Innovent Biologics, Inc. · HKEX:1801
Innovent Biologics — H1 2023 Earnings Presentation
33 slides from Innovent Biologics's earnings presentation, August 2023
Slide 1: Innovent Biologics 2023 Interim Results
Innovent Biologics 2023 Interim Results Appendix - Pipeline Overview August, 2023
Slide 2: Robust Pipeline Across Novel Therapeutics – Oncology
Robust Pipeline Across Novel Therapeutics – Oncology 8 approved, 1 NDA, 3 in pivotal stage and over 10 assets in clinical stage cover monoclonal antibodies, bispecific antibodies, CAR-T and small molecules Status Pivotal Phase 2 / Products Target (s) Modality Therapeutic Area Rights Pre-clinical IND
Slide 3: Robust Pipeline Across Novel Therapeutics – Non-oncology
Robust Pipeline Across Novel Therapeutics – Non-oncology 2 approved, 4 in pivotal stage, 4 assets in clinical stage represent long-term growth potential in major therapeutic areas including autoimmune, metabolic, and ophthalmology Pivotal Phase 2 / Products Target (s) Modality Therapeutic Area Right
Slide 4: Selected Pipeline - Oncology
Selected Pipeline - Oncology 4
Slide 5: TYVYT (Sintilimab): Only PD-1 Approved in First-line for Five Cancers
TYVYT ®(Sintilimab): The Only PD-1 Inhibitor Approved and Included in NRDL for the First-line Treatment of Five Major Types of Cancer EGFRm nsqNSCLC cHL 1L sqNSCLC 1L ESCC 2023.05 sNDA Approval 2018.12 NDA Approval 2021.06 sNDA Approval 2022.06 sNDA Approval Globally first PD-1 for EGFRm nsqNSCLC 1L
Slide 6: Pemazyre® (Pemigatinib)
Pemazyre® (Pemigatinib) China first approved target therapy to fill the unmet medical need for cholangiocarcinoma Enzyme Inhibitory Activity of IBI375 mOS Reached 2 Years in Chinese Patients with 2L mCCA Waterfall Plot for Updated Confirmed ORR by IRRC Updated median PFS by IRRC IBI375 Desired targe
Slide 7: Olverembatinib (BCR-ABL TKI)
Olverembatinib (BCR-ABL TKI) China’s first approved and NRDL included third-generation BCR-ABL TKI Clinical Highlights Differentiated Advantages • IBI348 shown highly and durably efficacious in heavily TKI-pretreated patients with • IBI348 is an oral third-generation BCR-ABL1 inhibitor designed for
Slide 8: Cyramza® (ramucirumab)
Cyramza®(ramucirumab) A VEGFR2 antagonist approved for five indications of NSCLC, GC, HCC and CRC globally Clinical Highlights Development Plan GC: RAINBOW-Asia (ASCO GI 2021) HCC: Chinese population analysis in REACH-2 (2020 CSCO) • Entered into strategic collaboration with Eli Lilly in 2022.03 for
Slide 9: Retsevmo® (selpercatinib)
Retsevmo® (selpercatinib) First-in-class selective RET inhibitor showing robust efficacy Clinical Highlights Differentiated Advantages Retsevmo ® global clinical trial data (LIBRETTO-001) • Retsevmo® is a highly selective and potent, CNS active RET inhibitor that exhibits unprecedented strong and du
Slide 10: FUCASO® (Equecabtagene Autoleucel, BCMA CAR-T)
FUCASO®(Equecabtagene Autoleucel, BCMA CAR-T) First approved fully-human BCMA CAR-T Clinical Highlights (2023 ASCO) Differentiated Advantage • Improved efficacy likely due to the lower binding affinity of BCMA CAR (facilitate serial triggering of CAR-T cell) and long-term persistence of CAR-T cells.
Slide 11: IBI376 (Parsaclisib hydrochloride, PI3Kδ)
IBI376 (Parsaclisib hydrochloride, PI3Kδ) Potential Best-in-class PI3Kδ under NMPA review IBI376 Demonstrated a High Rate of Rapid and Durable Response in r/r FL Phase 2 Study Evaluating the Efficacy and Safety of Parsaclisib in Patients with Relapsed or Refractory Follicular Lymphoma in China (ASCO
Slide 12: IBI351 (KRAS G12C)
IBI351 (KRASG12C) A potential Best-in-class KRASG12C selective inhibitor in pivotal Phase 2 IBI351 Preliminary PoC data 2023H1 Update 2L NSCLC: Phase I study efficacy & safety updated data in solid tumors (AACR 2023 #CT030) • 2L KRASG12C muted NSCLC; CRC • As of February 10, 2023, of the 67 evaluabl
Slide 13: IBI344 (Taletrectinib, ROS1 TKI)
IBI344 (Taletrectinib, ROS1 TKI) Leading next-generation ROS1 inhibitor at pivotal Phase 2 Clinical Highlights (2023 ELCC) Phase 2 Data (Data cutoff date: 2022.12.31) A: Crizotinib naive pts: ORR 92.5%（62/67）DCR 95.5% (64/67) B: Crizotinib pre-treated pts: ORR 52.6% (20/38) DCR 81.6% (31/38) C: Brai
Slide 14: IBI126 (tusamitamab ravtansine)
IBI126 (tusamitamab ravtansine) Global First-in-class and only Phase 3 stage ADC targeting CEACAM5 Potential FIC ADC with humanized antibody of high selectivity for CEACAM5 2023H1 Update • Potential FIC ADC with humanized antibody of high selectivity for CEACAM51 - Tusamitamab ravtansine is currentl
Slide 15: IBI939 (TIGIT)
IBI939 (TIGIT) Encouraging preliminary efficacy signal in 1L PD-L1 TPS>=50% NSCLC ESMO-IO CONGRESS 2022 (#86P) STUDY DSIGN PROGRESSION-FREE SURVIVAL Fully human IgG4 mAb Meaningful mPFS Improvement • As data cutoff (Oct 15, 2022), 42 pts were enrolled. 40 pts (27 in Arm A vs 13 in Arm B) performed a
Slide 16: IBI110 (LAG3)
IBI110 (LAG3) Potentially improve the efficacy of sintilimab in the 1st line of major cancer indications SWIMMING POOL OF OVERALL RESPONSE 1L sqNSCLC (IBI110+Sintilimab+TP)：ESMO-IO CONGRESS 2022 (#86P) • As data cutoff (Oct 25, 2022), the data of 20 squamous NSCLC pts previously reported was updated
Slide 17: IBI343: Potential Best-in-Class CLDN18.2 ADC
IBI343: Potential Best-in-Class CLDN18.2 ADC Differentiated design for potential wide therapeutic window and high potency Differentiated Design for Potential Best-in-Class Profiles Better In-vivo Efficacy than MMAE and Dxd Heterogeneous TAA expression Asn297 • World leading ADC technology collaborat
Slide 18: IBI343: Potential Best-in-Class CLDN18.2 ADC
IBI343: Potential Best-in-Class CLDN18.2 ADC Preliminary efficacy and favorable safety signals observed with dose escalated to 10mg/kg Observed better-than-peer safety at high dose level Encouraging ORR and high DCR observed • Dose escalation reached 10mg/kg. • Dosed over 60 GC/PDAC patients with CL
Slide 19: IBI363 (PD-1/IL-2): Highly Potent Bispecific Fc Fusion Protein
IBI363 (PD-1/IL-2) : Highly Potent Bispecific Fc Fusion Protein Mechanistically Enhance IO Treatment, including PD-1/PD-L1 Resistant/refractory and Cold Tumors Unique Molecular Design Based on Breakthrough Findings to Enhance Antitumor Efficacy and Reduce Toxicity • IL-2α-bias agonists that preserve
Slide 20: IBI363 (PD-1/IL-2): Highly Potent Bispecific Fc Fusion Protein
IBI363 (PD-1/IL-2) : Highly Potent Bispecific Fc Fusion Protein Dose escalation reach unprecedented level and preliminary efficacy observed in IO-failed cancers Phase 1 MRCT ongoing with 200+ patients dosed Durable response in IO-failed cancers and cold tumors pembrolizumab-resistant melanoma Baseli
Slide 21: Selected Pipeline – Non-Oncology
Selected Pipeline – Non-Oncology 21
Slide 22: SINTBILO® (tafolecimab injection)
SINTBILO® (tafolecimab injection) First approved domestic PCSK9 monoclonal antibody Data of Ph3 Studies (CREDIT-1 , CREDIT-2 and CREIDT-4) Percent change from baseline in 20 1.8%, placebo 600 mg Q6W LDL-C (%), LS mean (SE) 0 0.5%, placebo 450 mg Q4W −20 CREDIT-4 CREDIT-1 non-FH & non-FH −40 HeFH −55
Slide 23: Mazdutide (IBI362): Globally First GLP-1R/GCGR Dual Agonist in Phase 3
Mazdutide (IBI362) : Globally First GLP-1R/GCGR Dual Agonist in Phase 3 Potentially Best-in-class therapy for obesity and diabetes Mazdutide Development Overview Expected Ph2 Ph3 • Potential disruptive therapy to treatment regimen for launch huge obese and overweight population Obesity (6mg) GLORY-1
Slide 24: Mazdutide (IBI362) 9mg and 6mg Phase 2 in Obesity or Overweight
Mazdutide (IBI362) 9mg and 6mg Phase 2 in Obesity or Overweight Potentially Best-in-class weight reduction Among the GLP-1 class drugs approved and under clinical development globally, mazdutide is… Placebo-adjusted mean body weight reduction at Week 24 (Indirect comparison) BMI: 31.8 BMI: 34.3 mean
Slide 25: Mazdutide (IBI362) 6mg Phase 2 in Chinese T2DM Patients
Mazdutide (IBI362) 6mg Phase 2 in Chinese T2DM Patients Achieve both weight loss and glycemic control for long-term benefits Primary & Key Secondary Endpoints HbA1c reduction from baseline at Week 20 0.5 • HbA1c reduction trend is sustained in patients receiving 6mg Change from baseline 0 0.03% in H
Slide 26: Tigulixostat (IBI128)
Tigulixostat (IBI128) Potentially Best-in-class Phase 3 XOI for gout patients with hyperuricemia Xanthine oxidase inhibitors prevent the production of uric acid URAT inhibitors enhance renal uric acid excretion Allopurinol / Febuxostat / Tigulixostat Benzbromarone / Sulfinpyrazone / Lesinurad /Probe
Slide 27: Pincankibart (IBI112): Potentially Best-in-class IL-23p19 Inhibitor
Pincankibart (IBI112) : Potentially Best-in-class IL-23p19 Inhibitor Extended half-life, long-dosing interval and compelling efficacy observed in Ph3 IL-23 complex is an upstream regulatory cytokine Pincankibart (IBI112) Ph3 optimized dose regime to fully exhibit compelling efficacy Dendritic cell I
Slide 28: IBI353 (Orismilast)
IBI353 (Orismilast) Potentially Best-in-class Phase 2 PDE4 inhibitor Clinical Highlights 2023H1 Update Indirect comparison from Ph2a suggests Psoriasis Orismilast oral Share of Psoriasis potential to be ~50% ● UNION therapeutics announced positive topline with 75% more efficacious results in the IAS
Slide 29: IBI302 (efdamrofusp alfa): First-in-Class VEGF/Complement Fusion Protein
IBI302 (efdamrofusp alfa) : First-in-Class VEGF/Complement Fusion Protein Potential effect in anti-macular atrophy and extended durability Non-inferior BCVA gain MA incidence decreased Extended dose interval potential IBI302 2mg/4mg Ph2: BCVA gains with were IBI302 2mg/4mg Ph2: less macular atrophy
Slide 30: IBI311 (IGF-1R): Eyes on Unmet Medical Needs of TED in China
IBI311 (IGF-1R) : Eyes on Unmet Medical Needs of TED in China Only IGF-1R antibody in registrational study in China for thyroid eye disease IGF-1R/TSHR complex activation is the IBI311 Eyes on Unmet needs of TED in China key step in TED provoking Fast acting characteristic First domestic IGF-1R in P
Slide 31: VEGF Cluster: IBI333 (VEGF-A/VEGF-C) & IBI324 (VEGF-A/ANG-2)
VEGF Cluster: IBI333 (VEGF-A/VEGF-C) & IBI324 (VEGF-A/ANG-2) A bispecific recombinant fully humanized A bispecific antibody targeting VEGF- IBI333 fusion protein targeting VEGF-A and VEGF-C IBI324 A and Ang2 Free VEGF A VEGFR domain2 ✱ Anti-VEGF-A scFv Inhibit neovascularization Inhibit vascular lea
Slide 32: From Molecule to Blockbuster
From Molecule to Blockbuster: Robust pipeline to address unmet medical needs with huge global market potential Innovent focus on therapeutic area with unmet medical needs and large market potential Inno focused TAs Others 377 Oncology Next-generation IO: LAG3, TIGIT, PD-L1/IL2, CLDN18.2/CD3… ADC : C
Slide 33: Confidential
Confidential Copyright© 2023 Innovent 33