Shanghai Henlius Biotech, Inc. Class H · HKEX:2696

Shanghai Henlius Biotech, Inc. Class H — Henlius — H1 2025 Earnings Presentation

54 slides from Shanghai Henlius Biotech, Inc. Class H's earnings presentation, August 2025

  1. Slide 1: Henlius (2696.HK) 2025 Interim Results Investor Presentation

    Henlius (2696.HK) 2025 Interim Results Investor Presentation August 2025 Œ+HQOLXV

  2. Slide 2: 2025 1H Business Highlights & Company Strategy

    01 2025 1H Business Highlights & Company Strategy Œ+HQOLXV

  3. Slide 3: Revenue Tops 2.8B RMB with Net Profit of 386M RMB

    Revenue Tops 2.8B RMB with Net Profit of 386M RMB BD Contract Global Commercial Overseas Revenue Cash Inflow Pipeline Capacity Product Profit 2.8B RMB >1B RMB ~50 ͹1,150 >200% ͣYoY Growthͤ Commercialization BD R&D Manufacturing Financial • Achieved sustainable and • The BD contract cash inflow of RM

  4. Slide 4: Our Mission and Vision

    Innovative Drugs Explore new mechanisms, new technology platforms and broader therapeutic areas. Our Mission and Vision Globalization Develop into a biopharma with global presence & scale Affordable Innovation Reliable Quality Biosimilars Maximize the commercialization value in China and internation

  5. Slide 5: HLX10: Potential Best-in-class PD-1 Antibody with Global Market Opportunity

    HLX10: Potential Best-in-class PD-1 Antibody with Global Market Opportunity World's first anti-PD-1 mAb for the first-line treatment of SCLC HLX10 (PD-1) Serplulimab Long-term results and patient-reported outcomes from the ASTRUM-005 study, first published 4-year OS rate: 21.9% HANSIZHUANG | Zerpidi

  6. Slide 6: HLX22: HER2 Monoclonal Antibody Poised to Succeed KEYNOTE-811

    HLX22: HER2 Monoclonal Antibody Poised to Succeed KEYNOTE-811 HLX22 has significantly prolonged PFS and OS, and holds the potential to change the HLX22 (novel epitope HER2) current first-line SOC for GC with >2-year follow-up (median follow-up period of 28.5 months). HER2 domain IV Trastuzumab ͧHLX0

  7. Slide 7: HLX43: a PD-L1 ADC Entering Global Ph 2

    HLX43: a PD-L1 ADC Entering Global Ph 2 with High Efficacy, Low Toxicity, and I/O Functionality HLX43 was well tolerated with no new safety signals across different doses and exhibited HLX43 (PDL-1 ADC) encouraging preliminary efficacy in patients with advanced solid tumors, including those with NSC

  8. Slide 8: 2025H1 The key milestones of globalization

    2025H1 The key milestones of globalization North America Europe HLX13 (Ipilimumab) out-licensed to Sandoz in the U.S., and Canada Serplulimab (trade name in Europe: Hetronifly®) has been approved in UK and EU HLX15 (daratumumab) out-licensed to Dr. Reddy’s in the U.S. HLX13 (Ipilimumab) out-licensed

  9. Slide 9: Henlius' Products Hit Global Markets: Revenue and Profits Set to Surge

    Henlius’ Products Hit Global Markets such as the US, UK, and India: Revenue and Profits Set to Surge 2024 Overseas product revenue* The 4 key products have been (100 million RMB) Double-digit approved for sale overseas and are growth shipped to Europe, the Middle East, Latin America, and other regio

  10. Slide 10: Robust Biosimilar Pipeline is Aiming at Global Market

    Robust Biosimilar Pipeline is Aiming at Global Market • 2025H1 sales revenue of biosimilars reached 1.86 billion RMB. HLX11 (pertuzumab) and HLX14 (denosumab) received new EMA GMP Certification. The biosimilar pipeline covers global popular targets such as CTLA-4 and CD38. The Company simultaneously

  11. Slide 11: Business Development

    02 Business Development Œ+HQOLXV

  12. Slide 12: Recent Major Out-licensing Products, Contribute Cash Inflow in 1H25

    Recent Major Out-licensing Products, Contribute Cash Inflow ~670 million RMB in 1H25 Alvogen Korea Dr. Reddy’s Co., Ltd. (wholly-owned Sandoz AG Laboratories SA subsidiary of Lotus) Contract signing date: 2025/02/06 Contract signing date: 2025/04/25 Contract signing date: 2025/04/29 Out-licensing Ou

  13. Slide 13: Recent In-licensing Deal - Next-Generation IO Pipeline

    Recent In-licensing Deal - Actively Introduce Next-Generation IO Pipeline /TROIKTYOTM HCB101 (SIRPα–Fc fusion protein) is a fusion protein with differentiated design, fusioned with engineered SIRPα and IgG4 Fc • High binding affinity to CD47 on tumor cells, and low binding affinity to CD47 on erythr

  14. Slide 14: In-licensing Focus: Expand Portfolio into Breast Cancer Sub-types

    In-licensing Focus: Leverage BD to Expand Portfolio into Different Sub-types of Breast Cancer HR+/ Type HLX87/GQ1005 (HER2 ADC): Breast cancer HER2+ HER2- • HLX87/GQ1005 is an innovative HER2 ADC, products developed based on GeneQuantum (GQ)‘s proprietary enzymatic site-specific conjugation technolo

  15. Slide 15: Out-licensing Focus: International Quality Biosimilars Provide Stable Cash Flow

    Out-licensing Focus: Henlius’ International Quality Biosimilars Provide Stable Cash Flow and Support Innovative Pipelines Market Size of Originators and Marketed Biosimilars Biosimilars with existing out-licensing partners Biosimilars to be out-licensed US/EU Market Global sales in 2024 (M USD) Glob

  16. Slide 16: Pre-clinical Innovative Assets

    03 Pre-clinical Innovative Assets Œ+HQOLXV

  17. Slide 17: Strategic Planning of Early Research

    Strategic Planning of Early Research: Leveraging Core Strengths to Align with Henlius Overall Strategy Major Modality: Antibody and Key Indications: Oncology, Antibody-Derivatives Autoimmune Disease Antibody: mAb, bispecific, Tier1 Cancer: breast cancer, multi-specific lung cancer, colon cancer ADC:

  18. Slide 18: Three Major Technology Platforms Support Mid-to-Long-Term Pipeline Development

    Three Major Technology Platforms Support Mid-to-Long-Term Pipeline Development Tri-specific T cell engager HanjugatorTM ADC platform HAI Club platform Anti- TAA Activation Signaling 2 of T cells Activation Anti- Signaling 1 TAA of T cells • Persistent specific T-cell activation effect • Expand the t

  19. Slide 19: A Safer and More Effective TAAxCD3xCD28 TCE Tri-specific Platform

    A Safer and More Effective TAAxCD3xCD28 TCE Tri-specific Platform Efficacy: better in lower E/T ratio 1 TAA-dependent T cell Activation 3 Redirected Tumor Lysis Safety: Lower CRS IL-6 IL-4 IL-10 5 1.0 150 4 0.8 IL-6 (pg/mL) IL-10 (pg/mL) 100 IL-4 (pg/mL) 3 0.6 2 0.4 2 CD3-dependent CD28 Activation 5

  20. Slide 20: HLX3902: A Potential Best-In-Class Anti-STEAP1 Tri-specific Ab

    HLX3902: A Potential “Best-In-Class” Anti-STEAP1 Tri-specific Ab Effector (T cells): Tumor (TAApos)= high Effector (T cells): Tumor(TAApos ) = low Trispecific: HLX3902 BMK: AMG509 Bispecifc: in-house BsAb 20 Œ+HQOLXV

  21. Slide 21: HLX97: A Potential Best-In-Class KAT6A/B inhibitor

    HLX97: A Potential “Best-In-Class” KAT6A/B inhibitor Significantly more efficacious than competitor compounds in the ZR-75-1 model 1500 Vehicle Tumor volume (mm3) Benchmark 0.1 mg/kg 1200 Benchmark 0.3 mg/kg HLX97 0.1 mg/kg 900 HLX97 0.3 mg/kg 600 300 0 0 7 14 21 28 35 Days after the start of treatm

  22. Slide 22: HLX37: PD-L1xVEGF bsAb, a next-generation I/O product

    HLX37: PD-L1xVEGF bsAb, a next-generation I/O product after Serplulimab (PD-1) More efficient induction of PDL1 internalization enhances T cell activation αPD-L1 αVEGF-A WT IgG1 Higher enrichment rate in TME compared to combo Better efficacy compared to competitor in A549 model 2500 Tumor volume (mm

  23. Slide 23: HLX48: Anti-EGFRxcMET ADC for NSCLC and CRC

    HLX48: A Potential ”Best-In-Class” Anti-EGFRXcMET ADC for NSCLC and CRC Anti-cMET Bispecific Ab with higher internalization efficiency Anti-EGFR Target posive cell 100 High dose 80 Medium dose %Internalization Low dose 60 40 20 0 b b G b A -A A Ig ET FR 48 LX M G i-c i-E H nt nt A A HLX48 ADC is sig

  24. Slide 24: HLX49: Anti-HER2 biparatopic ADC

    HLX49: A Potential “Best-In-Class” Anti-HER2 biparatopic ADC 150 anti-HER2 mAb Trastuzumab HLX49-Ab-GGFG-Dxd （HLX22） （HLX02） 100 DAR6 % Viability Enhertu HLX49 (DAR 6) is significantly more 50 efficacious than HER2 ADC (DAR 8) 0 10 -3 10 -2 10 -1 10 0 10 1 10 2 Conc.(nM) LP CDX PDX 0 Tumor Growth in

  25. Slide 25: HLX318: Anti-BAFFxTACIxBCMA tri-specific

    HLX318: A Potential “Best-In-Class”Anti-BAFFxTACIxBCMA tri-specific HLX318 is significantly more efficacious than HLX318 is significantly more efficacious than competitor in dual Anti-BAFF competitor in BAFF-induced activation: (BAFF/APRIL)-induced activation: 5-10X 5-200X TACI activation blocking T

  26. Slide 26: Preclinical Pipeline Landscape Strategy

    Preclinical Pipeline Landscape Strategy Multidimension driven project selection: modality, indication, market size, novelty Indication FIC HLX41 HLX316 HLX37 BIC HLX97 HLX48 HLX3901 fast follow HLX49 Tier 1 Cancer: HLX98 BC, Lung, Colon HLX86 Market Potential HLX322 HLX402 HLX321 HLX323 HLX105 high

  27. Slide 27: SAB Members (Pre-clinical Assets Focused)

    SAB MembersͣPre-clinical Assets Focusedͤ K. Christopher Garcia Kun-Liang Guan Yang-Xin Fu K. Christopher Garcia, Ph.D is a Professor of Kun-Liang Guan, a biochemist and cell biologist, Professor Yang-Xin Fu is an endowed Molecular and Cellular Physiology, and of is a chair professor at Westlake Univ

  28. Slide 28: Clinical Pipelines

    04 Clinical Pipelines Œ+HQOLXV

  29. Slide 29: Product Portfolio and Pipeline

    Product Portfolio and Pipeline Pre-IND / IND Phase 1 Phase 2 Phase 3 NDA In-Market HLX17 (pembrolizumab) HLX6018 Serplulimab (4) + HLX07 (7) Serplulimab (4) + Chemo (12) Serplulimab (4) HLX04-O GARP/TGF-β1 PD-1+EGFR PD-1 PD-1 PD-1 VEGF IPF sqNSCLC, etc. ES-SCLC 1L sqNSCLC, ES-SCLC, ESCC, nsNSCLC NSC

  30. Slide 30: Clinical Pipeline Milestones: 2025 H1 Review & 2025 H2 Outlook

    Clinical Pipeline Milestones: 2025 H1 Review & 2025 H2 Outlook 2025H1 2025H2 HLX10 HLX10 HLX10 HLX10 HLX10 HANSIZHUANG HLX04-O HANSIZHUANG HANSIZHUANG HANSIZHUANG HANSIZHUANG ES-SCLC1 Wet AMD4 ES-SCLC1 sqNSCLC5 nsqNSCLC10 1L (Hong Kong, Mexico, ESCC11 (CN) 1L (South Korea, 1L (EU, the Philippines, 1

  31. Slide 31: Clinical Pipeline Milestones: Expected in 2026 H1

    Clinical Pipeline Milestones: Expected in 2026 H1 2026 H1 HLX10 HANSIZHUANG HLX10 HLX14 ES-SCLC1 HANSIZHUANG PMOP6 , etc. 1L GCneo4 NDA/BLA/MAA (US, Macau) (China) (Japan) Submission HLX10 HLX10 HLX10 HLX10 HANSIZHUANG HANSIZHUANG HANSIZHUANG HANSIZHUANG ESCC5 nsqNSCLC7 sqNSCLC12 ES-SCLC1 1L 1L 1L 1

  32. Slide 32: HLX43 Phase 2 Clinical Trials Exploration in Various Tumor Types

    HLX43 Phase 2 Clinical Trials Exploration in Various Tumor Type, Enroll >600 Patients Expression observed in a broad spectrum of solid tumors Low expression in normal tissue | Primarily expressed in immune cell Epidemiology PDL1 Expression in Solid Tumors Epidemiology Ongoing clinical trial Ongoing

  33. Slide 33: Global Clinical Sites Summary

    /TZKXTGZOUTGR/TNU[YK-RUHGR:KGS)U\KXOTM1K_8KMOUTY -RUHGR)ROTOIGR9Z[J_9OZKY )UUVKXGZOUT9[SSGX_ • )U[TZXOKY Japan USA China • YOZKY • VGZOKTZYͧ LXUSK^)NOTGͨ • )85LXKKLUXQK_XKMOUTY ͧ)4;906';ͨ ]OZN GT Australia OTNU[YK IROTOIGRZKGS ULdVXULKYYOUTGRY 33 Œ+HQOLXV

  34. Slide 34: HLX43-NSCLC201: NSCLC Later Line Ph 2 Trial

    HLX43-NSCLC201: Non-Small Cell Lung Cancer Later Line Ph 2 Trial MRCT led by top global KOLs Part A Part B Primary endpoints: HLX43 2.5mg/kg • ORR (IRRC) Key inclusion criteria: Q3W N=50 HLX43 dose Country: • Age ≥ 18 years; 8 Q3W • Non-small cell lung cancer; • China, United States, Europe, N=143 •

  35. Slide 35: HLX10-005-SCLC301-E: Serplulimab ES-SCLC US Bridging Study

    HLX10-005-SCLC301-E: Serplulimab (PD-1) ES-SCLC US Bridging Study Key Inclusion Criteria Arm A: 1.Age>l8 years HLX10 (300mg.D1) + Carboplatin 2.Histologically or cytologically (AUC=5,D1) + Etoposide (100/m2,D1-3) Primary Endpoints diagnosed with ES-SCLC 3. No prior systemie therapy for 8 ES-SCLC • O

  36. Slide 36: HLX22-GC301: 1L HER2+ GC Ph 3 Study

    HLX22-GC301: 1L HER2+ GC Ph 3 Study MRCT led by top global KOLs Key Inclusion Criteria 1. Age≥18Y (JP ≥20Y) HLX22 (15mg/kg) + SOC r placebo(Keytruda), Q3W 2. Treatment naïve, advanced Primary Endpoints unresectable, HER2+ G/GEJ 8 Dr. Shen Lin • PFS (IRRCͨ Beijing Cancer Hospital, CSCO GC Chair adeno

  37. Slide 37: SAB Members (Research & Development)

    SAB Members ͣResearch & Developmentͤ David R. Gandara Shun Lu Jianjun Zhang ?[>[K David Gandara, Professor of Medicine Professor Lu Shun is a lifetime Dr. Jianjun Zhang is a thoracic oncology Fudan University Huashan Hospital Emeritus at the University of California, professor at the Shanghai Chest

  38. Slide 38: Commercialization

    05 Commercialization Œ+HQOLXV

  39. Slide 39: HANQUYOU (Trastuzumab): China-developed Biosimilar with World-class Quality

    HANQUYOU (Trastuzumab): China-developed Biosimilar with The Most Approved Countries and Regions World-class Quality Leader in China BC Market • First approved trastuzumab biosimilar in China • Commercial team with ~600 professionals, focusing on 1.44B RMB breast cancer area • First “China-developed”

  40. Slide 40: HANQUYOU: Unique Multiple Specifications Bring Higher Sales Per Capita

    HANQUYOU: Unique Multiple Specifications and International Quality Brings Higher Sales Per Capita Enhance product 9_TKXM_HKZ]KKT .OMNKX9GRKY6KX)GVOZG :NKUTR_ZXGYZ[`[SGH strengths to build .'47;?5;GTJ :NGT*USKYZOI6KKXY ]OZNZ]UYVKIOLOIGZOUTY competitive advantages .'44'/0/' • 2 specifications were • H

  41. Slide 41: HANNAIJIA (neratinib): Product Synergy to Strengthen HER2+ Breast Cancer

    HANNAIJIA (neratinib): Product Synergy to Strengthen HER2+ Breast Cancer Pipeline Strengthen extended adjuvant 97M RMB Revenue in 1H2025 Product Synergy concept education • Leverage HANQUYOU commercial team’s market • Promoteawareness and adoption of extended adjuvant coverage and customer connectio

  42. Slide 42: HANSIZHUANG (Serplulimab): Full coverage in LC And EC

    HANSIZHUANG (Serplulimab): Full coverage in LC And EC Widespread recognition Differentiated strategies to grab market share 598M RMB • First Approved PD-1 mAb for 1L ES-SCLC • Developed differentiated marketing strategies, strengthen leading position in SCLC market,increase • In Feb 2025, approved i

  43. Slide 43: HANSIZHUANG: Outstanding Commercialization Efficiency and Differentiated Strategy

    HANSIZHUANG: Outstanding Commercialization Efficiency and Differentiated Strategy First-class Commercialization Differentiated Strategy To Efficiency Tackle Challenges And Win Opportunities • Proactively tackle with challenges Differentiated Strategy from competitors in SCLC area, and accurately int

  44. Slide 44: HANBEITAI (Bevacizumab): Rapidly Grow In Dual-channel Market

    HANBEITAI (Bevacizumab): Rapidly Grow In Dual-channel Market Acceleration on market access and Exploration for new medication penetration methods 116M RMB Domestic Market • Covered by NRDL in 31 provinces, and completed tendering and • The only bevacizumab biosimilars with phase 3 clinical Revenue i

  45. Slide 45: HANLIKANG and HANDAYUAN: Market Leader Position and Autoimmune Entry

    HANLIKANG (Rituximab): Strengthen the Market Leader Position HANDAYUAN (Adalimumab): Entered Autoimmune Disease Area 274M RMB Revenue recognized by Henlius and licensing income in 1H2025 27M RMB Revenue recognized by Henlius and licensing income in 1H2025 First Biosimilar in China First biosimilar i

  46. Slide 46: Manufacturing

    06 Manufacturing Œ+HQOLXV

  47. Slide 47: International Leading Capabilities on Manufacturing and Quality Management

    International Leading Capabilities on Manufacturing and Quality Management Xuhui Site Songjiang Songjiang L 1st Plant 2nd Plant L 0 0 00 00 2 4, 2 4, • Supply Covered Globally: Commercial • Global GMP standards: obtained GMP • Phase 1 of the plant will be completed GMP production exceeds 1,150 batch

  48. Slide 48: Operation Excellence and Continuous Innovation

    Operation Excellence and Continuous Innovation AI Empowerment Lean Operations Multifaceted AI Tool Practice Lean Operations Diagnosis AI enhances the efficiency, Lean Identification of 100+ lean improvement standardization, and comprehensiveness Operations points identified Estimated annualized of q

  49. Slide 49: 2025H1 Financial Review

    07 2025H1 Financial Review Œ+HQOLXV

  50. Slide 50: 2025 1H Revenue of RMB 2.82 Billion, Product Revenue of RMB 2.56 Billion

    2025 1H Revenue of RMB 2.82 Billion, Product Revenue of RMB 2.56 Billion Revenue (in Billion RMB) Product Sales (in Billion RMB) 2025 Revenue Breakdown (in Million RMB) 2025 2024 %2025 share % 49.9% 2.5 2.6 2.7 2.8 2.5 2.2 21.1% 9.7% 10.8% 4.1% 1.0% 3.4% 23H1 24H1 25H1 23H1 24H1 25H1 Revenue Growth

  51. Slide 51: Achieved Profitability in 2025H1 with RMB ~771M Operating CF

    Achieved Profitability in 2025H1 with RMB ~771M Operating CF Net profit: Keep profitability (in Million RMB) R&D related investment (in Million RMB) Net profit margin Net profit Cost of Services Provided* Capitalized Expensed 14.1% 13.8% 1,128 1,121 1,013 126 302 339 410 9.6% 126 343 386 390 240 548

  52. Slide 52: Financial Highlights

    Financial Highlights Financial Data (selected) 25H1 24H1 YoY Growth Unit In Million RMB % of revenue In Million RMB % of revenue % Revenue 2,819.5 100.0% 2,746.1 100.0% 2.7% Product sales 2,556.8 90.7% 2,479.4 90.3% 3.1% BD and other revenue 262.8 9.3% 266.7 9.7% (1.5%) Cost of sales (620.4) (22.0%)

  53. Slide 53: Disclaimer

    ‫ރב‬ Disclaimer • ‫ࡎؐז‬望澝ஐଚы۪‫҈ݕ‬ы‫ކߎث‬ўӄ‫ކͧؠ‬ўӄ‫ؠ‬у߄Օਈԕ‫ܬ‬ӹ䨶‫ۅ‬ஐଚ֮ͨЉҟӟ‫ޢ‬ॐ۪௳ॐङґચ澝‫۪ޢג‬ஐଚͧԕ‫ܬ‬ѸЉஒй͹ߎӄ‫ث୓ؠ‬ОѠ۞ࣔؔऩङ৲Ҽйӄ‫ؠ‬ ۱Ӏ߄ङՃ‫ۅޞ‬澝ପऀ‫ۅ‬澝তे‫ۅ‬ङ‫۪ͫޢג‬ৱҼй҅ऀߎ‫ކ‬ўӄ‫ؠ‬۱ੂ‫ڱ‬Ғ‫ޗێ‬નՕҒङ‫ͨޢג‬澞‫߄֜ײ‬Ҽӄ‫֨؂ؠ‬୪ન澝଴ࢥ۪‫ע‬ӕФ‫ה‬৲‫ږ‬ਚङ੧О۪ৈߧͫ‫ࡎؐז‬望澝ஐ ଚы۪‫҈ݕ‬ы‫࠴ث‬Љ‫ુܛ܈‬Ѡ澞 • ߎ‫ކ‬ўՃҿИ۱ԕխӄ‫ؠ‬ङ۱߄ߓӯԕ‫ࡎؐזं֮ߓ࣍ܬ‬望ࣞ‫؟‬۱߄ͫҿИबҼङȔ.K

  54. Slide 54: Henlius - Reliable Quality, Affordable Innovation

    @ Henlius #zxNz FRB ANRT (HA RA one Reliable Quality Affordable Innovation

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