‫قدمت شركة Daewoong Pharmaceutical طلب دواء جديد لعقارها العالمي الجديد Fexuclue في 11 دولة، بعد عام واحد فقط من الموافقة في كوريا  

“من المتوقع أن يغير مشهد سوق أدوية الارتداد المعدي المريئي”

  •  تم تقديم طلب الموافقة على منتج  Fexuclue ، وهو دواء جديد لداء الارتداد المعدي المريئي ( (GERD ، بالكامل إلى كولومبيا وفيتنام والمملكة العربية السعودية
  • تم الانتهاء من تقديم الطلبات الجديدة للدواء في 11 دولة في وقت قصير بين الأدوية الجديدة  K-pharma  … لتسريع التوسعات في السوق بقيمة 1.61 مليار دولار

سيول، كوريا الجنوبية، 26 يناير/كانون الثاني 2023 / PRNewswire / —  يجذب  Fexuclue  (العنصر النشط:  Fexuprazan ) التابع لشركة  Daewoong Pharmaceutical  الانتباه باعتباره مغيرًا لقواعد اللعبة في سوق علاج داء الارتداد المعدي المريئي ( GERD ) العالمي حيث تقدم بطلب للحصول على الموافقة في 11 دولة في جميع أنحاء العالم في غضون عام واحد بعد الموافقة في كوريا.

وقالت الشركة أنها قدمت مؤخرا في 25 من الشهر الجاري طلبًا جديدًا للدواء ( NDA ) لعقار  Fexuclue ، وهو دواء  GERD ، في المملكة العربية السعودية. مع هذا الطلب، أكملت  Daewoong  تطبيقات الطلبات الجديدة للدواء في 11 دولة حول العالم في غضون عام واحد بعد الحصول على إذن لـ  Fexuclue  في كوريا.

وفقًا لبيانات عام 2021 الخاصة بِـ  IQVIA Global MIDAS ، وهي شركة أبحاث سوق الأدوية، فإن سوق الأدوية التراكمية المضادة للقرحة في 11 دولة حيث قدمت  Daewoong Pharmaceutical  الموافقات على المنتجات تقدر قيمتها بـ 1.61 مليار دولار (2 تريليون وون كوري). الدول الـ11 التي قدمت فيها الشركة حتى الآن طلبات للحصول على موافقة  Fexuclue  تشمل البرازيل والفلبين وإندونيسيا وتايلاند والمكسيك وتشيلي والإكوادور وبيرو وكولومبيا وفيتنام والمملكة العربية السعودية.

أكملت  Daewoong  أيضًا تقديم طلبات لجميع دول أمريكا اللاتينية الأربعة (كولومبيا والإكوادور وبيرو وتشيلي) التي وقعت اتفاقيات ترخيص خارجي في عام 2021، وقدمت طلب دواء جديد إلى فيتنام لتسريع تقدمها في السوق الآسيوية.

بناءً على الإنجاز الأخير المتمثل في إقامة شراكة مع 15 دولة، تخطط الشركة لزيادة تسريع توسعها العالمي من أجل نمو أدويتها الجديدة الرائجة. في البداية، تخطط للتقدم بطلب للحصول على الموافقة على المنتج في 30 دولة حول العالم بحلول عام 2025 وإطلاقها في 100 دولة بحلول عام 2030. على وجه الخصوص، فازت بالموافقة على المنتج في الفلبين في نونبر/تشرين الثاني من العام الماضي لأول مرة في العالم، وستقدم هذا العام طلبًا للموافقة على المنتج للتقدم إلى الصين، التي نمت لتصبح أكبر سوق للأدوية المضادة للقرحة في العالم خارج الولايات المتحدة بحجم سوق يبلغ 3.53 مليار دولار (4.37 تريليون وون كوري) اعتبارًا من عام 2021.

Fexuclue Tablet  هو دواء جديد للارتداد المعدي المريئي تم إطلاقه رسميًا من قبل  Daewoong Pharmaceutical  في كوريا في يوليوز/تموز من العام الماضي وهو عقار مانع لأحماض البوتاسيوم ( P-CAB ). من خلال تحسين عيوب مثبطات مضخة البروتون الموجودة ( (PPIs ، فإنه يرتبط بمضخة البروتون دون تنشيط حمض المعدة ويمنع إفراز حمض المعدة بسرعة وثبات. هناك نوعان من الدلائل التي تم تأمينها حتى الآن: علاج للارتداد المعدي المريئي (40 ملغ) وتحسين آفات الغشاء المخاطي في المعدة في التهاب المعدة الحاد والمزمن (10 ملغ). على وجه الخصوص،  Fexuclue  هو دواء  P-CAB  الوحيد لمؤشرات التهاب المعدة في كوريا. تنتهي صلاحية براءة الاختراع المركبة تقريبًا في عام 2036، مع إمكانية التمديد.

قال جيون سينغ-هو، الرئيس التنفيذي لشركة  Daewoong Pharmaceutical : “حقيقة أن  Fexuclue  أكملت طلبات الموافقة في معظم البلدان في مثل هذه الفترة القصيرة من الوقت بعد الموافقة على الأدوية الجديدة التي تم تطويرها في كوريا، تثبت معرفتنا التراكمية وقدرتنا على تطوير الأدوية العالمية الجديدة الرائجة. جنبًا إلى جنب مع التوسع المتسلسل للموافقة والبدء في الخارج، سنعمل ليس فقط على تسريع توسيع المؤشرات من خلال الترويج للتجارب السريرية متعددة الأوجه، ولكن أيضًا تنويع الصياغة لتحسين قيمة المنتج”.

تجري شركة  Daewoong Pharmaceutical  تجارب سريرية في المرحلة 3 للحصول على مؤشرات إضافية لعلاج الصيانة بعد علاج الارتداد المعدي المريئي والوقاية من القرحة التي تسببها العقاقير غير الستيرويدية المضادة للالتهابات ( (NSAIDs ، كما بدأت أيضًا في التجارب السريرية لاستئصال بكتيريا الملوية البوابية. بالإضافة إلى ذلك، تستعد لتوسيع تشكيلتها من خلال تطوير أقراص التي تتفكك عن طريق الفم وتركيبات  IV  (الحقن) لراحة المريض.

الشعار –  https://mma.prnewswire.com/media/1676530/Daewoong_Pharmaceuticals_Logo.jpg

Daewoong Pharmaceutical submitted NDA for its global new drug Fexuclue in 11 countries, only 1 year after approval in Korea

“Expected to change GERD drug market landscape”

  • Application for product approval of Fexuclue, a new drug for gastroesophageal reflux disease (GERD), has been completely submitted to Colombia, Vietnam, and Saudi Arabia
  • NDA submissions in 11 countries completed in the shortest time among K-pharma new drugs… accelerating expansions into $1.61 billion market

SEOUL, South Korea, Jan. 26, 2023 /PRNewswire/ — Daewoong Pharmaceutical’s Fexuclue (active ingredient: Fexuprazan) is attracting attention as a game changer in the global gastroesophageal reflux disease (GERD) treatment market as it applied for approval in 11 countries across the world within one year after approval in Korea.

The company said on the 25th that it recently submitted a new drug application (NDA) for Fexuclue, a GERD drug, in Saudi Arabia. With this application, Daewoong completed NDA applications in 11 countries around the world in one year after securing permission for Fexuclue in Korea.

According to the 2021 data of IQVIA Global MIDAS, a pharmaceutical market research firm, the cumulative anti-ulcer drug market in 11 countries where Daewoong Pharmaceutical has submitted product approvals is estimated to be worth $1.61 billion (2 trillion won). The 11 countries in which the company has thus far submitted applications for Fexuclue approval include Brazil, the Philippines, Indonesia, Thailand, Mexico, Chile, Ecuador, Peru, Colombia, Vietnam, and Saudi Arabia.

Daewoong has also completed the submission of NDA for all four Latin American countries (Colombia, Ecuador, Peru, and Chile) that signed out-license agreements in 2021, and submitted an NDA to Vietnam to further accelerate its advance into the Asian market.

Based on the recent achievement to make a partnership with 15 countries, the company plans to further accelerate its global expansion for the growth of its blockbuster new drug. First of all, it plans to apply for product approval in 30 countries across the world by 2025 and launch in 100 countries by 2030. In particular, it won product approval in the Philippines in November last year for the first time in the world, and this year it will submit an application for product approval to advance into China, which has grown into the world’s largest anti-ulcer drug market beyond the United States with a market size of $3.53 billion (4.37 trillion won) as of 2021.

Fexuclue Tablet is a new drug for GERD officially launched by Daewoong Pharmaceutical in Korea in July last year and is a potassium-competitive acid blocker (P-CAB) drug. By improving the drawbacks of existing proton pump inhibitors (PPIs), it binds to the proton pump without activating gastric acid and quickly and stably inhibits the secretion of gastric acid. There are two indications it has secured so far: treatment of erosive GERD (40 mg) and improvement of gastric mucosal lesions in acute and chronic gastritis (10 mg). In particular, Fexuclue is the only P-CAB drug for gastritis indications in Korea. The compound patent expires approximately in 2036, with extension potential.

Seng-ho Jeon, CEO of Daewoong Pharmaceutical, said, “The fact that Fexuclue completed applications for approval in the most countries in such a short period of time after approval among new drugs developed in Korea proves our cumulative know-how and ability to develop global new blockbuster drugs. Along with the sequential expansion of overseas approval and launch, we will accelerate not only the expansion of indications through the promotion of multifaceted clinical trials but also but also diversify formulation to improve the value of product.”

Daewoong Pharmaceutical is conducting phase 3 clinical trials for additional indications for maintenance therapy after treatment of erosive GERD and prevention of ulcers caused by non-steroidal anti-inflammatory drugs (NSAIDs), and also commenced on clinical trials for eradicating Helicobacter pylori. In addition, it is preparing to expand its lineup through the development of orally disintegrating tablets and IV formulations (injections) for patient convenience.

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Doodles 2 Launching on Flow, as the Web3 Giant Begins its Journey to Onboard Millions

The scalability, security and composability of Flow blockchain will power the next generation of creativity, utility and value for the growing Doodles community

MIAMI, Fla.,, Jan. 25, 2023 /PRNewswire/ — Doodles, a leading Web3 media and entertainment franchise, will launch the highly anticipated Doodles 2 on Flow blockchain, the platform powering next-generation games, apps and digital assets, and home to brands like the NBA, NFL, Ticketmaster and Mattel.

The scalability, security and composability of Flow blockchain will power the next generation of creativity, utility and value for the growing Doodles community.

The multi-chain expansion supports a wider range of creative and technical possibilities, enabling the next generation of Doodles products. The first is Doodles 2, a new NFT experience that allows holders to personalize their own Doodle on-chain, choosing their look with attributes like body, hairstyle, emotion, apparel and accessories. Wearable collections will be released via limited-edition IRL drops tied to specific events and brand collaborations with notable partners and public figures. These wearables can be sold, bought and traded on the Gaia marketplace.

With no gas fees and a seamless consumer checkout experience on Flow, Doodles 2 holders can enjoy endless customization of their own personalized, dynamic NFT identities to use across social networks, gaming platforms, live events, streaming content, retail activations and other imaginative moments.

“Doodles 2 is the perfect combination of self-expression, collecting, and community, inside a frictionless app that’s powered by blockchain technology,” said Jordan Castro, Co-Founder and Head of Product at Doodles. “We’ve productized the community’s desire to customize their Doodles so that it matches their IRL vibe exactly. Tech aside, Doodles 2 is the passport that’s used in all of our products – experiences, games, apps, music, animation releases, to bring further personalization, customization and rewards to our fans.”

Flow’s frictionless onboarding and world-class security, safety and recoverability make inviting people into the colorful world of Doodles just as easy for Web3 newcomers as it is for natives in the space.

“Doodles is one of the most recognizable brands in Web3, with a community as vibrant as the Doodles themselves,” said Dieter Shirley, Chief Architect of Flow. “With Doodles 2, they are unlocking more value for their existing community, while setting the stage for many more folks to join the joyful, inclusive world of Doodles. Their vision of accessible, interactive, and personalized fun is exactly the kind of project we had in mind when we designed Flow. I’m so excited for the launch!”

The Doodles 2 launch on the Flow blockchain will also mark the start of a future of strong cross-interoperability with Ethereum.

“We’re excited to continue investing in Doodles’ core collections on Ethereum, while also connecting Doodles everywhere our community lives and creates,” said Julian Holguin, CEO of Doodles. “As we grow our brand across other verticals like animation and music, Flow’s accessible and seamless onboarding experience enables us to capture audiences that are introduced through traditional media channels. We believe the combination of Ethereum and Flow is the ideal format to support and invest in our core Web3 community, while opening the gates to welcome new collectors.”

The first step of the Doodles 2 product experience opens to Doodles holders on January 31, with full details here in the coming days. If holders don’t own a Dooplicator, they can purchase one on OpenSea. For those who own a Dooplicator, but not a Doodle, holders will soon be able to lend out their Doodle on a future marketplace.

About Doodles 

Doodles  is a series of digital collectibles derived from characters created by world-renowned artist Burnt Toast. Since its launch in October 2021, Doodles has quickly become one of the most promising projects born out of the Web3 boom thanks to its inclusive characters, experiential immersive activations, and passionate community. The brand has developed into a multi-faceted franchise that spans animation, gaming, merchandise, music and live events with notable partnerships and investors. For more information on Doodles, visit doodles.app. Join our online communities on Twitter, Instagram and Discord.

About Flow

Flow is a decentralized layer one blockchain designed to support exceptional experiences for consumers at mainstream scale, from easy onboarding to ongoing utility. Frictionless, secure and eco-friendly, Flow empowers developers to innovate and push the limits that will bring the next billion to Web3. Today, Flow is home to a thriving ecosystem of creators from top brands, development studios, venture-backed startups, crypto leaders, and more. For more information, visit www.flow.com.

Doodles 2 is a new NFT experience that allows holders to personalize their own Doodle on-chain, with attributes and accessories minted on the Flow blockchain.

Photo – https://mma.prnewswire.com/media/1989960/Flow_Doodles_2_Launching_on_Flow__as_the_Web3_Giant_Begins_its_J.jpg
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Media Contact — Doodles, The 5th Column, Shirley Cedeno, Doodles@the5thcolumnpr.comMedia Contact — Flow, Rachel Rogers, press@dapperlabs.com

The Czech Republic calls for an agreement on the constitutional basis for holding the Libyan elections

Tripoli, Minister of Foreign Affairs and International Cooperation of the Government of National Unity, Naglaa Al-Manqoush, received this morning, Thursday, the Czech Ambassador to Libya, Jan Visital.

The Ministry of Foreign Affairs said that Al-Mangoush discussed with the Czech ambassador ways to develop relations between the two countries in the fields of energy and economy. In order to enhance opportunities for joint cooperation between Libya and the Czech Republic.

The ministry added that the Czech ambassador, Jan Visital, expressed during the meeting his country’s support for the national unity government in enhancing security and stability.

The Czech ambassador to Libya emphasized his country’s position on the crisis in Libya, calling for the importance of reaching an agreement on the constitutional basis. To hold the Libyan elections as soon as possible.

Source: Libya News Agency

Tajani : we must do our best to hold the Libyan elections in 2023.

Rome The Italian Deputy Prime Minister and Minister of Foreign Affairs, Antonio Tajani, described bringing stability to Libya through consensual electoral process between the Libyan parties as “a very important matter”, for his country’s authorities.

The Italian agency AKI quoted Tajani, addressing the Italian Parliament, Wednesday, during accountability session, that this goal is “at the heart of our talks with the actors that have an impact on this country.

“We must do our best to allow to holding the elections in 2023, in line with the mediation of the UN, which Italy strongly supports,” he added.

Source: Libya News Agency

(Batili) and (Tebboune) assert that the elections are the means to overcome the political impasse in Libya

Algeria, Algerian President Abdelmajid Tebboune stressed the need to take all necessary steps to overcome the political impasse in Libya through elections.

This came during President Abdelmajid Tebboune’s meeting with the Special Representative of the Secretary-General of the United Nations in Libya, “Abdullah Batili”, on Wednesday, in the Algerian capital.

“Batili” said in a tweet on Twitter that Algerian President Abdelmajid Tebboune shared his views on the situation in Libya, stressing the importance of the elections being inclusive, transparent and safe, and the need to provide appropriate conditions for their successful conduct.

The Algerian president expressed his unwavering support for the efforts of the United Nations, stressing that stability in Libya is a regional need for all countries, especially those in its vicinity.

Source: Libya News Agency