CELLTRION

On May 30, Celltrion (KRX:068270) signed an agreement with Yonsei University Health System on the joint development and license-in of Fc-Saxatilin, a candidate drug for ischemic strokes in a bid to develop new biopharmaceuticals for cerebrovascular diseases.

Under the agreement, Celltrion and Yonsei University Health System will conduct joint development for the optimization of the Fc-Saxatilin molecule, after which Celltrion will have an option for the exclusive worldwide license to conduct clinical trials, to obtain approvals, and to commercialize the drug.

Fc-Saxatilin, which is a new molecule developed by Professor Ji Hoe Heo-led team of the Severance Integrative Research Institute for Cerebral & Cardiovascular Diseases of Yonsei University with funding by the Ministry of Health and Welfare’s Healthcare Technology Research and Development Project, is expected to have superior efficacy and safety to existing treatments in terms of thrombolytic effect and lower side effects (cerebral hemorrhage) in patients with ischemic stroke (cerebral infarction) caused by the blocking of cerebral blood vessel.

The global market size of the diagnosis and treatment drugs for ischemic stroke is expected to grow 6.8% each year and to reach an estimated KRW 2.3 trillion by 2020¹ . Currently, the only drug for ischemic stroke approved by major regulatory authorities is the thrombolytic agent Activase^® (Alteplase) developed and marketed by Genentech in the U.S. If Celltrion succeeds in the joint development and commercialization of the new biopharmaceutical, the drug may be used together with or replace the current thrombolytic agent Activase®.

An executive of Celltrion said: “In order to bolster our next-generation pipeline, in addition to the development of antibody biosimilars, we have continued efforts to explore platform technologies and new molecules in relation to the development of new biopharmaceuticals and synthetic drugs.” He added: “Through the agreement with Yonsei University Health System, we will push for open innovation to secure new drug pipelines such as for cerebrovascular diseases, autoimmune diseases, breast cancer, etc.”

About Celltrion, Inc.

Headquartered in Incheon, Korea, Celltrion is a leading biopharmaceutical company, specializing in research, development and manufacture of biosimilar and innovative drugs. Celltrion strives to provide more affordable biosimilar mAbs to patients who previously had limited access to advanced therapeutics. Celltrion received FDA and EC’s approval for INFLECTRA® and Remsima®, respectively, which is the world’s first mAb biosimilar to receive approval from a regulatory agency in a developed country. For more information, visit www.celltrion.com .

Yonsei University Health System

Yonsei University Health System (YUHS) was founded in 1885 as the first modern medical institution in Korea. YUHS includes 3 colleges (Medicine, Dentistry, Nursing), graduate schools, and 4 hospitals named as Severance hospitals. The hospitals have around 3,700 beds and see around 3 million outpatients and 1 million inpatients annually. Based on more than 130 years of experience in medicine and scientific manpower in research fields, YUHS strives to achieve its goal of becoming the medical research hub through close cooperation.

¹ TMR report 2014

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Contact:

Celltrion, Inc.
Gunn Lee, +82 32 850 5168
Gunhyuk.lee@celltrion.com
or
Heewon Park, +82 32 850 5356
Heewon.park@celltrion.com

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