Latest news with #MFDS
Yahoo
26-05-2025
- Business
- Yahoo
Huonslab Achieves Last-Patient-In (LPI) in Phase 1 Pivotal Study for Recombinant Human Natural Hyaluronidase PH20
Phase 1 Pivotal Study in Korea for HLB3-002 Plans to apply for marketing approval with the MFDS by the 2H 2025 PANGYO, South Korea, May 26, 2025--(BUSINESS WIRE)--Huonslab Co., Ltd. ("Huonslab"), a subsidiary of Huons Global (KOSDAQ:084110) has announced the successful completion of patient enrollment in its pivotal phase 1 clinical trial of Hydizyme™ (recombinant human natural hyaluronidase PH20; rHuPH20; HLB3-002), marking a significant milestone in the ongoing HLB3-002 development program. HLB3-002 Phase 1 Study (NCT06713317) was designed to evaluate the safety and allergenicity of HLB3-002 in 243 healthy volunteers. The study is being conducted as a two-part, randomized, double-blind, placebo-controlled study. The first part focuses on evaluating allergenicity of HLB3-002 upon single intradermal administration of HLB3-002, while the second part focuses on evaluating safety of HLB3-002 upon single subcutaneous administration. The study is ongoing at four leading medical institutions in South Korea, known for their excellence in clinical research: Seoul National University Hospital, Asan Medical Center, Konkuk University Medical Center, and Chung-Ang University Hospital. The participating sites were selected to support consistent trial conduct and participant recruitment. Huonslab expects to submit a Biological License Application (BLA) for marketing approval with the MFDS by the second half of this year, pending trial outcomes. Huonslab's official said, "This milestone represents an important step in advancing the HLB3-002 development program. The results of this phase 1 will provide Huonslab with important insights into the safety and allergenicity profile of HLB3-002, laying a solid foundation for future clinical trials and regulatory submission." In April, Huonslab attracted much attention at the 2025 Annual Meeting of the American Association for Cancer Research (AACR 2025), held in Chicago, when the company announced the result of formulation conversion using recombinant human hyaluronidase HLB3-002 in a poster presentation. About Huonslab Huonslab, a South Korean biologics R&D leader and subsidiary of Huons Global (KOSDAQ:084110), is a fast-paced Bio, Pharmaceuticals & Healthcare business holding company with more than 2,200 employees, worldwide. Huonslab was established in 2018 to innovate human hyaluronidase-based biologics for subcutaneous (SC) delivery. Its proprietary HyDIFFUZE™ platform, manufactured with a recombinant CHO cell line and patented process, offers a patient-friendly and economical alternative to traditional intravenous (IV) delivery by streamlining SC administration of various therapeutic modalities. View source version on Contacts Media Contact Dr. Byung Ha LeeChief Business Officerblee@
Yahoo
26-05-2025
- Business
- Yahoo
Huonslab Achieves Last-Patient-In (LPI) in Phase 1 Pivotal Study for Recombinant Human Natural Hyaluronidase PH20
Phase 1 Pivotal Study in Korea for HLB3-002 Plans to apply for marketing approval with the MFDS by the 2H 2025 PANGYO, South Korea, May 26, 2025--(BUSINESS WIRE)--Huonslab Co., Ltd. ("Huonslab"), a subsidiary of Huons Global (KOSDAQ:084110) has announced the successful completion of patient enrollment in its pivotal phase 1 clinical trial of Hydizyme™ (recombinant human natural hyaluronidase PH20; rHuPH20; HLB3-002), marking a significant milestone in the ongoing HLB3-002 development program. HLB3-002 Phase 1 Study (NCT06713317) was designed to evaluate the safety and allergenicity of HLB3-002 in 243 healthy volunteers. The study is being conducted as a two-part, randomized, double-blind, placebo-controlled study. The first part focuses on evaluating allergenicity of HLB3-002 upon single intradermal administration of HLB3-002, while the second part focuses on evaluating safety of HLB3-002 upon single subcutaneous administration. The study is ongoing at four leading medical institutions in South Korea, known for their excellence in clinical research: Seoul National University Hospital, Asan Medical Center, Konkuk University Medical Center, and Chung-Ang University Hospital. The participating sites were selected to support consistent trial conduct and participant recruitment. Huonslab expects to submit a Biological License Application (BLA) for marketing approval with the MFDS by the second half of this year, pending trial outcomes. Huonslab's official said, "This milestone represents an important step in advancing the HLB3-002 development program. The results of this phase 1 will provide Huonslab with important insights into the safety and allergenicity profile of HLB3-002, laying a solid foundation for future clinical trials and regulatory submission." In April, Huonslab attracted much attention at the 2025 Annual Meeting of the American Association for Cancer Research (AACR 2025), held in Chicago, when the company announced the result of formulation conversion using recombinant human hyaluronidase HLB3-002 in a poster presentation. About Huonslab Huonslab, a South Korean biologics R&D leader and subsidiary of Huons Global (KOSDAQ:084110), is a fast-paced Bio, Pharmaceuticals & Healthcare business holding company with more than 2,200 employees, worldwide. Huonslab was established in 2018 to innovate human hyaluronidase-based biologics for subcutaneous (SC) delivery. Its proprietary HyDIFFUZE™ platform, manufactured with a recombinant CHO cell line and patented process, offers a patient-friendly and economical alternative to traditional intravenous (IV) delivery by streamlining SC administration of various therapeutic modalities. View source version on Contacts Media Contact Dr. Byung Ha LeeChief Business Officerblee@ Sign in to access your portfolio
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
