Slide 1: 2023 Q3 Results
2023 Q3 Results November 2023
Slide 2: China's Leading Innovative Pharmaceutical Enterprise
China’s Leading Innovative Pharmaceutical Enterprise R&D Capabilities Manufacturing Capabilities • 8 R&D platforms • 10+ pharmaceutical production bases • 5 R&D centres located in China & the U.S. • Nano formulation：27 production lines • ~ 2,000 R&D staff built with production capacity of 20M • ~ 30
Slide 3: 2023 YTD Q3 Highlights
2023 YTD Q3 Highlights R&D BD 4 new drug approvals: Covid-19 mRNA vaccine (EUA) Desvenlafaxine succinate extended- • Nectin-4ADC: licensed-out the release tablets rights in the US, EU, UK, Canada, Narlumosbart for injection Australia, Iceland, Liechtenstein, Irinotecan liposome injection Norway and
Slide 4: Financial Highlights, Business Review, R&D Capabilities, Pipeline, BD & ESG
01 02 03 04 05 Financial Business R&D Pipeline BD & ESG Highlights Review Capabilities
Slide 5: Part 01 Financial Highlights
Part 01 Financial Highlights
Slide 6: Financial Highlights
Financial Highlights Unit: RMB ‘000 Revenue 1-9/2023 1-9/2022 Change +1.6% 23.87bn 23.50bn Revenue 23,865,076 23,495,518 +1.6% Gross profit 16,792,100 17,082,304 -1.7% Gross profit margin 70.4% 72.7% -2.3pp R&D expenses 3,677,949 2,920,249 +25.9% 1H2022 1-9/2022 1H2023 1-9/2023 Underlying profit att
Slide 7: Revenue
Revenue Revenue by product category Finished drug revenue Unit: RMB MM Unit: RMB MM 1-9/2023 1-9/2022 Change 1-9/2023 1-9/2022 Change Finished drugs 19,338 18,613 +3.9% Nervous system 6,926 6,012 +15.2% 1,513 1,978 -23.5% Oncology 4,624 5,866 -21.2% Bulk vitamin C Anti-infective 3,143 2,646 +18.8% B
Slide 8: Operating Profit
Operating Profit Unit: RMB MM 1-9/2023 1-9/2022 1-9/2023 1-9/2022 Change Change OPM OPM Finished drug 4,959 4,587 +8.1% 25.6% 24.6% +1.0pp Bulk vitamin C 52 403 -87.2% 3.4% 20.4% -17.0pp Bulk antibiotics 104 89 +16.1% 7.6% 7.7% -0.1pp Functional Food 440 476 -7.6% 26.6% 27.2% -0.6pp and Others Note:
Slide 9: Part 02 Business Review
Part 02 Business Review
Slide 10: Finished Drug Overview by Therapeutic Areas
Finished Drug Overview by Therapeutic Areas Nervous • Major products include NBP (butylphthalide soft capsules, butylphthalide and sodium chloride injection), Ouyuexin (desvenlafaxine succinate extended-release system tablets),Shuanling (pentoxifylline extended-release tablets, pentoxifylline inject
Slide 11: Key Products Overview
Key Products Overview NBP Mingfule Ouyuexin Butylphthalide soft capsules and injections Recombinant human TNK tissue-type Desvenlafaxine succinate extended- plasminogen activator for injection release tablets • 1st Class 1 new drug of cardio- cerebrovascular field in China • The third-generation ant
Slide 12: Key Products Overview
Key Products Overview Jinyouli Duomeisu PEG-rhG-CSF Doxorubicin Hydrochloride liposome • 1st long-acting white blood cell booster injection drug in China • No.1 in market share in China • Expanding coverage in major municipal hospitals and county-level markets • The first player passed consistency e
Slide 13: Bulk Product Business, Functional Food and Others
Bulk Product Business, Functional Food and Others Bulk vitamin C Bulk antibiotics Functional food and others • Major products: vitamin C, • Major products: 7-ACA • Recorded sales of RMB1,652 vitamin C - sodium, vitamin C - (intermediate), cefazolin million for the period, a calcium and granular vita
Slide 14: Part 03 R&D Capability
Part 03 R&D Capability
Slide 15: R&D Overview
R&D Overview Project under Science Projects& R&D Centre Technology Platform Development & IPs Government Support • 5 R&D centres • 8 national science & • Approx.300 projects under • 87 national projects located in China & technology qualifications development (approx. 130 the U.S. innovative drug pr
Slide 16: Innovative R&D Platforms
Innovative R&D Platforms Nano- mRNA ADC formulation vaccine siRNA ➢ Mitoxantrone liposome ➢ Albumin-bound docetaxel ➢ Covid-19 mRNA ➢ PCSK9 siRNA and ➢ HER2 ADC ➢ Paclitaxel cationic liposome vaccine and various other chronic disease ➢ Cisplatin micelle preventive and ➢ CLDN18.2 ADC drugs therapeuti
Slide 17: Nano-formulation Platform
Nano-formulation Platform Nano-formulation Novel Industrialized Novel drug carrier Novel drug delivery Novel preparation development and production technology design technology method manufacturing platform • Invented single-phase solution • Invented continuous flow • Invented Albumin • Invented amm
Slide 18: mRNA Vaccine platform
mRNA Vaccine platform 1 Advantages of antigen 2 mRNA vaccine design 3 Manufacturing capabilities design • Mutation prediction platform • Base modification, UTR screening, • Manufacturing capabilities of codon optimization and structural CSPC • The combination of bioinformatics elements inclusion and
Slide 19: siRNA Platform
siRNA Platform 1 HTS screening platform 2 CMC platform 3 Manufacturing capabilities • Rational sequence design based • Build strong oligonucleotides • Manufacturing capabilities of on bioinformatics and CMC platform based on QbD CSPC experienced scientists strategy • Two GMP-compliant • Comprehensiv
Slide 20: ADC Platform
ADC Platform ADC Design Characteristics Advantages Conjugation Engineering TGase The specific conjugation on the homogeneous Mode catalysis glutamine residue in the Fc region catalyzed by Conserved Q295 residue engineering modified Tgase can produce highly Conjugation purified ADC molecule with stab
Slide 21: Bispecific Antibody Platform
Bispecific Antibody Platform Antibody-interferon fusion protein platform ✓ The proliferation inhibitory activity in TAA+ cells is more • High expandability than 20- fold higher than that of IFNα • stronger targeting ability ✓ The proliferation inhibitory activity in TAA- cells is more • Better safet
Slide 22: Part 04 Pipeline
Part 04 Pipeline 22
Slide 23: Candidates under Clinical Trial Stage
Candidates under Clinical Trial Stage （26） （15） (17) (7) PhI PhII (POC) PhII / III pivotal trial NDA NBL-012 NBL-015 NBL-020 CLDN18.2 CM326 JMT101 CM310 rhTNK-tPA IL23-P19 CLDN18.2 mAb TNFR2 ADC TSLP EGFR mAb IL4R ＜4.5h AIS☆ NBL-028 SYS6002 ALMB0166 ALMB0168 KN026 TG103 SYSA1802 SYS6010 CLDN6-CD137
Slide 24: Pipeline – Large Molecule
Pipeline – Large Molecule Over 40 new biologic drugs under development: 4 filed BLA, 21 under clinical trial stage(7 under pivotal trial stage) and over 20 under pre-clinical stage Pre- Ph II / III TA Major Candidates Target Indication (s) Phase I Phase II NDA clinical pivotal trial Giant-cell tumor
Slide 25: Pipeline – Large Molecule
Pipeline – Large Molecule Pre- Ph II / III TA Major Candidates Target Indication (s) Phase I Phase II NDA clinical pivotal trial Cardio- Mingfule rhTNK-tPA Acute ischemic stroke (AIS) vascular Psychiatry BLA accepted ALMB0166 CX43 antagonist Spinal cord injury, AIS & Neurology Digestion & TG103 GLP-
Slide 26: Pipeline - Small Molecule
Pipeline - Small Molecule Over 40 small molecule new drugs under development: 1 filed NDA, 25 under clinical trial stage (5 under Phase III / pivotal trial stage) and over 20 under pre-clinical stage Ph II / III TA Major Candidates Target Indication (s) Pre-clinical Phase I Phase II NDA pivotal tria
Slide 27: Pipeline - Small Molecule
Pipeline - Small Molecule Ph II / III TA Major Candidates Target Indication (s) Pre-clinical Phase I Phase II NDA pivotal trial Primary Cardio- SYH2053 PCSK9 siRNA hypercholesterolaemia or vascular mixed dyslipidaemia DBPR108 DPP-4 Diabetes NDA accepted Digestion & SYHA1402 ARI Diabetic neuropathy M
Slide 28: Pipeline - New Preparation
Pipeline - New Preparation Over 30 new preparations under development: 2 applied marketing approval, 11 under clinical trial, and over 20 under pre-clinical stage Phase III / TA Major Candidates Indication(s) Pre-clinical Phase I Phase II Pivotal Clinical NDA Trial Mitoxantrone hydrochloride liposom
Slide 29: Pipeline Products Launch Plan
Pipeline Products Launch Plan 13 - 57 New Drugs /Indications approved in coming 6 years mRNA vaccine RSV 12 TG103 11 mRNA vaccine Obesity, Diabetes Rabies 10 Semaglutide SYHX1901 mRNA vaccine Diabetes Psoriasis VZV Vaccine Paliperidone palmitate Meloxicam nanocrystal CM310 (IL-4Rα) Tramadol celecoxi
Slide 30: Common Generics Launch Plan
Common Generics Launch Plan 14 applications have been filed for marketing approvals，expecting to receive approval in 2024-2025； Over 20 candidates under pharmaceutical research，expecting to receive approval in 2026-2027 No. Product Therapeutic Area Expected to be launched 1 Desvenlafaxine succinate
Slide 31: IND Approvals Obtained as of November
IND Approvals Obtained as of November 30 IND approval for the 1st indication (15+2) SYH2045 (solid tumors) Meloxicam nanocrystal injection (moderate-to-severe pain for adults) Clevidipine injectable emulsion (hypertension) Octreotide long-acting injection (acromegaly) NBL-020 (advanced solid tumors)
Slide 32: Part 05 BD&ESG
Part 05 BD&ESG
Slide 33: Strategic Layout and Roadmap in Business Development
Strategic Layout and Roadmap in Business Development Focusing on strategic areas, deepening BD strategies, and establishing an international ecosystem in business development Product Positioning：Aligning closely with clinical needs, emphasizing clinical benefits, grasping international cutting-edge
Slide 34: Key Therapeutic Area Strategy for 2023 in Business Development
Key Therapeutic Area Strategy for 2023 in Business Development Reinforce Leading Position in Explore Novel Therapeutic Areas and Established Areas Technology Platforms • Comprehensive Management of Stroke • Address primary and • Concentrate on well- • Focus on therapeutic nuclear • Strengthen differ
Slide 35: Aim to Become an ESG Leader in Pharmaceutical Industry
Aim to Become an ESG Leader in Pharmaceutical Industry • Awarded “AAA Enterprise with • Adhere to the procurement Continuous MSCI ESG Harmonious Labour Relations in principle of “fair, impartial, green Hebei Province” and “National and transparent” rating upgrade Advanced Enterprise in Employment” •
Slide 36: Thanks!
WeChat of CSPC IR Team： Thanks！