Givetini tablets, a wholly owned subsidiary of Tiansli, obtained a drug registration certificate

On the evening of January 8th, Tiansli announced that its wholly-owned subsidiary, Jiangsu Tiansli Diyi Pharmaceutical Co., Ltd., had recently received a "drug registration certificate" approved and issued by the State Drug Administration, which is adaptive: a single drug is suitable for local late stage or metastasis non-small cell lung cancer (NSCLC) with a gene-sensitive mutation of the skin growth factor (EGFR).
jifeitinib tablets in February 2017 completed the BE record, in November 2017 completed the BE trial, in January 2018 declared CDE (receiving number CYHS1800007), by the CDE technical review, to achieve the same quality and efficacy of the original drug, and then by the national audit and verification center for research and development, production, clinical and other aspects of on-site verification, recently obtained the National Drug Administration approved the issuance of the "drug registration certificate."
Gifetinib is a reversible inhibitor of wild and certain mutant EGFR, which inhibits the self-phosphorylation of the EGFR subject tyrosine, further inhibiting downstream signaling and preventing cell proliferation on which EGFR depends.
, developed by AstraZeneone, was first listed in Japan in July 2002 and has since been listed in the United States and Europe.
AstraZene Cumbernauld (commodity name: Iresha) was approved for listing in February 2004.
company's generics are consistent with the quality and efficacy of Iriza.
, the company has invested a total of RMB 12.4781 million in research and development of the project.
China Clinical Guidelines for Radiotherapy of Non-Small Cell Lung Cancer (2020 Edition) show that lung cancer is the most common and leading malignant tumor in China and the world, with non-small cell lung cancer (non-small celllung cancer, NSCLC) accounting for 80%-85% of all lung cancer cases.
PIONEER study showed that Chinese mainland mutation frequency of EGFR was 50.2% in patients in the subgroup.
treatment of advanced lung cancer has limited efficacy, the prognosis is not optimistic.
target drug with EGFR as the target of treatment significantly prolonged the survival time of disease-free progression, improved the objective remission rate, and had good tolerance.
as the drug of choice for EGFR inhibitors, the medical terminal data for mi-in-net drugs show sales of RMB2.19 billion in 2019.
has approved seven domestic listings, including AstraZenecom and Qilu Pharmaceuticals.
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