Latest news with #MFDS
Korea Herald
18-07-2025
- Business
- Korea Herald
MFDS Clears DeepQure's HyperQure™ for Clinical Trial in Atrial Fibrillation
SEOUL, South Korea, July 18, 2025 /PRNewswire/ -- DeepQure announced today that South Korea's Ministry of Food and Drug Safety (MFDS) has approved a clinical trial of HyperQure™ RDM System, the company's novel laparoscopic renal denervation (RDN) system, for the treatment of atrial fibrillation (AF). The trial is designed to evaluate the safety and efficacy of laparoscopic RDN in patients with recurrent AF following pulmonary vein isolation (PVI) and resistant hypertension. It will be conducted as a multicenter, prospective, single-arm, open-label exploratory study. HyperQure™ is a next-generation laparoscopic RDN device developed over the past decade under the leadership of Professor Chang-Wook Jeong at Seoul National University Hospital. By adopting an extravascular approach, HyperQure™ addresses key limitations of conventional intravascular RDN, offering direct anatomical access to renal nerves with the potential for improved precision and outcomes. DeepQure is also conducting RDN clinical trials for resistant hypertension in both South Korea and the United States. Patient enrollment is nearing completion domestically, while trials are actively underway at five major academic medical centers across the U.S. The MFDS's approval for this new indication marks an important milestone, expanding HyperQure™'s potential from hypertension to atrial fibrillation and reinforcing its technical scalability and multi-disease therapeutic potential. HyperQure™ is ISO 13485–certified, GMP-compliant, and was designated as Innovative Medical Device No. 36 by the MFDS, underscoring its clinical relevance and breakthrough innovation. "This approval validates HyperQure™ as a next-generation solution that overcomes the limitations of traditional RDN techniques," said a DeepQure spokesperson. "With parallel trials in resistant hypertension and now atrial fibrillation, we are accelerating our push into the global cardiovascular market with a truly differentiated solution." About DeepQure DeepQure is a medical technology company pioneering minimally invasive therapies for cardiovascular and autonomic nervous system disorders. Founded by experts in clinical medicine, engineering, and global healthcare, the company is focused on developing breakthrough solutions that address unmet needs in cardiovascular diseases. DeepQure is headquartered in Seoul, South Korea, with clinical programs active in both Korea and the United States. About HyperQure™ RDN System HyperQure™ is DeepQure's proprietary laparoscopic renal denervation (RDN) system designed to treat conditions such as resistant hypertension and atrial fibrillation. Unlike conventional intravascular approaches, HyperQure™ utilizes an extravascular route to access and ablate renal nerves with enhanced precision. The system has been designated as an Innovative Medical Device by the Korean MFDS and has obtained ISO 13485 and GMP certifications, enabling global clinical deployment.
Korea Herald
10-07-2025
- Business
- Korea Herald
IASO Bio Receives Orphan Drug Designation from the Ministry of Food and Drug Safety of South Korea for Equecabtagene Autoleucel
SHANGHAI, NANJING, China and SAN FRANCISCO, July 9, 2025 /PRNewswire/ -- IASO Biotherapeutics ("IASO Bio"), a biopharmaceutical company focused on the discovery, development, manufacturing, and commercialization of innovative cell therapies and biologics, today announced that its self-developed anti-BCMA CAR-T cell therapy product, Equecabtagene Autoleucel (Fucaso), has been granted Orphan Drug Designation (ODD) by the Ministry of Food and Drug Safety (MFDS) of South Korea for the treatment of adult patients with relapsed or refractory multiple myeloma (R/R MM) who have received at least three prior lines of therapy, including a proteasome inhibitor and an immunomodulatory agent. Currently, the Korean MFDS adopts a dual standard for orphan drug designation: 1. Drugs used for diseases with a domestic patient population (prevalence) of 20,000 or fewer; 2. Drugs used for diseases for which appropriate treatment methods or drugs have not been developed, or drugs that demonstrate significantly improved safety or efficacy compared to existing alternative drugs. For orphan drugs that are "available abroad but not domestically", South Korea has policies to facilitate their import*. Following ODD, the registration and approval process of Equecabtagene Autoleucel Injection in South Korea is expected to be accelerated, potentially enabling earlier access for local patients. Ms. Jinhua Zhang, Founder, Chairwoman, and CEO of IASO Biotherapeutics, stated: "The Orphan Drug Designation granted to Equecabtagene Autoleucel Injection in South Korea marks another significant international regulatory milestone for the product, following its ODD approval in Saudi Arabia in May. This Designation is expected to accelerate patient access to this CAR-T therapy in South Korea. IASO Bio is implementing its global registration strategy of 'parallel multi-country submissions with regional synergy'to obtain approvals for this innovative cell therapy in additional countries and regions, ultimately extending its benefits to a wider patient population." About Multiple Myeloma（MM) Multiple myeloma (MM) is the second most common hematological malignancy globally. According to Globocan data, the global incidence of multiple myeloma in 2022 was 1.8 per 100,000 people, with a 5-year prevalence of 6.8 per 100,000. Despite progress in current anti-myeloma treatments, MM remains largely incurable with multiple relapses and tendency to develop refractoriness to several drug classes, presenting a major therapeutic challenge. Thus, there is an unmet need for new treatment options beyond these current anti-myeloma therapies for the treatment of relapsed or refractory MM, capable of achieving deep and durable responses. About Equecabtagene Autoleucel（Fucaso） Equecabtagene Autoleucel（Fucaso） is an innovative fully human anti-BCMA CAR-T cell therapy which uses lentivirus as a gene vector to transfect autologous T cells. The CAR contains a fully human scFv, CD8a hinge and transmembrane domain, and 4-1BB co-stimulatory molecule and CD3ζactivation domains. Based on rigorous molecular structure screening and comprehensive in vitro and in vivo functional evaluations, Fucaso demonstrates rapid and potent efficacy, accompanied by exceptional long-term persistence in vivo, enabling patients to achieve deep and durable remission,providing continuous protection and care for patients with multiple myeloma. About IASO Bio IASO Bio is a biopharmaceutical company focused on the discovery and development of innovative cell therapies and biologics for oncology and autoimmune diseases. IASO Bio possesses comprehensive capabilities spanning the entire drug development process, from early discovery to clinical development, regulatory approval, and commercialization. Its pipeline includes a diversified portfolio of over 10 novel products, including Equecabtagene Autoleucel (a fully human BCMA CAR-T injection). Equecabtagene Autoleucel received Biologics License Application (BLA) approval from China's National Medical Products Administration (NMPA) in June 2023and U.S. FDA IND approval for the treatment of R/RMM in December 2022. Leveraging its strong management team, innovative product pipeline, as well as integrated and high quality manufactural and clinical capabilities, IASO aims to deliver transformative, curable, and affordable therapies that fulfil unmet medical needs to patients in China and around the world. For more information, please visit or
Associated Press
25-06-2025
- Business
- Associated Press
Liminatus Pharma Charts Dual-Front Attack on Cancer with IBA101
La Palma, CA June 24, 2025 --( )-- Next-generation CD47 inhibitor advances toward human trials in U.S. and Korea, with the prospect of safer, more potent immunotherapy. Since its Nasdaq debut earlier this year, Liminatus Pharma has been preparing to redefine the immune-oncology landscape with IBA101, a novel CD47 checkpoint inhibitor engineered to eliminate the anemia and thrombocytopenia that halted earlier candidates. By sparing red blood cells and platelets through targeted epitope selection and Fc engineering, IBA101 enables higher dosing levels—potentially unlocking more robust anti‑tumor responses without compromising patient safety. Behind the scenes, the company is preparing its IND-enabling package after completing pivotal GLP toxicology and pharmacology studies in non‑human primates at Charles River Laboratories, as well as downstream process development for clinical‑grade production. These data indicated that IBA101 did not induce clinically meaningful reductions in hemoglobin or platelet counts, clearing the path for simultaneous submissions to the U.S. Food and Drug Administration (FDA) and Korea's Ministry of Food and Drug Safety (MFDS) in the second half of 2026. Liminatus anticipates site activations and patient screening to begin in early 2027. Building on a Dual-Axis Mechanism IBA101 leverages a two-pronged approach: it blocks CD47—the 'don't‑eat‑me' signal—on tumor cells to reactivate macrophage‑mediated clearance, and it remodels the tumor microenvironment by enhancing macrophage turnover and antigen presentation. This innate immune activation primes T cells to exert more potent cytotoxicity. In preclinical combination studies, pairing IBA101 with PD‑1/PD‑L1 inhibitors resulted in significant increases in complete response rates versus monotherapy, bolstering expectations for superior clinical efficacy. A Strategic Collaboration in Seoul Liminatus has partnered with Dr. Se-Hoon Lee, a leading lung cancer specialist at Samsung Medical Center in Seoul, South Korea. This partnership secures access to advanced non‑small‑cell lung cancer patients and state‑of‑the‑art translational laboratories. Serial tumor biopsies, immune‑cell phenotyping, and multimodal omics analyses will be integrated into the Phase 1 protocol, which features a 3 + 3 dose‑escalation design followed by expansion cohorts and adaptive combination arms with approved PD‑1/PD‑L1 agents. The trial will focus on elucidating the specific conditions under which the combination of IBA101 and PD‑1/PD‑L1 blockade delivers superior anti‑tumor efficacy, and Dr. Sehoon Lee is the ideal partner to lead this purpose‑driven research. Lessons from Early CD47 Efforts Interest in CD47 blockade has been intense but challenging. Gilead acquired Forty Seven Inc., the primary asset for which was a CD47 blockade [technology][patent] and Pfizer signed a licensing deal for a CD47 blockade [patent], but both programs were paused due to severe anemia and thrombocytopenia caused by off‑target binding to red blood cells and platelets. By contrast, IBA101 selectively binds CD47 epitopes on tumor and immune cells: additional glycosylation on RBC and platelet CD47 proteins prevents IBA101 engagement, minimizing off‑target interactions and reducing the risk of cytopenias. Preclinical primate data suggest this design will translate into a markedly improved safety profile in humans. Top row: intact RBC pellets with clear supernatant after IBA101 treatment (no hemolysis). Bottom row: diffuse red supernatant in control wells (RBC lysis). Beyond Cancer: Toward Chronic Inflammation While oncology is the primary focus, Liminatus is also exploring IBA101's potential in chronic inflammatory diseases. Early mechanistic studies in humanized mouse models are underway to evaluate whether macrophage activation can clear senescent cells and pro‑inflammatory debris—hallmarks of age‑related conditions such as atherosclerosis and neurodegeneration. Although these investigations remain exploratory, they establish a foundation for future indication expansion. Economic Upside and Market Context Global PD‑1/PD‑L1 sales exceeded $30 billion in 2024, but looming patent expirations will invite biosimilar competition. Combining CD47 blockade technology with PD‑1/PD‑L1 therapies offers two key advantages: enhanced response rates in combination regimens and a fresh patent lifecycle to extend commercial value. Liminatus projects that a successful IBA101 launch could secure a significant share of the post‑patent market. Looking Ahead With a Nasdaq listing, a robust nonclinical data package, and strategic clinical partnerships in Korea and the United States, Liminatus Pharma is poised to enter the clinic in 2027. With safety and synergy at its core, IBA101 aims to fulfill the long‑awaited promise of CD47 blockade and usher in a new era of combination immunotherapy. About IBA101 IBA101 is a second‑generation CD47 blockade antibody licensed from InnobationBio (Seoul, South Korea). IBA101 minimizes erythrocyte and platelet binding, thereby avoiding the severe cytopenias that plagued first‑generation agents. By enhancing macrophage activation and antigen presentation, IBA101 complements adaptive checkpoint inhibitors such as PD‑1/PD‑L1 antibodies and may offer broader applications in chronic inflammatory diseases. About Liminatus Pharma Liminatus Pharma (Nasdaq: LIMN) is a preclinical‑stage immuno‑oncology company advancing IBA101 toward best‑in‑human trials. Building on over a decade of CD47 research and lessons learned from industry setbacks, Liminatus's mission is to develop next‑generation immunotherapies that restore immune balance—bridging innate and adaptive immunity to drive safer, more durable anti‑tumor responses. Forward-Looking Statements Certain statements in this press release constitute forward-looking statements. Forward-looking statements include, but are not limited to, statements regarding management's expectations, hopes, beliefs, intentions or strategies regarding the future. In addition, any statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. The words 'anticipate,' 'believe,' 'continue,' 'could,' 'estimate,' 'expect,' 'intends,' 'may,' 'might,' 'plan,' 'possible,' 'potential,' 'predict,' 'project,' 'should,' 'will,' 'would' and similar expressions may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. The following factors, among others, could cause actual results and future events to differ materially from those set forth or contemplated in the forward-looking statements: · the success of clinical trials · the ability of Liminatus to raise financing in the future; · the attraction and retention of qualified directors, officers, employees and key personnel of Liminatus; · the ability of Liminatus to execute its business plans and strategy; · the ability of Liminatus to compete effectively in a highly competitive market; · the competition from larger pharmaceutical and biotechnology companies that have greater resources, · The success of competing therapies and products that are or may become available; · the costs, timing, and results of Liminatus's preclinical studies and clinical trials, as well as the number of required trials for regulatory approval and the criteria for success in such trials; · legal and regulatory developments in the United States, or U.S., and foreign countries, including any actions or advice that may affect the design, initiation, timing, continuation, progress, or outcome of clinical trials or result in the need for additional clinical trials; · cost of complying with current laws and regulations, and any changes in applicable laws or regulations; · The ability to protect and enhance Liminatus's corporate reputation and brand. · The impact of future regulatory, judicial, and legislative changes in Liminatus's industry; · The ability of Liminatus to obtain and maintain regulatory approval of any of its product candidates; · The ability of Liminatus to research, discover, and develop additional product candidates; · risks related to manufacturing active pharmaceutical ingredients, drug products, and other materials we need; · the performance of third parties upon which Liminatus depends, including contract research organizations, contract manufacturing organizations, contract laboratories, and independent contractors; · The ability of Liminatus to grow and manage growth profitably. · The ability of Liminatus to obtain and maintain intellectual property protection and not infringe on the rights of others. · The ability of Liminatus to limit its exposure under product liability lawsuits; · The inability to develop and maintain effective internal controls; · The impact of pandemics and other similar disruptions in the future. · those factors set forth in documents of Liminatus filed, or to be filed, with the SEC; and · Other factors that Liminatus may not have identified or quantified. The forward-looking statements contained in this press release are based on our current expectations and beliefs concerning future developments and their potential effects. Future developments affecting Liminatus may not be those that Liminatus has anticipated. These forward-looking statements involve a number of risks, uncertainties (some of which are beyond the control of Liminatus), or other assumptions that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements. Should one or more of these risks or uncertainties materialize, or should any of our assumptions prove incorrect, actual results may vary in material respects from those projected in these forward-looking statements. Liminatus undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, except as may be required under applicable securities laws. In addition, statements that 'we believe' and similar statements reflect beliefs and opinions on the relevant subject. These statements are based upon information available to Liminatus as of the date of this press release, and while Liminatus believes such information forms a reasonable basis for such statements, such information may be limited or incomplete, and such statements should not be read to indicate that Liminatus has conducted an exhaustive inquiry into, or review of, all potentially available relevant information. These statements are inherently uncertain, and investors are cautioned not to unduly rely upon these statements as predictions of future results. Liminatus's actual future results may be materially different from what it expects. Liminatus qualifies all forward-looking statements by these cautionary statements. For more information, please contact: Chris Kim, Chief Executive Officer [email protected] Contact Liminatus Pharma, Inc Chris Kim 213-273-5453 Contact Information: Liminatus Pharma, Inc Chris Kim 213-273-5453 Contact via Email Read the full story here: Liminatus Pharma Charts Dual-Front Attack on Cancer with IBA101 Press Release Distributed by
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
