Jiangsu Hansoh and Suzhou Techpool Resubmit Erlotinib NDA for NSCLC Treatment in China

On August 30, the CPM Database of China’s New Drug R&D Monitoring, maintained by the China National Pharmaceutical Industry Information Center, showed that the Center for Drug Evaluation (CDE) accepted on the same day the marketing authorization applications for erlotinib, a targeted therapy for lung cancer, submitted by Jiangsu Hansoh Pharmaceutical Group Co., Ltd. and Teray Pharmaceutical Inc. As early as 2013, Jiangsu Hansoh had filed a domestic marketing application for the generic drug, while Teray Pharmaceutical also submitted its domestic marketing application in 2015; both applications were approved to proceed with relatedClinical Trial。

On August 30, the CPM Database of China's New Drug R&D Monitoring, managed by the China Pharmaceutical Industry Information Center, showed that the Center for Drug Evaluation (CDE) accepted the marketing applications for the lung cancer targeted drug erlotinib from Jiangsu Hansoh Pharmaceutical Group Co., Ltd. and Suzhou Teray Pharmaceutical Inc. on the same day. As early as 2013, Jiangsu Hansoh submitted a domestic marketing application for its generic version, while Suzhou Teray also filed a domestic marketing application in 2015; both were approved to proceed with relatedClinical Trial。

Erlotinib was developed by Genentech (acquired by Roche) and Astellas, and was first approved by the FDA in 2004. It subsequently received approval from the EMA,FDA、CFDAApproved as a first-generation EGFR-TKI inhibitor. Erlotinib monotherapy is indicated for locally advanced or metastatic NSCLC after failure of at least one prior chemotherapy regimen.

Domestic Generic Drug Development Is in Full Swing

The domestic manufacturer of Erlotinib Hydrochloride Tablets is ShanghaiRoche PharmaceuticalsCo., Ltd. (brand name “Tarceva”) has been included in China’s National Reimbursement Drug List. Currently, there are 26 other domestic companies that have submitted marketing applications for generic versions, while only the originator manufacturer, Roche, has filed clinical trial applications. Once Roche’s patent expires in May 2019, the first domestic generic drugs will inevitably flood the market, competing for market share.

Global Marketing Authorization Holders for Erlotinib: Roche and Chugai Pharmaceutical

30 Billion Lung Cancer Market: Despite a Brief Decline, the Future Outlook Remains Promising

According to monitoring by the PDB Comprehensive Drug Database of the China Pharmaceutical Industry Information Center, erlotinib sales have contracted to some extent both globally and in China.

In February 2018, the National Cancer Center released the latest national cancer statistics. In terms of incidence, lung cancer remained the most common cancer in China, with approximately 780,000 new cases annually. Lung cancer is highly associated with EGFR mutations. As a commonly used first-generation EGFR inhibitor for targeted therapy of lung cancer, erlotinib is expected to see further expansion in its overall market size. (Bio ValleyBioon.com）