Green leaf Pharmaceutical Co develops poziotinib with South Korea and the United States

According to the agreement, LVYE pharmaceutical is granted the exclusive right to develop, produce and commercialize poziotinib in China in the name of the group, while Korea and the United States reserve the exclusive right in other markets The group and South Korea and the United States will fully exchange R & D information based on China and other countries to accelerate the commercialization of poziotinib The group will contribute to the development, production and commercialization in China and will pay certain payments to South Korea and the United States The group will apply for registration with poziotinib state food and drug administration, and the new drug certificate will also be approved in the name of the group According to China's National Bureau of statistics, oncology accounted for about 25% of China's disease deaths in 2012, making it the leading cause of death in that year According to statistics of China Medical economic information network, oncology is the largest pharmaceutical product market (by revenue) in China in 2013, accounting for 18.8% of the total market South Korea and the United States have 23 global R & D projects, including new long-acting biological agents, including weekly insulin, weekly to monthly GLP, and their compound products, which are used to treat diabetes and obesity (collectively referred to as quantum project); new targeted anti-cancer drugs with improved tolerance and safety; and gradually improved drugs and fixed dose compound drugs South Korea and the United States have conducted diversified R & D and business cooperation with a number of global companies Poziotinib is a novel, oral and irreversible universal her inhibitor that blocks EGFR family receptors Mutations or overexpression or amplification of EGFR family receptors are related to a variety of cancers, including non-small cell lung cancer, breast cancer and gastric cancer The completed phase I clinical study showed that poziotinib showed tolerable safety and anticancer effect on cancer patients who had experienced a lot of treatment before Currently, poziotinib is being studied in Korea and the United States for EGFR mutant non-small cell lung cancer (phase II), gastric cancer (phase II), head and neck cancer (phase II), and HER2 positive breast cancer (phase II) News extension: Hanmi licenses the Chinese rights of poziotinib, a cancer drug, to Greenleaf Pharmaceutical Co., Ltd announced that it has reached a license agreement with Greenleaf group to jointly develop poziotinib, a pan her inhibitor discovered and developed by Hanmi Greenleaf is a leading Chinese company with research and development capabilities in the field of cancer According to the terms of the license agreement, green leaf will have the exclusive right to develop, produce and commercialize poziotinib in China, while Hanmi still reserves the right to all other regions Green leaf will implement and invest in development, production and commercialization in China Hanmi will receive advance payment, development and milestone payment based on listing declaration, with a total amount of US $20 million, as well as royalties for poziotinib's future net sales in China Poziotinib is a new type of oral pan her inhibitor that blocks EGFR family receptors Mutations or overexpression / proliferation of EGFR family receptors are associated with many cancers, including non-small cell lung cancer (NSCLC), breast cancer, and gastric cancer At present, poziotinib is being used by Hanmi for NSCLC (phase 2 test), gastric cancer (phase 2 test), head and neck cancer (phase 2 test) and HER2 positive breast cancer (phase 2 test) with EGFR mutation According to the data provided by IMS, the market size of China's tumor drug products in 2013 was about US $4.91 billion, with a compound annual growth rate of 18.3% from 2011 to 2013 "We believe that green leaf, with its strong R & D capability in the field of cancer, will develop poziotinib into a differentiated targeted therapeutic drug to give full play to its potential in the Chinese market Like green leaf, Hanmi will try to promote the treatment of cancer through the development of poziotinib in accordance with the well planned global development strategy, "said Lim, President of Hanmi "Green leaf has been committed to global cooperation So far, we have established successful cooperative relationships with many multinational pharmaceutical companies This time we are also full of confidence in our cooperation with Hanmi Poziotinib will further enrich the research and development line of green leaf tumor drugs in China, consolidate the dominant position of green leaf in the field of tumor treatment, and may bring more help to cancer patients, "commented Mr Liu, President of green leaf Green leaf focuses on the development, production, sale and sale of innovative pharmaceutical products in the three largest and fastest growing areas (cancer, cardiovascular system, digestive tract and metabolism) The company's patented products accounted for 92.2%, 85.9% and 83.6% of the total sales in 2011, 2012 and 2013, respectively Green leaf has strong R & D, sales and marketing capabilities LVYE also has a reliable record of identifying, acquiring and integrating leading pharmaceutical and technology companies in the market 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 wher 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-ba sed 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 overex pression/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), gastric cancer (Phase 2), head & neck cancer (Phase 2) and HER2 positive breast cancer (Phase 2)
According to IMS, the market for o ncology pharmaceutical products in China in 2013 was a bout $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 co ntribute 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 multinatio nal pharmaceutical companies We are also full of co nfidence to collaboration with Hanmi this time Poziotinib will further enrich Luye’s o ncology drug pipeline in China, co nsolidate Luye’s advantage position in the o ncology therapeutic areas, and could co ntribute 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 me tabolism 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.