Hansoh Pharmaceutical's Erlotinib Hydrochloride Tablets Approved for Market Launch in China as Second Domestic Generic

On June 7, Hansoh Pharmaceutical Group Company Limited announced that its Erlotinib Hydrochloride Tablets have been granted marketing approval by the National Medical Products Administration (NMPA) and are deemed to have passed the consistency evaluation.

Erlotinib is a first-generation EGFR inhibitor indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring sensitizing mutations in the EGFR gene. The innovator erlotinib was developed by Roche, first approved by the US FDA in 2004, and approved for marketing in China in 2006 under the brand name Tarceva.

Data from Yaozhi indicates that this is the second generic erlotinib approved for marketing in China. In addition to Suzhou Tairui Pharmaceutical and Jiangsu Hansoh Pharmaceutical, which have already received approval and are deemed to have passed the consistency evaluation, applications for erlotinib tablets from several other companies, including Hunan Kelun and Shenzhen Salubris, remain under regulatory review and approval.

Data Source: Yaozhi Data

Responsible Editor: Liuli

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