Hanmi Pharmaceutical (Hanmi), which recently surprised the nation's pharmaceutical market with a series of blockbuster licensing deals valued at 8 trillion won (US$6.42 million), pledged to step up R&D efforts, CEO Lee Gwan-sun said during a press conference in March
Lee attributed the last year’s success through licensing deals with multinational pharmaceutical companies to Hanmi Pharmaceutical's persistent investment in the R&D sector.
"Nearly 15 percent of the company's total sales revenue is reinvested in the company's R&D for the past 15 years. Such a ratio is unseen in any other pharmaceutical company in the world."
"Despite last year's immense success, the company is still quite small compared to other global drug companies. In order to compete in the global market, Hanmi should further develop core technologies in specialized categories," said Chief Medical Officer Son Jee-woong.
To address the challenges ahead, the company has decided to focus on two areas: first, novel long-acting biologics based on the Company’s Lapscovery platform and their combinations in diabetes and obesity called the Quantum Project; and second, novel targeted agents against cancer and autoimmune disorders.
Hanmi Pharmaceuticals follows a step-by-step strategy marked by developing incrementally modified drugs and fixed-dose combination drugs, followed by new drugs. Moreover, adopting the so-called “open innovation strategy,” the company seeks to work with the world’s promising pharmaceutical companies and bio ventures for R&D.
Currently, 28 R&D cases are underway both at home and abroad.
Quantum Project to Change Diabetes Treatment Paradigm
Hanmi has developed a technology called Lapscovery that prolongs the effects of drug for up to a month and incorporates that technology into the production of 6 new biopharmaceuticals targeting diabetes, growth hormones and neutropenia.
The term Quantum Project refers to tying together three diabete drugs: Efpeglenatide, LAPSInsulin115 and LAPSInsulin combo. Hanmi Pharmaceuticals entered into an exclusive licensing agreement with Sanofi for the development and commercialization of the Quantum Project in November last year. The contract is worth 3.9 billion euros. Under the terms of the agreement, Sanofi will obtain exclusive worldwide rights to develop and commercialize the Quantum Project except in Korea and China.
Meanwhile, HM12525A (LAPSGLP/GCG) is an oxyntomodulin-based drug (GLP-1/glucagon receptor dual agonist) that improves the metabolism and secretion of insulin and suppresses appetite. As a long-acting once-weekly therapy, this drug is known to have the potential to be a best-in-class oxyntomodulin-based treatment.
Hanmi entered into an exclusive license agreement with Janssen Pharmaceuticals, Inc. (Janssen) in November last year for the development and commercialization of oxyntomodulin-based drugs including HM12525A (LAPSGLP/GCG).
Under the terms of the agreement, Janssen will obtain exclusive worldwide rights to develop and commercialize HM12525A except in Korea and China. Hanmi received an upfront payment of US$105 million and is eligible for up to US$810 million in potential clinical development and sales achievements. If HM12525A is successfully commercialized, Hanmi would also be eligible for tiered double-digit royalty payments.
Hanmi entered into a licensing agreement with Chinese pharmaceutical company Luye Pharma in August 2014 and with Spectrum Pharmaceuticals in Feb 2015. Under the terms of the agreement, Spectrum Pharmaceuticals received exclusive licensing rights to develop, manufacture and commercialize drugs worldwide, excluding Korea and China, whereas Luye obtained such rights for the Chinese market.
Poziotinib is a novel, oral pan-HER inhibitor jointly being developed by Hanmi Pharmaceuticals and the Anticancer Drug Development Agency, which is led by Director Kim In-cheol and supported by the Korean government's National Cancer Center, under the Ministry of Health and Welfare.
In March of this year, Spectrum Pharmaceuticals announced that the company initiated Phase 2 breast cancer trials for Poziotinib, a novel pan-HER inhibitor. The study will enroll approximately 70 patients with HER2-positive metastatic breast cancer who have failed existing therapies, and the Poziotinib dosage and cycle will be based on Hanmi’s Phase 1 and 2 studies in Korea.