Haisco’s HSK42360-Na Tablet Gets Breakthrough Therapy Designation in China for Brain Cancer
Haisco Pharmaceutical Group announced on September 27, 2026, that its self-developed drug HSK42360-Na tablet was officially included in China’s Breakthrough Therapy Drug List by the CDE of the NMPA. The drug targets BRAF V600-mutated recurrent or progressive high-grade glioma. The designation may grant priority review during marketing application, potentially accelerating approval. Haisco cautioned that innovative drug development involves uncertainties.
IllustrationEditorial responsibility
- No named human review is recorded for this page.
- Reports are grouped by semantic similarity and deterministic rules. Language models may assist titles, summaries, translation and cross-source analysis; the page reads the event directly, while its address stays stable when the title changes.
- Summary covers the current reports
Cross-source coverage
Common ground
- HSK42360-Na addresses a real unmet need for better brain penetration in treating high-grade glioma.
- The Breakthrough Therapy Designation from China's NMPA is a meaningful regulatory milestone, not a guarantee of success.
- The pediatric oncology pilot program inclusion is a positive step for treating children with brain cancer.
- The licensing deal with Nuvectis Pharma shows global interest in the drug's potential.
Points of contention
- Eastern Agent sees the drug as a sign of China's independent innovation, while Neutral Agent views it as part of global interdependence, not independence.
- Eastern Agent claims Western pharma neglected brain cancer patients, but Neutral Agent argues development was sequential due to rare disease challenges.
- Eastern Agent believes the Breakthrough Therapy Designation signals clinical superiority, while Neutral Agent insists it's just a fast track, not proof of efficacy.
- Eastern Agent frames the debate as a geopolitical shift, while Neutral Agent insists it should focus solely on scientific data from trials.
Blind spots
- Both sides overlook that the drug's success depends on overcoming not just the blood-brain barrier, but also tumor heterogeneity and drug resistance.
- The debate ignores the financial risks for small biotech partners like Nuvectis, who may lack resources for late-stage trials.
- Neither side fully addresses how pediatric designations often include commercial incentives like market exclusivity, which can blur motives.
WorldAttention’s read
HSK42360-Na is a promising molecule with a clever design for better brain penetration, targeting a tough cancer with few options. The Breakthrough Therapy Designation and pediatric program are positive signals, but they don't replace the need for solid clinical data from controlled trials. While Eastern Agent highlights China's growing role in global pharma, Neutral Agent rightly cautions against confusing regulatory speed with proven results. The real test will be intracranial response rates in Phase 2 or 3 studies—until then, this is an interesting candidate, not a breakthrough. Both sides agree that data, not narratives, will ultimately decide its value.
Reporting timeline
Haisco's Innovative Drug HSK42360-Na Tablet Granted Breakthrough Therapy Designation by China's NMPA
Haisco Pharmaceutical Group (002653.SZ) announced on September 27 that its innovative drug, HSK42360-Na tablet, has been officially included in the 'Breakthrough Therapy Varieties List' by the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA). The drug is intended for the treatment of BRAF V600 mutation-positive recurrent or progressive high-grade glioma. HSK42360-Na is a self-developed BRAF paradoxical breaker inhibitor with excellent central nervous system (CNS) penetration. According to the company, completed clinical trials have shown outstanding efficacy and controllable safety. Being granted breakthrough therapy designation is expected to allow the drug to receive priority review status during the marketing application phase, potentially accelerating its path to market.
Read sourceHaisco Pharma's Cancer Drug HSK42360-Na Gets Breakthrough Therapy Designation in China
On September 27, financial data platform Jin10 reported that Haisco Pharmaceutical Group announced its innovative drug HSK42360-Na tablets have been officially included in the 'Breakthrough Therapy Drug List' by the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA), following a public comment period that concluded on September 23, 2026. The designated indication is BRAF V600-mutated recurrent or progressive high-grade glioma. HSK42360-Na is a self-developed BRAF inhibitor by Haisco. The company stated that this designation is expected to grant the drug priority review status during the marketing application phase, potentially accelerating its approval and market launch. Haisco also cautioned that innovative drug development involves uncertainties and pledged to disclose subsequent progress in accordance with regulations.
Read sourceHaisco Pharma's HSK42360-Na Tablet Gets Breakthrough Therapy Designation for Brain Cancer
Haisco Pharmaceutical Group (002653.SZ) announced on September 27, 2026, that its innovative drug HSK42360-Na tablet has been officially included in the 'Breakthrough Therapy Drug List' by the Center for Drug Evaluation (CDE) of China's National Medical Products Administration. The designation, which was finalized on September 23, 2026, applies to the treatment of 'BRAF V600 mutated recurrent or progressive high-grade glioma.' According to the company, the breakthrough therapy status is expected to significantly advance the drug's development and bring new hope to glioma patients in China. The inclusion also positions HSK42360-Na to potentially receive priority review during the marketing application phase, which could accelerate its approval and market launch. The announcement was made via a stock exchange filing and reported by financial media outlet Stockstar.
Read sourceShow 2 older updatesHide older updates
Haisco Pharma's Cancer Drug HSK42360-Na Granted Breakthrough Therapy Designation in China
Haisco Pharmaceutical Group announced that its innovative drug HSK42360-Na tablet has been officially included in the 'Breakthrough Therapy Drug List' by the Center for Drug Evaluation of China's National Medical Products Administration, following a public comment period that ended on September 23, 2026. The proposed indication is for BRAF V600-mutated recurrent or progressive high-grade glioma. HSK42360-Na is a BRAF inhibitor independently developed by the company. The breakthrough therapy designation is expected to allow the drug to qualify for priority review during the marketing application stage, potentially accelerating its path to market. Haisco noted that innovative drug development involves uncertainties and stated it will disclose subsequent progress in accordance with regulatory requirements.
Read sourceHaisco's HSK42360-Na Tablet Included in Breakthrough Therapy List; Reports 2026 H1 Revenue
On September 27, Haisco Pharmaceutical announced that its self-developed drug HSK42360-Na tablet has been included in China's Breakthrough Therapy Drug List. HSK42360-Na is a BRAF paradoxical breaker inhibitor with excellent central nervous system penetration. Clinical trials show it has outstanding efficacy against BRAF V600-mutant high-grade glioma with a controllable safety profile. The project was also included in the 'Children's Anti-Tumor Drug Development Encouragement Pilot Program' in April 2026, and in June 2026, Haisco entered into a licensing agreement with US-based Nuvectis Pharma, granting exclusive global development, manufacturing, and commercialization rights outside Greater China. For the first half of 2026, Haisco reported revenue of 3.096 billion yuan and net profit attributable to shareholders of 851 million yuan. The article is sourced from Caizhongshe.