Cspc Pharmaceutical Group Limited · HKEX:1093
Cspc Pharmaceutical — H1 2023 Earnings Presentation
35 slides from Cspc Pharmaceutical's earnings presentation, August 2023
Slide 1: 2023 1H Results
H#® EB saRo2S SPC CSPC PHARMACEUTICAL GROUP LIMITED 2023 1H Results | August 2023
Slide 2: China's Leading Innovative Pharmaceutical Enterprise
China’s Leading Innovative Pharmaceutical Enterprise R&D Capability Manufacture Capability • 8 R&D platforms • 10+ production bases • 5 R&D centres located in China & U.S. • Nano formulation：27 production lines • ~ 2,000 R&D staff built with production capacity of 20M • ~300 R&D projects (~130 innov
Slide 3: 2023 1H Highlights
2023 1H Highlights R&D BD New drug approval: • Nectin-4ADC: licensed out the Covid-19 mRNA vaccine (EUA) rights in the US, EU, UK, Canada, Desvenlafaxine succinate Australia, Iceland, Liechtenstein, extended-Release tablets Norway and Switzerland to Corbus, 5 applications for marketing with US$7.5M
Slide 4: Financial Highlights, Business Review, R&D Capability, Pipeline, BD & ESG
01 02 03 04 05 Financial Business R&D Pipeline BD & ESG Highlights Review Capability
Slide 5: Part 01 Financial Highlights
Part 01 Financial Highlights
Slide 6: Financial Highlights
Financial Highlights Unit: RMB ‘000 Revenue 1H2023 1H2022 Change +3.0% 16.08bn 15.61bn Revenue 16,080,412 15,610,026 +3.0% Gross profit 11,237,639 11,338,484 -0.9% Gross profit margin 69.9% 72.6% -2.7pp R&D expenses +22.3% 1H2022 1H2023 2,303,611 1,884,077 Underlying profit attributable to sharehold
Slide 7: Revenue
Revenue Revenue by product category Finished drug revenue Unit: RMB MM Unit: RMB MM 1H2023 1H2022 Change 1H2023 1H2022 Change Finished drugs 12,934 12,293 +5.2% Nervous system disease 4,553 3,874 +17.5% products 1,040 1,399 -25.7% Oncology products 2,988 4,035 -26.0% Bulk vitamin C +19.1% Anti-infec
Slide 8: Operating Profit
Operating Profit Unit: RMB MM 1H2023 1H2022 1H2023 1H2022 Change Change OPM OPM Finished drug 3,192 3,008 +6.1% 24.7% 24.5% +0.2pp Bulk vitamin C 68 321 -79.0% 6.5% 23.0% -16.5pp Bulk antibiotics 71 72 -0.3% 7.7% 9.2% -1.5pp Functional Food and Other 331 286 +15.8% 28.1% 25.1% +3.0pp Business 8
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), Shuanling(pentoxifylline extended-release tablets, pentoxifylline system injection), Oulaining (oxiracetam capsules, oxiracetam for injection)
Slide 11: Key Products Overview
Key Products Overview NBP Mingfule Xuanning Anfulike Butylphthalide soft capsules and injections Recombinant human TNK tissue-type Levamlodipine maleate tablets Amphotericin B Cholesteryl Sulfate • 1st Class 1 new drug of cardio- plasminogen activator for injection and dispersible tablets Complex fo
Slide 12: Bulk Product Business, Functional Food and Other Business
Bulk Product Business, Functional Food and Other Business Bulk vitamin C Bulk antibiotics Functional food and others • Major products: vitamin C, • Major products: 7-ACA • Sales was RMB1,177 million, vitamin C - sodium, vitamin C - (intermediate), cefazolin an increase of 3.5%. During calcium and gr
Slide 13: Part 03 R&D Capability
Part 03 R&D Capability
Slide 14: R&D Overview
R&D Overview Project under Science Projects& R&D Centre Technology Platform Development & IP Government Support • 5 R&D centres • 8 national science & • Around 300 projects under • 87 national projects located in China & technology qualifications development (around 130 U.S. innovative drug projects
Slide 15: 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 nanoparticles vaccine other chronic disease (instant type) ➢ CLDN18.2 ADC ➢ Various preventive and drugs ➢ Cisplatin micelle ➢
Slide 16: 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 17: mRNA Vaccine platform
mRNA Vaccine platform 1 Advantages of antigen 2 mRNA vaccine design 3 Industrialization advantage design • Mutation prediction platform • Base modification, UTR screening, • Multiple nano-formulation codon optimization and structural products launched • The combination of bioinformatics elements inc
Slide 18: siRNA Platform
siRNA Platform 1 HTS screening platform 2 CMC platform 3 Industrializationn advantage • Rational sequence design based • Build strong oligonucleotides • Industrialization advantage of on bioinformatics and CMC platform based on QbD CSPC experienced scientists strategy • Pilot scale and commercial •
Slide 19: 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 20: Bispecific Antibody Platform
Bispecific Antibody Platform YBODY bispecific antibody platform ✓ Intact IgG：good PK/PD，convenient purification process • In-house developed, global leading asymmetrical bispecific ✓ Construction strategy for KIH and salt bridge：highly efficient antibody platform YBODY® for tumor treatment heterodi
Slide 21: Pipeline
Part 04 Pipeline 21
Slide 22: Candidates under Clinical Trial Stage
Candidates under Clinical Trial Stage （24） （14） (16) (8) PhI PhII (POC) PhII / III pivotal trial NDA ALMB0166 NBL-012 NBL-015 CLDN18.2 CM326 JMT101 CM310 JMT103 Cx43i mAb IL23-P19 CLDN18.2 mAb ADC TSLP EGFR mAb IL4R RANKL NBL-020 SYS6002 SYS6010 JMT601 KN026 TG103 rhTNK-tPA ALMB0168 TNFR2 Nectin-4 A
Slide 23: Pipeline – Large Molecule
Pipeline – Large Molecule Over 40 new biologic drugs under development: 5 filed BLA, 18 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 24: Pipeline – Large Molecule
Pipeline – Large Molecule Pre- Ph II / III TA Major Candidates Target Indication (s) Phase I Phase II NDA clinical pivotal trial Cardiovascu Mingfule rhTNK-tPA Acute ischemic stroke lar Psychiatry BLA accepted ALMB0166 CX43 antagonist Spinal cord injury & Neurology Digestion & TG103 GLP-1 Obesity, D
Slide 25: Pipeline - Small Molecule
Pipeline - Small Molecule Over 40 small molecule new drugs under development: 1 filed NDA, 22 under clinical trial stage (4 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 26: Pipeline - Small Molecule
Pipeline - Small Molecule Ph II / III TA Major Candidates Target Indication (s) Pre-clinical Phase I Phase II NDA pivotal trial DBPR108 DPP-4 Diabetes Digestion & NDA accepted SYHA1402 ARI Diabetic neuropathy Metabolism SYHA1805 FXR Agonist NASH NBP soft capsule* VaD, Ischemic stroke(US) Psychiatry
Slide 27: 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 28: Pipeline Products Launch Plan
Pipeline Products Launch Plan - approx. 58 New Drugs /Indications approved within coming 6 years 12 12 12 Semaglutide mRNA vaccine mRNA vaccine Diabetes Rabies RSV Clevidipine injectable 10 emulsion SYHX1901 Psoriasis mRNA vaccine Hypertension VZV Vaccine Paliperidone palmitate CM310 (IL-4Rα) TG103
Slide 29: Common Generics Launch Plan
Common Generics Launch Plan 9 candidates have filed applications for marketing approval，expecting the approval in 2023-2024； Over 20 candidates are under pharmaceutical research，expecting the approval in 2025-2026 No. Product Therapeutic Area Expected to be launched 1 Sacubitril Valsartan Sodium Tab
Slide 30: IND Approvals Obtained as of August 23
IND Approvals Obtained as of August 23 IND approval for the 1st indication (8+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) SY
Slide 31: BD&ESG
Part 05 BD&ESG
Slide 32: BD Strategic Layout and Path of Advancement
BD Strategic Layout and Path of Advancement Focusing on strategic domains, deepening BD strategies, and establishing an international BD ecosystem BD Product Positioning：Aligning closely with clinical needs, emphasizing clinical benefits, grasping international cutting-edge technology and product tr
Slide 33: 2023 BD Strategy in Key Therapeutic Areas
2023 BD Strategy in Key Therapeutic Areas Reinforce Leading Position in Explore Novel Therapeutic Areas and Established Areas Technology Platforms • Comprehensive management of stroke • Strengthen differentiation in •Address primary and •Concentrate on well- •Focus on therapeutic nuclear disease, wi
Slide 34: 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 35: Thanks!
WeChat of CSPC IR Team： Thanks！
CSPC Pharmaceutical Group — H1 2023 Earnings Presentation on 6ix