Latest news with #BCD
Associated Press
2 days ago
- Business
- Associated Press
Vitalgen Completes Phase III Enrollment for VGR-R01 Gene Therapy Targeting Bietti Crystalline Dystrophy
Company on track for BLA submission in H2 2026 for potential first-in-class treatment 'Completing enrollment for our Phase III trial represents a pivotal milestone in bringing the first potential treatment to BCD patients who currently have no therapeutic options'— Dr. David Wu, Business Development Director SHANGHAI, SHANGHAI, CHINA, May 27, 2025 / / -- Vitalgen BioPharma Co., Ltd., a clinical-stage gene therapy company, today announced the completion of patient enrollment in March 2025 for its Phase III pivotal trial (VGR-R01-301) evaluating VGR-R01, an investigational AAV-based gene therapy for Bietti Crystalline Dystrophy (BCD). The multicenter trial, conducted across five leading clinical institutions in China, will evaluate the efficacy and safety of VGR-R01 in BCD patients. The therapy has received Breakthrough Therapy Designation from China's Center for Drug Evaluation (CDE) and Orphan Drug Designation from the U.S. FDA. With these regulatory designations, VGR-R01 is positioned to potentially become both a first-in-class and best-in-class treatment, with a Biologics License Application (BLA) submission targeted for the second half of 2026. 'Completing enrollment for our Phase III trial represents a pivotal milestone in bringing the first potential treatment to BCD patients who currently have no therapeutic options,' said Dr. David Wu, Business Development Director at Vitalgen. 'The strong safety profile and efficacy demonstrated in our Phase I/II trials, combined with our regulatory designations, underscore VGR-R01's potential to transform the treatment landscape for this devastating disease.' Positive Phase I/II Results Support Advancement Phase I/II clinical data demonstrated that VGR-R01 improved best-corrected visual acuity (BCVA) and functional vision in low-luminance conditions. The therapy showed benefits in patients with disease duration exceeding 10 years and reported no VGR-R01-related serious adverse events. VGR-R01 delivers a functional copy of the CYP4V2 gene to retinal pigment epithelial cells, addressing the underlying metabolic dysfunction that causes progressive vision loss in BCD patients. By restoring lipid metabolism in the retina, the therapy aims to prevent structural and functional deterioration, offering hope for halting or slowing disease progression. About Bietti Crystalline Dystrophy BCD is a rare inherited retinal disorder primarily affecting East Asian populations, particularly in China, Japan, and Korea, with an estimated 80,000+ patients globally. The disease causes progressive vision loss, night blindness, and visual field constriction. No approved treatments currently exist, representing a significant unmet medical need. About Vitalgen Vitalgen BioPharma Co., Ltd. is a clinical-stage biotechnology company developing gene therapies for rare and common diseases. Founded in 2020 and headquartered in Shanghai, the company operates GMP-compliant facilities meeting both Chinese and U.S. regulatory standards. For more information, visit Contact: Business Development Email: [email protected] Forward-Looking Statements This press release contains forward-looking statements regarding VGR-R01's development, including expectations for regulatory submissions and the therapy's potential benefits. These statements are based on current expectations and are subject to risks and uncertainties that could cause actual results to differ materially. Factors include, but are not limited to, clinical trial outcomes, regulatory review processes, and manufacturing capabilities. Vitalgen undertakes no obligation to update these forward-looking statements except as required by law. David Wu Vitalgen BioPharma email us here Legal Disclaimer: EIN Presswire provides this news content 'as is' without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.
Time of India
6 days ago
- Politics
- Time of India
CM lays foundation for biggest tribal boys' hostel
1 2 Ranchi: Jharkhand CM Hemant Soren on Thursday laid the foundation stone for a 520-bed multi-storey boys' hostel at the Adivasi Hostel Campus in Karamtoli. The Rs 26.24-crore project, to be executed by the Building Construction Department (BCD), will be one of the biggest with an aim to provide free, quality residential facilities for Scheduled Tribe (ST) students pursuing higher education in the state capital. The hostel will have a total of 520 beds, with 40 accommodations on the first floor and the remaining spread across six upper floors. According to officials, the construction will begin next week and is expected to be completed by 2027. Alongside this project, three more hostels, including a 528-bedded girls' hostel, are in the pipeline, with only one witnessing today's bhumi pujan. "This vision is finally taking shape. We want to ensure every child from tribal and marginalised communities gets the right environment to study and succeed. From school to competitive exams, medical, engineering, and law, the state govt is supporting students at every level," the CM said. BCD secretary Arava Rajkamal said, "This project reflects our commitment to inclusive and future-ready infrastructure. The boys' hostel will be a G+6 structure with 520 beds, equipped with two 8-passenger lifts, fire safety systems, modern sanitation facilities, and study-focused amenities. From deep borewells and septic tanks to well-ventilated rooms and terrazzo-tiled roads, every detail has been planned to ensure that tribal students have a safe, dignified, and conducive environment to pursue their education. " "I stay in a govt hostel and prepare for UPSC. The hostel gives me a safe place to live and study without worrying about food or rent. With the new facilities coming up, students like me will get even better opportunities," Ramesh Horo, a student from Gumla preparing for civil services, said. "Meals will be served free in hostels now. We want students to focus on their studies and push Jharkhand forward," welfare minister Chamra Linda said. He also confirmed that separate hostels for boys and girls will be built in both Ranchi and Palamu. "In Ranchi district alone, the welfare department is currently operating 64 hostels to support students from marginalised communities. These include 42 for ST students, six for SC, four for BC, and 12 for minorities. Of these, 40 are boys' hostels and 24 are for girls," said Ranchi DC Manjunath Bhajantri. The CM also reiterated the govt's plan to establish Dr B R Ambedkar libraries in every district, aiming to create academic spaces across the state.
Time of India
12-05-2025
- Business
- Time of India
Soon, a J'khand Bhavan in Puri
Ranchi: Jharkhand govt will build a guest house in Puri in Odisha to extend accommodation facilities for visitors from the state. The new facility will come up over a 35-decimal plot at Balukhand, near Konark Wildlife Sanctuary and eight kilometres from Jagannath Temple, officials here state Building Construction Department (BCD) has floated an e-tender to appoint a consultancy firm for the preparing a detailed project report (DPR) and project management consultancy (PMC) firm for the project. A BCD notice states that bids can submitted online until May 26.A pre-bid meeting is scheduled for May 19, where consultancy firms will present their concept proposals and architectural drawings. "We are expecting reputed firms to showcase their designs and execution plans. One firm will be selected based on their presentation and technical expertise," said Manoj Kumar, executive engineer of the said the firm will be required to prepare the DRP within a month as the department aims to begin construction later this year. "Once the DPR is ready, construction will start without delay," he it has not yet been decided whether the upcoming guesthouse will be reserved for govt dignitaries only or made accessible to the public. "That decision is still under discussion and will be taken at a later stage," Kumar from this upcoming project, Jharkhand already has two guesthouses in New Delhi. The one at Vasant Vihar, built nearly a decade ago, is expected to be opened to the public soon. Chief minister Hemant Soren inaugurated a swanky new Jharkhand Bhawan in New Delhi's Bangla Sahib Road in September last year. That apart, plans are afoot to set up another Jharkhand Bhawan in Mumbai.
Time of India
07-05-2025
- Politics
- Time of India
Final phase of housing complex for legislators likely to be ready by June: BCD secy
Patna: Construction of residential complexes for legislators in Patna is nearing completion on 44.41-acre complex will feature 246 modern bungalows, with 158 expected to be finished by June. The project is being executed in three phases, including 88 bungalows that were already completed, with 65 in the first phase and 23 in the second phase. Additionally, 158 bungalows are almost ready, with finishing touches and cleaning work Ravi, secretary of the building construction department (BCD), said, "A total of 243 plus three additional residential flats were to be built, in which 88 were completed earlier and handed over to the legislators. Besides, the work for the remaining 158 is in full swing. The remaining flats will be completed by the end of June. Additionally, 75 residential bungalows were built for the legislative council members and have been handed over to them."Ravi further said the construction site is being continuously inspected to accelerate the work. A zero-discharge policy has been adopted to make this modern project completely environmentally friendly and sustainable. The sewage generated on the premises will be treated and reused for gardening, he an effective rainwater harvesting system has been implemented to promote water conservation. LED street lights are being installed throughout the complex to save energy. Each bungalow has a built-up area of 3,693 square feet, providing legislators and council members with ample and modern facilities. The total project cost is approximately Rs 390 crore."The residential complex will not only have bungalows but also an MLA hostel, canteen, community centre, and other necessary facilities for the legislators. Once the project is completed, legislators will have access to accommodation according to their assembly constituencies, making their work operations more convenient and efficient," the BCD secretary Bihar's legislative composition of 243 assembly members and 75 council members, the state govt constructed 243 three-storey residences along Beer Chand Patel Path for MLAs, whilst establishing 75 duplex bungalows on Atal Path for MLCs. The construction work started in construction expense for each three-storey residence, spanning 3,693 square feet, averages Rs 93.5 lakh. The bungalows, designated for MLAs, feature three bedrooms, a drawing room, a guest room, two air conditioners, four double-bed sets, a dining table, an office chamber, and shared amenities including a sewage treatment plant, rainwater harvesting, and security guard residential society incorporates a convenience block, community hall, and swimming pool. Additionally, plans include developing a community centre, shopping complex, and police post in proximity to the govt residential complex.
Yahoo
30-04-2025
- Business
- Yahoo
Weebit Nano and DB HiTek to demonstrate chips integrating Weebit ReRAM at PCIM 2025
Weebit's ultra-low-power, high-density NVM moves towards qualification in DB HiTek's BCD 130nm process HOD HASHARON, Israel and SEOUL, South Korea, April 30, 2025 (GLOBE NEWSWIRE) -- Weebit Nano Limited (ASX:WBT) (Weebit), a leading developer and licensor of advanced memory technologies for the global semiconductor industry, and tier-1 semiconductor foundry DB HiTek will show the first demonstration of DB HiTek's Bipolar-CMOS-DMOS (BCD) silicon integrating Weebit's Resistive Random-Access Memory (ReRAM) non-volatile memory (NVM) technology at PCIM 2025. PCIM is Europe's largest power semiconductor exhibition, being held in Nuremberg, Germany, from May 6-8, 2025. This is the latest step in the continued collaboration between the companies as they progress towards full qualification of Weebit's embedded ReRAM module in DB HiTek's 130nm BCD process, expected later this year. This process is ideal for analog, mixed-signal and high-voltage designs in consumer, industrial, IoT, and a range of other applications. Weebit ReRAM IP provides a high-density, low-power embedded NVM for these applications that is cost effective and has proven excellent retention at high temperatures. The edge AI demonstration, running on DB HiTek chips with embedded Weebit ReRAM, shows an application of gesture recognition. It was developed in collaboration with Nanoveu's (ASX: NVU) Embedded AI Systems Pte. Ltd. (EMASS) and will be shown in DB HiTek's booth 680 in Hall 7 at PCIM. Coby Hanoch, CEO of Weebit Nano, said: 'Our collaboration with DB HiTek, one of the world's leading foundries for mixed-signal and power integrated circuits, continues strongly and we are advancing steadily towards making our ReRAM IP available for production in its 130nm BCD process. This demo will provide a first look at the integrated technology and show the advantages of integrating ReRAM on-chip.' Ki-Seog Cho, CEO, DB HiTek, said: 'Weebit ReRAM provides a cost-effective and high-density non-volatile memory in our 130nm BCD process. We look forward to demonstrating the advantages of this innovative embedded IP to designers at PCIM. PCIM is a key show for DB HiTek as we expand our footprint in the growing European market, and we are delighted that Weebit will join us in our booth to highlight our integrated solution.' Weebit ReRAM will be qualified in DB HiTek's BCD 130nm process and ready for production in calendar 2025. Once qualified, DB HiTek will add Weebit's memory module to its BCD 130nm Process Design Kit (PDK). DB HiTek customers can use the standard 1Mb modules in the PDK or have modules customized for their needs. Weebit ReRAM is available now to select DB HiTek customers for design prototyping. About DB HiTek Headquartered in South Korea, DB HiTek Co., Ltd. is world leader in specialty foundry with a broad range of support services plus a robust portfolio of competitive process technologies that include Analog/Power (BCDMOS), CMOS Image Sensor (CIS), Mixed-Signal, High Voltage CMOS, RF HRS/SOI CMOS, Super Junction MOSFET technologies. For more information, visit About Weebit Nano Limited Weebit Nano Ltd. is a leading developer and licensor of advanced semiconductor memory technology. The company's ground-breaking Resistive RAM (ReRAM) non-volatile memory (NVM) addresses the growing need for significantly higher performance and lower power memory solutions in a range of electronic products such as AI, Internet of Things (IoT) and wearable devices, automotive, industrial automation, robotics, neuromorphic computing, and many others. For these applications, Weebit ReRAM allows semiconductor memory elements to be significantly faster, less expensive, more reliable and more energy efficient than those using existing flash memory solutions. As it is based on fab-friendly materials, the technology can be quickly and easily integrated with existing flows and processes, without the need for special equipment or large investments. See Weebit Nano and the Weebit Nano logo are trademarks or registered trademarks of Weebit Nano Ltd. in the United States and other countries. Other company, product, and service names may be trademarks or service marks of others. Media – USJen Bernier-Santarini, Weebit NanoP: +1 650-336-4222E: jen@ Media – AustraliaDylan Mark, Automic GroupP: +61 475 783 675E: InvestorsDanny Younis, Automic GroupP: +61 420 293 042E:
