Brazil’s Agencia Nacional de Vigilancia Sanitaria has granted marketing authorization for Samsung Bioepis’ Ontruzant, a trastuzumab biosimilar (Original: Herceptin), the company said Monday.The approval comes 13 months after the company submitted its biologics license application to the Brazilian health authority in December 2017.Ontruzant is used to treat patients with early breast ca
Law firm Hankyul is pursuing a lawsuit against Kolon Life Science and Kolon TissueGene on behalf of minority shareholders who claim that they made losses due to the two companies’ unfaithful public disclosure about now-suspended drug Invossa-K. The law firm is receiving applications for damage compensation by June 15 from investors who bought shares of Kolon Life Science from Aug. 12, 2017, to
The Ministry of Food and Drug Safety said additional material submitted by Kolon Life Science was not convincing enough to clarify how Invossa-K’s cell ingredient was mislabeled.The ministry said it would have to combine the results of the inspection into Kolon TissueGene in the U.S. and the ministry’s direct analysis of Invossa to find out the details about the mislabeling. Ear
The Seoul Central District Prosecutors Office is seeking an arrest warrant of Samsung BioLogics CEO Kim Tae-han, as part of its investigation into the company's alleged accounting fraud.The prosecutors also sought warrants for two Samsung Electronics vice presidents on similar charges.The charges brought against Kim include ordering the concealment and manipulation of Samsung BioLogics and
More than 50 days have passed since the Ministry of Food and Drug Safety (MFDS) suspended the sales of Invossa-K, an osteoarthritis gene therapy, due to the mislabeling of a cell ingredient.However, the ministry, the drug manufacturer Kolon Life Science and its subsidiary Kolon TissueGene have failed to address the issue and ease fears of patients treated with the injection quickly, critics sa
A lawmaker and civic groups urged the government to nullify the license of Invossa-K, an osteoarthritis gene therapy developed by Kolon Life Science and Kolon TissueGene, to protect patients’ safety. They also called for an active investigation into the mislabeling of Invossa’s cell ingredient.Rep. Youn So-ha of the minor opposition Justice Party, who is a member of the National Assembly’s Hea
Kolon Life Science said it would conduct a long-term follow-up study on over 3,700 patients who were treated with osteoarthritis gene therapy Invossa for 15 years.The regulator recently suspended the sales of Invossa after the company revealed that the cell ingredient of the second fluid of the drug was kidney-derived GP2-293 cells, not the authorized cartilage-derived cells.The so-called
“It’s been 19 years since I started this business. The first decade was a time of hardship. I only hope that junior people can become successful without going through too much trouble as I did. I hope other companies will join our effort to lead innovation in the biotech industry. I will do the best I can to lay the ground for the next generation before I retire.”Celltrion founder and CEO Seo
CHA Biotech said in a public filing on Wednesday that it recorded 124.4 billion won ($104.6 million) sales, 730 million won operating profit, and 3.4 billion won net profit in the first quarter.Compared to a year earlier, the sales grew 12.6 percent, but operating profit and net profit plummeted 92.3 percent and 34.6 percent, respectively.The company attributed a steep drop in operating in
“KangStem Biotech aims to become a leader in the global stem cell therapy market with the recent completion of a factory for a stem cell treatment.”So said CEO Lee Tae-hwa during a ceremony to celebrate the dedication of what he said was the world’s largest-capacity plant to manufacture stem cell therapies, on Wednesday.The new Stem Cell GMP Center is capable of producing five times more d
Prosecutors are speeding up the probe into Samsung BioLogics for alleged accounting fraud after securing evidence for the suspicion.After the company was found to have tried to destroy internal accounting documents, minority shareholders have also filed a lawsuit against the firm to demand compensations for damages.Arrests of executives and employees at Samsung BioLogics and its subsidiary
Biopharmaceutical firm Celltrion said it suffered a 32.9 percent decline in operating profit in the first quarter from a year earlier.The company posted 77.4 billion won ($65.6 million) operating income in the January-March period. Sales went down 9.5 percent on-year to 221.7 billion won, and net profit slid 28.4 percent to 63 billion won.Celltrion attributed the disappointing results
The licensing deal between Kolon Life Science and Mundipharma for osteoarthritis gene therapy Invossa-K has been partially changed, Kolon said.Under the revised agreement, Kolon Life Science should return 15 billion won ($12.8 million) upfront payment to Mundipharma if Invossa's Korean license gets nullified or the U.S. regulator does not decide on the resumption of the phase-3 clinical trial
Kolon TissueGene finally broke silence amid a growing suspicion that it might have pretended to be unaware of the mislabeling of the drug ingredient of Invossa-K although it had known it two years ago.Last Friday, the company said in a public filing it was aware in March 2017 that the cell ingredient of the second fluid of Invossa was not cartilage-derived but kidney-derived cells (GP2-293 cel
Kolon TissueGene said in a public filing that it notified its parent company Kolon Life Science in March 2017 that the cell ingredient of the second fluid of Invossa-K was not cartilage-derived but kidney-derived cells (GP2-293 cells).The public disclosure runs against Kolon Life Science’s allegation that it found the mislabeling through a short tandem repeat (STR) testing for the first time i
The Ministry of Food and Drug Safety is likely to decide in mid-May on when it will visit U.S.-based Kolon TissueGene for inspection over how the main ingredient of Invossa-K was mislabeled for over a decade.The ministry and Kolon Life Science, the parent company of Kolon TissueGene, are reportedly in talks to finalize the schedule. It is highly likely that the decision will come after May 15,
A non-government consumer group has complained with the prosecution against Kolon Life Science for the mislabeling of the drug ingredient of Invossa-K, and the Ministry of Food and Drug Safety for poorly assessing the osteoarthritis therapy Citizens United for Consumer Sovereignty (CUCS) on Tuesday accused Kolon and its CEO Lee Woo-sok of selling the drug that contained unauthorized ingredient
Celltrion said that the U.S. Food and Drug Administration has approved Linezolid, the company’s antibiotic generic.Linezolid is a second-generation antibiotic that uses oxazolidinone as the main ingredient and treats infections caused by gram-positive bacteria, such as methicillin-resistant staphylococcus aureus and vancomycin-resistant enterococci.The drug is the company’s second synt
Huons and Genexine have agreed to collaborate on developing new biopharmaceuticals.Based on their contract, Huons will develop promising biopharmaceuticals and treatments related to rare diseases derived from Genexine while Genexine will promote its products to the global biopharmaceutical market through Huons’ global network.Genexine is conducting clinical trials for cancer patients w
Korea’s biotech industry is stepping up efforts to develop biobetters -- upgraded versions of a biologic -- with various techniques aiming to improve the short half-life and low activity of protein drugs. The Pharmaceutical Society of Korea held a spring academic forum on the “Present and Future of Protein Drug Development,” at the Millennium Seoul Hilton, Friday. Yoon Jae-seung, CEO of PanGen