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  • www.asymchem.com

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    China R&D and Manufacturing sites

    CMC Solutions

    CMC SolutionsIntegrate, Optimize, Succeed

    Asymchem Labs.

    600 Airport Blvd, Suite 1000 Morrisville, NC, 27560, USA

    Tel: +1 (919) 468-3884 Fax: +1 (919) 468-3916

    Asymchem Inc. (USA)

    No.71, 7th Avenue, TEDA Tianjin, 300457, P.R.China

    Tel+86 22 6625 2888 Fax+86 22 6625 2777

    Asymchem Life Science (Tianjin) Co., Ltd.

    No.42, Road E, Development Zone, Fuxin, Liaoning, 123000, P.R.China

    Tel+86 0418 2535888/2774999 Fax+86 0418 2272558

    Asymchem Laboratories (Fuxin) Co., Ltd.

    No.99, Hongda Road, Economic Development Zone, Dunhua, Jilin, 133700, P.R.China

    Tel+86 0433 6341788 Fax+86 0433 6361266

    Jilin Asymchem Laboratories Co., Ltd.

    TEDA Tianjin, 300000, P.R.China Tianjin Asymchem Pharmaceuticals Co., Ltd.

    Fluorine Chemical Industry Park Fuxin, Liaoning, 123129, P.R.ChinaLiaoning Asymchem Laboratories Co., Ltd.

    No.71, 7th Avenue, TEDA Tianjin, 300457, P.R.China

    Tel+86 22 6625 2888 Fax+86 22 6625 2777

    Tianjin Asymchem Pharma Analytical Testing Service Co., Ltd.

    6-501, No. 399, Cailun Road, Zhangjiang, Shanghai, 201203, P.R.China

    Asymchem Shanghai Office

    No.6, Dongting 3rd Avenue, TEDA Tianjin, 300457, P.R.China

    Tel+86 22 5983 1988 Fax+86 22 5983 1999

    Asymchem Laboratories (Tianjin) Co., Ltd.

    No.19, Chaoyong Park Road, Chaoyong District, Beijing, 100000, P.R.ChinaAsymchem Laboratories (Tianjin) Co., Ltd. Beijing Office

  • www.asymchem.com

    CMC SolutionsIntegrate, Optimize, Succeed

    CATALOGASYMCHEM OVERVIEW OF FACILITIESP-01INTRODUCTIONP-03

    ASYMCHEM OVERVIEW OF MANUFACTURING CAPABILITIESP-07BOARD OF SCIENTIFIC ADVISORP-06

    ASYMCHEM OVERVIEW OF R&D CAPABILITIESP-09DISCOVERY CHEMISTRYP-11CMC SOLUTION P-13ANALYTICAL SERVICESP-15PROCESS RESEARCH AND DEVELOPMENTP-16BIOTECHNOLOGYP-17FLOW CHEMISTRYP-19HIGH POTENCY CAPACITYP-21PHARMACEUTICAL SERVICESP-23ENVIRONMENTAL HEALTH & SAFETY (EHS)P-25QUALITY ASSURANCE & IP PROTECTIONP-26

    P-05 INTERNATIONAL GREEN CHEMISTRY COLLABORATION LABORATORY

    P-27 SYMPOSIUM

  • Beijing Fuxin

    Tianjin

    Jilin

    Shanghai

    ASYMCHEMOVERVIEW OF FACILITIES

    Asymchem Laboratories Inc. (USA) Holding Company

    Asymchem Laboratories (Tianjin) Co., Ltd. USFDA inspected in 2014 High Potency R&D and Manufacturing

    Asymchem Life Science (Tianjin) Co., Ltd. USFDA inspected in 2011 & 2014QP inspected in 2013 New Technology Development cGMP API & Drug Product Manufacturing Pharmaceutical Development Analytical Research Stability Testing Process Engineering/Safety Biotransformation

    Asymchem Laboratories (Fuxin) Co. Ltd. USFDA inspected in 2011 & 2014 Dedicated Carbapenem Manufacturing

    USA

    USA600 Airport Blvd Morrisville, NC 27560 Tel: +1 (919) 468-3884Fax: +1 (919) 468-3916

    0201Asymchem Laboratories Inc. (USA)

    Asymchem Labs.

    Jilin Asymchem Laboratories Co., Ltd. QP inspected in 2014TGA inspected in 2015 Commercial cGMP Manufacturing

    Tianjin Asymchem Pharmaceuticals Co., Ltd. API and Drug Product Manufacturing (under construction)

    Liaoning Asymchem Laboratories Co.,Ltd. Back Integration non-GMP Manufacturing (Under Construction)

    Tianjin Asymchem Pharma Analytical Testing Service Co., Ltd. Analytical Testing Service

    Asymchem Inc. (USA) Business Development & Technical Support

    Asymchem Laboratories (Tianjin) Co., Ltd. Beijing Office Sales Office

    Asymchem Shanghai Office Sales Office

    Asymchem Laboratories (Tianjin) Co., Ltd. Tianjin Asymchem Pharmaceuticals Co., Ltd.

    Jilin Asymchem Laboratories Co., Ltd Asymchem Laboratories (Fuxin) Co. Ltd.

    Liaoning Asymchem Laboratories Co.,Ltd.

    Asymchem Life Science (Tianjin) Co., Ltd.

  • 0403

    Since our beginning in 1995, Asymchem has built up a broad in-house technical expertise with a proven track record of on-time deliveries with high quality products. Solid fiscal growth since our beginning has gone hand in hand with the level of satisfied repeat customers year after year, including receiving supplier awards from Pfizer, Merck and Roche to name a few.

    An integrated solution from a CRO/CMO is the most efficient way to bring more drug candidates to your R&D pipeline and commercialization through:

    Benefits

    Reduction of handoffs to multiple suppliers Eliminate time gaps in drug development Access to flexible resource when needed Reduce R&D cost through integrated prining Effectively manage the risk of drug development

    At the forefront of Asymchems Technical Development Team is the senior management group, which can focus resources quickly to develop and implement solutions before obstacles can affect cycle times or cost. The R&D base of Asymchems integrated Chemical Development team consists of over 500 scientists experienced in the most challenging syntheses.

    Asymchems current four R&D and manufacturing sites offer innovative research and process development at every stage, from preclinical to commercial, running under either non-cGMP or cGMP conditions in labs, kilo labs, pilot plants, commercial scale cGMP production from Asymchems facilities in P.R. China. Projects are handled at high standards of safety and environmental responsibility.

    Solution: Integrated Development

    Asymchem is a custom synthesis CRO/CMO for the development and manufacturing of intermediates, APIs and Drug Products. We strive to deliver innovative processes at every stage of your new product pipeline, providing practical and cost-effective scale-ups from route development, through pilot scale to launch.

    INTRODUCTION

    Asymchem R&D and Manufacturing Facilities (P.R. China) Multipurpose,Meets ICH Q7A and ICH Q10 Guidelines

    * Expansion Plan

    Asymchem Life Science (Tianjin) Co., Ltd

    Jilin Asymchem Laboratories Co., Ltd

    *

    * * **

    Asymchem Laboratories (Tianjin) Co., Ltd

    Tianjin Asymchem Pharmaceuticals Co., Ltd

    Liaoning Asymchem Laboratories Co.,LtdTianjin Asymchem Pharma Analytical

    Testing Service Co., Ltd.

    Discovery ChemistrySynthesis Synthesis Process R&D

    FormulationDevelopment Analytical Service RM/RSM cGMP Intermediates HiPo API API Drug Products

    Asymchem Laboratories (Fuxin) Co. Ltd

    Asymchem Labs.

    Merck awarded Asymchem with 2007Supplier Tier One Award in 2008

    Asymchem won Pfizers 2008 Top intermediates CMO Award in 2009

  • 0605

    In 2014, Asymchem initiated external research collaborations with Professors Baran, Sharpless, and Yu, all members of Asymchems Board of Scientific Advisor, for the development of new process methodology that both improves on existing methods and is environmentally friendly, or green. Several new laboratories at Asymchems Tianjin2 site were fitted out for the work. The first manuscripts of research papers have already been submitted to prestigious journals from the group on a less polluting and cheaper alternative to aryl triflates and on novel electrochemical chemistry. In 2015, Asymchem is extending our commitment to green chemistry investment by joining a consortium of 4 US-based major pharma companies for the development of more sustainable alternatives to common metal-catalyzed cross coupling reactions.

    Professor K. Barry Sharpless, of the Scripps Research Institute, is the winner of the 2001 Nobel Prize in Chemistry. Over a long career, Professor Sharpless has opened entire new fields in transition metal catalysis and is famous for developing practical and efficient new synthetic methodology, especially his breakthroughs in asymmetric epoxidation and dihydroxylation.

    Asymchem has assembled a Board of Scientific Advisor consisting of 9 distinguished academic and industrial scientists with expertise in areas including enzyme evolution, asymmetric catalysis, and green chemistry. The advisory board will provide advice on high level strategic issues faced by Asymchem, and to assist in identification of new business opportunities.

    Dr. Zhang joined Yale University in 1998 to pursue her Ph.D. research in Chemical Engineering, in the area of biomolecule separation and mechanistic modeling. She became the head of Process R&D in 2012. Her area is responsible to develop the chemical processes and prepare active pharmaceutical ingredient (API) to enable clinical trials, toxicology studies and drug product development for the advancement of Abbvies pipeline.

    Asymchem Labs.

    INTERNATIONAL GREEN CHEMISTRY COLLABORATION LABORATORY

    BOARD OF SCIENTIFICADVISOR

    Dr. Shuhong Zhang

    Professor K. Barry Sharpless

    Dr. Stephane Caron, Senior Director of Chemical Process R&D at Pfizer. Dr. Caron leads the process group for one of the worlds biggest and most successful pharmaceutical companies.

    Dr. Stephane Caron

    Dr. Christopher Sinko is the Senior Vice President of Pharmaceutical Development at BMS. He possesses senior management and leadership skills gained from a broad background spanning the disciplines of Chemical Development, Analytical Development and Drug Product Development. Dr. Sinko also has significant experience in scientific and managerial talent and with leading multi-functional teams.

    Professor Nicholas Turner, Chemistry and Biotechnology, University of Manchester, is one of the leading global experts for making better enzymes. His team research on the use of biocatalysts (enzymes and engineered whole cells) in the manufacture of chemicals offers major advantages in terms of econom