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The Leader in Combination Product Services WUXI APPTEC WUXI APPTEC

WuXi AppTec Medical Device Preclincal Testing Services

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Page 1: WuXi AppTec Medical Device Preclincal Testing Services

The Leader in Combination Product Services

WUXI APPTEC WUXI APPTEC

Page 2: WuXi AppTec Medical Device Preclincal Testing Services

A Leading Pharmaceutical, Biotech and Medical Device R&D Outsourcing Company with a Global Platform

Note: (1) Current good manufacturing practice

Shanghai, ChinaHeadquarters

Laboratory services, consisting of synthetic and medicinal chemistry, DMPK/ADME, biology, microbiology, In Vivo pharmacology, toxicology, pharmaceutical development, analytical services, biopharmaceutical, in vitro and in vivo biocompatibility testing and efficacy testingManufacturing services, focusing on advanced intermediates, active pharmaceutical ingredients (APIs), and biologics-based manufacturing, testing and related services

Service Offerings

4,142 employees (3,721 in China and 421 in the US)Employees

~ 2.0 million sq. ft. lab, animal facilities and manufacturing spaceChina:► 1 million ft² total research facilities in Shanghai and Tianjin► 291,000 ft² total cGMP(1) quality process development and manufacturing facilities in

Shanghai► 314,000 ft² drug safety evaluation center in Suzhou United States:► 208,000 ft² total three state-of-the-art FDA-registered facilities in St. Paul, Philadelphia

and Atlanta

Facilities

Over 800 clients worldwide including 110 for pharmaceutical services and 700 for biologics, combination product and device services100% repeat business from top 10 customers

Customers

Page 3: WuXi AppTec Medical Device Preclincal Testing Services

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Facilities in the U.S.Facilities in the U.S.• 83,000 ft² FDA-registered facility for in vitro and in vivo biocompatibility, toxicology, contract

cGMP manufacturing and processing for tissue-based products, in St. Paul, US• 50,000 ft² FDA-registered facility for microbiology, medical device chemistry, sterilization

validations, package testing in Atlanta, US• 75,000 ft² FDA-registered facility for process development, cGMP manufacturing of cell banks

and cellular therapeutics, cell biology, molecular biology, virology, analytical services, viral clearance studies in Philadelphia, US

Philadelphia Atlanta St. Paul

Page 4: WuXi AppTec Medical Device Preclincal Testing Services

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Approximately 1,000,000 ft² R&D facility for chemistry, bio-analytical, discovery biology, DMPK and process research in Shanghai, China253,000 ft² R&D facility for chemistry in Tianjin, China293,000 ft² cGMP-quality process development and manufacturing plant in Shanghai, China22,000 ft² cGMP-quality formulation pilot plant in Shanghai, China58,000 ft² large- and small-animal facilities currently in operation (China and US)314,000 ft² GLP pre-clinical drug safety testing facility in Suzhou, China

Shanghai

Tianjin Suzhou

Jinshan, Shanghai

GLP pre‐clinical drug safety testing 

Facilities in ChinaFacilities in China

Page 5: WuXi AppTec Medical Device Preclincal Testing Services

• 82,000 ft² FDA-registered facility for in vitro and in vivo biocompatibility, toxicology, contract cGMP manufacturing and processing for tissue-based products, in St. Paul, US

• 314,000 ft² GLP pre-clinical drug safety testing facility in Suzhou, China

St. Paul Suzhou

PrePre--Clinical Testing FacilitiesClinical Testing Facilities

Page 6: WuXi AppTec Medical Device Preclincal Testing Services

WuXi AppTec Service PortfolioWuXi AppTec Service Portfolio

Guidance and Services Across Therapeutic DeliveriesMedical Device

• Testing Programs• Cell Therapy and Specialty Ortho Bio Manufacturing

Biologics • Testing Programs

Pharmaceutical• Laboratory Discovery Services• Development and Manufacturing Services

Page 7: WuXi AppTec Medical Device Preclincal Testing Services

Convergence

Combination Products

Combination Products

Page 8: WuXi AppTec Medical Device Preclincal Testing Services

Services & Guidance to Meet Regulatory RequirementsServices & Guidance to Meet Regulatory Requirements

Page 9: WuXi AppTec Medical Device Preclincal Testing Services

WX Combination Product PlatformsWX Combination Product Platforms