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Related Concept Videos

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Post-approval, manufacturers may modify an approved new or generic drug product. Such modifications can encompass alterations in the Active Pharmaceutical Ingredient (API), manufacturing process, formulation, batch size, manufacturing site, and container closure system (FDA Guidance for Industry, April 2004). Often, a drug product may undergo multiple changes.These modifications require careful evaluation to determine their potential impact on the drug product's identity, strength, quality,...
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Tumor Necrosis Factor (TNF), a proinflammatory cytokine, contributes significantly to the inflammation seen in Crohn's disease. It exists as soluble TNF and membrane-bound TNF, with actions mediated through TNF receptors (TNFR). TNFR activation leads to the release of proinflammatory cytokines, T-cell activation, collagen production, and leukocyte migration, all contributing to inflammation in Crohn's disease. Anti-TNF monoclonal antibodies, namely infliximab (Remicade), adalimumab...
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Related Experiment Video

Updated: Dec 26, 2025

Dynamic Imaging of Chimeric Antigen Receptor T Cells with [18F]Tetrafluoroborate Positron Emission Tomography/Computed Tomography
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Tislelizumab: First Approval.

Arnold Lee1, Susan J Keam2

  • 1Springer Nature, Private Bag 65901, Mairangi Bay, Auckland, 0754, New Zealand. dru@adis.com.

Drugs
|March 19, 2020
PubMed
Summary

Tislelizumab, an anti-PD-1 antibody, is a new immunotherapy for cancer. It has gained approval in China for classical Hodgkin

Area of Science:

  • Immunology
  • Oncology
  • Pharmacology

Background:

  • Tislelizumab is a novel anti-human programmed death receptor-1 (PD-1) monoclonal IgG4 antibody.
  • It is developed as an immunotherapeutic, anti-neoplastic drug by BeiGene.
  • Tislelizumab has been investigated for various hematological cancers and advanced solid tumors.

Purpose of the Study:

  • To summarize the key development milestones of tislelizumab.
  • To highlight its initial approval for classical Hodgkin's lymphoma in China.
  • To discuss potential future approvals in other indications.

Main Methods:

  • Review of clinical development data for tislelizumab.
  • Analysis of regulatory milestones and approval processes.
  • Summary of preclinical and clinical trial outcomes.

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Main Results:

  • Tislelizumab received its first approval in China in December 2019.
  • The approval was for adult patients with relapsed or refractory classical Hodgkin's lymphoma.
  • The drug is indicated for patients who have undergone at least second-line chemotherapy.

Conclusions:

  • Tislelizumab represents a significant advancement in cancer immunotherapy.
  • The drug's initial approval marks a major milestone in its development.
  • Further indications and global approvals are anticipated for tislelizumab.