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KOLON TISSUEGENE COMPLETES PATIENT DOSING IN TWO PIVOTAL US PHASE III CLINICAL TRIALS FOR TG-C

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Completed patient dosing in US Phase 3 clinical trials.There will be a two-year follow-up period, followed by submission of the Biologics License Application (BLA) to permit marketing of TG-C once approved.

ROCKVILLE, Md., July 11, 2024 /PRNewswire/ — Kolon TissueGene, Inc. (‘the Company”) announced today that patient dosing has been completed on the US Phase 3 clinical trials for Knee Osteoarthritis. Since resuming patient recruitment in November 2021, the Company has completed 2 large clinical trials involving 1,066 patients in about 30 months.

Completion of patient dosing is a big milestone which enabled the Company to complete the pivotal Phase 3 clinical trials. The Company worked diligently with the US Food and Drug Administration (FDA) to get the clinical hold lifted in April 2020, which allowed resumption of the Phase 3 clinical trials in the US. The clinical hold was successfully lifted through extensive research based on scientific data on TG-C and an intensive regulatory review process.

Even though there were difficulties in the Phase 3 clinical trial process such as significant delays of the clinical studies in the US due to the global pandemic, the Company was able to complete patient dosing in the Phase 3 clinical trials with the determination and conviction to succeed in developing the world’s first and only cell and gene therapy for osteoarthritis of the knee.

During the patient recruitment process, approximately 6,700 patients signed up to participate in the Phase 3 clinical trials. Among them, more than 1,000 patients met eligibility criteria and were enrolled in the Phase 3 clinical trials.

In accordance with the protocol, the Company will continue a two-year follow-up on all dosed patients to assess the safety and efficacy after TG-C administration. The results of the Phase 3 clinical trials will be published at the end of the two-year follow-up period.

During the follow-up period, the Company will prepare the BLA submission package for the US FDA in order to obtain marketing authorization of TG-C in the US. The Company has already begun preparations related to commercial production (manufacturing) and is collaborating with Lonza, the world’s largest pharmaceutical CDMO.

“We expect the Phase 3 clinical trials to provide positive results, similar to the successfully completed Phase 2 clinical trial in the US” said Moon Jong Noh, PhD, CEO of the Company, adding, “When the Phase 3 clinical trials are successfully completed, we will start discussions with potential partners for commercial sales and marketing along with completion and submission of the BLA for product approval.” In addition, he said, “All executives and employees will do their best to repay all customers, shareholders, and others who have trusted and waited for the Company for a long time with meaningful results.”

About Kolon TissueGene, Inc. 
Kolon TissueGene, Inc., is an advanced cell therapies company that has developed a first-in-class cell and gene therapy targeting OA of the knee. The Company’s lead product, TG-C, is an allogeneic cell and gene therapy. The Company is conducting Phase 3 clinical trials in the US under a Special Protocol Assessment (SPA) agreement reached with the US FDA. Information about the trials can be found at the National Institutes of Health registry, www.clinicaltrials.gov.  For additional information about Kolon TissueGene, Inc., please visit www.tissuegene.com.

About TG-C
TG-C is a first-in-class cell and gene therapy targeting OA of the knee through a single intra-articular injection. Clinical trials held in the US and abroad have demonstrated pain relief and increased mobility, as well indicators towards decreased progression of OA and improvements in joint structure. The allogeneic (off-the-shelf) drug could provide an alternative to traditional treatment and surgery, or delay the progression of OA to minimize the need for multiple surgical interventions. In a concluded US Phase 2 clinical trial, Kolon TissueGene demonstrated a two-year improvement of pain and function. The Company seeks to continue to support these results through its Phase 3 clinical trials. In addition, the Company has designed the trials to seek a disease-modifying osteoarthritis drug (DMOAD) designation for TG-C from the US FDA—potentially making TG-C the first therapy to receive such a DMOAD label.

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SOURCE Kolon TissueGene, Inc.

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Emeren Group Sells 65 MWp Solar Project Portfolio in Germany to Trina Solar

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NORWALK, Conn., Jan. 15, 2025 /PRNewswire/ — Emeren Group Ltd (“Emeren” or the “Company”) (www.emeren.com) (NYSE: SOL), a leading global solar project developer, owner, and operator, today announced the sale of a 65 MWp solar project portfolio to Trina Solar International System Business Unit (“ISBU”). Trina Solar ISBU (“Trina”) is the downstream project development arm of Trina Solar Co., Ltd. (SHA: 688599), specializing in development, engineering, procurement, construction (EPC), operations and maintenance (O&M), and asset management of solar and battery storage utility-scale projects worldwide.

The portfolio, which strengthens Emeren’s position in Germany’s prominent renewable energy market, comprises three projects: One in Saarland, western Germany; the second an innovative Agri-PV project in Mecklenburg-Western Pomerania, northern Germany; and finally, another Agri-PV initiative located in Lower Saxony, northern Germany. These projects are expected to close in mid-to-late 2025 and may offer potential for Battery Energy Storage Systems (BESS) integration, further enhancing operational efficiency and long-term value.

Yumin Liu, CEO of Emeren Group, commented, “This sale builds on the success of our previous collaboration with Trina Solar in France several months ago, further advancing our renewable energy footprint in Europe. Germany, as one of the most dynamic markets for solar energy, is a key focus for us. The development and sale of this high-quality portfolio highlight the expertise of our team and our commitment to delivering impactful projects. Partnering with Trina Solar once again enables us to achieve our shared vision of driving innovation and sustainability in some of the world’s most competitive renewable energy markets.”

Leonardo Lotti, Head of EMEA for Trina, added, “This portfolio marks the beginning of Trina Solar ISBU’s activities in the German renewable energy market, anticipated to be a key European market for our downstream PV and BESS project development efforts. We have recently formed a diverse and ambitious team in Germany, which is expected to grow alongside our business. Germany’s ambitious renewable energy goals make it a crucial market for solar energy development, and we are pleased to collaborate with Emeren Group on this portfolio. Their expertise in market execution and commitment to high standards have been crucial in advancing these projects. We are confident in the successful delivery of these projects and look forward to strengthening our partnership with Emeren as we contribute to Europe’s transition to a sustainable energy future.”

About Emeren Group Ltd

Emeren Group Ltd (NYSE: SOL), a renewable energy leader, showcases a comprehensive portfolio of solar projects and Independent Power Producer (IPP) assets, complemented by a significant global Battery Energy Storage System (BESS) capacity. Specializing in the entire solar project lifecycle — from development through construction to financing — we excel by leveraging local talent in each market, ensuring our sustainable energy solutions are at the forefront of efficiency and impact. Our commitment to enhancing solar power and energy storage underlines our dedication to innovation, excellence, and environmental responsibility. For more information, go to www.emeren.com.

About Trina Solar ISBU Europe

Trina Solar ISBU, a business unit of Trina Solar, is an innovative solutions utility-scale global solar power and battery storage solutions developer for international markets. With more than 15 years of professional experience and track records in project development, financing, EPC, and O&M, Trina Solar ISBU is committed to being a global leader in the development and management of smart renewable energy solutions and creating value for local stakeholders and international investors. We are active in more than 20 countries and regions, including but not limited to the USA, UK, Italy, France, Greece, Spain, Japan, Colombia, Mexico, Chile, Peru, Australia, South Korea, Vietnam, Malaysia, Philippines, Cambodia, Brazil, Poland, Germany, Hungary, Croatia.In Europe, it is currently active in 9 countries and – to date – it has constructed over 2.5GW of grid-connected energy projects.

For investor and media inquiries, please contact:

Emeren Group Ltd – Investor Relations
ir@emeren.com 

The Blueshirt Group
Gary Dvorchak
+1 (323) 240-5796
gary@blueshirtgroup.co 

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SOURCE Emeren Group Ltd

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MIT Sloan CIO Symposium Announces 2025 CIO Leadership Award Nominations

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CAMBRIDGE, Mass., Jan. 15, 2025 /PRNewswire/ — The MIT Sloan CIO Symposium seeks nominations for the 18th Annual MIT Sloan CIO Leadership Award. The Award honors Chief Information Officers (CIOs) who lead their organizations to deliver exemplary levels of business value through innovative use of IT.

Nominees must hold the title of Chief Information Officer (CIO) or equivalent and must be the highest-level IT leader in the organization. Applicants, including self-nominations, are welcome from for-profit and not-for-profit organizations and will be assessed on a common set of criteria. The Award judges include CIOs, industry thought leaders and MIT Sloan-affiliated professionals.

The Award attracts applicants from a wide diversity of industries and backgrounds. All Award finalists are great leaders of IT, and most have significant roles in leading digital transformation in their enterprises. They are seen by their peers as business executive colleagues, not just technology experts.

Past Award winners and their companies have received significant attention and recognition as a result of the Award. Recent Award winners include:

Chris Bedi, Chief Digital Information Officer, ServiceNow (2024)Tom Peck, EVP, Chief Information and Digital Officer of Sysco (2023)Wafaa Mamilli, EVP and Chief Information and Digital Officer of Zoetis (2022)

Judging Criteria

Key characteristics of MIT Sloan CIO Leadership Award winners include:

Exceptional Communicator – Articulates a vision for strategic business value from IT and works across the organization to build partnership around this vision. Focuses communications on value and innovation, not technology. Helps all IT staff to understand the business and speak the language of business leaders.

Recognized IT Leader – Clearly demonstrates value-for-money in the management of core IT services – providing the right services at the right price and the right level of quality. Recognized among peers as an effective leader of the IT unit.

Driver of Business Value – Understands the business and needs of the CEO, CFO, Line-of-Business heads and other senior executives. Ensures clear focus on potential and realized value in all IT initiatives. Incorporates IT into business decision-making by participating in key strategic conversations, suggesting innovative uses of IT, and for managing risk.

Trusted Partner – Exercises authority beyond IT itself. Considered a trusted member of the senior executive team, not just a technology leader. Suggests innovative uses of IT to transform the business – and successfully executes the changes. May receive additional non-IT responsibilities such as Chief Operating Officer or VP of Strategy, or strategic temporary roles such as Head of M&A integration.

These criteria are adapted from the award-winning book The Real Business of IT: How CIOs Create and Communicate Value, which draws extensively upon research conducted at MIT Sloan.

“As we begin 2025, we look forward to hosting the 22nd annual MIT Sloan CIO Symposium, and we are pleased to once again invite nominations for the CIO Leadership Award,” announced Dr. George Westerman, Co-Chair of the Award Program. “As we navigate the AI-driven era—one filled with both extraordinary opportunities and complex challenges–we are eager to engage with, and be inspired by, these exceptional leaders. Celebrating their accomplishments and impacts on their organizations is a highlight of the Symposium each year.”

Award finalists will be formally recognized at an exclusive dinner on May 19, 2025, where the winner will be announced. All finalists will also have opportunities to share their insights in panels on the day of the Symposium. 

A panel of CIOs, industry thought leaders and MIT Sloan-affiliated professionals will act as judges. To be considered, applicants should complete part one of the initial application immediately to indicate their interest. Applicants who wish to move forward in the process must finalize part two by the deadline of February 25, 2025 at 11:59 p.m. ET. The online application can be found at https://mitcio.info/award. Please contact award@mitcio.com with any questions about the application process.

About the MIT Sloan CIO Symposium

The MIT Sloan CIO Symposium is the premier global conference for CIOs and digital business executives to become more effective leaders. CIOs and senior IT executives explore enterprise technology innovations, business practices and receive actionable information that enables them to meet the challenges of today and the future. The Symposium offers a unique learning environment by bringing together the academic thought leadership of MIT with the in-the-trenches experience of leading global CIOs and industry experts. The MIT Sloan CIO Symposium is organized and developed by the MIT Sloan Boston Alumni Association. For more information and to register for this year’s Symposium, visit www.mitcio.com.

 Editor’s Note:

Journalists interested in a press credential should contact Kim Schaefer (kim@warnerpr.com or 702-326-6750), Warner Communications.

Media Contact:
Kim Schaefer
Warner Communications       
702-326-6750
kim@warnerpr.com

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SOURCE MIT Sloan CIO Symposium

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Beat the Looming Deadline by Getting Required W2 To Employees Before January 31

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New 2025 ezPaycheck payroll software allows tax service professionals to optimize the workload for multiple clients both in-house and remotely which will eliminate immense outsourcing costs. 

REDMOND, Wash., Jan. 15, 2025 /PRNewswire/ — Newest EzPaycheck payroll software from  Halfpricesoft.com offers a less expensive solution for clients to process W-2 and W-3 forms to beat the January 31, 2025 deadline. Print forms for employees, in-house on plain white paper with this application and get an abundance of additional features for only $169.00 for a calendar year.

 

Dr. Ge stated, “The in-house payroll processing software, ezPaycheck 2025, includes W-2, W-3, 941, 943 and 940 forms for customer convenience and efficiency.”

Potential and seasoned clients are invited to visit halfpricesoft.com to download ezPaycheck for up to 30 days with no cost or obligation. The download includes the full version of the paycheck software along with a sample database. The sample database allows new customers to try all of ezPaycheck software’s exciting features, including the intuitive graphical interface, without wasting time entering data. (Please note: TRIAL appears on checks and forms until the purchased license key is entered).

A wide variety of features for ezPaycheck payroll software include, but are not limited to:

PDF feature available at no additional costSupports multiple differential – pay rates such as: hourly, salary, night shift, by piece, by load, or by mileage rates for employeesSupports multiple accounts at no additional chargeSupports network access for 2-10 users (additional cost)Supports daily, weekly, biweekly, semimonthly and monthly payroll periods. Features report functions, print functions, and pay stub functionsPrints miscellaneous checks as well as payroll calculation checksPrints payroll checks on blank computer checks or preprinted checksAutomatically calculates federal withholding tax, social security, Medicare tax and employer unemployment taxesIncludes built-in tax tables for all 50 states and the District of ColumbiaCreates and maintains payroll for multiple companies, and does it simultaneouslyPrints Tax Forms 940, 941, 943, W2 and W3 (Copy A preprinted form required)NEW e941 Feature add on (additional cost.)

ezPaycheck payroll software is compatible with Windows 11, 10, 8, 7 and other Windows systems. We also sell a MAC version separately.

Priced at $169 .00 per calendar year for a single installation, ezPaycheck payroll software is affordable and flexible for any size business. To download and test drive,visit Halfpricesoft.com at no cost or obligation for up to 30 days. Please note: Trial appears on checks and forms until the license key is purchased and entered into the demo version.

Halfpricesoft.com is a leading provider of small to mid-size business software, including online and desktop payroll software, online employee attendance tracking software, accounting software, in-house business and personal check printing software, W2, software, 1099 software,1095 form software and ezACH direct deposit software. Software from halfpricesoft.com is trusted by customers for over 20 years and will allow US business owners to simplify payroll processing and streamline business management.

View original content to download multimedia:https://www.prnewswire.com/news-releases/beat-the-looming-deadline-by-getting-required-w2-to-employees-before-january-31-302348535.html

SOURCE Halfpricesoft.com

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