Can the FDA license new drugs

Hanmi Pharmaceutical awaits FDA approval for 2 new drugs in the US

Seoul, South Korea, Jan. 28 / PRNewswire /) -

  • The BLA / NDA approval of Rolontis and Oraxol by the U.S. FDA is expected later this year
  • LAPSTriple Agonist, an innovative, triple-acting new drug for the treatment of NASH, expanded indication
  • Efpeglenatide met the primary endpoint of global phase 3
  • Strive to develop rare diseases such as B. a once-a-month drug for short bowel syndrome

Hanmi Pharmaceutical Co., Ltd. plans to create a global R&D effort based on innovations in the treatment of inflammation and fibrosis, a triple-acting new drug to treat NASH (non-alcoholic steatohepatitis), and various other innovations in metabolic diseases, oncology and rare diseases.

  • What is Hanmi's R&D strategy for new drugs in 2021?

In particular, it is expected that two new, manufactured by Hanmi Pharmaceutical Co., Ltd. drugs developed to be approved by the US FDA later this year. "Rolontis," a drug for the treatment of neutropenia, the technology of which has been out-licensed to Spectrum Pharmaceuticals, Inc., and "Oraxol," which is a drug for the treatment of metastatic breast cancer to Athenex, Inc., are under priority review by the FDA and are about to announce the results of their BLA / NDA approval (Biologics License Application; BLA).

"Hanmi Pharmaceutical Co., Ltd.'s R&D capabilities and strong multi-partner trust remain solid," said Dr. Kwon, emphasizing, "The two new drugs will be approved by the FDA in the near future, and expectations for Hanmi's pipeline are greater than ever this year."

  • Indication extension for LAPSTriple Agonist (HM15211) announced

LAPSTriple Agonist (HM15211), a triple agonist, has shown a 50% or greater reduction in fatty liver disease in recent clinical trials in the United States and is being developed as the world's most effective NASH treatment. The effect of fatty liver reduction within 12 weeks was up to 80% compared to the placebo control group, and the liver enzyme-lowering effect was also statistically significant.

On this basis, a global phase 2 clinical trial is currently underway for the LAPSTriple agonist, which has been granted fast-track status by the FDA to accelerate drug development for NASH.

The US FDA has also designated the LAPS triple agonist (HM15211) as an orphan drug for the treatment of primary sclerosing cholangitis (PSC) and primary biliary cholangitis (PBC) in 2020, and the indications will also be for idiopathic pulmonary fibrosis (IPF) and chronic obstructive pulmonary disease (COPD).

A phase 3 clinical trial (Amplitude-M) of efpeglenatide, which is being developed for the treatment of diabetes, was recently completed and met the primary endpoint of a successful 30-week reduction in glycated hemoglobin (HbA1c) compared to Placebo "in the dose cohorts. The study also confirmed the effect of weight loss, which was a secondary endpoint. Hanmi Pharmaceutical Co., Ltd. plans to maximize treatment effects by combining Efpeglenatide with other new drugs such as LAPSGlucagon Analog (HM15136).

In addition, LAPSGLP / GCG (Efinopegdutide), which was out-licensed to MSD last year, entered the Phase 2 clinical trial this year, and development as a NASH therapy is accelerating.

  • Leader in oncology through open innovation

Hanmi Pharmaceutical Co., Ltd. has also emphasized intense development plans in immuno-oncology, inflammation and fibrosis, new platforms and rare diseases through open innovation.

Poziotinib, which was successfully tested in clinical trials for patients with HER2-mutated non-small cell lung cancer (NSCLC) last year, is scheduled for approval by the US FDA later this year. Belvarafenib (HM95573, solid tumor), which is licensed to Genentech, Inc., is about to enter into a global clinical trial, and dose escalation and expansion clinical trial for the FLT3 / SYK dual inhibitor (HM43239), who has shown complete remission in patients with acute myeloid leukemia (AML) with the FLT3 mutation who could not be successfully treated with any of the previous therapies, is making rapid progress.

Hanmi Pharmaceutical Co., Ltd. is also pursuing the development of T-cell-targeted cancer drugs through the identification of preclinical compounds based on AI platform technology with Standigm, Inc. It will also explore the potential of combining an oral immunological cancer drug candidate (FLX475) from RAPT Therapeutics, Inc. with Keytruda studied by Merck for the treatment of gastric cancer.

At the same time, a robust study is being carried out that includes the bispecific antibody acquired from Phanes Therapeutics, Inc. This study aims to increase anti-cancer activity in the tumor microenvironment (TME) through synergy with Pentambody, which is also the bispecific antibody platform technology developed by Beijing Hanmi Pharm. Co., Ltd.

In addition, a clinical trial of the bispecific PD-1 / HER2 antibody developed in collaboration with Innovent Biologics, Inc. is currently being conducted in China to find a suitable dose for patients with solid tumors.

  • Endeavor to develop treatment for rare diseases as well

Hanmi Pharmaceutical Co., Ltd. also plans to focus on its role as a pharmaceutical company serving a small number of rare disease patients where there is a high unmet need.

LAPS GLP-2 analog, which is being developed to treat short bowel syndrome, which affects three in a million people, confirmed its safety and once-monthly option in the first phase 1 human study.

LAPSGLP-2 Analog was also classified as an orphan drug by the FDA and EMA in 2019 and designated as a drug for rare pediatric diseases (RPDs) by the FDA in 2020. It will enter a phase 2 clinical trial this year.

In addition, the development for congenital hyperinsulinemia (CHI) and lysosomal storage disease (LSK) syndrome is under steady progress. In particular, the Phase 2 clinical trial for the treatment of congenital hyperinsulinemia was recently approved by the FDA (9th) and development is accelerating.

Se Chang Kwon, CEO of Hanmi Pharmaceutical Co., Ltd. said, "Hanmi Pharmaceutical Co., Ltd. will accomplish pharmaceutical companies' mission which is to deliver value to lives, especially in this global COVID-19 pandemic. We plan to do so by completing the projects to continue coping with COVID-19, including development of diagnostics, vaccines and treatments, and we will do our best to meet the R&D expectations of Hanmi Pharmaceutical Co., Ltd. by obtaining FDA approval for Receive new drugs and accelerate clinical progress to add value to various pipelines. "

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