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History of Chipscreen Bioscences

Chipscreen History

Our pioneering journey to bring China-innovated pharmaceuticals to the world began in Shenzhen in 2001.


Fast forward to 2025, we are now a globalized modern biotech firm with integrated research, production and sales capacity.

Start-up

Start-up

Mar. 2001 | Shenzhen Chipscreen Biosciences, Ltd. established.

  • March | Shenzhen Chipscreen Biosciences, Ltd. established.

  • Cutting-edge integrated chemical genomics platform for drug discovery and early evaluation successfully constructed.

 

  • Chiglitazar Sodium (a peroxisome proliferator-activated receptor pan-agonist) and Chidamide (an isoform-selective histone deacetylase inhibitor) discovered.

  • Cross-transfer agreement signed with the National Center for Toxicology Research (NCTR), a branch of the U.S. FDA, to develop software for toxicogenomics research. 

  • December | Clinical trial application for Chiglitazar Sodium, an original anti-diabetic drug, submitted to the State Food and Drug Administration (now the National Medical Products Administration).

  • June | Application for phase I clinical trials of Chiglitazar Sodium formally approved by the SFDA.

 

  • December | Clinical trial application for Chidamide, an original anti-tumor drug, submitted to the SFDA.

 

  • December | Chipscreen’s Innovative Chemical Drug Engineering Technological Center s awarded municipal-level engineering center status.

  • October | Licensing agreement signed with HUYA Bioscience International for patent protection and licensing of Chidamide in regions including the United States, EU, and Japan.

 

  • November | Phase IIa proof-of-concept clinical trial for Chiglitazar Sodium completed.

 

  • November | Phase I clinical trials of Chidamide formally approved by the SFDA.

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Steady Growth

Steady Growth

In Dec. 2009, Chipscreen Biosciences was awarded the "Special Contribution Award" by the Center for Drug Evaluation, CFDA

  • Discovery of Chiauranib, a multi-kinase inhibitor.

  • May | Phase I clinical trials of Chidamide completed in China, with encouraging efficacy and safety.

  • March | Clinical trial of Chidamide in rare cancers initiated to obtain marketing approval.

 

  • June | Chipscreen included as an “Original Drug Incubator” in China’s Significant New Drug Discovery Program, a major national science and technology initiative. 

 

  • July | “Shenzhen Biomedical Accelerator Pilot Project” initiated by the Shenzhen government to accelerate the industrialization of Chidamide.

  • January | Phase I clinical trials of Chidamide approved by the U.S. FDA.

 

  • July | Applications for phase II and III clinical trials of Chidamide for patients with non-small cell lung cancer, breast cancer, and prostate cancer approved by the SFDA.

  • March | Application for a phase III clinical trial of Chiglitazar Sodium for registration purposes approved by the SFDA.

 

  • August | Application for clinical trials of Chiauranib for cancer treatment submitted to the SFDA 

  • February | New drug application (NDA) and a fast track marketing authorization application (MAA) for patients with PTCL submitted to the SFDA based on the phase II clinical trial of Chidamide.

 

  • August | Application for phase I clinical trial of Chiauranib approved by the CFDA (succeeding the SFDA).

 

  • October | Chidamide out-licensed to GNT Biotech & Medicals Corporation in Taiwan, China.

 

  • Discovery of CS12192, a selective JAK3/JAK1/TBK1 kinase inhibitor.

  • April | Establishment of Chengdu Chipscreen Pharmaceutical Ltd., a wholly-owned subsidiary.

 

  • July | Phase I clinical trials of Chidamide approved by the Japanese PMDA.

 

  • December | Chidamide approved for marketing by the CFDA.
  •     The world’s first subtype-selective histone deacetylase (HDAC) inhibitor
  •     The world’s first oral medication for the treatment of peripheral T-cell lymphoma, filling the gap in the treatment of peripheral T-cell tumors in China.
  •     The first Class 1.1 innovative drug for rare diseases approved based on phase II clinical trial results in China

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Rapid Development

Rapid Development

Jan. 2015 | Chipscreen Biosciences’ original new drug Chidamide received Chinese FDA approval with its press conference officially launched.

  • February | GMP certification of Chidamide manufacturing base and commercial launch of Chidamide.

 

  • July | Phase III clinical trial initiated to study Chidamide in combination with Exemestane for the treatment of hormone receptor-positive advanced breast cancer.

  • October | Enrollment for the phase III clinical trial of Chiglitazar Sodium completed.

  • April | Application for a phase III clinical trial of Chidamide in the treatment of breast cancer approved by the TFDA in Taiwan, China.

 

  • July | Chidamide included in national medical insurance coverage.

 

  • October | Construction of Chengdu Chipscreen Pharmaceutical's R&D center for innovative drugs and regional headquarters formally begins.

 

  • November | Phase III clinical trials of Chiglitazar Sodium completed.

  • May | Chipscreen’s Innovative Chemical Drug Engineering Technological Center awarded provincial-level engineering technology research center status.

 

  • June | Application for phase II/III clinical trials of Chiauranib approved by the CFDA.

 

  • November | Marketing application for Chidamide in the treatment of breast cancer submitted to the National Medical Products Administration (NMPA).

  • August 12 | Accession to the STAR Market.

 

  • September | New drug application for Chiglitazar Sodium in the treatment of type 2 diabetes accepted by the NMPA.

 

  • November | Marketing application for Chidamide in breast cancer approved by the NMPA, the second indication for Chidamide approved in China.

  • October | Marketing application for Chidamide in the treatment of adult T-cell leukemia  accepted by the Japanese PMDA, the first approved indication for Chidamide in Japan.

 

  • October | Incorporation of Chipscreen Biosciences (United States) Limited, a wholly-owned subsidiary of Chipscreen Biosciences in the United States.

  • March | Chiauranib included in the “Breakthrough Therapy Category” for the treatment of ovarian cancer by the CDE.

 

  • March | Application for pivotal phase III clinical trials of Chiauranib in the treatment of ovarian cancer approved by the NMPA.

 

  • April | Investigational new drug  application for phase Ib/II clinical trials of Chiauranib in the treatment of advanced solid tumors approved by the FDA, the first approved trial indication for Chiauranib in the U.S.

 

  • April | New drug application for Chidamide in the treatment of peripheral T-cell lymphoma (PTCL) accepted by the PMDA.

 

  • June | Marketing application for Chidamide in the treatment of ATL accepted by the PMDA, the first Chinese-developed drug to be approved for marketing overseas.

 

  • October| Chiglitazar was approved for marketing by the National Medical Products Administration (NMPA) to treat Type 2 Diabetes.

 

  • December | Chidamide monotherapy in the treatment of Relapsed/Refractory (R/R) Peripheral T-cell Lymphoma (PTCL) was approved for marketing in Japan, a new indication approved following ATL in Jun. 2021 in the country.

  • April | The new headquarters and the R&D center of the Group were officially put into use.

 

  • November | Chengdu Chipscreen Pharmaceutical Ltd. was successfully certified as a high-tech enterprise.

  • January丨Our innovative drug for the treatment of type 2 diabetes mellitus, chiglitazar sodium (trade name: Bilessglu®), was included for the first time in the National Reimbursement Drug List.

 

  • February丨 Chipscreen NewWay reached a licensing agreement with Eucure Biopharma, a subsidiary of Biocytogen, for the bispecific antibody YH008 in Greater China. In March, the application for the project's phase 1 clinical trial was approved by the National Medical Products Administration.

 

  • March丨 Chipscreen Biosciences's innovative product chidamide was approved for the indication of breast cancer in Taiwan, China.

 

  • June丨the application for a phase I clinical trial of CS23546, a new oral small molecule anti-tumor immunotherapeutic drug, was approved by the National Medical Products Administration.

 

  • October丨 The clinical trial application for CS32582 capsules, a new immune-regulated small molecule drug, for the treatment of psoriasis was approved by the National Medical Products Administration.

  • February | The phase 2 clinical trial (CGZ203 study) of Chiglitazar Sodium monotherapy for nonalcoholic steatohepatitis (NASH) reached the primary efficacy endpoint.

 

  • April | Chidamide in combination with R-CHOP was approved for the treatment of diffuse large B-cell lymphoma.

 

  • June | Chidamide tablets were granted a Breakthrough Therapy Designation (BTD) by the Center for Drug Evaluation (CDE) of China National Medical Products Administration (NMPA). The proposed indication is for Chidamide in combination with sintilimab and bevacizumab for the treatment of patients with advanced microsatellite stable or proficient mismatch repair (MSS/pMMR) colorectal cancer who have failed ≥ 2 lines of standard treatment.

 

  • June  | The application for a phase 2 clinical trial of Chiauranib combined with albumin-bound paclitaxel and gemcitabine as a first-line treatment for advanced pancreatic cancer was approved by the NMPA.

 

  • July | The new drug application for Chiglitazar Sodium in the treatment of type 2 diabetes has been approved by the NMPA.

 

  • July | The application for a phase 3 clinical trial of Chidamide in combination with sintilimab and bevacizumab in the treatment of colorectal cancer was approved.

 

  • December  | The investigational new drug (IND) application for CS231295, a selective inhibitor of brain-penetrating Aurora B, was approved by the NMPA.

 

  • December | Chidamide was successfully included in the National Drug Reimbursement List for the new indication of DLBCL, and Chiglitazar Sodium was renewed at the original price for the indication of type 2 diabetes mellitus.

  • January 丨The IND application for a clinical trial of CS12088 tablet, a new anti-hepatitis B virus drug, was approved by the NMPA.

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