Hanall Biopharma and Daewoong Pharmaceutical said they filed an investigational new drug (IND) application with the U.S. Food and Drug Administration Tuesday to conduct a phase 2 clinical trial for its dry eye treatment.
The dry eye treatment, HL036, is being developed to treat patients who lack tear production or experience excessive tear evaporation, resulting in ocular surface damage.
The number of patients with dry eye symptom has been increasing in an aging society, excessive use of computers, and environmental changes such as more use of air conditioning and heating appliances.
The market for anti-dryness treatment has been estimated to be around 3 trillion won ($2.66 billion) worldwide.
The companies expect HL036, an anti-TNF antibody, to have a greater effect on treating dry eye syndrome because it has exhibited more excellent tissue distribution, stability and activity compared to conventional antibodies.
Hanall한울바이오파마 became Daewoong’s subsidiary in August, 2015. The two companies are jointly managing R&D projects for the third consecutive year and have seen notable synergy, Daewoong대웅제약 said.
Daewoong and Hanall have also seen synergy on the immunotherapy front, developing new cancer therapies such as HL161, HL186, and HL187, the companies said.
HL161 is a next-generation, first-in-class antibody drug that treats autoimmune diseases such as myasthenia gravis, pemphigus, and optic neuritis, caused by autoantibodies that attack itself, Hanall said. The company expects the drug to dramatically improve drug efficacy and safety and lower costs, compared to existing treatments.
Hanall will submit the phase one clinical trial IND application in the third quarter of this year and begin clinical trials in Australia in the fourth quarter.
Hanall has also set spun off synthetic drug research in 2016 to establish Immunomet in the U.S. to strengthen immunotherapy research, the company said.
The two companies have also invested around 6 billion won in October to create an in-house venture-type research organization comprised of KAIST and Yonsei University professors to develop new immunotherapies.
The study aims to develop a drug for cancer patients that have not responded to first-generation immunotherapies such as Yervoy, Opdivo, Keytruda, and Tecentriq.
The two have aimed to achieve synergy on the sales and marketing front and will begin implementing its cross-selling strategy from the third quarter of this year, hoping to see a 20 percent increase in sales from the expected synergy.
They will also pursue cost-effective strategies to achieve synergy regarding production, Hanall said.
“The synergy plans that have been prepared and carried out during the third year of joint management are leading to success in each division,” said Hanol BioPharma CEO Park Seung-guk. “In particular, we were able to strengthen our global capabilities by concentrating research funding on biologics such as antibody drugs and R&D."
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