January 26, 2023

‫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

January 26, 2023

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.

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

January 26, 2023

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 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
Logo – https://mma.prnewswire.com/media/1989959/Flow_Doodles_2_Launching_on_Flow__as_the_Web3_Giant_Begins_its_J.jpg

Media Contact — Doodles, The 5th Column, Shirley Cedeno, Doodles@the5thcolumnpr.com; Media Contact — Flow, Rachel Rogers, press@dapperlabs.com

January 26, 2023

WFP welcomes major donation of €65.5 million from the European Union in Eastern and Southern Africa to address the unprecedented global food crisis in eleven countries

NAIROBI / JOHANNESBURG –?An essential and timely contribution of €65.5 million from the European Union, received through its Humanitarian Aid department (ECHO), has been immediately put to work by WFP to address the unprecedented needs caused by the global effects of the war in Ukraine, climate shocks, conflict, and economic pressures.

The special funding was welcomed by WFP for its operations in DRC, Ethiopia, Kenya, Madagascar, Mozambique, Rwanda, Somalia, South Sudan, Sudan, Tanzania and Zimbabwe.

“The number of severely hungry people in countries across Eastern and Southern Africa hit new peaks in 2022, and we continue to face an unprecedented global food crisis today,” said WFP Executive Director David Beasley. “As we begin a very uncertain 2023, the European Union has stepped up at a critical time for some of the most vulnerable communities on the planet, who live with the daily threat of starvation. We are truly thankful for their partnership.”

Commissioner for Crisis Management Janez Lenarcic said “The global food insecurity is our utmost concern, including in Eastern and Southern Africa . ?Just now, famine is already knocking on the door in Somalia. The newly-allocated funds will help those in a dire situation meet their emergency food needs. We remain committed to supporting our humanitarian partners, like the WFP, in providing assistance to those who need it the most.”

Much of the funding will go towards meeting the basic food and nutrition needs of millions of people across eastern and southern Africa. This includes, among other emergencies, the millions of people in need of assistance in Sudan, those affected by conflict in northern Mozambique, and Burundian and Congolese refugees in Tanzania.

Targeting eleven countries, the contribution allows WFP to provide life-saving assistance at a time when humanitarian needs continue to soar.

Source: World Food Programme

January 26, 2023

African Leaders Discuss Path to Food Security at Dakar Summit

DAKAR, SENEGAL — African heads of state and development partners will discuss ways to increase Africa’s agricultural production at a summit in progress in Senegal. Climate change, soaring inflation, and the effects of Russia’s war on Ukraine have combined to make food security precarious throughout much of Africa.

The consensus throughout the three-day event has been that it’s time for Africa to end its dependence on food imports.

The continent has enough arable land to feed 9 billion people, yet it spends $75 billion each year to import more than 100 million metric tons of food, according to the African Development Bank, which organized the summit.

“Only a secure continent can develop with pride,” said Akinwumi Adesina, President of the African Development Bank. “For there is no pride in begging for food. The timing is right. And the moment is now. My heart and my determination is that Africa feeds itself.”

Around 282 million Africans suffer from hunger, according to U.N. figures, and persistent drought has pushed some areas such as the Horn of Africa and Madagascar to the brink of famine.

Recent disruptions in the global food supply chain have also aggravated the issue.

Africa typically imports 30 million metric tons of food from the now warring nations of Russia and Ukraine, and energy, fertilizer and food prices have increased by 40 to 300 percent, according to the African Development Bank.

In order to become self-sufficient, Nigerian President Muhammadu Buhari said, African nations must increase funding toward agricultural initiatives and rural infrastructure.

“To succeed, there is no doubt that we need to subsidize farmers,” he said. “We must reduce the rate of rural to urban migration through the development of rural areas. We must invest heavily in irrigation to help address the increasing frequency of droughts.”

Due to high lending risks, less than 3 percent of total financing from African commercial banks goes towards funding agriculture, Buhari said, and central banks must pick up the slack.

At a CEO roundtable Thursday, Ahmed Abdellatif, president of Sudanese business conglomerate CTC Group, said risks can be minimized with agri-insurance.

“If you’re one of the unlucky half a percent where the rain does not come, it wipes you out totally, and you’re in very big trouble,” he said. “So agri-insurance would be a big enabler.”

Various speakers pointed to success stories on the continent. Ethiopia increased production of a heat resistant wheat variety from 5,000 to 800,000 hectares over a four-year period and is now on its way to becoming a wheat exporter.

The adoption of a drought-resistant maize variety in Kenya, Tanzania and Uganda has more than doubled outputs.

In response to the conflict in Ukraine, Zimbabwe began producing its own fertilizer and wheat. Zimbabwean President Emmerson Mnangagwa said the country expects to produce enough wheat to begin exports next year.

“A country must be ruled by the people of that country. A country must be developed by the people of that country,” he said. “And a country must eat what it sows – that is village wisdom.”

The conference will continue through Friday.

Source: Voice of America

January 26, 2023

US Military Kills Senior Islamic State Official in Somalia

WASHINGTON — U.S. special operations forces have killed a senior Islamic State group official and 10 other terrorist operatives in remote northern Somalia, the Biden administration announced Thursday.

The operation carried out on Wednesday targeted Bilal al-Sudani, a key financial facilitator for the global terrorist organization, in a mountainous cave complex.

“This action leaves the United States and its partners safer and more secure, and it reflects our steadfast commitment to protecting Americans from the threat of terrorism at home and abroad,” Defense Secretary Lloyd Austin said in a statement.

Months of planning

President Joe Biden was briefed last week about the proposed mission, which came together after months of planning. He gave final approval to carry out the operation this week following the recommendation of Austin and the chairman of the Joint Chiefs of Staff, Army General Mark Milley, according to two senior Biden administration officials who briefed reporters on the operation on the condition of anonymity.

Al-Sudani, who has been on the radar for U.S. intelligence officials for years, played a key role in helping to fund IS operations in Africa as well as the ISIS-K terrorist branch operating in Afghanistan, Austin said.

The U.S. Treasury Department alleged last year that al-Sudani had worked closely with another IS operative, Abdella Hussein Abadigga, who had recruited young men in South Africa and sent them to a weapons training camp.

Abadigga, who controlled two mosques in South Africa, used his position to extort money from members of the mosques. Al-Sudani considered Abadigga a trusted supporter who could help the IS supporters in South Africa become better organized and recruit new members, according to Treasury.

Helped foreign fighters

Al-Sudani had originally been designated by the Treasury Department in 2012 for his role with al-Shabab, another terrorist organization operating in Somalia. He helped foreign fighters travel to an al-Shabab training camp and facilitated financing for violent extremists in Somalia, according to a senior administration official.

No civilians were injured or killed in the operation, Pentagon officials said. One American involved in the operation was bitten by a military dog, but was not seriously injured, according to an administration official.

U.S. officials provided scant details about how the operation was carried out or the circumstances surrounding al-Sudani’s killing. One official said that U.S. forces had intended to capture al-Sudani but that did not prove to be “feasible” as the operation was carried out.

The operation comes days after Africa Command said it had conducted a collective self-defense strike northeast of Mogadishu, the capital, near Galcad. In that incident, Somalia National Army forces were engaged in heavy fighting following an extended and intense attack by more than 100 al-Shabab fighters.

The U.S. estimated approximately 30 al-Shabab fighters were killed in that operation.

The offensive by Somalian forces against al-Shabab has been described as the most significant in more than a decade.

Al-Shabab holds a much larger footprint in Somalia than does IS.

Source: Voice of America