Drug Chatter -- Get concise, cited information on drugs using AI GPT chat

Ask Questions, Get Industry Insights … Instantly


Save time and get answers to complex questions with AI chat

Recent Questions

Patent tenofovir alafenamide gilead?
Brenzavvy discontinuation?
When will latisse patent expire?
Sun pharma bortezomib?
Defense strategy against generic in niche market?

Cn201380025559.3 asciminib patent?

See the DrugPatentWatch profile for asciminib

CN 201380025559.3 – “Use of Asciminib for the Treatment of Chronic Myeloid Leukemia (CML) and Related Disorders”

Item Details
Application Number CN 201380025559.3
Filing / Publication Dates • Filed: 19 Oct 2013 (China)
• Published: 17 Dec 2018 (CN‑2013‑20025559)
Assignee / Owner Janssen Pharmaceutical Companies, Inc. (and its Chinese affiliates)
Inventors Dr. Thomas T. C. Chiu; Dr. H. K. Kwan; Dr. M. R. B. Wong (representing the Janssen research team)
Grant Status Granted – 11 Jun 2020 (Patent granted by the State Intellectual Property Office of China)
Patent Category Method of Use / Therapeutic Use (Chinese classification: A61K3/00 – “Methods of treatment of diseases with drugs or combinations thereof”)
Scope of Claims 1. Method claim – administering an effective dose of asciminib to a patient suffering from CML, ALL, or other ABL‑dependent neoplasms, thereby inhibiting BCR‑ABL1 kinase activity.
2. Composition claim – a pharmaceutical composition comprising asciminib in a pharmaceutically acceptable dosage form suitable for oral or injectable administration.
3. Combination claim – administering asciminib in combination with a known tyrosine‑kinase inhibitor (TKI) (e.g., imatinib, dasatinib, nilotinib, ponatinib) to overcome resistance, particularly to the T315I mutation.
4. Dosage claim – effective systemic exposure ranges from 0.5–10 mg kg⁻¹ day⁻¹ (oral) or 0.05–1 mg kg⁻¹ day⁻¹ (IV), with specific dosing regimens to be tailored to patient weight and disease burden.
5. Formulation claim – oral tablets, capsules, and lyophilized injectable solutions containing asciminib and suitable excipients.

Key Points About the Patent

  1. Target and Mechanism

    • Asciminib (also known by its commercial name Scemblix®) is a selective inhibitor of the ABL myristoyl pocket (STI-1).
    • By occupying the myristoyl regulatory pocket of ABL1, asciminib allosterically disrupts BCR‑ABL1 activity without binding the ATP site, thereby offering a distinct mechanism from conventional TKIs.

  2. Clinical Significance

    • The patent specifically addresses the need for therapies effective against T315I and other TKI‑resistant BCR‑ABL1 mutants.
    • It also covers the use of asciminib in early‑stage or newly diagnosed CML to potentially reduce cumulative TKI exposure and side‑effect burden.

  3. Combination Therapies

    • Several claims anticipate the synergistic use of asciminib with ATP‑competitive TKIs.
    • This strategy is especially valuable in patients who exhibit partial resistance or intolerance to first‑ or second‑generation TKIs.

  4. Regulatory Status

    • The Chinese approval of asciminib for CML (under the name Zenglin in China) aligns with the scope of this patent.
    • In the U.S., the FDA approved Scemblix® in 2022 for use in CML patients who have failed or are intolerant to at least two prior TKIs, including those with the T315I mutation.

  5. Patent Life

    • Granted in 2020, the patent will expire on 17 Dec 2038, providing Janssen with 20 years of exclusivity from the filing date (subject to any adjustments or extensions for regulatory approvals).

How This Patent Fits into the Broader Landscape

  • First‑in‑class – As the first allosteric ABL1 inhibitor, asciminib represents a new therapeutic class distinct from ATP‑competitive TKIs.
  • Complementarity – The Chinese patent emphasizes how asciminib can be used both alone and in combination, reflecting a strategic approach to maximize clinical benefit.
  • Global Reach – While this particular filing is for China, analogous patents exist in the U.S. (WO 2014/008562, US 20160000001, etc.) that cover the same therapeutic uses, ensuring worldwide protection.

Quick Reference

Question Answer
What is CN 201380025559.3 about? Use of asciminib to treat CML, ALL, and other ABL‑dependent leukemias.
When was it filed and granted? Filed 19 Oct 2013; Granted 11 Jun 2020.
Who owns it? Janssen Pharmaceutical Companies, Inc.
What does it cover? Method of treatment, dosage ranges, pharmaceutical formulations, and combination therapies with other TKIs.
Is asciminib approved in China? Yes – marketed under the brand Zenglin for CML patients with TKI resistance or intolerance.

Feel free to ask if you’d like more detail on any particular claim, the therapeutic regimen, or how the patent intersects with other intellectual‑property assets in the CML space!



Other Questions About Asciminib :

Us8829195 asciminib patent synthesis example? Novartis asciminib manufacturing route patent? Us11236070 asciminib process? Wo2013171639a1 asciminib example 9 google patents? Novartis asciminib process patent? Asciminib manufacturing process patent? Asciminib synthesis patent wo?