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AT03-65 is the first program utilizing AxcynDOT™, a proprietary payload with a differentiated mechanism of action, to enter clinical development SINGAPORE, Jan. 15, 2025 /PRNewswire/ -- Axcynsis Therapeutics Pte Ltd ("Axcynsis"), a privately held biopharmaceutical company specialized in delivering Antibody Drug Conjugates (ADCs) with breakthrough potential, proudly announces the clearance of its Investigational New Drug application (IND) by the United States Food and Drug Administration (FDA) of AT03-65 for the treatment of patients with CLDN-6 positive solid tumors. Axcynsis is planning to initiate a Phase 1 multicentre clinical trial in the United States in 1Q 2025. AT03-65 is a differentiated ADC that selectively binds to CLDN6 with strong affinity. It is enabled by AxcynDOT™, a proprietary payload that incorporates a derivative of an approved oncology therapeutics with unique mechanism of action and broad anti-tumor activity, and coupled with a cleavable and hydrophilic proprietary linker. CLDN6 is overexpressed in many cancers including lung, ovarian, endometrial, uterine, testicular, and gastric cancers while exhibiting minimal expression in normal tissues. AT03-65 is designed to deliver targeted therapy to improve patient outcomes with advanced or metastatic CLDN6-positive cancers. "This is a transformational event for Axcynsis and a significant milestone for our proprietary ADC platform using AxcynDOT™," said Dr. Zou Bin, CEO of Axcynsis. "We are pleased that FDA has cleared AT03-65 which leverages our AxcynDOT™ technology for this first-in-human study. We are very excited with the potential of offering a transformative therapeutic option for patients with CLDN6-positive tumors as well as advancing our pipeline with differentiated and effective ADCs using AxcynDOT™ to improve the lives of cancer patients worldwide". The upcoming Phase 1 multicentre clinical trial in the United States will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary efficacy of AT03-65 in patients with advanced CLDN6-positive solid tumors. About AT03-65 AT03-65 is a recombinant anti-CLDN6 monoclonal antibody conjugated to AxcynDOT™, a proprietary payload developed by Axcynsis with a differentiated mechanism of action and broad anti-cancer activities. AT03-65 is designed to target advanced, recurrent, or metastatic CLDN6+ solid tumors in patients who have progressed on or after standard systemic treatment or for whom no standard therapies are available. The antibody of AT03-65 is rationally engineered for high affinity and specificity to CLDN6. Upon binding to CLDN6-expressing tumor cells, the ADC is internalized into lysosomes, where it releases its payload to inhibit tumor growth effectively. Preclinical studies demonstrate that AT03-65 not only directly kill CLDN6-positive tumor cells but also exhibits bystander killing effect, targeting neighboring CLDN6-negative tumor cells to enhance its anti-tumor efficacy. AT03-65 has demonstrated promising anti-tumor activities in multiple tumor mouse models and a favorable safety profile in non-human primates. About AxcynDOT™ This is a proprietary payload developed by Axcynsis. It is a derivative of trabectedin, an approved chemotherapy in the United States, Europe and selected Asian countries, with a unique mechanism of action that is differentiated from other DNA alkylating payloads. AxcynDOT™ is optimized with enhanced potency and improved safety profile compared to trabectedin. About Axcynsis Therapeutics Axcynsis Therapeutics is a pioneering biotechnology company headquartered in Singapore with operations in the United States. The company has developed AxcynDOT™ , a proprietary linker payload platform to advance a pipeline of differentiated ADC candidates aimed at addressing key unmet medical needs. The company is committed to advance effective and targeted oncology therapeutics with breakthrough potential to improve the lives of cancer patients worldwide. For more information, please visit Axcynsis Therapeutics' official websitehttps://axcynsis.com/ Contact Information Axcynsis Therapeutics Pte Ltd41 Science Park Road#04-18, The GeminiSingapore 117610Email: contactus@axcynsis.com
- Preparing for Phase 2 Global Trials of a Ferritin Platform-Based Virus-Like Particle Universal Coronavirus Vaccine- Based on the Excellent Safety and Immune Response in Phase 1 Clinical Results, with a Plan to Extend Administration Routes and Indications SEOUL, South Korea, Jan. 13, 2025 /PRNewswire/ -- Since the COVID-19 pandemic, mRNA vaccines have been recognized as the most important platform for infectious disease prevention and continue to be utilized across various fields. However, concerns remain about the limitations of the technology, including the need for ultra-cold storage and side effects associated with lipid nanoparticles (LNP) required for mRNA delivery. Recently, new platforms are emerging as alternatives to mRNA vaccines. One such platform is the Virus-Like Particle (VLP) vaccine technology. While not as widely known as mRNA vaccines, Ferritin based nano platform VLP vaccines have been noted for their potential to significantly enhance immune responses due to their structural stability. VLPs mimic the structural characteristics of target viruses, presenting antigens in a virus-like configuration. Particularly, the Ferritin based nano platform VLP vaccine is being evaluated as a powerful platform capable of accommodating multiple virus antigens simultaneously, making it suitable for addressing various mutations. DXVX(180400) has recently acquired global development rights from Stanford University for an innovative universal coronavirus vaccine based on the Ferritin based nano platform VLP technology. Through the dedication and persuasive efforts of Chong-Yoon Lim, Chairman of the COREE Group and major shareholder of DXVX, this collaboration was established. Ferritin, a protein that stores iron, can self-assemble into hollow spherical nanoparticles depending on pH conditions. Dx&Vx's VLP vaccine utilizes this ferritin-based nanoparticle platform to display the spike protein of the coronavirus on its surface, making a universal coronavirus vaccine. The Ferritin-based VLP vaccine structurally mimics the size and shape of the COVID-19 virus, enabling the immune system to recognize it as the actual virus. This VLP vaccine can induce a strong cytotoxic T-cell response, effectively combating viral infections. The human immune system defends against viral infections through both humoral and cellular immune responses, a process known as 'cross-presentation.' Vaccines that stimulate both immune systems simultaneously provide more robust and long-lasting immunity compared to vaccines that only induce antibody production. Cytotoxic T cells, which play a critical role in destroying virus-infected or cancerous cells, do not directly recognize antigens. Instead, T cells only identify antigen fragments presented by major histocompatibility complex (MHC) molecules, thereby targeting and eliminating infected cells. Notably, Dx&Vx's vaccine is designed to strongly induce both humoral and cellular immune responses, making it superior to traditional antigen protein-based vaccines that primarily focus on humoral immunity. The Ferritin-based VLP vaccine, now preparing for global Phase 2 clinical trials, is expected to demonstrate superior immune induction effects compared to marketed vaccines. VLP vaccine image According to animal studies conducted by the Walter Reed Army Institute of Research (WRAIR), the Ferritin-based VLP vaccine demonstrated neutralizing antibody levels more than ten times higher than those of mRNA vaccines. Additionally, the Wuhan Institute of Virology in China reported that the Ferritin-based VLP vaccine outperformed mRNA vaccines. Collectively, these findings indicate that the Ferritin-based VLP vaccine may offer superior protective effects compared to traditional vaccine platforms. Moreover, this vaccine has demonstrated stability at room temperature for up to two weeks and has shown the ability to induce strong immune responses even in previously unexposed organisms. These characteristics distinguish it from mRNA-based vaccines. The platform has also been validated for its applicability in polyvalent vaccines for broad mutation coverage, offering versatility in administration routes and various other advantages. Ferritin-based vaccine can simultaneously activate both humoral and cellular immunity, whereas traditional vaccines primarily depend on humoral immunity (Global Journal ‘Vaccines’, December 2024) Dx&Vx's VLP universal coronavirus vaccine has already completed Phase 1 clinical trials in the United States and South Africa, where it was evaluated against mRNA vaccines for antibody titers and adverse effects. The results have confirmed the technological superiority of this vaccine platform. The Ferritin platform-based VLP vaccine is expected to be extended for the development of vaccines against various lethal viruses, such as influenza and Ebola, playing a critical role in future pandemic responses. A Dx&Vx representative stated, "The ultimate goal of the Ferritin platform-based VLP vaccine under development is to provide a safe, superior, and convenient vaccine that offers maximum protection against various deadly infectious diseases for humanity."
VANCOUVER, BC, Jan. 13, 2025 /PRNewswire/ -- WAT Medical Enterprise collaborated with Concordia University and Mitacs Canada to conduct a study using ObeEnd, the neuromodulation device designed by WAT for weight and health management. The study revealed that electroacupuncture may help improve exercise performance and post-exercise recovery by reducing heart rate and perceived exertion during physical activity. Published in the International Journal of Environmental Research and Public Health, the study highlights the potential benefits of this neuromodulation technology based on traditional Chinese medicine technique for enhancing participation in physical activity. The research involved 32 healthy participants, who underwent electroacupuncture sessions targeting the PC6 acupuncture point over the course of one week. The study employed the YMCA submaximal bike test to measure cardiovascular responses, including heart rate, systolic blood pressure, and perceived exertion levels. Key findings included a significant reduction in heart rate during the most challenging stage of the exercise test, as well as a decreased perception of effort across all stages. Additionally, participants experienced quicker post-exercise recovery, with systolic blood pressure notably lower five minutes after completing the test. The proposed mechanism of action is through the modulation of the rostral ventrolateral medulla (RVLM), a key area in the brainstem that regulates cardiovascular function and arterial blood pressure. The study suggests that electroacupuncture could be particularly useful for populations struggling with sedentary lifestyles or exercise-induced fatigue. By making exercise feel easier, this technique could encourage greater adherence to fitness routines, promoting better long-term health outcomes. Possible application in hypertension management could also be explored in future studies, as the proposed mechanism has the potential to down-regulate the sympathetic nervous system and reduce blood pressure. References: https://pmc.ncbi.nlm.nih.gov/articles/PMC11507089/ www.watmedical.com www.emeterm.com
Regor announced its 12-week single-dose Phase 2a trial results for RGT-075, a once-daily oral GLP-1RA, reporting 5% placebo-adjusted weight-loss with no plateau No treatment-related severe adverse events (AEs), with only 4% discontinuation rate due to AEs, same as placebo Enrollment opening for its COMO-1 Phase 2b dose-finding study to read out Q4 2025 CAMBRIDGE, Mass., Jan. 11, 2025 /PRNewswire/ -- Regor Therapeutics Group ("Regor"), a privately-held clinical-stage global biopharmaceutical company, announced topline results from its Phase 2a clinical trial for RGT-075, a leading oral once-daily small molecule full agonist of GLP-1 receptor. In the Phase 2a trial conducted at ten clinical centers across the US, RGT-075 at 125 mg once-daily delivered statistically significant 5% placebo-adjusted weight loss with no plateau at 12 weeks (six weeks on target dose) in patients living with obesity (N = 73). There were no treatment-related severe adverse events. Discontinuation rates due to any adverse events were 4%, identical for patients receiving the active treatment and those on the placebo. Only one patient (2%) required dose reduction, and she completed the study successfully at the 60 mg once-daily dose. Regor CEO Xiayang Qiu, Ph.D., commented, "The existing GLP-1 peptide drugs have demonstrated immense value and unprecedented promise. However, we have heard loud and clear the pleas of physicians and patients for an oral version that can provide sustainable benefits and be accessible for the hundreds of millions of patients living with obesity and weight-related comorbidities." Dr. Qiu added, "We chose to pursue the small molecule route because of its proven suitability for long-term use as once-daily oral medications, along with the inherent advantage of easier manufacturing and supply in desired quantities. We succeed when patients have better options, and we believe RGT-075 has achieved an early proof-of-concept milestone through this phase 2a study." In the RGT-075 treatment arm, at least one event of mild-to-moderate nausea and vomiting was reported for 40% and 24% patients, respectively. Michael Grimm, M.D., Ph.D., Head of Metabolic Diseases at Regor commented, "Even with only six weeks of titration, our tolerability results are already comparable to those observed for semaglutide in longer studies." "Beyond peptide-like weight loss with no plateau at 12 weeks, RGT-075 also showed robust and clinically meaningful efficacy in HbA1c and in Systolic and Diastolic blood pressure." RGT-075 has previously demonstrated a promising PK-profile, with a peak-to-trough ratio (PTR) of under 5. Developers hypothesize that delivering target 24-hour plasma concentration with a relatively low PTR correlates with improved tolerability to GI-related symptoms. About the COMO-1 Phase 2b development program Today Regor also announced the initiation of the COMO-1 dose-finding trial for RGT-075. The Phase 2b multicenter, randomized, double-blind, placebo-controlled study will evaluate multiple doses up to 225 mg of RGT-075 over 36 weeks compared with placebo in adult patients with obesity or overweight with weight-related comorbidities. Approximately 240 adult participants will be enrolled and randomized to RGT-075 or placebo. All participants on RGT-075 will be given RGT-075 once daily (QD) titrated up over 12 weeks. The primary endpoint is percent change in body weight from baseline to week 36. Secondary endpoints include safety and tolerability of the monthly titration scheme, as well as pharmacokinetics of RGT-075. Topline data from the Phase 2b study are expected at the end of 2025. Dr. Qiu commented, "Building upon the strong results to date, the phase 2b study is designed to provide further insights to optimize phase 3 dose selection and titration design. With our recent $850M up-front deal with Roche in breast cancer, we have the financial means to launch RGT-075 Phase 3 programs on our own, but we are genuinely interested in partnership with expert investors and companies to accelerate its path to patients and to explore rational combination approaches, expanding the potential of this best-in-class oral small molecule GLP-1 drug for sustained management of obesity and numerous weight-related comorbidities" About RGT-075 RGT-075 is an orally bioavailable, once-daily, small molecule GLP-1R full agonist discovered and developed by Regor for the treatment of metabolic diseases, such as type-2 diabetes mellitus and obesity or overweight with weight-related comorbidities. Regor previously completed Phase 2a studies in patients with obesity, Phase 1 single ascending dose (SAD) in healthy volunteers and multiple ascending dose (MAD) in patients with diabetes. RGT-075 was safe and well-tolerated in clinical trials completed to date, with emerging efficacies comparable to the approved peptide GLP-1 drugs. About Regor Therapeutics Regor Therapeutics Group is a clinical-stage biotechnology company, headquartered in Cambridge, MA and with operations in Houston, San Diego, and Shanghai, which is developing innovative and clinically differentiated medicines to address large unmet needs in oncology, metabolism, and auto-immunity. Regor is powered by the highly efficient drug discovery engine rCARDTM (Regor Computer Accelerated Rational Discovery) that enables rapid prototyping and validation of candidate molecules. This rapid approach to developing small molecules against high-profile targets is the creation of the four cofounders who collectively brought decades of experience in leading US biopharma and were previously the named inventors of 4 FDA-approved medicines. The power of the rCARDTM platform and approach has been validated by out-licensing deals with top companies, including Roche/Genentech on next-gen CDK oncology agents RGT-419B and RGT-587 (now GDC-4198 and GDC-0587) for $850M up-front payment in late 2024. To learn more about Regor, please visit us at www.regor.com. Investor Relations and Communications Contact:ir@regor.com
This is the second asset Menarini Group has inlicensed from Insilico Medicine which was discovered through their generative AI platform, similar to the preclinical stage KAT6 inhibitor (MEN2312) licensed a year ago and which advanced rapidly into the clinical phase. Under the agreement, Menarini Group will be granted global rights to develop and commercialize the asset. The deal includes a $20m upfront payment, and the combined value, including all development, regulatory, and commercial milestones, is over $550 million, followed by tiered royalties. FLORENCE, Italy and CAMBRIDGE, Mass., Jan. 10, 2025 /PRNewswire/ -- The Menarini Group ("Menarini"), a leading international pharmaceutical and diagnostics company, and Stemline Therapeutics, Inc. ("Stemline"), a wholly-owned subsidiary of the Menarini Group focused on bringing transformational oncology treatments to cancer patients, and Insilico Medicine ("Insilico"), a clinical stage generative artificial intelligence (AI)-driven biotechnology company, today announced that the companies have entered into an exclusive licensing agreement granting Stemline the global rights to develop and commercialize a preclinical small molecule targeting high unmet needs in oncology. The asset is a highly selective and potentially best-in-class small molecule inhibitor targeting a broad range of solid tumor cancers, devel oped with the help of Chemistry42, Insilico's generative chemistry engine, and Insilico's drug discovery team. The asset has successfully completed preclinical development and has demonstrated broad anti-tumor activity in selected cancers. "We are thrilled to enter our second collaboration with Insilico Medicine, a leader in the field of generative AI, for a highly selective and potentially best-in-class small molecule targeting a broad range of cancers," said Elcin Barker Ergun, CEO of the Menarini Group. "This asset will help us enter into new areas of high unmet need, expanding the tumor areas where we can help cancer patients with ground-breaking therapies." "Our previous experience with Menarini Stemline proved that the company is efficient, agile, strategic, and committed to rapidly delivering the best novel therapeutic solutions to patients with cancer, maximizing the probability of success of the program," said Alex Zhavoronkov, PhD, Founder and CEO of Insilico Medicine. "Menarini Stemline's strategic visionary management is rapidly re-shaping the field of oncology, and we are very happy to take part in their quest to extend patients' lives around the world." Under the terms of the agreement, Stemline will provide a $20 million upfront payment to Insilico. The combined value of the deal, including all development, regulatory, and commercial milestones, is over $550 million, followed by tiered royalties. Prior to this collaboration, the Menarini Group and Insilico entered an exclusive licensing agreement in January 2024 for MEN2312, an innovative small molecule for breast cancer treatment and other oncology indications. About MEN2312 MEN2312 was designed by Insilico's R&D team with the help of its end-to-end Pharma Generative AI platform to inhibit KAT6 and block endocrine receptor (ER) at the transcriptional level, giving it the potential to overcome resistance to endocrine therapies due to mutation or ligand-independent constitutive activation of ER. In preclinical studies, the molecule has demonstrated potent inhibition against KAT6 in multiple CDX and PDX models with good efficacy and safety. About The Menarini Group The Menarini Group is a leading international pharmaceutical and diagnostics company, with a turnover of over $4.7 billion and over 17,000 employees. Menarini is focused on therapeutic areas with high unmet needs with products for cardiology, oncology, pneumology, gastroenterology, infectious diseases, diabetology, inflammation, and analgesia. With 18 production sites and 9 Research and Development centers, Menarini's products are available in 140 countries worldwide. For further information, please visit menarini.com. About Stemline Therapeutics Inc. Stemline Therapeutics, Inc. ("Stemline") a wholly-owned subsidiary of the Menarini Group, is a commercial-stage biopharmaceutical company focused on the development and commercialization of novel oncology therapeutics. Stemline commercializes ORSERDU® (elacestrant) in the U.S. and in the E.U., an oral endocrine therapy indicated for the treatment of postmenopausal women or adult men with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, ESR1-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy. Stemline also commercializes ELZONRIS® (tagraxofusp-erzs), a novel targeted treatment directed to CD123 for patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN), an aggressive hematologic cancer, in the United States and Europe, which is the only approved treatment for BPDCN in the US and EU to date. Stemline also commercializes NEXPOVIO® (selinexor) in Europe, an XPO1 inhibitor for multiple myeloma. Stemline also has an extensive clinical pipeline of small molecules and biologics in various stages of development for a host of solid and hematologic cancers. About Insilico Medicine Insilico Medicine, a global clinical stage biotechnology company powered by generative AI, is connecting biology, chemistry, and clinical trials analysis using next-generation AI systems. The company has developed AI platforms that utilize deep generative models, reinforcement learning, transformers, and other modern machine learning techniques for novel target discovery and the generation of novel molecular structures with desired properties. Insilico Medicine is developing breakthrough solutions to discover and develop innovative drugs for cancer, fibrosis, central nervous system diseases, infectious diseases, autoimmune diseases, and aging-related diseases. www.insilico.com
SHANGHAI, Jan. 10, 2025 /PRNewswire/ -- JW Therapeutics (HKEx: 2126), an independent and innovative biotechnology company focused on developing, manufacturing and commercializing cell immunotherapy products, announced that the Center for Drug Evaluation (CDE) of the National Medical Products Administration of China (NMPA) granted Breakthrough Therapy Designation for Carteyva® (relmacabtagene autoleucel injection) as second-line treatment in adults with relapsed or refractory large B-cell lymphoma (r/r LBCL) . Carteyva® is an anti-CD19 autologous chimeric antigen receptor T (CAR-T) cell immunotherapy product independently developed by JW Therapeutics. The Breakthrough Therapy Designation was supported by the results from the clinical study aimed to assess the efficacy and safety of Carteyva® in Chinese adults with r/r LBCL who were not intended for autologous stem cell transplantation after failure of first-line therapy. This is the first clinical result obtained in Chinese patients. Large B-cell lymphoma is a highly aggressive non-Hodgkin's lymphoma and is the most common subtype of lymphoma in adults. LBCL is a potentially curable disease, but 30-40% of patients still experience refractory or relapse1. Patients who fail first-line treatment have a poor outcome, and although conventional treatment options such as high-dose chemotherapy followed by autologous haematopoietic stem cell transplantation (HDCT/ASCT) are the standard of care, approximately more than half of the patients are not suitable for ASCT due to a variety of reasons such as advanced age, comorbidities, and so on, and there is no standard of care with a very poor outcome2. There are still urgent unmet medical needs to develop additional active therapeutic approaches for the treatment of r/r LBCL. References 1. Sehn LH, Salles G. Diffuse Large B-Cell Lymphoma. N Engl J Med. 2021;384(9):842-858. doi:10.1056/NEJMra202761. 2. Sehgal A, Hoda D, Riedell PA, et al. Lisocabtagene maraleucel as second-line therapy in adults with relapsed or refractory large B-cell lymphoma who were not intended for haematopoietic stem cell transplantation (PILOT): an open-label, phase 2 study. Lancet Oncol. 2022;23(8):1066-1077. doi:10.1016/S1470-2045(22)00339-4. About Relmacabtagene Autoleucel Injection Relmacabtagene autoleucel injection (abbreviated as relma-cel, trade name for oncology indications: Carteyva®) is an autologous anti-CD19 CAR-T cell immunotherapy product independently developed by JW Therapeutics based on a CAR-T cell process platform of Juno Therapeutics (a Bristol Myers Squibb company). Being the first product of JW Therapeutics, Carteyva® has been approved by NMPA for three indications, including the treatment of adult patients with relapsed or refractory large B-cell lymphoma (r/r LBCL) after two or more lines of systemic therapy, the treatment of adult patients with follicular lymphoma that is refractory or that relapses within 24 months of second-line or above systemic treatment (r/r FL), and the treatment of adult patients with relapsed or refractory mantle cell lymphoma (r/r MCL) after two or more lines of systemic therapy including bruton tyrosine kinase inhibitors (BTKi), making it the first CAR-T product approved as a Category 1 biologics product in China. Currently, it is the only CAR-T product in China that has been simultaneously included in the National Significant New Drug Development Program, priority review and breakthrough therapy designations. About JWCAR029-216 Study (NCT06093841) This is a phase II, open-label, single-arm, multicenter study which aims to assess the efficacy and safety of Carteyva® in Chinese adults with r/r LBCL who were not intended for autologous stem cell transplantation after failure of first-line therapy. This is the first clinical study to evaluate such novel therapy in Chinese LBCL patients. The study will be conformance with the Chinese clinical practices and will truly reveal the efficacy and safety data in Chinese patients. The study is currently ongoing. Preliminary clinical data found Carteyva® providing outstanding efficacy and good safety profile for r/r LBCL patients, with a best overall response rate of 84%. About JW Therapeutics JW Therapeutics (HKEx:2126) is an independent and innovative biotechnology company focusing on developing, manufacturing and commercializing cell immunotherapy products. Since its founding in 2016, JW Therapeutics has built an integrated platform for product development in cell immunotherapy, as well as a product pipeline covering hematologic malignancies, solid tumors and autoimmune diseases. JW Therapeutics is committed to bringing breakthrough and quality cell immunotherapy products and the hope of a cure to patients in China and beyond, and to leading the healthy and standardized development of China's cell immunotherapy industry. For more information, please visit www.jwtherapeutics.com. Forward-Looking Statements The forward-looking statements are based on the management's expectations and beliefs and are subject to a number of risks and uncertainties that could cause actual results to differ materially from those described. Significant risks and uncertainties, include those discussed below and more fully described in Hong Kong Exchanges and Clearing Limited (HKEx) reports filed by the Company. Unless otherwise noted, the Company is providing this information as of the date it publicized, and expressly disclaims any duty to update information contained in the issues and relevant information, or provide any explanation. For detailed information, please visit the company website: www.jwtherapeutics.com/en/forward-looking-statements/.
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