Page 187 - CW E-Magazine (11-3-2025)

Special Report Special Report

receiving a Complete Response Letter the addition of cagrilintide, a long- that targets the interleukin-13 (IL-13) the fi ve groups of Neisseria menin- Moderna’s mRESVIA (respiratory HER2-) advanced breast cancer. If
(CRL) last July (July 2024) by the acting amylin analogue. It potentially pathway, considered important in ad- gitidis (A, B, C, W, and Y), which syncytial virus vaccine) approved, it would become the fi rst
US Food and Drug Administration. At holds improved effi cacy over Novo’s dressing infl ammatory diseases, such is responsible for the most invasive Moderna’s mRESVIA (respiratory PROteolysis Targeting Chimera (PROTAC)
the time of receiving the CRL in July GLP-1’ agonists, Ozempic/Wegovy, as atopic dermatitis. The other two IL- meningococcal disease cases world- syncytial virus [RSV] vaccine) was protein degrader on the market. De-
2024, Novo Nordisk said that FDA had and Lilly’s GLP-1 agonists, Mounjaro/ 13 biologics for treating atopic derma- wide. It combines the antigenic com- approved by FDA in May 2024 and signed to target and degrade the oestro-
requested information related to the Zepbound (tirzepatide) in treating obe- titis are Sanofi ’s Dupixent (dupilumab) ponents of GSK’s licensed meningo- joins two RSV vaccines, which made gen receptor protein, early studies sug-
manufacturing process and the Type-1 sity and Type-2 diabetes. It leverages and Leo Pharma’s Adbry/Adtralza coccal vaccines, Bexsero (MenB) and Clarivate’s Drug to Watch list in 2024, gest PROTAC-induced degradation is
diabetes indication before the review the benefi ts of GLP-1s, such as enhanced (tralokinumab). Ebglyss’s less-frequent Menveo (MenACWY), both of which GSK’s Arexvy and Pfi zer’s Abrysvo. more complete than with oral selective
of the application could be completed. insulin secretion and appetite reduction dosing, more selective IL-13 inhibi- have established effi cacy and safety Clarivate projects sales of $1.40-bn in oestrogen receptor degraders, thereby
Novo Nordisk said it would work with while incorporating amylin’s effects, tion, and strong effi cacy and safety data profi les. Clarivate projects sales of G7 markets in 2030. potentially overcoming endocrine resis-
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FDA to fulfi l the requests and did not including slowed glucose absorption position it as a likely fi rst-line treat- $905-mn in the US and EU 4 (France, tance in breast cancer. Potential label
expect to complete FDA’s requests and release, according to the Clarivate ment for moderate-to-severe atopic Italy, Germany, and Spain) markets Sobi’s and Cartesian Therapeutics’/ expansions include the drug in combi-
during 2024. The CRL followed a report. If approved, CagriSema will dermatitis when topical corticosteroids in 2030. Selecta Biosciences’ SEL-212 nation with another breast cancer drug
IndiaChemTrade
meeting of the FDA Endocrinologic be the fi rst fi xed-dose combination of are inadequate, according to Clarivate, ChemImpex Sobi’s and Cartesian Therapeutics’/ by Pfi zer, Ibrance (palbociclib). Clari-
and Metabolic Drugs Advisory Commit- amylin and GLP-1 receptor agonists in which projects $6.00-bn in sales in Amgen’s Imdelltra (tarlatamab-dlle) Selecta Biosciences’ SEL-212 offers vate estimates sales of $1.19-bn in the
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tee in May 2024, which concluded that the obesity and Type-2 diabetes mar- the G7 markets in 2030. Amgen’s Imdelltra (tarlatamab-dlle) potential advantages in the treatment G7 markets in 2030.
ChemImpex, the trade database, tracks, on a daily
IndiaChemTrade provides consolidated trade statistics
the data available at that time were not kets. Clarivate projects sales of $4.7-bn is a fi rst-in-class immunotherapy for of gout. It is a once-monthly treatment
of India. The information provided here is based on the
basis, exports and imports of chemicals and related
suffi cient to conclude a positive benefi t- in the G7 markets in 2030 for obesity Sanofi ’s and Alnylam Pharma- extensive-stage small cell lung cancer combining pegylated uricase (pegadri- Exelixis’ zanzalintinib
annual trade data published by the Directorate General
risk in Type-1 diabetes. The Advisory and $3.6-bn in the G7 markets in 2030 ceuticals’ fi tusiran (ES-SCLC.). The drug was granted case) with ImmTOR, an immune tole- Exelixis’ zanzalintinib is being ex-
products through the major ports in India — a vital
Committee did not discuss the use of for Type-2 diabetes. Sanofi ’s and Alnylam Pharma- accelerated approval by FDA in May rance technology designed to inhibit for- plored in multiple cancers and is an
of Commercial Intelligence and Statistics, Government
source of commercial intelligence. Find out on-line
once-weekly insulin icodec in Type-2 ceuticals’ fi tusiran is an investigational 2024 and was given orphan drug and mation of anti-drug antibodies (ADAs). oral tyrosine kinase inhibitor targeting
of India. The database can be searched by: Chemical
how international markets are moving; where your
diabetes. Analysts project approval in Bristol-Myers Squibb’s Cobenfy RNAi therapeutic for treating haemo- breakthrough drug designation. The For this application, ImmTOR consists VEGF receptors, MET, and TAM
Name/Harmonised Code to obtain the consolidated
competitors are exporting and at what price; where
US in 2025. (xanomeline-trospium) philia A and B, with or without inhibi- drug uses Amgen’s proprietary bispeci- of SEL-110.36, an inhibitor of uricase- kinases involved in tumour growth and
trade (import or export) in that item; or by Country to
imports are coming from and how their prices are
Bristol-Myers Squibb’s Cobenfy tors. It was developed as part of an fi c T cell engager (BiTE) molecules specifi c ADA. This approach may help immunosuppression. Currently in Phase
obtain the trade (import or export) in all chemicals and
moving. Download all this data, seamlessly, for a
The therapeutic pipeline for Type-2 (xanomeline-trospium), for treating RNAi therapeutics rare-disease alliance and targets CD3 on T cells and DLL3 overcome the limitations of reduced II trials for non-clear-cell renal cell car-
related products between India and that country
small fee — online, anytime, with no hassles.
diabetes is extremely crowded, with schizophrenia and psychosis related to between Sanofi and Alnylam Pharma- on tumour cells, enabling T cells to effi cacy and tolerability seen with other cinoma (nccRCC), colorectal cancer
more than 150 drugs in active clinical Alzheimer’s disease, was approved by ceuticals. Sanofi expects to secure FDA attack and lyse the tumour. DLL3 is biologic treatments, such as Amgen’s (CRC), and squamous cell carcinoma
ChemXchange
development, according to information FDA in September 2024 for treating approval by the Prescription Drug User expressed on the surface of small-cell Krystexxa (pegloticase) for treating of the head and neck (SCCHN), it is
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from Clarivate. In addition, glucagon- schizophrenia, marking the fi rst anti- Fee Act (PDUFA) target action date of lung cancer cells in more than 85% chronic gout. Clarivate project sales expected to gain FDA approval fi rst for
ChemXchange — the chemical exchange with a difference — is where you can identify your buyers and sup-
like peptide-1 receptor agonists (GLP-1 psychotic drug to treat schizophrenia March 28, 2025. This small interfering of patients but is minimally expressed of $1.70-bn in the G7 markets in 2030. nccRCC. Compared to Exelixis’s Cabo-
plyers on-line, any time. This unique platform is free to all advertisers in the print version of Chemical Weekly.
Ras) are dominating the Phase III that targets cholinergic receptors, a RNA (siRNA) therapy works by inhibi- on healthy cells, thereby making it an metyx (cabozantinib), zanzalintinib may
pipeline and include more convenient novel mechanism of action, instead of ting SerpinPC1 mRNA, reducing anti- attractive target, according to Clarivate. Pfi zer’s/Arvinas’ vepdegestrant offer benefi ts, including approval for
For more information contact: 022-24044477. Fax: 022-24044450
oral options (e.g., Eli Lilly and Co.’s dopamine receptors, which has been thrombin levels, promoting thrombin This mechanism positions it as a Pfi zer’s/Arvinas’ vepdegestrant is nccRCC histology and a broader patient
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orforglipron), GLP-1 combination thera- the standard of care. Further evaluation generation, and helping to rebalance potential standard of care for previously an investigational oral medication de- population, according to information
pies (e.g., Novo Nordisk’s IcoSema is also ongoing for a second indication. haemostasis to prevent bleeds and treated ES-SCLC. Clarivate projects signed to treat oestrogen receptor (ER)- from Clarivate, which projects sales of
(insulin icodec and semaglutide), and While further data are needed to assess leverages Alnylam’s ESC-GalNAc sales of $2.10-bn in the G7 markets in positive, human epidermal growth fac- $2.60-bn for CRC, RCC and SCCHN
Novo Nordisk’s CagriSema (cagrilin- the drug’s effectiveness in Alzheimer’s conjugate technology, according to 2030. tor receptor 2 (HER2)-negative (ER+/ in the G7 markets in 2030.
tide and semaglutide) and other insulin disease-related psychosis, the addition Clarivate. Fitusiran could become the
analogues (Eli Lilly and Co.’s insulin of that indication adds further strong fi rst antithrombin-lowering therapy
efsitora alfa). commercial potential. Cobenfy shows based on a double-stranded RNA
strong commercial potential if proven molecule, pending approval. Clarivate
Novo Nordisk’s CagriSema (cagril- effective in treating Alzheimer’s disease- projects sales of $1.00-bn in the G7
intide and semaglutide) related hallucinations and delusions. markets in 2030. Missed a copy !!!
Novo Nordisk’s CagriSema (cagril- Forecast sales of $1.60-bn is estimated For Digital Edition of this month’s issue & all other past issues
intide and semaglutide), a combination for 2030. GSK’s Neisseria meningitidis
therapy for treating Type-2 diabetes and (A, B, C, W, and Y) vaccine Visit www.hpicindia.com
obesity, is also projected for blockbuster Eli Lilly and Company’s and Amirall’s candidate, GSK-3536819 PDF copies available for download
status by 2030. It contains the same Ebglyss (lebrikizumab) GSK’s Neisseria meningitidis (A, Register Now
active ingredient, semaglutide, found Lilly’s and Amirall’s Ebglyss B, C, W, and Y) vaccine candidate,
in Novo’s Type-2 diabetes and obesity (lebrikizumab) is the third biologic GSK-3536819 is a fi ve-in-one, fi rst- Contact: For Subscription : Mrs. Usha S. - usha@hpicindia.com
treatments, Ozempic and Wegovy, with for treating atopic dermatitis (eczema) generation formulation that targets For Advertising : Mr. Vijay Raghavan - vijay@hpicindia.com
Mrs. Usha S. - usha@hpicindia.com
186 Chemical Weekly March 11, 2025 Chemical Weekly March 11, 2025 187
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