Zhejiang Hisun 
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  • ||||||||||  pritumumab (CLNH 11) / Nascent Biotech
    Enrollment open, Trial initiation date:  Safety Study of Pritumumab in Brain Cancer (clinicaltrials.gov) -  Mar 21, 2021   
    P1,  N=42, Recruiting, 
    Not yet recruiting --> Recruiting | Initiation date: Jun 2020 --> Mar 2021
  • ||||||||||  Seebri Breezhaler (glycopyrronium bromide) / Novartis, Vectura, Sosei
    Journal:  Expanded table: Correct use of inhalers for asthma. (Pubmed Central) -  Jan 26, 2021   
    HS016 resembled adalimumab in efficacy and safety over the 24-week treatment period. No abstract available
  • ||||||||||  desferroxamine (DFO) / ZoneOne Pharma, PLX038 / ProLynx, firtecan pegol (PEG-SN38) / Zhejiang Hisun, Belrose
    Journal:  PET imaging of the EPR effect in tumor xenografts using small 15 nm diameter polyethylene glycols labeled with zirconium-89. (Pubmed Central) -  Jan 13, 2021   
    PEG conjugates of the zirconium ligand desferroxamine B (DFB) of similar size and charge to PLX038 were prepared that contained one or four DFB, as well as one that contained three SN-38 moieties and one DFB...Compared to diagnostic liposomes, the PEG nanocarriers have a longer serum half-life, are retained in tumors at higher levels, remain there longer, and afford higher tumor exposure. The small PEG40kDa nanocarriers studied here show properties for passive targeting of tumors that are superior than most nanoparticles and might be effective probes to identify tumors susceptible to a similar size therapeutic nanocarriers such as PLX038.
  • ||||||||||  Seebri Breezhaler (glycopyrronium bromide) / Novartis, Vectura, Sosei
    Journal:  Drugs for COPD. (Pubmed Central) -  Dec 30, 2020   
    The small PEG40kDa nanocarriers studied here show properties for passive targeting of tumors that are superior than most nanoparticles and might be effective probes to identify tumors susceptible to a similar size therapeutic nanocarriers such as PLX038. No abstract available
  • ||||||||||  PLX038 / ProLynx, firtecan pegol (PEG-SN38) / Belrose, Rubraca (rucaparib) / Pharma& Schweiz
    Trial completion date, Trial primary completion date:  PLX038 (PEGylated SN38) and Rucaparib in Solid Tumors and Small Cell Cancers (clinicaltrials.gov) -  Oct 26, 2020   
    P1/2,  N=62, Recruiting, 
    Patients taking LAMA have features characteristic of even more severe asthma. Trial completion date: Dec 2022 --> Dec 2024 | Trial primary completion date: Dec 2022 --> Dec 2023
  • ||||||||||  Enerzair Breezhaler (glycopyrrolate/indacaterol/mometasone) / Novartis, Seebri Breezhaler (glycopyrronium bromide) / Novartis, Vectura, Sosei
    [VIRTUAL] Cost-Effectiveness of Once-Daily Single-Inhaler Indacaterol Acetate/Glycopyrronium Bromide/Mometasone Furoate in Patients with Uncontrolled Moderate-to-Severe Asthma () -  Oct 3, 2020 - Abstract #ISPOREU2020ISPOR-EU_204;    
    At a threshold of €20,000 per QALY, IND/GLY/MF has nearly 100% probability of being cost-effective.CONCLUSIONS : The results indicate that IND/GLY/MF is cost-effective among the considered comparisons in a representative cohort of adult asthma patients in Italy. At a willingness-to-pay threshold of $50,000/QALY, treatment with IND/GLY/MF is cost-effective in patients with uncontrolled moderate-to-severe asthma compared with SAL/FLU+Tio or SAL/FLU from a Canadian health care payer perspective.
  • ||||||||||  Xolair (omalizumab) / Roche, Novartis, HS632 (omalizumab biosimilar) / Zhejiang Hisun
    Enrollment change:  Comparison of Pharmacokinetics and Safety of HS632 and Xolair (clinicaltrials.gov) -  Aug 24, 2020   
    P1,  N=60, Not yet recruiting, 
    It is essential for payers to assess the range of factors, including the risks and benefits of triple FDCs, and consider which restrictions would ensure the most efficient use of limited healthcare resources. N=252 --> 60
  • ||||||||||  HS627 (pertuzumab biosimilar) / Zhejiang Hisun, Herceptin (trastuzumab) / Roche, Perjeta (pertuzumab) / Roche
    New P3 trial, Combination therapy, Metastases:  Treatment of Breast Cancer With Trastuzumab + HS627/ Pertuzumab + Docetaxel (clinicaltrials.gov) -  Aug 16, 2020   
    P3,  N=408, Recruiting, 
  • ||||||||||  Xolair (omalizumab) / Roche, Novartis, HS632 (omalizumab biosimilar) / Zhejiang Hisun
    Trial initiation date:  Comparison of Pharmacokinetics and Safety of HS632 and Xolair (clinicaltrials.gov) -  Aug 7, 2020   
    P1,  N=252, Not yet recruiting, 
    These results support the value of the single-mouse experimental design. Initiation date: Jun 2020 --> Oct 2020
  • ||||||||||  PLX038 / ProLynx, irinotecan / Generic mfg.
    Journal:  PLX038: a PEGylated prodrug of SN-38 independent of UGT1A1 activity. (Pubmed Central) -  Jul 2, 2020   
    Consistent with data from other studies, a more pronounced bronchodilator effect is seen in the subset of patients with PAL. The disposition of PEGylated SN-38 is independent of UGT1A activity in rats, and PLX038 may find utility in full-dose treatment of patients who are UGT1A1*28 homozygotes or have metastatic disease with coincidental or incidental liver dysfunction.
  • ||||||||||  Seebri Breezhaler (glycopyrronium bromide) / Novartis, Vectura, Sosei
    Journal:  Synthesis of C-14 labeled Rac-(3R,2S)-Glycopyrronium Bromide. (Pubmed Central) -  Jun 3, 2020   
    During the synthesis, an unexpected decarboxylation of phenylglyoxylate resulted in the loss of much of the radiolabeled compound. Chiral chromatography was utilized to isolate and deliver the proper pair of enantiomers as [ C]-1.
  • ||||||||||  pritumumab (CLNH 11) / Nascent Biotech
    New P1 trial:  Safety Study of Pritumumab in Brain Cancer (clinicaltrials.gov) -  May 21, 2020   
    P1,  N=42, Not yet recruiting, 
  • ||||||||||  firtecan pegol (PEG-SN38) / Zhejiang Hisun, Belrose, PT2385 / Merck (MSD)
    [VIRTUAL] HIF2ALPHA PARTAKES TO AML DIFFERENTIATION BLOCKADE, AND ITS INHIBITION DRIVES AML DIFFERENTIATION () -  May 16, 2020 - Abstract #EHA2020EHA_387;    
    Pro-differentiation activity of the specific HIF2α antagonist PT2385 was evaluated in AML cell lines, and ex vivo in AML cells from the bone marrow of 8 PDX models...Conclusion With this study, we defined a new role of HIF2α in the pathogenesis of AML, as a novel regulator of the AML differentiation blockade. Moreover, we suggest that HIF2α inhibition could be exploited as a new therapeutic avenue to treat AML, and to overcome resistance towards ATRA-induced differentiation therapy.
  • ||||||||||  Seebri Breezhaler (glycopyrronium bromide) / Novartis, Vectura, Sosei
    Journal:  Abnormal Presentation of Hypoxic Ischemic Encephalopathy Attributed to Polysubstance Exposure. (Pubmed Central) -  Apr 26, 2020   
    Clonidine was used to control the NAS symptoms, ranitidine was used to treat the gastroesophageal reflux, and glycopyrronium bromide was used for the neonate's excessive secretions. After delivery, the patient was placed on a nasal noninvasive cannula for respiratory distress and was transferred to a different hospital for treatment of the more serious comorbid conditions.
  • ||||||||||  Xolair (omalizumab) / Roche, Novartis, HS632 (omalizumab biosimilar) / Zhejiang Hisun
    New P1 trial:  Comparison of Pharmacokinetics and Safety of HS632 and Xolair (clinicaltrials.gov) -  Apr 23, 2020   
    P1,  N=252, Not yet recruiting, 
  • ||||||||||  Seebri Breezhaler (glycopyrronium bromide) / Novartis, Vectura, Sosei
    Clinical, Review, Journal:  Pharmacology, toxicology and clinical safety of glycopyrrolate. (Pubmed Central) -  Apr 14, 2020   
    More recently, topical formulations of glycopyrrolate (GPB, also known as glycopyrronium bromide) have gained interest as a treatment option for excessive sweating (hyperhidrosis)...The information on the nonclinical and clinical safety profile of glycopyrronium supporting various therapeutically approved uses has been obtained from published literature, our own data as well as summary documents issued by regulatory bodies. Collectively, these data support the conclusion that the benefits of glycopyrronium generally outweigh the risks in chronic use indications that require muscarinic receptor antagonism to provide therapeutic effects.
  • ||||||||||  PLX038 / ProLynx, firtecan pegol (PEG-SN38) / Belrose, Rubraca (rucaparib) / Pharma& Schweiz
    Enrollment open:  PLX038 (PEGylated SN38) and Rucaparib in Solid Tumors and Small Cell Cancers (clinicaltrials.gov) -  Apr 8, 2020   
    P1/2,  N=62, Recruiting, 
    Collectively, these data support the conclusion that the benefits of glycopyrronium generally outweigh the risks in chronic use indications that require muscarinic receptor antagonism to provide therapeutic effects. Not yet recruiting --> Recruiting