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Wuxi Chemistry Wuxi Chemistry – Leading a New Era of CRDMO

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Wuxi Chemistry Wuxi Chemistry – Leading a New Era of CRDMO WuXi Chemistry WuXi Chemistry – leading a new era of CRDMO 3 Established Global Brands IDSU CSU STA (International Discovery Service Unit) (Chemistry Service Unit) (CDMO/CMO subsidiary of WXAT) Unique CRDMO Model Captures Entire Value Chain CRO CDMO CMO Target Hit Lead Commercial Preclinical Phase I Phase II Phase III Submission& to Hit to Lead to PCC ManufacturingLaunch Global Platform, Global Talents 17,967 15 1,831 employees global sites clients worldwide 2021 H1 Rich CRDMO pipeline drives sustainable high growth “R” 274,212 Individually synthesized compounds 2020.7 – 2021.6 1,113 Preclinical & Phase I “D” 220 Phase II 48 Phase III “M” 32 Commercial Delivered in 2020.7-2021.6 A dominant leader in China chemistry-based CRDMO market 2020 Chemistry Based Revenue (¥ Million RMB) 9,531 WuXi Chemistry Competitor 1 Competitor 2 Competitor 3 Competitor 4 Source: companies annual reports and investor analysis report 15 sites across the globe continue to expand China Shanghai Waigaoqiao Shanghai Zhangjiang Tianjin Wuhan, Hubei Chengdu, Sichuan Qidong, Jiangsu R D M R R R R R Shanghai Jinshan Changzhou, Jiangsu Changshu, Jiangsu Taixing, Jiangsu Wuxi city, Jiangsu D M D M M M D M R Research 7 United States Switzerland D Development 5 M Manufacturing San Francisco, CA San Diego, CA Middletown, DE Couvet, Neuchâtel 9 R D M M M The largest chemistry services workforce in the world Research Development Manufacturing 10,190 3,741 4,036 2,549 process chemists & analytical scientists 1,192 formulation scientists & analytical scientists 9,510 chemists 3,592 API manufacturing 680 analytical scientists 444 DP manufacturing 17,967 WuXi Chemistry Employees WuXi Chemistry leadership team Minzhang Chen, Ph.D. Tao Guo, Ph.D. Jingchao Dong, Ph.D. Xiaoyong Fu, Ph.D. Jinling Chen, Ph.D. Yu Lu Co-CEO, WuXi AppTec SVP, IDSU SVP, CSU CTO, API SVP, DP CBO & New Modality 20+ years 20+ years 20+ years 20+ years 20+ years 20+ years of experience of experience of experience of experience of experience of experience Healthy CRDMO client base drives long term growth CR“D”MO C“R”DMO CRD“M”O 1340 269 203 19 “R” only clients “R” + “D” clients “D” only clients “D” + “M” clients 1,831 WuXi Chemistry CRDMO clients in 2021 H1 WuXi Chemistry C“R”DMO WuXi Chemistry C“R”DMO capability overview Discovery Medicinal Custom Library Catalog Non-GMP Process Chemistry Synthesis Synthesis Business Manufacture Chemistry Technology Platform Specialty Chemistry Integrated Discovery PROTAC®, AI for Retrosynthesis, Carbohydrate, Nucleoside/tides, Medchem Design, Computer-Aided Quantum Mechanics for Synthesis, Macrocyclic, Boron, Deuteration, Drug Design, Project Management， Flow Chemistry, Electrochem, Lipids, Polymer, Fluorescent Bio- Compound Management Photoredox, Catalyst Screening, probe and Labeling, Steroids, Automation Fluorine, Late Stage Functionalization Strong, loyal and expanding “R” client base BROAD CLIENT BASE DEEP ENGAGEMENT LONG HISTORY COLLABORATION 1,609 global clients 516 have FTE collaboration 458 clients with >5 years’ collaboration including: 20 of global top 20 27 clients with 50+ FTE team • 75 clients with >10 years’ pharmaceutical companies including: collaboration • 13 clients with 100+ FTE team WuXi Chemistry CR“D”MO WuXi Chemistry CR “D”MO capability overview DISCOVERY PRE-CLINICAL PHASE 1 PHASE 2 PHASE 3 COMMERCIAL Process R&D, API and Advanced Intermediates Manufacturing API Pre-formulation Study , Formulation & Process Development, Drug Drug Product Manufacturing, Packaging and Labeling product Analytical Development, Quality Control and Stability Studies Analytical Regulatory Global Regulatory CMC Filing Support CMC Our pipeline outgrew global clinical stage small molecule new drug candidate pipeline by 2+ times 46%* increase of WuXi Chemistry clinical stage new drug pipeline 602 550 561 474 487 14% 413 444 2019Q4 2020Q1 2020Q2 2020Q3 2020Q4 2021Q1 2021Q2 2021 Q2 12% 20%* increase of global clinical stage new drug pipeline 4278 3918 4072 3579 3620 3743 3816 2019 Q4 2019Q4 2020Q1 2020Q2 2020Q3 2020Q4 2021Q1 2021Q2 * Growth rate from 2019Q4 to 2021Q2 Source: Clarivate Cortellis, July. 01, 2021 WuXi Chemistry CR “D”MO capability overview: API process chemists & processes developed 2,549 analytical scientists 846 APIs & Intermediates in 2021 H1 Globally Leading API Enabling Technology Platform Crystallization Biocatalysis Chemo Continuous Preparative & Particle Catalysis Processing HPLC and SFC Engineering (Flow Chemistry) WuXi Chemistry CR “D”MO capability overview: Drug Product One-Stop Bioavailability Solid State Enhancing Platform Development 1,192 formulators and analytical scientists Pre- Formulation 1,704 275 Formulation Spray Dried Dispersion Hot Melt Extrusion Development pre-formulation molecules formulations developed evaluated in 2021H1 in 2021H1 Broad Dosage Forms Advanced Delivery Technologies tablets | capsules | powder | pediatrics | modified release liquid capsules | granules | sublingual delivery Nano Suspension Liquid Capsules injectable | liquid in bottle Maximizing synergies from API to DP API and DP client overlap API DP molecule conversion 132 125 115 152 179 156 103 110 88 124 137 161 2019 2020 2021 H1 2019 2020 2021H1 API only Both DP only • Number of clients using both API and DP services increased by 74% from 2019 • API to DP molecule conversion increased by 73% from 2019 Accelerating new drug development for both early and late phases via integrated CMC offering 4-6 months saving for IND submission 3-9 months saving for NDA submission TIME & COST SAVINGS streamlined process and seamless tech transfer REDUCED RISK same high quality and EHS systems across all sites IMPROVED EFFICIENCY simplified CMC vendor management with ONE partner Data source: Expediting IND Submission, PharmTech, March 2021 The 3rd WiXi STA New Drug Development Strategy Summit, October 2019 WuXi Chemistry CRD“M”O An engine to support global launch of new drugs Supported 23 new drugs approved between 2017-2020 6-8** 7 7 6 4 3 2017 2018 2019 2020 2021 *: only count first approval, all of those drugs are approved by FDA, EMA, NMPA or PMDA. ** 6-8 molecules in WuXi Chemistry pipelines are estimated to be approved in 2021 H2 Growing weight of CRD“M”O business in WuXi Chemistry 2015-2021 WuXi Chemistry Commercial Project Revenue 4000 (RMB ¥ Million) 25% 3500 20% 19% 18% 18% 20% 3000 2,751 15% 2500 14% 15% 2000 1,845 9% 10% 1500 1,325 1000 964 684 5% 500 471 271 0 0% 2015 2016 2017 2018 2019 2020 2021Est A proven track record of global standard quality system 7 successful US FDA inspections 30+ successful China NMPA inspections 2013, 2014, 2016, 2018 and 2019 2015-2020 2 successful EU EMA inspections 2 successful Japan PMDA inspections 2019 2019 3 successful SwissMedic inspections 200+ client audits 2018, 2019 & 2020 every year Our winning strategy: follow the molecule Case study u: Support ibrutinib API and intermediates from phase 1 to commercial through different partners Cumulative API and Intermediate Delivery 105 countries launched 125+ MT delivered 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 Nov 2013 FDA approval acquired Initiated project at announced co-development Aug 2017 STA in phase I and worldwide license NMPA approval agreement Our winning strategy: follow the molecule Case study v : Won the business to cover the entire supply chain of niraparib over time 32 countries approved Out licensed in 2012 FDA approval acquired EMA approval 2008 2012 2014 2015 2016 2017 2018 2019 2020 2021 1st starting 1st starting 1st starting 1st starting 1st starting material material material material material + + + + 2nd starting 2nd starting 2nd starting 2nd starting material material material material + + + intermediate intermediate intermediate + + API API + drug product Increasing Business Scope Enabled Zejula® fast track NDA approval by FDA and EMA Key Challenges: Key Criteria when Selecting CDMO: • Both strong in R&D and production • Complex process but fast timeline Why STA? • Late stage and launch experience • Tightened regulatory oversight • Quality and regulatory inspection track record • Virtual biotech company without CMC resources • Team size, technical capability and capacity Resolved Regulatory Starting Material Completed process development and Result: push back from EMA (converted 2 non-GMP Process Performance Qualification in 8 steps to GMP steps in <4 months vs. 8-12 months if months (vs. 18 months quoted by another CDMO) switching to another CDMO) Data Source: DCAT Sharp Sourcing 2018 - Launching Innovative Oncology Drugs Through External Collaboration Our winning strategy: follow the molecule Case study w : Supported Orelabrutinib approval by NMPA via integrated CMC offering Supported Orelabrutinib Approval by NMPA (Dec.2020) st 1 CDMO in China to support a new drug launch involving Spray Dried Dispersion (SDD) technology st 1 CDMO in China to support a new drug launch with an integrated CMC platform across 4 sites • Shanghai Waigaoqiao: API and DP R&D • Jinshan: API manufacturing • Changzhou: SDD manufacturing • Wuxi: Drug product manufacturing and packaging WuXi Chemistry CRD“M”O capacity overview: API Changzhou, China Current Capacity 2021H1 Delivered 15 1400 m3 (1,400,000 L) 6195 141 MT plants total reactor volume batches products Large and rapidly growing API manufacturing capacity Changzhou, China Taixing, China Expansion in Next 2 Years 15 new plants 2,486 m3 (2,486,000 L) 6 from Changzhou phase III and 9 from Taixing phase I additional total reactor volume WuXi Chemistry CRD“M”O capacity overview: Drug Product Wuxi, China
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