Easyendo Surgical Inc. has won the South Korean Ministry of Food and Drug Safety’s (MFDS) latest breakthrough device designation for its robotized ureteroscope. The device, currently known as Easyuretero, is the first of its type to be developed in South Korea. The next goal for Easyendo will be regulatory approval, said the MFDS. Daejeon, South Korea-based Easyendo is already working towards winning that approval. “We are now preparing to start clinical trials in South Korea, and discussing the start date and scope of the trials with MFDS,” an Easyendo spokesperson told BioWorld.
Ildong Pharmaceutical Co. Ltd. inked a partnership with Shionogi & Co. Ltd. to co-develop S-217622, the latter’s orally administered 3CL protease inhibitor treating COVID-19 and has obtained an IND for a phase II/III trial in South Korea to enroll more than 200 patients who are asymptomatic or suffering from mild to moderate COVID-19.
Lunit Inc. has raised $61 million in a fundraising round, getting it closer to its planned list on South Korea’s Kosdaq. “We will use these funds as working capital to research and develop artificial intelligence (AI) products, as well as developing our global market,” a Lunit spokesperson told BioWorld. Seoul, South Korea-based Lunit secured new investors for this round, including U.S. life science investors Healthquest Capital, Casdin Capital LLC, and The American Cancer Society’s Brightedge fund. Asia Pacific-based global health care investors included Tybourne Capital Management Ltd. and NSG Ventures Pte. Ltd.
Sotio Biotech AS has licensed Legochem Biosciences Inc.’s technology for five new antibody-drug conjugates (ADC) in a deal that could bring the latter over $1 billion. Prague, Czech Republic-based Sotio will have the rights to deploy Legochem’s Conjuall and potent linker-payload platform, including multiple different payloads, for five therapeutic programs targeting solid tumors and combine its proprietary antibodies with it.
Top-line results of Daiichi Sankyo Co. Ltd.’s phase III Quantum-First study, testing the addition of quizartinib to chemotherapy vs. chemotherapy alone for adults with newly diagnosed FLT3-ITD positive acute myeloid leukemia (AML), found the combination therapy provided a “statistically significant and clinically meaningful improvement” in overall survival vs. standard treatment alone, meeting the trial’s primary endpoint, Ken Takeshita, global head of R&D at Daiichi Sankyo, told BioWorld.
Lunit Inc. has won FDA approvals for the company’s breast cancer detection product Lunit Insight MMG and the triage and notification software Lunit Insight CXR Triage, only days apart. Lunit Insight MMG is an artificial intelligence (AI) product for breast cancer detection from mammography images. Lunit’s second approval is for Lunit Insight CXR Triage, its AI-powered chest X-ray triaging product.
Voronoi Inc. licensed global rights to its monopolar spindle1 (MPS1) inhibitor, VRN-08, and a second undisclosed asset to Pyramid Biosciences Inc. in a deal worth up $846 million that preserves Voronoi’s rights to both assets in South Korea.
Vuno Inc. has received its third breakthrough device designation from South Korea’s Ministry of Food and Drug Safety (MFDS), for its artificial intelligence (AI)-based electrocardiogram (ECG) analysis software Vuno Med DeepECG. Vuno is the first company to have three such designations to its name. “We developed Vuno Med DeepECG via long-term ECG data analysis research. With this breakthrough designation, we target expanding our market share in the medical AI industry via our bio-signal businesses. Among these is ECG data, which can help diagnose various heart diseases and has high potential,” Yeha Lee, chairman at Vuno, told BioWorld.
Celltrion Inc.’s Regkirona (regdanvimab), a monoclonal antibody treatment for COVID-19, received its latest approval from the European Commission (EC), making it the first Mab developed in South Korea to be approved there. The green light for Celltrion Healthcare Hungary Kft., the Hungarian arm of Korean biopharmaceutical company Celltrion, is for the treatment of adults with COVID-19 aged 18 and over who do not require supplemental oxygen and who are also at increased risk of severe disease.