Shandong Luoxin Pharmaceutical Group, a well-established pharma company in China, and Yuhan Corporation, one of the largest pharmaceutical companies in South Korea, have entered into a license and co-development agreement under which Luoxin will acquire exclusive rights 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 $1.3 billion by 2019. In Asian population, approximately half of NSCLC patients are epidermal growth factor receptor mutation positive (EGFRm+). While the 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 the brain to treat BM and has showed promising in-vivo efficacy using relevant animal models.

“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,” said Baoqi Liu, chairman, Luoxin. “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 $120 million and two-digit royalty.

“We are excited to collaborate with Luoxin through a harmonized development plan that will accelerate to bring an innovative medicine to NSCLC patients in Asian region,” said Jung Hee Lee, president and chief executive officer, Yuhan. “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.”