中国制药与生物技术：2025年美国临床肿瘤学会（ASCO）会议第一部分——信达生物的IBI363和再鼎医药的ZL1310表现较为积极；SBP强劲亮相

www.bernsteinresearch.com BERNSTEIN TICKER TABLETickerRating9926.HK (Akeso)OONC (BeiGene)M1093.HK (CSPC)M3692.HK (Hansoh)O1801.HK (Innovent)O600276.CH (Hengrui)O1177.HK (Sino BioPh)M9688.HK (Zai Lab)MASIAXSPXO - Outperform, M - Market-Perform, U - Underperform, NR - Not Rated, CS - Coverage SuspendedONC valuation is EV/Sales (x); 1801.HK valuation is Gross Profit CAGR; ONC, 1801.HK, 1177.HK, 9688.HK base year is 2024;Source: Bloomberg, Bernstein estimates and analysis.CHINA PHARMA AND BIOTECH DETAILSINNOVENT IBI363 (PD-1/IL-2-ALPHA): COMPETITIVE PHASE 1 RESULTS IN IMMUNOTHERAPY-FAILEDCOLORECTAL CANCER AND MELANOMAMSS/pMMR CRC: competitive ph1 ORR, survival, and safety data from IBI363+beva compared to other PD-1/VEGFR combos(Note: MSS/pMMR stands for microsatellite-stable / proficient mismatch repair — the majority and harder-to-treat type ofcolorectal cancer.)Abstract: Efficacy and safety of IBI363 monotherapy or in combination with bevacizumab in patients with advanced colorectalcancer. - ASCOEXHIBIT 1:In 2L+ MSS/pMMR CRC, IBI363+beva showed competitive ORR, survival, and safety, compared to otherPD-1/VEGFR combos.SponsorProductTarget & modalityTrial No.Trial locationPhaseIndicationTherapy typePatientcharacteristicSubgroupInterventionEfficacyevaluable ptsmOS (months)mPFS (months)ORR %DCR %Safety profileNote: MSD is covered by Courtney BreenSource: Company disclosures, ASCO, ClinicalTrials.gov, Nih.gov, Bernstein analysisCHINA PHARMA AND BIOTECH University of Pittsburgh/AZ/ExelixisDurvalumabPembrolizumabPD-L1 mAbPD-1 mAbNCT03539822NCT03797326USGlobalI/IIAdvanced CRCAdvanced CRC3L+MSS/pMMRMSS/pMMRIBI363 monoIBI363 + bevacombinedIBI363 + bevacombined, No livermetastasisOverallOverallIBI363 mono 0.1-3mg/kg Q2W/Q3WDurvalumab 1500mg Q4W +Cabozantinib 40mg Q1DPembrolizumab 200mgQ3W + Levatinib 20mg6368312916.19.19.63.712.7%23.5%38.7%27.6%83.9%86.2%Grade ≥ 3 TEAEs:23.5%Grade ≥ 3 TEAEs: 39%,TEAE relateddiscontinuation: 9%Grade ≥ 3 TEAEs:50%, TEAE relateddiscontinuation: 9.4%ASCO 2025IBI363 0.6mg/kg Q2W / 1 mg/kg Q3W +beva at 7mg/kg Q2W / 7.5 mg/kg Q3WGrade ≥ 3 TEAEs: 30.1%InnoventIBI363PD-1/IL-2 BsAb Fusion proteinNCT05460767ChinaIMSS/pMMRAdvanced CRC2L+ (over 50% 4L+) MSDI/II3L+Q1D327.52.322%47% Acral and mucosal melanoma: similar ORR and better PFS than pembrolizumabAbstract: Efficacy and safety results of a first-in-class PD-1/IL-2α-bias bispecific antibody fusion protein IBI363 in patients(pts) with immunotherapy-treated, advanced acral and mucosal melanoma. - ASCOEXHIBIT 2:In I/O-treated acral and mucosal melanoma, IBI363 showed similar ORR and better PFS thanpembrolizumab did for ipilimumab-refractory melanoma in KEYNOTE-002 (note: KEYNOTE-002 was notrestricted to acral and mucosal).SponsorProductTarget &modalityTrial No.Trial locationPhaseIndicationTherapy typeSubgroupOverallw/ postbaselineassessmentTreated1mg/kg andaboveTreated at 1mg/kg Q2WLow dosePembrolizumabInterventionIBI363 1mg/kg Q2WPembrolizumab2mg/kg Q3WEfficacyevaluable pts91877430180mOS (months)13.4mPFS (months)5.72.9ORR %26.4%28.4%21%Safety profileGrade ≥ 3TEAEs: 11%,TEAE relateddiscontinuation:3%2L (refractory to ipilimumab)NCT01295827 (KEYNOTE-002)Advanced MelanomaOverall Grade ≥ 3 TEAEs: 29.7%, TEAE relateddiscontinuation: 3.3%, TEAE related death: 1.1%NCT05460767, NCT06081920I/II2L (IO treated)IBI363 100-3000 μg/kg QW/Q2W/Q3WASCO 2025InnoventIBI363PD-1/IL-2 BsAb Fusion proteinChinaNote: Keytruda OS data was in an article published later than the efficacy and safety dataSource: Company disclosures, ASCO, thelancet.com, ClinicalTrials.gov, bmj.com, onclive.com, Bernstein analysisCHINA PHARMA AND BIOTECH High dosePembrolizumabChemotherapycontrolPembrolizumab10mg/kg Q3WChemotherapycontrol18117914.711.02.92.725%4%Grade ≥ 3TEAEs: 14%,TEAE relateddiscontinuation:7%Grade ≥ 3TEAEs: 26%,TEAE relateddiscontinuation:6%IIAdvanced MelanomaGlobalMSDPembrolizumabPD-1 mAb HENGRUI SHR-A1811 (HER2 ADC): SIMILAR EFFICACY BUT NO CLEAR ADVANTAGE OVER LEADING HER2/TROP2ADCSHER2+ breast cancer with brain metastasis: SHR-A1811 better ORR but falling short in PFS vs. EnhertuAbstract: HER2-ADC trastuzumab rezetecan (SHR-A1811) in HER2-positive breast cancer with brain metastases: Updateresults from REIN trial. - ASCOEXHIBIT 3:In HER2+ BC with brain metastasis, SHR-A1811 showed better ORR but slightly worse PFS in the cross-trial comparison.SponsorDaiichi Sankyo/AZDaiichi Sankyo/AZProductEnhertuEnhertuTarget & modalityHER2 ADCHER2 ADCTrial No.TUXEDO-1, NCT04752059DESTINY-Breast01, NCT03248492Trial locationAustriaGlobalPhaseIIIITherapy type2L+2L+IndicationHER2+ BC w/ BMHER2+ BC w/ BMPatient characteristic60% had brain metastasesprogressing after previous localtherapy and 60% had receivedprevious T-DM1Median of six prior therapies in themetastatic settingInterventionSHR-A1811monoSHR-A1811 +bevacizumab5.4mg/kg IV Q3W5.4mg/kg IV Q3WEfficacy evaluable pts32221524mPFS (months)13.2NM14.018.1ORR--IC %a84.4%72.7%73.3%58.3%bSafety profileGrade 3/4TRAEs:78.8%Grade 3/4TRAE