AZD9291/Osimertinib is the first domestic generic drug to complete BE1

AZD9291/Osimertinib is the first domestic generic drug to complete BE

Objective: To study the single oral administration of oxitinib mesylate tablets (specification: 80 mg, produced by Jiangsu Wanbang Biochemical Pharmaceutical Group Co., Ltd.) and reference preparation oxitinib mesylate tablets (tagrisso, specification: 80 mg; AstraZeneca) under fasting and postprandial conditions Objective to evaluate the bioequivalence of the two preparations in fasting and postprandial state.

Secondary trial Objective: To study the safety of oxitinib mesylate tablets (specification: 80 mg) and reference preparation oxitinib mesylate tablets (tagrisso?) (specification: 80 mg) in healthy adult male subjects.

A total of 56 domestic participants have completed the test on July 20, 2020, and are expected to apply to CDE soon.

However, it is worth mentioning that the domestic patent cn 103702990 of oxitinib / azd9291 will expire in 2032

AZD9291

In March 2017, the National Drug Administration (nmpa) approved the third generation of lung cancer targeting drug tiresox (oxitinib mesylate tablets), Azd9291 is used for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have been treated with epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) or after treatment, and confirmed to have EGFR T790M mutation.

In October 2018, oxitinib mesylate entered the national health insurance catalogue through the special negotiation on the access of anti-cancer drug medical insurance. The indication is the second-line treatment of advanced non-small-cell lung cancer. The payment standard of medical insurance is 510 yuan (80mg / tablet) and 300 yuan (40mg / tablet), which is 70% lower than before.

On August 31, 2019, the State Drug Administration (nmpa) approved oxitinib mesylate tablets (tiresar) for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with positive epidermal growth factor receptor (EGFR) gene mutation. The approval of oxitinib for the first-line treatment of advanced NSCLC patients with EGFR mutation is mainly based on the phase III flaura study: compared with EGFR-TKI standard first-line therapy (gefitinib or erlotinib), oxitinib 80mg as the first-line treatment has a considerable advantage in progression free survival (PFS) (18.9 vs 10.2 months).

Fy2019: global sales revenue of Theresa (ositinib) reached US $3.189 billion, with a year-on-year increase of 74%. Emerging markets, including China, will achieve $762 million in 2019. According to the latest semi annual report in 2020, the global sales revenue of Thalassa (oshitinib) will reach US $2.016 billion, a year-on-year increase of 45%.

According to the data of aikunwei sample hospitals, the sales performance of Theresa in China in 2019 is 2.135 billion yuan. It has been on the market for 3 years and has become a leader in the field of lung cancer in China. (the data of sample hospitals are for reference only, and the amount of unofficial sales) is no accident. In 2020, the indications for first-line lung cancer will also be included in China's national health insurance catalogue.

Research on three generations of EGFR in China

According to the data of drug fusion circle, in addition to ametinib of hausen Pharmaceutical Co., Ltd., which is already on the market, the fastest progress is efetinib of Ellis pharmaceutical, which is expected to be approved in the second half of this year.

Other enterprises under research include:

Beida pharmaceutical / Yifang Biology (bpi-d0316), Yangzi River Pharmaceutical (yzj-0318), Tongyuan Kang (ty-9591), Shenghe Pharmaceutical (sh-1028), chentai pharmaceutical, Zhongsheng Pharmaceutical (zsp0391), beierda (bpi-7711), Zhengda Tianqing (tqb-3456), Suzhou Runxin biological rx518 (CK101), Zhengda Fenghai (fhnd-9041), Jiangsu maidu (kenetinib), aosaikang (ask120067), etc Bibert, Heyuan medicine, Hainan yuekang biology, Bosheng medicine, Wuxi Shuangliang, Shandong xuanzhu, etc.