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The Korea Herald

Bio

November 28, 2019
SK Chemical’s SID 710 receives FDA sales approval

SK Chemical on Nov. 27 announced that its SID 710, a patch-type medication that aims to treat people with Alzheimer’s disease has won sales approval from the US Food and Drug Administration. The patch has been sold under the name Wondron Patch, a generic version of Novartis’ Exelon Patch for Alz...
November 26, 2019
Celltrion’s Remsima SC wins European approval

South Korean biopharmaceutical firm Celltrion said Nov. 26 that its drug Remsima SC for the treatment of autoimmune diseases has won sales approval in Europe. The European Medicines Agency has given the green light to Celltrion’s application to sell the subcutaneous version of Remsima, a biosi...
November 25, 2019
SK Biopharma to raise at least W5tr in IPO

South Korean drug firm SK Biopharmaceuticals is expected to raise at least 5 trillion won ($4.25 billion) through a planned share sale, analysts said Nov. 25. The company said that XCOPRI has won approval from the US Food and Drug Administration for the treatment of partial-onset seizures in ad...
November 22, 2019
Bridge Biotherapeutics plans expansion after IPO

South Korean biotech firm Bridge Biotherapeutics CEO Lee Jung-kyu announced Nov. 22 that the company plans to expand further after going public in December. The company expects to be listed on the second-tier Kosdaq market. “We hope to become a global biotech company by advancing both our busine...
November 22, 2019
SK Biopharma’s anti-epileptic drug wins FDA approval

SK Biopharmaceuticals said Nov. 22 its anti-epileptic drug has won approval from the US Food and Drug Administration. The company said the FDA granted approval of XCOPRI, or cenobamate tablets, for the treatment of partial-onset seizures in adults. This is the first time a South Korean phar...
November 21, 2019
FDA commences review of Samsung Bioepis’ biosimilar SB8 for sales in US

South Korea’s Samsung Bioepis said Nov. 20 that the US Food and Drug Administration has started reviewing its application for sales of SB8, a proposed biosimilar referencing Avastin. Samsung Group’s biosimilar development unit had applied for FDA’s marketing approval in September. Avastin is a...
November 18, 2019
SK Biopharm’s Sunosi receives positive CHMP opinion

SK Biopharm announced on Nov. 18 that its narcolepsy drug Sunosi received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP). Narcolepsy is a debilitating neurological disorder characterized by excessive sleepiness. According to SK Biopha...
November 15, 2019
Celltrion Pharm posts W47.43 b sales in Q3

Celltrion Pharm, the generic arm of Celltrion, announced Nov. 14 that its sales jumped 36.6 percent in the third quarter from a year earlier to 47.43 billion won ($40.7 million). The South Korean company added that its operating profit and net profit moved into the black this quarter, respectively...
November 14, 2019
Samsung Biologics receives ISO certification

Samsung Biologics announced Nov. 14 that it has received 27001 security certification from the Geneva-based International Organization for Standardization. The company emphasized that it is the first contract manufacturing organization to obtain ISO 27001 certification. German Ambassador to South...
November 13, 2019
Hugel’s operating profit reaches W18.2b in Q3

Korean biotech firm Hugel announced Nov. 12 that its operating profit jumped 225 percent in the third quarter from a year earlier to 18.2 billion won ($15.57 million). Its sales increased by 46.4 percent to 51.1 billion won. Hugel said its overall profit improved recently due to the sales growth ...
November 10, 2019
Samsung BioLogics’ German partner eyes expansion in Korea

GOTTINGEN, Germany -- Behind the market expansion of Samsung’s biologics business is 149-year-old Sartorius, a German firm that has helped it grow rapidly. Founded in 1870, the German company supplies single-use bags and membrane filters on top of many others that are necessary for biopharmaceuti...
November 07, 2019
Samsung Bioepis inks commercialization agreement with Biogen

South Korean pharmaceutical firm Samsung Bioepis said Nov. 7 it has entered into a new commercialization agreement worth $370 million with US partner Biogen. Under the partnership, Biogen will be responsible of marketing and sales of Samsung Bioepis’ two ophthalmology biosimilars -- SB11 and S...
November 05, 2019
Celltrion to start phase 3 clinical trials for patch-type donepezil

Celltrion announced on Nov. 5 that it will start phase 3 clinical trials of its patch-type donepezil, a medication that aims to treat people with Alzheimer’s disease, jointly with local drugmaker Icure. Established in 2000, Icure is a Kosdaq-listed firm that possesses more than 50 patents related...
November 01, 2019
SillaJen to pay back W110b to Kiwoom Securities

Bio company SillaJen announced Oct. 31 it will pay back 110 billion won (94.25 million), which it received by issuing convertible bonds, to Kiwoon Securities in March. “The annual interest rate for convertible bonds that were issued, including the ones issued to Kiwoon, rose from 3 to 6 percent a...
October 30, 2019
Kolon Life’s innovative drug company status likely to be revoked

South Korea’s Health Ministry said Oct. 30 that it is considering revoking Kolon Life Science’s innovative drug company certification for mislabeling and falsely reporting ingredients in its gene therapy drug, Invossa. A key material used in Invossa came from a kidney cell instead of from car...

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