SillaJen announced on Jan. 1 that it has applied to the U.S. Food and Drug Administration (FDA) for approval to amend the Investigational New Drug (IND) application for Phase 1 clinical trials of its BAL0891 cancer drug candidate.BAL0891 is a mitotic checkpoint inhibitor (MCI) class anticancer drug
JW Pharmaceutical announced on Jan. 15 that it has received approval from the Malaysian National Pharmaceutical Regulatory Agency (NPRA) for a phase 3 clinical trial plan, or investigational new drug (IND), of its gout treatment drug Epaminurad (code name URC102).The Phase 3 clinical trial for Epami
MedPacto announced on Jan. 2 that it has received approval from the U.S. Food and Drug Administration (FDA) for an Investigational New Drug (IND) application for the combination therapy of Vactosertib and Pembrolizumab (commercially known as Keytruda).This clinical trial targets patients with previo
Dong-A Socio Group’s specialty drug affiliate, Dong-A ST, will enter the ADC market through the acquisition of an antibody-drug conjugate (ADC) linker platform company. ADCs are a treatment that combines an antibody that combines a target antigen with a cytotoxic drug as a linker and is known for it
SK bioscience, a global innovative vaccine and biotech company committed to promoting human health from prevention to cure, announced today that SK bioscience and Sanofi have initiated the submission process of an Investigational New Drug(IND) amendment to the U.S. Food and Drug Administration(FDA)
On Aug. 17, GC Cell announced that its U.S. affiliate, Artiva Biotherapeutics, has received approval from the U.S. FDA for the Investigational New Drug application of its AB-101 natural killer (NK) cell therapy for lupus nephritis.Lupus is an autoimmune disease caused by immune system abnormalities
NeuroBo Pharmaceuticals, a subsidiary of Dong-A ST, announced on April 4 that it has filed a second phase U.S. Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) to develop DA-1241 for the treatment of non-alcoholic steatohepatitis (NASH).The clinical trial w
The authors are analysts of Shinhan Securities. They can be reached at shawn1225@shinhan.com and sehunjang@shinhan.com, respectively. – Ed. ADC platform tech transfer deal worth KRW1.6tr sealed with AmgenLegoChem Biosciences disclosed on December 23 that it has signed an antibody-drug conjugate (ADC
Daewoong Pharmaceutical will launch a phase 1 clinical trial of a new drug for autoimmune diseases in the United States. It is a first-in-class medication in the autoimmune disease family that simultaneously inhibits two enzymes involved in immune cell activation. The clinical trial on 72 patients i
Spectrum Pharmaceuticals, a U.S. biopharmaceutical company that has licensed poziotinib from Korea's Hanmi Pharmaceutical, announced on Sept. 22 that the U.S. Food and Drug Administration’s (“FDA”) Oncologic Drugs Advisory Committee (“ODAC”) met to review poziotinib for the treatment of patients
SK Inc. and SK Innovation (collectively, “SK”) invest in a next-generation small modular reactor (SMR) developer in the United States, stepping up their efforts to reduce global carbon emission. The investment is likely to provide a boost to SK Group’s strategy for the early achievement of net-zero
Daewoong Pharmaceutical announced on July 19 that its drug for idiopathic pulmonary fibrosis, dubbed DWN12088, has been granted fast-track designation by the U.S. Food and Drug Administration (FDA).The designation will allow Daewoong Pharmaceutical to accelerate the development of DWN12088. The comp
EOFlow Co. announced on May 20 that the first patient has been enrolled in the pivotal study of two-part wearable artificial pancreas “EOPatch X” on people with type 1 diabetes in Korea.According to the company, the first EOPatch X patient was enrolled by Dr. Kim Jae-hyeon of the Department of Endoc
LG Chem announced on Jan. 19 that it has received approval from the US FDA for clinical phase 1 studies (investigational new drug; IND) for ‘LC542019,’ which is a new drug candidate material for treating type 2 diabetes that can improve insulin resistance.With the approval, LG Chem has now procured
Cerecin Inc., a clinical-stage biotechnology company pioneering innovative neurotherapeutics, announced on Oct. 19 that it has raised US$40 million in an oversubscribed round of financing. A Series II investment was initially made by long-term investor, Nestle. In follow up to this round, Series IIA
The authors are analysts of Shinhan Investment Corp. They can be reached at sehunjang@shinhan.com and shawn1225@shinhan.com, respectively. -- Ed. Global biotech company focused on antibody drugs like anti-FcRnHanall Biopharma manufactures and sells medicines and focuses on R&D of new antibody drugs.
SK Bioscience announced on Aug. 30 that it has started administering the COVID-19 vaccine candidate "GBP510" to the first subjects in its phase 3 clinical trial. The company jointly developed the candidate drug with the Institute of Protein Design (IPD) at the University of Washington. This is the f
Corporate interest in microbiomes is growing as microorganisms in the human body such as germs, viruses, and molds can be used to treat cancer and other diseases.Accordingly, companies that used to make health enhancement foods and cosmetics using microbiomes are starting to develop treatments for d
GC Pharma has succeeded in entering the Chinese hemophilia drug market.The company said on Aug. 14 that it has obtained approval from China's National Medical Products Administration (NMPA) for its hemophilia treatment GreenGene F. This is the first time that a genetically recombined hemophilia
A COVID-19 vaccine under development by SK Bioscience is about to enter Phase 3 clinical trials for the first time among vaccines being developed by Korean companies.SK Bioscience announced on June 28 that it submitted a Phase 3 investigational new drug (IND) plan for COVID-19 candidate GBP510 to th