CStone Pharmaceuticals Announces 2024 Annual Results and Recent Business Progress
Financial Performance: Strong Year-over-Year Improvement- Total Revenue: RMB 407.2 million, including RMB 232.1 million in licensing and royalty income.- Net Loss Reduction: 71.5% year-over-year improvement.
Key Product Advancements- Sugemalimab (Anti-PD-L1 mAb)- Regulatory Milestones: - China: Approved for first-line treatment of gastric/gastroesophageal junction adenocarcinoma (GC/GEJC). - EU & UK: Approved for first-line treatment of stage IV non-small cell lung cancer (NSCLC); stage III NSCLC new indication application submitted to EMA.- Global Partnerships: Three strategic partnerships across 40+ countries, to accelerate global commercialization.
- Avapritinib (AYVAKIT®)- Localized Production: Approved for localized manufacturing in China, enhancing cost efficiency.- Commercial Collaboration: Partnered with Hengrui to expand market access in China.
Clinical Pipeline Progress- CS5001 (ROR1 ADC):- Leading Position: Top 2 globally in clinical development for ROR1-targeted ADCs.- Phase I Clinical Data: Demonstrated encouraging monotherapy efficacy in aggressive/indolent lymphomas with a manageable safety profile; positioned for accelerated registration.- Phase Ib Expansion: Evaluating first-line/frontline, monotherapy/combination therapies in lymphomas and solid tumors across the U.S., Australia, and China.
- CS2009 (PD-1/VEGF/CTLA-4 Trispecific Antibody):- First-in-Human Trial: Global Phase I study initiated in Australia; first patient dosed.- Preclinical Differentiation: Superior tumor suppression vs. benchmarked competitors; potential first-in-class/best-in-class IO backbone therapy.
Pipeline 2.0: Fueling Long-Term Innovation- More than 9 Differentiated Candidates: Focus on first-in-class/best-in-class assets, including multispecific antibodies and ADCs, with global rights and broad therapeutic potential.- Proprietary ADC Platform: Enables rapid development of high-value candidates, reinforcing leadership in next-generation oncology.
SUZHOU, China, March 27, 2025 /PRNewswire/ -- CStone Pharmaceuticals ("CStone", HKEX: 2616), a biopharmaceutical company dedicated to developing innovative cancer therapies, today reported 2024 annual results and recent business updates.
Business Highlights
For the year ended December 31, 2024 and up until the date of this results announcement, key milestones have been achieved across regulatory approvals, clinical advancements, and strategic collaborations, reinforcing our position as a leader in innovative therapeutics. A shortlist of our achievements over this period includes:
Commercial Products
• CEJEMLY® (sugemalimab), anti-PD-L1 antibody
– Global expansion and regulatory approvals
Sugemalimab secured three new drug application approvals in 2024, including its fifth indication in mainland China for first-line treatment of gastric/gastroesophageal junction adenocarcinoma (GC/GEJC). Sugemalimab also gained approvals in the EU and UK for first-line treatment of stage IV NSCLC, marking its entry into major international markets. We have recently completed the regulatory submission to the European Medicines Agency (EMA) for the new indication application of sugemalimab in the treatment of Stage III NSCLC.
– Strategic alliances drive global commercialization
Partnered with Ewopharma AG in May 2024 for commercialization in Central and Eastern Europe (CEE) and Switzerland.
Collaborated with Pharmalink Store, L.L.C, O.P.C in November 2024 to expand access across the Middle East, North Africa (MENA) Region and South Africa.
Entered an agreement with SteinCares in January 2025 for Latin America (LATAM).
Additional partnerships in Western Europe, Southeast Asia, and Canada are anticipated in 2025.
– Robust clinical data reinforce efficacy
GEMSTONE-304 Study: Final progression-free survival (PFS) and interim overall survival (OS) data for the first-line esophageal squamous cell carcinoma (ESCC) published in Nature Medicine (February 2024).
GEMSTONE-302 Study: Four-year OS data for stage IV NSCLC presented at the 2024 Congress of European Society for Medical Oncology (ESMO), confirming sustained survival benefits.
GEMSTONE-303 Study: Final PFS and OS analysis for GC/GEJC with combined positive score (CPS) ≥5 published in the top-tier medical journal-Journal of the American Medical Association (JAMA) (February 2025).
ESMO Guideline Recognition: CEJEMLY® recommended as first-line NSCLC therapy in ESMO's 2025 Non-Oncogene-Addicted Metastatic NSCLC Living Guidelines, covering both squamous and non-squamous NSCLC (February 2025).
• AYVAKIT® (avapritinib), KIT/PDGFRA inhibitor
– Localized manufacturing in
