Korea:006280

GC Biopharma and Novelty Nobility Enter into Joint Research and Development Agreement for Geographic Atrophy Therapies

YONGIN, South Korea, Oct. 28, 2024 /PRNewswire/ -- GC Biopharma announced that it has signed an agreement with Novelty Nobility, a biotech company specializing in the development of antibody-based therapeutics, for the joint research and development of a novel treatment for geographic atrophy (GA...

2024-10-29 09:13 1661

GC Biopharma and Hanmi Pharmaceutical Receives IND Clearance for Phase 1/2 Clinical Trial from the U.S. FDA

* Co-development of innovative new drug for the treatment of Fabry disease as "the world's first once-monthly subcutaneous treatment" * Improves efficacy compared to existing treatment for kidney function, vascular disease, and peripheral nerve disorders YONGIN, South Korea, Sept. 3, 2024 /PR...

2024-09-03 15:59 1193

GC Cell Signs an MOU with PT Bifarma Adiluhung, an affiliate of KALBE group

* GC Cell and PT Bifarma Adiluhung announced a strategic partnership to facilitate the entry of 'Immuncell-LC', the only approved autologous T-cell therapy for HCC into the Indonesian market. YONGIN, South Korea, June 19, 2024 /PRNewswire/ --GC Cell , a fully inte...

2024-06-20 08:44 2037

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 ...

2024-06-10 16:18 2076

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...

2024-06-04 13:00 1500

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 ,  a leader in the cell and gene therapy (CGT) sector within the biopharmaceutical industry, proudly announces its role as the first Korean Business Forum sponsor at the upcoming 2024 BIO International Convention. Set ...

2024-05-28 23:00 1472

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,...

2024-05-21 15:12 1419

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...

2024-05-20 14:07 1462

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 , a fully integrated cell therapy pioneer has announced poster presentations from studies of its preclinical study of GL205 (GCC2005), a CD5 CAR-NK targeting malignant T-cell lymphoma, and real-world data f...

2024-04-02 23:00 2176

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...

2024-02-26 21:30 1414

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...

2024-02-14 16:33 1844

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...

2024-01-23 11:53 1515

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

2024-01-09 00:00 1799

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...

2023-12-18 09:49 1610

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...

2023-12-06 08:56 1866

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...

2023-12-01 16:31 1775

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...

2023-11-06 09:11 1494

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...

2023-10-11 08:49 1626

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...

2023-10-10 14:20 1472

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...

2023-10-06 08:12 2427
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