ASCO15: Hanmi Pharma ‘HM61713’ Demonstrated The Effect Of Tumor Volume Reduction

- Presentation on the interim results of the phase I/II domestic clinical trial at 2015 ASCO annual Conference

- 800mg dose on T790M mutation positive NSCLC patients, demonstrated its effectiveness on 54.8% tumor volume reduction

SEOUL, South Korea--(BUSINESS WIRE)--Hanmi Pharmaceutical Co., Ltd. (KSE:128940) presented the interim results of phase I/II domestic clinical trial on HM61713 at the 51^st American Society of Clinical Oncology (ASCO) annual conference, being held May 29 – June 2 in Chicago.

“Through current clinical trial, Hanmi Pharmaceutical was able to demonstrate anti-tumor effect of optimal HM61713 dose. We will continue to strive in order to provide new treatment for those suffering from lung cancer.”

HM61713, an orally active novel epidermal growth factor receptor (EGFR) mutant selective inhibitor, is considered a 3^rd-generation EGFR mutation tyrosine kinase inhibitor (TKI) which excelled in reducing resistance and side-effects after administration with previous EGFR TKIs Iressa^® and Tarceva^®.

During the conference, Hanmi Pharmaceutical gave a poster presentation on the results of the phase I/II clinical trial with 195 T790M mutation positive non-small cell lung cancer (NSCLC) patients at 16 different participating sites including Seoul National University Hospital.

According to the interim result, daily single administration of HM61713 800mg showed 95.2% disease control rate (DCR) in 59 patients (of 62) with T790M positive mutation who developed resistance to previous EGFR TKI. Objective response rate of 54.8% was observed in 34 of 59 patients. Hanmi Pharmaceutical also had presented result of HM61713 300mg daily single administration at last year’s ASCO.

Currently, Hanmi Pharmaceutical is proceeding with phase II global and domestic trials with EGFR mutation-positive NSCLC patients as 2^nd line and phase II domestic trial with lung-cancer patients to examine its efficacy to be qualified as a 1st line therapy.

Clinical Research Director Jin-ah Jung said, “Through current clinical trial, Hanmi Pharmaceutical was able to demonstrate anti-tumor effect of optimal HM61713 dose. We will continue to strive in order to provide new treatment for those suffering from lung cancer.”

Hanmi Pharmaceutical Co., Ltd.

Hanmi Pharmaceutical is a Korea-based pharmaceutical company. The Company invests over 20 percent of its sales in R&D and has over 20 programs consisting of the novel long acting biologics including weekly Insulin, weekly to monthly GLP-1, and their combination for diabetes and obesity (collectively referred as Quantum Project), the novel targeted anti-cancer drugs with improved tolerance and safety profile and fixed-dose combination drugs. For more detail about the company, visit http://www.hanmipharm.com.

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