Cstone Pharmaceuticals · HKEX:2616
Cstone Pharmaceuticals — H1 2026 Earnings Presentation
61 slides from Cstone Pharmaceuticals's earnings presentation, Aug 28, 2026
Slide 1: CStone 2026 Interim Results
CStone 2026 Interim Results Advancing Pipeline 2.0 & Global Commercialization August 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 CS2009 CS5008 CS5009 CS5006 (B7H3/PD-L1 Sugemalimab (PD-1/VEGF/CTLA-4 trispeci
Slide 5: Progress of Pipeline 2.0
Progress of Pipeline 2.0 Preclinical Right Indication Discovery IND-Enabling FIH POC Development Antibodies (Oncology) CS2009 (PD-1/VEGF/CTLA-4 trispecific antibody) Solid tumors CS1012 (GDF-15 antibody) Solid tumors ADCs (Oncology) Solid tumors; CS50011 (ROR1 ADC) hematologic malignancies CS5007 (E
Slide 6: Business Highlights
01 Business Highlights 2026 Interim >
Slide 7: Sustained Momentum in Pipeline 2.0 and Commercialization
Sustained Momentum in Pipeline 2.0 and Commercialization R&D Advancements Expanding Global Commercialization • CS2009 (PD-1/VEGF/CTLA-4 tsAb) Phase I/II data CEJEMLY®/sugemalimab (anti-PD-L1) presented at ASCO 2026; two rapid oral • Fifth international commercialization partnership presentations at
Slide 8: Clinical Stage Assets
02 Clinical Stage Assets 1. CS2009 (PD-1/VEGF/CTLA-4 trispecific antibody) 2. CS5007 (EGFR/HER3 ADC) 3. CS5001 (ROR1 ADC) >
Slide 9: Innovative MOA: Enhancing Survival Benefit while Minimizing Toxicity via Triple Synergy
Innovative MOA: Enhancing Survival Benefit while Minimizing Toxicity via Triple Synergy Potential First-in-Class / Best-in-Class Next-Generation Immuno-Oncology (I/O) Backbone Triple synergy (PD-1/VEGF/CTLA-4) Anti-angiogenesis & Vascular Normalization • Simultaneously targets three pathways to rest
Slide 10: Innovative MOA: Multi-target engagement enhances CS2009 activities in TME
Innovative MOA: Multi-target engagement and synergistic interactions enhance CS2009’s activities in TME while sparing peripheral CTLA4+ T cells to widen its therapeutic window Tumor Microenvironment (TME) Peripheral Within the TME, CS2009 preferentially binds In the peripheral, CS2009’s monovalent C
Slide 11: Triple Synergy in the Tumor Microenvironment leads to enhanced anti-tumor activities
Triple Synergy in the Tumor Microenvironment leads to enhanced anti-tumor activities 3a Anti-VEGFA Actions ➢ Cut off blood supply • Blocks pathological angiogenesis • Prunes immature & leaky tumor vessels • Restricts tumor nutrient supply & growth 2 Anti-PD-1 Action in TME ➢ Revive exhausted T-cells
Slide 12: CS2009: Vision for the Next-Gen I/O Backbone
CS2009: Vision for the Next-Gen I/O Backbone Replacing & Expanding beyond Current PD-1/L1 Standard of Care (SOC) PD-1/L1 Fully Established SOC PD-1/L1 Partially Established SOC PD-1/L1 Ineligible (IO-based Regimens) (CPS-Dependent) (I/O Not Yet Approved as SOC) 1L metastatic NSCLC: 1L TNBC: Pembroli
Slide 13: Trispecific mAb holds great clinical and commercial value
PD-1/VEGF/CTLA-4 trispecific mAb holds great clinical and commercial value with potentially durable OS benefit Greater potential than PD-1/VEGF bsAbs to become the next-generation I/O backbone to replace anti-PD-(L)1 antibodies in current SOC Approved indications for 3 targets Broad indications with
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: Three Important Key Clinical Validations Achieved from over 300 Patient Data
Three Important Key Clinical Validations Achieved from over 300 Patient Data Phase I/II key updates Aug. 2026 ➢ Proof of Safety • Grade ≥3 irAEs 12.7%; CTLA-4-related tox markedly reduced from CTLA-4 mAb monotherapy or in combination with PD-1/L1, including extremely rare colitis, due to preserved C
Slide 16: Three Important Key Clinical Validations Achieved from over 300 Patient Data
Three Important Key Clinical Validations Achieved from over 300 Patient Data Phase I/II key updates Aug. 2026 ➢ Proof of Safety • Grade ≥3 irAEs 12.7%; CTLA-4-related tox markedly reduced from CTLA-4 mAb monotherapy or in combination with PD-1/L1, including extremely rare colitis, due to preserved C
Slide 17: Phase I Safety: Phase I Data Demonstrate Compelling Safety Profile
Phase I Safety: Phase I Data Demonstrate Compelling Safety Profile • Dose escalation completed; no DLT; MTD not reached • Without excessive toxicities that typically occurred in CTLA-4- and PD-(L)1-containing combination therapies; low ≥G3 VEGF-related AEs • Up to date, no new safety signals identif
Slide 18: Safety Comparison: Lower incidence of frequent any-grade irAE
Safety Comparison: Much lower incidence of frequent any-grade irAE vs. PD-(L)1/CTLA-4 bispecific or combination regimens CS2009 PD-(L)-1/CTLA-4 Bispecific CTLA-4 mAb PD-(L)1 mAb + CTLA-4 mAb Rash Diarrhea Pruritus Hypothyroidism Hyperthyroidism ALT increased AST increased 50% 46.60% 37.90% 36.40% 34
Slide 19: Safety Comparison: Lower any-grade or Grade ≥3 TRAE related to anti-VEGF
Safety Comparison: Markedly lower incidence of any-grade or Grade ≥3 TRAE possibly related to anti-VEGF vs. PD-(L)1/VEGF bispecifics Any-grade TRAE possibly related to anti-VEGF Grade ≥3 TRAE possibly related to anti-VEGF Hypertension Proteinuria Haemorrhage Thromboembolism Hypertension Proteinuria
Slide 20: VEGFA Internalization Assay
VEGFA Internalization Assay: CS2009 mediates VEGFA internalization by T cells via dual PD-1 and CTLA-4 pathways CS2009 Mediates Robust VEGFA Internalization by Jurkat T Cells Expressing PD-1 and CTLA-4 CS2009 (orange bar) vs. control (black bar) 20 CS2009 Mediates VEGFA Internalization via Dual PD-
Slide 21: Three Important Key Clinical Validations Achieved from over 300 Patient Data
Three Important Key Clinical Validations Achieved from over 300 Patient Data Phase I/II key updates Aug. 2026 ➢ Proof of Safety • Grade ≥3 irAEs 12.7%; CTLA-4-related tox markedly reduced from CTLA-4 mAb monotherapy or in combination with PD-1/L1, including extremely rare colitis, due to preserved C
Slide 22: Robust T cell activation (Ki67 and ICOS up-regulation)
ICOS upregulation Efficacy in “cold tumors” Efficacy in IO-pretreated NSCLC Robust T cell activation (Ki67 and ICOS up-regulation with plateau at doses ≥10 mg/kg) Ki67 expression on CD4+ T cells Ki67 expression on CD8+ T cells • T-cell proliferation & activation: On Cycle 1 Day 8, CS2009 induced not
Slide 23: CS2009 monotherapy efficacy in later-line metastatic CRC
ICOS upregulation Efficacy in “cold tumors” Efficacy in IO-pretreated NSCLC (1/3) CS2009 monotherapy demonstrated promising clinical efficacy in later-line metastatic CRC, mostly pMMR/MSS — a “cold tumor” not sensitive to PD-(L)1 mAb Monotherapy at 30 mg/kg, Q3W Aug-2026 Cutoff 2026-ASCO Cutoff Eval
Slide 24: CS2009 monotherapy efficacy in later-line soft tissue sarcoma
ICOS upregulation Efficacy in “cold tumors” Efficacy in IO-pretreated NSCLC (2/3) CS2009 monotherapy demonstrated promising clinical efficacy in later-line soft tissue sarcoma (STS) — a “cold tumor” not sensitive to PD-(L)1 mAb Monotherapy at 1, 3, 10, 20, 30, 45 mg/kg, Q3W Aug-2026 Cutoff 2026-ASCO
Slide 25: CS2009 monotherapy efficacy in later-line nccRCC
ICOS upregulation Efficacy in “cold tumors” Efficacy in IO-pretreated NSCLC (3/3) CS2009 monotherapy demonstrated promising clinical efficacy in later-line non- clear-cell renal cell carcinoma (nccRCC) — a “cold tumor” not sensitive to PD-(L)1 mAb Monotherapy at 20, 30, 45 mg/kg, Q3W Aug-2026 Cutoff
Slide 26: CS2009 monotherapy efficacy in later-line, post-IO NSCLC
ICOS upregulation Efficacy in “cold tumors” Efficacy in IO-pretreated NSCLC CS2009 monotherapy demonstrated promising clinical efficacy in later-line, post-IO NSCLC Monotherapy at 30 mg/kg, Q3W Aug-2026 Cutoff 2026-ASCO Cutoff ORR*, % DCR, % ORR*, % DCR, % (n) (n) (n) (n) 2L Patients 38.5% 84.6% 30.
Slide 27: Three Important Key Clinical Validations Achieved from over 300 Patient Data
Three Important Key Clinical Validations Achieved from over 300 Patient Data Phase I/II key updates Aug. 2026 ➢ Proof of Safety • Grade ≥3 irAEs 12.7%; CTLA-4-related tox markedly reduced from CTLA-4 mAb monotherapy or in combination with PD-1/L1, including extremely rare colitis, due to preserved C
Slide 28: Monotherapy Efficacy in NSCLC Continues Trending Up
Monotherapy Efficacy in NSCLC Continues Trending Up with Longer Follow-up and Larger Sample Size AUG-2026 CUTOFF · LATEST 2026-ASCO CUTOFF • N = 24 • ORR 83.3% (20/24) • N = 16 1L NSCLC - At 30 mg/kg: ORR 100% (11/11) • ORR 81.3% (13/16) PD-L1 TPS ≥50% • DCR 95.8% (23/24) • DCR 100% (16/16) (20 & 30
Slide 29: 1L NSCLC mono: efficacy in PD-L1 TPS ≥50%
1L NSCLC mono PD-L1 TPS ≥50% 1L NSCLC mono PD-L1 TPS ≥1% ≥2L NSCLC mono 1L NSCLC mono: CS2009 monotherapy demonstrated promising clinical efficacy in first-line NSCLC (PD-L1 TPS ≥50%) Monotherapy at 20 or 30 mg/kg, Q3W; enrollment completed; median PFS / DoR not reached due to short follow-up All Ev
Slide 30: 1L NSCLC mono: efficacy in PD-L1 TPS ≥1%
1L NSCLC mono PD-L1 TPS ≥50% 1L NSCLC mono PD-L1 TPS ≥1% ≥2L NSCLC mono 1L NSCLC mono: CS2009 monotherapy demonstrated promising clinical efficacy in first-line NSCLC (PD-L1 TPS ≥1%) Monotherapy at 20 or 30 mg/kg, Q3W; enrollment completed; median PFS / DoR not reached due to short follow-up All Eva
Slide 31: Higher ORR with CS2009 Monotherapy vs. IO Monotherapy and IO-Based Combo
1L NSCLC mono PD-L1 TPS ≥50% 1L NSCLC mono PD-L1 TPS ≥1% ≥2L NSCLC mono Higher ORR with CS2009 Monotherapy vs. IO Monotherapy and IO-Based Combo across TPS Subgroups in 1L PD-L1+ NSCLC CS2009 AK112 3 Pembrolizumab 4 Nivolumab +/- Ipilimumab 5 (PD-1/VEGF/CTLA-4) (PD-1/VEGF) (anti-PD-1) (anti-PD-1 +/-
Slide 32: ≥2L NSCLC mono: efficacy in heavily pre-treated NSCLC
1L NSCLC mono PD-L1 TPS ≥50% 1L NSCLC mono PD-L1 TPS ≥1% ≥2L NSCLC mono ≥2L NSCLC mono: CS2009 monotherapy demonstrated promising clinical efficacy in heavily pre-treated NSCLC Monotherapy at 10, 20, 30, or 45 mg/kg, Q3W All Evaluable Patients 30 mg/kg SQ, 30 mg/kg NSQ, 30 mg/kg ORR, % (n) DCR % (n)
Slide 33: Higher Monotherapy ORR with CS2009 vs. Bispecific Antibodies
1L NSCLC mono PD-L1 TPS ≥50% 1L NSCLC mono PD-L1 TPS ≥1% ≥2L NSCLC mono Higher Monotherapy ORR with CS2009 vs. Bispecific Antibodies in Heavily Pre-Treated NSCLC 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/CT
Slide 34: Three Important Key Clinical Validations Achieved from over 300 Patient Data
Three Important Key Clinical Validations Achieved from over 300 Patient Data ➢ Proof of Safety • Grade ≥3 irAEs 12.7%; CTLA-4-related tox markedly reduced from CTLA-4 mAb monotherapy or in combination with PD-1/L1, including extremely rare colitis, due to preserved CTLA-4 signaling in peripheral Tre
Slide 35: Clinical Data and CMC Readiness for FDA Meetings and Phase III Initiation
Clinical Data and CMC Readiness for FDA Meetings and Phase III Initiation Clinical Safety & Efficacy Dataset Phase 1 Phase 2 Phase 1/2 Phase 2 Phase 2 for NSCLC Meetings ► All solid tumors 1L NSCLC Later-line NSCLC 1L NSCLC 2L NSCLC (n≈130) mono (n≈40) mono (n≈57) combo (n≈60) combo (n≈40) CMC Meeti
Slide 36: Global Development and Regulatory Window Open for CS2009 Phase III (NSCLC)
Global Development and Regulatory Window Wide Open for CS2009 Phase III Trials (NSCLC) 2024 2025 2026 2027 2028 2029 2030 2031 H1 H2 H1 H2 H1 H2 H1 H2 H1 H2 H1 H2 H1 H2 H1 H2 1L SQ & NSQ NSCLC, Chemo Combo (Ph III) Q4 2026 – Q1 2030 CS2009 2L/3L NSCLC, Combo (Ph III) Q4 2026 – Q2 2029 (CStone) 1L SQ
Slide 37: Global Development and Regulatory Window Open for CS2009 Phase III (MSS CRC)
Global Development and Regulatory Window Wide Open for CS2009 Phase III Trials (MSS CRC) 2025 2026 2027 2028 2029 2030 H1 H2 H1 H2 H1 H2 H1 H2 H1 H2 H1 H2 1L mCRC, Chemo Combo (Ph III) Q4 2026 – Q1 2030 CS2009 (CStone) Later-line mCRC, ADC Combo (Ph III) Q3 2027 – Q4 2029 AK112 1L CRC Combo (HARMONi
Slide 38: CS2009 Upcoming Catalysts
CS2009 Upcoming Catalysts • All pivotal registrational studies are multi-regional clinical trials (MRCTs) using global standard-of-care as control • Trial design and timeline are not impacted by data readouts from other bispecific/trispecific competitors, giving CS2009 an independent development spa
Slide 39: Clinical Stage Assets
02 Clinical Stage Assets 1. CS2009 (PD-1/VEGF/CTLA-4 trispecific antibody) 2. CS5007 (EGFR/HER3 ADC) 3. CS5001 (ROR1 ADC) >
Slide 40: Modular proprietary antibody drug conjugate (ADC) platform
CStone has built a modular proprietary antibody drug conjugate (ADC) platform, enabling customized molecular design and screening Antibody • Customized target and antibody selections based on clinical needs and antibody features CS5007 • High selectivity and internalization rate (EGFR/HER3 • To over
Slide 41: Next-generation dual-payload ADC platform
CStone has also developed a proprietary next-generation ADC platform to support the development of dual-payload ADCs incorporating novel MoA Antibody • Customized target and antibody selections based on clinical needs and antibody features • High selectivity and internalization rate (biparatopic ant
Slide 42: CS5007 (EGFR/HER3 ADC): Potential BIC Candidate for Precision Oncology
CS5007 (EGFR/HER3 ADC)：Potential BIC Candidate for Precision Oncology Global multi-center Phase I trial has achieved first-patient enrollment in Australia, with NMPA IND approval secured for China Built upon CStone’s in-House ADC Platform Robust antitumor activities in Phase I – Mono Dose Escalation
Slide 43: Clinical Stage Assets
02 Clinical Stage Assets 1. CS2009 (PD-1/VEGF/CTLA-4 trispecific antibody) 2. CS5007 (EGFR/HER3 ADC) 3. CS5001 (ROR1 ADC) >
Slide 44: 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 in Australia and China Four Key Differentiators Support Best-in-class Potential Novel Prodrug and Linker Technology Minimizes Systemic Toxicity Of Conventional PBD 1 2 Fully human
Slide 45: CS5001 with R-CHOP in 1L DLBCL
CS5001 in Combination with R-CHOP Demonstrated Broad and Deep Antitumor Activity (ORR: 100%, CR: 100%) in 1L DLBCL Temporarily pausing the trial to evaluate existing clinical data for long-term benefit-risk and to optimize doses and dosing schedule All Dose Levels CS5001 40 μg/kg CS5001 50 μg/kg CS5
Slide 46: Early Assets
03 Early Assets Preclinical/IND-Enabling Programs >
Slide 47: Pipeline 2.0 Preclinical Assets
Pipeline 2.0 Preclinical Assets: Highly Differentiated ADCs and Mono-/Multi-Specific Antibodies Preclinical Discovery IND-Enabling Development ADCs (Oncology) CS5006 (ITGB4 ADC) Solid tumors CS5008 (SSTR2/DLL3 bispecific ADC) Solid tumors CS5009 (B7H3/PD-L1 bispecific dual-payload ADC) Solid tumors
Slide 48: Commercial Products
04 Commercial Products 1. CEJEMLY® (sugemalimab), anti-PD-L1 antibody 2. Pralsetinib, RET inhibitor 3. Avapritinib, KIT/PDGFRA inhibitor >
Slide 49: CEJEMLY (sugemalimab): Expanded Global Indication and Market
Sugemalimab Pralsetinib Avapritinib CEJEMLY® (sugemalimab): Expanded Global Indication and Market, and Increased Guideline Recognition Jul. 2024: EU Approval Nov. 2025: Feb. 2026: China NMPA Approvals Oct. 2024: U.K. Approval EU Approval U.K. Approval One of the only two anti-PD-(L)1 therapies appro
Slide 50: CEJEMLY: Robust Multi-Indication Clinical Evidence Base
Sugemalimab Pralsetinib Avapritinib CEJEMLY® (sugemalimab): Robust Multi-Indication Clinical Evidence Base Published in Leading Journals Clinical Trial Results Published in a Series of Top-Tier Journals 50
Slide 51: CEJEMLY: Global Commercialization Driven by Strategic Partnerships
Sugemalimab Pralsetinib Avapritinib CEJEMLY® (sugemalimab): Global Commercialization Driven by Strategic Partnerships CEJEMLY® international footprint now extends to over 60* countries and regions worldwide July 2025 June 2026 Jan. 2025 * Commercial partnerships with Ewopharma in Switzerland and 18
Slide 52: Pralsetinib Capsules: First Shipment of Locally-Manufactured Product
Sugemalimab Pralsetinib Avapritinib Pralsetinib Capsules: First Shipment of Locally-Manufactured Product • First domestically manufactured batch of pralsetinib capsules shipped in May 2026, transitioning from import-dependent to local supply for national commercial distribution — following NRDL incl
Slide 53: Pralsetinib & Avapritinib: Sales Growth Following NRDL and Local Supply Launch
Sugemalimab Pralsetinib Avapritinib Pralsetinib & Avapritinib: Sales Growth Following NRDL and Local Supply Launch 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 by almost 500% y
Slide 54: Financial Highlights
05 Financial Highlights >
Slide 55: 2026 H1 Financial Results
2026 H1 Financial Results Robust cash position to support the rapid development of key pipeline assets and commercial strategies execution Mn RMB 2026 H1 2025 H1 Change GROUP REVENUES 205.1 49.5 315% Revenue of RMB205.1 mn Sales of Pharmaceutical Products 183.2 20.2 806% • Revenue growth was primari
Slide 56: Q&A
Q&A >
Slide 57: Appendix
Appendix >
Slide 58: Well-balanced portfolio of 16 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 59: Well-balanced portfolio of 16 innovative assets (2/2)
Well-balanced portfolio of 16 innovative assets (2/2) – Pipeline 2.0 Preclinical Right Indication Discovery IND-Enabling FIH POC Development Antibodies (Oncology) CS2009 (PD-1/VEGF/CTLA-4 trispecific antibody) Solid tumors CS1012 (GDF-15 antibody) Solid tumors ADCs (Oncology) Solid tumors; CS50011 (
Slide 60: Trusted Global Partner: Proven Track Record Across Continents
Trusted Global Partner ─ Proven Track Record Across Continents Sugemalimab (PD-L1) Pralsetinib (RET) Avapritinib (KIT/PDGFRA) Ivosidenib (IDH1) CS5001 (ROR1) Nofazinlimab (PD-1) CS1002 (CTLA-4) Regorafenib Co-D CS2006 (PD-L1/4-1BB/HSA) Discovery Collaboration CStone has built a strong track record o
Slide 61: CStone's Leadership Depth and Expertise Translates Science into Patient Value
CStone's Leadership Depth and Expertise Translates Science into Patient Value Jason Yang, MD, PhD Chief Executive Officer & President of R&D Michael Choi, Qingmei Shi, Yujuan La, Ye Shi, Weicong (Nicky) Ni, Yinghua Zhang, Qinzhou Qi, MBA MD, PhD PhD MS MBA, CFA MS PhD Chief Business & Strategy Offic
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