Green Cross Co., Ltd.

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 (Sanfilippo syndrome Type A) treatment, GC1130A. This designation follows the FDA's clearance of the investigational new drug (IND) application for GC1130A last month. With Fast Track Designation, the development process for GC1130A is set to be expedited. About Sanfilippo Syndrome Type A Sanfilippo syndrome Type A is a rare genetic disorder that causes central nervous system damage through the accumulation of heparan sulfate, leading to progressive neurological decline. Without treatment, patients face life-threatening complications by the age of 15. GC1130A represents a potential breakthrough as the first and only treatment option specifically targeting MPSIIIA. GC1130A GC1130A is a biological drug that is being developed using high-concentration protein formulation technology, designed for administration to the central nervous system. It is delivered directly into the brain's ventricles through intracerebroventricular (ICV) injection, a method first applied globally by GC Biopharma's Hunter syndrome treatment, 'Hunterase', which has received market approval in Japan. The potential of GC1130A to meet the unmet medical needs of Sanfilippo syndrome has been recognized by major drug regulatory agencies; in 2023, the FDA granted GC1130A Rare Pediatric Disease Designation (RPDD) and Orphan Drug Disease (ODD), and earlier this year, the European Medicines Agency (EMA) also granted GC1130A ODD status. Currently, GC Biopharma and Novel Pharma are preparing to initiate a multinational first-in-human clinical trial to evaluate the safety and tolerability of GC1130A in Korea, the US, and Japan. FDA's Fast Track Program U.S. FDA's Fast Track program is designed to expedite the development and review of drugs intended to treat serious or unmet medical needs. Fast Track designation provides extensive support, including frequent meetings with the FDA throughout the drug development, clinical, and approval stages. GC Biopharma and Novel Pharma stated, "We are pleased with the FDA's decision to grant Fast Track designation for GC1130A, especially given the lack of approved treatments for Sanfilippo syndrome." The company added, "This designation will enable us to accelerate the development of this new drug, bringing hope to patients and families affected by Sanfilippo syndrome." [Attachment] GC Biopharma's Lysosomal Storage Disease research and development status About GC Biopharma GC Biopharma (formerly known as Green Cross Corporation) is a biopharmaceutical company that delivers lifesaving and life-sustaining protein therapeutics and vaccines. Headquartered in Yongin, South Korea, GC Biopharma is one of the leading plasma protein and vaccine product manufacturers globally and has been dedicated to quality healthcare solutions for more than half a century About Novel Pharma Inc. Novel Pharma is an emerging biotechnology company that focuses on developing first-in-class treatments for rare pediatric diseases (MPS/LSD) utilizing ICV (intracerebral ventricular) administration. Headquartered in Seoul, South Korea, it is currently engaged in the development of (i) MPSIIIA, (ii) GM1, (iii) MPSIVB and (iv) Krabbe disease. 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 Corp. Contacts (Media) Sohee Kim [email protected] Yelin Jun [email protected] Rachel Kim [email protected] SOURCE GC Biopharma

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, the development of GC1130A is set to accelerate, with multinational clinical trials expected to commence this year. Clinical trial sites have been established in the United States, South Korea, and Japan, focusing on demonstrating the drug's safety and tolerability. GC Biopharma and Novel Pharma have been co-developing this intracerebroventricular enzyme replacement therapy (ICVa ERT) for treatment for MPSIIIA patients who lack Heparan N Sulfatase. GC1130A has received Orphan Drug Designation (ODD) from both FDA and EMA based on the robust safety and efficacy profile observed during preclinical studies. It also received Rare Pediatric Disease Designation (RPDD) from the FDA. Sanfilippo Syndrome Type A is a genetic disorder that causes central nervous system damage through the accumulation of heparan sulfate, leading to progressive neurological decline. Without treatment, patients often face life-threatening complications by the age of 15. GC1130A represents a potential breakthrough as the first and only treatment option specifically targeting MPSIIIA. GC Biopharma's representative further emphasized, "The IND clearance for GC1130A marks a significant milestone in our mission to bring hope to patients and families affected by Sanfilippo Syndrome. We are committed to advancing to phase 1 clinical trials and are dedicated to the development of new therapies, that address unmet medical needs. About GC Biopharma Corp. GC Biopharma Corp. (formerly known as Green Cross Corporation) is a biopharmaceutical company that delivers life-saving and life-sustaining protein therapeutics and vaccines. Headquartered in Yongin, South Korea, GC Biopharma Corp. is one of the leading plasma protein and vaccine product manufacturers globally and has been dedicated to quality healthcare solutions for more than half a century. About Novel Pharma Inc. Novel Pharma is an emerging biotechnology company that focuses on developing first-in-class treatments for rare pediatric diseases (MPS/LSD) utilizing ICV (intracerebral ventricular) administration. Headquartered in Seoul, South Korea, it is currently engaged in the development of (i) MPSIIIA, (ii) GM1, (iii) MPSIVB and (iv) Krabbe disease. 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 Corp. Contacts (Media) Sohee Kim [email protected] Yelin Jun [email protected] Rachel Kim [email protected] SOURCE GC Biopharma

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 trials commencing this year. Clinical trial sites have been set up in the US, Korea and Japan, and focus of the trial will center around proving the drug's safety and tolerability. GC Biopharma and Novel Pharma have been co-developing ICV ERT (intracerebral ventricular enzyme replacement therapy) for MPS IIIA to address the lack of Heparan N Sulfatase expression in the patient's body. 'GC1130A' also received ODD and RPDD designations from the FDA and EMA during the pre-clinical phase on the back of robust safety and efficacy profile. Sanfilippo Syndrome (type A) is a genetic disorder that triggers central nervous system damage by accumulating Heparan sulfate, leading to a progressive damage. If left untreated, it may result in a life-threatening outcome around the age of 15. With this approval, MPS III type A could become the first and only treatment option for patients with such disease. GC Biopharma's representative further emphasized, "With this IND approval, we can now enter phase 1 clinical and we will do our utmost in new drug development to provide hope to patients suffering from the disease." About GC Biopharma Corp. GC Biopharma Corp. (formerly known as Green Cross Corporation) is a biopharmaceutical company that delivers life-saving and life-sustaining protein therapeutics and vaccines. Headquartered in Yongin, South Korea, GC Biopharma Corp. is one of the leading plasma protein and vaccine product manufacturers globally and has been dedicated to quality healthcare solutions for more than half a century. 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 Corp. Contacts (Media) Sohee Kim [email protected] Yelin Jun [email protected] Rachel Kim [email protected] SOURCE GC Biopharma