New drug development at Hanmi Pharmaceutical, an icon of the Korean pharmaceutical industry, is at a standstill, raising questions about the company’s drug development capabilities.
Currently, the company’s pipeline has 28 new drug candidates. Although the number increased by five from 23 in early 2017, all of these products are in the preclinical stage.
The company is expected to launch only one new drug this year. It is neutropenia treatment Rolontis, for which Hanmi has signed a technology export contract with U.S. biotech company Spectrum in 2012. Spectrum applied for approval to the U.S. Food and Drug Administration (FDA) at the end of last year and is expecting to receive it in the second half of this year.
The original drug of Rolontis is Amgen's Neulasta. In the previous clinical trials, Rolontis was shown to be more effective than Neulasta, and it is expected to be a biobetter, which refers to an improved biopharmaceutical drug. Once it is launched in the United States next year, Rolontis is expected to account for 1 trillion won (US$892 million) of the 4 trillion won (US$3.57 million) market. Hanmi will get a share of the sales in royalties and license sales.
Hanmi has emerged as the leading pharmaceutical company in Korea in 2015 when it signed a technology export agreement worth 3.9 billion euros (about 5 trillion won) with global pharmaceutical company Sanofi. This technological export has inspired other Korean biopharmaceutical companies to enter the global market.
Through the technological export contract, Hanmi made over 1 trillion won in annual sales in 2015 for the first time since its foundation. In 2016, however, it has been notified by Boehringer Ingelheim of cancellation of the US$730 million (820 billion won) technology export agreement for the lung cancer treatment Olita. Olita was regarded as an innovative drug and was granted a conditional approval at the end of Phase II clinical trials in Korea, but the clinical trials were halted in April last year due to the lack of marketability.
While some analysts see that Hanmi's new drug development is stagnating, others believe that the company is following a selection and focus strategy. Hanmi currently has 28 new drugs under development, which is the largest number among Korean biopharmaceutical companies. Among Korean pharmaceutical companies, it receives the most attention from the global pharmaceutical industry. In addition, it has won recognition by emphasizing transparency in research and development. It is the first Korean pharmaceutical company to disclose new drug candidates on its website in real time.