Celltrion said it has completed its application to the U.S. FDA for the approval of CT-P39, a biosimilar referencing Xolair (ingredient: omalizumab). Xolair was developed by Genentech and Novartis for the treatment of allergic asthma, chronic rhinosinusitis with nasal polyposis, and chronic idiopath
Shaperon, a Korean biotech company, said Thursday that it has completed enrollment of the first patient in its U.S. phase 2 clinical trial of NuGel for treating atopic dermatitis.The trial is designed to evaluate NuGel in 210 patients of various ethnicities with mild to moderate atopic dermatitis fo
Samsung Biologics said Tuesday that it has signed a contract manufacturing agreement worth 381.9 billion won ($352.79 million, based on USD/KRW 1,082.90 on Dec. 21, 2017) with Belgium-based UCB. The contract is an extension of a $41.65 million contract signed with the Belgian company in 2017.UCB is
Curocell, a Kosdaq-listed biotech company, said it received the topline data from its phase 2 clinical trial for its CAR-T (chimeric antigen receptor-T) therapy, Anbal-cel, to treat diffuse large B-cell lymphoma (DLBCL).The study is Korea's first clinical trial of a CAR-T therapy, involving 79 adult
Osang Healthcare said it recorded a 2,126 to 1 competition ratio in the company’s public share subscription for retail investors on Monday and Tuesday. The subscription deposit amounted to about 5.26 trillion won ($39.3 billion).Osang Healthcare's five-day demand forecast from Feb. 21 to 27 attracte
Bridge Biotherapeutics has reported a significant downturn in its financial performance for the year 2023.The company's annual revenue plummeted to 100 million won ($74,878), marking a drastic 96.7 percent decrease compared to the previous year.This downturn is attributed to the absence of additiona
Cosmetic device maker ilooda said Monday that it had signed a settlement agreement with Serendia LLC to resolve a U.S. International Trade Commission (ITC) investigation.In March 2023, Serendia filed a complaint with the ITC, alleging ilooda’s infringement on its "invasive RF" patent.Invasive RF is
Celltrion said it reported consolidated sales of 2.1 trillion won ($1.5 billion) and operating income of 651 billion won in 2023, down 4.71 percent and up 0.66 percent, respectively, from the previous year.The company also posted a net profit of 539.2 billion won, down 0.53 percent, and an operating
CHA Biotech said it had achieved its highest-ever annual revenue, posting a consolidated revenue of 954 billion won ($798 million) for the year 2023, up 13 percent from the previous year, thanks to strong business performance overseas.Despite the global economic slowdown, CHA Biotech attributed its
NGeneBio, a precision diagnostics platform company, has received approval from the Thai Food and Drug Administration (TFDA) to market HLAaccuTest™ All, an in vitro diagnostic medical device based on next-generation sequencing (NGS) technology.It is the fourth NGS-based product approved for registrat
Biotech companies developing new drugs are plagued by rumors that adversely affect investor sentiment.Faced with a series of speculations about the equity sale by the largest shareholders and plans for a capital increase, SCM Lifescience, ABL Bio, NKMAX, and Genome & Company have responded with offi
Celltrion said it has commenced the first shipment of Zymfentra, the world’s first subcutaneous form of infliximab, to the U.S. targeting autoimmune diseases. The company announced that the initial shipment batch was airlifted today to Atlanta, U.S., with plans to complete three shipment phases by e
CHA Biotech has launched a study to enhance the anticancer efficacy of its natural killer (NK) cell therapeutic drug by making the most of polymer, a cationic compound.The cationic compounds used in the study are synthetic polymers, in which monomers, molecules with low molecular weight, are repeate
Pharos iBio will collaborate with the team of Professor Shin Sang-joon of the Department of Medical Oncology at Yonsei Cancer Center to conduct the translational study of PHI-501 under development for treating solid tumors.PHI-501 is a pipeline of solid tumor therapeutics in preclinical development.
AriBio said Monday that the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) has formally approved POLARIS-AD, a global phase 3 clinical trial of AR1001, an oral treatment for Alzheimer's disease.AriBio plans to initiate the phase 3 trial in the U.K. before the end of the first quarte
Samsung Bioepis said that the European Medicines Agency (EMA)'s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for Pyzchiva, also known as SB17, a biosimilar candidate referencing Stelara, last Sunday. This biosimilar, referencing Janssen's Stelara (ingredient: uste
Alteogen, a Kosdaq-listed biotech company, said it has made an amendment to its existing license agreement with the global pharmaceutical company MSD, known as Merck & Co. in the U.S. and Canada.The revised agreement grants MSD exclusive global rights to ALT-B4, a recombinant human hyaluronidase enz
Samsung Bioepis said it has made significant progress with its autoimmune disease treatment biosimilar, SB17, suggesting its potential use across all indications treatable by the original drug, Stelara.Stelara is an interleukin (IL)-12, 23 inhibitor developed by Janssen. It is used to treat inflamma
Samsung Bioepis has begun clinical development of its next flagship pipeline, a biosimilar of Keytruda (pembrolizumab).Samsung Bioepis said Wednesday that the company had initiated a global phase 1 clinical trial of SB27, a Keytruda biosimilar, and its 11th biosimilar pipeline.Samsung Bioepis will r
Gradiant Bioconvergence said Thursday that it has entered into a research collaboration agreement with U.S. messenger ribonucleic acid (mRNA) therapeutics developer Strand Therapeutics to develop next-generation mRNA therapeutics.Under the agreement, the companies will collaborate on developing a fo