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中国生物制药-JPM-202401 .pdf

1、中國生物製藥有限公司SINO BIOPHARMACEUTICAL LIMITED(1177 HK)2024 J.P.Morgan Healthcare ConferenceInnovation-driven Leading Pharma Co.in ChinaJan 2024This presentation has been prepared by Sino Biopharmaceutical Co.,Ltd.(hereinafter referred to as the“Company”)for reference purposes only.By reviewing or obtaini

2、ng the information contained in this material,you hereby acknowledge and agree that the company,or any of its directors,shareholders,employees,agents,affiliates,consultants or representatives,makes no representations,warranties or undertakings,express or implied.And should not rely on the accuracy,f

3、airness,completeness or correctness of the information or opinions provided or contained in this presentation.The company or any of its directors,shareholders,employees,agents,affiliates,consultants or representatives are not(by negligence or otherwise)caused by any information provided or contained

4、 in this presentation or other reasons related to this presentation.Any liability for any loss.Information provided or contained in this presentation is subject to change without notice and is not guaranteed.This presentation does not constitute an offer to sell or issue,nor does it constitute an in

5、vitation or recommendation to purchase or subscribe for any securities sold by the Company.No part of this presentation constitutes a basis or reliance on any contract or investment decision relating to any securities or otherwise.This presentation does not contain all relevant information about the

6、 company or its securities,especially information relating to the risks and special considerations of investing in the companys securities.Nothing contained in this presentation shall be a commitment or representation of the companys past or future performance.Past performance is not guaranteed or p

7、redicts future performance.You acknowledge that any evaluations you may have about the Company will be independent of this presentation and that you will be solely responsible for your own assessment of the companys market and market position,and that you will conduct your own analysis and form your

8、 own responsibilities for the future performance of the companys business.Certain statements in this presentation and other statements that the company may make are forward-looking statements.These statements reflect the companys intentions,beliefs or current expectations for the future.Such stateme

9、nts may be identified by the words expect,plan,will,estimate,forecast,intended,expected,believe,confident or similar Words.These forward-looking statements are not guarantees of future performance,but are based on assumptions about the companys operations and other factors,many of which are beyond t

10、he companys control and,therefore,actual results may differ materially from these forward-looking statements.The company or any of its affiliates,consultants or representatives has no obligation or commitment to modify forward-looking statements to reflect future events or circumstances.This present

11、ation also includes adjusted financial indicators that are not intended to be considered as isolation or substitution of financial information prepared and stated in accordance with Hong Kong Financial Reporting Standards.In addition,the companys calculation of adjusted financial indicators may be d

12、ifferent from the calculations used by other companies,so comparability may be limited.The information contained in this document is highly confidential and is provided solely for the purpose of providing you with information and for your use only in connection with the use of this presentation.The

13、information contained in this document may not be reproduced,reproduced,redistributed or disclosed to any other person in whole or in part.This presentation may not be forwarded,distributed or reproduced in whole or in part.Your viewing,access or participation in this presentation is the basis for y

14、our knowledge and confidentiality of the contents of this presentation and these materials.You agree not to remove these materials or any materials provided in connection with the conference room in which the document is provided.You further agree that you may not photograph,reproduce or otherwise r

15、eproduce this presentation or transfer it to any other person for any purpose during this briefing or in a conference room.At the end of this presentation,you must return this presentation and all other materials provided in connection with the company.Your access to,access to,or participation in th

16、is presentation is hereby agreed to be bound by the above limitations.Disclaimer23About Sino BiopharmInnovation-4 key TAsBD&Globalization-invoXWhy usSino Biopharm:largest Rx pharma company in China by revenueRMB 29bn2022RevenuelargestRx Pharma in ChinaRMB 5bn2022Total Profit4Employee26,000+R&D perso

17、nnel 4,300+Products 200+Innovativepipeline 60+Salespersonnel 14,000+Production personnel 5,400+5About Sino BiopharmInnovation-4 key TAsBD&Globalization-invoXWhy us000070809020002120222023E2024E2025E2027E2030ENumber of innovative drugs(RHS)Total Revenue(LHS

18、)Innovation:driving revenue growth with newly launched drugs(RMB bn)艾贝格司亭注射液Number of innovative drugs202312+202540+20302024TQ-B3139(ALK inhibitor)TQ-B3101(ROS1/ALK/c-Met inhibitor)TQB2450(Anti PD-L1)TQ-B3525(PI3K/inhibitor)2025TQB3616(CDK2/4/6 inhibitor)TQ05105(JAK/ROCK inhibitor)D-1553(

19、KRAS G12C inhibitor)PL-5(antimicrobial peptide)Revenue from innovative drugs,as a%of total revenue8%9%10%12%18%22%21%23%25%30%40%50%60%30%+Revenue from innovative drugs CAGR(2020-2022)6Innovation:focus on 4 TAs to strengthen market leadership in ChinaScience for a healthier worldOncologyTop 54mn new

20、 cases per yearLiver diseasesTop 1100mn HBV and NASH patientsSurgery/analgesicTop 3100mn surgical patients0.7mnCumulative number of patients treated0.1mn30mn3.5mnAnlotinibHydrochloride CapsulesAbiraterone Acetate TabletsMagnesium Isoglycyrrhizinate InjectionEntecavir Dispersible Tablets75mnFlurbipro

21、fen CataplasmsCalcitriol Soft Capsules40mn8.9mnBudesonide Suspension for InhalationRespiratoryTop 2200mn patients with interstitial,obstructive and infectious lung diseases7Next Focus2000022Note:1)Source:Frost&Sullivan,HKEX;2)As of Aug 2022,there are more than 600 PD

22、-1/PD-L1 clinical trials in ChinaExpand existing drugs indications and enrich drugcombination therapies Globalization through in-license&out-licenseMore BDs with focus on bispecific antibodies and cutting-edge technologies2013-22 CAGR35.3%2013-2022 Revenue of the Oncology TA TOP 5 in ChinaFast-growi

23、ng market shareLarge and fast growing market1)China:RMB278bnby 2022,RMB660bnby 2030(CAGR:11.4%)Fierce competition,commercialization is the key2)3,000+sales personnel(oncology),covering 27,000+hospitalsInternal R&D+External BDs Acquired F-star(next generation bispecific immunotherapies)in 2023Oncolog

24、y:Huge market potential,commercialization is key to win competition8Oncology:Competitive portfolio with RMB10bn+peak sales,blockbuster Anlotinib as the core9IndicationsAnlotinib+Expected NDA ApprovalSCLC(1st-line)PD-L1chemo2024 H1HCC(1st-line)PD-12025 H1Endometrial cancer(2nd/3rd-line)PD-L12025 H1St

25、age III NSCLC(adjuvant therapy after chemoradiation)PD-L12025 H2RCC(1st-line)PD-L12025 H2NSCLC(1st-line)STS (1st-line)CRC(1st-line)glioma(1st-line)HCC(adjuvant)platinum-resistant ovarian cancerPD-1PD-L1Chemo2025 H2TQB2450Anti PD-L1Peak SalesRMB10bn+NSCLC(3rd line)SCLC(3rd line)STSMTCDTCRASBRAFwildty

26、pe CRC(1st line)STS(1st line)Ovarian cancer(2nd line)HCC(1st line)HCC(adjuvant)SCLC(1st line)NSCLC(1st line)nsNSCLC(1st line)sNSCLC(1st line)RCC(1st line)Endometrial cancerApprovedPhase III/NDA10Comprehensive Clinical EvidenceThe only G-CSF product that has undergone head-to-head clinical trials wit

27、h both short-acting andlong-acting competitive products.Novel StructureThe worlds first dimeric G-CSF Fc fusion protein.The only innovative G-CSF product with generic name different from Filgrastim.First 3rd-gen:YilishuLess Allergic Reactions3 CharaterisctisNo PEG-induced allergic reactionsNo Tween

28、80 added to formulaMore natural,and lower incidence of AEsContinuous Protection Grade 4 neutropenia significantly less frequent in cycles 3-4than other long-acting G-CSFSuperior performance in terms of ANC nadir level and recovery timeEarlier Administration24h after ChemoClinical trial results show

29、that Yilishucan be administered 24 hours after chemotherapy completion3rd-GenerationrhG-CSF-Fc fusion protein(novel long-acting G-CSF)2nd-GenerationPEG-rhG-CSF(traditional long-acting G-CSF)Fc-fusions Dimeric CHO cell-expressed PEGylation Monomeric E.coli-expressedUnique product featuresThe unique M

30、OA brings clinical benefits in many aspects:continuous protection&less allergic reactions&earlier administration.Professional marketing team2,000+sales personnel in oncology area,Yilishu could be jointly promoted with anlotinib and penpulimab to create synergies.Oncology:Yilishu,FIC 3rd-gen G-CSF,pr

31、ovides better safety and efficacy FDA approval NCCN recommendationOncology:Garsorasib,D-1553(KRAS G12C inhibitor),potential FIC in ChinaFeatures:The first KRAS G12C inhibitor that is independently developed and has entered the clinical trial stage in Mainland China,and has been granted a Breakthroug

32、h Therapy Designation by CDE.Synergize with SHP2 inhibitor,MEK inhibitor and other inhibitorsDevelopment Stage:China:KRAS G12C+NSCLC2021.01:Phase I/II clinical trial2022.05:Pivotal phase II clinical trial(KRAS G12C-mutated NSCLC)2023.12:NDA submissionGlobal:Solid TumorInternational multi-center clin

33、ical Phase II clinical trial ongoingmonotherapy and combination therapy in the 1L treatment of NSCLC as well as other solid tumors such as colorectal cancer,pancreatic cancerNSCLC monotherapy(Journal of Thoracic Oncology):ORR-40.5%,DCR-91.9%,mPFS-8.2moHigher mPFS than other drugs(same target)approve

34、d by FDA previously 2L advanced or metastatic CRC monotherapy(2023 ASCO):ORR-20.8%,DCR-95.8%Compared with drugs(same target)approved globally,efficacy and safety are among the bestD-1553(KRAS G12C inhibitor)Unmet NeedsD-1553 Phase I11Incidence of major KRAS G12C-mutated cancers in China(ppl 000)KRAS

35、 G12C mutation was more commonly found in lung,colorectal,pancreatic and biliary cancers.No standard-of-care treatment options for solid tumors with KRAS G12C mutations in China.Chemotherapy and immunotherapyhave limited efficacy.3843525EBackground:Aug 2023,CTTQ was granted an exclusive l

36、icense by Inventisbio to develop,register,manufacture and commercialize D-1553 in Mainland China.In addition,based on potential future cooperation in data sharing,CTTQ will be granted a certain percentage of rights outside Mainland China in due course.CDK2 activation drives CDK4/6 inhibitor resistan

37、ceTQB3616 has better ability to inhibit CDK2 than Abemaciclib&Palbociclib,and may reverse early CDK4/6 resistanceInhibition of CDK2 Oncology:TQB3616(CDK2/4/6 inhibitor),potential next-gen treatment for HR+/HER-BC12Clinical StudyTreatmentCriteriaEnrollmentORR(%)DCR(%)CBR(%)TQB3616-II-01FTQB3616(singl

38、e arm)1st-,2nd-line BC(100%Chinese)2nd-line:6459.4%89.1%75.0%1st-line:4770.2%95.7%91.5%MONARCH plusF+Abemaciclibvs F2nd-line BC(85%Chinese)10450.0%92.3%77.9%DAWNA-1F+Dalpiciclibvs F2nd-line BC(100%Chinese)24127.0%88.8%61.0%MONALEESA-3F+Ribociclibvs F1st-,2nd-line BC2nd-line:34541.0%83.9%70.2%1st-lin

39、e:367MONARCH 2F+Abemaciclibvs F2nd-line BC44648.1%82.4%73.3%PALOMA-3F+Palbociclibvs F2nd-line BC34724.6%83.3%67.0%Superior efficacy of TQB3616 against other CDK4/6 inhibitorsCDK2/4/6 inhibitorFeature:Potential me-better CDK2/4/6 inhibitor-Good safety profile-Better efficacy profile-May reverse early

40、 CDK4/6 resistance-Currently in Phase IIIDevelopment plan:TQB3616According to Ph2 clinical data,TQB3616 has better ORR/CBR than Abemaciclib,Dalpiciclib,Ribociclib,Palbociclib.Better EfficacyWider therapeutic window than Abemaciclib&PalbociclibSound safety profile supports adjuvant therapySound Safet

41、yHR+HER-Breast Cancer2024202520262nd-line1st-lineAdjuvantNDA Submission2000022Note:1)CLD:chronic liver disease,NAFLD:non-alcoholic fatty liver disease,early stage of NASH,HBV:hepatitis B virus;2)Source:Moon AM,Singal AG,Tapper EB.Contemporary epidemiology of chronic

42、liver disease and cirrhosis.Clin Gastroenterol Hepatol 2020;3)Source:Chinanews,European Pharmaceutical ReviewLarge market size1)2)3)Global:1,500mnCLD cases China:450mnCLD cases,largest hepatitis B marketNext FocusNon-alcoholic steatohepatitis(NASH)80mn patientsCure treatmentfor Hepatitis B30mn patie

43、ntsCirrhosis7mn patientsAcute Hepatitis2mn cases per year2013-18 CAGR10.5%2013-2022 Revenue of the Liver Diseases TA TOP 1 in China25%hepatitis market share2020-22 CAGR5.9%VBPMarket Size:RMB100bn+Market leader in China25%liver diseases market share(No.1)Comprehensive product portfolio Hepatic steato

44、sis,liver fibrosis,cirrhosis,liver cancer,etc.Liver Disease:No.1 in China for years,continuous investment in the future1314Liver Disease:Lanifibranor(pan-PPAR agonist)first oral drug for NASH that has entered Ph3 in ChinaPPARPPAR/PPARNFkB-dependent gene activationInflammasomeINFLAMMATION&BALLOONINGB

45、allooningVASCULARPortal pressureIntrahepatic vascular resistanceLSEC capillarizationSTEATOSISFA uptakeLipogenesisFA catabolismMETABOLISMInsulin sensitivity HDL-CTriglyceridesFIBROSISStellate cell proliferation and activationCollagen and fibronectin productionPan-PPAR agonistFeature:-Activation of th

46、e three PPAR isoforms addresses the key features of NASH-Moderate and balanced pan-PPAR agonist activity-Improved safety and efficacy in other single and dual PPAR agonists-Once-daily oral administrationLanifibranorKey Feature of NASHNote:BAT:brown adipose tissue;WAT:white adipose tissue;FA:fatty ac

47、id;HDL-C:high density lipoprotein-Cholesterol;LSEC:liver sinusoidal endothelial cells;NASH:Nonalcoholic Steatohepatitis;PPAR:peroxisome proliferators activated receptors.Reference:1.Francque SM,Bedossa P,Ratziu V,et al.A Randomized,Controlled Trial of the Pan-PPAR Agonist Lanifibranor in NASH.N Engl

48、 J Med.2021;385(17):1547-1558.doi:10.1056/NEJMoa2036205;2.Inventiva.Data on file;3.Francque S,Szabo G,Abdelmalek MF,et al.Nonalcoholic steatohepatitis:the role of peroxisome proliferator-activated receptors.Nature reviews.Gastroenterology&hepatology.2021;18(1):24-39.doi:10.1038/s41575-020-00366-5.20

49、232024202520262023.07BTD by NMPA2023.08Ph3 initiation2024H1Ph3 enrollmentcompleted2025H2Data readout2026H1NDA submission in ChinaChina Ph3:100+patients,60 centers,F2-F3 fibrosis stage17%40%36%59%PlaceboPlacebo 800mg 1200mgPlacebo10mg25mgPlacebo80mg100mg80mgPlacebo28mg50mgPlacebo0.1mg0.2mg0.4mgPlaceb

50、o15mgQW30mgQW44mgQ2W19%33%45%6.5%24.7%Note:1)Source:Inventiva;2)No head-to-head clinical trials have been conducted;results obtained from different trials,with different designs,endpoints and patient populations.Results may not be comparable.Ph26 mo N=247OcalivaEfruxiferminPh218 mo N=320Ph318 mo N=9

51、31LanifibranorResmetiromPh29 mo N=125Ph2b6 mo N=113SemaglutidePh312 mo N=955ITT populationPP populationPegozaferminPh26 mo N=2228%11.2%11.7%10%26%30%15%47%76%2%37%23%26%OralInjectables0.001*0.043*0.12680.18140.0001*0.0001*0.024*0.001*0.01*0.001*0.0005*0.0009*0.0001*Effect size 26%Effect size 20%Effe

52、ct size 18.2%Effect size 61%Effect size 42%Effect size 24%Effect size 3.7%pan-PPARFXRTHR-FGF-21GLP-1FGF-21ITT population all subjectsPP population a subgroup of subjects who were compliant with the protocol strictly24%28%42%9.6%14.1%22.4%14%24%26%24%29%20%39%41%33%49%32%43%7%22%26%27%Effect size 12%

53、Effect size 21%Effect size 10%Effect size 20%Effect size 12.8%0.011*0.530.0001*0.0001*0.0002*0.650.05*Patches Infection-PL-5Current layoutSurgery/analgesic-musculoskeletal painPatches:No.1 in China with leading technology platform and modified preparationsCataplasmHot-melt Pressure-sensitive Adhesiv

54、e Plaster Solvent transdermal patchMicroneedles232025920241120261316KBPK B P20272030LSCFBPTTPFBCF B CLTPTRD81F B PTRD86TRD310T T PTRD312TRD315L T PT R D8 6To have the largest pipeline of topical/transdermal medicines in China in 2027,and 13 new products are expected to be marketed in 10 y

55、ears.Technology:The drug is mixed with a hydrophilic polymer gel matrix and coated on the backing material.Advantage:Promote skin hydration,good breathability,less prone to allergiesNot hair-sticky,no odorHigh elasticity,no sense of restraintTechnology:Oily drugs with low melting points are mixed wi

56、th polymers under high temperature,coated on the backing,condensed and solidified into a patch.Advantage:Thin,highly adhesive,not easily detachedGood penetration,available for systemic administrationTechnology:The drug is dissolved in the polymer glue,coated on the backing,heated to remove the solve

57、nt to form a patch.Advantage:Very thin,long durationStrong penetration,high release rate,systemic effect achieved by local administrationsTechnology:Continuous drug delivery is achieved by applying the drug to the tip of the microneedle or loading it inside a hollow microneedle,which pierces the hum

58、an stratum corneum.Advantage:Active delivery systems to improve efficiency A wider selection of drugs,available for large molecule deliverySurgery/analgesic-infectionPL-5(antimicrobial peptide):address the unmet needs for drug-resistant bacteria90KeyFeatures22Completed Phase III clinical study for t

59、he treatment of secondary wound infectionsAim to submitNDA in 2024 Background:Jan 2023,CTTQ entered into an exclusive commercial cooperation agreement with ProteLight for PL-5 in China.InnovationThe first antimicrobial peptide in ChinaThe first non-antibiotic antimicrobialBroad-spectrumG+,G-bacteria

60、,and drug-resistant bacteriaSafetyTopical application,no blood penetration,better safetyLow drug resistanceLow risk of drug resistance and no cross-resistanceConvenienceSpray is easy to use,and can evenly spray the wound surfaceGood competitive environmentNo competitors and no VBP risk in the short

61、termTopical medication,generics need to go through clinical trialsLarge unmet market30mn patients with burn wound infection,diabetic foot wound infection,traumatic wound infection,etc.Peak sales:RMB2bn+23About Sino BiopharmInnovation-4 key TAsBD&Globalization-invoXWhy usBD:the best partner for domes

62、tic and global companies in ChinaBeijingQingdaoShanghaiNanjingLianyungangHuaianYanchengProduction CenterResearch&Production CenterSales Coverage24Excellent clinical R&D capabilitiesR&D personnel 4,300+Technology platform 10+Patent 1,500+Significant clinical R&D efficiency and cost advantagesLarge-sc

63、ale&low-cost production capacityChemical drug capacity(m2)1,000,000+Biological drug capacity(L)42,000+Significant lower-than average cost for biologicsComprehensive sales&marketing networkLargest sales team in China 14,000+Hospital coverage 90%+Largest commercialization team with best efficiencyBD:p

64、roven record of collaborations with domestic and global companies2520221.02 Out-licensingBIC ROCK2 inhibitor2021.03 M&AOne of the only 2Soft Mist Inhalation Platforms in the world2022.03 CollaborationFully human antibody drugs2022.03&12 CollaborationNew small molecule drugs(oncology&liver

65、 disease)2022.04 CollaborationPD-1 mAb+AXL inhibitor2022.04 In-licensingFIC FGF21,BIC FGF21/GLP-12022.05 In-licensingLAG3 mAb2022.09 In-licensingChina FIC/Global BIC pan-PPAR2023.01 In-licensingFIC Antimicrobial peptide2023.01 In-licensingFIC Denosumab(Proliabiosimilar)2023.03 M&AWorld-leading Bispe

66、cific Abs Platform2023.03&07 Out-licensingBispecific&multi-specific antibodies2023.08 In-licensingChina FIC KRAS G12C2023.06 In-licensingBIC GIP/GLP-12021.06 M&AWorld-leading mRNA Delivery Platform2021.08 In-licensingBIC 3rd-gen G-CSF2021.11 CollaborationMSI test to identify tumorsServier2022.12 In-

67、licensingGlobal BIC 3CL Globalization:“in China for global”and“in global for global”One of the only 2 Soft Mist Inhalation Platforms in the worldBelgiumWorld-leading Bispecific Abs PlatformUKWorld-leading mRNA Delivery PlatformUKFully integrated biopharmaceutical company Europe艾贝格司亭注射液BlockbustersRe

68、venueRMB30bnChinaSoutheast AsiaBiosimilarsMiddle EastInnovative DrugsBiosimilarsStrategic CollaborationUSInnovative DrugsGlobal for GlobalChina for GlobalCountries Joining Belt and Road Initiatives26invoX at a Glance27MissionWe aspire to improve peoples lives by creating access to innovative medicin

69、es180+Full-time employees8Global MNC partnerships3Core next-generation technology platforms4Clinical-stage assetsSoft Mist InhalationBispecific AntibodiesTechnology PlatformsOncology Therapeutic Focus AreasRespiratory Experienced leadership team,previously held senior positions at Novartis,Pfizer an

70、d AstraZenecaWorld-class scientists with expertise in drug discovery and development in oncology and respiratoryEstablished global clinical and regulatory capabilitiesLeadership TeamLocationsHQ in London,UKRegional office in Cambridge,UKAntibody research laboratory in Cambridge,UKRespiratory researc

71、h laboratory near Brussels2Therapeuticfocus areasinvoXs Key Areas of Focus:Oncology&Respiratory28GLOBAL ONCOLOGY MARKET$171B$177B$193B$215B$240B$267B$295B$319B202272025202320262028$45B$46B$48B$50B$52B$52B$53B$54B202232026202520272028invoXs Respiratory R&D Platform has developed

72、 a highly effective soft mist inhalation device Soft mist inhalation delivers medication to the lungs more effectively than powder or spray inhalersGLOBAL RESPIRATORY MARKETSource:Evaluate Pharma CAGR:Compound annual growth rateinvoXs proprietary Technology Platforms in oncology are developing thera

73、pies to address unmet needsTherapies are based on novel approaches to immuno-oncology that can be applied to a wide range of cancers3%CAGRover next 5 years(2023-2028)9%CAGR*over next 5 years(2023-2028)Bispecific Antibodies:Next-Generation Oncology Platform29Potential market opportunity for bispecifi

74、c antibodies Potential to transform the oncology market as the future backbone of I-O therapyLong-term opportunities in chronic diseases outside oncologyNeurologyImmunologyHaematologyRespiratoryInfectious diseaseImmuno-oncology(I-O)has transformed the treatment of cancer1High response rates and long

75、er duration of responseMonospecific mAb targeting single immune checkpointResistance to first-gen I-O therapies limits effectivenessMulti-target approach has higher efficacy and treats r/r cancer2Proven improvement in efficacy from two different antibodies targeting different checkpoints at once e.g

76、.PD1+CTLA4 or PD1+LAG3Bispecific antibodies are the future backbone of I-O therapy3Single molecule targeting multiple complementary immune mechanisms at onceVersatile with ability to turn the immune system against cancer cells,block key cancer signalling pathways,and deliver toxic drugs specifically

77、 to cancer cells Investment from all major biopharma companiesOphthalmology5Marketed/Approved BsAb1)100bsAb in clinical stageGlobal bsAb Market Size in all TAs:(Frost&Sullivan)c.$5bnc.$80bn2022E2030ENote:1)Includes Hemlibra,Vabysmo,Rybrevant,Blincyto and Kimmtrak.Source:Evaluate Pharma,Nature and Fr

78、ost&Sullivan(Harbour BioMed IPO prospectus).Bispecific Antibody Platform using F-star technology30Tetravalency Drives Differentiated MoACrosslinking:Potent tetravalent binding(avidity)bringing cells togetherClustering:Fcabs drive potent immune cell activationConditionality:Strong localized antitumor

79、 effectUnique Bispecific StructureNatural human IgG antibody format with only 15-20 amino acid substitutionsRetains Fc functionsReduced potential for immunogenicitySimplified manufacturingBenefits for Patients and Healthcare SystemsCombining two target sites in the same molecule offers biological ad

80、vantages over combining two separate antibodiesManufacturing and cost advantages deliver value to patients and healthcare systems2 natural binding sites2 new Fc antigen binding(Fcab)sitesFcyR null for improved safety potentialBispecific Antibody Platform using F-star technology31Tetravalent Bispecif

81、ic mAbFS118Rescuing CPI-treatment failures&improving outcomes in CPI na veLAG-3/PD-L1 DUAL INHIBITORPoC trial in head&neck PD-1 acquired resistance patientsCPI-na ve NSCLC&DLBCL trialDifferentiated patient selection biomarker strategyFS222Improving outcomes in PD-L1 low tumorsCD137(4-1BB)STIMULATOR/

82、PDL1 INHIBITORTarget PD-L1 low expression indications in solid tumors e.g.colorectal cancer,ovarian cancer,NSCLC,etc.Phase 1 trial with differentiated patient selection biomarker strategyFS120Improving CPI and chemotherapy outcomesCONDITIONAL OX40/CD137(4-1BB)DUAL STIMULATORPhase 1 trial in solid tu

83、morsMSD clinical supply agreement in place for pembrolizumabSB 11285Improving CPI outcomes2ND GENERATION STINGAGONISTMonotherapy and PD-L1(atezo)combination trialDose escalation and pursuing strategic business development opportunitiesCyclic DinucleotideNote:CPI=Checkpoint InhibitorinvoXs Leadership

84、 Team32PORTFOLIO MANAGEMENTJing Shao,PhDREGULATORY&QUALITYPatricia Hurley,PhDCHIEF EXECUTIVE OFFICERBen Toogood25+years experience in the industry and 16+years leading business development roles globallyFormerly Novartis,Aspen,and PharmathenCHIEF FINANCIAL OFFICERJo Hume,PhD13+years experience in th

85、e biotech/pharmaceutical industryFormerly at F-star Therapeutics,AstraZeneca and MedImmuneCHIEF SCIENTIST George Orphanides,PhD20+years of experience in small molecule and biological drug development12 years in senior leadership roles at AstraZenecaCHIEF MEDICAL OFFICERRobert Ilaria Jr.,MD20 years p

86、harmaceutical industry experience in clinical and medical affairs35+years as a practicing physician in oncologyFormerly at Bristol-Myers Squibb,Celgene,and LillyCHIEF DEVELOPMENT OFFICERJames Sandy35+years experience Formerly CDO at Ellipses Pharma,Immunocore and CreabilisFormerly at AstraZeneca and

87、 PfizerBUSINESS DEVELOPMENTChris Price,PhD15+years experience in the biopharmaceutical industry,last 10 years in BDFormerly at BMS,BioMarin,Gruenenthal,and Novartis/SandozRESPIRATORY INNOVATION CENTERJuergen Rawert,Dr.rer.nat.30+years experience in the pharmaceutical,cosmetic/F&F,consumer goods indu

88、stryFormerly at Wyeth Pharma,Asta Medica AG9+years experiencePreviously worked at Sandoz and IQVIA20+years experienceFormerly at F-star Therapeutics,PPD,EpistemLEGAL&COMPLIANCETyron Hussey13+years experienceFormerly at Syneos Health,National Physical Laboratory,UBCHUMAN RESOURCESRebekah Fryer20+year

89、s experienceFormerly at Vifor Pharma,British Gas,SanofiBusiness Development:Approach and Capabilities33Though in-licensing we aim to gain access to innovation complimentary to our platformsLicensing AgreementsOut-licensing and partnerships to maximize the value of our assets and ensure patients have

90、 access to these medicinesTechnology Platform Partnering Create a diverse R&D pipeline through disciplined M&AFuture M&A focused on bolt-on acquisitions to complement our capabilities and therapy areasM&A and ManagementClinical development and regulatory expertise to get products approvedClinical De

91、velopmentAbility to partner with key government regulators including CFIUS and NSIARegulatory ClearanceFlexible approach accelerates delivery of innovative medicines to patientsDeep expertise and experienceSuccessfully integrated three acquired entities into a fully integrated pharmaIntegration Expe

92、riencePARTNER OF CHOICEBUSINESS DEVELOPMENT invoXs Technology Platforms have a Track Record of Attracting Top Tier MNCs with Substantial Upfront Payments with Material Future Milestones34PartnerCollaboration description/DateFinancial TermsProducts/IndicationsF-star AlphaIn 2014,BMS gained an exclusi

93、ve option to acquire F-star Alpha HER2 Fcab FS102In 2017,BMS dropped the option to acquire FS102,following a strategic reprioritization HER2 landscape was too competitiveUp to$475mm($50mm upfront)totalFS102 HER2F-star GammaIn 2016,F-star Gamma entered into a collaboration agreement with Denali to de

94、velop Fcabs designed to enhance delivery of therapeutics across the blood-brain barrierUp to$1bn+royaltiesDNL301(iduronate 2-sulfatase)Phase I Hunter syndrome10 additional pre-clinical programsF-star Beta/DeltaIn 2017,Merck KGaA and F-star entered into a collaboration agreement for five bispecific o

95、ncology antibodies,at the time including F-stars lead asset,FS118Up to 1bn(115mm upfront)4 pre-clinical immuno-oncology programsIn 2016,F-star entered into a collaboration agreement with AbbVie to develop FcabsF-star provided AbbVie with the assets as part of the agreement,which is now complete,with

96、 future decisions on development now in the hands of AbbVieUndisclosed2 immuno-oncology targetsIn 2021,AstraZeneca entered into an exclusive license agreement for F-stars novel STING inhibitor compoundsAstraZeneca received global rights to research and commercialization of the compoundsUp to$300mm o

97、f development and sales milestones+single digit royaltiesSTING antagonistIn 2021,F-star entered into a collaboration and license agreement with Janssen to research,development and commercialization for up to five novel bispecific antibodies directed to Janssen therapeutic targetsUp to$1.35bn($17.5mm

98、 upfront)with tiered mid-single digit royalties5 undisclosed targetsIn 2018,Denali and Takeda entered into a collaboration agreement,pursuant to which Takeda was granted an option for three programs comprising F-stars Fcab$150mm through a combination of cash upfront+equityAdditional$90mm in pre-clin

99、ical milestones+opt-in payments3 programs targeted for CNSIn 2022,F-star announced a license agreement with Takeda for a novel next-generation immuno-oncology bispecific antibodyUp to$40mm in development and commercialization milestonesBispecific antibody against an immuno-oncology target In 2023,F-

100、star announced license agreement with Takeda for second novel next-generation immuno-oncology bispecific antibody$1bn+in technical and sales milestones;tiered mid-single digit royaltiesCollaboration and license agreement to discover and develop two new Fcabs35About Sino BiopharmInnovation-4 key TAsB

101、D&Globalization-invoXWhy usWhy us:largest commercialization team in ChinaIncreasing bargaining power of buyersShortening product life-cycleValue-Based Purchasing(VBP):Average price cut of 58%for the 9th national-wide VBP.1)National Reimbursement Drug List(NRDL):Average price cut of 61.7%for 2023.2)0

102、55-2,000 4,000 6,000 8,000 10,000 12,000 14,000 16,000Sino Biopharm Jiangsu HengruiCSPCHansohBeiGeneInnoventZai LabShanghaiJunshiAkesoRemeGenInnoCareSales personnel(LHS)2022 Sales,RMB bn(RHS)Big pharmaBiotechPowerful commercialization team3)Sino Biopharm has the largest commercialization

103、team(14,000+sales personnel)in ChinaNote:1)State Council of the Peoples Republic of China;2)National Healthcare Security Administration;3)Source:public information from companies websites,announcements,interim/annual reports,etc.4)Finished drugs364)0.20 0.19 0.24 0.27 0.38 0.50 0.79 0.89 1.21 1.25 1

104、.93 20000200022InterimFinalWhy us:robust cash flow and financial position with continuous dividendsNote:1)Cash reserves include cash and bank balances,bank deposit,and the wealth management products as at 30 June 2023.Net c

105、ash flows from operating activities(RMB mn)Cash reserves1)RMB20bnInvestment in core competenciesPayout toshareholdersStrategic growthHKD1bn share purchase plan announced3,7335,0945,3255,3255,3666,2652002020212022Consistent cash inflows from operating activitiesDividends declared(RMB bn)As

106、 at 31 Dec 2022,aggregate dividend distributionHKD10bn37Why us:attractive valuation as compared to global peersNote:1)Source:Capital IQ;2)MNC big pharma includes AstraZeneca,Bayer,Johnson&Johnson,Merck,Novartis,Pfizer,RocheHang Seng Healthcare Index vs.Hang Seng Index Cumulative Change1 Jan 2018 to

107、31 December 2023Sino Biopharmaceutical Limited(1177.HK)vs.MNC Big Pharma2)Monthly NTM PEG Ratio1)1 Jan 2018 to 31 December 20230123452018/1/12019/1/12020/1/12020/12/312021/12/312022/12/31Global MNCSino BiopharmGlobal MNC(5-yr avg.)Sino Biopharm(5-yr avg.)2.21.62.41.4-60%-40%-20%0%20%40%60%80%100%2018/1/32019/1/32020/1/32021/1/32022/1/32023/1/3HSIHSHCI-40%-44%VBPVBP38健康科技,温暖更多生命Science for a healthier world

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