Icotinib hydrochloride is a National Class 1.1 new drug that is independently developed by Betta Pharmaceuticals Co., Ltd. for nearly a decade. It is also China's first small molecule targeted anti-cancer drug. Icotinib is a potent and highly selective oral epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI), and it is used for the first-line treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) patients carrying EGFR mutations.
On June 7th, 2011, Icotinib hydrochloride was approved by the National Medical Products Association (NMPA), fulfilling the unmet medical needs in China.
On August 12th, 2011, the market launch of Icotinib hydrochloride was held in the Great Hall of the People in Beijing. It was praised as a groundbreaking scientific and technological achievement in the China healthcare industry.
In 2012, Icotinib hydrochloride was included on Citeline’s “Pharm R&D Annual Review for 2012”, which was the first time a Chinese innovative drug was included on such report.
On August 13th, 2013, the phase III ICOGEN clinical trial results of Icotinib hydrochloride were published on the Lancet Oncology (Shi, Y., et al., The Lancet Oncology 14 (10) p953-961). Professor of the University of Colorado, Dr. David Camidge, commented that Icotinib has opened a new era of anticancer drug research in China, which is a significant milestone in the global oncology research. |  |
In 2012 and 2014, icotinib hydrochloride won the Golden Prize of Chinese Patent Award for its composition of matter and the crystal form patents.
In 2015, icotinib hydrochloride won “First Prize of National Science and Technology Progress Award 2015”.
In 2016, icotinib hydrochloride won “Chinese Industry Award”. In the same year, it was included in the first round of the price negotiation with the Chinese National Health Commission and created a new model for medical insurance negotiation, which reduced the burden of Chinese patients.
In 2017, icotinib hydrochloride was enlisted on the National Reimbursement Drug List (NRDL). On July 19th, the BRAIN clinical study results of icotinib hydrochloride for NSCLC brain metastasis treatment were published in the Lancet Oncology (Jin-Ji, Y., et al., The Lancet Oncology 5 (9) p707-716). It is the first phase III study of EGFR TKI targeting NSCLC patients with brain metastasis, and this treatment is recommended in the clinical guide. On August 23rd, the first-line clinical study of icotinib hydrochloride in NSCLC patients carrying EGFR mutations was published in the Annual of Oncology, which provided clinical support for its use in the first-line setting.
In 2018, icotinib hydrochloride was included on the National Essential Drug List (EDL), giving access to more Chinese patients.
In 2019, icotinib hydrochloride was included on the General Drug Access Catalogue of National Medical Insurance, further reducing the economic burden of NSCLC patients.
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