HK inno.N said Thursday that it has obtained product approval from China's National Medical Products Administration (NMPA) for K-CAB (ingredient: tegoprazan), a gastroesophageal reflux disease (GERD).The indication approved in China is for erosive esophagitis.The approval comes after HK inno.N signe
RedHill Biopharma’s investigational Covid-19 treatment opaganib is effective against the Omicron variant, an in vitro study said. Attention is on whether the study results will benefit Kukbo, which licensed in the oral Covid-19 treatment from RedHill Biopharma.The Israel-based biopharmaceutical comp
AstraZeneca (AZ) said its new anti-cancer drug candidate MEDI5752, a bispecific antibody targeting PD-1 and CTLA-4 simultaneously, showed a promising potential to overcome the toxicity of AZ’s CTLA-1 inhibitor tremelimumab in the first clinical trial.Dr. Ben Tran at the Peter MacCallum Cancer Centre
SK Bioscience will develop a new drug that prevents infections, such as the Covid-19 virus, by spraying antiviral protein into the nose.The company said Wednesday that it would cooperate with overseas research institutes, such as the International AIDS Vaccine Initiative (IAVI) and the University of
Kolon TissueGene's Invossa, the world's first osteoarthritis cell gene therapy, may get back on track as the company successfully licensed the drug to a foreign biopharmaceutical firm.Kolon Life Science, the parent company of Kolon Tissuegene, said Wednesday that it had signed a technology export co
LG Chem is gearing up to enter the Chinese market with a premium hyaluronic acid filler brand.On Thursday, the Korean chemical company updated the status of the clinical trial of YVOIRE Y-Solution 360 to “recruiting,” according to ClinicalTrials.gov, a registry of clinical trials run by the U.S. Nat
Amgen’s first KRAS targeted therapy, Lumakras (ingredient: sotorasib), demonstrated consistent clinical benefits in the longest follow-up of patients with KRAS G12C-mutated non-small cell lung cancer (NSCLC).On Sunday, Amgen released the two-year data of the CodeBreak100 phase 1/2 trial of Lumakras
Novartis Korea aims to address the unmet needs of non-small cell lung cancer (NSCLC) patients with MET exon 14 skipping mutation with the launch of Tabrecta, the company said Tuesday."Lung cancer is the third most common cancer in Korea, and NSCLC has a five-year relative survival rate of only 8.9 p
Yuyu Pharmaceutical said that it has received approval from the U.S. Food and Drug Administration to conduct phase 2 clinical trials for YP-P10, a new dry eye treatment.YP-P10 is a new biopharmaceutical using synthetic peptides and aims to relieve signs and symptoms of dry eye syndrome caused by inf
Zuellig Pharma Korea fell to full-scale capital erosion for the second year as its liabilities exceeded assets due to continued losses in 2021.Complete capital erosion refers to a situation in which the total amount of capital for a company goes below zero as the company's deficit widens, surplus ru
Yuhan Corp. said that its U.S. partner Spine Biopharma has received approval from the U.S. Food and Drug Administration for the phase 3 clinical trial of YH14618, a degenerative disc treatment candidate.Spine Biopharma plans to start trials in June and obtain results by the first half of 2024.YH1461
Roche Korea’s profits aggravated last year as sales dropped and expenses increased.According to Roche Korea, the company posted 343.9 billion won ($278.9 million) in sales last year, down 22.53 percent from 443.9 billion won in 2020. It also registered annual sales of below 400 billion won for the f
SK Chemicals said it has agreed to develop new drugs with inCerebro, a local artificial intelligence (AI) drug development company based on quantum mechanics technology.Under the accord, inCerebro will derive new drug candidate substances for specific diseases based on its quantum mechanics-based mo
Hugel said a complete response letter (CRL) from the U.S. FDA on botulinum toxin (BTX) Letybo requires supplementary documents, but it would not have a significant impact on the drug approval.News reports said that Hugel received the FDA’s CRL on Letybo (brand name in Korea: Botulax) on March 31.Hug
The U.S. health insurance authorities finalized the policy for coverage of aducanumab and future monoclonal antibodies against Alzheimer’s disease as it had planned earlier this year.The decision is likely to hurt Biogen, which recently released Aduhelm (aducanumab), and other drugmakers who plan to
HK inno.N said it completed a phase 1 study of K-Cab (ingredient: tegoprazan), a gastroesophageal reflux disease (GERD) treatment, in the U.S.In a public disclosure on Thursday, HK inno.N said it finished the phase 1 trial in 30 healthy adults. The study was randomized, double-blind, placebo-control
AbClon said that it has partnered with the National Cancer Center (NCC) to develop a CAR-T (Chimeric Antigen Receptor-T) cell therapy for solid cancer and target Claudin (CLDN)-18.2 antigen.According to the company, the recent breakthrough success of CAR-T cell therapy for blood cancer has accelerat
Pfizer’s Lorviqua (ingredient: lorlatinib), a third-generation anaplastic lymphoma kinase (ALK) targeted therapy, passed the review for health insurance coverage for the treatment of adult patients with ALK-positive advanced non-small-cell lung cancer (NSCLC).On Thursday, the Health Insurance Review
Affyxell Therapeutics, a joint venture between Daewoong Pharmaceutical and Avacta Life Science, said that it would conduct more efficient preclinical trials through a three-party joint project with Biocytogen, Korea Non-Clinical Technology Solution Center (KNTSC)In drug development, preclinical tria
BeiGene’s Brukinsa (ingredient: zanubrutinib), a next-generation BTK inhibitor, passed the Health Insurance Review and Assessment Service’s (HIRA) Cancer Drugs Benefit Appraisal Committee review just 40 days after winning marketing approval in Korea.Merck’s anti-PD-L1 immunotherapy Bavencio (aveluma