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Celltrion said it has been named a “Top 1%” company in the biotechnology sector of the Corporate Sustainability Assessment conducted by S&P Global. The CSA evaluates the environmental, social and governance performance of more than 12,000 companies worldwide, with the top 1 percent, 5 percent and 10 percent in each industry included in its annual Sustainability Yearbook. Celltrion, which ranked in the top 5 percent last year, advanced to the top 1 percent this year, becoming the only Korean comp
Yuhan Corp. said Monday its investigational drug YH35995 has received designation as an orphan drug from the US Food and Drug Administration for the treatment of Gaucher disease. The designation is granted to therapies targeting rare diseases with limited treatment options, offering incentives such as tax credits for clinical trials, exemption from FDA review fees and up to seven years of market exclusivity upon approval. Gaucher disease is a rare inherited lysosomal storage disorder caused by e
JW Pharmaceutical said Thursday it has secured exclusive domestic rights to bofanglutide, a next-generation GLP-1 receptor agonist, under a licensing agreement with China’s Gan & Lee Pharmaceuticals. Under the deal, JW Pharmaceutical will lead development, regulatory approval and commercialization in Korea, while Gan & Lee will provide data and documentation needed for investigational new drug and product approvals. The contract is valued at up to $81.1 million, including a $5 million upfront pa
Celltrion’s blood cancer treatment Truxima has become the first Korean biosimilar to top its segment in the United States life sciences market and is now the most prescribed rituximab drug in the world’s largest pharmaceutical market, the company said Tuesday. According to life sciences market analytics firm IQVIA, Truxima, which was developed by Celltrion as a rituximab biosimilar, accounted for a 35.8 percent prescription share in the US as of February this year. The milestone came about six y
LG Chem has doubled down on developing an innovative cancer treatment by zeroing in on undruggable targets through a license-in agreement with Frontier Medicines, a United States-based biotechnology company. According to LG Chem’s announcement Wednesday, it acquired the exclusive worldwide license to develop and commercialize Frontier Medicines’ FMC-220 outside Greater China, with the latter retaining ownership and full control in Greater China. Under the agreement, LG Chem will be responsible f
Samsung Biologics has officially acquired a biopharmaceutical manufacturing plant in Rockville, Maryland, to signify its first production foothold in the United States, the company said Wednesday. The Korean contract development and manufacturing organization, or CDMO, announced the $280 million deal to acquire GSK’s plant in Rockville in December. The newly added site features two Current Good Manufacturing Practice, or cGMP-certified, manufacturing plants with a combined 60,000-liter drug subs
SK Biopharmaceuticals announced that it submitted a new drug application to the US Food and Drug Administration for the oral suspension formulation of its epilepsy drug Cenobamate. In addition to the existing tablet form, this NDA seeks approval for a liquid option for adult patients with partial-onset seizures. The liquid-form oral suspension aims to enhance convenience for patients who have difficulty swallowing tablets, offering flexible administration based on patient needs. According to res
Celltrion announced Friday that it has obtained product approval from the Japanese Ministry of Health, Labor and Welfare for Omlyclo, a biosimilar of allergic disease treatment Xolair, and Eydenzelt, a biosimilar of the ophthalmic disease treatment Eylea. "This is an opportunity to further strengthen our influence in the Japanese market," an official from Celltrion said. "Based on the performance of our existing flagship lineup, we will do our best to facilitate the early adoption of our latest
Sam Chun Dang Pharm has surged to become the new heavyweight of Korea’s Kosdaq, as investor enthusiasm builds around its next-generation drug pipeline, including oral insulin and a weight-loss pill. Shares closed at 1.16 million won ($770) on Thursday, up 3.86 percent that day, pushing its market capitalization to 27.16 trillion won. The stock earlier hit a record 1.19 million won, after closing above the 1 million won mark the previous day — the first such milestone for a Kosdaq-listed company
SK Biopharmaceuticals said Thursday it has officially launched its epilepsy drug Cenobamate in China, marking the start of full-scale commercialization in one of the world’s largest pharmaceutical markets. The drug, marketed locally as Yifurui, was approved by China’s National Medical Products Administration in December as a treatment for partial-onset seizures in adult patients. Initial prescriptions have already begun at major hospitals across the country. Cenobamate is an in-house developed t
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