Cstone Pharmaceuticals · HKEX:2616
Cstone Pharmaceuticals — FY2025 Earnings Presentation
43 slides from Cstone Pharmaceuticals's earnings presentation, Mar 27, 2026
Slide 1: FY2025 Annual Results Presentation
FY2025 Annual Results Presentation Advancing Pipeline 2.0 & Accelerating Global Commercialization March 27, 2026 Stock Code: 2616. HK
Slide 2: Presentation Disclaimer
Presentation Disclaimer • By attending the meeting where this presentation is made, or by reading the presentation materials, you agree to be bound by the following: • The information in this presentation has been prepared by representatives of CStone Pharmaceuticals (the "Company" and, together wit
Slide 3: An Innovative Biopharma Driven by Globally Recognized R&D Capability
An Innovative Biopharma Driven by Globally Recognized R&D Capability Proven track record for high-quality and efficient drug development worldwide Stock Code: 2616. HK Established in late 2015, CStone is an innovation-driven biopharmaceutical company focused on the research and development of therap
Slide 4: Maximizing commercial value of in-market products and advancing Pipeline 2.0
To drive business growth by maximizing commercial value of in-market products and advancing innovative Pipeline 2.0 Key Clinical Programs Innovative Early Programs Commercial-stage Programs in Pipeline 2.0 in Pipeline 2.0 CS5007 CS5006 CS5008 Sugemalimab CS2009 (EGFR/HER3 (ITGB4 ADC) (SSTR2/DLL3 (PD
Slide 5: Progress of Pipeline 2.0
Progress of Pipeline 2.0 Preclinical Asset Right Indication Discovery IND-Enabling FIH POC Development CS2009 (PD-1/VEGF/CTLA-4 trispecific antibody) Solid tumors Solid tumors; CS50011 (ROR1 ADC) hematologic malignancies CS5007 (EGFR/HER3 bispecific ADC) Solid tumors CS5006 (ITGB4 ADC) Solid tumors
Slide 6: Business Highlights
01 Business Highlights 2026YTD >
Slide 7: 2025 Marks a Critical Inflection Point in Advancing Pipeline 2.0 and Transforming Commercialization
2025 Marks a Critical Inflection Point in Advancing Pipeline 2.0 and Transforming Commercialization R&D Advancements Expanding Global Commercialization • CS2009 reported Phase I data at 2025 ESMO (first-time CEJEMLY®/sugemalimab (anti-PD-L1) for a PD-1/VEGF/CTLA-4 tsAb globally) and advanced • Two m
Slide 8: Clinical Stage Core Assets: CS2009
02 Clinical Stage Core Assets 1. CS2009, PD-1/VEGF/CTLA-4 trispecific antibody >
Slide 9: CS2009: Potential FIC/BIC Next-Generation I/O Backbone
CS2009: Potential FIC/BIC Next-Generation I/O Backbone Key Differentiation First-in-class/Best-in-class Potential: Potential next-generation I/O backbone that simultaneously targets PD-1/VEGF/CTLA-4 Better Efficacy with Durable OS Expected: Multidimensional synergistic antitumor activities within th
Slide 10: Innovative MOA of CS2009
Innovative MOA: Multi-target engagement and synergistic interactions among anti-PD-1, CTLA- 4, and VEGFA arms enhance CS2009’s activities in TME, while sparing peripheral CTLA4-single- positive T cells, potentially leading to significant improvement of its therapeutic window Tumor Microenvironment (
Slide 11: Potent Synergistic Activities Among Three Arms
Potent Synergistic Activities Among Three Arms: CS2009 clustering with VEGFA dimers (highly upregulated in TME) enhances its binding to PD-1 and CTLA-4 Concurrent binding to Binding to PD-1 Binding to CTLA-4 PD-1 & CTLA-4 CS2009 KD 1.606E-08 1.837E-08 1.060E-09 CS2009 + VEGFA KD 1.234E-09 7.026E-10
Slide 12: First Data Disclosure at 2025 ESMO
First Data Disclosure at 2025 ESMO: CS2009 Demonstrated Favorable Safety and Preliminary Antitumor Activity in Heavily Pre-Treated Solid Tumor Patients in Phase I Trial ⚫ Well tolerated with manageable safety profile • Dose escalation across 1-45 mg/kg completed without DLTs 2025 ESMO • Low incidenc
Slide 13: CS2009: Accelerating Phase II to Support Global Phase III
CS2009: Accelerating Phase II Clinical Trial to Support Global Phase III Initiation by End of 2026 Sept. 2025 Oct. 2025 Feb. 2026 Q2/Q4 2026 First patient China IND approved US IND approved Data Disclosure Planned dosed in Phase II for Phase II Combo for Phase II at ASCO and/or ESMO Phase II Clinica
Slide 14: CS2009 Clinical Development Plan
CS2009 Clinical Development Plan: Efficient and Clearly Defined Global Development Path Forward Phase I – Mono Dose Escalation (Completed) + Backfilling Phase II – Dose Expansion Prioritized Phase III MRCT Trials Lung DL6, 45 mg/kg, Q3W 1L metastatic NSQ-NSCLC, AGA(-), 1L NSQ-NSCLC, AGA(-), plus PEM
Slide 15: CS2009 Safety: Up-to-Date Phase I Data
CS2009 Safety: Up-to-Date Phase I Data Demonstrate Compelling Safety Profile Without excessive toxicities that typically occurred in CTLA-4- and PD-(L)1-containing combination therapies; low ≥G3 VEGF-related AEs As of mid-March 2026, 113 patients with advanced solid tumors enrolled in Phase I Median
Slide 16: CS2009 Efficacy (1/5): First-Line NSCLC Monotherapy
CS2009 Efficacy (1/5): Up-to-Date Phase I/II Data Demonstrates Potent Antitumor Activity in First-Line NSCLC (PD-L1 TPS ≥50%) as Monotherapy Monotherapy at 20/30 mg/kg, Q3W Best Change in Sum of Diameter from Baseline, % ORR 90.0% (9/10) | DCR 100.0% (10/10) NSCLC: non-small cell lung cancer; NSQ: n
Slide 17: CS2009 Efficacy (2/5): vs. Bispecific Antibodies in 1L NSCLC
CS2009 Efficacy (2/5): Monotherapy Activity in First-Line NSCLC (PD-L1 TPS ≥50%) vs. Bispecific Antibodies CS20091 Ivonescima/AK1122 BNT327/PM80023 SSGJ-7074 RC1485 AK104+anlotinib6 (PD-1/VEGF/CTLA-4) (PD-1/VEGF) (PD-L1/VEGF) (PD-1/VEGF) (PD-1/VEGF) (PD-1/CTLA-4+TKI) Phase 3 Stage of data cited Phas
Slide 18: CS2009 Efficacy (3/5): Heavily-Pretreated NSCLC
CS2009 Efficacy (3/5): Up-to-Date Phase I/II Data Demonstrates Potent Antitumor Activity in Heavily-Pretreated NSCLC as Monotherapy ≥2L NSCLC, AGA(-); monotherapy at 30 mg/kg, Q3W ORR 25.0% (6/24) | DCR 58.3% (14/24) Best Change in Sum of Diameter from Baseline, % ≥2L: second-/later-line; NSCLC: non
Slide 19: CS2009 Efficacy (4/5): vs. Bispecific Antibodies in Pretreated NSCLC
CS2009 Efficacy (4/5): Monotherapy Activity in Heavily-Pretreated NSCLC vs. Bispecific Antibodies CS20091 AK104+AK1092 AK104+anlotinib3 AK1044 AK1045 AK1126 BNT327/PM80027 (PD-1/VEGF/CTLA-4) (PD-1/CTLA-4+VEGF) (PD-1/CTLA-4+TKI) (PD-1/CTLA-4) (PD-1/CTLA-4) (PD-1/VEGF) (PD-L1/VEGF) Phase 1/2 Phase 1 P
Slide 20: CS2009 Efficacy (5/5): Later-Line Cold Tumors
CS2009 Efficacy (5/5): Demonstrated Potent Antitumor Activity in Later- Line “Cold” Tumors that are Not Sensitive to PD-(L)1 mAb Non-clear-cell Renal Cell Carcinoma (RCC) (n=5) Soft Tissue Sarcoma (STS) (n=9) Monotherapy at 20/30/45 mg/kg, Q3W Monotherapy at 1/3/10/20/45 mg/kg, Q3W ORR 40.0% | DCR 1
Slide 21: CS2009 Key Takeaway
CS2009 Key Takeaway ◼ Based on current clinical data, we expect transformative efficacy for CS2009 across broad tumor types ◼ Updated Phase I and II data to be presented at 2026 ASCO Phase I Update Phase II Update ◼ 113 patients with advanced solid tumors enrolled 85 patients enrolled in 9 cohorts c
Slide 22: Clinical Stage Core Assets: CS5001 (ROR1 ADC)
02 Clinical Stage Core Assets 2. CS5001 (ROR1 ADC) >
Slide 23: CS5001, a ROR1-ADC with Innovative Design
CS5001, a ROR1-ADC with Innovative Design for Better Efficacy & Tolerability No. 2 position globally with Phase Ib study actively ongoing in Australia and China Four Key Differentiators Support Best-in-class Potential Novel Prodrug and Linker Technology Minimizes Systemic Toxicity Of Conventional PB
Slide 24: CS5001 Phase Ib Update in 1L and 2L DLBCL
CS5001 Phase Ib Update: Potent and Competitive Antitumor Activity Demonstrated in 1L and 2L DLBCL Assets Combination Therapy Monotherapy • + R-CHOP for first-line DLBCL: No DLT; ORR 100% and CR rate >90% across 50-90 μg/kg • Antitumor activity observed in indolent Hematologic (FL, MZL) and aggressiv
Slide 25: CS5001 in Combination with R-CHOP in 1L DLBCL
CS5001 in Combination with R-CHOP Demonstrated Broad and Deep Antitumor Activity (ORR: 100%, CR: 95.5%) in 1L DLBCL CS5001 CS5001 CS5001 All Dose Levels 50 μg/kg 70 μg/kg 90 μg/kg (N=22) (n=11) (n=8) (n=3) ORR*, n (%) 22 (100%) 11 (100%) 8 (100%) 3 (100%) CR*, n (%) 21 (95.5%) 10 (90.9%) 8 (100%) 3
Slide 26: Commercial Products
03 Commercial Products 1. CEJEMLY® (sugemalimab), anti-PD-L1 antibody 2. GAVRETO® (pralsetinib), RET inhibitor 3. AYVAKIT® (avapritinib), KIT/PDGFRA inhibitor >
Slide 27: Reignite and Accelerate Growth of In-Market Products
Reignite and Accelerate Growth of In-Market Products Assets 2025 Milestones Expected Impact Indication approval in EU/UK for Revenue growth driven by out- CEJEMLY® ◼ ◼ Stage III & IV NSCLC licensing milestones and ex- (sugemalimab) ◼ New commercial partnerships China sales income ◼ First-time NRDL i
Slide 28: CEJEMLY: Expanded Global Indication and Market
CEJEMLY® (sugemalimab): Expanded Global Indication and Market, and Increased Brand Visibility Jul. 2024: EU Approval Nov. 2025: Feb. 2026: China NMPA Approvals Nov. 2024: U.K. Approval EU Approval U.K. Approval One of only two anti-PD-(L)1 therapies approved in both the EU & U.K. for Stage III NSCLC
Slide 29: CEJEMLY: Global Commercialization Driven by Strategic Partnerships
CEJEMLY® (sugemalimab): Global Commercialization Driven by Strategic Partnerships CEJEMLY® international footprint now extends to over 60* countries and regions worldwide July 2025 Jan. 2025 * Commercial partnerships with Ewopharma in Switzerland and 18 Central Eastern European countries ; with Phar
Slide 30: Pralsetinib: Rapid Commercial Ramp-Up Following NRDL Inclusion
Pralsetinib: Rapid Commercial Ramp-Up Following NRDL Inclusion Following its inclusion in the NRDL effective Jan. 1, 2026, Based on the localized supply implementation since Feb. 2025, pralsetinib's in-market sales volume increased nearly fourfold. Pralsetinib Ava has demonstrated steady sales growt
Slide 31: Early Assets & Platform
04 Early Assets & Platform 1. Preclinical/IND-Enabling Programs 2. Proprietary ADC Platform >
Slide 32: Pipeline 2.0 Preclinical Assets
Pipeline 2.0 Preclinical Assets: Highly Differentiated ADCs and Mono-/ Multi-Specific Antibodies Discovery Preclinical Development IND-Enabling ADCs (Oncology) CS5006 (ITGB4 ADC) Solid tumors CS5007 (EGFR/HER3 bispecific ADC) Solid tumors CS5008 (SSTR2/DLL3 bispecific ADC) Solid tumors CS5009 (B7H3/
Slide 33: CStone Proprietary ADC Technology Platform and Pipeline
CStone Proprietary ADC Technology Platform and Pipeline CStone is actively advancing next-generation linker This in-house proprietary ADC technology platform technology to improve systematic stability and tumor optimizes ADC safety/efficacy profiles, broadens selectivity of ADCs. Our proprietary tan
Slide 34: First Wave of ADC Pipeline: Highlights & Near-term Milestones
First Wave of ADC Pipeline: Highlights & Near-term Milestones CS5006 CS5007 CS5008 ITGB4 ADC EGFR/HER3 Bispecific ADC SSTR2/DLL3 Bispecific ADC Positioning: FIC ADC against novel Positioning: Potential BIC candidate Positioning: Novel candidate utilizing pan-tumor target integrin β4 (ITGB4). for pre
Slide 35: Financial Highlights
05 Financial Highlights >
Slide 36: 2025 Financial Results
2025 Financial Results Robust cash position to support the rapid development of key pipeline assets and commercial strategies execution Mn RMB FY 2025 FY 2024 Change GROUP REVENUES 269.6 407.2 -34% Total Group Revenue of RMB 269.6 mn Sales of Pharmaceutical Products 78.3 175.1 -55% • Pralsetinib sal
Slide 37: Near-term Catalysts and Outlook
06 Near-term Catalysts and Outlook >
Slide 38: 2026 Outlook: Expected Near-Term Catalysts
2026 Outlook: Expected Near-Term Catalysts Assets Catalyst H1 2026 H2 2026 ◼ Present key clinical data at major global conference CS2009 ◼ Initiate Phase III registrational MRCT (PD-1/VEGF/CTLA-4 tsAb) ◼ Pursue strategic global partnership Present key clinical data at major global conference CS5001
Slide 39: Maximizing commercial value of in-market products and advancing Pipeline 2.0
To drive business growth by maximizing commercial value of in-market products and advancing innovative Pipeline 2.0 Key Clinical Programs Innovative Early Programs Commercial-stage Programs in Pipeline 2.0 in Pipeline 2.0 CS5007 CS5006 CS5008 Sugemalimab CS2009 (EGFR/HER3 (ITGB4 ADC) (SSTR2/DLL3 (PD
Slide 40: Q&A
Q&A >
Slide 41: Appendix
Appendix >
Slide 42: Well-balanced portfolio of innovative assets (1/2)
Well-balanced portfolio of 16 innovative assets (1/2) – Commercial/Late-stage Programs Approval Asset Indication POC Pivotal NDA Marketed Partners Partnering Regions CN TW HK US EU UK 1L NSCLC 2L NSCLC Pralsetinib (RET) NSCLC Mainland China TC Multiple tumors PDGFRA exon 18 GIST PDGFRA D842V GIST
Slide 43: Well-balanced portfolio of innovative assets (2/2)
Well-balanced portfolio of 16 innovative assets (2/2) – Pipeline 2.0 Preclinical Asset Right Indication Discovery IND-Enabling FIH POC Development CS2009 (PD-1/VEGF/CTLA-4 trispecific antibody) Solid tumors Solid tumors; CS50011 (ROR1 ADC) hematologic malignancies CS5007 (EGFR/HER3 bispecific ADC) S
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