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BEIJING, Oct. 30, 2025 /PRNewswire/ -- Coinciding with Programmer's Day, the "2025 Booster Robotics Ecosystem Conference" was successfully held at the National Speed Skating Oval (The Ice Ribbon) in Beijing. Centered on the theme "Boosting the Arrival of the Embodied Intelligence Era," the event gathered developers, partners, and industry experts from around the world to witness the comprehensive strategy of Booster Robotics in embodied intelligence, spanning from product development to ecosystem building. A Long-Term Vision: Becoming the 'Personal Computer' of the AI Era The conference opened with Booster Robotics outlining its enduring vision: "To make humanoid robots as simple, reliable, and practical as personal computers." This vision is rooted in a profound understanding of technological evolution — the personal computer, which served as the "universal hardware foundation" of the information age, transitioned from a niche hobbyist device to a professional tool, and eventually an integral part of daily life. Similarly, the humanoid robot represents the "personal computer" for the AI era, acting as the physical platform and ecological cornerstone for future intelligent applications. Launch Equals Shipment: Booster K1 Defines 'Entry-Level as High-End' A key announcement at the conference was the official launch of Booster Robotics' "entry-level platform for embodied development — Booster K1." Guided by the product philosophy of "affordable and powerful," the platform aims to significantly lower the barrier to entry for embodied intelligence development. Booster K1 boasts the following core features: Exceptional Durability: Validated by 30 hours of continuous 500N impact testing and 100 hours of real-machine operation. Lightweight and Portable: Total weight under 20kg, includes a dedicated carrying case, supporting "out-of-the-box use and easy transport." Intelligent Control: Supports smartphone app control; receives ongoing updates with free action library upgrades; allows creation of custom actions through simple demonstration. Broad Scenario Adaptability: Fully compatible with various scenarios including robotic soccer competitions, STEM education, and scientific research experiments. To precisely meet diverse development needs in basic education, research, demonstrations, and more, the Booster K1 is available in three variants: K1 Geek, K1 Edu, and K1 Pro. All models feature 22 degrees of freedom as standard and support secondary development, truly realizing the "entry-level as high-end" vision. The K1 Geek Edition is priced at USD 5,999, with a limited-time offer starting at USD 4,999 before November 11th making it one of the most accessible humanoid robots in its class. Beyond Hardware: Booster K1 Ushers in the 'Era of Embodied Agents' Booster Robotics not only introduced the Booster K1 but also launched Booster Agents, heralding the official dawn of the "Era of Embodied Agents." The Booster K1 serves as the first "universal body" for these Agents. It can host diverse intelligent agent roles such as dance masters, soccer experts, and home tutors, while also empowering users to independently develop and share customized Agent applications. The future application ecosystem for embodied intelligence will thus be shaped by developers worldwide. Launching the 'Voyage Plan' to Empower the Developer Ecosystem To reduce development barriers and foster innovation, Booster Robotics officially launched the "Voyage Plan," offering comprehensive technical, resource, and financial support: Free access to integrated development tools and video tutorials. Open-source upgrades for the Booster GYM simulation platform and RoboCup core algorithm demos. Establishment of a seed investment fund for Agent development teams to help bring creative ideas to fruition. This initiative aims to democratize technology, ensuring every developer—from university research teams to secondary school student makers — has the opportunity to advance machine intelligence. Commitment to Quality Products and Reliable Service Addressing common industry challenges such as "inadequate product stability and durability," "excessive marketing and long delivery cycles," "insufficient after-sales support," and "hardware-centric offerings with limited solutions," Booster Robotics adheres to the principle of "dedicated to quality products, committed to reliable service." To back this principle, beyond fielding world-champion robots proven in RoboCup competitions, the company has publicly committed to triple compensation for any undelivered Double 11 full-payment orders by the end of December. It also guarantees a 2-hour initial response for after-sales inquiries and solution provision within 48 hours, and offers comprehensive support including curriculum systems, competition frameworks, software development tools, and performance programs, all aimed at accelerating the adoption and expansion of embodied development applications. Building a 'Teach-Learn-Practice-Compete-Apply' Cycle; Launching the 'Hundred Cities, Ten Thousand Schools' Plan Regarding ecosystem development, Booster Robotics presented a systematic, full-chain education and competition solution centered on Booster K1, covering the complete cycle from instruction and experimentation to competition and practical application. Concurrently, the company announced the "Hundred Cities, Ten Thousand Schools" plan, targeting partnerships with over ten thousand educational institutions globally within the next three years to promote the widespread adoption of robotics education and cultivate talent. To further expand its ecosystem, Booster Robotics entered into strategic collaborations with several partners at the event, including Beijing Robot Financial Leasing Co., Ltd., and recognized gold-tier channel agents, collectively advancing the large-scale deployment of robots across diverse scenarios and regions. Pragmatic Approach Drives Growth; Market Recognition Follows Real Deliveries Since its establishment in August 2023, Booster Robotics has consistently pursued a "pragmatic" spirit in commercializing its technology. To date, the company has shipped over 700 units globally, serving more than 200 clients across over 20 countries and more than 70 universities and research institutions. At the 2025 RoboCup in Brazil, Booster Robotics's robots enabled the Tsinghua Hephaestus Team to secure China's first championship in the competition, while also achieving top placements across multiple categories, demonstrating exceptional product performance and technical maturity. Although the conference has concluded, the ecosystem continues to grow. Booster Robotics cordially invites global developers to join this intelligent expedition commencing on Programmer's Day, working collaboratively to accelerate the arrival of the "Era of Embodied Agents." For further information, please visit the official Booster Robotics website: https://www.booster.tech/ Media Contact: Hannah Zhangzhangbohan@boosterobotics.com
BEIJING, Oct. 30, 2025 /PRNewswire/ -- The 2025 Chishui River Forum was held in Maotai Town of Renhuai City in southwest China's Guizhou Province on Tuesday. With "Interweaving Harmony" as the theme, the forum attracted nearly 400 representatives from renowned liquor companies and industry experts at home and abroad to discuss and explore the sustainable development of global liquor industry. Participants of the forum believed that the global liquor industry is currently confronting common challenges such as homogeneous competition, the loss of young consumer groups, and pressure to achieve sustainable development. The global baijiu industry is also grappling with transformation needs, calling for a more open vision and inclusive mindset. Industry experts proposed that in the context of deep integration of the global economy and culture, collaborative development has become an industry consensus for the liquor sector's future. Deepening cross-border cooperation, promoting technological innovation, sharing industry resources, and jointly building quality standards will inject new vitality into the mutual learning of Chinese and foreign liquor cultures while boosting the high-quality development of the global liquor industry. By hosting thematic sub-forums, dialogues and other sessions, the 2025 Chishui River Forum facilitated industry-wide brainstorming on topics including exploring application scenarios for baijiu development, engaging the "Gen Z" consumer group, and the digital transformation of the liquor industry. Original link: https://en.imsilkroad.com/p/348101.html
NovaBridge subsidiary Visara assigned its exclusive license to Everest Medicines to accelerate the development of potential best-in-class therapy for wet AMD, VIS-101, leveraging Everest Medicines' strong clinical and commercialization expertise in Greater China and other Asian markets NovaBridge also named Mr. Ian Woo, President and Chief Financial Officer of Everest Medicines, to its Board of Directors, bringing substantial expertise in international biopharma finance, operations and management VIS-101 is a novel bifunctional biologic targeting VEGF-A/ANG2, with potential to provide more effective and durable treatment than the current standard of care for patients with wet AMD, DME and RVO. The program is completing a Phase 2 study in China and is expected to be Phase-3-ready in 2026 ROCKVILLE, Md., Oct. 30, 2025 /PRNewswire/ -- NovaBridge Biosciences (Nasdaq: NBP) (NovaBridge or the Company) a global biotechnology platform company committed to accelerating access to innovative medicines, today announced that its subsidiary Visara, Inc. (Visara) has assigned it exclusive license agreement to Everest Medicines (HKEX: 1952) for the development, manufacture and commercialization of VIS-101, a novel bifunctional biologic targeting VEGF-A and ANG-2, in Greater China, and certain other Asian countries In addition, NovaBridge has appointed Mr. Ian Woo to its Board of Directors (the Board). "This Agreement with Everest Medicines is an excellent fit with NovaBridge's focus on collaborating with global innovators to accelerate the development of novel medicines such as VIS-101," said Sean Fu, PhD, Chief Executive Officer of NovaBridge. "In addition, I believe Ian's extensive track record in strategic transactions, operations and management will be a valuable asset to NovaBridge as we work to accelerate the global development of transformative medicines and create value for patients and investors." "Everest Medicines' clinical and commercial expertise could enable us to accelerate the development and bring VIS-101 to patients across Asia sooner," said Emmett T. Cunningham, Jr. MD, PhD, MPH, Co-Founder and Executive Chairman of Visara. "With its unique potency and potential to provide more durable treatment benefits, we believe VIS-101 has a robust opportunity to be a second-in-class with best-in-class potential treatment for patients around the world with wet AMD, DME and RVO." "Partnering with Visara brings a highly differentiated and commercially attractive asset to Everest's late-stage pipeline and paves the way for our entry into the ophthalmology market, an area of significant unmet need," said Ian Woo, President and Chief Financial Officer of Everest Medicines. "We are pleased to leverage our core clinical development and commercialization expertise to advance VIS-101 in Greater China and across Asia." As previously reported, through an assignment agreement with AffaMed and a direct license with AskGene, Visara acquired exclusive rights for VIS-101 globally. Visara has assigned its direct license with AskGene to Everest Medicines to develop, manufacturing and commercialize VIS-101 in Greater China, Singapore, South Korea, and certain Southeast Asian countries. Everest will assume all payment obligations under the assigned license agreement and reimburse Visara any upfront payment it has already made. About Ian Woo Mr. Ian Ying Woo is an experienced biopharma finance professional bringing substantial strategy, capital markets and operations and management expertise to NovaBridge. Currently, Mr. Woo is President, Chief Financial Officer and Executive Director of Everest Medicines Limited (HKEX: 1952), and also serves as an operating partner of CBC Group. He has recently served as an independent director and chairman of the audit committee of Prenetics Global Limited. Before that, Mr. Woo's held the role of managing director of CBC Group. Prior to that, Mr. Woo was a managing director in the global healthcare group of Lazard Frères & Co. LLC, working in the New York and Hong Kong offices. Throughout his investment banking career, Mr. Woo helped to raise over US$1 billion in equity financings and advised on merger and acquisition transactions aggregating more than US$35 billion in value. Mr. Woo received his Bachelor of Science in Biology from Tufts University, his Master of Arts in Cellular, Molecular and Biomedical studies from the Columbia University Graduate School of Arts and Sciences and his Master of Business Administration from the Columbia University Graduate School of Business. About VIS-101 VIS-101 is a novel bifunctional biologic targeting VEGF-A and ANG-2, and a more potent molecule that could potentially provide more durable treatment benefits for patients with wet age-related macular degeneration (wet AMD), diabetic macular edema (DME) and retinal vein occlusion (RVO) than current standard of care. VIS-101 has completed initial safety and dose-escalation studies in both the US and China, and is currently completing a randomized, dose-ranging Phase 2 study in China. VIS-101 is anticipated to be Phase 3-ready in 2026. About Visara, Inc. Visara is a clinical-stage biopharmaceutical company focusing on the development of best-in-class ophthalmic therapeutics. The Company is led by Co-Founder and Executive Chairman Emmett T. Cunningham, Jr., MD, PhD, MPH, a physician, innovator, entrepreneur, and investor and internationally recognized specialist in infectious and inflammatory eye disease. NovaBridge is the majority shareholder of Visara, and Visara controls global rights to VIS-101, outside of Greater China and certain countries in Asia. About NovaBridge NovaBridge is a global biotechnology platform company committed to accelerating access to innovative medicines. We combine deep business development expertise with agile translational clinical development to identify, accelerate, and advance breakthrough assets. By bridging science, strategy, and execution, NovaBridge enables transformative therapies to progress rapidly from discovery toward patients in need. The Company's differentiated pipeline is led by givastomig, a potential best-in-class, bispecific antibody (Claudin 18.2 x 4-1BB), and VIS-101, a second-in-class, potentially best-in-class bifunctional biologic, targeting VEGF-A and ANG2. Givastomig conditionally activates T cells via the 4-1BB signaling pathway in the tumor microenvironment where Claudin 18.2 is expressed. Givastomig is being developed to treat Claudin 18.2-positive gastric cancer and other gastrointestinal malignancies. The Company is also collaborating with its partner, ABL Bio, for the development of ragistomig, a bispecific antibody integrating PD-L1 as a tumor engager and 4-1BB as a conditional T cell activator, in solid tumors. Additionally, NovaBridge owns worldwide rights outside of China to uliledlimab, an anti-CD73 antibody that targets adenosine-driven immunosuppression in cancer. VIS-101 targets VEGF-A and ANG-2 to provide more potent and durable treatment benefits for patients with wet age-related macular degeneration (wet AMD) and diabetic macular edema (DME). VIS-101 is currently completing a large, randomized, dose-ranging Phase 2 study for wet AMD. NovaBridge is the majority shareholder of Visara, and Visara controls global rights to VIS-101, outside of Greater China and certain countries in Asia. For more information, please visit https://www.novabridge.com and follow us on LinkedIn. About Everest Medicines Everest Medicines is a biopharmaceutical company focused on discovering, developing, manufacturing and commercializing transformative pharmaceutical products and vaccines that address critical unmet medical needs for patients in Asian markets. The management team of Everest Medicines has deep expertise and an extensive track record from both leading global pharmaceutical companies and local Chinese pharmaceutical companies in high-quality discovery, clinical development, regulatory affairs, CMC, business development and operations. Everest Medicines has built a portfolio of potentially global first-in-class or best-in-class molecules in the company's core therapeutic areas of renal diseases, infectious diseases and autoimmune disorders. For more information, please visit its website at www.everestmedicines.com. Forward Looking Statements This announcement contains forward-looking statements. These statements are made under the "safe harbor" provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements can be identified by terminology such as "will", "expects", "believes", "designed to", "anticipates", "future", "intends", "plans", "potential", "estimates", "confident", and similar terms or the negative thereof. NovaBridge may also make written or oral forward-looking statements in its periodic reports to the U.S. Securities and Exchange Commission (the SEC), in its annual report to shareholders, in press releases and other written materials and in oral statements made by its officers, directors or employees to third parties. Statements that are not historical facts, including statements about the Company's beliefs and expectations, are forward-looking statements. Forward-looking statements in this press release include, without limitation, statements regarding: the potential benefits of the collaboration with Everest Medicines; the strategy, clinical development, plans, results, safety and efficacy of givastomig and VIS-101 and its other drug candidates; the strategic and clinical development of NovaBridge's drug candidates, including givastomig and VIS-101; anticipated clinical milestones and results, and related timing. Forward-looking statements involve inherent risks and uncertainties that may cause actual results to differ materially from those contained in these forward-looking statements, including but not limited to the following: the Company's ability to demonstrate the safety and efficacy of its drug candidates; the clinical results for its drug candidates, which may or may not support further development or New Drug Application/Biologics License Application (NDA/BLA) approval; the content and timing of decisions made by the relevant regulatory authorities regarding regulatory approval of the Company's drug candidates; the Company's ability to achieve commercial success for its drug candidates, if approved; the Company's ability to obtain and maintain protection of intellectual property for its technology and drugs; the Company's reliance on third parties to conduct drug development, manufacturing and other services; the Company's limited operating history and the Company's ability to obtain additional funding for operations and to complete the development and commercialization of its drug candidates; and those risks more fully discussed in the "Risk Factors" section in the Company's annual report on Form 20-F filed with the SEC on April 3, 2025 as well as the discussions of potential risks, uncertainties, and other important factors in the Company's subsequent filings with the SEC. All forward-looking statements are based on information currently available to the Company. The Company undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, except as may be required by law. NovaBridge Investor & Media Contacts PJ Kelleher Kyler Lei LifeSci Advisors NovaBridge +1-617-430-7579 +1-240-745-6330 pkelleher@lifesciadvisors.com kyler.lei@imabbio.com IR@imabbio.com
JINAN, China, Oct. 30, 2025 /PRNewswire/ -- Recently, Niutech Environment Technology Corporation (Abbreviated as: Niutech) announced the signing of a new sales contract with a European client. Under this contract, Niutech will provide a "New-Generation • Large-Scale Industrial Continuous Intelligent Waste Tire Pyrolysis Production Line" for the client's overseas demonstration project, with a total contract value of 14 million US dollars. As a world-class supplier of integrated intelligent continuous pyrolysis solutions, Niutech has extensive practical experience in 10,000-ton scale resource recycling international demonstration projects. It can customize and provide clients with large-scale intelligent pyrolysis production lines that are safe, environmentally friendly, efficient and low-carbon, accurately meeting the EU's circular transition requirements. It is understood that this cooperation marks the fourth collaboration between the two parties on European projects. The client's repeated orders fully demonstrate Niutech's outstanding reputation and comprehensive strength in the European market.Driven by EU policies such as the green transition, the vigorous development of circular economy and recycled material technologies has posed new upgrading challenges to Europe's waste tire disposal methods. In response to EU environmental policies and industrial trends, Niutech has independently developed the "New-Generation • Large-Scale Industrial Continuous Intelligent Waste Tire Pyrolysis Production Line". This production line integrates the company's latest-generation intelligent control system. It can achieve long-term, full-load continuous operation of the production line under large-capacity disposal scenarios and accurately regulate product conversion. It can efficiently convert waste tires into high-quality pyrolysis oil, recycled carbon black, steel wires, non-condensable combustible gas and other products. After further deep processing, these products can be applied in the manufacturing of high-end products, creating a closed-loop "waste tire - pyrolysis - recycled resource" circular model. This not only effectively solves the environmental problems caused by waste tires but also realizes the high-value recycling of waste resources through high-end technologies, which is highly in line with the core concept of green and low-carbon development. Currently, Niutech's advanced technologies and complete sets of equipment have obtained EU CE certification, German TÜV certification and EU ATEX certification. Its projects have passed ISCC EU/PLUS certification, and its products meet the requirements of the EU Renewable Energy Directive (RED II). Niutech has become the first high-end intelligent continuous pyrolysis equipment manufacturing enterprise in China that can meet this series of standards simultaneously. Niutech - International Demonstration Pyrolysis Resource Recycling Project Site The company has successfully achieved industrial application in dozens of countries around the world, including the United States, the United Kingdom, South Korea and Denmark. The materials it disposes of cover more than 30 waste resource recycling fields such as waste tires, low-value waste plastics, marine waste plastics, wind turbine blades and biomass. Niutech leads the world in multiple indicators such as technology maturity, equipment reliability and comprehensive energy-saving and carbon-reduction performance, and has become a mature, replicable and promotable solution verified by markets in developed countries such as Europe and the United States. Under the global "dual carbon" and circular economy policies, Niutech is gradually becoming an important participant in the international high-end environmental protection equipment market by virtue of technological breakthroughs, intelligent upgrading and industrial chain advantages. Niutech's again securing of an international order is the best proof of the feasibility and superiority of its innovative intelligent pyrolysis solutions in the international market. In the future, Niutech will continue to strengthen technological innovation and contribute its strength to building a global model of efficient resource utilization, environmental friendliness and sustainable economic development. More Information: Niutech Website: www.niutechenergy.comNiutech Business Email: sales@niutech.comNiutech Youtube: www.youtube.com/@niutechpyrolysis
The U.S. FDA approved STOBOCLO® (denosumab-bmwo) and OSENVELT® (denosumab-bmwo) as interchangeable with the reference products PROLIA® (denosumab) and XGEVA® (denosumab), respectively, for all approved indications, effective as of October 29, 2025 The interchangeability (IC) designations of STOBOCLO and OSENVELT were granted based not only on the comparative clinical data – including pharmacokinetics, efficacy, safety and an immunogenicity study in postmenopausal women with osteoporosis[1] - but also on analytical data demonstrating similarity of STOBOCLO and OSENVELT versus the reference product The IC designations enhance patient access and provider choice in the treatment of osteoporosis-related fracture as well as cancer-related bone loss INCHEON, South Korea, Oct. 30, 2025 /PRNewswire/ -- Celltrion, Inc. today announced that the U.S. Food and Drug Administration (FDA) has designated STOBOCLO® (denosumab-bmwo) and OSENVELT® (denosumab-bmwo) as interchangeable biosimilars to the reference products PROLIA® (denosumab) and XGEVA® (denosumab), respectively, for all approved indications. The interchangeability (IC) designation is a regulatory designation granted by the FDA, which means STOBOCLO and OSENVELT may now be substituted at the pharmacy for the reference products without consulting the prescriber, subject to state laws.[2] "Today's IC designations reinforce confidence in STOBOCLO and OSENVELT among physicians and pharmacists, facilitating a more seamless switch from the reference products to our denosumab biosimilars," said Thomas Nusbickel, Chief Commercial Officer at Celltrion USA. "Building on our strong heritage in biosimilars, Celltrion remains committed to offering more affordable and much-needed treatment options to patients living with skeletal diseases, creating greater potential to deliver savings to patients and the U.S. healthcare system." The interchangeability designations of STOBOCLO and OSENVELT were based on the comprehensive evidence including the clinical results from Phase III clinical trials in postmenopausal women with osteoporosis designed to evaluate the efficacy, pharmacodynamics (PD), pharmacokinetics (PK), safety and immunogenicity of denosumab biosimilar to its reference product. [1] STOBOCLO and OSENVELT were introduced in the U.S. market in July 2025. STOBOCLO is currently available in 60 mg/mL injection and OSENVELT is offered in 120 mg/1.7 mL (70 mg/mL) injection. According to recent FDA draft guidance, biosimilar applicants can request an interchangeability designation using existing data from their Biologics License Application (BLA). Previously, the FDA granted this status only to biosimilars that submitted multiple switch studies meeting additional data criteria. About STOBOCLO® (denosumab-bmwo)[3] STOBOCLO® (denosumab-bmwo) is a receptor activator of NF-κb ligand (RANKL) inhibitor referencing PROLIA® (denosumab). STOBOCLO 60 mg/mL injection is approved by the FDA based on comprehensive data and clinical evidence confirming the therapeutic equivalence to PROLIA. In the U.S., STOBOCLO is approved to treat postmenopausal women with osteoporosis at high risk for fracture, to increase bone mass in men with osteoporosis at high risk for fracture, to treat glucocorticoid-induced osteoporosis in men and women at high risk for fracture, to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer, and to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer. INDICATIONS STOBOCLO® (denosumab-bmwo) is a RANK ligand (RANKL) inhibitor indicated for treatment: of postmenopausal women with osteoporosis at high risk for fracture to increase bone mass in men with osteoporosis at high risk for fracture or in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer of glucocorticoid-induced osteoporosis in men and women at high risk for fracture to increase bone mass in women at high risk for fracture receiving an adjuvant aromatase inhibitor therapy for breast cancer IMPORTANT SAFETY INFORMATION WARNING: SEVERE HYPOCALCEMIA IN PATIENTS WITH ADVANCED KIDNEY DISEASE Patients with advanced chronic kidney disease, including those on dialysis, face a higher risk of severe hypocalcemia after denosumab administration, with reported cases leading to hospitalization, life-threatening events, and fatalities. The presence of chronic kidney disease-mineral bone disorder (CKD-MBD) markedly increases the risk of hypocalcemia in these patients Before starting STOBOCLO® (denosumab-bmwo) in advanced chronic kidney disease patients, assess for CKD-MBD. Treatment should be supervised by a healthcare provider experienced in diagnosing and managing CKD-MBD. STOBOCLO is contraindicated in hypocalcemia, pregnant women, and in patients with known hypersensitivity to denosumab. Severe Hypocalcemia: Ensure adequate calcium and vitamin D; monitor for severe hypocalcemia. Drug Products with Same Active Ingredient: Do not use with other denosumab products. Hypersensitivity: If an anaphylactic or other clinically significant allergic reaction occurs, initiate appropriate therapy and discontinue further use of STOBOCLO. Osteonecrosis of the Jaw (ONJ): ONJ can occur in patients on STOBOCLO. Conduct oral exams before treatment; maintain oral hygiene; consider discontinuation of STOBOCLO if ONJ develops. Atypical Subtrochanteric and Diaphyseal Femoral Fractures: Monitor for thigh, hip, or groin pain; evaluate for fractures. Interruption of STOBOCLO therapy should be considered, pending a benefit-risk assessment, on an individual basis. Multiple Vertebral Fractures (MVF) Following Discontinuation of Treatment: Increased risk post-discontinuation of denosumab; transition to alternative therapy if discontinuing STOBOCLO. Serious Infections: Higher risk in denosumab users; assess benefit-risk profile, especially in immunocompromised patients. Assess the benefit-risk profile before starting STOBOCLO and reconsider its use if serious infections develop. Dermatologic Adverse Reactions: Consider discontinuing STOBOCLO if severe dermatitis, eczema, or rashes occur. Musculoskeletal Pain: Consider discontinuation of STOBOCLO if severe pain develops. Bone Turnover Suppression: In clinical trials in women with postmenopausal osteoporosis, denosumab significantly suppressed bone remodelling; patients should be monitored for these outcomes. Hypercalcemia in Pediatrics Patients with Osteogenesis Imperfecta: Not for pediatric use; hypercalcemia reported in patients osteogenesis imperfecta treated with denosumab products. Most common Adverse Reactions: In (>5%) of patients with: Postmenopausal osteoporosis were back pain, pain in extremity, hypercholesterolemia, musculoskeletal pain, and cystitis. Pancreatitis has been reported in clinical trials. Male osteoporosis were back pain, arthralgia, and nasopharyngitis. Glucocorticoid-induced osteoporosis (> 3%) were back pain, hypertension, bronchitis, and headache. Bone loss due to hormone ablation for cancer (≥ 10%) were arthralgia and back pain. Pain in extremity and musculoskeletal pain have also been reported in clinical trials. For more information, see Full Prescribing Information including Boxed Warning. To learn more about the STOBOCLO REMs program please visit stoboclorems.com. About OSENVELT® (denosumab-bmwo)[4] OSENVELT® (denosumab-bmwo) is a receptor activator of NF-κb ligand (RANKL) inhibitor referencing XGEVA® (denosumab). OSENVELT 120 mg/1.7 mL (70 mg/mL) injection is approved by the FDA based on a robust clinical trial and comprehensive data confirming the therapeutic equivalence to XGEVA. In the U.S., OSENVELT is indicated to prevent skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors, to treat adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity, and to treat hypercalcemia of malignancy refractory to bisphosphonate therapy. INDICATION OSENVELT® (denosumab-bmwo) is indicated for: Prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors. Treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity. Treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy. IMPORTANT SAFETY INFORMATION Contraindications: Patients with hypocalcemia or with known clinically significant hypersensitivity to denosumab products. Drug Products with Same Active Ingredient. Patients receiving OSENVELT should not receive other denosumab products concomitantly. Hypersensitivity. If an anaphylactic or other clinically significant allergic reaction occurs, initiate appropriate therapy and discontinue further use of OSENVELT. Hypocalcemia. Severe hypocalcemia can occur, and fatal cases have been reported. Monitor calcium levels and calcium and vitamin D intake. Osteonecrosis of the Jaw (ONJ): ONJ can occur in patients on OSENVELT. Conduct oral exams and appropriate preventive dentistry before and during treatment; maintain oral hygiene and avoid invasive dental procedures; consider discontinuation of OSENVELT if ONJ develops. Atypical Subtrochanteric and Diaphyseal Femoral Fractures: Monitor for thigh, hip, or groin pain; evaluate for fractures. Interruption of OSENVELT therapy should be considered, pending a benefit-risk assessment, on an individual basis. Hypercalcemia Following Treatment Discontinuation in Patients with Giant Cell Tumor of Bone and in Patients with Growing Skeletons. Clinically significant hypercalcemia, potentially requiring hospitalization, can occur within a year after stopping denosumab in patients with giant cell tumor of bone or growing skeletons; monitor serum calcium and manage calcium and vitamin D needs post-discontinuation. Multiple Vertebral Fractures (MVF) Following Treatment Discontinuation. Increased risk post-discontinuation of denosumab; evaluate for risk for vertebral fractures after discontinuing OSENVELT. Embryo-Fetal Toxicity. Denosumab may cause fetal harm; verify pregnancy status before starting OSENVELT and advise effective contraception during treatment and for 5 months after the last dose. Most common Adverse Reactions: Bone Metastasis from Solid Tumors (≥ 25%) were fatigue/asthenia, hypophosphatemia, and nausea. In patients (≥ 10%) with: Multiple Myeloma were diarrhea, nausea, anemia, back pain, thrombocytopenia, peripheral edema, hypocalcemia, upper respiratory tract infection, rash, and headache; Giant Cell Tumor of Bone were arthralgia, headache, nausea, back pain, fatigue, and pain in extremity. Hypercalcemia of Malignancy (> 20%) were nausea, dyspnea, decreased appetite, headache, peripheral edema, vomiting, anemia, constipation, and diarrhea. For more information, see Full Prescribing Information. About Celltrion, Inc. Celltrion is a leading biopharmaceutical company that specializes in researching, developing, manufacturing, marketing and sales of innovative therapeutics that improve people's lives worldwide. Celltrion is a pioneer in the biosimilar space, having launched the world's first monoclonal antibody biosimilar. Our global pharmaceutical portfolio addresses a range of therapeutic areas including immunology, oncology, hematology, ophthalmology and endocrinology. Beyond biosimilar products, we are committed to advancing our pipeline with novel drugs to push the boundaries of scientific innovation and deliver quality medicines. For more information, please visit our website www.celltrion.com/en-us. and stay updated with our latest news and events on our social media - LinkedIn, Instagram, X, and Facebook. About Celltrion USA Celltrion USA is Celltrion's U.S. subsidiary established in 2018. Headquartered in New Jersey, Celltrion USA is committed to expanding access to innovative biologics to improve care for U.S. patients. Celltrion's FDA-approved biosimilar products in immunology, oncology, hematology, and endocrinology include: INFLECTRA® (infliximab-dyyb), TRUXIMA® (rituximab-abbs), HERZUMA® (trastuzumab-pkrb), VEGZELMA® (bevacizumab-adcd), YUFLYMA®(adalimumab-aaty), AVTOZMA® (tocilizumab-anho), STEQEYMA® (Ustekinumab-stba) STOBOCLO® (denosumab-bmwo), OSENVELT® (denosumab-bmwo), OMLYCLO® (omalizumab-igec), and EYDENZELT® (aflibercept-boav) as well as the novel biologic ZYMFENTRA® (infliximab-dyyb). Celltrion USA will continue to leverage Celltrion's unique heritage in biotechnology, supply chain excellence and best-in-class sales capabilities to improve access to high-quality biopharmaceuticals for U.S. patients. For more information, please visit www.celltrionusa.com. and stay updated with our latest news and events on our social media - LinkedIn FORWARD-LOOKING STATEMENT Certain information set forth in this press release contains statements related to our future business and financial performance and future events or developments involving Celltrion, Inc. and its subsidiaries that may constitute forward-looking statements, under pertinent securities laws. These statements may be also identified by words such as "prepares", "hopes to", "upcoming", "plans to", "aims to", "to be launched", "is preparing", "once gained", "could", "with the aim of", "may", "once identified", "will", "working towards", "is due", "become available", "has potential to", the negative of these words or such other variations thereon or comparable terminology. In addition, our representatives may make oral forward-looking statements. Such statements are based on the current expectations and certain assumptions of Celltrion, Inc. and its subsidiaries' management, of which many are beyond its control. Forward-looking statements are provided to allow potential investors the opportunity to understand management's beliefs and opinions in respect to the future so that they may use such beliefs and opinions as one factor in evaluating an investment. These statements are not guarantees of future performance and undue reliance should not be placed on them. Such forward-looking statements necessarily involve known and unknown risks and uncertainties associated with the company's business, including the risk factors disclosed in its Annual Report and/or Quarterly Reports, which may cause actual performance and financial results in future periods to differ materially from any projections of future performance or results expressed or implied by such statements. Celltrion, Inc. and its subsidiaries undertake no obligation to update forward-looking statements if circumstances or management's estimates or opinions should change except as required by applicable securities laws. Trademarks STOBOCLO® and OSENVELT® are registered trademarks of Celltrion, Inc.PROLIA® and XGEVA® are registered trademarks of Amgen Inc. References [1] Reginster JY et al. Efficacy and safety of candidate biosimilar CT-P41 versus reference denosumab: a double-blind, randomized, active-controlled, Phase 3 trial in postmenopausal women with osteoporosis. Osteoporos Int. 2024 Nov;35(11):1919-1930. doi: 10.1007/s00198-024-07161-x. Epub 2024 Jul 23. PMID: 39042292; PMCID: PMC11499533. Available at: https://pubmed.ncbi.nlm.nih.gov/39042292/ [Last accessed October 2025][2] FDA. Biosimilar and Interchangeable Biologics: More Treatment Choices. Available at: https://www.fda.gov/consumers/consumer-updates/biosimilar-and-interchangeable-biologics-more-treatment-choices [Last accessed October 2025][3] STOBOCLO U.S. prescribing information (2025)[4] OSENVELT U.S. prescribing information (2025) US-CT-P41-25-00008 For further information please contact:Katie Gallagherkgallagher@jpa.com +1 617-657-1324
SHANGHAI, Oct. 30, 2025 /PRNewswire/ -- Soul AI Lab, the AI technology team behind the social platform Soul App, has officially open-sourced its voice podcast generation model, SoulX-Podcast. Designed specifically for multi-speaker, multi-turn dialogue scenarios, the model supports multiple languages and dialects, including Mandarin, English, Sichuanese, and Cantonese, as well as paralinguistic styles. It is capable of stably generating natural, fluent multi-turn voice dialogues exceeding 60 minutes in length, with accurate speaker switching and rich prosodic variation. Beyond podcast-specific applications, SoulX-Podcast also achieves outstanding performance in general speech synthesis and voice cloning tasks, delivering a more authentic and expressive voice experience. Demo Page: https://soul-ailab.github.io/soulx-podcast Technical Report: https://arxiv.org/pdf/2510.23541 Source Code: https://github.com/Soul-AILab/SoulX-Podcast Hugging Face: https://huggingface.co/collections/Soul-AILab/soulx-podcast Performance of SoulX-Podcast Key Capabilities: Fluid Multi-Turn Dialogue, Multi-Dialect Support, Ultra-Long Podcast Generation 1. Zero-Shot Cloning for Multi-Turn Dialogue: In zero-shot podcast generation scenarios, SoulX-Podcast demonstrates exceptional speech synthesis capabilities. It not only accurately reproduces the timbre and style of reference audio but also dynamically adapts prosody and rhythm according to the dialogue context, ensuring that every conversation is natural and rhythmically engaging. Whether in extended multi-turn dialogues or emotionally nuanced exchanges, SoulX-Podcast consistently maintains vocal coherence and authentic expression. Additionally, the model supports controllable generation of various paralinguistic elements, such as laughter and throat clearing, enhancing the immediacy and expressiveness of synthesized speech. 2. Multi-Lingual and Cross-Dialect Voice Cloning: In addition to Mandarin and English, SoulX-Podcast supports several major Chinese dialects, including Sichuanese, Henanese, and Cantonese. More notably, the model achieves cross-dialect voice cloning — even when provided only with a Mandarin reference speech, it can flexibly generate natural speech featuring the phonetic characteristics of these target dialects. 3. Ultra-Long Podcast Generation: SoulX-Podcast supports the generation of ultra-long podcasts while consistently maintaining stable timbre and style throughout. Collaborative Exploration: Expanding Possibilities for AI and Social Interaction Although recent open-source research has begun to explore multi-speaker, multi-turn speech synthesis for podcast and dialogue scenarios, existing work remains largely confined to Mandarin and English, offering limited support for widely used Chinese dialects such as Cantonese, Sichuanese, and Henanese. Furthermore, in multi-turn voice dialogues, appropriate paralinguistic expressions, such as sighs, breaths, and laughter, are essential for enhancing vividness and naturalness, yet these nuances remain underexplored in current models. SoulX-Podcast is designed to address these very gaps. By integrating support for extended multi-speaker dialogues, comprehensive dialect coverage, and controllable paralinguistic generation, the model brings synthesized podcast speech closer to real-world communication, making it more expressive, engaging, and immersive for listeners. The overall architecture of SoulX-Podcast adopts the widely-used "LLM + Flow Matching" paradigm for speech generation, where the LLM models semantic tokens and the flow matching module further models acoustic features. For semantic token modeling, SoulX-Podcast is built upon the Qwen3-1.7B foundation model, initialized with its original parameters to fully leverage its robust language understanding capabilities. Although SoulX-Podcast is specifically designed for multi-speaker, multi-turn dialogues, it also demonstrates exceptional performance in conventional single-speaker speech synthesis and zero-shot voice cloning tasks. In podcast generation benchmarks, the model achieves top-tier results in both speech intelligibility and speaker similarity compared to recent related works. The open-source release of SoulX-Podcast marks a significant milestone in Soul's engagement with the open-source community. The Soul AI technology team has announced plans to continue enhancing core interactive capabilities, including conversational speech synthesis, full-duplex voice calls, human-like expressiveness, and visual interaction, and to accelerate the integration of these technologies across diverse application scenarios. The ultimate goal is to deliver more immersive, intelligent, and emotionally resonant experiences that foster user well-being and a stronger sense of belonging.
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