Novartis' 3 new biologic drugs were approved in China today for clinical targeting PD-1 TGF-β TIM-3

On September 17, China's State Drug Administration's Drug Review Center (CDE) announced that Novartis' three new Class 1 biologic drugs have been approved for clinical trials, namely TGF-beta inhibitor NIS793, PD-1 inhibitor PDR001, and single-clone antibody MBG453 targeting TIM-3 receptors.
according to CDE's official website, the three new drugs were approved clinically in China, and the proposed adaptations are: MBG453, NIS793 single drug or a joint use with PDR001 to treat bone marrow fibrosis.
screenshot Source: CDE Website According to Novaral.com, a three-drug combination therapy for bone marrow fibrosis is currently being studied in Phase 1.
in this study, combination therapies with new drugs, including immunotherapy, will focus on identifying and promising combinations and hopefully provide patients with acceptable safety and effectiveness in addition to JAK inhibitors.
, the combination of immunotherapy for MBG453 and NIS793 may offer the potential for cross-genetic heterogeneity-targeted bone marrow fibrosis.
(1) TGF-beta inhibitor: NIS793 NIS793 is a conversion growth factor beta 1 (transforming growth factor beta, TGF-beta) inhibitor.
TGF-beta signaling pathline is mainly involved in the normal growth and development of mediated tissues and organs, the body's immune response and other biological processes by regulating the growth, proliferation, differentiation, migration and apoptosis of cells.
studies have shown that TGF-beta 1 affects apoptosis of fibroblasts and myocytosis cells and is directly related to T-cell failure, PD-L1, and CTLA-4 ascension in tumor micro-environments.
these studies suggest that NIS793 has a wide range of applications in a variety of fibrosis and cancer diseases.
novart has registered three clinical trials of NIS793, according to its website.
are: NIS793 and PDR001 in patients with advanced malignancies in Phase 1/1b studies, NIS793 (with or without PDR001) in combination with SOC chemotherapy in first-line metastatic pancreatic catheterized adenocarcinoma (mPDAC) Phase 2 studies, NIS793 and MMG453, PDR00 in combination for adult myelomatic Phase 1 studies.
(2) PD-1 inhibitors: PDR001 injection with a strong solution PDR001 is a novart developed PD-1 inhibitor, a.k.a. partalizumab.
is currently conducting clinical trials of PDR001 monotherapy or combination drugs with other drugs in a variety of cancers.
, the fastest progress has been made to Phase 3 clinical, which is a treatment with B-Raf inhibitors dabrafenib and MEK inhibitors traminib patients with BRAF V600 mutation metastasis melanoma, and has achieved initial efficacy, objective mitigation rate of 78%, complete remission rate of 42%.
introduction to Sparta-DabTram therapy (Photo Source: References) This PDR001 has been approved for clinical use in China and is intended to develop adaptive disorders for the treatment of bone marrow fibrosis in combination with drugs such as MMG453 and NIS793.
, PDR001 has been granted more than 10 clinical trials in China, according to CDE's official website.
includes localized late stage or metastasis non-small cell lung cancer in association with the MET inhibitor INC280 and ALC re-negative, TNO155 with CDK4/6 inhibitor LEE011, or with PDR001 for the treatment of specific advanced malignancies.
In addition, according to the drug clinical trial registration and information disclosure platform, PDR001 single drug treatment of patients with advanced nasopharyngeal cancer Phase 2 clinical studies, PDR001 single drug or in a joint treatment with INC280 advanced hepatocellular carcinoma phase 1b/2 studies, have completed patient recruitment.
TNO155 in a joint phase 1 study with LEE011 or PDR001 for specific advanced malignancies is also under way, involving cancerous species including non-small cell lung cancer, head and neck squamous cell carcinoma, esophageal squamous cell carcinoma, gastrointestinal mesothelioma, and colorectal cancer.
screenshot Source: chinadrugtrials (3) TIM-3 Antibodies: MBG453 MBG453 is a monoclonal antibody that targets TIM-3 receptors.
TIM-3 is an inhibitory subject expressed on the surface of immune cells and myeloid leukemia cells.
its expression levels were associated with the severity of acute myeloid leukemia (AML) and myeloid growth syndrome (MDS).
MBG453, by inhibiting the function of TIM-3 receptors, can play a role in targeting both myeloid leukemia cells and immune cells, not only can kill cancer cells, but also may enhance the vitality of immune cells.
treatment strategies for targeting TIM-3 receptors (Photo source: Resources) MBG453 has previously shown good safety and anti-cancer activity in Phase 1 clinical trials in patients treating MDS and AML.
is understood to have high hopes for the innovative treatment, which it believes could be the cornerstone of the treatment of a variety of myelin diseases.
, MBG453 is conducting a number of clinical trials involving adaptive disorders including AML, MDS, advanced malignancies, etc.
according to Novarma's official website, MBG453 is currently in the fastest progression of the research project to clinical phase 3, for high-risk bone marrow abnormal growth syndrome (HR-MDS).
In July this year, MBG453 obtained the first implied permission for clinical trials in China to develop adaptations for patients with combined azatide therapy IPSS-R strated medium-risk, high-risk or very high-risk MDS or chronic granulocytic leukemia-2 (CMML-2).
based on the drug clinical trial registration and information disclosure platform, this is a randomized, double-blind, placebo-controlled phase 3 international multi-center study, which is currently under way.
screenshot Source: Chinadrugtrials Novartics is committed to improving access to innovative medicines so that more patients benefit from innovation as quickly as possible.
more than 60 new drugs have been approved in China since 1987, covering cardiovascular, diabetes, ophthalmology, immunology and skin, central nervous system, respiratory, transplantation and other fields.
the company expects to submit nearly 30 approved applications for new products and adaptive disorders in China between 2020 and 2024, according to Novartic's official website.
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