Jingfeng medicine obtained erlotinib clinical approval

Jingfeng Pharmaceutical Co., Ltd (SZ: 000908): Announcement on the approval of clinical trials obtained by its holding subsidiary I Basic information recently, Hainan Jinrui Pharmaceutical Co., Ltd., a holding subsidiary of Hunan Jingfeng Pharmaceutical Co., Ltd (hereinafter referred to as "the company"), received three approval documents for clinical trials of drugs approved and issued by the State Food and drug administration 2、 Product introduction 1 Erlotinib hydrochloride dosage form: API application matters: domestic drug registration classification: Chemicals class 3.1 approval No.: 2016l06427 applicant: Hainan Jinrui Pharmaceutical Co., Ltd, Shanghai Guochuang Pharmaceutical Co., Ltd 2 Erlotinib hydrochloride tablet form: tablet specification: 0.1g (calculated by c22h23n3o4) application item: domestic drug registration classification: chemical drug class 6 approval No.: 2016l06325 applicant: Hainan Jinrui Pharmaceutical Co., Ltd 3 Erlotinib hydrochloride tablet form: tablet specification: 0.15g (calculated by c22h23n3o4) application item: domestic drug registration Registration classification: chemical category 6 approval No.: 2016l06326 applicant: helotinib hydrochloride of Hainan Jinrui Pharmaceutical Co., Ltd is a tyrosine kinase inhibitor of epidermal growth factor receptor (EGFR) / human epidermal growth factor receptor I (HER1), specifically binding with ATP binding bag located in the tyrosine kinase structural region of HER1 / EGFR fraction in the cytoplasm By inhibiting the combination of adenosine triphosphate and HER1 / EGFR, it can reversibly inhibit the activity of EGFR kinase in cells, prevent the receptor related tyrosine residues from phosphorylation and further inhibit the downstream signal, so as to inhibit the proliferation, invasion and metastasis of tumor cells, reduce the adhesion ability of tumor cells, promote the apoptosis of tumor cells, enhance the sensitivity to chemotherapy, and thus prolong the survival period of tumor patients Erlotinib monotherapy is suitable for locally advanced or metastatic non-small cell lung cancer (NSCLC) patients who have previously received at least one chemotherapy regimen failure In October 2014, the company signed a contract with Shanghai Guochuang Pharmaceutical Co., Ltd to jointly invest in the development of "erlotinib hydrochloride raw materials and erlotinib hydrochloride tablets" varieties, with each party accounting for 50% of the product income rights The variety was registered and accepted on February 15, 2015 (raw material acceptance No.: cxhl1500438 Qiong, tablet acceptance No.: cyhs1500399 qiong-0.1g; cyhs1500400 qiong-0.15g) The above-mentioned products will undergo bioequivalence test after obtaining the clinical approval documents, and apply for the production approval documents after completing the clinical test They can be put into production after obtaining the production approval documents and passing the GMP certification Therefore, the clinical approval of the above products will not affect the company's recent performance Listing and registration in China: according to Xianda database, erlotinib hydrochloride tablets were first listed in China by Roche in 2006, with the trade name of "tecaro" At present, no generic drugs are listed in China In 2015, the global sales volume of this product was about 1.7 billion US dollars, while the sales volume of domestic sample hospitals was about 174 million yuan, ranking the fourth in the sales list of domestic "TiNi" products The sales volume is still considerable At present, nearly 20 domestic enterprises have obtained the clinical approval of be for this product Qilu pharmaceutical is the first one, and it was approved in August 2015 According to the current severity of be, which is the first generic drug to be listed?