FDA Grants Fast Track Designation to GCBP and Novel Pharma's GC1130A
* FDA's Fast Track designation speeds up the development of new biologic drugs for rare diseases YONGIN, South Korea, June 10, 2024 /PRNewswire/ -- GC Biopharma (006280. KS) and Novel Pharma have announced that the U.S. FDA has granted Fast Track Designation for their jointly developed MPSIIIA ...
GCBP Sponsors 2024 Spring Symposium for KASBP and Present Research Findings
YONGIN, South Korea, June 4, 2024 /PRNewswire/ -- GC Biopharma announced that it will attend 2024 Spring Symposium of the Korean American Society in Biotech and Pharmaceuticals (KASBP) onJune 7-8th at Waltham, Massachusetts as a sponsor to share keynote presentation, present Korean Scientist Awar...
GC Cell participates 2024 BIO International Convention, Unveiling its future Blueprint 2.0, as the First Korean Business Forum Sponsor
SAN DIEGO, May 28, 2024 /PRNewswire/ -- GC Cell
GC Biopharma/Novel Pharma's Sanfilippo Syndrome Treatment Obtains FDA IND Clearance
YONGIN, South Korea, May 21, 2024 /PRNewswire/ -- GC Biopharma (006280. KS) and Novel Pharma have announced that the U.S. FDA has cleared the investigational new drug (IND) application for their jointly developed MPSIIIA (Sanfilippo Syndrome Type A) treatment, GC1130A. With this FDA clearance,...
GC Biopharma/Novel Pharma's Sanfilippo Syndrome Treatment Obtains FDA IND Approval
YONGIN, South Korea, May 20, 2024 /PRNewswire/ -- GC Biopharma (006280. KS) and Novel Pharma announced that its jointly developed MPS IIIA 'GC1130A' treatment has received FDA IND approval. With this approval, development of 'GC1130A' is expected to accelerate with multinational clinical trial...
GC Cell to Present Multiple Posters at the American Association for Cancer Research (AACR) Annual Meeting 2024
YONGIN, South Korea, April 2, 2024 /PRNewswire/ -- GC Cell
GC Cell and BioCentriq® Execute Process Transfer Agreement in Anticipation of the U.S. entry of Immuncell-LC Inj.
* Immuncell-LC Inj. is an autologous Cytokine Induced Killer (CIK) cell therapy approved for Commercial use inSouth Korea as an adjuvant cell therapy for the treatment of Hepatocellular Carcinoma (HCC) after curative resection and has receivedFDA Orphan Drug Designations (ODDs) for liver, brain...
GC Biopharma Presents Updates on its LSD Treatments at the WORLDSymposium 2024
* Recent updates on its development of LSD treatments were presented YONGIN, South Korea, Feb. 14, 2024 /PRNewswire/ -- GC Biopharma (CEO, Eun-Chul Huh), a South Korean biopharmaceutical company, announced onFeb. 14th that it has presented the development updates on its LSD (Lysosomal Storage D...
European Medicines Agency (EMA) Grants Orphan Drug Designation (ODD) to GC Biopharma's Treatment for Sanfilippo Syndrome (Type A)
YONGIN, South Korea, Jan. 22, 2024 /PRNewswire/ -- GC Biopharma Corp. (006280.KS) announced that the European Medicines Agency (EMA) has granted Orphan Drug Designation (ODD) to its intracerebroventricular (ICV) Enzyme Replacement Therapy (ERT) candidate, GC1130A, designed for Sanfilippo Syndrome...
GC Cell's Promising AB-201 Cancer Treatment to Begin Phase 1 Trials Using Lunit AI Platform
South Korea's first CAR-NK cell therapy cleared for human trials in Australia
and domestically; Cancer Moonshot participant GC Cell partnering with medical
AI leader Lunit to collaborate on AB-201 clinical development
YONGIN, South Korea and SYDNEY, Jan. 9, 2024 /PRNewswire/ -- GC Cell
GC Biopharma Announces US FDA Approval for ALYGLO™ (Immune Globulin Intravenous, Human-stwk) 10% Liquid for Adults with Primary Humoral Immunodeficiency (PI)
YOGIN, South Korea, Dec. 17, 2023 /PRNewswire/ -- GC Biopharma Corp (006280.KS) today announces that the US Food and Drug Administration (FDA) has approved ALYGLO (immune globulin intravenous, human-stwk) 10% Liquid, formerly referred to as "GC5107," for the treatment of adult patients aged 17...
GC Biopharma's groundbreaking for the plasma fractionation plant in Indonesia
* To commence operation by 2027…with max. 400K liters of plasma production capacity per annum * The first step towards localization of Indonesia's critical medical product YONGIN,South Korea, Dec. 5, 2023 /PRNewswire/ -- GC Biopharma, a South Korean biopharmaceutical company, announced onDece...
GC Biopharma establishes mRNA production facility in Hwasun, Korea
* Completed the construction of a GMP pilot plant in its Hwasun production plant in Jeollanam-do, Korea * Plans to expand its domain from vaccine development to the field of rare disease treatments by proactively securing mRNA platforms YONGIN, South Korea, Dec. 1, 2023 /PRNewswire/ -- GC Bio...
The World's First "Recombinant Anthrax Vaccine": GC Biopharma applies for MFDS Approval
YONGIN, South Korea, Nov. 5, 2023 /PRNewswire/ -- GC Biopharma announced 1 Nov. 2023 that it has applied for the marketing approval of "GC1109", an anthrax vaccine jointly developed by GC Biopharma and the Korea Disease Control and Prevention Agency (KDCA), to the Korean Ministry of Food and Drug...
GC Biopharma Shares its Successful HR System Transformation at SAP Success Connect 2023
YONGIN, South Korea, Oct. 10, 2023 /PRNewswire/ -- GC Biopharma Corp. announced today that it has presented the successful adoption of SAP SuccessFactor Work Zone, which is a cloud-based HR solution by SAP, at the SAP Success Connect 2023 held onOctober 3rd in Las Vegas. SAP Success Connect is...
GC Biopharma Signs Power Purchase Agreement with SK E&S
YONGIN, South Korea, Oct. 10, 2023 /PRNewswire/ -- GC Biopharma Corp. announced on today that it has signed Power Purchase Agreement (PPA) with SK E&S Co., Ltd onOctober 5th at its Ochang Plant. PPA is an electricity trading contract signed directly between a power generator and a customer c...
FDA Grants Orphan Drug Designation to GC Biopharma's Drug Candidate for Thrombotic Thrombocytopenic Purpura
YONGIN, South Korea, Oct. 5, 2023 /PRNewswire/ -- GC Biopharma Corp. announced today that GC1126A, its drug candidate for Thrombotic Thrombocytopenic Purpura (TTP), received an Orphan Drug Designation onSeptember 27 from the U.S. Food and Drug Administration (FDA). When designated as an orphan...
GC Biopharma to organize "Donate Blood with Love", a healthy way of giving back to the community
With the participation of all affiliated group entities YONGIN, South Korea, Aug. 30, 2023 /PRNewswire/ --All executives and employees of GC Biopharma, a South Korean biopharmaceutical company, rolled up their sleeves to practice ESG and social value. On Aug. 30th, the company held the "Donate...
GC Biopharma to Produce Cholera Vaccines Jointly with Eubiologics
YONGIN, South Korea, Aug. 25, 2023 /PRNewswire/ -- GC Biopharma (006280.KS), a South Korean biopharmaceutical company, announced today that it has signed a MOU at its headquarters in Yongin,South Korea with Eubiologics for a co-production of Euvichol, an oral cholera vaccine. Under the MOU, bo...
Thrombotic AEs of Hemlibra (emicizumab) were 2.8 times more frequent than those of FVIII replacements.
* Analyzed the FDA FAERS data…to compare the thrombotic AEs of Hemlibra vs. FVIII replacements. YONGIN, South Korea, Aug. 17, 2023 /PRNewswire/ -- GC Biopharma (006280.KS), a South Korean biopharmaceutical company, announced on August 17, 2023 that it has presented the results of analyzing and...
