine kinase inhibitor: A network meta-analysis. (Pubmed Central) -  Jan 23, 2021   
    Apatinib combined with Tezio's preoperative neoadjuvant chemotherapy can improve the chemotherapy effect of advanced gastric cancer, increase the rate of surgical R0 resection, and reduce the patient's immunosuppressive status during treatment. VEGR-TKIs, particularly Sunitinib and Regorafenib appear to be associated with increased risk of bleeding incidence.
  • ||||||||||  Pegylated rhG-CSF (mecapegfilgrastim) / Jiangsu Hengrui Pharma
    Enrollment open, Trial initiation date:  Mecapegfilgrastim(PEG-G-CSF) for Prophylaxis of Chemotherapy-induced Neutropenia in Patients With Lymphoma (clinicaltrials.gov) -  Jan 22, 2021   
    P2,  N=170, Recruiting, 
    Apatinib in combination with dose-dense paclitaxel and carboplatin neoadjuvant therapy are effective and well tolerated in locally advanced TNBC patients. Not yet recruiting --> Recruiting | Initiation date: Aug 2020 --> Dec 2020
  • ||||||||||  AiRuiKa (camrelizumab) / HLB Bio Group
    Enrollment open, Trial initiation date:  NACI: Pd-1 Antibody Combined Neoadjuvant Chemotherapy for Locally Advanced Cervical Cancer (clinicaltrials.gov) -  Jan 22, 2021   
    P2,  N=84, Recruiting, 
    Not yet recruiting --> Recruiting | Initiation date: Aug 2020 --> Dec 2020 Not yet recruiting --> Recruiting | Initiation date: Sep 2020 --> Dec 2020
  • ||||||||||  remimazolam tosylate (HR-7056) / Jiangsu Hengrui Pharma
    Trial initiation date:  Impact of Remimazolam on Prognosis After Bladder Cancer Surgery (clinicaltrials.gov) -  Jan 20, 2021   
    P4,  N=1128, Not yet recruiting, 
    Not yet recruiting --> Recruiting | Initiation date: Sep 2020 --> Dec 2020 Initiation date: Oct 2020 --> Jan 2021
  • ||||||||||  Hansoh Xinfu (flumatinib) / Jiangsu Hengrui Pharma, Jiangsu Hansoh Pharma
    Enrollment open:  Flumatinib in CML-CP Patients With Ph+ Post Imatinib Failure (clinicaltrials.gov) -  Jan 19, 2021   
    P4,  N=200, Recruiting, 
    Initiation date: Oct 2020 --> Jan 2021 Not yet recruiting --> Recruiting
  • ||||||||||  AiTan (rivoceranib) / HLB Bio Group, AiRuiKa (camrelizumab) / HLB Bio Group
    Enrollment open:  AMBITION: Neoadjuvant Therapy for Locally Advanced Colon Cancer (clinicaltrials.gov) -  Jan 19, 2021   
    P2,  N=64, Recruiting, 
    Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting
  • ||||||||||  Review, Journal:  Metastatic Human Epidermal Growth Factor Receptor 2-Positive Breast Cancer: Current Treatment Standards and Future Perspectives. (Pubmed Central) -  Jan 16, 2021   
    Dual HER2 blockade with pertuzumab and trastuzumab in combination with docetaxel in previously untreated patients, and trastuzumab emtansine (T-DM1, an antibody-drug conjugate [ADC] consisting of trastuzumab, a linker and a cytotoxic payload) after prior trastuzumab therapy have demonstrated progression-free survival (PFS) and overall survival (OS) superior to what was achieved with the previous treatment routine...Accepted options include treatment with trastuzumab beyond progression, in combination with a broad variety of single-agent chemotherapies used sequentially, or lapatinib (an HER2-targeting tyrosine kinase inhibitor [TKI]) in combination with either trastuzu-mab or capecitabine...After a median of 6 prior lines of therapy, trastuzumab deruxtecan (T-DXd), a novel ADC, showed a meaningful overall response and PFS...Tucatinib, neratinib, margetuximab, and T-DXd expand the armamentarium for treatment beyond the second line. Pyrotinib might be another option, especially for patients, who do not have access to pertuzumab and T-DM1.
  • ||||||||||  plinabulin (BPI 2358) / BeyondSpring
    Trial completion date:  PROTECTIVE-2: Plinabulin vs. Pegfilgrastim in Prevention of TAC Induced Neutropenia (clinicaltrials.gov) -  Jan 15, 2021   
    P3,  N=221, Active, not recruiting, 
    Pyrotinib might be another option, especially for patients, who do not have access to pertuzumab and T-DM1. Trial completion date: Nov 2020 --> Sep 2025
  • ||||||||||  AnDaJing (vunakizumab) / Jiangsu Hengrui Pharma
    Trial completion, Trial completion date, Trial primary completion date:  Safety, Tolerability and PK of SHR1314 in axSpA (clinicaltrials.gov) -  Jan 13, 2021   
    P1,  N=45, Completed, 
    Active, not recruiting --> Completed Recruiting --> Completed | Trial completion date: Aug 2019 --> Jan 2020 | Trial primary completion date: Jun 2019 --> Jan 2020
  • ||||||||||  AiTan (rivoceranib) / HLB Bio Group
    Enrollment open, Trial completion date, Trial primary completion date:  Drug-drug Interaction Study of Gefitinb on Apatinib in NSCLC Patients (clinicaltrials.gov) -  Jan 11, 2021   
    P1,  N=22, Recruiting, 
    Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting | Trial completion date: Aug 2020 --> Mar 2021 | Trial primary completion date: Jul 2020 --> Feb 2021