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Celltrion said it has submitted a global phase 3 clinical trial plan for CT-P47, a biosimilar for rheumatoid arthritis treatment Actemra (ingredient: tocilizumab), to Poland's drug agency, the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products.Celltrion started the
Bio
Lee Han-soo
2022.05.17 15:14
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Samsung Bioepis received marketing approval for Amelivu Inj. (ranibizumab), a biosimilar referencing Lucentis to treat various eye diseases in Korea.However, the local market release of the treatment will take some time due to a patent-related agreement between Samsung Bioepis and Genentech, the dev
Bio
Kim Chan-hyuk
2022.05.16 14:20
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As cloud-based medical software products such as AI-based diagnostic assistance solutions are rapidly growing, medical institutions need new criteria for patient data management to reduce confusion, an expert said.Lim Joon-seok, head of the Digital Health Division of Yonsei University Health System,
Bio
Kim Chan-hyuk
2022.05.12 15:06
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Korean biotech companies said they would gather at Bio Korea 2022, a health and pharmaceutical industry trade fair, to discuss business strategies in the post-Covid-19 era.The Korea Health Industry Development Institute (KHIDI) and North Chungcheong Province jointly organized the annual event, which
Bio
Kim Chan-hyuk
2022.05.11 15:40
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Celltrion Healthcare said that it would expand direct sales, previously limited to only some products, to all products in the European market.The company has sold Remsima (ingredient: infliximab), a biosimilar for treating autoimmune diseases, directly in Europe since 2019. Since then, despite inten
Bio
Lee Han-soo
2022.05.10 14:20
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Matica Biotechnology, a U.S. affiliate of CHA Biotech, said that the company has dedicated its contract development manufacturing organization (CDMO) facility for cell and gene therapy.Located in College Station, Texas, Matica’s new CDMO manufacturing facility has a 500L bioreactor and meets the FDA
Bio
Lee Han-soo
2022.05.04 12:23
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Samsung Biologics said that it achieved the highest quarterly performance ever in the first quarter by posting 511.3 billion won ($401.6 million) in sales in the first quarter of this year, up 96 percent from the same period in 2021.The company also registered 176.4 billion won in operating profit,
Bio
Lee Han-soo
2022.04.28 16:41
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Celltrion said that it recently completed a patent agreement with AbbVie, the developer of the blockbuster autoimmune disease treatment Humira (Ingredient: adalimumab), and will start selling its biosimilar version, Yuflyma, in the U.S. from July 2023.Celltrion applied Yuflyma to the U.S. Food and D
Bio
Lee Han-soo
2022.04.27 14:34
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Thelma Therapeutics requested the Korea Exchange to evaluate whether the company duly implemented its business improvement plan.Attention is on whether the biopharmaceutical firm, whose stock transaction has been suspended since late March last year, can escape from the risk of being delisted from t
Bio
Kim Chan-hyuk
2022.04.27 10:37
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President-elect Yoon Suk-yeol vowed to give full support to the bio-health industry to make it “a second semiconductor,” a major driver of the Korean economy.The new government will establish a Pharmaceutical and Biopharmaceutical Innovation Committee, bring up physician-scientists, operate a regula
Bio
Kwak Sung-sun
2022.04.26 12:09
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“STgen Bio’s entry into the global market and a growth to become a global contract development and manufacturing organization (CMDO) will play a significant role for Dong-A Socio Group to become a global healthcare player by 2025.”STgen Bio CEO Choi Kyung-eun said this and other remarks at a recent
Bio
Kim Chan-hyuk
2022.04.25 16:14
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KangStem Biotech said that it has signed a contract development and manufacturing organization (CDMO) contract with YJ Cerapeutics to treat cross-differentiated neural progenitor cells.Under the accord, KangStem will develop and produce YJ Cerapeutics' cross-differentiated neural progenitor cell the
Bio
Lee Han-soo
2022.04.25 16:13
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Exostemtech said it applied for a phase 1 trial of EST-P-EXO1, an osteoarthritis treatment candidate, to the Food and Drug Safety Ministry.If the company gets the nod for the study, EST-P-EXO1 will become the first exosome-based treatment that enters a clinical trial in Korea.According to Exostemtec
Bio
Kim Chan-hyuk
2022.04.22 12:53
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The lockdown of Shanghai prompted by Covid-19 has entered the third week, and it is likely to disrupt Korean pharmaceutical and biotech firms’ clinical trials there, observers said.According to ClinicalTrials.gov, a U.S. clinical trial registry site, SK Biopharm and HanAll Biopharma were conducting
Bio
Kim Chan-hyuk
2022.04.20 15:23
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Celltrion said it has released the phase 3 clinical trial results of CT-P16, a biosimilar for Avastin (ingredient: bevacizumab), at the American Association for Cancer Research 2022 (AACR).AACR is an international cancer association with over 40,000 members from 120 countries. This year, the meeting
Bio
Lee Han-soo
2022.04.13 15:36
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3billion, a rare disease genetic test developer, said it would enter the U.S. market in earnest.The Korean company obtained the College of American Pathologists (CAP) certification in November and recently raised 13.1 billion won ($10.5 million) pre-IPO funding to tap the global diagnostic market.Th
Bio
You Ji-young
2022.04.12 16:54
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With cannabis-based foods and pharmaceutical products getting more popular worldwide, governments and companies are closely monitoring how the cannabis market is moving.An industry report said that the Korean government is also showing signs of easing regulations on medical cannabis.On Monday, the K
Bio
Kim Chan-hyuk
2022.04.05 12:08
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NKMax, a biotech firm focusing on natural killer (NK) cell therapies, announced on Monday that an abstract of a phase 1 study in solid cancer (sarcoma) has been accepted for presentation at the upcoming annual meeting of the American Society of Clinical Oncology (ASCO) in June.NKGen Biotech, a subsi
Bio
Kim Chan-hyuk
2022.04.04 15:56
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“I don’t think we can produce influenza vaccine SKYCellflu this year. So we had to choose between a Covid-19 vaccine and a flu vaccine with limited manufacturing lines. So we decided to make a Covid-19 vaccine from the public health aspect because the world population needs it a little more.”Ahn Jae
Bio
Kim Chan-hyuk
2022.04.01 14:25
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Korean conglomerates, including retail giant Lotte Group and shipbuilding behemoth Hyundai Heavy Industries, have picked the biotech and healthcare industries as their future growth engines.Industry attention is on how their business expansion with enormous funding power will affect the bio and heal
Bio
Kim Chan-hyuk
2022.04.01 14:12
