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

Cutting-edge integrated chemical genomics platform for drug discovery and early evalsuation 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 Biosescience 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 Biosesciences (United States) Limited, a wholly-owned subsidiary of Chipscreen Biosesciences 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 evalsuation (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 Biosesciences'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 Biosesciences 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.

February | The phase II clinical trial (CGZ203 study) of Chiglitazar Sodium monotherapy for nonalcoholic steatohepatitis (NASH) reached the primary efficacy endpoint.
March | The CAPability-01 study, investigating the efficacy of Chidamide in combination with sintilimab and bevacizumab as a third-line and beyond treatment for colorectal cancer, has been published in Nature Medicine, a premier academic journal with an impact factor of 82.9.
April | The combination therapy of Chidamide + bevacizumab + a PD-1 antibody has been included in the 2024 edition of the Chinese Society of Clinical Oncology (CSCO) Guidelines for the Diagnosis and Treatment of Colorectal Cancer as a recommended third-line treatment for metastatic colorectal cancer (mCRC).
April | Chidamide in combination with R-CHOP was approved for the treatment of diffuse large B-cell lymphoma (DLBCL).
June | The interim analysis of the phase III DEB study of Chidamide was presented in the oral LBA abstract session at the 2024 ASCO annual meeting.
June | Chidamide tablets were granted a Breakthrough Therapy Designation (BTD) by the Center for Drug evalsuation (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 II clinical trial of Chiauranib combined with albumin-bound paclitaxel and gemcitabine as a first-line to treat advanced pancreatic cancer was approved by the NMPA.
July | The new drug application for Chiglitazar Sodium to treat  type 2 diabetes has been approved by the NMPA.
July | The application for a phase III clinical trial of Chidamide in combination with sintilimab and bevacizumab to treat colorectal cancer was approved.