Shenzhen Chipscreen Biosciences Co.
Shenzhen Chipscreen Biosciences Co. is a Chinese original innovative drug company developing first-in-class and best-in-class therapeutics.
Last updated October 12, 2026
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Overview
Shenzhen Chipscreen Biosciences Co. is an original innovative drug company that describes itself as a pioneer in China's original innovative drug field. It uses an AI plus chemical genomics integrated technology platform to develop innovative mechanism drugs with revolutionary efficacy that address urgent clinical needs. The company has two approved original innovative drugs, chidamide (Epidaza) and chiglitazar (Shuangluoping), and has laid out R&D pipelines in oncology, metabolic diseases, autoimmune diseases, and neurodegenerative diseases. It has a global industrial layout including a Shenzhen headquarters/R&D center/GMP production base, a Chengdu regional headquarters/R&D center/GMP production base, Pengzhou Chipscreen Pharmaceutical, Beijing and Shanghai branches, and a US subsidiary, ThalassaX Therapeutics.
History
Shenzhen Chipscreen Biosciences Co., Ltd. was established in March 2001. In 2002, it successfully built an internationally advanced integrated drug discovery and early evaluation platform based on chemical genomics, and first discovered the peroxisome proliferator-activated receptor pan-agonist chiglitazar and the subtype-selective histone deacetylase inhibitor chidamide. In December 2003, it signed a cross-transfer agreement with the US FDA's National Center for Toxicological Research for the development of drug toxicogenomics application software. In December 2004, it submitted a clinical trial application to China's drug regulatory authority for the original diabetes treatment drug chiglitazar. In June 2005, Phase I clinical trials of chiglitazar were officially approved by China's drug regulatory authority. In December 2005, it submitted a clinical trial application for the original anti-tumor drug chidamide. In October 2006, patent and commercialization rights for chidamide in the US, EU, and Japan were licensed to US-based HUYABIO. In November 2006, it completed Phase IIa clinical trials of chiglitazar, achieving proof of concept. In November 2006, the Phase I clinical trial application for chidamide was officially approved by China's drug regulatory authority. In 2007, it first discovered the multi-target selective kinase inhibitor chiauranib. In May 2008, it completed Phase I clinical trials of chidamide in China. In March 2009, chidamide entered clinical trials for rare oncology diseases with the goal of marketing. In June 2009, the first batch of 'Enterprise Innovative Drug Incubation Bases' under the National 'Major New Drug Creation' major science and technology program was established at Chipscreen. In July 2009, the Shenzhen municipal government tailored the 'Shenzhen Biomedical Accelerator Pilot Project' for the industrialization of chidamide. In January 2010, the Phase I clinical trial of chidamide was approved by the US FDA. In July 2010, applications for Phase II and III clinical trials of chidamide for solid tumors including non-small cell lung cancer, breast cancer, and prostate cancer were approved by China's drug regulatory authority. In March 2012, the application for the registrational Phase III clinical trial of chiglitazar was approved by China's drug regulatory authority. In August 2012, it submitted a clinical trial application to China's drug regulatory authority for chiauranib in oncology. In February 2013, it completed Phase II clinical trials of chidamide and submitted an application for a new drug certificate and marketing authorization fast-track approval with PTCL as the indication to China's drug regulatory authority. In August 2013, the Phase I clinical trial application for chiauranib was approved by China's drug regulatory authority. In October 2013, patent rights for chidamide in Taiwan, China were licensed to Hua Shang Biotechnology. It first discovered the selective JAK3/JAK1/TBK1 kinase inhibitor CS12192. In April 2014, it established the wholly-owned subsidiary Chengdu Chipscreen Pharmaceutical Co., Ltd. In July 2014, the Phase I clinical trial of chidamide was approved by Japan's PMDA. In December 2014, chidamide (Epidaza) was approved for marketing by China's drug regulatory authority as the world's first subtype-selective histone deacetylase (HDAC) inhibitor, the world's first oral drug for PTCL, filling a gap in China's peripheral T-cell lymphoma treatment field, and China's first original rare disease National Class 1.1 new drug approved for marketing based on Phase II clinical trial results. In January 2015, a press conference was held for the original innovative drug chidamide, a result of the National 863 Program and 'Major New Drug Creation' special project.
- 2015
A press conference was held for the original new drug chidamide, a result of the National 863 Program and the 'Major New Drug Creation' special project.
- 2014
Established the wholly-owned subsidiary Chengdu Chipscreen Pharmaceutical Co., Ltd.
- 2014
Phase I clinical trial of chidamide was approved by Japan's PMDA.
- 2014
Chidamide (Epidaza®) was approved for marketing by China's drug regulatory authority; the world's first subtype-selective histone deacetylase (HDAC) inhibitor, the world's first oral drug for PTCL, filling a gap in the treatment of peripheral T-cell lymphoma in China, and China's first original rare disease National Class 1.1 new drug approved for marketing based on Phase II clinical trial results.
- 2013
Completed Phase II clinical trial of chidamide and submitted a fast-track new drug certificate and marketing authorization application to China's drug regulatory authority for the PTCL indication.
- 2013
Phase I clinical trial application of chiauranib was approved by China's drug regulatory authority.
- 2013
Licensed the patent rights of chidamide in Taiwan, China to Hua Shang Biotechnology; first discovered the selective JAK3/JAK1/TBK1 kinase inhibitor CS12192.
- 2012
Application for the registrational Phase III clinical trial of chiglitazar sodium was approved by China's drug regulatory authority.
- 2012
Submitted a clinical trial application to China's drug regulatory authority for chiauranib in the treatment of tumors.
- 2010
Phase I clinical trial of chidamide was approved by the U.S. FDA.
Products and positioning
Pioneer in China's original innovative drug field, committed to providing patients with affordable, urgently needed innovative mechanism drugs with revolutionary efficacy.
Chidamide (Epidaza)
Subtype-selective HDAC inhibitor (HDAC 1,2,3,10); epigenetic regulator and immune regulator. Indications include relapsed/refractory peripheral T-cell lymphoma, HR+ breast cancer (combined with AI), diffuse large B-cell lymphoma (first-line/combined with standard treatment), non-small cell lung cancer (with envafolimab KN035), and non-small cell lung cancer (with tislelizumab BGB-A317). Approved in China mainland and Hong Kong, China.
Chiglitazar (Shuangluoping)
Novel insulin sensitizer; non-TZD conformationally restricted PPAR pan-agonist. Indications include type 2 diabetes (inadequately controlled with diet and exercise), type 2 diabetes (combined with metformin), and non-alcoholic steatohepatitis. Global rights.
Chiauranib
Three-pathway targeted kinase inhibitor (Aurora B/VEGFRs/CSF1R). Indications include small cell lung cancer (third-line/monotherapy), small cell lung cancer (third-line/monotherapy, US), ovarian cancer (platinum-resistant/combined chemotherapy), liver cancer (second-line/monotherapy), lymphoma (monotherapy or combined with chidamide), triple-negative breast cancer (monotherapy and combination), soft tissue sarcoma (STS), and extensive-stage small cell lung cancer combined with AK104. Global rights.
CS23546
PD-L1 small molecule inhibitor.
CS231295
Brain-penetrant Aurora B selective inhibitor for oncology.
CS32582
Tyrosine kinase 2 (TYK2) highly selective small molecule allosteric inhibitor.
CS08399
Brain-penetrant PRMT5-MTA inhibitor for oncology.
CS43158
Multi-target protein kinase inhibitor for oncology.
NW001
Immune conjugate drug (EIMAC) for oncology.
Controversies
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