Samsung Bioepis has completed the global phase 3 clinical trials of its SB12, a biosimilar drug of Soliris (ingredient: eculizumab), for treating paroxysmal nocturnal hemoglobinuria (PNH).The company received the last patient to end the clinical trials of SB12 and updated the study in clinicaltrials
Geninus said it set its public offering price at 20,000 won ($17.14) for the initial public offering on the Kosdaq market in November.In a public filing on Tuesday, the biotech company said that the two-day book building on Thursday and Friday showed that the competition rate of institutional invest
CHA Biotech’s patented technology to culture and freeze natural killer (NK) cells has been featured in the Journal of Experimental and Clinical Cancer Research, an international journal providing a quality forum with all oncology works.In collaboration with a research team led by Professor An Hee-ju
DeepBio has obtained approval from the ethics committee of the University of Utah to conduct a real-world study to validate the performance of its AI-based prostate cancer diagnosis software with ARUP Laboratories.At the University of Utah ARUP Laboratories, the company intends to assess the impact
Sillajen said it has appointed a new CEO and planned to add new businesses at a shareholders meeting late this month to normalize and bolster its business.On Thursday, the company’s board of directors appointed vice president Jang Dong-taek as new CEO and senior managing director Park Sang-keun as h
Genencell said Tuesday that it asked the Ministry of Food and Drug Safety to authorize phase 2 and 3 clinical trials of ES16001, the company’s oral Covid-19 therapy. The company expects the domestic study to serve as a starting point for its global clinical trials of ES16001 in European countries.ES
Celltrion said that it has completed the approval application procedure for CT-P16, a biosimilar of Avastin (ingredient: bevacizumab), to the European Medicines Agency (EMA)."We submitted the application after completing global clinical trials for a total of 689 patients at 164 sites in 21 countries
EuBiologics, developing a home-grown Covid-19 vaccine, said it would apply for a local phase 3 study of its vaccine candidate in several days.The company said it would also apply for a global phase 3 trial of EuCorVac-19 to the Ministry of Food and Drug Safety within this week.EuBiologics plans to u
SK Bioscience said its Covid-19 vaccine candidate GBP510 has recently received approval from the Vietnamese government to run phase 3 clinical trials, speeding up the development through global studies in five countries.The International Vaccine Institute (IVI), collaborating with SK Bioscience for
Samsung Biologics has signed an agreement with Texas-based biotech company Enzolytics for developing and manufacturing monoclonal antibody therapy for Covid-19.Under the accord, Samsung Biologics will provide an end-to-end service to develop cell lines, manufacture clinical trial material, and apply
SK Biopharm has applied for a new global clinical trial plan of its epilepsy drug Xcopri (ingredient: cenobamate) to expand the treatment of pediatric patients.According to the U.S. National Institutes of Health, SK Biopharm submitted a new global phase 3 clinical trial plan of Xcopri. The study see
SK Bioscience has extended its capacity reservation contract with the Coalition for Epidemic Preparedness Innovations (CEPI) to use its L-House plant in Andong, North Gyeongsang Province, to produce Covid-19 vaccines supported by CEPI.Under the accord, three of SK Bioscience's nine L-House productio
CartiLife, an autologous cartilage-derived chondrocyte cell therapy for regenerating knee cartilage, will be easier to inject with a new injector, industry officials said.CartiLife won a conditional nod from the Ministry of Food and Drug Safety in April 2019 to treat knee cartilage defects (ICRS Gra
Celltrion has submitted an application to obtain approval for CT-P16, a biosimilar of Roche's Avastin (ingredient: bevacizumab), for colorectal cancer treatment in the U.S. and Korea.The company completed global clinical trials of CT-P16 at 150 cites in 20 countries in Europe, South America, and Asi
Ildong Group is speeding up preparations to list its affiliate Ildong Bioscience on the stock market.The group said it decided to sell some of its stake in Ildong Bioscience within the limit that does not affect management rights. The move is part of preparations for an initial public offering of Il
EuBiologics, a Korean Covid-19 vaccine developer, is expected to license out a vaccine adjuvant technology to a U.S. biopharmaceutical company, industry sources said.The vaccine adjuvant market used to be dominated by multinational pharmaceutical companies, but industry officials pay attention to wh
Cytiva, a U.S. company supplying raw and subsidiary materials for vaccine production, decided to invest $52.5 million in Korea until 2024 to build manufacturing facilities for global capacity expansion.Vaccine developers and research institutes from Korea and the U.S. also agreed to cooperate in dev
Samsung Biologics said Wednesday that it has launched S-Cellerate, a pharmaceutical consignment development organization (CDO) platform that shortens the period for developing drugs, at the 2021 BioProcess International Conference.According to the company, S-Cellerate significantly shortens the time
Korea and the U.S. will strengthen vaccine partnerships in the private sector to overcome the global health crisis driven by the Covid-19 pandemic, Cheong Wa Dae said Tuesday.On Tuesday morning in New York, vaccine companies and research institutes from the two countries held a signing ceremony to e
After getting the nod in Europe, Samsung Bioepis has gained U.S. marketing approval for a biosimilar referencing Lucentis to enter the 4 trillion won ($3.38 billion) worth global age-related macular degeneration (AMD) market.Samsung Bioepis recently signed a license agreement with Genentech, the dev