Local drug developer GI Innovation said Thursday its Merkel cell cancer drug GI-101, used to treat a rare type of skin cancer, has received orphan drug designation from the United States Food and Drug Administration.The designation is given to drugs that treat rare diseases that affect less than 100,000 people. The status gives tax cuts during clinical trials, and waives certain restrictions and fees. It also allows market monopolization for seven years after the drug is launched.Merkel cell cancer appears between the dermis and epidermis of the skin and mostly affects those over 50. The five-year survival rate is less than 20 percent.GI Innovation said it hopes the designation will accelerate clinical trials for its Merkel cell cancer drug. Read More

SEOUL -- A material patent for GI-301, an allergy treatment drug candidate developed by South Korea's bio-venture company GI Innovation, has been registered in Japan where pollen allergy diseases are widespread. The company would try to accelerate technology transfer to Japanese pharmaceutical companies.GI-301 is a biologic for the treatment of allergic diseases, including atopic dermatitis and chronic idiopathic. Yuhan, a pharmaceutical and chemical company in South Korea, signed a contract worth some 20 billion won ($15 million) in 2020 to co-develop and sell GI-301 in overseas markets except for Japan. Read More

GI-101, an immunotherapy agent being developed by South Korea's bio-venture company GI Innovation, has been selected for a government-initiated drug development program to receive financial support at clinical stages. GI Innovation said it would get up to seven billion won ($5.5 million) in research support for two years from the Korea Drug Development Fund (KDDF), which supports the investment, nurture and development of promising drugs. KDDF's move is seen as a symbolic recognition of GI Innovation's technological prowess. Read More

Local drug developer GI Innovation has submitted a preliminary application for listing on the country’s secondary tech-heavy bourse Kosdaq with its eyes set on going public in the second half of the year, the company said Thursday.GI Innovation’s initial public offering will be carried out under Kosdaq’s special listing track, known as the “unicorn special listing.”The Korea Exchange established the unicorn special listing process in April last year to simplify the technological evaluation process for companies with excellent market evaluation. Read More

GI Innovation, an innovative new drug development company, announced on February 23 that it has signed a biomarker joint research MoU with CellKey, a Glycoprotein biomarker development company, to develop next-generation innovative immuno-oncology. GI Innovation signed MoU with CellKey for biomarker joint research to develop next-generation innovative immuno-oncology. (from left) Ji-Soo Kim director, Na-Ri Yun VP, Myoung-Ho Jang Chairman of GI Innovation and Nam-Yong Lee CEO, Sang-Yong Lee COO, Kwang-Hoe Kim Head of Bio-R&D center of CellKey participated in the MoU ceremony. Under the MoU, GI Innovation will progress joint biomarker research to develop next-generation protein and antibody drugs using GI Innovation’s bispecific fusion protein development platform GI-SMART™ and CellKey’s AI-powered biomarker discovery platform SpAC9 Pipeline. Read More

GI Innovation said it has entered into a partnership with GI Cell and Yonsei University Health System (YUHS) to establish a cell therapy center for advanced biopharmaceuticals.Under the accord, GI Innovation and GI Cell will increase the production capability of advanced biopharmaceuticals with YUHS by establishing good manufacturing practice (GMP) facilities in Severance Hospital and Songdo Severance Hospital under construction. Read More

GI Innovation said it has entered a clinical collaboration agreement with AstraZeneca to develop a combination therapy of GI-101 and Imfinzi. Under the accord, GI Innovation and AstraZeneca will conduct clinical trials assessing a combination regimen between GI-101 and Imfinzi to treat small cell lung cancer, gastric and gastroesophageal junction cancer, biliary tract cancer, and triple-negative breast cancer in the U.S., Australia, and Korea.AstraZeneca will provide Imfinzi and expertise in developing immunotherapy for successful completion of clinical trials by co-designing and developing a plan for the clinical trials. Read More

Merck said it has signed a memorandum of understanding (MoU) with GI Innovation, a Korean bioventure company, to further R&D efforts on critical life-saving cancer treatments and drugs for allergy-related conditions.Under the accord, Merck will support GI Innovation with technologies and services, including the CHOZN platform, which improves the accuracy and efficiency in developing new drugs in the early stage, cell culture media, and overall process consulting and technical support, to help the latter develop immunotherapy and allergy treatments. Read More

South Korea's bio-venture company GI Innovation will cooperate with a domestic clinical development and research organization for the development and commercialization of candidate materials for next-generation immuno-cancer drugs.GI Innovation and Medirama will jointly develop two cases of immune-cancer drugs, including GI Innovations's new dual fusion protein, and share profits after commercialization. Read More

지아이이노베이션이 지난 12일(현지시간) FDA(식품의약국)로부터 면역항암제 'GI-101'에 대한 임상 1/2상 시험계획(IND)을 승인 받았다고 15일 밝혔다.회사는 지난 4월 식품의약품안전처로부터 GI-101에 대한 IND 승인을 받은 바 있다. 지아이이노베이션은 이달부터 미국·한국 동시 임상을 진행할 계획이다. ....(중략)지아이이노베이션은 대규모 임상을 진행하기 위해 최근 1603억원의 프리IPO(상장 전 지분투자) 투자유치를 마쳤다.지아이이노베이션은 유한양행, 아이마켓코리아에 이어 SK와 제넥신 등으로부터 전략적 투자(SI) 450억원을 유치했다. 또 NH투자증권, 디에스자산운용, 브레인자산운용, 안다자산운용, 리가인베스트먼트, 클라우드&케이클라비스, 아주IB 등으로부터 재무적 투자(FI) 1155억원을 유치하며 보유 파이프라인의 기술력을 인정받았다. Read More

[출처: 한경바이오인사이트 5월호]

수익성과 신약 개발을 모두 잡은 바이오 기업이 있다. 벌써 조 단위 기술 수출 계약도 성사시켰다. 한국 바이오벤처 업계에서는 매우 드문 일이다. 이들이 개발한 면역항암제 후보 물질은 올해 한국과 미국에서 동시에 임상도 진행한다. 2017년 창업한 지아이이노베이션 얘기다. Read More