Cstone Pharmaceuticals · HKEX:2616
Cstone Pharmaceuticals — Investor Presentation (April 2022)
35 slides from Cstone Pharmaceuticals's investor presentation, April 2022
Slide 1: CStone Company Presentation
2616.HK CStone Company Presentation Apr 2022 1
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 with it
Slide 3: Introduction & Overview
Introduction & Overview 3
Slide 4: 2021 & 2022YTD Business Highlights
Introduction & Overview 2021 & 2022YTD Business Highlights • Successfully launched avapritinib in Mainland China / Taiwan, China in May 2021 / June 2021 and pralsetinib in Mainland China in June 2021, generating a total Commercial revenue* of RMB79 million as of 30 June, 2021 • Successfully launched
Slide 5: Full-fledged Biopharma
Introduction & Overview 2616.HK Full-fledged Biopharma 6 Years Since Company Inception Industry leading management Solid financial position and team with proven track record ability to support growth and complementary expertise initiatives Well-balanced oncology portfolio with 15 immuno- Full-fledge
Slide 6: Industry leading management team
Introduction & Overview Industry leading management team Leadership with proven track record and complementary expertise Frank Jiang, MD, PhD Chairman, Chief Executive Officer Jason Yang, MD, PhD Archie Tse, MD, PhD Chief Medical Officer Chief Scientific Officer Josh Zhou, MD Sanhu Wang, MPH Greater
Slide 7: Well-balanced oncology portfolio of 15 innovative assets
Introduction & Overview Well-balanced oncology portfolio of 15 innovative assets Focused on immuno-oncology and precision medicine Approval Drug candidate Rights Indication Pre-clinical FIH POC Pivotal NDA Marketed Partner CN5 TW6 HK7 US 2L NSCLC Pralsetinib 1L NSCLC (RET) 1L MTC / TC Multiple tumor
Slide 8: Business Highlights
Business Highlights 8
Slide 9: Strong commercial team with seasoned industry leaders
Commercial 2 3 4 5 Business Highlights Strong commercial team with seasoned industry leaders Supporting CStone's oncology leadership with successful launches • 16+ years of experience in China’s pharmaceutical industry at multinational corporations and global strategy consulting firms • Seasoned lea
Slide 10: Launches set industry benchmark for speed of delivery
Commercial 2 3 4 5 Business Highlights Launches set industry benchmark for speed of delivery Go-to market strategy enabled rapid and broad day one sales MNC CStone Quality Speed GAVRETO® AYVAKIT® Achieved rapid NMPA approval, Time to reach distribution partners 6.5 months within a shorter timeframe
Slide 11: Expanding accessibility of assets on the market
Commercial 2 3 4 5 Business Highlights Expanding accessibility of assets on the market Commercial team taking additional steps to bolster sales growth Reimbursement Coverage Scientific Influence ▪ >80 major government and commercial insurance ▪ >10 national treatment & diagnosis plans have included
Slide 12: Bolstering commercial potential of pipeline developments
Commercial 2 3 4 5 Business Highlights Bolstering commercial potential of pipeline developments Preparing market for indication expansions and upcoming launches Indication expansion of launched assets Launch preparation of more assets GAVRETO® SUGEMALIMAB • NSCLC – 1L RET • NSCLC – Stage III fusion
Slide 13: Preparing Sugemalimab for full-scale commercial launch
Commercial 2 3 4 5 Business Highlights Preparing Sugemalimab for full-scale commercial launch NDA approval for stage IV NSCLC granted by NMPA in Dec 2021 US$200mn equity investment with three paths for collaboration Commercialization of Co-development of 1 Sugemalimab 2 Pfizer assets 3 ▪ Up to $280m
Slide 14: Unrivalled clinical development engine
1 Clinical 3 4 5 Business Highlights Unrivalled clinical development engine Robust strategy, innovative trial designs and agile execution Jason Yang, MD, PhD, Chief Medical Officer ➢ A physician scientist and senior executive with 25+ years biomedical research and biopharma R&D experience in oncolog
Slide 15: Poised for rapid growth with numerous clinical successes
1 Clinical 3 4 5 Business Highlights Poised for rapid growth with numerous clinical successes Industry leading number of NDA submissions, approvals, data readouts Roadmap for new product Indication & geographic expansion of launched products Ivosidenib AML (R/R) Pralsetinib Avapritinib ▪ NDA approve
Slide 16: Outstanding efficacy data with well-tolerated safety profile
1 Clinical 3 4 5 Business Highlights Outstanding efficacy data with well-tolerated safety profile 4 oral and 1 poster presentations at 2021 WCLC and ESMO Pralsetinib (1L/2L NSCLC) Avapritinib (Advanced GIST) Ivosidenib (R/R AML) Efficacy Efficacy Efficacy For Chinese patients who have previously For
Slide 17: Expanding addressable patient population for key assets
1 Clinical 3 4 5 Business Highlights Expanding addressable patient population for key assets More indications to unlock full commercial potential ~90,000 1L NSCLC Pralsetinib Avapritinib 2L NSCLC Ivosidenib x225% MTC PTC Basket trial GIST (mPDGFRα） AdvSM ~40,000 ISM x400% 1L NSCLC 2L NSCLC Others1 M
Slide 18: Sugemalimab poised to reshape lung cancer landscape
1 Clinical 3 4 5 Business Highlights Sugemalimab poised to reshape lung cancer landscape Only PD-(L)1 with efficacy in stage III & IV NSCLC in “all-comers” setting The first PD-(L)1 to cover the entire advanced Positioned to become physicians’ preferred NSCLC through innovative trial design PD-(L)1
Slide 19: Outstanding efficacy & safety data for both studies
1 Clinical 3 4 5 Business Highlights Outstanding efficacy & safety data for both studies presented in 2021 WCLC and ESMO, and published by The Lancet Oncology GEMSTONE-301 Primary endpoint：BICR PFS Preliminary OS GEMSTONE-302 Primary endpoint：Investigator-Assessed PFS Preliminary OS* 19 Note: Formal
Slide 20: Accelerated clinical advancement of sugemalimab
1 Clinical 3 4 5 Business Highlights Accelerated clinical advancement of sugemalimab Entered the 1st tier of NSCLC from the 12th place with “CStone Speed” From IND to Stage IV NDA approval Cover both Stage III and Stage IV NSCLC 1st PD-(L)1 for the treatment of both stage III 4th PD-(L)1 and IV NSCL
Slide 21: Growing BD team expands global partnership network
1 2 BD 4 5 Business Highlights Growing BD team expands global partnership network Deeper capabilities to support pipeline and commercialization efforts Michael Choi, Chief Business Officer ➢ 23+ years of experience in biopharmaceutical strategy and business development ➢ Executive experience with Pf
Slide 22: Further deepening our strategic partnership with Pfizer
1 2 BD 4 5 Business Highlights Further deepening our strategic partnership with Pfizer Agreement to co-develop Lorlatinib strengthens lung cancer offering US$200mn equity investment with three paths for collaboration Commercialization of Co-development of 1 Sugemalimab 2 Pfizer assets 3 ▪ Up to $280
Slide 23: Preparing sugemalimab for global launch
1 2 BD 4 5 Business Highlights Preparing sugemalimab for global launch Leveraging EQRx’s business model to penetrate PD-L1 market US$150mn upfront payment, up to US$1.15bn milestone payments and tiered double-digit royalties on net sales ~US$30bn in market value1 (NSCLC, Gastric, Esophageal) Rest of
Slide 24: Strategic partnership with Hengrui Pharmaceuticals
1 2 BD 4 5 Business Highlights Strategic partnership with Hengrui Pharmaceuticals Out-licensing of CS1002 (CTLA-4) in Greater China Hengrui CStone Exclusive rights for research, development, Upfront payment and potential milestone registration, manufacturing, and payments of up to $200 mn in additio
Slide 25: Translating innovation into safe and effective therapies
1 2 3 Pipeline 2.0 5 Business Highlights Translating innovation into safe and effective therapies Stellar in-house team, evident research and translation differentiation Archie Tse, MD, PhD, Chief Scientific Officer ➢ 20+ years of experience in translational oncology research covering cytotoxics, ta
Slide 26: Translating innovation into safe and effective therapies
1 2 3 Pipeline 2.0 5 Business Highlights Translating innovation into safe and effective therapies Accelerating the development of assets from Discovery to POC stage Abundance of sources for In-house infrastructure in place Sustainably deliver cutting-edge drug dev. ideas for implementation innovativ
Slide 27: Harnessing full potential of next-gen candidates
1 2 3 Pipeline 2.0 5 Business Highlights Harnessing full potential of next-gen candidates Significant progress developing portfolio of FIC/BIC/FW assets ADC PCC Declaration IND Submission FIH Initiation US FIH study CS5001 (ROR1 ADC) initiation 1 of top 3 ADCs globally and top 2 in China 2022/3 CS50
Slide 28: CS5001 (ROR1 ADC)
1 2 3 Pipeline 2.0 5 Business Highlights CS5001 (ROR1 ADC) Potential FIC/BIC asset in new modality with differentiation in design Differentiation In Design Clinical & Business Value Potentially wider ➢ Potential applications for a wide range therapeutic window of tumor types Fully human mAb v.s. • N
Slide 29: CS5001 in vivo antitumor activity
1 2 3 Pipeline 2.0 5 Business Highlights CS5001 (ROR1 ADC) Remarkable in vivo antitumor activity for ROR1-expressing hematological and solid malignancies In vivo efficacy in MCL xenografts In vivo efficacy in TNBC xenografts PBS, IV, PBS, IV, QWx3 QW PBS, PBS, IV, IV,QWx3 QW CS5001,1mg/kg, CS5001, 1
Slide 30: CS2006 (PD-L1x4-1BBxHSA)
1 2 3 Pipeline 2.0 5 Business Highlights CS2006 (PD-L1x4-1BBxHSA) Potential BIC 4-1BB agonist and next generation PD-(L)1 inhibitor Asset Highlights ▪ A potential best-in-class drug with special design to reduce unwanted toxic effects and improve therapeutic index Next − Unique monovalent 4-1BB bind
Slide 31: Harnessing full potential of next-gen antibody therapies
1 2 3 Pipeline 2.0 5 Business Highlights Harnessing full potential of next-gen antibody therapies Accelerating antibody drug discovery via global collaboration with DotBio Partner profile Key terms of the collaboration Spin-off from the Karolinska Institute Jointly develop up to 3 preclinical FIC/BI
Slide 32: Expanding capital markets access
1 2 3 4 Capital Markets Business Highlights Expanding capital markets access Inclusion in key index to support share trading and broaden ownership • Included in Hang Seng Composite • Included in Hong Kong Stock Connect Index on August 20, 2021, and effective on September 6, 2021 from September 6, 20
Slide 33: Business Outlook
Business Outlook 33
Slide 34: 2022 Business outlook
Business Outlook 2022 Business outlook Unlocking the global potential of our business and portfolio Maximizing commercial potential with new product launches and market expansion & penetration for in-market products Commercial • Target 3 NDA approvals for commercial launch of ivosidenib, as well as
Slide 35: THANK YOU
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