Latest news with #GCBiopharma
Korea Herald
2 days ago
- Health
- Korea Herald
GC Biopharma's Phase 3 Clinical Trial Results for Hunterase Published in SCIE-Indexed Journal
YONGIN, South Korea, May 30, 2025 /PRNewswire/ -- GC Biopharma, a South Korean pharmaceutical company, announced that the Phase 3 clinical trial results for Hunterase (idursulfase beta), its investigational drug for Hunter Syndrome (MPS II), have been published in Genetics in Medicine, an SCIE-indexed journal. Conducted at Samsung Medical Center, the Phase 3 clinical trial enrolled 24 newly diagnosed Hunter Syndrome patients with no prior treatment. It evaluated the efficacy and safety of Hunterase over a one-year treatment period. Hunter Syndrome is a rare genetic disorder caused by a deficiency of iduronate-2-sulfatase (IDS), an enzyme critical for glycosaminoglycan (GAG) catabolism. This deficiency leads to the progressive accumulation of GAGs in various organs and tissues, resulting in multisystemic dysfunction, including joint stiffness and hepatosplenomegaly. The clinical trial results demonstrated that Hunterase significantly enhanced functional mobility, reduced urinary GAG concentrations, and markedly alleviated hepatosplenomegaly. In the 6-Minute Walk Test (6-MWT), the primary endpoint of the study, patients treated with Hunterase walked an average of 62.2 meters more after treatment. This improvement was more than eight times greater compared to the placebo group, which saw an average increase of just 7.3 meters. The 6-MWT measures the distance a patient can walk on a flat surface within 6 minutes. It is a widely used clinical measure for evaluating functional mobility, cardiopulmonary function, muscle strength, and overall physical health. In the context of Hunter syndrome, it serves as a standardized and meaningful indicator of disease progression and quality of life. In addition to the primary endpoint, the study also achieved positive outcomes in secondary endpoints, including changes in urinary total glycosaminoglycan (GAG) levels, as well as heparan sulfate (HS) and dermatan sulfate (DS) levels. The GAG levels decreased by 71%, while HS and DS levels decreased by 89% and 88%, respectively. Moreover, liver and spleen volumes were reduced by 27% and 26%, respectively, demonstrating the drug's effectiveness in addressing organ enlargement commonly associated with the disease. Hunterase also demonstrated a favorable safety profile. Most adverse events were mild or moderate, and no patients discontinued treatment due to side effects. Notably, only 19% of the patients had neutralizing antibodies detected three or more consecutive times, which is significantly lower than the 62.5% observed with the existing treatments. This suggests that Hunterase may offer a more sustained therapeutic effect compared to other currently available therapy. "This clinical trial is especially meaningful as it represents the first Phase 3 study in Asian patients to validate the clinical efficacy of Hunterase", said Professor Young Bae Sohn of Ajou University School of Medicine and Ajou University Hospital, the journal's first author. "The results showed significant clinical improvement not only in metabolic markers but also in organ size normalization and restoration of physical mobility." "We are thrilled to publish our encouraging phase 3 clinical trial results", stated Jae Uk Jeong, Head of R&D at GC Biopharma. "Hunterase, developed in Korea using our proprietary technology, has the potential to significantly improve the lives of patients with Hunter syndrome." Hunter Syndrome is an X-linked lysosomal storage disorder, affecting approximately 1 in 100,000 male births. In severe cases, the patients experience early death before they reach adulthood, highlighting the need for early diagnosis and treatment. Currently, two treatments are widely available worldwide for Hunter Syndrome: GC Biopharma's Hunterase and Takeda's Elaprase. About GC Biopharma GC Biopharma (formerly known as Green Cross Corporation) is a biopharmaceutical company headquartered in Yong-in, South Korea. The company has over half a century of experience in the development and manufacturing of plasma derivatives and vaccines, and is expanding its global presence with successful US market entry of Alyglo™(intravenous immunoglobulin G) in 2024. In line with its mission to meet the demands of future healthcare, GC Biopharma continues to drive innovation by leveraging its core R&D capabilities in engineering of proteins, mRNAs, and lipid nanoparticle (LNP) drug delivery platform to develop therapeutics for the field of rare disease as well as I&I (Immunology & Inflammation). To learn more about the company, visit This press release may contain biopharmaceuticals in forward-looking statements, which express the current beliefs and expectations of GC Biopharma's management. Such statements do not represent any guarantee by GC Biopharma or its management of future performance and involve known and unknown risks, uncertainties, and other factors. GC Biopharma undertakes no obligation to update or revise any forward-looking statement contained in this press release or any other forward-looking statements it may make, except as required by law or stock exchange rule.
Malaysian Reserve
3 days ago
- Health
- Malaysian Reserve
GC Biopharma's Phase 3 Clinical Trial Results for Hunterase Published in SCIE-Indexed Journal
YONGIN, South Korea, May 30, 2025 /PRNewswire/ — GC Biopharma, a South Korean pharmaceutical company, announced that the Phase 3 clinical trial results for Hunterase (idursulfase beta), its investigational drug for Hunter Syndrome (MPS II), have been published in Genetics in Medicine, an SCIE-indexed journal. Conducted at Samsung Medical Center, the Phase 3 clinical trial enrolled 24 newly diagnosed Hunter Syndrome patients with no prior treatment. It evaluated the efficacy and safety of Hunterase over a one-year treatment period. Hunter Syndrome is a rare genetic disorder caused by a deficiency of iduronate-2-sulfatase (IDS), an enzyme critical for glycosaminoglycan (GAG) catabolism. This deficiency leads to the progressive accumulation of GAGs in various organs and tissues, resulting in multisystemic dysfunction, including joint stiffness and hepatosplenomegaly. The clinical trial results demonstrated that Hunterase significantly enhanced functional mobility, reduced urinary GAG concentrations, and markedly alleviated hepatosplenomegaly. In the 6-Minute Walk Test (6-MWT), the primary endpoint of the study, patients treated with Hunterase walked an average of 62.2 meters more after treatment. This improvement was more than eight times greater compared to the placebo group, which saw an average increase of just 7.3 meters. The 6-MWT measures the distance a patient can walk on a flat surface within 6 minutes. It is a widely used clinical measure for evaluating functional mobility, cardiopulmonary function, muscle strength, and overall physical health. In the context of Hunter syndrome, it serves as a standardized and meaningful indicator of disease progression and quality of life. In addition to the primary endpoint, the study also achieved positive outcomes in secondary endpoints, including changes in urinary total glycosaminoglycan (GAG) levels, as well as heparan sulfate (HS) and dermatan sulfate (DS) levels. The GAG levels decreased by 71%, while HS and DS levels decreased by 89% and 88%, respectively. Moreover, liver and spleen volumes were reduced by 27% and 26%, respectively, demonstrating the drug's effectiveness in addressing organ enlargement commonly associated with the disease. Hunterase also demonstrated a favorable safety profile. Most adverse events were mild or moderate, and no patients discontinued treatment due to side effects. Notably, only 19% of the patients had neutralizing antibodies detected three or more consecutive times, which is significantly lower than the 62.5% observed with the existing treatments. This suggests that Hunterase may offer a more sustained therapeutic effect compared to other currently available therapy. 'This clinical trial is especially meaningful as it represents the first Phase 3 study in Asian patients to validate the clinical efficacy of Hunterase', said Professor Young Bae Sohn of Ajou University School of Medicine and Ajou University Hospital, the journal's first author. 'The results showed significant clinical improvement not only in metabolic markers but also in organ size normalization and restoration of physical mobility.' 'We are thrilled to publish our encouraging phase 3 clinical trial results', stated Jae Uk Jeong, Head of R&D at GC Biopharma. 'Hunterase, developed in Korea using our proprietary technology, has the potential to significantly improve the lives of patients with Hunter syndrome.' Hunter Syndrome is an X-linked lysosomal storage disorder, affecting approximately 1 in 100,000 male births. In severe cases, the patients experience early death before they reach adulthood, highlighting the need for early diagnosis and treatment. Currently, two treatments are widely available worldwide for Hunter Syndrome: GC Biopharma's Hunterase and Takeda's Elaprase. About GC Biopharma GC Biopharma (formerly known as Green Cross Corporation) is a biopharmaceutical company headquartered in Yong-in, South Korea. The company has over half a century of experience in the development and manufacturing of plasma derivatives and vaccines, and is expanding its global presence with successful US market entry of Alyglo™(intravenous immunoglobulin G) in 2024. In line with its mission to meet the demands of future healthcare, GC Biopharma continues to drive innovation by leveraging its core R&D capabilities in engineering of proteins, mRNAs, and lipid nanoparticle (LNP) drug delivery platform to develop therapeutics for the field of rare disease as well as I&I (Immunology & Inflammation). To learn more about the company, visit This press release may contain biopharmaceuticals in forward-looking statements, which express the current beliefs and expectations of GC Biopharma's management. Such statements do not represent any guarantee by GC Biopharma or its management of future performance and involve known and unknown risks, uncertainties, and other factors. GC Biopharma undertakes no obligation to update or revise any forward-looking statement contained in this press release or any other forward-looking statements it may make, except as required by law or stock exchange rule. GC Biopharma Contacts (Media) Sohee Kimshkim20@ Yelin Junyelin@ Yoonjae Nayjy6520@
Yahoo
14-05-2025
- Business
- Yahoo
GC Biopharma Receives FDA Approval for its U.S. Plasma Collection Center in Calexico, California
YONGIN, South Korea, May 14, 2025 /PRNewswire/ -- GC Biopharma, a South Korean pharmaceutical company, announced that its U.S. subsidiary, ABO Holdings, has received FDA approval for its plasma collection center located in Calexico, California. Following the successful U.S. launch of ALYGLO (immune globulin intravenous, human-stwk) 10% Liquid, GC Biopharma acquired ABO Holdings in January to support the product's expected mid-to long-term revenue growth. With this approval, ABO Holdings is now operating all six plasma collection centers—two each in California, Utah, and New Jersey. The company plans to ramp up donor recruitment efforts in the second quarter, setting the stage for substantial business growth in the second half of the year. Additionally, ABO Holdings is on track to complete construction of two new plasma centers in Texas and aims to obtain FDA approval for both facilities by 2027. GC Biopharma anticipates gradual growth in its source plasma business starting in the latter half of this year. "With all six FDA-approved plasma centers now operational, the company is well-positioned to achieve sustainable revenue growth for Alyglo," said Eun-chul Huh, President and CEO of GC Biopharma. "This milestone represents a significant contribution to our overall business profitability." About GC Biopharma GC Biopharma (formerly known as Green Cross Corporation) is a biopharmaceutical company headquartered in Yong-in, South Korea. The company has over half a century of experience in the development and manufacturing of plasma derivatives and vaccines, and is expanding its global presence with successful US market entry of Alyglo™(intravenous immunoglobulin G) in 2024. In line with its mission to meet the demands of future healthcare, GC Biopharma continues to drive innovation by leveraging its core R&D capabilities in engineering of proteins, mRNAs, and lipid nanoparticle (LNP) drug delivery platform to develop therapeutics for the field of rare disease as well as I&I (Immunology & Inflammation). To learn more about the company, visit This press release may contain biopharmaceuticals in forward-looking statements, which express the current beliefs and expectations of GC Biopharma's management. Such statements do not represent any guarantee by GC Biopharma or its management of future performance and involve known and unknown risks, uncertainties, and other factors. GC Biopharma undertakes no obligation to update or revise any forward-looking statement contained in this press release or any other forward-looking statements it may make, except as required by law or stock exchange rule. GC Biopharma Contacts (Media) Sohee Kimshkim20@ Yelin Junyelin@ Yoonjae Nayjy6520@ View original content to download multimedia: SOURCE GC Biopharma Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Korea Herald
09-04-2025
- Health
- Korea Herald
GC Biopharma Receives MFDS Approval for World's First Recombinant Anthrax Vaccine
YONGIN, South Korea, April 9, 2025 /PRNewswire/ -- GC Biopharma announced 09. Apr. 2025 that the Korean Ministry of Food and Drug Safety (MFDS) has approved its anthrax vaccine, BARYTHRAX, jointly developed by GC Biopharma and the Korea Disease Control and Prevention Agency (KDCA). With the approval by MFDS, BARYTHRAX has become Korea's 39 th novel drug. Following the application on 31 Oct. 2023, GC Biopharma and KDCA successfully received the product approval from MFDS on 8th this month. Anthrax, caused by Bacillus anthracis, is class-1 infectious disease capable of surviving extreme conditions and spreading easily through airborne transmission. If untreated, its fatality rate can reach up to 97%, making it a significant threat as a potential biological weapon. BARYTHRAX utilizes protective antigen (PA) proteins produced through genetic recombination techniques. In anthrax infections, PA acts as a gateway for 2 Bacillus anthracis toxins, lethal factor (LF) and edema factor (EF), to enter host cells. By utilizing PA proteins, the vaccination can train and stimulate an immune response to neutralize anthrax. Traditional vaccines are made by attenuating Bacillus anthracis or culturing non-pathogenic Bacillus anthracis, which may contain residual toxin components. BARYTHRAX, being the world's first recombinant protein anthrax vaccine, removed this risk and improved vaccine safety. BARYTHRAX has also improved vaccine stability by overcoming a key limitation of recombinant protein vaccines, which is "the reduction in immunogenicity within the shelf life". In the Phase II clinical trial, healthy adult subjects, who received the vaccination generated sufficient antibodies to neutralize anthrax toxins, while reporting no acute or severe adverse events. Bacillus anthracis is highly lethal, making it unethical to carry out phase 3 human clinical trials. In such cases, under the "Animal Rule" of The Special Act for Promotion of the Development and Emergency Supply of Medical Products in Response to Public Health Crisis of Korea, animal trials can be conducted as a substitute for phase 3 clinical studies. In the animal efficacy study, the vaccinated subjects maintained high levels of neutralizing antibodies even after 6 months following the 4 th dose of the vaccine, with a high survival rate against the Bacillus anthracis spore challenge. The MFDS's approval, supported by GC Biopharma's production capacity, will pave the way for the company to supply Korea's essential anthrax vaccine reserve. Eun-chul Huh, President and CEO of GC Biopharma, said, "This achievement underscores our commitment to localizing critical medicines for public health and national security. GC Biopharma will continue leading efforts to ensure stable supplies of essential medical products, as we have been doing with other vaccines and blood products since our founding." About GC Biopharma GC Biopharma (formerly known as Green Cross Corporation) is a biopharmaceutical company headquartered in Yong-in, South Korea. The company has over half a century of experience in the development and manufacturing of plasma derivatives and vaccines, and is expanding its global presence with successful US market entry of Alyglo™(intravenous immunoglobulin G) in 2024. In line with its mission to meet the demands of future healthcare, GC Biopharma continues to drive innovation by leveraging its core R&D capabilities in engineering of proteins, mRNAs, and lipid nanoparticle (LNP) drug delivery platform to develop therapeutics for the field of rare disease as well as I&I (Immunology & Inflammation). To learn more about the company, visit This press release may contain biopharmaceuticals in forward-looking statements, which express the current beliefs and expectations of GC Biopharma's management. Such statements do not represent any guarantee by GC Biopharma or its management of future performance and involve known and unknown risks, uncertainties, and other factors. GC Biopharma undertakes no obligation to update or revise any forward-looking statement contained in this press release or any other forward-looking statements it may make, except as required by law or stock exchange rule. Yelin Jun
Yahoo
09-04-2025
- Health
- Yahoo
GC Biopharma Receives MFDS Approval for World's First Recombinant Anthrax Vaccine
YONGIN, South Korea, April 9, 2025 /PRNewswire/ -- GC Biopharma announced 09. Apr. 2025 that the Korean Ministry of Food and Drug Safety (MFDS) has approved its anthrax vaccine, BARYTHRAX, jointly developed by GC Biopharma and the Korea Disease Control and Prevention Agency (KDCA). With the approval by MFDS, BARYTHRAX has become Korea's 39th novel drug. Following the application on 31 Oct. 2023, GC Biopharma and KDCA successfully received the product approval from MFDS on 8th this month. Anthrax, caused by Bacillus anthracis, is class-1 infectious disease capable of surviving extreme conditions and spreading easily through airborne transmission. If untreated, its fatality rate can reach up to 97%, making it a significant threat as a potential biological weapon. BARYTHRAX utilizes protective antigen (PA) proteins produced through genetic recombination techniques. In anthrax infections, PA acts as a gateway for 2 Bacillus anthracis toxins, lethal factor (LF) and edema factor (EF), to enter host cells. By utilizing PA proteins, the vaccination can train and stimulate an immune response to neutralize anthrax. Traditional vaccines are made by attenuating Bacillus anthracis or culturing non-pathogenic Bacillus anthracis, which may contain residual toxin components. BARYTHRAX, being the world's first recombinant protein anthrax vaccine, removed this risk and improved vaccine safety. BARYTHRAX has also improved vaccine stability by overcoming a key limitation of recombinant protein vaccines, which is "the reduction in immunogenicity within the shelf life". In the Phase II clinical trial, healthy adult subjects, who received the vaccination generated sufficient antibodies to neutralize anthrax toxins, while reporting no acute or severe adverse events. Bacillus anthracis is highly lethal, making it unethical to carry out phase 3 human clinical trials. In such cases, under the "Animal Rule" of The Special Act for Promotion of the Development and Emergency Supply of Medical Products in Response to Public Health Crisis of Korea, animal trials can be conducted as a substitute for phase 3 clinical studies. In the animal efficacy study, the vaccinated subjects maintained high levels of neutralizing antibodies even after 6 months following the 4th dose of the vaccine, with a high survival rate against the Bacillus anthracis spore challenge. The MFDS's approval, supported by GC Biopharma's production capacity, will pave the way for the company to supply Korea's essential anthrax vaccine reserve. Eun-chul Huh, President and CEO of GC Biopharma, said, "This achievement underscores our commitment to localizing critical medicines for public health and national security. GC Biopharma will continue leading efforts to ensure stable supplies of essential medical products, as we have been doing with other vaccines and blood products since our founding." About GC Biopharma GC Biopharma (formerly known as Green Cross Corporation) is a biopharmaceutical company headquartered in Yong-in, South Korea. The company has over half a century of experience in the development and manufacturing of plasma derivatives and vaccines, and is expanding its global presence with successful US market entry of Alyglo™(intravenous immunoglobulin G) in 2024. In line with its mission to meet the demands of future healthcare, GC Biopharma continues to drive innovation by leveraging its core R&D capabilities in engineering of proteins, mRNAs, and lipid nanoparticle (LNP) drug delivery platform to develop therapeutics for the field of rare disease as well as I&I (Immunology & Inflammation).To learn more about the company, visit This press release may contain biopharmaceuticals in forward-looking statements, which express the current beliefs and expectations of GC Biopharma's management. Such statements do not represent any guarantee by GC Biopharma or its management of future performance and involve known and unknown risks, uncertainties, and other factors. GC Biopharma undertakes no obligation to update or revise any forward-looking statement contained in this press release or any other forward-looking statements it may make, except as required by law or stock exchange rule. GC Biopharma Contacts (Media) Sohee Kimshkim20@ Yelin Junyelin@ Yoonjae Nayjy6520@ View original content to download multimedia: SOURCE GC Biopharma
