By Fineline Cube 
The Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) announced today that Novartis’ (NYSE: NVS) Asciminib (ABL001) hydrochloride tablets/microcapsules have been proposed for inclusion in the “Pilot Program to Encourage the Research and Development of Anti‑tumor Drugs for Children (SPARK Program)”. The drug is intended for the treatment of Philadelphia chromosome‑positive chronic myeloid leukemia in the chronic phase (Ph⁺ CML‑CP) in pediatric patients.
Key Highlights
- Program Inclusion – Asciminib will be the first targeted therapy in the SPARK program to address a rare pediatric leukemia indication.
- Regulatory Status – The drug was approved for marketing by the NMPA in May 2025 and is now positioned for accelerated pediatric development.
- Strategic Fit – The SPARK program provides streamlined review, financial incentives, and expanded market access for innovative anti‑tumor agents in children.
Mechanism of Action
Asciminib is a novel allosteric inhibitor targeting the BCR‑ABL1 kinase:
- Binding Site – Binds to the myristoyl pocket (STAMP)—an allosteric site distinct from conventional tyrosine‑kinase inhibitors (TKIs).
- Conformational Change – Induces a structural shift that blocks kinase activity without competing with ATP.
- Clinical Advantage – Offers an alternative to standard TKIs, potentially reducing resistance and toxicity in pediatric patients.
Impact on Pediatric Oncology
- First of Its Kind – Provides a precision‑medicine option specifically engineered for children with Ph⁺ CML‑CP.
- Accelerated Development – Leveraging SPARK’s incentives may shorten the time to market and enhance clinical trial recruitment.
- Broader Reach – Aligns with China’s national priority to expand access to life‑saving treatments for children.
Forward‑Looking Statements
This release contains forward‑looking statements that involve risks and uncertainties. Actual results may differ materially.-Fineline Info & Tech