Shanghai Xihua Scientific Co.,Ltd.(Xihua) was established in 2015. The headquarters is located in the core area of the Pharmaceutical Valley in Zhangjiang Hi-Tech Park, Shanghai. We have subsidiaries Xihua Pharmaceuticals, Xihua  PharmaTech, Xihua Clinical , Suzhou Xihua Scientific, Chuzhou Xihua, etc. Besides, Xihua holds Primera Analytical Solutions Corp.(U.S.) and TCM Groups (U.S.) as well. With drug testing as the core, Xihua provides the global pharmaceutical industry with high-quality and efficient one-stop research and development service from druggability to marketing. We currently have over 20,000m² of space and over 700 employees, serve more than 300 customers.

Xihua scientific provides professional bioanalytical services, including method development, method validation, sample analysis, long-term sample storage, and consulting services for Large-molecule biopharmaceuticals, small-molecule chemical drugs and biomarkers. So far, we have nearly 200 Chinese and foreign customers, passed over 110 times of NMPA on-site inspection and 20 times exempt from inspection, five consecutive years passed External Quality Assessment(EQA) from the National Health Commission and 2022 CNAS certification. The core members, with experience in bioanalytical departments of world-renowned pharmaceutical companies and CROs, are well versed in both domestic and international bioanalytical regulations and quality systems. Meanwhile, our team is experienced in passing inspections of NMPA, FDA, OECD and EMA, and all verified items were accepted by Chinese and Western medical and drug administrations.

Xihua has been certified as a Shanghai High-tech Enterprise, one of the Little Giants Companies, has won the honorary title of excellent enterprise in the growth group of the biomedical industry in the 8th China Innovation & Entrepreneurship Competition national final.

Suzhou Xihua Scientific provides drug metabolism and pharmacokinetics (DMPK) services, including in-vivo PK and in-vitro ADME, biopharmaceutical PK and biosimilars, and IND application service. With extensice experience in drug discovery and development, our expert team has the capability to identify druggability issues and provide targeted structural modification suggestions for our clients to ensure the quality of drug candidates and reduce the risk of later phase. At present, Suzhou Xihua has SPF-Class Housing of laboratory for small animals and General Grade Laboratory for large animals, and laboratories for large and small molecule bioanalysis, furthermore, Biosafety Laboratory 2 (BL2) for large and small animals are under construction, species of animals include rat, mouse, dog, monkey, guinea pig and rabbit. Up to now, Suzhou Xihua Scientific has completed dozens of IND application for our clients.

Shanghai Xihua Clinical Co., Ltd. (“Xihua Clinical”), which is a wholly domestic subsidiary of Shanghai Xihua Scientific Co., Ltd. Xihua Clinical operates in both China and the United States, with offices in Shanghai, New Jersey and Boston. Xihua Clinical is committed to providing clinical data management, statistical analysis and programming services that meet international CDISC standards, as well as clinical pharmacology, quantitative pharmacology, and pre-marketing and post-marketing pharmacovigilance services.

TCM Groups, Inc. (“TCM”) was founded in 2003 and operates in both U.S. and China with offices in New Jersey, USA and Shanghai, China (Shanghai Xihua Clinical, Co., Ltd.), which is a holding subsidiary of Shanghai Xihua Scientific Co. Ltd. We are a contract research organization (CRO) dedicated to providing clinical data management, statistical analysis and programming, medical writing, pharmacovigilance, and regulatory strategy services for global pharmaceutical companies. Based on the core service conception of 'Comprehensive project design and effective planning at the early stage with simplified budget and create more added value for clients' and continuous development, TCM has accumulated rich practice and experience in FDA filing services. On the basis of characteristic FDA communication process and integrated professional resources, TCM developed a deep understanding of diseases and drugs.

Xihua Pharma provides one-stop services from R&D to manufacturing of API and formulation (DP), analysis of large/small molecular and GCTP, and regulatory filing, which are integrated solutions for innovative and generic drugs. Xihua Pharma’s R&D teams provide services including API process R&D and scale-up, analysis for small & large molecules as well as gene and cell therapy products (GCTP), innovative formulation development, clinical supplies manufacturing and commercial formulation manufacturing, and regulatory affairs services. Additionally, the formulation R&D team also focuses on generic products development including formulation process R&D, scale-up, technology transfer, analytical support and regulatory affairs services.

Shanghai Xihua Pharmaceutical Technology Co. Ltd.Xihua PharmaTechprovide integrated services for generic and innovative drugs, from product development, formulation and process development, scale-up production, process validation, quality study to IND/ (A)NDA application preparation, in the dosage form of tablets, capsules, oral liquid, injections, eye drops, etc. So far, all the generic bioequivalence tests undertaken by Xihua have 100% one-time passed , including narrow therapeutic window drugs, highly variable drugs, endogenous drugs, and extremely low bioavailability insoluble drugs. Xihua PharmaTech has a gradient team composed of senior experts of generic R&D and manufacturing technical from well-known US and domestic pharmaceutical companies.

Fujian Xihua Pharma, as the production base of Xihua Pharma, is located in Sanming, Fujian, which is engaged in process R&D and commercial manufacturing of advanced intermediates and API. The initial factory, with over 120,000 m², provides integrated solutions for innovative and generic drugs, which is expected to be completed by the end of 2023.

Primera Analytical Solutions, Xihua’s subsidiary, provides analytical services for small/large molecules, cell & gene therapy products. Primera occupies over 4500 m² laboratory space. There are over 120 employee and more than 200 customers now, which broadens Xinhua’s capability in bioanalysis, pharmaceutical analysis, and clinical data statistical analysis in the United States.