Kolon TissueGene, an affiliate of Kolon Life Science, is on the verge of being kicked out of the Kosdaq market.The Korea Exchange (KRX)'s Corporate Review Committee decided to delist Kolon TissueGene on Monday. The decision gives the regulator 15 business days to open a meeting of the Kosdaq Market Committee and make the final ruling by Sept. 18.If the company appeals the decision of the K
Medipost said that the U.S. Food and Drug Administration has given a fast- track designation for Pneumostem, a bronchopulmonary dysplasia treatment for preterm infants.The fast-track designation comes after the FDA gave an orphan drug designation for the drug in 2014. The company has also completed phase 1 and 2 clinical trials in the U.S. in January this year.FDA’s fast-track designat
GenNBio said it would officially enter the market of transplanting organs from pigs to humans.“GenNBio’s vision is to provide living tissues, cells, and organs from gnotobiotic miniature pigs for patients,” GenNBio CEO Kim Sung-joo said in a news conference at the Plaza Hotel in Seoul, Wednesday. To specialize in xenotransplantation, the company appointed Kim, former head of the
Celltrion Healthcare said that Japan's Ministry of Health, Labour and Welfare has approved a three-week cycle method for Herzuma (Ingredient: Trastuzumab), an anticancer antibody biosimilar, in treating breast cancer.Trastuzumab biopharmaceutical has two methods – a one-week cycle method (52 doses) and three-week cycle (18 doses) -- in treating breast cancers. The company received approval
Pharmicell said that it has filed an investigational new drug application to conduct the clinical trials of Cellgram-DC, a treatment for ovarian cancer, to the Ministry of Food and Drug Safety.The trial will use dendritic cells differentiated from the patient's bone marrow to evaluate the safety, tumor-specific immune response, and efficacy on metastatic or recurrent epithelial ovarian cancer.
Kolon Life Science, once one of the most promising bio-stocks, has been downgraded to an administrative issue.The company put a public notice Wednesday, saying it received "qualified" opinion from an external auditor. Companies receive a qualified opinion if the evidence is insufficient or the balance sheets are not made according to auditing principles."The impact of asset impairment in t
Medipost’s stem cell therapy Cartistem for osteoarthritis and umbilical cord blood bank CellTree have pulled off two-digit sales growth in the first half.According to the company’s public filing on Wednesday, Cartistem sold 8.1 billion won ($6.7 million) in the first half, a 24.7 percent increase from 6.5 billion won a year earlier.The revenue from Cartistem accounted for 34.4 percent of t
CHA Biotech said that it has obtained a patent for the use of placenta-derived mesenchymal stem cell lines.By acquiring the patent, the company has secured the right to develop treatments for degenerative neurological diseases using placental-derived mesenchymal stem cells.Compared to existing adult stem cells, the company's placenta-derived mesenchymal stem cells contain various therapeut
Samsung BioLogics said that it has implanted a new cell-culturing technology at its third plant, which can shorten its production time by 30 percent.The technology, called N-1 Perfusion, boosts productivity by increasing cell concentration up to 10 times by simultaneously carrying out cell culture and removing impurities at the N-1 stage, a procedure that comes just before the final cell c
Korean researchers have developed a technology of scaffolding stem cells with hydrogels so that injected stem cells can show differentiation at a designated lesion without spreading to the entire body.A research team, led by Dr. Song Soo-chang at the Korea University of Science and Technology (KIST)’s Biomedical Science and Technology Division, said the results of their studies on “Stem Cell D
HLB said it would request for a pre-New Drug Application (NDA) meeting with the U.S. Food and Drug Administration to seek approval for rivoceranib, a targeted anticancer therapy, based on data of phase-3 gastric cancer trial.The company initially planned to conduct an additional trial after the phase-3 study did not meet its primary endpoint. However, it recently reversed its stance and decide
Roche, MSD (Merck in the U.S.), and AstraZeneca achieved the most significant growth in stock prices among large biotech and pharmaceutical firms listed on NASDAQ in the first half of this year, a report showed.EvaluatePharma, a global pharmaceutical market research firm, evaluated the U.S. pharmaceutical and biotech market in a report, titled, “Vantage Pharma, Biotech & Medtech Half-Year Revi
Pharmicell said that it has filed an investigational new drug application to conduct the clinical trials of Cellgram-DC, a prostate cancer treatment, to the Ministry of Food and Drug Safety.The clinical trial will evaluate the safety, tumor-specific immune response and efficacy of Cellgram-DC in patients with metastatic castration-resistant prostate cancer.“Myeloid dendritic cell, whic
Shares of Sillajen continued to take a nosedive Monday after the biotech firm announced that it was in danger of aborting its phase 3 clinical trial for Pexa-Vec (trial name: PHOCUS) treating liver cancer.The company, which once had a market value of 10 trillion won ($8.2 billion), said Friday that it was advised to suspend the clinical trials by the Independent Data Monitoring Committee (DMC)
SillaJen said Pexa-Vec, an oncolytic viral drug, still had significant potentials despite the recent failure of the global phase-3 liver cancer trial.Even though the company failed to prove the experimental treatment’s efficacy in a combination treatment with targeted therapy, using Pexa-Vec with immunotherapy showed positive results, including complete remission, the company said.SillaJen
With the likely suspension of SillaJen’s trial on its major anticancer pipeline Pexa-Vec, investors raised suspicion that the company’s executives might have predicted the drug would fail in a futility test and sold their shares in advance.SillaJen said in a public filing on Friday that the Independent Data Monitoring Committee (DMC) advised the company to discontinue the trial on Pexa-Vec for
Local biotech shares went down altogether on Friday after SillaJen said it would scrap a global phase-3 trial on Pexa-Vec, an oncolytic viral therapy for liver cancer.Earlier in the morning before the stock market’s opening, SillaJen said in a public filing that the Independent Data Monitoring Committee (DMC) advised the company to discontinue the trial after a meeting for the evaluation of th
Eutilex CEO Kwon Byeong-se said he felt sorry for the recent fall of the company’s stock prices, adding that the latest suspension of a trial on a single pipeline unfairly made the entire pipelines’ potential undervalued.Eutilex shares have been bearish in recent weeks. The stock price went down below 60,000 won ($50.51) for the first time on Tuesday and hit a new 52-week low at 52,400 won on
Samsung BioLogics logged an operating loss of 5.4 billion won ($13.1 million) in the second quarter, turning into a deficit unlike the same period last year.The company, which is under probe for its alleged accounting fraud, posted the sales of 78.1 billion won, a 37.7 percent drop from a year ago. Its net loss came to 13.4 billion won, down 31.3 year on year, despite a strong performance
Samsung Bioepis’ sales in the European Union surpassed $180 million in the second quarter of this year, data showed Wednesday.According to the earnings report of Biogen, Samsung Bioepis' marketing partner in EU, the sales of three biosimilar products – Benepali, Flixabi, and Imraldi -- totaled $184.4 million in the second quarter of 2019, up 5.7 percent from the previous quarter.Benepa