Shanghai, China, and Seoul, South Korea – July 28, 2016 — Shandong Luoxin Pharmaceutical Group Stock Co., Ltd. (HK: 8058) (“Luoxin”), a well-established pharma company in China which has full capability of R&D and commercialization, and Yuhan Corporation (KRX: 000100), one of the largest and most respected pharmaceutical companies in South Korea, announced that they have entered into a license and co-development agreement under which Luoxin will acquire exclusive right in China (including Hong Kong and Macau) to develop, manufacture and distribute YH25448, a novel, 3rd -generation EGFR targeted therapy for the treatment of non-small-cell-lung-cancer (NSCLC) patients.
A global data report has estimated that the number of non-small cell lung cancer (NSCLC) patients will reach roughly 690,000 in China by 2022 and the therapeutic drug market will exceed USD 1.3 billion by 2019. In Asian population, approximately half of NSCLC patients are epidermal growth factor receptor mutation positive (EGFRm+). While majority of NSCLC patients with EGFRm+ respond to earlier generation of EGFR tyrosine kinase inhibitor (TKI) such as erlotinib, gefitinib, icotinib, or afatinib, almost all patients develop acquired resistance to these therapies predominantly due to second EGFR mutation, T790M. Brain Metastasis (BM) is also a common and lethal complication of NSCLC which portend a poor prognosis. YH25448 is a potent, highly selective EGFR-targeting TKI developed to target both initial-activating EGFR mutation and T790M resistance mutation. It has been also designed to penetrate into brain to treat BM and has showed promising in-vivo efficacy using relevant animal models.
Mr. Baoqi Liu, Chairman of Luoxin said that
"We are pleased to partner with Yuhan Corporation, to develop and commercialize the new generation EGFR targeted therapy to address the unmet needs of Chinese patients with NSCLC diseases. It showcases that we have made a solid step forward in the development of new drugs, which also enriches our product pipeline and expands our areas of development field, thus enabling us to lay a solid foundation for future development.”
Both companies agreed to initiate an integrated Asian clinical development to pursue accelerated approval for patients in great needs. Luoxin will take responsibility for China and Yuhan will cover South Korea and Taiwan, aiming for simultaneous new drug application (NDA) submission in Asian region including China, South Korea and Taiwan. Under the agreement, Yuhan will receive total milestone of USD 120 million and two-digit royalty.
Mr. Jung Hee Lee, President and CEO of Yuhan said that
“We are excited to collaborate with Luoxin through a harmonized development plan which will accelerate to bring an innovative medicine to NSCLC patients in Asian region. We are very pleased that we have a right partner who has strong sense of commitment and passion along with R&D expertise to implement successful clinical development strategies.”
About Shandong Luoxin Pharmaceutical Group Stock Co., LTD.
Founded in 1988, Luoxin is a well-established domestic pharmaceutical company in China, which has the full capability of R&D, manufacture, supply, commercialization (total employees 5500 in 2015). In 2014, Luoxin Shanghai R&D center was set up, with the commitment to enrich current pipelines (generics) with innovative medicines, through in-licensing and strategic partnerships. With the comprehensive capabilities in China market, Luoxin is committed and dedicated to provide good medicines to Chinese patients. Luoxin focuses on the therapeutic areas such as cardiovascular diseases, endocrinology, gastroenterology, respiratory diseases and oncology. Luoxin (HK: 8058) is a publicly-listed company traded on the Hong Kong Stock Exchange. For further information, please visit www.luoxin.cn.
About Yuhan Corporation
Yuhan Corporation is a South Korea-based healthcare company founded in 1926. The company has positioned itself as one of the top pharmaceutical companies in terms of market capability and sales revenue in Korea. The core business consists of primary & specialty care, dietary supplements, household & animal care, and contract manufacturing of active pharmaceutical ingredients. It has a number of subsidiaries and a global presence in the form of joint ventures with Janssen (Belgium), the Clorox Company (USA), and Kimberly-Clark Corporation (USA). Yuhan (KRX: 000100) is a publicly-listed company traded on the Korea Stock Exchange. For further information, pleases visit www.yuhan.co.kr.
A global data report has estimated that the number of non-small cell lung cancer (NSCLC) patients will reach roughly 690,000 in China by 2022 and the therapeutic drug market will exceed USD 1.3 billion by 2019. In Asian population, approximately half of NSCLC patients are epidermal growth factor receptor mutation positive (EGFRm+). While majority of NSCLC patients with EGFRm+ respond to earlier generation of EGFR tyrosine kinase inhibitor (TKI) such as erlotinib, gefitinib, icotinib, or afatinib, almost all patients develop acquired resistance to these therapies predominantly due to second EGFR mutation, T790M. Brain Metastasis (BM) is also a common and lethal complication of NSCLC which portend a poor prognosis. YH25448 is a potent, highly selective EGFR-targeting TKI developed to target both initial-activating EGFR mutation and T790M resistance mutation. It has been also designed to penetrate into brain to treat BM and has showed promising in-vivo efficacy using relevant animal models.
Mr. Baoqi Liu, Chairman of Luoxin said that
"We are pleased to partner with Yuhan Corporation, to develop and commercialize the new generation EGFR targeted therapy to address the unmet needs of Chinese patients with NSCLC diseases. It showcases that we have made a solid step forward in the development of new drugs, which also enriches our product pipeline and expands our areas of development field, thus enabling us to lay a solid foundation for future development.”
Both companies agreed to initiate an integrated Asian clinical development to pursue accelerated approval for patients in great needs. Luoxin will take responsibility for China and Yuhan will cover South Korea and Taiwan, aiming for simultaneous new drug application (NDA) submission in Asian region including China, South Korea and Taiwan. Under the agreement, Yuhan will receive total milestone of USD 120 million and two-digit royalty.
Mr. Jung Hee Lee, President and CEO of Yuhan said that
“We are excited to collaborate with Luoxin through a harmonized development plan which will accelerate to bring an innovative medicine to NSCLC patients in Asian region. We are very pleased that we have a right partner who has strong sense of commitment and passion along with R&D expertise to implement successful clinical development strategies.”
About Shandong Luoxin Pharmaceutical Group Stock Co., LTD.
Founded in 1988, Luoxin is a well-established domestic pharmaceutical company in China, which has the full capability of R&D, manufacture, supply, commercialization (total employees 5500 in 2015). In 2014, Luoxin Shanghai R&D center was set up, with the commitment to enrich current pipelines (generics) with innovative medicines, through in-licensing and strategic partnerships. With the comprehensive capabilities in China market, Luoxin is committed and dedicated to provide good medicines to Chinese patients. Luoxin focuses on the therapeutic areas such as cardiovascular diseases, endocrinology, gastroenterology, respiratory diseases and oncology. Luoxin (HK: 8058) is a publicly-listed company traded on the Hong Kong Stock Exchange. For further information, please visit www.luoxin.cn.
About Yuhan Corporation
Yuhan Corporation is a South Korea-based healthcare company founded in 1926. The company has positioned itself as one of the top pharmaceutical companies in terms of market capability and sales revenue in Korea. The core business consists of primary & specialty care, dietary supplements, household & animal care, and contract manufacturing of active pharmaceutical ingredients. It has a number of subsidiaries and a global presence in the form of joint ventures with Janssen (Belgium), the Clorox Company (USA), and Kimberly-Clark Corporation (USA). Yuhan (KRX: 000100) is a publicly-listed company traded on the Korea Stock Exchange. For further information, pleases visit www.yuhan.co.kr.
