Cspc Pharmaceutical Group Limited · HKEX:1093
Cspc Pharmaceutical — Q3 2024 Earnings Presentation
40 slides from Cspc Pharmaceutical's earnings presentation, November 2024
Slide 1: 2024 3Q Results Presentation
2024 3Q Results Presentation Nov. 2024
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 40,000L • Chemical drugs production capacity of OSD~30B tab
Slide 3: 2024 YTD 3Q Updates
2024 YTD 3Q Updates Regulatory Major Clinical Updates Trial Progress 37 IND approvals : 4 new drugs approved: • Mingfule (AIS) : First approved in • China (34) : CAR-T, RSV vaccine etc. China in similar products, which is its second indication • North America (3) : Of which • Enshuxing (PD-1) : Firs
Slide 4: Financial Highlights
01 Financial Highlights
Slide 5: Financial Highlights
Financial Highlights Revenue Unit: RMB’ M 23.87bn -4.9% 1-9/2024 1-9/2023 Change 22.69bn Revenue 22,686 23,865 -4.9% Gross profit 15,985 16,792 -4.8% 1-9/202 3 1-9/202 4 Gross profit margin 70.5% 70.4% +0.1pp R&D expenses 3,880 3,678 +5.5% Underlying profit attributable to shareholders 4.72bn Underl
Slide 6: Revenue
Revenue Revenue by product category Revenue by therapeutic area (excluding license fee income ) Unit: RMB’ M 2023年 1-12月 1-9/2024 1-9/2023 Change 1-9/2024 1-9/2023 Change 2022年 1-12月Finished drugs 18,670 19,338 -3.5% Nervous system 7,234 6,926 +4.5% 变动 Oncology 3,809 4,624 -17.6% 1,462 1,513 -3.4% 成
Slide 7: Operating Profit
Operating Profit Unit: RMB’ M 1-9/2024 1-9/2023 1-9/2024 1-9/2023 Change Change OPM OPM Finished drugs 4,232 4,959 -14.7% 22.7% 25.6% -2.9pp Bulk vitamin C 111 52 +114.8% 7.6% 3.4% +4.2pp Bulk antibiotics 239 104 +130.8% 18.9% 7.6% +11.3pp Functional Food 235 440 -46.5% 18.2% 26.6% -8.4pp and Others
Slide 8: Business Review
02 Business Review
Slide 9: 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，Oulaining, Enliwei (lacosamide injection, lacosamide tablets), and Oushuan (paliperidone Extended-release tablets) Oncolo
Slide 10: 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 • The 1st long-actin
Slide 11: Key Innovative Products Overview
Key Innovative Products Overview Duoenda Jinlitai Enshuxing Mitoxantrone hydrochloride Narlumosbart for injection Enlonstobart injection liposome injection • Approved for marketing approval in Sep. • Approved for marketing in June 2024, for • Approved for marketing in Jan. 2022, 2023 second-line and
Slide 12: Key New Formulations and Bio-similar Drugs Overview
Key New Formulations and Bio-similar 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 13: 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), • The year-on-year decrease in revenue of sodium, vitamin C - calcium and cefazolin sodium, penicil
Slide 14: Overview of Key Products Clinical Development
03 Overview of Key Products Clinical Development
Slide 15: Oncology: SYHX2011 Injection, Upgraded Albumin Paclitaxel
Oncology: National Nano-Formulation Platform, Targeting the “Paclitaxel " Market. SYHX2011 Injection-the Upgraded Albumin Paclitaxel n Enhance efficacy and Improve survival Indication Phase II Phase III NDA n Reduce skin-related adverse ≥1L Breast Cancer reactions （vs keaili） data locked 2024 n Fast
Slide 16: Oncology: Daunorubicin Cytarabine Liposome for Secondary AML
Oncology: Daunorubicin Cytarabine Liposome-Breakthrough Therapy for Secondary AML p 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 pol
Slide 17: Oncology: HER2 Bispecific Antibody KN026
Oncology: HER2 Bispecific Antibody, Focusing on the Layout of Major Tumors Types Dual blockade of HER2 and IV epitopes KN026 Overview of Indication Development Indication Phase II Phase III BLA Breast Cancer 1L breast cancer Enrolling 2026 （Co Docetaxel albumin ） Neoadjuvant therapy for In preparati
Slide 18: Oncology: JSKN003 HER2-ADC
Oncology：JSKN003 HER2-ADC Glycan-specific conjugation platform JSKN003-2024 ESMO-HER2 positive（IHC 3+）solid tumors H R2 DI ER2 Efficacy (N=28): ORR (75.0%) and DCR (89.3%) HE IV D Patients previously treated with anti-HER2 ADC: ORR was 71.4% ORR for gastric and colorectal cancer were 83.3% (5/6) and
Slide 19: Oncology: JMT101 (EGFR Monoclonal Antibody)
Oncology: JMT101(EGFR Monoclonal Antibody) Indication Phase II Phase III BLA EGFR 20ins NSCLC(1L) JMT101+osimertinib vs Platinum-based 2026 doublet chemotherapy EGFR high expression lung Phase II Enrolling squamous cell carcinoma JMT101+Docetaxel albumin (Linkage of PhII and (2L+) vs Docetaxel PhIII
Slide 20: Oncology: EGFR ADC
Oncology: EGFR ADC Exploring in multiple directions EGF R 1 EGFR mutation NSCLC、head and neck cancer、 Esophageal squamous cell 2 carcinoma、Lung squamous cell carcinoma Data accumulation for the single-agent treatment is underway, with plans to start preparing for the pivotal clinical trial in 2025 3
Slide 21: Oncology: Simmitinib Entering Pivotal Trial for ESCC
Oncology: Simmitinib- Entering Pivotal Trial for Esophageal Squamous Cell Carcinoma 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 I
Slide 22: Oncology: SYHA1813, Foundation of Combined Anti-cancer Therapy
Oncology: SYHA1813—the Foundation of Combined Anti-cancer Therapy Targeting VEGFR1-3/CSF1R , with dual system function of immune regulation and anti-blood vessel Strong blood-brain barrier penetration ability Indication Treatment Phase I Phase II Phase III Status Included by ESMO for 3 consecutive y
Slide 23: Immunity: SYHX1901 Covering 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 indications being approved for clinical evaluation Positive results from phase II trial of psoriasis, with all dosage groups
Slide 24: Immunity: BCMA CAR-T for Autoimmune Diseases
Immunity: BCMA CAR-T, Introducing a New Therapy for Drug-Free Remission of Autoimmune Diseases Indication IIT Phase I Phase II IND approval 2024/7 Dose escalation MM Phase I dose escalation + 2024/8 SLE cohort expansion Phase I dose escalation + 2024/10 MG cohort expansion Target Population and Expe
Slide 25: Cardiovascular and Endocrine: Chronic Disease Management
Cardiovascular and Endocrine : Extension of Chronic Disease Management NDA Pivotal Trial Early-Clinical Pre-Clinical Clevidipine butyrate Semaglutide long-acting injection(IND TG103（Fc-GLP1） JMT202（FGFR1c/βkloth）（Phase I） application ） injectable emulsion • Hypertension Semaglutide injection SYH2053
Slide 26: Cardiovascular and Endocrine: PCSK9 siRNA & AGT siRNA
Cardiovascular and 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) **** **** **** **** **** **** **** **** **** ***
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Slide 28: R&D Overview
R&D Overview • 5 R&D centres located • 8 national science & • Approx.300 projects under • 90 national projects in China & the U.S. technology qualifications development (approx. 130 innovative drug projects) • 8 national prizes • R&D expenses in 2023 : • 2 national key labs RMB4.83B • 2023 IP applic
Slide 29: Innovative R&D Platforms
Innovative R&D Platforms Nano- mRNA ADC formulation vaccine siRNA Ø Covid-19 mRNA Ø Mitoxantrone liposome Ø EGFR-ADC vaccine 、RSV mRNA Ø PCSK9 siRNA , AGT Ø Albumin-bound docetaxel vaccine and various siRNA and other Ø CLDN18.2 ADC Ø Paclitaxel cationic liposome preventive and chronic disease drugs
Slide 30: Key Innovative Products in Clinical Stage
Key Innovative Products in Clinical Stage NBL-012 NBL-015 NBL-020 ALMB0166 CM326 JMT101 DP303C SYS6010 Batoclimab IL23-P19 CLDN18.2 mAb TNFR2 Cx43i mAb TSLP EGFR mAb HER2 ADC EGFR ADC NBL-028 SYS6002 KN026 TG103 CLDN18.2 JMT202 JMT601 ALMB0168 Meloxicam CLDN6-CD137 Nectin-4 ADC FGFR1c/βkloth Her2 Bs
Slide 31: R&D Pipeline--Biological Agents
R＆D Pipeline--Biological Agents 3 commercialised , 1 BLA filed, 10 under pivotal trial stage , ＞17 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/B
Slide 32: 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 Launch: CSU; Under clinical development: Asthma Ulsinumab IL-12/IL-23 Bio-similar Psoriasis Secukinumab IL-17A Bio-similar Psoriasis Pertuzumab HER2 Bio-similar Breast
Slide 33: R&D Pipeline--New Formulations
R＆D Pipeline--New Formulations 3 commercialised ，4 NDA filed，5 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 l
Slide 34: R&D Pipeline--Small Molecule Drugs
R＆D Pipeline--Small Molecule Drugs 1 NDA filed ，6 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, Pilo
Slide 35: Remarkable Success of the R&D Pipeline
Remarkable Success of the R&D Pipeline Innovative products launched since 2021 provide Milestones：by the end of 2024 to 2025 growth momentum Approved for marketing DBPR108 Batoclimab 2021-2022 Amphotericin B liposome T2DM MG Marketing (U.S.） approval Clevidipine injectable Anfulike Duoenda Duweilisa
Slide 36: Common Generics 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 Peram
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Slide 38: 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 39: 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 unit of re
Slide 40: Thanks!
E-mail Address of CSPC IR Team： ir@cspc.hk Thanks！
CSPC Pharmaceutical Group — Q3 2024 Earnings Presentation on 6ix