The first challenge of Biosimilar and the anticipations of Dong-A ST
Last year, the domestic biopharmaceutical industry suffered many hardships, including license returns and clinical failures.
However, companies persisted and steadily increased R&D investment. Even without large-scale technology export contracts this year, some companies still display R&D achievements that have been carried out for a long time. We have listed domestic pharmaceutical companies aiming for US FDA approval in 2023.
■Hanmi Pharmaceutical begins full-fledged sales of 'Rolontis' in the U.S.
Hanmi Pharmaceutical is one of the most anticipated domestic pharmaceutical companies this year.
First, Hanmi Pharmaceutical's new bio drug Rolontis will start proactive sales in the U.S.
Rolontis, a new bio-drug whose technology was transferred to Spectrum in 2012, is used to treat or prevent neutropenia in cancer patients who receive myelosuppressive chemotherapy.
'Labscovery' has applied an independent platform technology that dramatically increases the efficacy of biopharmaceuticals.
Another expected product, 'Labs triple Agonist,' a new drug candidate for non-alcoholic steatohepatitis (NASH), is scheduled to be released in the first half of this year.
The FDA has also designated labs triple Agonist as a Fast Track development drug for the treatment of NASH.
■immunoglobulin ‘IVIG-SN’ of Green Cross
GC Green Cross is attempting to get the U.S. FDA approval for IVIG-SN 10% immunoglobulin. GC has been stretching for it since 2015.
This product is an immunoglobulin preparation administered to people with congenital or acquired weakened immune function to prevent and treat infections.
According to the data presented at the Korean Encephalitis/Encephalitis Society, IVIG-SN 10% was administered to patients with autoimmune encephalitis for five days and showed apparent symptom improvement in all five neurological indicators from 3 days later.
The effect lasted up to 29 days. Only mild side effects were identified after intravenous administration.
IVIG-SN 10%, delayed due to COVID-19 last year, is to be approved through a factory inspection this year.
■Yuhan Corporation’s anti-cancer drug ‘Rexraza’
Yuhan Corporation is attempting to apply for permission from the US FDA for its new anti-cancer drug Rexraza this year.
Lexraza, a non-small cell lung cancer treatment, is a targeted anti-cancer drug that inhibits the proliferation and growth of lung cancer cells. It received domestic approval in 2020 as a second-line treatment. Lexraza interferes with the epidermal growth factor receptor (EGFR) signaling, which is involved in lung cancer cell growth.
In addition, Lexraza is aiming to be promoted as a first-line treatment in Korea this year. The results of phase 3 clinical trial recently unveiled at the Asian Congress of the European Society of Oncology held in Singapore confirmed the possibility.
■Dong-A ST, the first biosimilar challenge
Dong-A ST is taking its first step into the U.S. and European markets with its first Biosimilar.
Dong-A ST conducted a global phase 3 clinical trials of DMB-3115, a biosimilar to Stellara, in nine countries, including the United States and Poland, from 2021 to the end of last year, confirming the therapeutic equivalence and safety compared to the original drug.
Stellara, developed by Janssen, is a treatment for inflammatory diseases such as plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis.
Dong-A ST plans to apply for product approval in the U.S. and Europe in the first half of this year based on the results of a global phase 3 clinical trials.
HeeMok Won, chairman of the Korea Pharmaceutical Bio Association, stated, "Despite the recession last year, domestic pharmaceutical companies continued to grow by investing in R&D." "This year, many pharmaceutical companies will raise the status of K-Pharma with global phase 3 clinical results and FDA approval," he added.
