Cstone Pharmaceuticals · HKEX:2616
Cstone Pharmaceuticals — H1 2025 Earnings Presentation
41 slides from Cstone Pharmaceuticals's earnings presentation, Aug 15, 2025
Slide 1: 2025 Interim Results Presentation
2025 Interim Results Presentation August 15, 2025 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 RESEARCH DEVELOPMENT COMMERCIAL Clinical insight driven Efficient, high-quality and Leverage the strength of modular R&D model innovative clinical dev. e
Slide 4: Business Achievements
01 Business Achievements 2025YTD 4
Slide 5: 2025YTD key achievements
2025YTD key achievements: Rapid clinical advancement of core assets; Strategic alliances for commercialized products expanding global footprint Financial R&D and Commercial Progress as of Jun. 30, 2025 as of Aug 15, 2025 • Patient recruitment: Actively enrolling in AU/CN → US Phase II expansion plan
Slide 6: Pipeline Updates
Pipeline Updates: 02 1. Commercial-stage Programs 2. Key Clinical Programs CS5001 (ROR1 ADC) CS2009 (PD-1/VEGF/CTLA-4 trispecific mAb) 3. Innovative Early Programs EGFR/HER3, SSTR2, ITGB4, Autoimmune Assets, Technology Platforms 6
Slide 7: Maximizing commercial value and advancing Pipeline 2.0
To drive business growth by maximizing commercial value of products in the market and advancing innovative Pipeline 2.0 Key Clinical Programs Innovative Early Programs Commercial-stage Programs in Pipeline 2.0 in Pipeline 2.0 CS5007 CS2011 Sugemalimab CS5001 (EGFR/HER3 (EGFR/HER3 bispecific ADC) bis
Slide 8: Commercial-stage Programs
02 Commercial-stage Programs Pipeline Updates 8
Slide 9: Sugemalimab approved in EU & UK; global partnerships
First-line stage IV NSCLC approved in EU & UK for all-comers population; four global partnerships established with additional collaborations anticipated in 2025 MAA approval achieved in EU & UK, positioning CStone as one of the Global partnerships to bring significant financial impact via immediate
Slide 10: Sugemalimab EMA engagement for Stage III NSCLC
Sugemalimab breakthrough: EMA engagement positively advanced for Stage III NSCLC indication If this new indication is approved, sugemalimab would address a critical unmet need in stage III NSCLC, where only one PD-L1 antibody is currently approved in Europe. The drug's dual utility in stage III and
Slide 11: ESMO guideline recommendation and top journal publications
ESMO guideline recommendation and publication in prestigious medical journals further supporting sugemalimab’s adoption by physicians and reimbursements Sugemalimab publications in top-tier journals with 400+ cumulative impact factor (JAMA, Lancet Oncology, Nature Medicine, Nature Cancer, JCO et al.
Slide 12: Strategic collaboration on pralsetinib and avapritinib
Strengthening strategic collaboration on pralsetinib and avapritinib to maximize commercial value Actively advancing manufacturing localization and patient access Pralsetinib Nov 8 2023 Avapritinib Jul 3 2024 RET inhibitor KIT/PDGFRA inhibitor Partner with Partner with for the commercial promotion i
Slide 13: Pralsetinib and avapritinib sales trends
Pralsetinib: Steady sales during 2025 NRDL preparation Avapritinib: Significant commercial growth post NRDL/local supply synergy Based on the price reduction effective April 1st (communicated Based on the localized supply implementation since Pralsetinib Avapritinib since February 2025), Pral's curr
Slide 14: Key Clinical Programs: CS5001 (ROR1 ADC)
02 Key Clinical Programs: Pipeline Updates CS5001 (ROR1 ADC) 14
Slide 15: Pipeline 2.0: CS5001 No. 2 position globally
Pipeline 2.0: an innovative portfolio with global rights CS5001: No. 2 position globally with first-to-market potential Preclinical Drug candidate Right Indication Discovery IND-Enabling FIH POC Development Solid tumors CS50011 (ROR1 ADC) hematologic malignancies CS2009 (PD-1/VEGF/CTLA-4 trispecific
Slide 16: CS5001 clinical development in lymphoma and solid tumors
CS5001 clinical development targeting lymphoma and solid tumors: across first- line, second-line, monotherapy and combination therapies Phase Ib dose expansion ongoing, multiple cohorts actively enrolling Phase Ia – Monotherapy Dose Escalation Phase Ib/II -- Dose Expansion / Pivotal Extension (BOIN
Slide 17: Key Highlights of CS5001 Clinical Progress
Key Highlights of CS5001 Clinical Progress 1 Monotherapy in Late-line DLBCL and CLL • Optimization for dose regimen in r/r DLBCL • Exploring monotherapy efficacy in r/r CLL patients 2 1L/2L DLBCL Combination Therapy • 1L DLBCL: Dose Level 1 safety evaluation completed without DLT • 2L DLBCL: Dose Le
Slide 18: Key Clinical Programs: CS2009
Key Clinical Programs: 02 CS2009 Pipeline Updates (PD-1/VEGF/CTLA-4 trispecific mAb) 18
Slide 19: Pipeline 2.0: CS2009 leading position globally
Pipeline 2.0: an innovative portfolio with global rights CS2009: leading position globally to target PD-1, VEGFA and CTLA-4 Preclinical Drug candidate Right Indication Discovery IND-Enabling FIH POC Development Solid tumors CS50011 (ROR1 ADC) hematologic malignancies CS2009 (PD-1/VEGF/CTLA-4 trispec
Slide 20: CS2009, a potential FIC/BIC PD-1/VEGF/CTLA-4 trispecific antibody
CS2009, a potential FIC/BIC PD-1/VEGF/CTLA-4 trispecific antibody With better OS benefit than PD-1/VEGF bsAbs, potential to be the next-gen IO backbone to replace anti-PD-(L)1 abs in current SOCs Designed to target broad indications, incl. Differentiated molecular design Preclinical data cold tumors
Slide 21: Multi-target engagement and synergistic interactions of CS2009
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 (TME) Peripheral In
Slide 22: CS2009 clustering with VEGFA dimers increases binding affinities
CS2009 clustering with VEGFA dimers leads to significant increase of its binding affinities to PD-1 and CTLA-4 on T cells in the TME The crosslinking between VEGFA dimers and CS2009 leads to over 20-fold increase of the blocking activities CTLA-4 against PD-1 and PD-1/CTLA4 in cell-based assay, due
Slide 23: CS2009 global phase I/II trial
CS2009 global phase I/II trial ongoing in Australia and China, to be expanded to the US A phase I/II, dose-escalation and dose-expansion study to evaluate the safety, tolerability, pharmacokinetics and antitumor activities of CS2009 in patients with advanced solid tumors Phase Ia – Mono Dose Escalat
Slide 24: CS2009 Key Highlights
CS2009 Key Highlights CS2009 preferentially blocks PD-1 and CTLA-4 on double-positive TILs via avidity-driven engagement, while minimizing interference with CTLA-4 signaling in peripheral T cells, thus potentially offering enhanced efficacy with lower systemic 1 toxicity. CS2009’s anti-PD-1 and anti
Slide 25: Innovative Early Programs
02 Innovative Early Programs Pipeline Updates 25
Slide 26: Pipeline 2.0: an innovative portfolio with global rights
Pipeline 2.0: an innovative portfolio with global rights Preclinical Drug candidate Right Indication Discovery IND-Enabling FIH POC Development Solid tumors CS50011 (ROR1 ADC) hematologic malignancies CS2009 (PD-1/VEGF/CTLA-4 trispecific antibody) Solid tumors CS5007 (EGFR/HER3 bispecific ADC) Solid
Slide 27: Innovative Early Programs: Pipeline Updates
Innovative Early Programs: 02 • Autoimmune • ADC platform and related assets Pipeline Updates (EGFR/HER3, SSTR2, ITGB4) • Tri-/tetra-functional antibody platform 27
Slide 28: Advance Pipeline 2.0 and expand into non-oncology
Advance innovative Pipeline 2.0 and strategically expand into non-oncology pipeline leveraging proprietary technology platforms and clinical development capabilities Innovative Early Programs in Pipeline 2.0 CS5007 CS2011 (EGFR/HER3 bispecific ADC) (EGFR/HER3 bispecific mAb) CS5008 CS5005 (SSTR2/DLL
Slide 29: CS2013, BAFFxAPRIL bispecific antibody for autoimmune diseases
CS2013, a potential first-in-class/best-in-class BAFFxAPRIL bispecific antibody to target autoimmune diseases Differentiated Molecular Design First-in-class/Best-in-class Potential Molecular Design • B-cell directed therapeutics • Constructed for blocking two important ligands for B cell development
Slide 30: CS2015, OX40LxTSLP bispecific antibody for type 2 inflammation
CS2015, a potential first-in-class/best-in-class OX40LxTSLP bispecific antibody to target type 2 inflammatory diseases First-in-class/Best-in-class Differentiated Molecular Design Preclinical Data Potential hTSLP mice hOX40L mice Molecular design • Th2 directed therapies • Constructed for blocking t
Slide 31: Modular proprietary ADC platform
CStone has built a modular proprietary antibody drug conjugate (ADC) platform, enabling customized molecular design and screening Antibody CS5007 (EGFR/HER3 • Customized target and antibody selections based on bispecific ADC) clinical needs and antibody features • High selectivity and internalizatio
Slide 32: Mature and innovative portfolio covering broad indications
CStone’s mature and innovative portfolio covers a broad of indications with rapidly growing commercial value 5,000K+ Global annual incidence[3] 2,000K+ Global annual incidence[2] ~200K China annual incidence[1] Precision Medicine Immuno-oncology Pipeline 2.0 • Pralsetinib (commercial) • Sugemalimab
Slide 33: Financial Highlights
03 Financial Highlights 33
Slide 34: 2025 H1 financial results
2025 H1 financial results Robust cash position to support the rapid development of key pipeline assets and commercial strategies execution Mn RMB 2025 H1 2024 H1 Change GROUP REVENUES 49.4 254.2 -81% Total Group Revenue of RMB49.4 mn • Sales of pralsetinib decreased period-on-period, which is primar
Slide 35: Catalysts
04 Catalysts 35
Slide 36: Expected Catalysts in the Near Term
Expected Catalysts in the Near Term 2025 Assets Q3 Q4 Exploring global BD partnerships for CS5001, CS2009, CS5007, CS2011, CS5008/CS5005，CS5006 and Nofazinlimab programs clinical CS5001 (ROR1 ADC) Planned clinical data presentation at ASH 2025 Key CS2009 (PD-1/VEGF/CTLA-4 tsAb) Periodic safety, PK,
Slide 37: Thanks
Thanks 37
Slide 38: Appendix
Appendix 38 [EE
Slide 39: Well-balanced portfolio of innovative assets (1/2) – Commercial/Late-stage Programs
Well-balanced portfolio of 16 innovative assets (1/2) – Commercial/Late-stage Programs Approval Drug candidate Indication POC Pivotal NDA Marketed Partners Partnering regions CN TW HK US EU UK 2L NSCLC 1L NSCLC Pralsetinib (RET) Mainland China 1L MTC / TC （TC） （TC） Multiple tumors PDGFRA exon 18 G
Slide 40: Well-balanced portfolio of innovative assets (2/2) – Pipeline 2.0
Well-balanced portfolio of 16 innovative assets (2/2) – Pipeline 2.0 Preclinical Drug candidate Right Indication Discovery IND-Enabling FIH POC Development Solid tumors CS50011 (ROR1 ADC) hematologic malignancies CS2009 (PD-1/VEGF/CTLA-4 trispecific antibody) Solid tumors CS5007 (EGFR/HER3 bispecifi
Slide 41: END
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