Mar. 2001 | 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.

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, and the only treatment for PTCL in China
•     The first Class 1.1 innovative drug for rare diseases approved based on phase II clinical trial results in China

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.

March | Phase III clinical trial of Chidamide for the treatment of breast cancer 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).

July | New drug application for Chiglitazar Sodium submitted to the 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.

March | Clinical trial application for CS12192 in the treatment of rheumatoid arthritis accepted by the NMPA.
May | Enrollment of the first subject in the phase III clinical trial of Chidamide for the treatment of diffuse large B-cell lymphoma.
September | Invention patent of Chidamide for breast cancer indication granted in China.
October | Marketing application for Chidamide in the treatment of adult T-cell leukemia (ATL) 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.
December | Strategic cooperation signed with Hisun Pharmaceutical, granting Hisun the right to market Chiglitazar Sodium in certain provinces and regions in China.
December | Chiauranib included in the “Breakthrough Therapy Category” for the treatment of small cell lung cancer by the Center for Drug Evaluation (CDE) of the NMPA.

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 small-cell lung cancer approved by the NMPA.
March | Application for pivotal phase III clinical trials of Chiauranib in the treatment of ovarian cancer approved by the NMPA.
April | Investigational new drug (IND) application for phase Ib/II clinical trials of Chiauranib in the treatment of small cell lung cancer 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, the second approved indication for Chidamide in Japan.
May | Application for phase II clinical trials for Chiauranib in the treatment of triple-negative breast cancer approved by the NMPA.
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.

July| the application for the phase II clinical trial of Chiauranib to treat Triple Negative Breast Cancer was approved by the National Medical Products Administration (NMPA). 
August| the Investigational New Drug (IND) application of CS12192 to treat  Graft-Versus-Host Disease (GVHD) was approved by the U.S. Food and Drug Administration (FDA). 
September| Chiauranib was granted Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) to treat Small Cell Lung Cancer (SCLC). 
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;

July| enrollment was completed for the critical phase 3 clinical trial regarding Chidamide in combination with the first-line treatment of dual-expression diffuse large B lymphoma (DLBCL);

August|  enrollment was completed for the phase 3 clinical trial regarding Chiglitazar in combination with Metformin for the treatment of uncontrolled type 2 diabetes mellitus after Metformin monotherapy;

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 sNDA of chiglitazar sodium combined with metformin was accepted by the National Medical Products Administration;

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;

July丨the marketing application of chidamide combined with R-CHOP as a first-line treatment for diffuse large B-cell lymphoma was accepted and included in Priority Review;

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;

October丨Chipscreen Biosciences was rated A in the SSE's first information disclosure rating of listed companies on the Sci-Tech Innovation Board;
November丨The "No. 2 Production Line" for the chiglitazar sodium production scale-up passed the GMP compliance inspection.