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 52nd among Deloitte Asia Pacific Technology Fast 500™ Rankings and 16th 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
化学新药设计、筛选及开发技术平台 | Technology Platform for Design, Screening, and Development of New Chemical Drugs |
化学部、生物部、（化学）工艺部、DMPK部、制剂部、注册部、分析部、项目管理部 | Chemistry Dept., Biology Dept., (Chemical) Process Dept., DMPK Dept., Preparation Dept., Registration Dept., Analysis Dept., Project Management Dept. |
化学仿制药开发、技术升级及一致性评价技术平台 | Technology Platform for Development, Technology Upgrade, and Consistency Evaluation of Chemical Generics |
（化学）工艺部、DMPK部、制剂部、注册部、分析部、项目管理部 | (Chemical) Process Dept., DMPK Dept., Preparation Dept., Registration Dept., Analysis Dept., Project Management Dept. |
生物药筛选、评价及检测技术平台 | Technology Platform for Screening, Evaluation, and Testing of Biological Drugs |
生物部、DMPK部、注册部、项目管理部 | Biology Dept., DMPK Dept., Registration Dept., Project Management Dept. |
国际申报药物研发技术平台 | Technology Platform for R&D of Drugs Applied Internationally |
化学部、生物部、Sundia MediTech USA、（化学）工艺部、DMPK部、制剂部、注册部、咨询公司、分析部、项目管理部 | Chemistry Dept., Biology Dept., Sundia MediTech USA, (Chemical) Process Dept., DMPK Dept., Preparation Dept., Registration Dept., Consulting Company, Analysis Dept., Project Management Dept. |
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
Registration category | Content undertaken | Application category | Variety state |
1.1 | API process, preparation process, and quality research | FDA\ IND | Under Phase II clinical study |
1.1 | Preclinical overall development (CMC, PD, PK, toxicology, project management, and application) | CFDA\ IND、FDA\ IND | Under Phase II clinical study |
1.1 | Preparation process and quality research | CFDA\ IND | Clinical trial approval received |
1.1 | API process, preparation process, and quality research | CFDA\ IND | Clinical trial approval received |
1.1 | API process, preparation process, and quality research | CFDA\ IND | Clinical trial approval received |
1.1 | API process, preparation process, and quality research | CFDA\ IND | Clinical trial approval received |
1.1 | API process, preparation process, and quality research | CFDA\ IND | Clinical trial approval received |
1.1 | Process, preparation, analysis FDA IND GMP sample production | CFDA\ IND | Clinical trial approval received |
1.1 | API & preparation pharmaceutical research | CFDA\ IND | Clinical trial approval received |
1.1 | Preclinical overall development (CMC, PD, PK, toxicology, project management, and application) | CFDA\ IND | Phase I clinical trial (CFDA) |
1.1 | Candidate validation, pharmacological and toxicological research (PD, PK, toxicology, project management, and application) | CFDA\ IND | Clinical trial approval received |
1.1 | PD and PK | CFDA\ IND | Clinical trial approval received |
Technology Platform for Development, Technology Upgrade, and Consistency Evaluation of Chemical Generics
化学仿制药开发 按最新技术要求开展化学仿制原料药、制剂开发 | Development of chemical generics Develop chemical generic APIs and preparations according to the latest technical requirements |
化学仿制药技术升级 对现有工艺进行特定的优化改进 对已获批仿制药进行系统研究，以达到最新技术要求 | Technology upgrade of chemical generics Conduct specific optimization and improvement of existing processes Conduct systematic research of approved generics, to meet the latest technical requirements |
化学仿制药一致性评价 已获批仿制药一致性评价，对不一致品种进行改进 正在开发及拟升级仿制药一致性评价 | Consistency evaluation of chemical generics Conduct consistency evaluation of approved generics, and improve varieties that are inconsistent Conduct consistency evaluation of generics under development and to be upgraded |
原料药开发 合成工艺研究，结构确证，杂质研究，质量研究，起始原料、中间体商业化定制 | API development Synthesis process research, Structure identification, Impurity research, Quality research, Commercial customization of starting materials and intermediates |
制剂开发 反向工程研究，晶型研究，处方工艺研究，杂质研究，质量研究 | Preparation development Reverse engineering research, Crystal form research, Prescription process research, Impurity research, Quality research |
一致性评价 体外一致性：杂质、稳定性、溶出等一致性评价；动物体内一致性：动物DMPK预BE研究；人体内一致性：临床预BE、正式BE（与临床CRO合作）；临床预BE、正式BE试验血样检测 | Consistency evaluation In-vitro consistency: Impurity, stability, and dissolution consistency evaluation, etc.; Animal in-vivo consistency: Animal DMPK pre-BE research; Human in-vivo consistency: Clinical pre-BE, and formal BE (cooperating with clinical CROs); Blood sample testing for clinical pre-BE, and formal BE trials |
Generic Drug Projects Successfully Developed and Applied (Some Cases)
Variety | Registration category | Content undertaken |
Ezetimibe tablets | 6 | Preparation process and quality research |
Ezetimibe | 6 | API process and quality research |
Temozolomide capsules | 6 | Preparation process and quality research |
Vinorelbine tartrate capsules | 5 | Preparation process and quality research |
Entecavir tablets | 6 | Preparation process and quality research |
Ezetimibe and simvastatin tablets | 6 | Preparation process and quality research |
Halobetasol propionate ointment | 3.1 | Preparation process and quality research |
Dutasteride API + preparation | 3.1 | Pharmaceutical research |
Simvastatin tablets | U.S. ANDA | Preparation process and quality research |
Technology Platform for Screening, Evaluation, and Testing of Biological Drugs
生物药早期开发与筛选 | Early Development and Screening of Biological Drugs |
分子及细胞生物学 基因克隆、突变诱导、载体及质粒构建；瞬时转染及稳定转染细胞株构建；蛋白表达 | Molecular and cell biology Gene cloning, mutation induction, and carrier and plasmid construction; Transient and stable transfected cell line construction; Protein expression |
药效筛选 以细胞为基础的药物筛选（原代细胞、稳转细胞系、抗药细胞系）；受体、酶学相关生化检测（>30激酶平台）；同位素标记的受体结合实验；采用荧光标记、化学发光、流式细胞术、酶联免疫吸附测定等方法进行的筛选 | PD screening Cell-based drug screening (primary cells, stable transfected cell lines, and drug-resistant cell lines); Receptor and enzymology associated biochemical detection (>30 kinase platforms); Isotope labeled receptor binding assays; Screening through fluorescent labeling, chemiluminescence, flow cytometry, and enzyme-linked immunosorbent assay (ELISA), etc. |
早期毒理学、组织学研究 单次给药毒性试验；多次给药毒性试验；最大耐受量试验；组织取材固定、石蜡/冰冻切片、常规组织学染色/免疫组化染色 | Early toxicologic and histological studies Single dose toxicity test; Repeated dose toxicity test; Maximum tolerance dose test; Tissue sampling and fixation, paraffin/frozen section, and routine histological staining/immunohistochemical staining |
生物药评价与检测 | Biological Drug Evaluation and Testing |
药效学评价与机制研究 肿瘤学；细胞活力检测（>160株人源肿瘤细胞株）；人源肿瘤细胞异种移植瘤模型（>60种异种移植瘤模型）；神经生物学；帕金森氏症；L-DOPA诱导的运动障碍；抑郁、焦虑、疼痛、学习、记忆；免疫与炎症；代谢相关（糖尿病、脂肪肝）；靶标确证、作用机制研究 | Pharmacodynamic evaluation and mechanism research Oncology; Cell viability testing (>160 human tumor cell lines); Human tumor cell xenograft model (>60 xenograft models); Neurobiology; Parkinson's disease; L-DOPA-induced dyskinesia; Depression, anxiety, pain, learning, and memory; Immunity and inflammation; Metabolism associated (diabetes, and fatty liver); Target validation, and mechanism of action research |
药代动力学研究 小鼠、裸鼠、大鼠、犬、猴的PK研究；单剂量给药、多剂量给药的PK研究；交叉试验；毒物代谢动力学（TK）研究；剂量递增研究 | PK studies PK studies of mice, nude mice, rats, dogs, and monkeys; PK studies of single dose administration and multiple dose administration; Crossover trials; Toxicokinetics (TK) studies; Dose escalation studies |
生物药检测 分析方法建立及验证（ELISA）；生物标记物鉴定及检测方法开发；动物及人体PK/PD试验血浆、组织、尿液、便中药物定量 | Biological drug testing Analytical method establishment and validation (ELISA); Biomarker identification and testing method development; Animal and human PK/PD test plasma, tissue, urine, and feces drug quantification |
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
网站：http://www.sundia.com
Website: http://www.sundia.com
E-mail：info@sundia.com
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