南宫NG·28

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.

• 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  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 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.

• 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.

• 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.

• February | The phase 2 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 | Chidamide in combination with R-CHOP was approved for the treatment of diffuse large B-cell lymphoma.

• June | The results of the phase 3 DEB study of Chidamide in the treatment of DLBCL were presented and announced in an oral presentation in the LBA abstract session at the 2024 ASCO annual meeting.

• 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.

• November  | The phase 2 clinical data of Chiglitazar Sodium monotherapy for MASH were announced in an oral presentation at the Annual Meeting of the American Association for the Study of Liver Diseases.

• 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.