PipelinePharma Logo
PipelinePharma Logo

CTD Dossier Marketplace

Direct connection with CTD dossier (IP) owners and manufacturers

Marketing Authorizations Database

Search across marketing authorization registers
Sign in Get started

Generics

Innovative Products found!

Biosimilars

Medical devices

Nutraceuticals

Filters

Pp-162 manufacturers

Filters

1 products found

pp-162

Tablets

Dossier type
CTD
Dossier status
Ready to file
Country of origin
United States
GMP approvals
FDA
Comments
Indication: ROS1-positive NSCLC (1L and 2L+, including after crizotinib or entrectinib); NTRK-positive solid tumours Clinical stage: FDA approved June 2025 (Ibtrozi); post-approval Phase 3 expansion ongoing Modality: Small molecule Mechanism / Target: Next-generation ROS1/NTRK1/2/3 kinase inhibitor — CNS-penetrant; active against G2032R and other solvent-front mutations causing resistance to crizotinib/lorlatinib Route / form: Oral tablet (once daily) Differentiation: CNS penetration for brain metastases; overcomes resistance to 1G/2G ROS1 inhibitors; covers NTRK fusions; once-daily oral; broader mutation coverage than entrectinib
Manufacturer #39189

Oncology company with an FDA-approved ROS1/NTRK inhibitor and next-generation solid tumour pipeline. Focuses on CNS-penetrant kinase inhibitors for molecularly defined lung and other cancers. Wholly owned US/global development with China territory licensed to Innovent Biologics.
 

Want to see all products?

Subscribe today to benefit from:

  • Streamlined product sourcing - the leading CTD dossiers database focused on finished dosage formulations

  • Direct negotiations - connect and negotiate directly with manufacturers without any brokerage fee

  • Increased profitability - secure the best commercial terms for your business by comparing offers from several manufacturers

Request Subscription

Popular Searches

Amoxicillin manufacturers Atorvastatin manufacturers Benzocaine manufacturers Calcium carbonate manufacturers Cloperastine fendizoate manufacturers Gabapentin manufacturers Hyaluronic acid manufacturers Ibuprofen manufacturers Ivermectin manufacturers Levothyroxine manufacturers Lisinopril manufacturers Losartan manufacturers Magnesium manufacturers Melatonin manufacturers Metformin manufacturers Methotrexate manufacturers Metoprolol manufacturers Omeprazole manufacturers Paracetamol manufacturers Prednisone manufacturers Pregabalin manufacturers Semaglutide manufacturers Testosterone enanthate manufacturers Vitamin B12 manufacturers

Willing to unlock more features?

Please fill out form and send us your specific requirements, and we will get back to you as soon as possible

Want unlimited access to the Pipelinepharma database?

Become a subscriber to unlock:

  • Streamlined product sourcing: access the only CTD dossier pipeline and sourcing platform.

  • Direct connections: communicate directly with CTD dossier owners and manufacturers with no brokerage fees.

  • Higher profitability: compare multiple supplier offers and secure the best commercial terms.

  • Expanded network: view supplier portfolios and stay updated on new products.

  • Value-added product ideas: discover products with lower competition potential.

  • Access to marketing authorizations for sale: find already registered products in your target markets.