Global Disease Statistics

 Belows are the epidemiology or statistics globally: Cancer: Global patterns and trends in incidence and mortality of thyroid cancer in children and adolescents : a population-based study doi: 10.3322/caac.21338 HIV: Epidemiology of HIV in the USA : epidemic burden, inequities, contexts, and responses do: 10.1016/S0140-6736(21)00395-0

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 cance r 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 2015年中国 恶性淋巴瘤 发病与死亡分析 中国肿瘤2021,30(01) 2001—2010年中国胃 肠胰神经内分泌癌 临床流行病学研究 中国肿瘤2021,30(01) 2015年中国 脑瘤 发病与死亡分析 中国肿瘤2021,30(01) 2000—2017年北京市前列腺癌发病和死亡流行趋势及发病年龄变化特征分析 中国肿瘤2021,30(02)

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-borneol 1 CYHS1800020 Ascletis Ravidasvir hydrochloride tablet 1 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

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 Purposes 3 2. Submission Components of Clinical Trial Data 4 2.1 Study database 4 2.2 Analysis database 5 2.3 Data Definition File 6 2.4 Annotated CRF 7 2.5 Programming Code 7 3. Submission Document Format and Conventions 8 3.1 Portable document format 8 3.2 Extensible mark-up language format 8 3.3 Plain text format 8 3.4 Data transport file format 8 3.5 Dataset split 9 3.6 Dataset name, variable name and length 9 3.7 Dataset labels and variable labels 10 4. Other Considerations 10 4.1 Traceability of trial data 10 4.2 Data files under eCTD 11 4.3 Foreign language database 11 4.4 Communication with regulatory agency 11 References 11 Guideline on the Submission of Clinical Trial Data 1. Background and Purposes Clinical trial data is one of the important mate

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.