Haisco’s HSK42360-Na Granted NMPA Breakthrough Therapy Designation – BRAF Paradoxical Breaker Targets High‑Grade Glioma with BRAF V600 Mutation

Haisco Pharmaceutical (SHE: 002653) announced that HSK42360-Na, its self‑developed BRAF paradoxical breaker inhibitor, has been granted Breakthrough Therapy Designation by China’s National Medical Products Administration (NMPA) for the treatment of recurrent or progressive high‑grade glioma harboring the BRAF V600 mutation.

Regulatory Milestone

Drug Profile & Mechanism of Action

• Molecule: HSK42360-Na, a self‑developed BRAF paradoxical breaker inhibitor (small molecule).
• Selective Targeting: Selectively inhibits active BRAF V600 monomers to block MAPK pathway signaling – the core proliferative driver in BRAF V600‑mutant tumors.
• Paradoxical Breaker Design: Unlike conventional RAF inhibitors, HSK42360-Na does not induce RAF homo‑ or heterodimerization or paradoxical activation of the MAPK pathway, a class‑limiting liability associated with earlier BRAF inhibitors.
• Therapeutic Benefit: The design provides durable inhibition and killing of BRAF V600‑mutant tumors, supporting sustained pathway suppression.

Disease Background – BRAF V600‑Mutant High‑Grade Glioma

• Condition: High‑grade gliomas are aggressive primary brain tumors with poor prognosis; a subset harbors the BRAF V600 mutation, which constitutively activates MAPK signaling and is associated with treatment resistance and recurrence.
• Unmet Need: Patients with recurrent or progressive disease have limited effective options, and the blood‑brain and tumor‑microenvironment challenges of CNS oncology make durable pathway inhibition particularly valuable.
• Precision‑Medicine Rationale: Biomarker‑selected targeting of BRAF V600 aligns with the growing role of molecular subtyping in neuro‑oncology treatment decisions.

Licensing & Global Strategy

• Out‑Licensing Deal: In June 2026, Haisco entered into a licensing agreement with US‑based Nuvectis Pharma, granting Nuvectis the exclusive rights to develop, manufacture, and commercialize HSK42360-Na globally outside of Greater China (financial terms not disclosed in this announcement).
• Territory Split: Haisco retains development and commercialization rights in Greater China, while Nuvectis leads the rest‑of‑world strategy – pairing NMPA expedited development with a US partner’s global registrational capability.

Market Impact & Outlook

• Expedited Pathway: Breakthrough Therapy Designation signals preliminary clinical evidence of substantial improvement over available therapies and unlocks NMPA priority interactions and expedited review, potentially accelerating HSK42360-Na’s path to patients in China.
• Differentiated Mechanism: As a paradoxical breaker, HSK42360-Na addresses a known mechanistic weakness of first‑generation BRAF inhibitors, positioning it competitively in the evolving BRAF‑targeted therapy landscape.
• Portfolio Catalyst: For Haisco Pharmaceutical (SHE: 002653), the designation reinforces the value of its self‑developed innovative‑drug pipeline following the Nuvectis out‑licensing transaction.
• Execution Watch Items: Clinical progression in BRAF V600‑mutant high‑grade glioma under breakthrough designation, Nuvectis’s global development plans outside Greater China, and potential expansion into other BRAF V600‑mutant solid tumors (not disclosed).

Forward‑Looking Statements
This brief contains forward‑looking statements regarding the clinical development, regulatory review, and commercialization of HSK42360-Na in China and global markets under the licensing agreement with Nuvectis Pharma. Breakthrough Therapy Designation does not guarantee approval. Actual results may differ materially due to risks including clinical setbacks, regulatory requirements, partnership execution, and competitive dynamics.-Fineline Info & Tech