HONG KONG – South Korea’s Hanmi Pharmaceutical Co. Ltd. has filed a new drug approval application for Rolontis (eflapegrastim) with the country’s Ministry of Food and Drug Safety (MDFS). Rolontis, a biologic to treat neutropenia, is the first of its kind in South Korea and, according to Hanmi, the first to be developed using the company’s Lapscovery platform.

The drug’s two protein components, an analogue of G-CSF and a Fc antibody fragment, are tethered by a flexible polyethylene-glycol link. Its granulocyte-colony stimulating factor (G-CSF) uses the Lapscovery (long acting protein/peptide discovery) platform to lengthen the drug’s short half-life as it enters the human body. The application was submitted based on the novelty of the Lapscovery platform’s peptide structure and the reduced number of doses required for a treatment course compared to other treatments, as well as the data from two global phase III trials (ADVANCE and RECOVER).

The clinical trials involved 643 early stage breast cancer patients who were administered the drug in four treatment cycles. The patients were found to have noninferiority in the duration of severe neutropenia compared with other competitors.

Once available in Korea, Rolontis will take on the neutropenia market, currently valued at ₩70 billion (US$57.2 million). Out of the three other biologics developed by Korean companies, two were not released or canceled. The remaining drug is currently recording ₩500 million in annual sales.

Hanmi licensed out the drug’s worldwide rights to American biopharmaceutical company Spectrum Pharmaceuticals Inc. in 2012. However, it kept the rights to the Korean and Chinese markets. The two companies have worked together before, as Hanmi licensed out the rights to poziotinib, its novel oral, pan-HER inhibitor treating breast cancer, to Spectrum in March 2015.

MDFS Assistant Director Jisang Yoon said the ministry would take 120 working days, or around six months, to reach a decision on the application. Should the MDFS approve the application within the time frame, the drug will be available in the Korean market by the first half of next year.

Yoon said the application would be judged based on “the safety and the efficiency of the drug, as well as good manufacturing practice.” Once approval is granted, Hanmi can start selling Rolontis in the domestic market even as it completes price negotiations.

Rolontis also is under review in the U.S., with a PDUFA date expected in October of this year.

“We developed the drug with a global focus and will continue to systematically seek approval from each market,” according to a Hanmi source, although she declined to specify which market was next.

Hanmi is also keeping busy with the rest of its pipeline, which consists of around 31 products, said the source. The company is in the middle of five global phase III trials for efpeglenatide, its GLP-1-based drug targeting diabetes.

Efpeglenatide is one of the three drugs in a portfolio of experimental, long-acting diabetes treatments, collectively known as the “Quantum Project,” for which Hanmi signed worldwide license agreements with Sanofi SA. The other two are a weekly insulin dose medication and a fixed-dosed weekly GLP-1-RA/insulin drug combination.

Hanmi raked in €400 million (US$433.325 million) as well as double-digit royalties on net sales from that deal. It also stands to receive further payments of up to €3.5 billion in development, registration and sales milestones.

Founded in 1973, Hanmi focuses on developing treatments for cancers, metabolic diseases, immune system diseases and other rare intractable diseases. The company actively seeks out global partnerships and has partnered with Genentech Inc., China’s Innovent Biologics Inc., Athenex Inc. and Allegro Ophthalmics LLC alongside its partnerships with Spectrum and Sanofi.

It inked a license agreement with Rapt Therapeutics Inc. worth up to $118 million for Rapt’s FLX-475, an oral, small-molecule CCR4 antagonist to treat cancer, in December 2019. More recently, Hanmi and GC Pharma signed a memorandum of understanding in February to develop and commercialize drugs for the treatment of lysosomal storage disease.

Hanmi’s stock dropped 1.81% to close at ₩271,000 (US$222.055) on May 11. It had climbed up to ₩276,000 on May 8.

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