Domestic No. 32 in the New Drug Drought?… Hanmi Pharm. Daewoong Pharm.

Input 2021.03.08 11:13 | Revision 2021.03.08 11:26

The drug developed by Daewoong Pharmaceuticals and Hanmi Pharmaceuticals is likely to be the next 32nd new drug, following Yuhan’s 31st domestic drug’Recraza’.

According to the pharmaceutical industry on the 8th Daewoong Pharmaceutical (069620)‘Peksuprazan’, a new drug candidate for gastroesophageal reflux disease developed by Hanmi Pharmaceutical (128940)‘Rolontis’, a new drug candidate for neutropenia, has completed phase 3 clinical trials, respectively, and is waiting for approval from the Korean Ministry of Food and Drug Safety.

The main character of this year’s No. 31 new drug is Yuhan Corporation’s Recraza. On January 18th, Yuhan received conditional approval from the Ministry of Food and Drug Safety for Rekraza (ingredient name, lasertinib), a treatment for non-small cell lung cancer.

Rekraja Yuhan Corporation (000100)It is the fruit of the representative open innovation (open innovation). Yuhan Corporation introduced Rekraza from Genosco, a subsidiary of Oscotech’s new drug development in 2015, to optimize the material and develop the process, and then went through the preclinical and clinical stages. The third-generation mutant epithelial cell growth factor receptor (EGFR) inhibitory lung cancer treatment Rekraza is a new drug that was jointly developed after exporting a total amount of 1.4 trillion won to Jansen Biotech in the United States in November 2018. It has also been approved by the US Food and Drug Administration (FDA).

Peksuprazan, developed by Daewoong Pharmaceutical, is a leading candidate to be listed on the No. 32 new drug. Daewoong Pharmaceutical applied for the approval of this drug to the Ministry of Food and Drug Safety in November 2019. Pexuprazan is a P-CAB formulation with a mechanism that reversibly blocks the proton pump that secretes gastric acid from the stomach wall. (Best-In-Class) The company explained that it is a new drug.

Daewoong Pharmaceutical aims to develop this new drug candidate into a global blockbuster drug. Last year, Daewoong Pharmaceutical signed a contract with Brazil’s No. 1 pharmaceutical company EMS to export Pegsuprazan for about 86 billion won.

Hanmi Pharm’s new bio-drug, Rolontis, is also likely to be listed as a new drug. In May of last year, Hanmi Pharm submitted an application for domestic approval for Lolontis to the Ministry of Food and Drug Safety. If this permit application is reviewed according to the scheduled procedure, Rollontis is expected to be released in Korea in the first half of this year.

Rollontis is a new biopharmaceutical developed by Hanmi Pharmaceutical and licensed out to Spectrum, a US pharmaceutical company in 2012, and has applied Hanmi Pharmaceutical’s proprietary platform technology’Labscovery’ that dramatically increases the efficacy and dosing cycle of biopharmaceuticals. Hanmi Pharm applied for a new bio drug license from the Ministry of Food and Drug Safety based on the novelty of the peptide structure itself implemented by this platform technology and the advancement of technology that reduces the number of administrations even with a smaller dose compared to existing drugs.

Rolontis is undergoing both domestic and US FDA approval procedures. Previously, Hanmi Pharm had exported Rollontis to the US spectrum. The technology was exported to Spectrum in the United States in 2012, and Spectrum applied for marketing permission from the FDA after completing phase 3 of global clinical trials in October last year. However, the approval of the new drug candidate has been delayed indefinitely in the aftermath of Corona 19.

There is high expectation that the new drug drought will be resolved this year, starting with Rekraza, which filled the gap in domestic new drugs. The government is also planning to invest 2 trillion won over the next 10 years in the national new drug development project with the aim of strengthening the competitiveness of domestic new drug development. The national new drug development project aims to create global new drugs with annual sales of more than KRW 1 trillion and develop domestic new drugs. It is a core project of the government that will determine the direction of the domestic pharmaceutical and bio industry over the next 10 years.

An official in the pharmaceutical industry said, “In the past few years, our competitiveness in the development of new drugs in Korea has strengthened.” “Even so, there is still a long way to go until the birth of a global blockbuster drug with annual sales of more than 1 trillion won. We hope to expand licensing and clinical tax support so that we can make it.”