Press release

Hanmi pharm enters agreement with Luye pharma group for Poziotinib license in China


Hanmi Pharm. Co., Ltd. (KRX:128940) has announced that it has entered into a license agreement with Luye Pharma Group .Ltd (HKEx:2186), a leading Chinese pharmaceutical company with R&D capability specialized in oncology, to co-develop Poziotinib, a pan-HER inhibitor discovered and developed by Hanmi for the treatment of cancer. The signing ceremony took place in Yantai, China where Luye is located.
Under the terms of the license agreement, Luye will receive exclusive rights to develop, manufacture and commercialize Poziotinib in China while Hanmi retains exclusive rights in all other territories. Luye will run and fund the development, manufacturing and commercializing work in China. Hanmi will receive an upfront payment, development and regulatory-based milestone payments up to $20 million and royalty payments on future net sales of Poziotinib in China.

Poziotinib is a novel, oral, pan-HER inhibitor blocking EGFR family receptors. Mutations or overexpression/amplification of EGFR family receptors have been associated with a number of cancers, including non-small cell lung cancer (NSCLC), breast cancer, gastric cancer, etc. Currently, poziotinib is being investigated by Hanmi in EGFR-mutant NSCLC (Phase 2, supported by National OncoVenture), gastric cancer (Phase 2), head & neck cancer (Phase 2) and HER2 positive breast cancer (Phase 2).

According to IMS, the market for oncology pharmaceutical products in China in 2013 was about $4.91 billion and grew at a CAGR of 18.3% from 2011 to 2013.
“We believe that Luye, with its strong R&D capability specialized in oncology, will develop Poziotinib as a differentiated targeted therapy to its full potential in China market. In parallel with Luye, Hanmi will also do its best to contribute to the treatment of cancers by developing Poziotinib with a well-planned global development strategy,” said Mr. Sung Ki Lim, Chairman of Hanmi.

“Luye always dedicates in carrying out the global collaborate, so far, we have established several successful partnership wih a number of multinational pharmaceutical companies. We are also full of confidence to collaboration with Hanmi this time. Poziotinib will further enrich Luye’s oncology drug pipeline in China, consolidate Luye’s advantage position in the oncology therapeutic areas, and could contribute more help to the cancer patients,” commented Mr. Liu Dianbo, Chairman of Luye.
Luye focuses on developing, producing, marketing and selling innovative pharmaceutical products in three of the largest and fastest growing therapeutic areas in the PRC-oncology, cardiovascular system and alimentary tract and metabolism. The sales of patent-protected products accounted for 92.2%, 85.9% and 83.6% of Luye’s total revenue for 2011, 2012 and 2013, respectively. Luye has strong R&D and sales and marketing capabilities. Luye also has a proven track record of identifying, acquiring and integrating pharmaceutical companies with market-leading drugs and technologies.

Aug 21, 2014 (source : Hanmi Pharmaceuticals)