Fintech PR
Gan & Lee Pharmaceuticals Announces U.S. FDA Clearance of the IND application for the innovative Bi-weekly GLP-1RA GZR18 Injection, Bofanglutide, with chronic weight management Indication (A Phase 2 head-to-head with Tirzepatide clinical trial)
BEIJING and BRIDGEWATER, N.J., Dec. 18, 2024 /PRNewswire/ — Gan & Lee Pharmaceuticals (Gan & Lee, Shanghai Stock Exchange: 603087.SH), is pleased to announce that the Food and Drug Administration (” FDA “) has cleared the Investigational New Drug (IND) application for GZR18 Injection to conduct a phase 2 clinical trial, a head-to-head with Tirzepatide from Eli Lilly and Company (NYSE: LLY) in the US (NCT06737042). GZR18 is a long-acting glucagon-like peptide-1 (GLP-1) receptor agonist (RA) being developed by Gan & Lee Pharmaceuticals. The clinical trial indication of this application is the chronic weight management for obese or overweight patients, with or without T2DM.
According to the latest data released by the World Obesity Federation (WOF) Global Obesity Report (2024), approximately 2.2 billion adults worldwide were overweight (referring to BMI ≥ 25kg/m2) in 2020, accounting for about 42% of the total adult population. It is expected that this number will rise to 3.3 billion by 20351. Obesity can lead to a series of complications, including diabetes, cardiovascular diseases and even mental diseases such as depression. The medical expenses caused by obesity and its complications have brought a heavy medical burden to patients and society.
GZR18, as a GLP-1 receptor agonist, can delay gastric emptying by activating GLP-1 receptors expressed on the gastrointestinal tract; and enhance satiety and suppress appetite by activating GLP-1 receptors in the hypothalamus and other parts, thereby reducing the patient’s weight. GZR18 injection is the first bi–weekly GLP-1 mono-agonist formulation. Current clinical data has demonstrated weight loss effects comparable to or even better than multi-target once-weekly GLP-1 formulations, providing new insights for the future development of GLP-1 drugs. The development of the bi-weekly GZR18 injection is expected to offer more flexible treatment options for obese patients , leading to improved long-term weight management efficacy and adherence.
About GZR18
GZR18 is a long-acting glucagon-like peptide-1 (GLP-1) receptor agonist (RA) being developed by Gan & Lee Pharmaceuticals. The indications currently under development are type 2 diabetes and chronic weight management for obese or overweight patients. Clinical data shows that administering GZR18 injection once a week and every two weeks can achieve good hypoglycemic or weight loss effects2.
References:
1. World Obesity Alliance 2024 World Obesity Report [EB/OL]. London: World Obesity Alliance,
2. LINONG JI, WEI CHEN, RUIHUA DONG, MINGXIA YUAN, DONG ZHAO, SHUGUANG PANG, LIYUAN ZHAO, JING ZHAO, ZHONG-RU GAN; 1858-LB: A Novel GLP-1 Analog, GZR18, Induced an 18.6% Weight Reduction in Subjects with Obesity in a Phase Ib/IIa Trial. Diabetes 14 June 2024; 73 (Supplement_1): 1858–LB. https://doi.org/10.2337/db24-1858-LB
About Gan & Lee
Gan & Lee Pharmaceuticals developed the first Chinese domestic insulin analog. Currently, Gan & Lee has six core insulin products, including five insulin analog varieties: long-acting glargine injection (Basalin®), fast-acting lispro injection (Prandilin™), fast-acting aspart injection (Rapilin®), mixed protamine zinc lispro injection (25R) (Prandilin™25), aspart 30 injection (Rapilin®30), and one human insulin injection – mixed protamine human insulin injection (30R) (Similin®30). The company has two approved medical devices in China, namely reusable insulin injection pen (GanleePen), and disposable pen needle (GanleeFine®).
In China’s 2024 National Insulin-Specific Centralized Procurement, Gan & Lee Pharmaceuticals ranked first among all selected companies in terms of procurement demand for insulin analogs. The company is also making strides in international markets, with the disposable pen needle (GanleeFine®) approved by the US Food and Drug Administration (FDA) in 2020 and received GMP inspection approval from the European Medicines Agency (EMA) in 2024. These achievements significantly boost Gan & Lee’s competitiveness in both international and domestic markets.
In the future, Gan & Lee will strive for comprehensive coverage in diabetes treatment. Moving forward with its mission to become a world-class pharmaceutical company, Gan & Lee will also actively develop new chemical entities and biological drugs, focusing on treatments for metabolic diseases, cardiovascular diseases, and other therapeutic areas.
Further Information:
[email protected] (Media)
[email protected] (Business Development)
[email protected] (Medical Information)
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Fintech PR
ZBD BECOMES FIRST TO RECEIVE EU MICAR LICENSE APPROVAL
– Approval positions the FinTech as a leader in crypto-asset innovation and compliance in the EU, allowing it to expand its transformative digital-native payments platform and enter new markets –
AMSTERDAM, Dec. 18, 2024 /PRNewswire/ — ZBD, the innovative payments company at the forefront of digital economies, today announced it has become the first company to receive approval for the new European Union (EU) crypto-asset service provider license under MiCAR (Markets in Crypto-Assets Regulation). This landmark achievement represents a major milestone both in crypto-asset regulation in the EU and in ZBD’s journey to build a digital-native payments platform on top of the Bitcoin Lightning Network.
The Dutch Authority for the Financial Markets (AFM) has approved ZBD’s license application under MiCAR, and will issue its license when MiCAR takes effect on 30th December 2024. MiCAR is a new regulatory framework that all crypto-asset service providers in the EU must comply with. Securing a license under MiCAR allows ZBD to expand its capabilities by offering a wide range of services including crypto-asset custody, administration, transfers, and—crucially—fiat-to-crypto and crypto-to-fiat exchange. It also demonstrates a strict adherence to the highest standards of compliance and consumer protection for ZBD’s EU users.
While many companies, including the world’s largest exchanges, are struggling to navigate MiCAR’s stringent requirements, ZBD’s comprehensive and proactive approach to compliance has positioned it to lead the way in crypto-asset innovation and better serve customers across the EU. MiCAR therefore presents a unique opportunity for ZBD as it begins its expansion into the EU market after establishing a strong presence in the US.
“Being the first to have received MiCAR license approval is a major leap forward for us,” says Marca Wosoba, COO of ZBD. “We’ve built a culture where compliance is at the forefront of what we do, and we see it as an enabler for new functionality, not a blocker. MiCAR gave us an opportunity to obtain licensing across all of the EU and facilitate our expansion in the region.”
This milestone aligns with ZBD’s broader vision to build digital-native payments infrastructure for the gaming and entertainment industries. Unlike traditional FinTech companies, which typically start with a fiat-first model and then add on crypto functionality, ZBD flips the script—building on Bitcoin’s Lightning Network to enable fast, low-cost, and globally scalable payments. This flexibility allows the company to find product market-fit in the gaming space, serving use cases that are simply not possible with traditional finance, such as instant reward payouts with no minimums – gamers can earn money playing games and cash out as soon as they’ve earned even a fraction of a cent.
“Having already built a stable revenue-generating business gives us a great entry point to expand what we do and move towards our vision of building a payments company that can instantly move money in any currency,” added Wosoba. “It’s not about being a crypto or Bitcoin business, it’s about being a digital-native payments business that happens to use Bitcoin on the Lightning Network as a core technology in our internal tech stack.”
ZBD took a proactive and strategic approach in anticipation of the new regulation, submitting its MiCAR registration application at the earliest opportunity. Its strong, collaborative relationship with The Dutch Authority for the Financial Markets (AFM), which was the first in the EU to accept and process applications, was also instrumental in achieving this significant milestone.
The license under MiCAR primes ZBD to launch more complex payment products built around Bitcoin, as well as grow rapidly in the EU in 2025. It also brings ZBD one step closer to achieving its ambitious vision as a transformative digital-native payments company. Following its ethos of building crypto-first and then adding complementary fiat functionality, the company is also in the final stages of receiving an Electronic Money Institution (EMI) license, which will complement the range of services ZBD can offer under MiCAR, by also granting it license to perform a wide range of fiat payments services in the EU.
About ZBD
ZBD is a leader in payments innovation, pushing the boundaries of how we move money across the internet. Within gaming, ZBD has made a name for itself by powering instant real-money rewards for partners ranging from Square Enix to 1047 Games. Beyond gaming, ZBD enables unique payments-based use cases across interactive entertainment and adjacent industries. Whether it’s streaming money alongside audio in podcasting apps like Fountain, or implementing instant revenue sharing for each ad impression for adtech innovators like Slice and AdInMo, ZBD makes money move online as seamlessly as information.
To learn more, visit https://zbd.gg/
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Fintech PR
Klarpay AG has officially transitioned to Bivial AG
ZUG, Switzerland, Dec. 18, 2024 /PRNewswire/ — Bivial AG is proud to announce the successful completion of its rebranding from Klarpay AG. This transformation represents a major milestone in the company’s journey, aligning its identity with its vision to become a global leader in comprehensive financial solutions for digital businesses.
The name ” Bivial ” encapsulates the company’s commitment to enabling seamless multidirectional financial flows, a core principle that has guided its evolution. This new identity underscores the company’s dedication to innovation and trust while expanding its capabilities.
With the rebrand complete, Bivial AG is poised to enhance its services beyond its established expertise in cross-border corporate payments. The company is actively working to broaden its portfolio with a range of financial and treasury solutions tailored to meet the needs of modern online businesses. This strategic shift underscores Bivial’s commitment to becoming a one-stop financial partner for its clients.
“The transition to Bivial reflects not just a change in name but an expansion with purpose,” said Martynas Bieliauskas, CEO of Bivial AG. “Our clients can expect the same innovative and reliable service they’ve always trusted, now complemented by a broader suite of offerings designed to support their growth in an interconnected world.”
As part of its growth strategy, Bivial is seeking to extend its regulatory footprint. Building on its existing regulatory framework under the Swiss Federal Banking Act Art 1b, the company has initiated processes to secure additional regulatory approvals in Switzerland.
Bivial’s rebrand signals a bold vision for the future of business finance. By integrating new technologies, expanding its regulatory reach, and broadening its offerings, the company is uniquely positioned to lead the way in financial services.
For more information about Bivial AG, visit www.bivial.ch.
About Bivial AG.
Bivial AG, formerly Klarpay AG, is a deposit-taking financial institution authorised and regulated by the Swiss Financial Market Supervisory Authority (FINMA) under the Swiss Federal Banking Act, Article 1b, offering modern Swiss accounts and cross-border payment solutions for digital businesses. Headquartered in Zug, Switzerland, Bivial AG specialises in offering online businesses access to multi-currency IBAN accounts, global payment acceptance, and digital disbursement solutions. As the first Swiss-licensed fintech company to work exclusively with e-commerce, digital entrepreneurs, and social media influencers, Bivial seeks to empower digital businesses through borderless, scalable, bespoke business accounts and payment solutions.
CONTACT: [email protected], + 41 41 552 0093
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View original content:https://www.prnewswire.co.uk/news-releases/klarpay-ag-has-officially-transitioned-to-bivial-ag-302335084.html
Fintech PR
FXCess CFD Broker Brings PMAM to the Market, Sets New Standards in the World of Trading Platforms
HAMILTON, Bermuda, Dec. 18, 2024 /PRNewswire/ — In a step towards empowering traders who manage multiple accounts, FXCess CFD broker has introduced PMAM, its innovative Personal Multi-Account Manager platform. PMAM is built on an intuitive interface and seamlessly integrates with MetaTrader 4 for easy multi-account management. The new platform gives users advanced money management tools and consolidates account handling into one cohesive solution that simplifies complex trading for FXCess clients.
“We have launched PMAM to prioritize efficiency and simplicity for clients,” a spokesperson for FXCess shared. “This platform is built with convenience in mind, offering a powerful suite of tools for seamless account management. PMAM allows users to manage multiple accounts from one master account interface, freeing them from having to switch between accounts and giving them access to everything they need in one place. This launch marks another step in our commitment to delivering innovation for our clients.”
PMAM’s Unique Features
PMAM offers traders dynamic functionality tailored for professionals and account managers alike. The allocation methods on the platform are flexible, which lets the traders allocate trades across multiple accounts using Lot Allocation, Percent Allocation, and Proportional by Balance Allocation among others. These methods enable users to control trade volume and equity allocation per account, giving them a level of precision and customizability. Alongside its versatile allocation options, PMAM features one-click trading, real-time monitoring, and detailed activity reports.
“At FXCess, our aim is to keep improving our trading ecosystem continually,” the spokesperson for FXCess added. “The introduction of PMAM is a key part of this initiative, reflecting our dedication to improving user experience and offering advanced solutions for traders and managers alike.”
About FXCess
FXCess CFD Broker supports its clients with a variety of trading options and valuable tools. Clients have access to hundreds of assets and can diversify across six asset classes, including forex, commodities, indices, and Futures. The firm also provides tight spreads, bonuses, and a range of trading accounts to improve the trading experience. Through constant enhancements, FXCess CFD broker ensures that clients have everything they need to thrive in today’s trading environment.
All trading involves risk. It is possible to lose all your capital.
FXCess is a trade name of Notesco Int Limited; a company incorporated in Anguilla with registration number A000001800 and registered address The Valley, AI2640, Cosely Drive, 1338, AI.
View original content:https://www.prnewswire.co.uk/news-releases/fxcess-cfd-broker-brings-pmam-to-the-market-sets-new-standards-in-the-world-of-trading-platforms-302335058.html
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