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Disease Statistics in China

Belows are the epidemiology or statistics in China:

Cancer:Cancer statistics in China, 2015.
doi: 10.3322/caac.21338

Cancer incidence and mortality in China, 2014 doi: 10.21147/j.issn.1000-9604.2018.01.01
Changing cancer survival in China during 2003-15: a pooled analysis of 17 population-based cancer registries. doi: 10.1016/S2214-109X(18)30127-X
Current cancer situation in China: good or bad news from the 2018 Global Cancer Statistics? doi: 10.1186/s40880-019-0368-6

Epidemiology of lung cancer in China (2018) doi: 10.1111/1759-7714.12916

Lung cancer molecular epidemiology in China: recent trends (2014)
doi: 10.3978/j.issn.2218-6751.2014.09.01
Current small cell lung cancer treatment in China (2014)
doi: 10.1111/1759-7714.12218

NMPA approved Siponimod for RMS in China

2020.5.11 NMPA published the new drug approval news. Siponimod from Novartis was approved under priority review for relapsing multiple sclerosis.

The following comes from Wikipedia:
Siponimod, sold under the brand name Mayzent, is a selective sphingosine-1-phosphate receptor modulator for oral use that is used for multiple sclerosis (MS). It is intended for once-daily oral administration. In March 2019, it was approved in the United States to treat adults with relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease.

2020.5 NDA/BLA Inspection Schedule by CFDI for NMPA

May 2020 NDA/BLA Inspection Schedule by CFDI for NMPA:

No. Acceptance number Company Products 1 CXHS1800031 Simcere d-borneol1 CYHS1800020 Ascletis Ravidasvir hydrochloride tablet1 CYHS1800032 Simcere d-borneol and edaravone Injection

Drug Review Package of Chinese New Chemical or Biologic Drug

Belows are the drug review package of Chinese new chemical or biologic drug:
Benaglutide(贝那鲁肽, HYBR-014, GLP-1) was developed by Benemae Pharma (filing for STAR), approved in 2016/12/19, click here.Anlotinib(安罗替尼, AL3818, VEGFR/FGFR/PDGFR) was developed by Chia Tai Tianqing Pharma (HK: 01177), approved in 2018/5/9, click here.Mecapegfilgrastim (硫培非格司亭, 19K, G-CSF) was developed by Hengrui Medicine (SH: 600276), approved in 2018/5/18, click here.Fruquintinib (呋喹替尼, HMPL-013, VEGFR) was developed by Hutchison MediPharma (NASDAQ: HCM), approved in 2018/9/5, click here.Toripalimab (特瑞普利单抗, JS001, PD-1) was developed by Junshi Biosciences (HK: 01877/filing for STAR), approved in 2018/12/17, click here.Sintilimab (信迪利单抗, IBI308, PD-1) was developed by Innovent Biologics (HK: 01801), approved in 2018/12/27, click here.Camrelizumab (卡瑞利珠单抗, SHR1210, PD-1) was developed by Hengrui Medicine (SH: 600276), approved in 2019/5/5, click here.Loxenatide(洛塞那肽, PEX168, GLP-1) was developed by Hansoh Pha…

Guideline on the Submission of Clinical Trial Data in China (2020.5 Draft for Public Review)

Guideline on the Submission of Clinical Trial Data
(Draft for Public Review)
Center for Drug Evaluation, NMPA
May, 2020


Table of Contents
1. Background and Purposes3
2. Submission Components of Clinical Trial Data4
2.1 Study database4
2.2 Analysis database5
2.3 Data Definition File6
2.4 Annotated CRF7
2.5 Programming Code7
3. Submission Document Format and Conventions8
3.1 Portable document format8
3.2 Extensible mark-up language format8
3.3 Plain text format8
3.4 Data transport file format8
3.5 Dataset split9
3.6 Dataset name, variable name and length9
3.7 Dataset labels and variable labels10
4. Other Considerations10
4.1 Traceability of trial data10
4.2 Data files under eCTD11
4.3 Foreign language database11
4.4 Communication with regulatory agency11
References11




Guideline on the Submission of Clinical Trial Data
1. Background and Purposes

Clinical trial data is one of the important materials submitted by sponsor to regulatory agencies. It is a valuable resource for both regulatory ag…

Shanghai Xunhe Pharma’s CDK4/6 Inhibitor XH-30002 IND Accepted by Chinese NMPA

2020.4.22, according to CDE website, NMPA accepted the IND of CDK4/6 Inhibitor XH-30002 from Shanghai Xunhe Pharma(上海勋和医药), held a pre-IND meeting with NMPA on Dec 2019.

According to the official websites, Shanghai Xunhe Pharma focused on innovation in oncology, cardiovascular, respiratory and mental disease, targeting PARP, JAK2, BET, CDK.

Shanghai Xunhe Pharma completed its first round tens of millions financing in 2018.

2020.4 NDA/BLA Inspection Schedule by CFDI for NMPA

April 2020 NDA/BLA Inspection Schedule by CFDI for NMPA:

No.Acceptance numberCompanyProducts1CXSS1900005 Xinjiang Deyuan BioengineeringHuman Immunnglnhlobulin (pH4) for Intravenous Injection2CXSS1700033 Shanxi Kangbao BiologicalHuman coagulation factor Ⅷ 3CYHS1900202 Chongqing Huapont PharmAminosalicylate  Enteric-CoatedGranules4CXHS1800035 Yichang Humanwell PharmaRamimazolam Besilate for Injection 5CXSS1800029 Heibei Daan Pharma Human Immunnglnhlobulin (pH4) for Intravenous Injection6Y20190000075 Chongqing Huapont Kaisheng PharmAminosalicylate 7CYSB1800230 Beijing Kawin Technology Recombinant Human Interferon α2b Injection 8CYSB1800229 Beijing Kawin Technology Recombinant Human Interferon α2b Injection9CYSB1800228 Beijing Kawin TechnologyRecombinant Human Interferon α2b Injection10CYSB1800231 Beijing Kawin TechnologyRecombinant Human Interferon α2b Vaginal Effervescent Tablets11CXSS1900029 Heibei Daan Pharma Human Prothrombin Complex 12CXSS1800007 China Biologic Products Human coagul…