CSPC Pharmaceutical Group Limited · HKEX:1093
CSPC Pharmaceutical — FY2024 Earnings Presentation
40 slides from CSPC Pharmaceutical's earnings presentation, March 2025
Slide 1: 2024 FY Results Presentation
2024 FY Results Presentation Mar. 2025
Slide 2: China's Leading Innovative Pharmaceutical Enterprise
China’s Leading Innovative Pharmaceutical Enterprise Manufacturing Capabilities R&D Capabilities • 10+ Production bases for pharmaceutical products • Nano formulation production capacity of 20M doses/year; Biologics fermentation capacity of 250,000L • Chemical drugs production capacity of OSD ~30B t
Slide 3: 2024 FY Updates
2024 FY Updates Regulatory Major Clinical Updates Trial Progress 66 IND approvals : 5 new drugs approved: • Mingfule (AIS)：First approved in • China (60) : CAR-T, VZV vaccine etc. China among similar products, which is the second indication • North America (6) : Of which SYS6023 • Enshuxing (PD-1) ：
Slide 4: Financial Highlights
01 Financial Highlights
Slide 5: Financial Highlights
Financial Highlights Unit: RMB’ M 2024 2023 Change Revenue 29,009 31,450 -7.8% Gross profit 20,299 22,177 -8.5% Gross profit margin 70.0% 70.5% -0.5pp R&D expenses 5,191 4,830 +7.5% Underlying profit attributable to shareholders* 4,683 6,275 -25.4% Reported profit attributable to shareholders 4,328
Slide 6: Revenue
Revenue Revenue by product category Revenue by therapeutic area Unit: RMB’ M 2023年 2024 2023 Change 1-12月 2024 2023 Change 2022年 Nervous system 9,645 9,089 +6.1% 1-12月Finished drugs 23,736 25,637 -7.4% Oncology 4,400 6,139 -28.3% 变动 1,994 1,929 +3.4% Anti-infectives 4,086 4,236 -3.5% 成药 Bulk vitamin
Slide 7: Operating Profit
Operating Profit Unit: RMB’ M 2024 2023 2024 2023 Change Change OPM OPM Finished drugs 4,828 6,700 -27.9% 20.3% 26.1% -5.8pp Bulk vitamin C 211 5 +4168.3% 10.6% 0.3% +10.3pp Bulk antibiotics 299 154 +93.8% 18.8% 9.0% +9.8pp Functional Food 305 562 -45.6% 18.1% 25.9% -7.8pp and Others Note: Certain p
Slide 8: Overview of Key Products Clinical Development
02 Overview of Key Products Clinical Development
Slide 9: Remarkable Success of the R&D Pipeline
Remarkable Success of the R&D Pipeline Innovative products launched since 2021 provide Milestones：The year of 2025 continuous growth momentum Approved for marketing Amphotericin B liposome DBPR108 Irinotecan liposome 2021-2022 (the U.S.） T2DM 1L Pancreatic cancer Marketing Irinotecan liposome approv
Slide 10: Oncology: Innovative Nano-Formulation Platform, unlocking the Paclitaxel Market
Oncology: Innovative Nano-Formulation Platform, unlocking the Paclitaxel Market SYHX2011 Injection - the Upgraded Albumin Paclitaxel ◼ Enhance efficacy and Improve survival Indication Phase II Phase III NDA Drug launch ◼ Reduce skin-related adverse ≥1L Breast Cancer （vs keaili） 2024.12 Plan for 2026
Slide 11: Oncology: Daunorubicin Cytarabine Liposome - A Breakthrough for Secondary AML
Oncology: Daunorubicin Cytarabine Liposome - A Breakthrough for Secondary AML Particles of double-layered liposomes with a diameter of 100nm. Cytarabine and daunorubicin are encapsulated within the liposome particles at a molar ratio of 5:1, exerting anti-leukemic effects by inhibiting DNA polymer
Slide 12: Oncology: HER2 BsAb-Targeting Indications with Large Patient Populations
Oncology: HER2 BsAb-Targeting Indications with Large Patient Populations Dual blockade of HER2 II and IV epitopes KN026 Overview of Indication Development Indication Phase II Phase III BLA Breast Cancer 1L breast cancer （Co Docetaxel albumin ） Enrolling(N=880) 2027 Neoadjuvant therapy HER2+Breast HE
Slide 13: Oncology: JSKN003 HER2-ADC
Oncology: JSKN003 HER2-ADC Glycan-specific conjugation platform JSKN003-2024 ESMO-HER2 positive（IHC 3+）solid tumors Efficacy (N=28): ORR (75.0%) and DCR (89.3%) Patients previously treated with anti-HER2 ADC: ORR was 71.4% ORR for gastric and colorectal cancer were 83.3% (5/6) and 66.7% (6/9), respe
Slide 14: Oncology: JMT101 (EGFR Monoclonal Antibody)
Oncology: JMT101 (EGFR Monoclonal Antibody) Indication Phase II Phase III BLA EGFR 20ins 2026 NSCLC(1L) JMT101+osimertinib vs Platinum-based chemotherapy EGFR high expression Phase II in follow-up JMT101+Docetaxel albumin Squ-NSCLC(2L+) ( PhII/III ) vs Docetaxel EGFR mutation 2027 NSCLC (1L) JMT101+
Slide 15: Oncology: SYS6010 EGFR ADC
Oncology:SYS6010 EGFR ADC Exploring in multiple directions；Launch of Pivotal Trial EGFR mutation NSCLC, head and neck cancer, ESCC, Gastrointestinal Tumors EGFR Indication Treatment Phase I Phase II Phase III Note 1 Enrolling Advanced Solid Tumor Monotherapy 2 (China, the U.S.) 2L EGFRmut NSCLC Mono
Slide 16: Oncology: Simmitinib — Entering Pivotal Trial for ESCC
Oncology: Simmitinib — Entering Pivotal Trial for ESCC Simmitinib is a Novel Tyrosine Kinase Inhibitor Targeting FGFR1-3, KDR and CSF-1R Approximately 240,000 new EC cases are reported annually in China, with ESCC accounting for 90% Indication Treatment Phase II Phase III NDA ESCC (2L) Sim vs Chem E
Slide 17: Immunity: SYHX1901—Covering a Variety of Autoimmune Diseases
Immunity: SYHX1901—Covering a Variety of Autoimmune Diseases Multi-target inhibition JAK1 JAK3 TYK2 Potential Syk inhibitory activity Clear mechanism of action, with multiple Positive results from phase II trial of psoriasis, with all dosage indications being approved for clinical evaluation groups
Slide 18: Immunity: CM326 — Covering Asthma Populations Regardless of Phenotype
Immunity: CM326 — Covering Asthma Populations Regardless of Phenotype Indication Phase I Phase II Phase III BLA Moderate-to-Severe Phase Ⅱ follow-up 2028 Asthma Chronic Rhinosinusitis with Phase Ⅱ follow-up 2028 Nasal Polyps Registration Category: Target Population and Expected Market Class 1 Therap
Slide 19: Immunity: BCMA CAR-T — A New Therapy for Autoimmune Diseases
Immunity: BCMA CAR-T — A New Therapy for Drug-Free Remission in Autoimmune Diseases Indication IIT Phase I Phase II IND approval 2024/07 Multiple Myeloma Dose escalation Systemic Lupus Phase I dose escalation + 2024/08 Erythematosus cohort expansion Myasthenia Gravis Phase I dose escalation + 2024/1
Slide 20: Cardiovascular & Endocrine: Advancing Chronic Disease Management
Cardiovascular & Endocrine: Advancing Chronic Disease Management NDA Pivotal Trial Early-Clinical Pre-Clinical JMT202（FGFR1c/βkloth) (Ph I) TG103（Fc-GLP1） ActRII A/B Antibody Clevidipine butyrate SYH2053（PCSK9 siRNA）（Ph II） Semaglutide injection SYH2070 Injection injectable emulsion AGTSiRNA（(Ph I)
Slide 21: Cardiovascular & Endocrine: PCSK9 siRNA & AGT siRNA
Cardiovascular & Endocrine: PCSK9 siRNA & AGT siRNA PCSK9 siRNA Early Clinical Data AGT siRNA Pre-clinical Data Angiotensinogen Relative Change 50 0 AGT %Change Vehicle(Saline) -50 SYH2062(0.5mpk) ** SYH2062(1.5mpk) *** -100 **** **** SYH2062(3mpk) **** **** **** **** **** **** **** **** **** **** *
Slide 22: R&D Pipeline
03 R＆D Pipeline
Slide 23: R&D Overview
R&D Overview R&D Centers& Intellectual Property Science and Technology Technology Platforms Projects Projects & Awards • 5 R&D centres located in • 8 national science & technology • 2132 patent applications • 90 national science and China & the U.S. qualifications technology projects • 992 patent au
Slide 24: 8 Innovative R&D Platforms
8 Innovative R&D Platforms Nano- mRNA ADC formulation vaccine siRNA ➢ Covid-19 mRNA ➢ Mitoxantrone liposome ➢ EGFR-ADC vaccine, RSV mRNA ➢ PCSK9 siRNA, ➢ Albumin-bound docetaxel vaccine and various ➢ AGT siRNA and other ➢ CLDN18.2 ADC ➢ Paclitaxel cationic liposome preventive and chronic disease dru
Slide 25: Key Innovative Products in Clinical Stage
Key Innovative Products in Clinical Stage Phase I Phase II (POC) Phase II/III Pivotal Trial NDA/BLA NBL-012 NBL-015 NBL-020 ALMB0166 ALMB0168 JMT101 DP303C SYS6010 Batoclimab IL23-P19 CLDN18.2 mAb TNFR2 Cx43i mAb Cx43s mAb EGFR mAb HER2 ADC EGFR ADC NBL-028 JMT203 JMT202 JMT601 CM326 KN026 TG103 CLD
Slide 26: R&D Pipeline--Biological Agents
R＆D Pipeline--Biological Agents 3 commercialized, 2 BLA filed, 8 under pivotal trial stage, ＞15 under pre-clinical stage —— Including various forms of drugs such as antibody drugs, cell therapies, and Antibody-Drug Conjugates (ADCs) Major candidates Target Type Phase I Phase II Phase II/III NDA/BLA
Slide 27: R&D Pipeline--Biological Agents
R＆D Pipeline--Biological Agents Major candidates Target Type Phase I Phase II Phase II/III NDA/BLA Launch Omalizumab IgE Bio-similar Chronic Spontaneous Urticaria, Asthma Ulsinumab IL-12/IL-23 Bio-similar Psoriasis Secukinumab IL-17A Bio-similar Psoriasis Pertuzumab HER2 Bio-similar Breast cancer KN
Slide 28: R&D Pipeline--New Formulations
R＆D Pipeline--New Formulations 3 commercialized, 6 NDA filed, 3 under pivotal trial stage, ＞5 under clinical development stage ——Including various forms of drugs such as liposomes, albumin and nanocrystals Major candidates; Type Phase I Phase II Phase II/III NDA/BLA Launch Mitoxantrone hydrochloride
Slide 29: R&D Pipeline--Small Molecule Drugs
R＆D Pipeline--Small Molecule Drugs 1 commercialized ，8 under pivotal trial stage ，＞ 10 under clinical development stage Major candidates Target Type Phase I Phase II Phase II/III NDA/BLA Launch DBPR108 DPP-4 Small molecule T2DM Semaglutide injection GLP-1 Polypeptide T2DM (PhIII)、lose weight/Obesity
Slide 30: Generic Drugs Launch Plan
Common Generics Launch Plan 20 generic drugs are expected to be approved during the years 2024-2025; Additionally, approximately 30 projects currently in the pharmaceutical research phase, are planed to be approved before 2027. 2024 2025 Dapagliflozin tablets Rabeprazole sodium Olaparib tablets Pera
Slide 31: BD & ESG
04 BD＆ESG
Slide 32: BD Strategic Layout and Path of Advancement
BD Strategic Layout and Path of Advancement Deepen BD strategies, and build an international BD ecosystem License out License in YS2302018 SYH2039 SYS6005 JSKN003 Lp(a) MAT2A ROR1 ADC In October 2024, executed an In December 2024, executed In February 2025, signed an In September 2024, signed an exc
Slide 33: Aim to Become an ESG Leader in Pharmaceutical Industry
Aim to Become an ESG Leader in Pharmaceutical Industry 2023 Key Environmental Protection Data Received MSCI ESG Rating of A for 4 *The emission reduction target is based on the emission in 2017 consecutive years Greenhouse gas emissions per Emission of non-hazardous Discharge of hazardous waste (gen
Slide 34: Appendix: Product Overview
05 Appendix: Product Overview
Slide 35: Finished Drugs Overview by Therapeutic Areas
Finished Drugs Overview by Therapeutic Areas Nervous • Major products: NBP, Mingfule-AIS (recombinant human TNK tissue-type plasminogen system activator for injection), Shuanling, Enliwei (lacosamide injection, lacosamide tablets), Enxi (Pramipexole Dihydrochloride Tablets), Oushuan (paliperidone Ex
Slide 36: Key Innovative Products Overview
Key Innovative Products Overview NBP Xuanning Jinyouli Butylphthalide soft capsules and Levamlodipine maleate tablets and PEG-rhG-CSF injection injections dispersible tablets • Approved for marketing in 2011 • Approved for marketing in 2004 (soft • Approved for marketing in 2003 (China) • The 1st cl
Slide 37: Key Innovative Products Overview
Key Innovative Products Overview Duoenda Jinlitai Enshuxing Mitoxantrone hydrochloride Narlumosbart for injection Enlonstobart injection liposome injection • Approved for marketing in Sep. 2023 • Approved for marketing in June 2024, for • Approved for marketing in Jan. 2022, second-line and above in
Slide 38: Key New Formulations and Biosimilar Drugs Overview
Key New Formulations and Biosimilar Drugs Overview Duomeisu Anfulike Duoenyi Doxorubicin Hydrochloride Amphotericin B cholesteryl sulfate Irinotecan hydrochloride liposome injection complex for injection liposome injection • Approved for marketing in 2012 • The exclusive product, obtained marketing
Slide 39: Bulk Products, Functional Food and Other Businesses
Bulk Products, Functional Food and Other Businesses 01 02 03 Bulk vitamin C Bulk antibiotics Functional food and others • Major products: vitamin C, vitamin C - • Major products: 7-ACA (intermediate), • Functional Food and others revenue sodium, vitamin C - calcium and cefazolin sodium, penicillin p
Slide 40: Thanks!
E-mail Address of CSPC IR Team： [email protected] IR official website: https://www.cspc.com.hk/en/ir/presentations.php Thanks！
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