Shanghai Henlius Biotech, Inc. Class H · HKEX:2696
Shanghai Henlius Biotech, Inc. Class H — FY2024 Earnings Presentation
47 slides from Shanghai Henlius Biotech, Inc. Class H's earnings presentation, Mar 24, 2025
Slide 1: 2024年度业绩推介
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Slide 2: 2024年度业绩亮点
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Slide 3: 2024业绩亮点
2024Ў働ࠃ͵㔀ݗҴ57.2ыͧӓӮ䃂8.2ы 㔀ݗҴ Ԇى܃ ֧ऒॡ ЎԖ㔀уৗ কਗࢻଟࡗ 57.2ы 4 ι50 48KL 12.4ы ЎԖ BD R&D ࣏у એԆ • ੧Џүङ୦։ࣲѽչ働 • ݉еDr. Reddy’s HLX15जЈࡨ • ࡎ®ࣙގйࠬनੂ܅Ї١ͫީ • ׂ֪ࡍڰЊߠ㿄ׂ֪ͧ▲ͨЏ • 2024ݶۈٶҵ57.2ьҫͫգࡁ ݼ澝ۼ੧ԃङ୦։ؘ֝ͫ࣫ ذչலਉࡨذДय़ӷֺ֨২֢Ճ ЗЌ֊▲֨ࠬनੂ܅Ї١ऀй ԗGMPࣿфࠩ܅1000ࣿͫ܅ 6.1% ҡډչՕܴ
Slide 4: Biopharma strategy and business model
࣏ࢢ६Ѷ哦 לޣԖЗ֡٠֪ո֡ଢ଼٠֪ࣩЎўҚ ۊњࣩ҄շ ոޑہ Ӫݰ哦ࢢ ݰॺܮӱ澝ٴޱ۪ݰՕЉ۞ࣣىஔ־ Օિܛङӫޏ қڱҒङսૅ ҵࣁԖ զࠆԖ澝֡ଢ଼ԖࣩbiopharmaऻҠՆى © 2025 Henlius.
Slide 5: Biosimilar commercialization revenue
יޟ६Ѷ哦ॡਠԍڬՆͧӹܗҵࣁ٠֪ • 2024ࢢ࣏ͧٵ६Ѷ哦㔀ଵֈ35.8ыъࠨٟ澞HLX11 (٦ࢿ׳Ԥ۱ͤ澝HLX14 (֩৭Ԥ۱) ૡҴІ٠࣓Ոࣂࠝͧդডॡ䃑ࣴCTLA-4澝CD38ॗҵࣁ䏣ୈ杴䎯ͧբࠖטࡢىڏК ͧټН١فҵࣁ٠֪ۙЇֲׁؗक • ޝѨ®֧ষ֡澝ԅלܔۦІ٠ۉ؎ٶநۦЎԖՆઓ২ԗষͧНҷ՚நЖૹFDAۦӔ֧ষ֡ىڏЎԖࣩуռ • Ӯ®ڈऱஸͧۦНҷ՚ॕЅࠏࡢטۦІ٠১ऒуռͧԅૻ㖥ՂݰҼ٠֪֡؞ • ઍࡋ®ࢼӮঢнAGEMEDۦӔІ٠ͧНҷ՚ॕ
Slide 6: HLX10 (PD-1) approvals
Ӫݰ哦ݯஸӮԤ۱͵ࢋ֧բ६҃ޣPD-1Ԥ۱ͧ恱Ҵҵࣁ٠֪ݰࠝ ҵࣁநЖ࣐ۦи࣠▁س劌剫䣪ࣩ۱PD-1Ԥ۱ HLX10 (PD-1) ݯஸӮԤ۱ 2024ٵASCOىठ֡ଢ଼יЗڵIIIޫASTRUM-005ऒाىठݰޣ୩੧ऒाগ߈ ® ࢩݯ | Zerpidio ® | Hetronifly ® 2022ٵ3ޤ 2023ٵ12ޤ 2025ٵ2ޤ З֡ۦ АԦнۦ ࠍࣸۦ ݕTূ劌ࡴۅ ݼڠحPD-1ӄթ ৈՠ੮ѹவ॥ם ԩࡁଇ55% ݕTূ劌ࡴۅ ӗ
Slide 7: Overseas approvals and global commercialization progress
望ҵࣁԖଂષІٜকՇ߈ۉיڰ ষ֡ ࠍࣸՂਅ֡ ޯݺ ࡎѩ®ੂ FDA܅ӕЇ١ͫۨ؏ٷ܅ЏԗՇૄ ࡎࠬ®ࣙގनੂٷͫ܅ҵਸ਼֢ӫޏકՕЊӕҵପଳ ࡎ৻®ࣙގՠાѦ࣯ԥܐչԗऐ▲ি࡞ऐ१ۅৈफ剔䣫֢எך ИڶIIIߊЛूٽ९֨ߎޙۨ؏ٷ܅ੂߎޙ҆ےৱো哦 HLX14(֪ਞԥ)ܐ, HLX11(٧࣯״ԥ)ܐЇ١કՕःબੂFDAՉࣲ HLX14(֪ਞԥࠬ)ܐनMAAੂՉࣲ HLX22 (HER2) ֢எךИڶIIIߊЛٽડੂۨٷيڐ܅ԅՓޙڐ HLX15 (ଇபػ״ԥ )ܐ42
Slide 8: Commercialization
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Slide 9: Zercepac (HLX02) trastuzumab
ޝѨ®ͣࢿ׳ޝԤ۱ͤ͵ۦІ٠֡؞ո֩ԙࣩ֡יޣу࣏ࢢ६Ѷ哦 ֡ଢ଼ռઔ पט㘦З 28.10ы* • Зੂ܅Ї١ङ֢ф࣯״ԥܐ • ਘڏЏԗ֝П֨حИ֢ӄङЏԗͫٺݐ • З֨ࠬࡳੂ܅Ї١ङ“И֢书”ԥ࣒ࣿܐঝѷ哦 600դЋЏыۨুבङЏԗ֝ͫৼࢾг 匝䣫࡞ऐֿͫҶவतҶ֢ҹם୦։Ԛֿ 2024ݗٵҴ • ֨২֢澝Ԇܳ܅ੂםЇ١ͫۨО֨И֢澝ࠬࡳ澝২֢ І֪֮ੂ܅ङ“И֢书”࣒ࣿঝѷ哦 • ਚԃйȔЉએ▲ЗHER2 ஆےۅৱЈȕܴͫ ֠ԛ؆ݾਃ澝ԛऐ݇ރם澝HER2ࠒࡹ
Slide 10: HLX11 pertuzumab biosimilar
ޝѨ®ࢮ▁ݸзࣩՄߡո֡ଢ଼ռઔ٪ਸ਼ЎஔҮࣩъ࣏֭уԂ Ѩи֡Ӄ Ӫݰ哦Ѣ ▁ъ࣏֭уԂ ࣩъ࣏֭ બ500Є уԂ 2024څٵ ։▁Մߡࣩࢿ׳ޝԤ۱ ڟԖуռѨԍͧैڎोеѨԍ ՆޝܝѨ®Љ®҃ר ࣩԢբҀ࣐ ٚڐԖज़ • ݽ୩֪Շ࣫١֫䡺ࢵͫОИ֢ • சवҿѕ࣯״ԥܐфսͫљՃ࣯״ • ۨԅЇ١ࡎ߁ܞשͧ®҄ש ࣛͧتڀ HER2+г匝䣫ےৱ૯ؔӲͫ ݐӟՅઁࠀӷֺ ԥܐजЈӷֺչ٧࣯״࣯״जЈӷֺ হҵԛґͫॼжہԎޙञߒז ͫͨؿЊࡎѩ®ԣգͫٺݐ ࡎؐזر
Slide 11: Hanshuyou neratinib
͵ͤؾޢۿרͣ®҃רуռԢբͧ⻒ؗHER2+в匝䣪ॡ 0.45ыҪ 2024ݗٵҴͣІ٠ଵֈ3Жͤޤי уռԢբ • (ؿ߁ܞשNeratinib)ީ▲य़Ս߆ङЉՕଢङࡤHER ى܃ЎԖ١ف • ҭӣӯऀࡎѩЏԗ֝ٝ߄ङ١֫तਈԃљ 懗㾓懤ࢬ懢܌Ӳӷ(TKI)澞ࡎީ®҄שҸ՛г匝䣫࡞ऐ Ճۯؚ࢛֪ͫڽ澝ݕ֪ࡤٺԟHER2ஆߊޝۅ ֿՁ▲୍фսͫЊিИ࣫߄фսࡎѩڥ г匝䣫ڠԗૼԉ࡞ऐङऽެࣤչ࡞ऐࣤͫݐԈڠԗ ۨԣգͫ߄߈▲࠵ѺHER2ஆߊޝۅг匝䣫ےৱ ૼԉऩ߶ы৩(ߊޝHER2
Slide 12: HLX10 Hansizhuang
ݯͣ®ࢩݯஸӮԤ۱ͤ͵૯ࣼࣤڀটͧۦҵ੍ࣴޫޏ剫䣪ոடॡ䣪 ࡅٹڰੜՔ ٚڐԖज़ࣛͧૻ۴Ԩ٠֪ 13.13ы* • ҶࣱЗੂ▲܅ি࡞ऐES-SCLCङܐPD-1ԥܐ • ▲িள沨ࣙளূش劌剫䣫ଠځऔй2024ٶ12߃֢֨ӄੂ ܅Ї١ • வثPD-(L)1١֫ࢬࢸङॼж࣪ͫӲؔٛڑԗङੈ୦ ঌऋͫ⼂ূشؘ劌剫䣫ֿ剰䣃Ҳ䡏࡞ऐङحৱ֪ ѹͫݕԟளূش劌剫䣫չௐ䣫١֫ѡௌͫڠԗثۯؚ 2024ݗٵҴ фսङҒڶ • 2025ٶ2߃ͫйࠬनੂ܅Ї١ͫऀй▲ি࡞ऐشߊࡤٺ ূ
Slide 13: HLX10 Phase III expansion
®ࢩݯӞ৸ࣩЎԖࢴݝոٚڐԖуռज़ࣛ ▁ࡗࣩ ▁ъ࣏֭уԂ ЎԖࢴݝ બ240Є 13.13ыҪ 2024څٵ 2024څٵ ٚڐԖज़ࣛͧ ҵڏՆ ܶԞடॡ沨䣪 ܶӸ١ف োࢎس劌剫䣪 ஂس劌剫䣪٠֪ ٠֪Ѡ গࣻ剔䣪ո剳䣪 ٚڐԖज़ ͣԨ㔀Ѽ剫䣪㕨ীࣩ15-20%ͤ • ள沨ࣙளূش劌剫䣫 • םԃ֨®ࣙގࡎٺݐௐ • ݕӹ٢ͫقОߌߛङ ࣛͧتڀ • ॥ߢॼثځս֨ূش劌 剫䣫ֿ٫ߛङܸ۫ͫ ଠځऔङੂءܢͫ܅ 䣫Ҳ䡏࡞ऐѩԎы৩ ৈफ剔䣫չ剳䣫ֿ дࡎ֨ࣙގ剫䣫ֿ ИङԤ
Slide 14: HLX04 bevacizumab
ઍࡋ®ͣઍѥࢿԤ۱ͤ͵Մૹଂ٠֪Ґܕளૻେ ऴ߃ى܃ЎԖ١ف ࣐哦ॺܮݰ 1.97ы 2024ݗٵҴ ֡Ӄ٠֪ • ؏ۨ31मԛґ֪ͫ28मܵ߶ܥৠ • И֢֊▲߄ܨ१ۅৈफ剔䣫IIIߊЛ݇ރٽङ ાѦ࣯ԥܐ • ৼࢾՅପଳ١֫ͫݕԟ١֫גͫڽବԆ୦ • Օ৻ՠࡎܐͧ®ࣙގPD-1ԥيڐͨܐ剰䣃Ҳ䡏 բࠢେ65% • ॥ߢࡌجளՅପଳ֪Ԛङԛஓӕҵߑѫ ৻ՠऐࡣͫऀࡤٺй՟ঝ剰䣃࡞ऐ • ॥ߢՀЊमதжՈߑѫ ֡ଢ଼٠֪ • Њ Eurofarma ՠҁͫ݉еҿ֨ւ澝߿ڎ澝 ӯঈ
Slide 15: HLX01 and HLX03
Ӯͣ®ڈӮ׳㨓Ԥ۱ͤ͵㌓֠٠֪ஔ֩جѸ ૢ®ͣެԤ۱ͤ͵١ف১ાұ䡎ࣣஔ־ 5.28ы 2024؏וٵ望 ۶ॏݗҴ 0.40ыҪ 2024؏וٵ望 ۶ॏݗҴ ֡ӃநЖ࣏ࢢ६Ѷ哦 ਫ਼ࠠ▁Ж㕨ীؿڀ • 2019.02ੂͫ܅И֢З࣒ࣿঝѷ哦ͫЗ֢фӯ״㨥ԥܐ • Ҹ՛࡞ऐਘ૯Ҳ䡏ऒओङфս • 2022.02ޏଠځऔੂͫ܅И֢Зੂ܅ঝ࢘Ҽਭ䎏ͧRAͨङӯ״㨥ԥܐ • ֢ӄЗثИ֢ୣㆼओےৱيڐIIIߊЛूٽ९ङଇߋԥ࣒ࣿܐঝѷ哦 • ۨॹ֢ӄЗثਘ૯Ҳ䡏
Slide 16: Business development
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Slide 17: Abbott and Dr. Reddy's licensing deals
ޫԆى܃һିܪטتуռ Abbott Products Dr. Reddy’s Operations AG. Laboratories SA ՟բढ़ਜ਼ޫݺ: 2024/12/31 ՟բढ़ਜ਼ޫݺ: 2025/02/06 ى܃՟Ҁуռո֩ԙ ܪטت ֙ࠏଜञ࣏ࢢ६Ѷ哦ո▁ࠏ࣏ࢢӪݰ哦 HLX15 (غ׳Ԥ۱࣏ࢢ६Ѷ哦) 69ЖݰҼ٠੍֪֡ࣴͣ؞нࡔ澝▂ۿষ ষ֡Ղ42Жࠍࡔ֡؞ո֩ԙ ࡔոԅԎࠢࡢ֩ԙՂЗАԗஂͤ 3300ЄষҪநѕࠏ澝㔀ଟબ1.3ыষҪ ंԽԥ▲֢؟ՠҁي۽ਙޏךҽ١࢛֫ͫޅՠ Ҷࣱघь١қ୍ॎфս
Slide 18: Breast cancer BD strategy
ڕטتૡোࢎ͵ૹBDڕૡتى܃в匝䣪Јբнֹࣩ١ف ER+/ ६ֹ в匝䣪ஔ־уռ HER2+ HER2- ॺۿ㨓৽ (سӢSERM*): • ܞফ㨥ਮثࢬপՉѽͧERͨङ࣒ࣿࡴۅӀ߄ুৃ ଣۅܫͺER֨г匝䣫औূ劌И੮࣫ӟ܌Ӳࡴͫۅգ ޞՕљࢬࡴুৃূ劌 ؾޢۿר ()®҃ר • ܞফ㨥ਮӀ߄ߛਘESR1ॳՊ䣫औङДЗIIߊЛٽડ ֟ޫޱ ङஆ݇ރۅͺЊાӯͧ䮠ߛCDK4/6܌Ӳӷͨ ৻ՠ҅ऀͫޗͧߊࣿيPFSͨଇӱ13.9З߃ͫ㾋 ՛৩৻ՠાӯङԷPFSО5З߃٘
Slide 19: Global commercialization partners
ܪטتোࢎ͵؏ו望֡ଢ଼ռઔࣩ࣏ࢢ६Ѷ哦ଵکҵࣁ٠֪ Լऒ哦Ղ࣏ࢢ६Ѷ哦٠֪ࠆ ٜܪטتޥ՟Ҁѩѳ ࠍݸظষܪ՟Ҁѩѳ 2024ٶҶࣱ୦։ௌͧь২ҫͨ 2024ٶҶࣱ୦։ௌͧь২ҫͨ HLX17- ࠍࣸ澝ষ֡澝ԅלܔ澝Аࣸ澝 HLX03- ٦ԧӮࢿԤ۱ ЗАոԗஂॗ֩ԙ՟Ҁѩѳ PD-1 ެԤ۱ 294.8 Abbott TNF-Į (362.6)* 161.5 HLX18- ঈࠗӮغԤ۱ HLX02- HLX15- PD-1 Аࣸ澝ЗАոԗஂॗ֩ԙ՟Ҁѩѳ 102.0 HLX16- ࢿ׳ޝԤ۱ غ׳Ԥ۱ HLX1102- HER
Slide 20: R&D
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Slide 21: Pipeline and clinical stages
уռঐ՟ոॡ Pre-IND / IND Iޫ IIޫ IIIޫ NDA І٠ (6) (1ͨ HLX6018 HLX10(5)ͧގ௩ӯԥͨܐ+ HLX07 HLX10(5)ͧގ௩ӯԥͨܐ+ ԗऐ HLX14֪ͧਞԥ( ͨܐ12) ࡎގͧ ®ࣙގ௩ӯԥ(ͨܐ5) HLX79 GARP/TGF-ȕ PD-1+EGFR PD-1 RANKL PD-1 ы⭧䃠懤懢壝ՠ堢ग ࣔՇۅ剫লԗ ףேୂ沨ࣙূ劌䣫ͫ௶ռ䣫ͫ沨ࣙளূش ূشߊࡤٺ劌剫䣫 1L ૅऎߠऔঈ 沨ࣙளূش劌剫䣫ͫূشߊࡤٺ劌剫䣫ͫ ࡴԈߊ副ࣱش副䎏 劌剫䣫ঈؘѽ䣃 ௐ
Slide 22: 2024 R&D milestones
Кټॡһିૡस͵2024֚ٵஐ 2024 HLX04ઍࡋ® HLX01Ӯ®ڈ HLX10®ࢩݯ HLX10®ࢩݯ HLX14 १ۅৈफ剔䣫ͫޮߊ澝 HLX11 ளமר䃷ٞ䣃ۣͫۅ ূشߊࡤٺ劌剫䣫 沨ࣙளূش劌剫䣫 ্եૅऎߠঈ १ז۪ۅՇۅளূش劌 г匝䣫 䃷ٞূ劌ग੦ओͫঝ ▲ি࡞ऐͧآگ澝ਸ਼֢澝 ▲ি࡞ऐͧԭؿ澝ࡪ֢澝 剫䣫ͫਇૅ࠾ূ劌䣃ঈ ૼޏԉ࡞ऐͧИ֢&২֢ͨ ͧࠬन&Ԇܳ&ם২֢ͨ ࢘Ҽਭ䎏 (ܞ২֢)؟ ࣶב澝ԧ澝ԭͨچ ߳ͨة־ ͧХͨ֩ܞ ܶрNDA/BLA
Slide 23: 2025 milestones
Кټॡһିૡस͵2025 2025H1 2025H2 HLX10®ࢩݯ HLX10®ࢩݯ HLX10®ࢩݯ HLX04ઍࡋ® HLX04-O HLX14 HLX10®ࢩݯ ূشߊࡤٺ劌剫䣫 沨ࣙளূش劌剫䣫 ள沨ࣙளূش劌剫 १ۅৈफ剔䣫ͫޮߊ澝 ࢘ٶۅ௹बҼۅ௰އՊۅ ্եૅऎߠঈ ௐ沨ࣙূ劌䣫 ▲ি࡞ऐͧИ֢澝 ▲ি࡞ऐͧ ͨآگ䣫 १ז۪ۅՇۅளূش劌剫 ▲ি࡞ऐ ͧਸ਼֢ ͨ ▲ি࡞ऐͧࠬनͨ ИБљՃԘள֢؟澝֦ ▲ি࡞ऐͧԭؿ澝 䣫ͫਇૅ࠾ূ劌䣃ঈ ͧ২֢ͨ ৶ҿ澝ܞ২֢ͨ؟
Slide 24: HLX10-015-CRC301 clinical results
HLX10-015-CRC301Кੰټயগ߈ ۬݇ރਙ2024/6/30ͺИѹசઘޞ31.0З߃ • ݯͣ®ࢩݯஸӮԤ۱ͤ՟ઍࡋ®ͣHLX04ͧઍѥࢿԤ۱ͤոԖ࣐࣠и▁࣠ૃश㓬গࣻ剔䣪ͣmCRCࣩͤIIIޫКټऒाͣHLX10-015-CRC301ͤগ߈ј۶ړڤҴ2025ٵ ষ֡Кټ剰䣂Ѫ剳剔ଂ剰䣂ऒѪͣASCO GIͤ • ੴऒाগ߈ދठ֧ͧૃश㓬গࣻ剔䣪㕨ীЗͧЉ،㘯ӶԅઍѥࢿԤ۱ոԖ࣠ࣼࠢͧݯஸӮԤ۱՟ઍѥࢿԤ۱ոԖ࣠ދਚޭݘকࣩ࣠mCRC㕨ী࣏ͧޫЋ،ҵ㓬Քܰ澞ГЖ࣠ ঐӞࢻʅ3ঃ࣠ࣼһЈ৶жѝ
Slide 25: HLX10 gastric cancer neoadjuvant
ݯஸӮԤ۱͵١فٚڐԖ૯ࣤڀ ݇Checkmate 649ડՉડৱׂি݇ރӣߤͫ60%ޮߊ剳䣫ےৱCPS5澞 ߎડગઋѤԯݕӹ୧ؔPD-L1ஆͧۅCPS5ͨы৩ͫ҅ގ௩ӯԥۨ߈߄ܐОҵࣁஔҮ澝 ֡Ӄ։▁剳䣪֟ޫޱұ䡎哦ࢢ 剳䣪 ۩֢ޏٶՇ剳䣫40Ѕ҆1,2ͫҿИ2/3ےৱଠؖ੧֠۴ߐߊ࡞ऐ2ͫசव剳୶ࠒ߲ޯ Ճͫથୂӣےৱرଦٶଧ ݰોԈ՟Ԗ࣠/ોԈݯஸӮԤ哦 ऩӹ剳䣫֠ߐߊ߶ӕ࡞ऐИѹޗзўࣿߊ3ײͫٶડۨԅͫઋୂםӣےৱ҅ऀގ ௩ӯԥرޞܐՕଇ20
Slide 26: HLX22 HER2 gastric cancer first-line
HLX22͵ҿݘޥՉࣹӸ▁剳䣪SOCࣩࢋԂ HLX22ͣHER2ͤ • HLX22杴էHer2ङdomain IVङЈբ੮ѹ澞ЊգО杴էHer2 domain IVङ࣯״ԥܐङ৻ՠͫՕգޞҏ HER2/HER2 գ࢛и ৼѽչ HER2/EGFR ࢛ڑиৼѽङӄթҁऀͫرHER2ङӄթݕ 40-80%ͫ PDxު݇ރॐ࣯ͫ״ԥܐЊHLX22ङ৻ऀऐࡣ֨剳䣫 ଠځऔЇࡁ࣯״ԥ৻ܐՠ٧࣯״ԥܐӀѩԎ • ׂй࣫உ࠼ЛٽIIߊ֨ͫ݇ރ१ۅ剳䣫չ剳ௐсउ䣫ङ▲ি࡞ऐ ИЊ࣫੧߶ӕ࡞ऐͧ2010܅ੂٶङ࣯״
Slide 27: HLX22-GC-201 clinical results
HLX22-GC-201Кੰټயগ߈ ۬݇ރਙ2024/6/30ͺИѹசઘޞHLX22ু20.3З߃ͫ؍㙁ӷু24.0З߃ • Ӫֹݰ۱HER2Ԥ۱HLX22՟ޝѨ®ͣHLX02ͧࢿ׳ޝԤ۱ͤոԖ࣐࣠и▁࣠HER2୕㓬فૃۋޫޏश㓬剳/剳டॡрࣙͣG/GEJͤ䣪ࣩIIޫКټऒाͣHLX22-GC-201ͤগ߈ј ۶ړڤҴ2025ٵষ֡Кټ剰䣂Ѫ剳剔ଂ剰䣂ऒѪͣASCO GIͤ • ऒाগ߈ދठ֧ͧHLX02+XELOXׁࣩकІԅҴHLX22ՔܶளHER2୕㓬G/GEJ䣪㕨ী▁ࣩ࣏࣠ޫո۱剰䣂Յͧڀ
Slide 28: HLX22-GC-201 PFS and OS data
HLX22-GC-201Оੌऒाও䎯͵ݸૡޫ࣏ىјՂ㔀࣏ޫ ंࣞॹڧҦછѳմѫ߿ؘ݇ѽ 䣃րځછѳ߶ӕ1.1࣍છѳ • ۍ২2024ٵ06ޤ30ͧݺҾЗHLX22ঐЗѸ୩੧ ݿ20.3Ж ͧޤ،㘯Ӷঐ24Жޤ HLX22 + ࢿ׳ޝԤ۱ + XELOX ،㘯Ӷ + ࢿ׳ޝԤ۱ + XELOX HLX22 ঐ ،㘯Ӷঐ (n = 31) (n = 31) mPFS, months (95% CI) NR (23.5–NE) 8.3 (5.7–12.7) HR (95% CI) 0.2 (0.06–0.45) p<0.0001
Slide 29: HLX43 PD-L1 ADC
HLX43͵TMALIN*ܯոTOPO1iࠡॹૉࣩ۱PD-L1 ADCͧ Ї▁іI/O ADCઞу ۱PD-L1۱Ѽ һିي㓬 ڏՆज़ࣛ • ৈՠਈԃչՕӄԗङы࢛ԗIgG1ͫЛूٽ९ٝ • PD-L1ͫࡤٺङ剰䣃И੮ଇͫ৲֨࠳ৃুٯИѺ ચ؍ҶͫۅӀ߄IP ੮ଇͫ▲ЗॼжࠀױقЌࡤٺऀځङADC杴ࢵ • ՕઆЌ剰䣂ͣࢺڲTMEͤࢍࡕङІ剮କݎ • ৻ؖTMALINକࣔࣞݎङࡀপୋߑݹӲ • ࣪ڲ੦䃠Иچ६ؔङକݎ • ݼਈङ߄ڐۘ܃懢1ۭӱӶૺਾͫӀ߄िԡੰߊչ • ݼչѺԡੰߊङ
Slide 30: HLX43 PD-L1 expression and patient populations
HLX43: ֧יम६ֹࣩؗѼ䣂IIޫКټЗૡਸ਼࣠ॺܮݝ ֧יमؗѼ䣂Зࡅٹ ࠳ৃুٯ੮ଇࡊٵѺ | ПقஒйҲ䡏ূ劌 ࡗਸ਼ࣣ ؗѼ䣂 PDL1 ࡗਸ਼ࣣ ऩ߶ଠځऔ ऩ߶ଠځऔ چٶзўރ چٶзўރ З֡/ҵࣁ HLX43 HLX43 З֡/ҵࣁ TPS ͽ1% | 50% CPS >1% 剫䣪 (NSCLC) 剳䣪 1000k/2000k ¥ 71% | 37% 84% ¥ 470k/1140k গ剔䣪 டॡ䣪 510k/1900k ¥ 31% | 5% 86% ¥ 320k/600k ㌐䣪 剑劌䣪
Slide 31: HLX43 preclinical and early clinical data
HLX43͵ࢻىѨڐКټӸ哦ٶܨݤݝٜૡҴКټIIޫ КټӸؗயগ߈ • HLX43تPD-L1୕㓬ъ६۱Լձ劌ݸұ䡎ࠡ㓬 HLX43تPD-L1୕㓬ъ६۱Լձ劌ݸұ䡎ࠡ㓬 HLX43ࢻىѨݳࣩڐীڀݝ • HLX43ࢻىѨݳࣩڐীڀݝ • ֧ѼӃ哦ݝऒाЗͧHLX43֧יमPD-L1+CDXոPDXࠆֹЗج剰䣂ࡤ૭ͧ ٶЋ哦ࢢ،ҵ㓬৶ͧװЉتঐࣼࠢ՞Ӷଞঐচ哦سѼଜ֭ދރݸՉԖ I. ֨MDA-MB-231ֺࠥИͫյো哦▲ࠩͫড࣠Ѕմդԇࢢࣩ剰䣂Ѽऴ ދਚবͧس
Slide 32: HLX43 efficacy in PDX and CDX models
HLX43֧ЈբPDXЉCDXࠆֹЗࣩ۱剰䣂Ԅݝ GC (treatment naïve, KRASm) 1 LU6437 PDX model 2 CRC (MSI-H, Pembro resistant) 3 PD-L1 IHC 3+, TPS 80% PD-L1 IHC 2+, TPS 70% (sqNSCLC PD-L1 IHC 2+, HLX10 resistant) Model with hPBMC reconstitution Vehicle control C24,0.24 mpk; TGI 34.12%(D21) 2000 HLX20, 10 mpk; TGI 14.89(
Slide 33: Innovation
4.1 ݾऒ © 2025 Henlius.
Slide 34: Innovation platforms
ҿޥҵࣁोеԂࣩٚڐԖӪݰऒՆٴՕ Tri-specific TCE Platform HanjugatorTM ADC Platform HAI Club Anti- TAA Activation Signaling 2 of T cells Activation Anti- Signaling 1 TAA of T cells • ܴСङࣔڑङTূ劌ࢬࡴځݼ • ࡞ם۽ऐॶՍ • ޏ܇جङ哦࣒杴ࢵ • ѺҲ䡏ূ劌䂫䃔ङ剰䣃ي࣪ڳॐױङ哦ݼ • ұ߆ऀ҅ࡤٺثङࡀপङ৳哦ۅ • ѺۨߎݕݼञङूՇ • ѺCRSङՇࣿ •
Slide 35: Tri-specific TCE platform
ޟ،ҵࣩݝޥTCEЅࢤڐ㓬ٴՕ ѹT劌䂙䃂ЇޟѨࣩ哦ݝ 1 TAA-dependent T cell Activation 3 Redirected Tumor Lysis ޟѹࣩ劌֛ଚݚ IL-6 IL-4 IL-10 5 1.0 150 4 0.8 IL-10 (pg/mL) IL-6 (pg/mL) 100 IL-4 (pg/mL) 3 0.6 2 0.4 2 CD3-dependent CD28 Activation 50 1 0.2 0 0.0 0 TAA: Tumor associated antigen 6h after first do
Slide 36: HLX97 KAT6A/B degrader
HLX97: ࢋ֧ “ Best-In-Class” ࣩ࣠ERŗ+в匝䣪ࣩՌާسӢۭӱӶ ՌާسӢۭӱӶ • ޏҽङ੮Ѯ杴ࢵKAT6A/B • ߄Ӭ࠵Лھࠢٽચङ杴ࢵ • ҶޏҁऀߑӲͫךय़৻ऀՕਈٷұ߆৳哦 • Ӏוէӹি࡞ऐ㞱ङࢪԃ • ࡁॼսڠङѽӄܐי剰䣃ࡴۅ • ࣞࣔङPKࣔͫګѺ哦࣒ङ࣪ڲர • ѩڑङADMETૅۅ • ߄߈આӐॼսङҼ୰Љૡ֨杴ङ੦बࡀۅ 36 © 2025 Henlius.
Slide 37: HLX316 B7H3 sialidase
HLX316: ▁ЖӪݰЋநӪB7H3杴䎯⬷䃎懤懢࣠ؗѼ䣂ࣩԄৗ㓬哦ࢢ 杴զԄৗӢ Sialidase • B7H3 (CD276): ▲Зޏҽङऀй䣫औ࡞ऐङܐԽ (TAA) Anti-B7H3 • Hypersialylation⭧䃠懤ԗ֨剰䣃ূ劌ଋچ੮ଇ VHH ܌ٷӲ剰䣃Ҳ䡏Նځ • HLX316: Fc壝ՠङB7H3杴է⭧䃠懤懢ͫث剰䣃ূ劌 Ծ⭧䃠懤ђ৲ڠҲ䡏Նځ Fc • Palleon EAGLEٵՖङ⭧䃠懤懢 • HenliusՇޢङܐB7H3 VHH • ӫޏЌӫ(FIC) 37 © 2025 Henli
Slide 38: HLX48 EGFR x c-MET ADC
HLX48: ࢋ֧ “ Best-In-Class” ࣩ࣠NSCLCոCRCࣩEGFR x c-MET ADC BISPECIFIC ANTIBODY • ѺEGFRъչԃͫӗূٯ࠳ص劌ࡀۅ Anti-c-MET Anti-EGFR • ڠc-METԥਖъչԃؘͫ࣫c-METѐح ङ杴էۅ • ܐڠѽӄթҁऀ • ґܴܐѽਖङ剰䣃܌Ӳࡴۅ LINKER PAYLOAD • ६ؔङକݎ • ѩԗङՠଠpotencyङpayload • םङЛ࡞ٽऐॶՍ 38 © 2025 Henlius.
Slide 39: Operations
05 ࣏у © 2025 Henlius.
Slide 40: Manufacturing capacity and GMP
֡ଢ଼ஔҮࣩ࣏уઔଞৗԂԈԂҵࣁЎԖ١ف ׂ֪ࡍڰ ߠ㿄ׂ֪ ߠ㿄ׂ֪ ͧ▲ͨ ͧиͨ • уৗܕডѨԖ • ֡ଢ଼ߗӔઔଞѼॸ ЏԗGMPࣿфࠩ܅બ1000ۦ • ࣹ▁ޫԮؑݗࢁ֣ذ (YS+SJ1) ࣏уۉԄࢴબ98% ੂڱЗ֡澝ࠍࣸ澝ষ֡GMPੜ੩ ٝ؏ۨ▲ߊாऩޅѽԴ۰ڏગͫфਈत • HLX02ͣޝѨ®ͤҵܕݖষ֡٠֪҇ڀ Լ䃎澝ࠫଢӱӶ澝ஓҬଢՂADCҡࣿф • ј֡ଢ଼Ԗռઔહਸ਼Ȑ望ઔଞȑ фս҈ځतЗ֡澝ࠍࣸ澝ٝੋ澝Ԭؾڅ • ԅૻܱૡݰуռІ٠ • ܱૻڼૡуࢻؗҵࣁԖ҇ڀ ੋн澝࠺ࢤ澝
Slide 41: AI and digital manufacturing
ԣભਗͧܕডӪͧݰ㌓֠ਸ਼Ўஔجী֩Ѹ ۪ޱӪݰ ॳ࣮ਗ AIટৗ ॳ࣮ࣹैબ200Ж ࣿфٗਫՃИ݇ރݏਘԈ܍ՈՃԎ ॳ࣮ਗ ࡹٶԗݶञІԞЅ* ࡹ؏ۨڐՇࡹડ HLX01ͧࡎӯͨ®ډՃHLX04 ͧࡎાࡪ® ͨପଋٗਫѩԗͫૻ ிӯ؏ۨܞҰ崭 2023ܶٶԞуଞબ10% ֨200LՆ֘ځЇङਘԈՆݏӲࡹડ ۪ޱӪݰ ॸঞٴՕڎ੦ ԣભ҇ڀ ԣભ҇ڀ BIॸঞ࣐ڀ ࣒މफݎߎ ࣿф澝ૅ澝҈ځҼ୰ܶޞؘރडࡹ 2024 ҵٵୠޯࠢ҅બ10%* க
Slide 42: 2024 financial overview
06 2024څٵએԆ֚ஐ © 2025 Henlius.
Slide 43: Revenue by product
2024ٵҵݗٵҴং57.2ыҪͧբࠢେ6.1% 㔀ݗҴ(ъࠨٟы) уռݗҴ(ъࠨٟы) 2024ݗٵҴ߄(ۉъࠨٟы) 2024 2023 % ՟фս2024ݶҵԩࡁ 8.3% 6.1% 70.2% 49.1% 67.8% 49.3 28.1 27.4 57.2 45.5 53.9 22.9% 32.1 26.8 13.1 11.2 13.8% 9.2% 7.9 8.4 5.3 5.2 3.4% 0.7% 0.8% 2.0 1.2 0.4 0.6 0.5 0.0 ࡎӯ®ډ ࡎѩ® ࡎଇଓ® ࡎ®ࣙގ ࡎાࡪ® ࡎ®҄ש BDՃ (ӯ״㨥ԥ
Slide 44: Profit, R&D expenses and cash
2024ҵܕٵড䥞Ӯͧকਗ㓬ࢻଟӓࡗҴ12.4ыҪ ӓӮ䃂(ӓ◚͵)ܤҐܕ䥞Ӯ(ъࠨٟы) ऒՆࣼһݖӞ(ъࠨٟы) Ӕӯ䃔(Ӕ☊݃)ࣤ Ӕӯ䃔(Ӕ☊݃) ߆҈ݕԇۨߎ* ߎԗूՇݵӟ ોऀԗूՇݵӟ 14.3% 25.2 24.8 10.1% 3.4 21.1 6.4 8.20 7.9 6.8 5.46 8.1 3.1 (6.95) 13.9 11.2 10.4 -21.6% 2022 2023 2024 2022 2023 2024 *߿݇ѫઋؘԇͫЊߓ݉יثङфս߄ҼङूՇҵઋҵ߆҈ݕԇۨߎ কਗ㓬ࢻଟࡗܕডНࠔ(ъࠨٟы) ՞ચ࣐Ԩ㔀
Slide 45: Financial summary YOY
એԆੌ݅ܨݤ ӢએԆܨݤ 2024 2023 YOYେ ԥѹ ыࡇ٠घЅҫ ԩݶҵ% ыࡇ٠घЅҫ ԩݶҵ% % ݗҴ 5,724.4 100.0% 5,394.9 100.0% 6.1% уռݗҴ 4,933.5 86.2% 4,553.5 84.4% 8.3% BDՂҾєݗҴ 790.9 13.8% 841.4 15.6% (6.0%) ଵֈޯۉ (1,539.8) (26.9%) (1,476.1) (27.4%) 4.3% ଵֈચ࣐ (1,917.4) (33.5%) (1,754.2) (32.5%) 9.3% ॡࣂચ࣐ (370.8) (6.
Slide 46: Disclaimer
ރב Disclaimer • ࡎؐז望澝ஐଚы۪҈ݕыކߎثўӄކͧؠўӄؠу߄Օਈԕܬӹ䨶ۅஐଚ֮ͨЉҟӟޢॐ۪௳ॐङґચ澝۪ޢגஐଚͧԕܬѸЉஒйߎӄثؠОѠ۞ࣔؔऩङ৲Ҽйӄؠ ۱Ӏ߄ङՃۅޞ澝ପऀۅ澝তेۅङ۪ͫޢגৱҼй҅ऀߎކўӄؠ۱ੂڱҒޗێનՕҒङͨޢג澞߄֜ײҼӄ֨ؠ୪ન澝ࢥ۪עӕФה৲ږਚङ੧О۪ৈߧͫࡎؐז望澝ஐ ଚы۪҈ݕы࠴ثЉુܛ܈Ѡ澞 • ߎކўՃҿИ۱ԕխӄؠङ۱߄ߓӯԕࡎؐזं֮ߓ࣍ܬ望ࣞ؟۱߄ͫҿИबҼङ“He
Slide 47: © 2025 Henlius.
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