Jiangsu Wanheng Submits China's First Generic Osimertinib Mesylate Tablets for Marketing Approval

On May 12, according to the official website of the Center for Drug Evaluation (CDE), Jiangsu Wanbang Medical Technology Co., Ltd. submitted a marketing application for its Class 4 new drug, Osimertinib Mesylate Tablets (Acceptance Number: CYHS2101145). This is the first domestically produced generic drug of this variety to be filed for marketing approval in China, having completed the relevant bioequivalence (BE) studies on July 20 last year.

Osimertinib is a third-generation, oral, irreversible, selective EGFR mutation inhibitor developed by AstraZeneca. It is the first such oncology drug approved globally, and the first approved in China, for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR T790M mutation-positive status.

In March 2017, the National Medical Products Administration (NMPA) approved Tagrisso® (osimertinib mesylate tablets, AZD9291), a third-generation targeted therapy for lung cancer, for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have experienced disease progression during or after prior treatment with an epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) and whose tumors test positive for the EGFR T790M mutation.

In October 2018, osimertinib mesylate was included in the National Reimbursement Drug List through special negotiations for access to anticancer drugs. Its indicated use was as a second-line treatment for advanced non-small cell lung cancer, with reimbursement payment standards set at RMB 510 per tablet (80 mg) and RMB 300 per tablet (40 mg), representing a price reduction of up to 70% compared to pre-reimbursement levels.

However, the Insight database shows that the compound patent for osimertinib (CN 103702990) will not expire in China until 2032, which is still a long time from now.

Furthermore, the domestic market for third-generation EGFR-TKIs is already highly competitive. According to the Insight database, three drugs have been approved for marketing: AstraZeneca’s osimertinib, Hansoh Pharma’s almonertinib, and Allist Pharmaceuticals’ furmonertinib. Additionally, Acea Biosciences’ ivonescimab, Betta Pharmaceuticals’ befotertinib, and CSPC/BeiGene’s rezivertinib have already submitted marketing applications.

From the Insight database (http://db.dxy.cn/v5/home/)