JS001sc / Toripalimab SC Trial

[Slide 1] Study Design Randomized, open-label, multi-center, phase III Noninferiority Induction therapy Maintenance Therapy (4 cycles, Q3W) (Q3W) elcc Group A: European Lung Cancer Congress 2026 Toripalimab SC 360 mg, SC Toripalimab SC + Pemetrexed 500 mg/m2 Primary endpoints: Key eligibility criteria Observed serum at Pemetrexed 500 mg/m2 until PD or Intolerable toxicity Cycle 1 (pre-dose Cycle 2) Age218 Carboplatin AUC 5 or Model-predicted AUC, Cisplatin 75 mg/m2 at Cycle 1 Untreated recurrent or metastatic Nsq-NSCLC R N=396 Secondary endpoints: 1:1 No EGFR-sensitive mutation and Efficacy. ORR, PFS, DCR, ALK fusion DoR, 6M-PFS rate Group B: Safety Measurable disease per RECIST v1.1 Toripalimab + Pemetrexed 500 mg/m3 Other PK parameters Toripalimab 240 mg, IV Immunogenicity ECOG PS 0-1 Pemetrexed 500 mg/m2 until PD or Intolerable toxicity (if applicable) Carboplatin AUC 5 or Cisplatin 75 mg/m2 SC: subcutaneous: IV: intravenous; AUCO2189 area under the concentration-time curve (AUC) from 0 to 21 days; ORR objective response rate: PFS: progression-free survival: DCR: disease control Fate DoR: duration at response PK: pharmacokinetic Lin Wu Organisers Partners Content of this presentation is copyright and responsibility of the author. Permission is required for re-use ESMO IASLC INTERNATIONAL ESTRO ETOP-IB 3 European Lung Cancer Congress 2026 --- [Slide 2] Safety Similar safety profiles were observed between Toripalimab SC and IV arms. 100 TEAEs with incidence = 20% in either group Toripalimab SC+ Toripalimab IV . chemotherapy 80 Grade Chemistherapy elcc European Lung (N=195) (N-198) Cancer Congress 2026 1-2 23 TEAE, (%) 195 (98.5) 194 (58.5) Toripalimab SC Grade 23 124(62.6) 110 (55.8) 60 Toripalimab IV Incidence (%) TRAE (%) 179(90.4) 180 on 4) Grade 23 75(37.9) 79(40.1) 40 AE, (%) 48 (242) (2 (21.3) Grade 23 13(6) 14 (7.1) Infusion/injection-relate 2(1.0)* 6(3.0) 20 reaction (%) TRAE leading to toripallmab 10(5.1) 9(4) discontinuation, n (%) 0 TRAE leading to death, n (%) 0 1(0.5)* . TRAE (Preatment related adverse events) reles to toripalemab-related Anemia AST increased ALT // 111 specifie Vorwing / . The specific manifiestations of ejection-rellated readions patient at CTCAL grade 1 were arm ash and skin tching and the other of CTCAE grade ware subcutaneous induration at the injection she $ The patient Sed of scule hepatits B. All basefine hepatitis B servings maders of this patient were negative. TEAE: Treatment-emergent adverse events; AST: Aspartate aminotransferase; ALT: Alanine aminotransferase Partners Organisers Lin Wu ESMO IASLC Content of this presentation is copyright and responsibility of the author Permission is required for re-use ESTRO E L ETOP-IBCSO European Lung Cancer Congress 2026 --- [Slide 3] Efficacy As in of September 30, 2025, the median follow up was 7.2 months in the toripalimab SC arm and 7.0 months the toripalimab IV arm. The comparable efficacy was observed between toripalimab SC and IV arms. elcc Toripalimab SC + chemotherapy European Lung Toripalimab N + chemotherapy Cancer Congress 2026 (N=198) (N=198) BOR, n (%) CR 1 (0.5) 0 PR 113 (57.1) 98 (49.5) SD 61 (30.8) 76(38.4) PD 10 (5.1) 18 (9.1) NE 1 (0.5) 0 NA 12 (6.1) 6 (3.0) ORR, n (%) 114 (57.6) 98 (49.5) 95% CI 50.4, 64.6 42.3,56.7 175 (88.4) 174 (87.9) DCR, n (%) 83.1, 92.5 82.5,92.1 95% CI 61.4 (49.1, 71.6) 65.4 (52.6, 75.6) 6-month DoR rate, % (95% CI) 8.1 (6.3, NE) 8.1 (6.0, 10.9) Median PFS, month (95% CI) 59.3 (50.6, 67.0) 56.8 (48.5,64.3) 6-month PFS rate, % (95% CI) 88.2(82.1,92.2) 90.6 (85.2, 94.1) 6-month OS rate, % (95% CI) Parmers Organisers Lin Wu ASLC Content of this presentation is copyright and responsibility of the author. Permission is required for re-use ESMD ESTRO L ETOP-IBCSG European Lung Cancer Congress 2026 --- [Slide 4] Study Design Randomized, open-label, multi-center, phase III Noninferiority Induction therapy Maintenance Therapy (4 cycles, Q3W) (Q3W) elcc Group A: European Lung Cancer Congress 2026 Toripalimab SC 360 mg, SC Toripalimab SC + Pemetrexed 500 mg/m2 Primary endpoints: Key eligibility criteria Observed serum at Pemetrexed 500 mg/m2 until PD or Intolerable toxicity Cycle 1 (pre-dose Cycle 2) Age218 Carboplatin AUC 5 or Model-predicted AUCs Cisplatin 75 mg/m2 at Cycle 1 Untreated recurrent or metastatic Nsq-NSCLC R N=396 Secondary endpoints: 1:1 No EGFR-sensitive mutation and Efficacy. ORR, PFS, DCR, ALK fusion DoR, 6M-PFS rate Group B: Safety Measurable disease per RECIST v1.1 Toripalimab 240 mg, IV Toripalimab + Pemetrexed 500 mg/m2 Other PK parameters Immunogenicity ECOG PS 0-1 Pemetrexed 500 mg/m2 until PD or Intolerable toxicity (if applicable) Carboplatin AUC 5 or Cisplatin 75 mg/m2 SC: subcutaneous: IV: intravenous; AUCO2189 area under the concentration-time curve (AUC) from 0 to 21 days; ORR objective response rate: PFS: progression-free survival: DCR: disease control Fate DoR: duration if response PK: pharmacokinetic Organisers Partners Lin Wu Content of this presentation is copyright and responsibility of the author. Permission is required for re-use ESMO ASLC - ESTRO ETOP-18 3 European Lung Cancer Congress 2026 --- [Slide 5] Geometric Mean for Co-primary Endpoints respectively, Geometric mean confirming ratios (GMR) noninferior for observed exposure Ctrough of toripalimab and model-predicted SC to IV. AUC₀-21day were 1.30 and 0.91, 12.5 CC European Lung Cancer Congress 2026 0.09 600 10.0 542 491 Cycle observed Crough (µg/mL) 6.84 7.5 400 5.0 2.5 Cycle model-predicted AUGOSTANA 200 0.0 Toripalimab SC Toripalimab IV 0 Toripalimab SC Toripalimab IV Treatment Group Treatment Group GMR 1.30 GMR 0.91 90% CI 0.99, 1.70 90% CI 0.86, 0.95 Organisers Partners ESMO ASLC - $ ESTRO L ETOP-IBCSG I European Lung Cancer Congress 2026 --- [Slide 6] Efficacy As in of September 30, 2025, the median follow up was 7.2 months in the toripalimab SC arm and 7.0 months the toripalimab IV arm. The comparable efficacy was observed between toripalimab SC and IV arms. elcc Toripalimab SC + chemotherapy European Lung Toripalimab N + chemotherapy Cancer Congress 2026 (N=198) (N=198) BOR, n (%) CR 1 (0.5) 0 PR 113 (57.1) 98 (49.5) SD 61 (30.8) 76(38.4) PD 10 (5.1) 18 (9.1) NE 1 (0.5) 0 NA 12 (6.1) 6 (3.0) ORR, n (%) 114 (57.6) 98 (49.5) 95% CI 50.4,64.6 42.3,56.7 175 (88.4) 174 (87.9) DCR, n (%) 83.1, 92.5 82.5,92.1 95% CI 61.4 (49.1, 71.6) 65.4(52.6,75.6) 6-month DoR rate, % (95% CI) 8.1 (6.3, NE) 8.1 (6.0, 10.9) Median PFS, month (95% CI) 59.3 (50.6, 67.0) 56.8 (48.5,64.3) 6-month PFS rate, % (95% CI) 88.2(82.1,92.2) 90.6 (85.2, 94.1) 6-month OS rate, % (95% CI) Partners Organisers Lin Wu ESMO ASLC ESTRO ETOP-IBCSG Content of this presentation is copyright and responsibility of the author. Permission is required for re-use European Lung Cancer Congress 2026 --- [Slide 7] Safety Similar safety profiles were observed between Toripalimab SC and IV arms. 100 TEAEs with incidence = 20% in either group Toripalimab SC+ Toripalimab IV . chemotherapy 80 Grade Chemotherapy elcc European Lung (N-195) (N-198) Cancer Congress 2026 1-2 23 TEAE, (%) 195 (98.5) 194 (58.5) Toripalimab SC Grade 23 124(62.6) 110 (55.8) 60 Toripalimab IV Incidence (%) TRAE (%) 179(90.4) 180(91.4) Grade 23 75(37.9) % 9 (40.1) (40. 40 AE, (%) 48 (24.2) (2 (21.3) Grade 23 13(6) 14 (7.1) Infusion/injection-relate 2(1.0)* 6(3.0) 20 reaction (%) TRAE leading to toripallmab 10(5.1) 9(4) discontinuation, n (%) 0 TRAE leading to death, n (%) 0 1(0.5)* Anemia . TRAE (treatment related adverse events) reles to toripalemab-related AST increased ALT // 111 specifie Vorwing / . The specific manifiestations of ejection-rellated readions patient of CTCAL grade 1 were arm rash and skin tching and the other of CTCAE grade ware subcutarenus induration . the injection she $ The patient Sed scule hepatitis B. All basefine hepalitis B servings maders of this patient were negative. TEAE: Treatment-emergent adverse events; AST: Aspartate aminotransferase; ALT: Alanine aminotransferase Partners Organisers Lin Wu ESMO IASLC Content of this presentation is copyright and responsibility of the author Permission is required for re-use ESTRO a L ETOP-IBCSO European Lung Cancer Congress 2026

[Slide 1] Gecp Subcutaneous Vs. Intravenous Toripalimab plus Chemotherapy, as - - 1st line treatment for recurrent or metastatic Non-squamous NSCLC Safety profile - 8MO: Wu L., ELCC, 2026. "Consistent safety profile between toripalimab SC and IV arms." - Dr. Lin Wu - Safety and practical aspects to consider Toripalimato Fortpalimab chemotherapy chemotherapy (N-198) (N=198) Although immunogenicity was the secondary TEAL (%) 195(98.5) 194(98.5) endpoint, data was not shown. Grade 23 124(62.6) 110(55.8) TRAE (%) 179(90.4) 180(91.4) Grade ≥ 3 adverse events were more frequent Grade 23 75(37.9) 79 (40.1) in the SC arm and warrant clarification HAE, (%) 48 (24 2) 42(21.3) Grade 23 13(6.6) 14(7.1) Infusion/injection-related 2(1.0)* 6(3.0) reaction (%) The main conclusion is PK non-inferiority, not TRAE leading to toripalimab 10(5.1) 0 (4.6) clinical superiority or full equivalence. discontinuation, n (%) TRAE leading to death, (%) 0 1 (0.5) * The comment of this presentation is the responsibility of the and . protected by 28 Permissions is required - - Mariano Provencio MD, PhD; Puerta de Hierro University Hospital, Madrid, Spain. --- [Slide 2] Gecp Subcutaneous Vs. Intravenous Toripalimab plus Chemotherapy, as - - 1st line treatment for recurrent or metastatic Non-squamous NSCLC Efficacy - 8MO: Wu L., ELCC, 2026. "There was comparable efficacy between toripalimab SC and IV arms." . Dr. Lin Wu - Although the clinical data is supportive, it is not definitive. Were tumor assessments conducted by independent central review or investigator assessment only? PD-L1 expression balance matters. Toripalimab (N-198) (N=198) BORL (%) CR 1(0.5) 0 PR 113(57.1) 96 (49 5) so $1 (30.8) 76 (38.4) PD 10(5.1) 18(9.1) NE 1(0.5) 0 NA 12(6.1) $(3.0) ORR,n(%) (%) 114(57.6) 98(49.5) 95% CI 50.4,64.6 423,567 DCR,n(%) (%) 175(98.4) 174(87.9) 95% 83.1.92.5 82.5.92.1 6-month Doll rate, %(90% Ci) 65.4(52.6,75.4) Median PFS, month (90% CI) 5.1(6.0,10.9) 6-month PFS rate, % (95% CI) 503(508 67.0) 56.8(48.5,64.3) Smonth 08 rate, %(M%C) 58.2(82.1,92.2) Data cutoff date: September 30, 2025 Short follow-up: Median follow-up was 7.2 months in the SC arm and 7.0 months in the IV arm. This consent of the responsibility If the subject and - by 27 5% - Mariano Provencio MD, PhD; Puerta de Hierro University Hospital, Madrid, Spain. --- [Slide 3] Gecp Subcutaneous Vs. Intravenous Toripalimab plus Chemotherapy, as - - 1st line treatment for recurrent or metastatic Non-squamous NSCLC Safety profile - 8MO: Wu L., ELCC, 2026. "Consistent safety profile between toripalimab SC and IV arms." - Dr. Lin Wu - Safety and practical aspects to consider Toripalimato Fortpalimab chemotherapy chemotherapy (N-198) (N=198) Although immunogenicity was the secondary TEAL (%) 195(98.5) 194(98.5) endpoint, data was not shown. Grade 23 124(62.6) 110(55.8) TRAE (%) 179(90.4) 180(91.4) Grade ≥ 3 adverse events were more frequent Grade 23 75(37.9) 79 (40.1) in the SC arm and warrant clarification HAE, (%) 48 (24 2) 42(21.3) Grade 23 13(6.6) 14(7.1) Infusion/injection-related 2(1.0)* 6(3.0) reaction (%) The main conclusion is PK non-inferiority, not TRAE leading to toripalimab 10(5.1) 0 (4.6) clinical superiority or full equivalence. discontinuation, n (%) TRAE leading to death, (%) 0 1 (0.5) * The comment of this presentation is the responsibility of the and . protected by 28 Permissions is required - - Mariano Provencio MD, PhD; Puerta de Hierro University Hospital, Madrid, Spain. --- [Slide 4] Gecp Subcutaneous Vs. Intravenous Toripalimab plus Chemotherapy, as rung - research 1st line treatment for recurrent or metastatic Non-squamous NSCLC J I M CARREY LIVE "Good morning, and in case / don't see ya: good afternoon, good evening, and good night!" If we want everything to stay as it is, everything must change. DAY the ON THE AIR, UNAWARE. The contant of the presentation is that reportsibility If Man suttor and n protected by 29 commone IN required to - Mariano Provencio MD, PhD; Puerta de Hierro University Hospital, Madrid, Spain.

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