- CEO
- Yan Chang
- Full Time Employees
- 1,173
- Sector
- Health technology
- Industry
- Pharmaceuticals: major
- Address
- Shanghai China
- IPO Date
- Sep 3, 2024
- Business
- Shanghai InnoStar Bio-tech Co., Ltd. is a China-based contract research organization (CRO) that provides comprehensive non-clinical research and development evaluation services for pharmaceutical and biotechnology companies worldwide. Founded in 2010 and headquartered in Shanghai, China, the company operates as a key preclinical research platform under the China National Biotec Group (CNBG), a subsidiary of the state-owned China National Pharmaceutical Group (Sinopharm). The company provides integrated preclinical drug evaluation solutions that comply with international Good Laboratory Practice (GLP) standards.
The company's primary service offerings include non-clinical safety assessment services, encompassing single-dose and repeated-dose general toxicology studies, safety pharmacology assessments, reproductive and developmental toxicity testing, genotoxicity studies, carcinogenicity studies, immunotoxicity evaluations, and local irritation and sensitization assays; non-clinical pharmacokinetics and drug metabolism (DMPK) services, covering in vitro and in vivo absorption, distribution, metabolism, and excretion (ADME) profiling, tissue distribution studies, mass balance assays, and metabolite identification; non-clinical pharmacodynamics evaluation services, offering in vitro cellular assays, target engagement characterization, and in vivo animal disease efficacy models; bioanalytical testing services, utilizing liquid chromatography-tandem mass spectrometry (LC-MS/MS), enzyme-linked immunosorbent assay (ELISA), electrochemiluminescence (ECL), flow cytometry, and quantitative polymerase chain reaction (qPCR) platforms for small molecule quantitation, large molecule pharmacokinetic assays, anti-drug antibody (ADA) screening, and neutralizing antibody evaluations; and translational research services supporting candidate screening through Investigational New Drug (IND) and New Drug Application (NDA) regulatory submissions. The company supports a wide spectrum of therapeutic modalities, including small molecule chemical drugs, monoclonal antibodies, bispecific antibodies, antibody-drug conjugates (ADCs), recombinant therapeutic proteins, cell and gene therapies (CGTs), mRNA vaccines, and oligonucleotide therapeutics.
Shanghai InnoStar Bio-tech conducts its research operations across specialized testing facilities in Shanghai, Nantong, and Shenzhen, with regulatory compliance recognized by the National Medical Products Administration (NMPA) of China, the U.S. Food and Drug Administration (FDA), the Organisation for Economic Co-operation and Development (OECD), and full accreditation from AAALAC International.
In recent operational developments, Shanghai InnoStar Bio-tech completed its initial public offering (IPO) and listed its Class A shares on the Science and Technology Innovation Board (STAR Market) of the Shanghai Stock Exchange under the ticker symbol 688710 in September 2024. The company has deployed proceeds from the public offering to expand laboratory capacity and high-throughput testing infrastructure at its Shanghai and Nantong campuses, scaling up specialized evaluation capabilities for cell and gene therapies, radiopharmaceuticals, and antibody-drug conjugates. Furthermore, the company has entered into strategic collaborations with global and domestic biopharmaceutical innovators to build integrated one-stop non-clinical evaluation platforms for emerging molecular modalities and to accelerate preclinical programs toward international regulatory approvals.