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RemeGen 2025 Q3 Report October, 2025
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Disclaimer The documents, opinions and materials presented in this presentation (the “Document”) have been prepared by RemeGen Co., Ltd. (the “Company”) for use in presentations by the Company and does not constitute a recommendation regarding the securities of the Company. You fully understand that the Document is being made available on a confidential basis and subject to the following provisions. The contents of this Document have not been reviewed by any regulatory authority in any jurisdiction. The distribution of this Document in certain jurisdictions may be restricted by law, and the recipients into whose possession this Document comes should inform themselves about, and observe such restrictions. By accessing this Document, you are agreeing (i) that you have read and agree to comply with the contents of this notice and disclaimer and (ii) to maintain absolute confidentiality regarding the information disclosed in this Document. 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Key Financial Summary Strong Revenue Growth Costs Under Control Improved Commercialization Efficiency Consistent Loss Reduction The balance of cash and cash equivalents was 1,450 million RMB. RMB MillionRMB Million RMB Million 330 411 467 508 525 573 622 2024Q1 2024Q2 2024Q3 2024Q4 2025Q1 2025Q2 2025Q3 331 475 347 386 329 318 243 74 73 87 82 90 56 70 2024Q1 2024Q2 2024Q3 2024Q4 2025Q1 2025Q2 2025Q3 R&D Expenses Admin Expenses 30% 40% 50% 60% 70% 80% 90% 2024Q1 2024Q2 2024Q3 2024Q4 2025Q1 2025Q2 2025Q3 Gross Profit Margin Ratio of Expenses to Sales (349) (432) (291) (397) (254) (195) (101) 2024Q1 2024Q2 2024Q3 2024Q4 2025Q1 2025Q2 2025Q3
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Ongoing Clinical Trials LaunchedNDAPivotal/Phase IIIPhase IIPhase IINDPre-clinicDrug Candidates Target Autoimmune Diseases Fusion Protein Telitacicept (RC18) BLyS/APRIL China 全球 ex-China Modality Indication Systemic Lupus Erythematosus IgA Nephritis China China China 全球 全球 China Rheumatoid Arthritis Myasthenia Gravis Sjögren's Syndrome ex-China Lupus Nephritis China Membranous Nephritis and Other Indications China Oncology ADC Disitamab Vedotin (RC48) HER2 HER2-Expressing Gastric Cancer HER2-Expressing Urothelial Cancer HER2 low expressing Breast Cancer HER2-Positive Breast Cancer with Liver Metastasis Combined PD-1 for stage I Urothelial Cancer Combined therapy for treatment of stage I HER2-expressing gastric cancer China China 中国 Cooperation with Pfizerex-China China China Cooperation with Pfizer RC88 RC148 ADCMesothelin Combined PD-1 for Advanced Malignant Solid Tumors PD-1/VEGF Bispeci Antibody RC278 Condential ADC Multiple Solid Tumors Therapy for Advanced Solid Tumors Ophthalmology RC28 Fusion ProteinVEGF/FGF Wet Age-Related Macular Degeneration Diabetic Macular Edema Diabetic Retinopathy 中国 中国 China China Cooperation with Vor Cooperation with Vor Cooperation with Santen Cooperation with Santen Cooperation with Santen Myasthenia Gravis Other Indications HER2-Expressing Gastric Cancer Combined PD-1 for stage I Urothelial Cancer China ex-China China China China RC288 Condential ADC Multiple Solid Tumors China Other Solid Tumors ex-China China China Cooperation with Pfizer
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Telitacicept - Maximize Commercial Potential Rheumatoid Arthritis Approved Indications for Marketing 3 Myasthenia Gravis Myasthenia Gravis Sjogren’s Syndrome IgA Nephropathy Lupus Nephritis Membranous Nephritis IgG4-Related Disease Pediatric Systemic Lupus Erythematosus Potential New Indications Autoimmune Hepatitis Systemic Lupus Erythematosus LAUNCHED Systemic Lupus Erythematosus Pivotal/Phase 3 CTD-ILD Idiopathic Thrombocytopenic Purpura Ocular Myasthenia Gravis Indications in Phase 3 Trials 2+ Indications in Planning/Initiating 8+ *Global Phase 3 Ready * Myasthenia Gravis * * China BLA Filed BLA Filing 2
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PRINCIPAL TERMS OF THE LICENSE AGREEMENT with VOR BIO Telitacicept – Substantial Global Opportunity Investors Telitacicept ex- China rights • $45mn+320mn shares of warrants • Up to US$4,1B milestone payments • High single digit to mid-teens royalty on product sales $175mn 700mn shares of warrants
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Commercialization – Telitacicept 泰爱 First-in-class BLyS/APRIL dual-targeting drug Approved for SLE, MG and RA in China ~900 member rheumatology focused sales team Listed in 1000+ hospital procurement list New indications (IgAN,SS, and etc) to provide sustained growth driver in the coming years Aim to become a leading therapy in treating B-cell- mediated autoimmune diseases ®
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MG Market Size Clinical Results Key Milestones 1.20 million patients in global 0.22 million patients in China $7.24 billion Market size expected in 2030 (Global) Source: Frost & Sullivan Phase 3 Clinical Trial in China Enrolled 114 patients •Telitacicept: 57 patients •Placebo: 57 patients Efficacy Data of Phase 3 Trial China Phase 3 Study met primary endpoint Q3 2024 China BLA filing Q4 2024 China BLA Approval Q2 2025 Telitacicept for Myasthenia Gravis (MG) Telitacicept 24 weeks: MG-ADL score improvement ≥3 reached 98.1% QMG score improvement ≥5 reached 87% Telitacicept 48 weeks: MG-ADL score continued to decline to -7.5 points
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MG: Results of a Phase 3 Study-24 weeks Efficacy Endpoints: Significant Change in MG-ADL (difference: -4.83) and QMG Scores (difference: -6.39) from Baseline for Telitacicept compared with Placebo Proportion of patients with a ≥3 point reduction in MG- ADL score from baseline over time A C Proportion of patients with a ≥5 point reduction in QMG score from baseline over timeD (*: P < 0.01, #: P < 0.001) Mean Change in MG-ADL Score† B Mean Change in QMG Score†
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MG: Results of a Phase 3 Study-24 weeks Safety Results Telitacicept (N=57) Placebo (N=57) n (%) Events n (%) Events Infections and infestations 26 (45.6) 46 34 (59.6) 50 Upper respiratory tract infection 12 (21.1) 17 20 (35.1) 24 Urinary tract infection 9 (15.8) 11 6 (10.5) 6 Pneumonia 1 (1.8) 1 6 (10.5) 6 Respiratory tract infection 1 (1.8) 1 2 (3.5) 2 Influenza 0 (0) 0 3 (5.3) 3 Telitacicept (N=57) Placebo (N=57) n (%) Events n (%) Events Serious AEs 4 (7.0) 4 6 (10.5) 7 Pneumonia 1 (1.8) 1 4 (7.0) 4 COVID-19 pneumonia 1 (1.8) 1 0 (0) 0 Influenza 0 (0) 0 1 (1.8) 1 Upper respiratory tract infection 0 (0) 0 1 (1.8) 1 Open fracture 0 (0) 0 1 (1.8) 1 Pneumonitis 1 (1.8) 1 0 (0) 0 Accidental death 1 (1.8) 1 0 (0) 0 Infection-associated AEs occurring in >5% of subjects Serious AEs • Injection site reactions were reported in 14.0% of the telitacicept group and 1.8% of the placebo group Safety conclusion: Telitacicept demonstrated a safety profile consistent with data from clinical trials in systemic lupus erythematosus, rheumatoid arthritis, progressive systemic sclerosis and IgA neuropathy, and post-marketing data
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MG: Results of a Phase 3 Study-48 weeks Efficacy Endpoints: After 24 weeks significant change in MG-ADL (difference: -4.83) , after 48 weeks the MG-ADL score continued to decline to -7.5 points
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IgAN Market Size Clinical Results Key Milestones 10.2 million patients in global 2.37 million patients in China $2.50 billion Market size expected in 2030 (Global) Source: Frost & Sullivan Phase 2 Clinical Trial in China Enrolled 44 patients •Telitacicept 160mg: 16 patients •Telitacicept 240mg: 14 patients •Placebo:14 patients Efficacy Data of Phase 2 Trial China Phase 3 Study LPI Q2 2024 9M Data readout 2H 2025 Potential BLA filing 2H 2025 Telitacicept for IgA Nephropathy (IgAN)
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pSS Market Size Clinical Results Key Milestones 4.28 million patients in global 0.65 million patients in China $6.1 billion Market size expected in 2030 (Global) Source: Frost & Sullivan Phase 3 Clinical Trial in China Enrolled 381 patients •Telitacicept 80mg: 127 patients •Telitacicept 160mg: 127 patients •Placebo:127 patients Efficacy Data of Phase 3 Trial China Phase 3 Study LPI Q2 2024 Data readout 2H 2025 Potential BLA filing 2H 2025 Telitacicept for Sjogrens Syndrome (pSS)
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SS: Results of a Phase 3 Study Telitacicept Is Driving Broad, Early Symptom Relief in SS Nearly 90% of patients report improvement as physicians confirm disease control in 3 out of 4 patients 73.0% 16.5% 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% 4 8 1 2 1 6 2 0 2 4 2 8 3 2 3 6 4 0 4 4 4 8 WEEK 160mg 80mg Placebo PROPORTION OF PARTICIPANTS WITH ≥3-POINT REDUCTION FROM BASELINE IN ESSDAI SCORE OVER TIME ⁜ ⁑ 49.1% # # Ϯ # Ϯ # ǂ # # # # # # # # # # # # # # (* P<0.05, Ϯ P<0.01, ǂ P<0.001, # P<0.0001) 33.3% 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% 4 8 1 2 1 6 2 0 2 4 2 8 3 2 3 6 4 0 4 4 4 8 WEEK 160mg 80mg Placebo PROPORTION OF PARTICIPANTS WITH ≥1-POINT OR ≥15% REDUCTION FROM BASELINE IN ESSPRI SCORE OVER TIME ⁜ ⁑ 89.1% 75.4% # # # # # # # # # # # # # # # # # # # # # *
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SS: Results of a Phase 3 Study Deep, Consistent ESSDAI Reduction Through 48 Weeks 7x greater improvement means fewer active symptoms and broader systemic relief for patients -4.4 -5.5 -4.5 -3.5 -2.5 -1.5 -0.5 0 4 8 1 2 1 6 2 0 2 4 CHANGE FROM BASELINE (POINT) IN ESSDAI SCORE WEEK 160mg 80mg Placebo CHANGE FROM BASELINE (POINT) IN ESSDAI SCORE OVER WEEKS 0-24 ⁜ -0.6 -3.0 * # # # # # Ϯ ǂ # # # -3.2 -0.4 -4.6 -5.5 -4.5 -3.5 -2.5 -1.5 -0.5 0 4 8 1 2 1 6 2 0 2 4 2 8 3 2 3 6 4 0 4 4 4 8 CHANGE FROM BASELINE (POINT) IN ESSDAI SCORE WEEK 160mg 80mg Placebo CHANGE FROM BASELINE (POINT) IN ESSDAI SCORE OVER WEEKS 0-48 ⁑ # # Ϯ # ǂ # # # # # # # # # # # # # # # # # # (* P<0.05, Ϯ P<0.01, ǂ P<0.001, # P<0.0001)
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SS: Results of a Phase 3 Study Deep, Consistent ClinESSDAI Reduction Through 48 Weeks Sustained improvement in clinical benefit beyond serologic change ESSDAI and ClinESSDAI remain nearly identical at week 48 -4.6 vs -4.5 ClinESSDAI excludes biological domain (IgG, complement), representing a more sensitive measure of pure clinical disease activity -3.2 -0.6 -5.5 -4.5 -3.5 -2.5 -1.5 -0.5 0 4 8 1 2 1 6 2 0 2 4 2 8 3 2 3 6 4 0 4 4 4 8 CHANGE FROM BASELINE (POINT) IN CLINESSDAI SCORE WEEK 160mg 80mg Placebo CHANGE FROM BASELINE (POINT) IN CLINESSDAI SCORE OVER WEEKS 0-48 ⁜ ⁑ -4.5
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SS: Results of a Phase 3 Study More Than Half of Patients Achieved Low Disease Activity Nearly 5x more patients on 160mg vs placebo achieved this threshold Low Disease Activity (ESSDAI <5) Represents Minimal Systemic Involvement 55% vs 12% Consistent improvement sustained through 48 weeks, indicating durable immune stabilization (* P<0.05, Ϯ P<0.01, ǂ P<0.001, # P<0.0001) 55.0% 12.2% 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% 4 8 1 2 1 6 2 0 2 4 2 8 3 2 3 6 4 0 4 4 4 8 WEEK 160mg 80mg Placebo PROPORTION OF PARTICIPANTS WITH ESSDAI SCORE <5 POINTS OVER TIME ⁜ ⁑ 32.7% ǂ # * # * # Ϯ # ǂ # Ϯ # Ϯ # ǂ # ǂ # ǂ # ǂ*
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SS: Results of a Phase 3 Study Sustained Improvement in ESSPRI Through 48 Weeks Reduction in patient-reported fatigue, pain, and dryness by ~2.6 points at one year (* P<0.05, Ϯ P<0.01, ǂ P<0.001, # P<0.0001) -1.88 -3 -2.5 -2 -1.5 -1 -0.5 0 0 4 8 1 2 1 6 2 0 2 4 CHANGE FROM BASELINE (POINT) IN ESSPRI SCORE WEEK 160mg 80mg Placebo CHANGE FROM BASELINE (POINT) IN ESSPRI SCORE OVER WEEKS 0-24 ⁜ -0.36 -1.31 * # # # # # Ϯ # # # # -1.74 -0.41 -2.56 -3 -2.5 -2 -1.5 -1 -0.5 0 0 4 8 1 2 1 6 2 0 2 4 2 8 3 2 3 6 4 0 4 4 4 8 CHANGE FROM BASELINE (POINT) IN ESSPRI SCORE WEEK 160mg 80mg Placebo CHANGE FROM BASELINE (POINT) IN ESSPRI SCORE OVER WEEKS 0-48 ⁑ # # Ϯ # ǂ # # # # # # # # # # # # # # # # # #
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SS: Results of a Phase 3 Study Consistent Reduction in IgG, IgA, IgM, and B Cells -30% -20% -10% 0% 10% 0 4 8 1 2 1 6 2 0 2 4 2 8 3 2 3 6 4 0 4 4 4 8 IGG CHANGE FROM BASELINE (%) (FAS, MEAN±SE ) WEEK 160mg 80mg Placebo IGG -50% -40% -30% -20% -10% 0% 10% 0 4 8 1 2 1 6 2 0 2 4 2 8 3 2 3 6 4 0 4 4 4 8 IGA CHANGE FROM BASELINE (%) (FAS, MEAN±SE ) WEEK 160mg 80mg Placebo IGA -60% -50% -40% -30% -20% -10% 0% 10% 0 4 8 1 2 1 6 2 0 2 4 2 8 3 2 3 6 4 0 4 4 4 8 IGM CHANGE FROM BASELINE (%) (FAS, MEAN±SE ) WEEK 160mg 80mg Placebo IGM -80% -60% -40% -20% 0% 20% 40% 0 4 8 1 2 1 6 2 0 2 4 2 8 3 2 3 6 4 0 4 4 4 8 B CELL CHANGE FROM BASELINE (%) (FAS, MEAN±SE ) WEEK 160mg 80mg Placebo B CELL (* P<0.05, Ϯ P<0.01, ǂ P<0.001, # P<0.0001)
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SS: Results of a Phase 3 Study Safety Profile Consistent with data from clinical trials in SLE, RA, gMG, and post-marketing data
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Clinical Strategy of Oncology Pipeline Focus on solid tumors Develop innovative drugs Drive therapeutic transformation 1 2 3 4 Expand indications for approved drug • UC 1L: RC48-C016 • GC 1L: RC48-C039/C040 • HR+/HER2-low: RC48-C012 • TNBC 1L: RC48-C036 Explore druggability for new targets Explore new treatment combinations Develop next-generation technology platform • BsAb-RC148 • MSLN-RC88 • cMET-RC108 • CLDN18.2-RC118 • RC278 • ADC+PD-1 RC48+Toripalimab in C016/C017 • ADC+TKI RC108+Furmonertinib in RC108 C001 • ADC+Chemo RC48+CAPOX/trastuzumab +Toripalimab in C027/C039/C040 • BsAb combination RC148+RC48/RC148+RC88/RC148+RC118 • New payload • New linker technology • Next-Generation ADC and BsAb platform
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Commercialization - Disitamab Vedotin 爱地希 The first domestic ADC drug approved in China Approved in 2L(+) UC and GC patients ~500 member oncology focused sales team Listed in 1000+ hospital procurement list Solidifying a leading position in HER-2 expressing urothelial cancer patients Multiple ongoing trials to expand the target patient pool ®
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Phase III RC48-C016 Study Results ® Background HER2-targeted antibody-drug conjugate monotherapy has demonstrated efficacy in the post-chemotherapy setting for HER2-positive UC and is approved in both China (disitamab vedotin) and the USA (T-DXd). An ORR of 76.3% and median PFS of 9.3 months were observed with DV plus toripalimab (a humanized anti- PD-1 monoclonal antibody) in patients with previously untreated or chemotherapy-refractory HER2-expressing (IHC 1+, 2+, or 3+) la/mUC based on the previous phase Ib/II RC48-C014 study. HER2 expression is highly prevalent in UC, with HER2 IHC ≥1+ accounting for up to 70% of UC. The RC48-C016, an open-label, multicenter, randomized phase 3 trial, was conducted to evaluate DV+T vs chemotherapy in the 1L treatment of patients with HER2-expressing la/mUC in China. We report the prespecified final PFS analysis and interim OS analysis.
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Phase III RC48-C016 Study Results ® C48-C016 Study Design (NCT05302284)
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Phase III RC48-C016 Study Results Progression-free Survival according to BIRC Clinically meaningful reduction in the risk of progression or death by 64% with DV+T
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Phase III RC48-C016 Study Results Overall Survival Clinically meaningful reduction in the risk of death by 46% with DV+T
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Phase III RC48-C016 Study Results Tumor Response Significant improvement in tumor response in patients with DV+T by BICR and investigators
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Phase III RC48-C016 Study Results Safety Summary Incidence of grade ≥3 TRAEs: 55.1% with DV+T vs 86.9% with chemo
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Progress in Ophthalmology Product (RC28) RC28-E is a novel dual decoy receptor Fc-fusion protein that can potentially block vascular endothelial growth factor (VEGF) and fibroblast growth factor-2 (FGF-2) simultaneously DME wAMD DR 8.8 million patients (China) Q1 2024 Completed enrollment for phase Ⅲ study (China) H2 2025 BLA filing (China) Market size expected in 2030 (China) Source: Frost & Sullivan 13.0 billion RMB 4.9 million patients (China) Q4 2024 Completed enrollment for phase Ⅲ study (China) H1 2026 BLA filing (China) Market size expected in 2030 (China) Source: Frost & Sullivan 8.0 billion RMB 2024 Phase Ⅱ study completed (China)
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License Agreement for RC28-E PRINCIPAL TERMS OF THE LICENSE AGREEMENT with SANTEN CHINA RC28-E rights in Greater China, South Korea, Thailand, Vietnam, Singapore, the Philippines, Indonesia, and Malaysia. RMB 250 million upfront payment RMB 520 million development and regulatory milestone RMB 525 million Sales milestone Tiered royalties on sales
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Remainder of 2025 Upcoming Catalysts Data read-out: • Telitacicept for IgAN – Interim China Phase III data (9 month UPCR) • Telitacicept for pSS – China Phase III data • Telitacicept for gMG - China Phase III 48 weeks data • RC-148 early stage data FY2026 • Potential China approval of Telitacicept for IgAN • Potential China approval of Telitacicept for SS • Potential China approval of RC48 in 1 st line UC • Potential China approval of RC 28 for DME • BLA filing of RC28 for wAMD • Data read-out from Telitacicept for IgAN China Phase III data (2 year full-data) • Updates of RC148 clinical progress • Updates of RC48 ex-China regulatory and clinical progress from Pfizer • Updates of Telitacicept ex-China clinical progress
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THANK YOU