Shares of Kolon Life Science shot up after the regulator decided to delay the decision on the delisting of Kolon TissueGene, a subsidiary of Kolon Life Science, by one year.The stock price of Kolon Life Science went up by a daily limit of 30 percent to hit 29,250 won ($24.73) as of 2:24 p.m., Monday.On Friday, the Korea Exchange’s Kosdaq Market Committee said it decided to defer its decisi
HLB said it would merge with its subsidiary Elevar, a U.S.-based developer of a targeted anticancer therapy rivoceranib. Elevar is the new name of LSK BioPharma.HLB USA, a subsidiary of HLB, clinched a deal on Friday to acquire a 100 percent stake of Elevar. HLB USA is a wholly-owned subsidiary of HLB. Upon the completion of the merger, HLB will achieve a triangular merger as HLB Chairman Jin
Samsung Bioepis said that it has unveiled the real-world data (RWD) of Benepali, an Etanercept biosimilar, in patients with moderate to severe psoriasis, from the British Association of Dermatologists Biologics and Immunomodulators Register (BADBIR).The company plans to present the results of the research at the 2019 European Academy of Dermatology and Venereology (EADV) Congress in Madrid
About 80 percent of companies listed on the Kosdaq stock market using the regulator’s “technology exception policy” was in the biotech industry. Still, only six firms turned from red to black last year, a lawmaker found.A couple of companies are under the suspicion that their executives and affiliated people used insider information to increase their wealth, he said, calling for the regulator’
SK Plasma said that it has won the $20-million bid to supply LIV-Gamma, a human immunoglobulin, to Brazil’s Ministry of HealthLIV-Gamma reduces the risk of infection in individuals with poorly functioning immune systems such as those with hereditary immunodeficiency syndromes, chronic lymphocytic leukemia (CLL), and following bone marrow transplantation, by increasing the platelet counts i
The Ministry of Food and Drug Safety is preparing to implement the “Act on Safety and Support for Advanced Regenerative Medicine and Advanced Biopharmaceuticals,” which takes effect on Aug. 27 next year. By the end of this year, the ministry aims to complete the draft of the enforcement decree and rules. As the law deals with R&D and safety management of advanced biopharmaceutical products suc
Samsung executives said Samsung BioLogics and Samsung Bioepis workers were responsible for deleting data excessively, during a trial over the alleged window dressing of Samsung BioLogics. They ordered data deletion to “prevent unnecessary misunderstandings” about Samsung, but the two companies unexpectedly replaced servers, they claimed. The Seoul Central District Court on Wednesday held t
Samsung Bioepis has presented the results of phase 3 study clinical evaluating the efficacy and safety of SB8, a bevacizumab biosimilar, at the European Society for Medical Oncology (ESMO) 2019 Congress in Barcelona, Spain.The research compared SB8 to the original in patients with metastatic or recurrent non-squamous non-small cell lung cancer (NSCLC).The primary endpoint of the study
Executives of Samsung BioLogics and affiliated companies claimed that they did not engage in any window dressing, although they deleted evidence which was an obstruction of justice. They argued that such acts were not serious enough, and therefore they cannot be charged with criminal destruction of evidence. However, prosecutors countered that their acts violated the law by tampering with
Celltrion Healthcare said that it won the bid to sell Herzuma, an anticancer antibody biosimilar, sponsored by a governorate in Iraq in the second quarter of this year. The company started marketing the drug from the third quarter of this year through Hikma, its Middle Eastern partner.“The entry into Iraq is expected to have a positive effect on expanding our products to neighboring countr
Helixmith used to be one of the promising biotech firms with its market capitalization ranking second on KOSDAQ.However, the company failed to complete the global phase-3 trial on a gene therapy due to its drug mix-up between the placebo and the treatment, and it is blaming others for its own mistake.Helixmith on Tuesday said it detected data contamination for its gene therapy Engensis, al
A Seoul court turned down Kolon Life Science’s appeal for stopping the government’s decision to nullify the license of Invossa-K.The Seoul High Court ruled on Tuesday against Kolon’s petition, after reviewing whether the ministry should stop the process to revoke the permit of Invossa on Sept. 9.Kolon filed the administrative suit against the Ministry of Food and Drug Safety to invalidate
The U.S. Food and Drug Administration has recommended Kolon TissueGene to remanufacture the second fluid of Invossa-K if the company wishes to resume the phase-3 trial on the drug. Invossa-K, a genetic treatment for osteoarthritis, was suspended in Korea due to the mislabeling of the ingredient in the second fluid.Kolon TissueGene said the remanufacturing was not a requirement for the trial re
Dong-A ST said that Sanwa Kagaku Kenkyusho (SKK), its Japanese partner, has received sales approval for DA-3880, Aranesp (Ingredient: darbepoetin alfa) biosimilar with indications for anemia, from Japan's Ministry of Health, Labour and Welfare.The Korean company signed a licensing-out agreement on the development and sale of the DA-3880 in Japan with SKK in January 2014, and the latter sta
An increasing number of biotech companies are eyeing on the Korea Exchange’s “growth potential exception policy” to avoid rigorous requirements in an initial public offering (IPO) and secure stronger protection for investors.Olipass, Bridge Biotherapeutics, and Syntekabio are planning to go public using the growth potential exception policy, industry sources said.The growth potential excep
The Financial Services Commission (FSC)'s disciplinary action against Samsung BioLogics will cease to be effective until the final ruling regarding the original lawsuit.The Supreme Court made a decision Tuesday to dismiss re-appeal made by the FSC regarding the previous ruling made by the Seoul Administrative Court to suspend the FSC's disciplinary action against Samsung BioLogics for alle
Celltrion said that Health Canada has given the go-ahead for Herzuma (Ingredient: Trastuzumab), an anticancer antibody biosimilar, in treating breast and gastric cancer.The Canadian authorities approved the drug after validating the comprehensive data from nonclinical and clinical trials, which demonstrated that the safety and efficacy of Herzuma for treating breast and gastric cancer were
Samsung Bioepis said that it has received sales approval for Brenzys, an Enbrel biosimilar product, from Brazil's Ministry of Health.In Brazil, more than 90 percent of autoimmune disease treatments such as Enbrel, Humira, and Remicade are available through the nation's productive development partnership (PDP) program.The PDP is a program where a global biopharmaceutical company, a Braz
“We’ve never heard when and how they would do a long-term follow-up. Kolon Life Sciences said it held a meeting with patients for better communication, but the meeting was for 10 people only. What kind of communication is that?”So said a patient who received the treatment of Invossa-K, now-suspended gene therapy for osteoarthritis by Kolon Life Sciences, venting his anger.Other patients tr
Professor Tasuku Honjo of Kyoto University said he was expecting a good outcome out of more than 1,000 clinical trials on combination therapies to improve the effectiveness of immunotherapies. He won the 2018 Nobel Prize in Physiology or Medicine for his identification of programmed cell death protein 1 (PD-1). “Soon, cancer will be regarded as a chronic disease,” he said. Professor Honjo