Founded by a group of senior research and management elites from the global pharmaceutical industry in 2004, Sundia MediTech Co., Ltd. is a Shanghai-based contract research organization (CRO) providing excellent and efficient “one-stop” new drug R&D and production services to global pharmaceutical enterprises and biotechnology companies.

Since its founding 12 years ago, Sundia has continued to expand its scale, and developed the laboratory area from the original 500m² to the present 23,000m², with first-class research and production facilities.

In 2008, Sundia Company ranked 52^nd among Deloitte Asia Pacific Technology Fast 500? Rankings and 16^th among Deloitte Technology Fast 50 China owing to its 928% financial growth, and it was rated as one of the “China top 50 most valuable companies for investment” for two consecutive years by a top VC. Sundia also won titles such as China’s “High-tech Enterprise”, “Shanghai Key Service Outsourcing Enterprise”, “Pudong New Area Institution of Enterprise Technical Development”, “Red Herring Top 100 Asia Winner”, “2009 China Top 100 Growing Service Outsourcing Enterprises”, and in January 2011 “Enterprise of the Year in Innovative Zhangjiang · Glorious Pharma Valley”.

Company Strength

The company has world-class expertise in organic synthesis, medicinal chemistry, combinatorial library, hit compound generation, lead optimization, process chemistry R&D, APIs manufacturing under cGMP, preparation development, pharmacological research, in vitro & in vivo pharmacokinetics (PK), and preclinical studies, etc., and has established a batch of professional laboratories with international advanced level and meeting GMP requirements such as efficient API laboratory, analytical laboratory, and drug stability laboratory. Over the past 12 years, Sundia has carried out comprehensive R&D cooperation with over 200 Chinese and overseas pharmaceutical companies, colleges and universities, and institutes, etc. through self-built new drug R&D platform, discovered more than a dozen different candidate drugs, and undertaken over 30 innovative drug preclinical R&D projects, wherein, more than 20 have entered the clinical study stage, and 2 have progressed to clinical trial Phase II.

The company has created characteristics in the high-end CRO services provided in the field of new drug discovery, and discovered more than a dozen candidate drugs for customer enterprises. In the new drug discovery and R&D services provided to the U.S. Xcovery Company, the company discovered 4 candidate drugs in two years and a half at a cost dozens of times lower than the international level, with the first clinical trial approval received in 2009, and its mode was rated as “absolutely the most efficient and economic new drug R&D mode” by the customer.

Development History

May 2004

? Sundia was founded

2005 ~ 2008

?  It initiated the first new drug development project

?  It was one of the first CRO companies receiving the U.S. FDA new drug IND approval in China

?  It received the first CFDA new drug IND approval

2009 ~ 2012

?  Its API GMP kilo lab successfully passed the audit of the first U.S. pharmaceutical enterprise

?  It established the oncology and nervous system pharmacology service platform

?  Its animal laboratory successfully passed the audit of the first EU pharmaceutical enterprise

?  It passed ISO 9001 certification

?  Its subsidiary Hebei Sundia Meditech Company Ltd. was formally put into operation

?  It won the honor of Deloitte Asia Pacific Technology Fast 500? Rankings for five consecutive years

?  Its 2 drugs entered clinical study

?  Its Taicang manufacturing base was put into operation

?  It won “2016 Member Unit with Outstanding Contributions of Shanghai Pudong Modern Service Industry Promotion Association”

Scope of Services

Committed to building a complete new drug R&D technology chain, Sundia has established an almost complete innovative drug preclinical R&D platform through years of effort, to furnish Chinese and foreign customers with integrated complete preclinical services.

The platform combines pharmacy, pharmacology and toxicology, registration application, and project management, and effectively integrates the existing chemical process study, drug quality study, preparation study, DMPK study, pharmacological study, and registration application sub-platforms, etc. of Sundia, and has established cooperation with several new drug toxicological research platforms in ZJ Innopark.

Provision of the one-stop preclinical R&D services to customers can help shorten R&D cycle, reduce R&D cost, and increase R&D efficiency.

Technology Platforms

Technology Platform for Design, Screening, and Development of New Chemical Drugs

Lead compound optimization design, and compound library synthesis

Druggability screening and assessment --Pre-experiment screening: Pharmacodynamics (PD), PK, safety, and preparations

Preclinical pharmaceutical development, and pharmacological and toxicological evaluation –APIs, preparations, quality research, PD, PK, and safety assessment (cooperating with safety assessment centers)

CFDA/FDA IND data writing –Technical data writing, overview data writing, and registration consulting

Preparation of samples for clinical Phase I and II trials –API and preparation sample preparation

CFDA/FDA NDA technical support –API and preparation process scale-up research

Starting material and intermediate CMO –Custom synthesis supply of kilogram to ton starting materials and intermediates

Examples of Projects Passing CFDA Review

Technology Platform for Development, Technology Upgrade, and Consistency Evaluation of Chemical Generics

Generic Drug Projects Successfully Developed and Applied (Some Cases)

Technology Platform for Screening, Evaluation, and Testing of Biological Drugs

Technology Platform for R&D of Drugs Applied Internationally

Team and organization

The technical management team of Sundia is composed of a group of experienced elites in the U.S. biomedical industry

Sundia MediTech USA, Inc. was founded in 2011

Resources

The multiple technology platforms of Sundia can meet R&D needs of different types of Chinese/foreign applied varieties at different stages

Sundia established long-term strategic cooperation with an U.S. registration consulting company in 2016

Business types and experiences

It has provided many customers with R&D services of drugs applied with FDA

IND projects: 7, wherein, 2 have been at U.S. clinical trial Phase II

API DMF: 2 filed

ANDA projects: 6, wherein, 1 has passed the U.S. formal BE, and 4 are under industrialized process research and transfer

R&D projects introduced from oversea and applied in China

Equipment and Facilities

?  The company has a large integrated R&D center that covers an area of 15,000m² in Shanghai ZJ Innopark; the company founded Hebei Sundia Meditech Company Ltd. in 2011 that covers an area of 6,500m².

?  The manufacturing base established by the company in Taicang City Taicang Port Development Zone formally commenced operation in September 2014, with nearly 3,500m² of plant, warehouse, and office space, capable of treating 50t wastewater every day, with main equipment including 20 units of reactor, centrifuge, drying equipment, and vacuum equipment, etc.

?  The company supports various R&D needs through Elsevier’s Reaxys organic synthesis database and chemical patent database, and stores and manages internal data through CBIS system database.

?  In terms of organic synthesis facilities and equipment, the company possesses high-pressure reaction equipment, hydrogenation equipment, and microwave reactors of different volumes, preparative HPLC, chiral HPLC, SFC-80 system, and other special instruments and equipment, besides the common laboratory instruments and equipment.

?  In terms of pilot scale-up, the company possesses large reactors from 50L to 5,000L and supporting facilities, including large rotary evaporators.

?  In terms of analytical and auxiliary equipment, the company possesses multiple units of HPLC, HPLC-MS, GC-MS, API-4000 MS/MS, 300MHz and 400MHz NMRs (with automatic sampling device), and automatic medium-pressure column chromatography system, etc.

Quality Assurance

?  Sundia has established quality management systems according to requirements of FDA’s cGMP, and ICH to ensure quality of customers’ products, including good documentation management system, material management system, production management system, laboratory control system, and quality management system, and set full-time QA personnel to monitor the whole process from material supplier evaluation, raw and auxiliary material procurement, warehouse entry acceptance, production process, finished product release, sales, to customer feedback, etc., to normalize and improve each quality management system; the entire quality system of the company is also managed through site patrol inspection, regular inspection, and regular quality report, etc., and GMP knowledge updating training is regularly organized to improve the quality idea of the staff. Sundia’s customers can conduct quality audit for their projects at Sundia.

Intellectual Property Protection

?  Sundia fully understands the critical importance of intellectual property (IP) protection to customers’ interests. It has taken comprehensive measures to guarantee the confidentiality and security of each project, and developed and strictly implemented the IP protection policy companywide. Each new employee is required to sign CDA (Confidential Disclosure Agreement) when joining Sundia. An information security system is deployed on the network of the company; laboratories are strictly divided according to different projects, and information exchange across projects is not allowed. All lab notebooks are uniformly managed and archived without exception, and can be returned to customers upon request.

Advantages

?  Flexible outsourcing and customization services (meeting customers’ different demands from compound screening to preclinical studies, and from gram to ton production);

?  Sound IP protection system, to guarantee security of customers’ project information;

?  Experience in successful R&D of multiple new drugs and generic drugs;

?  A group of experienced researchers (overseas returnees, doctors, and masters, etc.);

?  Sound quality assurance system, to guarantee the accuracy of experimental data;

?  Top-notch modern instruments and equipment, to guarantee the service quality;

Preferential prices, and most efficient and high-quality services;

Contact Information

Service Consulting Hotline:  +86 (21) -51098642-8024

網(wǎng)站：http://www.sundia.com

Website: http://www.sundia.com

E-mail：info@sundia.com