1114544‑31‑8, Ponatinib Hydrochloride – The Latest Developments | ANQING CHICO PHARMACEUTICAL CO., LTD.

Abstract:
Ponatinib hydrochloride (CAS 1114544‑31‑8) is a third-generation pan–BCR‑ABL tyrosine kinase inhibitor (TKI), effective even in treatment-resistant Philadelphia chromosome‑positive (Ph+) leukemias, including T315I mutants. Approved in December 2012, with subsequent label expansions including March 2024 for frontline Ph+ ALL, it has carved out a niche in rare, resistant hematologic cancers. Global sales are estimated, with approximate annual revenues of $230m (2020), $260m (2021), $300m (2022), $350m (2023), and $300m (2024). Competition from generics and next-gen TKIs, evolving reimbursement landscapes, and expanded indications in combination therapies influence its market dynamics. Key news includes Chinese approval in September 2024, FDA accelerated approval expansion, and multiple biosimilar development and bioequivalence studies.

Keywords:
Ponatinib hydrochloride, 1114544‑31‑8, Iclusig, BCR‑ABL, CML, ALL, T315I mutation, tyrosine kinase inhibitor, global sales, generics, ANHUI CHICO CHEMICAL.

1. Introduction

Ponatinib hydrochloride, marketed as Iclusig®, is designed to inhibit BCR‑ABL fusion kinase, including drug-resistant T315I mutations, also blocking VEGFR2, FGFR1, PDGFRα, and Src kinases .

2. Chemical Properties

• CAS No.: 1114544‑31‑8

• Molecular formula: C29H28ClF3N6O•HCl (Mw_w = 569.03)

• Biochemical potency (IC₅₀): Abl (0.37 nM), PDGFRα (1.1 nM), Src (5.4 nM), VEGFR2 (1.5 nM), FGFR1 (2.2 nM)

• Physical: cream-white to pale-yellow solid; soluble in DMSO (~11 mg/mL), limited solubility in ethanol, stored at –20 °C .

3. Original Research & Manufacturers

• Discovered and developed by ARIAD Pharmaceuticals; approved Dec 14, 2012 (FDA)

• Acquired by Takeda in 2017 for $5.2 billion

• Currently produced/formulated by Takeda and sold globally by its division, often in partnership or manufacturing collaborations (e.g., China).

4. Approval Timeline

• Dec 2012 (U.S.): FDA accelerated approval for resistant/intolerant Ph+ CML and Ph+ ALL

• Jul 2013 (EU): EMA approval .

• Nov 2013: Market withdrawal due to vascular toxicity; returned Dec 20, 2013 with enhanced warnings (REMS program)

• 2016: Full U.S. approval for broader CML/ALL indications

• Mar 19, 2024: FDA approves ponatinib with chemotherapy as first-line therapy for newly diagnosed Ph+ ALL

• Sep 2024: Approved in China via priority review

5. Clinical Data & Market Use

• PACE trial (449 patients, prior TKI-exposed): high response rates—5‑year OS ~73%, PFS ~53%

• Approved for T315I mutation, resistant disease; Phase II/III lymphoma trials ongoing.

6. Global Sales & Market Forecast (Estimates)

• 2020: $230 m

• 2021: $260 m

• 2022: $300 m

• 2023: $350 m

• 2024: $300 m (expected decline due to generics, COVID‑19 impact, label saturation, but offset by 2024 indication expansion)
  These estimates align with overall Ponatinib HCl market size—approx. $300 m USD in 2024, projected to reach $700 m by 2033 (CAGR ~10.2%).

7. Competitive Landscape & Generics

• Competition includes other 3rd-gen TKIs (e.g., asciminib), older TKIs (imatinib, dasatinib, nilotinib), and future alternatives.

• Generics under development: e.g., Apotex ANDA filed (July 14, 2023) .

• Chinese bioequivalence trials by Chengdu Shuode Pharma and Qilu Pharma (2025) .

8. Regulation, Pricing & Reimbursement

• U.S. list price ~$138 k/year .

• Varies globally (e.g., ~£61 k/year UK Cancer Drugs Fund).

• Market access in China supported by priority review & eventual insurance inclusion .

9. Recent News & Developments

• Mar 2024: FDA approves combination use with chemo in frontline Ph+ ALL.

• Sep 2024: China approval for CML and Ph+ ALL resistant or intolerant to prior TKIs.

• Ongoing trials: lymphoma, solid tumor indications, biosimilar pharmacokinetic studies in China .

10. Generics & Biosimilars

• High-income countries: Apotex filed in U.S. (ANDA July 2023).

• China: Multiple Phase I bioequivalence trials in 2025.

References

1. FDA approval package, 2012–2016

2. PACE trial outcomes

3. FDA label expansion Mar 2024

4. Chinese approval Sep 2024

5. Global market data & forecasts

6. Generics pipeline (Apotex, China BE trials)

7. Pricing and reimbursement .

Active Pharmaceutical Ingredient

1114544-31-8,Ponatinib hydrochloride,(chemical grade, purity ≥99.0%) are currently supplied by our company. [Own compliance factory, fully support factory audit] For details, you can call the bottom line to get the latest price of the product!

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