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Ozoralizumab

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Ozoralizumab

FormulaC1682H2608N472O538S12
CAS 1167985-17-2
Mol weight38434.3245 

PMDA JAPAN  APPROVED 2022 2022/9/26 Nanozora

anti-TNFα Nanobody®; ATN-103; Nanozora; PF-5230896; TS-152

Ozoralizumab is a humanized monoclonal antibody designed for the treatment of inflammatory diseases.[1]

Ozoralizumab was developed by Pfizer Inc, and now belongs to Ablynx NV. Ablynx has licensed the rights to the antibody in China to Eddingpharm.

Ozoralizumab has been used in trials studying the treatment of Rheumatoid Arthritis and Active Rheumatoid Arthritis.

Ozoralizumab is a 38 kDa humanized trivalent bispecific construct consisting of two anti-TNFα NANOBODIES® and anti-HSA NANOBODY® that was generated at Ablynx by a previously described method (23). Llamas were immunized with human TNFα and human muscle extract, which is rich in HSA, to induce the formation of anti-TNFα VHH and anti-HSA VHH. Both the anti-TNFα VHH and anti-HSA VHH were humanized by a complementary determining regions (CDR) grafting approach in which the CDR of the gene encoding llama VHH was grafted onto the most homologous human VHH framework sequence. Since binding to serum albumin prolongs the half-life of VHH (23, 26, 27), an anti-HSA VHH which efficiently binds murine serum albumin as well was incorporated into the two anti-TNFα VHHs. The three components were fused using a flexible Gly-Ser linker.

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Monoclonal antibody
TypeWhole antibody
SourceHumanized
Clinical data
ATC codenone
Identifiers
CAS Number1167985-17-2 
ChemSpidernone
UNII05ZCK72TXZ
KEGGD09944
Chemical and physical data
FormulaC1682H2608N472O538S12
Molar mass38434.85 g·mol−1
  • OriginatorAblynx
  • DeveloperAblynx; Eddingpharm; Pfizer; Taisho Pharmaceutical
  • ClassAnti-inflammatories; Antirheumatics; Monoclonal antibodies; Proteins
  • Mechanism of ActionTumour necrosis factor alpha inhibitors
  • Orphan Drug StatusNo
  • New Molecular EntityYes
  • RegisteredRheumatoid arthritis
  • DiscontinuedAnkylosing spondylitis; Crohn’s disease; Psoriatic arthritis
  • 05 Oct 2022Sanofi’s affiliate Ablynx has worldwide patent pending for Nanobodies® (Sanofi website, October 2022)
  • 05 Oct 2022Sanofi’s affiliate Ablynx has worldwide patent protection for Nanobodies® (Sanofi website, October 2022)
  • 26 Sep 2022First global approval – Registered for Rheumatoid arthritis in Japan (SC)

References

  1. ^ Kratz F, Elsadek B (July 2012). “Clinical impact of serum proteins on drug delivery”. J Control Release161 (2): 429–45. doi:10.1016/j.jconrel.2011.11.028PMID 22155554.

////////Ozoralizumab, Nanozora, Monoclonal antibody, nanobody, Treatment inflammation, ATN 103, APPROVALS 2022, JAPAN 2022

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DR ANTHONY CRASTO

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DR ANTHONY MELVIN CRASTO Ph.D

DR ANTHONY MELVIN CRASTO Ph.D

DR ANTHONY MELVIN CRASTO, Born in Mumbai in 1964 and graduated from Mumbai University, Completed his Ph.D from ICT, 1991,Matunga, Mumbai, India, in Organic Chemistry, The thesis topic was Synthesis of Novel Pyrethroid Analogues, Currently he is working with GLENMARK LIFE SCIENCES LTD, Research Centre as Principal Scientist, Process Research (bulk actives) at Mahape, Navi Mumbai, India. Total Industry exp 30 plus yrs, Prior to joining Glenmark, he has worked with major multinationals like Hoechst Marion Roussel, now Sanofi, Searle India Ltd, now RPG lifesciences, etc. He has worked with notable scientists like Dr K Nagarajan, Dr Ralph Stapel, Prof S Seshadri, Dr T.V. Radhakrishnan and Dr B. K. Kulkarni, etc, He did custom synthesis for major multinationals in his career like BASF, Novartis, Sanofi, etc., He has worked in Discovery, Natural products, Bulk drugs, Generics, Intermediates, Fine chemicals, Neutraceuticals, GMP, Scaleups, etc, he is now helping millions, has 9 million plus hits on Google on all Organic chemistry websites. His friends call him Open superstar worlddrugtracker. His New Drug Approvals, Green Chemistry International, All about drugs, Eurekamoments, Organic spectroscopy international, etc in organic chemistry are some most read blogs He has hands on experience in initiation and developing novel routes for drug molecules and implementation them on commercial scale over a 30 PLUS year tenure till date June 2021, Around 35 plus products in his career. He has good knowledge of IPM, GMP, Regulatory aspects, he has several International patents published worldwide . He has good proficiency in Technology transfer, Spectroscopy, Stereochemistry, Synthesis, Polymorphism etc., He suffered a paralytic stroke/ Acute Transverse mylitis in Dec 2007 and is 90 %Paralysed, He is bound to a wheelchair, this seems to have injected feul in him to help chemists all around the world, he is more active than before and is pushing boundaries, He has 9 million plus hits on Google, 2.5 lakh plus connections on all networking sites, 90 Lakh plus views on dozen plus blogs, 233 countries, 7 continents, He makes himself available to all, contact him on +91 9323115463, email amcrasto@gmail.com, Twitter, @amcrasto , He lives and will die for his family, 90% paralysis cannot kill his soul., Notably he has 33 lakh plus views on New Drug Approvals Blog in 233 countries......https://newdrugapprovals.wordpress.com/ , He appreciates the help he gets from one and all, Friends, Family, Glenmark, Readers, Wellwishers, Doctors, Drug authorities, His Contacts, Physiotherapist, etc

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