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· The European Commission (EC) granted marketing authorisation for Celltrion’s regdanvimab following positive opinion by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) last week (11/11/2021)
· Celltrion continues to discuss supply agreements with regulatory agencies and contractors in more than 30 countries in Europe, Asia and LATAM to accelerate global access to regdanvimab
· The use of regdanvimab across the Republic of Korea is rapidly increasing to address the ongoing outbreaks

INCHEON, South Korea, Nov 15 (Bernama-BUSINESS WIRE) — Celltrion Group announced today that the European Commission (EC) has approved Regkirona (regdanvimab, CT-P59), one of the first monoclonal antibody treatments granted marketing authorisation from the European Medicines Agency (EMA). The EC granted marketing authorisation for adults with COVID-19 who do not require supplemental oxygen and who are at increased risk of progressing to severe COVID-19. The decision from the EC follows a positive opinion by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) on November 11^th, 2021.^¹

“Today’s achievement, coupled with CHMP positive opinion for regdanvimab, underscores our ongoing commitment to addressing the world’s greatest health challenges,” said Dr. HoUng Kim, Ph.D., Head of Medical and Marketing Division at Celltrion Healthcare. “Typically, the recommendations from the CHMP are passed on to the EC for rapid legally binding decisions within a month or two, however, given the unprecedented times, we have received the EC approval within a day. As part of our global efforts to accelerate access, we have been communicating with the governments and contractors in 30 countries in Europe, Asia and LATAM. We will continue working with all key stakeholders to ensure COVID-19 patients around the world have access to safe and effective treatments.”

Monoclonal antibodies are proteins designed to attach to a specific target, in this case the spike protein of SARS-CoV-2, which works to block the path the virus uses to enter human cells. The EC approval is based on the global Phase III clinical trial involving more than 1,315 people to evaluate the efficacy and safety of regdanvimab in 13 countries including the U.S., Spain, and Romania. Data showed regdanvimab significantly reduced the risk of COVID-19 related hospitalisation or death by 72% for patients at high-risk of progressing to severe COVID-19.

Emergency use authorisations are currently in place in Indonesia and Brazil, and the monoclonal antibody treatment is fully approved in the Republic of Korea. In the U.S., regdanvimab has not yet been approved by the Food and Drug Administration (FDA), but the company is in discussion with the FDA to submit applications for an Emergency Use Authorisation (EUA).

As of November 12^th, 2021, more than 22,587 people have been treated with regdanvimab in 129 hospitals in the Republic of Korea.

Notes to Editors:

About Celltrion Healthcare

Celltrion Healthcare is committed to delivering innovative and affordable medications to promote patients’ access to advanced therapies. Its products are manufactured at state-of-the-art mammalian cell culture facilities, designed and built to comply with the US FDA cGMP and the EU GMP guidelines. Celltrion Healthcare endeavours to offer high-quality cost-effective solutions through an extensive global network that spans more than 110 different countries. For more information please visit: https://www.celltrionhealthcare.com/en-us.

About regdanvimab (CT-P59)

CT-P59 was identified as a potential treatment for COVID-19 through screening of antibody candidates and selecting those that showed the highest potency in neutralising the SARS-CoV-2 virus. In vitro and in vivo pre- clinical studies showed that CT-P59 strongly binds to SARS-CoV-2 RBD and significantly neutralise the wild type and mutant variants of concern. In in vivo models, CT-P59 effectively reduced the viral load of SARS-CoV-2 and inflammation in lung. Results from the global Phase I and Phase II/III clinical trials of CT-P59 demonstrated a promising safety, tolerability, antiviral effect and efficacy profile in patients with mild-to-moderate symptoms of COVID-19.^² Celltrion also has recently commenced the development of a neutralising antibody cocktail with CT-P59 against new emerging variants of SARS-CoV-2.

FORWARD LOOKING STATEMENT

Certain information set forth in this press release contains statements related to our future business and financial performance and future events or developments involving Celltrion/Celltrion Healthcare that may constitute forward-looking statements, under pertinent securities laws.

These statements may be identified by words such as “prepares”, “hopes to”, “upcoming”, ”plans to”, “aims to”, “to be launched”, “is preparing, “once gained”, “could”, “with the aim of”, “may”, “once identified”, “will”, “working towards”, “is due”, “become available”, “has potential to”, the negative of these words or such other variations thereon or comparable terminology.

In addition, our representatives may make oral forward-looking statements. Such statements are based on the current expectations and certain assumptions of Celltrion/Celltrion Healthcare’s management, of which many are beyond its control.

Forward-looking statements are provided to allow potential investors the opportunity to understand management’s beliefs and opinions in respect of the future so that they may use such beliefs and opinions as one factor in evaluating an investment. These statements are not guarantees of future performance and undue reliance should not be placed on them.

Such forward-looking statements necessarily involve known and unknown risks and uncertainties, which may cause actual performance and financial results in future periods to differ materially from any projections of future performance or result expressed or implied by such forward-looking statements.

Although forward-looking statements contained in this presentation are based upon what management of Celltrion/Celltrion Healthcare believes are reasonable assumptions, there can be no assurance that forward-looking statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Celltrion/Celltrion Healthcare undertakes no obligation to update forward-looking statements if circumstances or management’s estimates or opinions should change except as required by applicable securities laws. The reader is cautioned not to place undue reliance on forward-looking statements.

References

^¹ European Medicines Agency. COVID-19: EMA recommends authorisation of two monoclonal antibody medicines. Available at https://www.ema.europa.eu/en/news/covid-19-ema-recommends-authorisation-two-monoclonal-antibody-medicines [Last accessed November 2021].
^² Celltrion Data on file

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Contact

Holly Barber
hbarber@hanovercomms.com
+44 (0) 07759 301620

Donna Curran
dcurran@hanovercomms.com
+44 (0) 7984 550312

Source : Celltrion Healthcare

–BERNAMA

KUALA LUMPUR, Nov 3 — Mary Kay Inc has announced sponsorship of a project to improve water security in Monterrey, in partnership with The Nature Conservancy.

The project, led by a group of female entrepreneurs, focuses on restoring local species of trees in the surrounding areas of the city of Monterrey to help maintain ecosystem services, decrease the risk and impact of floods in the city, and restore the degraded forests in the region.

“As an advocate for women’s leadership, we are very proud to see how these local leaders are steering the change in our community, playing a critical role in the preservation of our most valuable natural resource and nurturing a sustainable future for thousands of families in the region,” said Mary Kay Inc Chief Operating Officer, Deborah Gibbins in a statement.

The City of Monterrey is currently home to four million people. Located in an area naturally prone to extreme hydrometeorological events such as hurricanes and flooding, the city often faces serious water supply challenges.

Near the city is the Cumbres de Monterrey National Park, a protected natural reserve that accounts for about 60 per cent of the water that comes to the city.

The area also supports the control of heavy stormwater runoff which impacts people, local livestock, and urban infrastructure. To maintain environmental resiliency, vegetation cover needs to be restored and the production of native plants in nurseries must be ensured.

Mary Kay and The Nature Conservancy are supporting a group of female entrepreneurs in the Laguna Sanchez community who are leading a unique initiative to combat these challenges.

This group of landowners is producing several native species of plants to be used for reforestation projects in the national park. The project will not only address the rising need for these species, but also improve livelihoods for their families and rural community members.

To help tell the story of empowerment and natural conservation of Angelica and Mujeres Unidas Para La Conservación de Laguna de Sanchez, Mary Kay Inc has produced a short film in partnership with The Nature Conservancy.

More details at http://www.marykayglobal.com.

— BERNAMA

Debuting on mobile and MacOS, the latest FarmVille franchise title empowers players to bring their own unique farm to life with endearing characters, lovable animals and unique gameplay features

SAN FRANCISCO, Nov 5 (Bernama-BUSINESS WIRE) — Today, Zynga Inc. (Nasdaq: ZNGA), a global leader in interactive entertainment, announced the worldwide launch of FarmVille 3, the exciting new edition of its iconic FarmVille franchise. The agriculture-simulation social game is now officially available to download on iOS and Android devices worldwide, as well as on the Mac M1.

This press release features multimedia. View the full release here: 
https://www.businesswire.com/news/home/20211104005004/en/ Twelve years – and over 700 million downloads – after the original FarmVille was introduced to the world in 2009, FarmVille 3 is bringing to life a new beautifully crafted world filled with a rich cast of fully animated characters and interactive animals.

Returning to the franchise is the beloved guide Marie, who will welcome back the FarmVille community and greet new players as they build their homesteads and complete challenges. She will be joined by a fresh cast of farmhands with diverse backgrounds and skills who will assist players with new elements in the game, including new customizable farms and animal husbandry.

As players escape into this new world, they can adopt, nurture and raise baby animals from more than 150 breeds – and be rewarded with farm goods, like wool and butter, for their parenting efforts.

“FarmVille 3 immerses players in a visually stunning new FarmVille experience infused with the sense of adventure, social connection and farming spirit that hundreds of millions of fans have come to love,” said Bernard Kim, President of Publishing at Zynga. “We warmly invite a new generation of players to meet the delightful new FarmVille characters and lovable animals who thrive in a gorgeous countryside filled with heart and humor.”

Click to watch

New Game Features

• Variety of animals – Collect, breed and nurture more than 150 breeds of animals, ranging from the mainstay chickens and cows to the exotic tigers and fluffy alpacas
• Diverse farmhands – Meet 30 characters with handy skills – such as baking, fishing, lumberjacking and crafting – that will assist you on your farm-building journey
• A living, breathing world – Control weather patterns with dynamic in-game mechanics to speed up your crop growth, catch more fish or earn more coins
• Customize everything – Dress your farmhands in seasonal outfits such as a pumpkin costume for Halloween or add a personal touch to your farm, animal house or vehicle by picking from a plethora of themed design options such as modern or Victorian decor
• Neighborly social gameplay features – Form your own “co-op” to exchange goods with other players and cooperate to win events and unique decorations

Starting today, players who download the game within the next two weeks will receive a special starter kit with interactive features to help customize their farms, such as decorative elements and the ‘Early Bird’ profile picture.

FarmVille 3 is the latest addition to the FarmVille series, which includes FarmVille 2: Country Escape and FarmVille 2: Tropic Escape.

To view the supporting still and video assets for FarmVille 3, please click here.

FarmVille 3 is available now for iOS, Android and Mac M1 as a free download.

For more information visit:
www.FarmVille3.com
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Well Positioned to Capture Significant and Growing Leisure Travel Demand with Enhanced End-to-End Offerings and an Increasingly Diversified Portfolio

Reaffirms Expanded Asset Sale Commitment to Generate an Additional $2 Billion of Proceeds by End of 2024; Fully Completes Existing Commitment

CHICAGO, Nov 3 (Bernama-BUSINESS WIRE) — Hyatt Hotels Corporation (NYSE: H) today announced that Hyatt has completed the previously announced acquisition of Apple Leisure Group® (ALG), a leading luxury resort-management services, travel and hospitality group, from affiliates of each of KKR and KSL Capital Partners, LLC.

This press release features multimedia. View the full release here: 
https://www.businesswire.com/news/home/20211102005724/en/
Hyatt is doubling its global resorts footprint through the addition of ALG’s AMR™ Collection brand portfolio, which comprises approximately 100 hotels and resorts operating in 10 countries, as well as a pipeline of 24 executed deals in the Americas and Europe. As a result, Hyatt now offers one of the largest collections of luxury all-inclusive resorts in the world, including new destinations for Hyatt such as Acapulco, Curaçao, the Canary Islands, Menorca and St. Martin. Through this acquisition, Hyatt has added properties in 11 new European markets and expanded its European brand footprint by 60%, strengthening Hyatt’s growth potential in a critical region for global leisure travel demand.
 In addition, Hyatt is offering even more options and experiences for its high-end guest and customer base and enhancing the end-to-end leisure travel experience through:

• Unlimited Vacation Club® by AMR™ Collection, an exclusive membership club whose members enjoy preferred rates and other benefits at participating AMR™ Collection properties
• ALG Vacations®, one of the largest packaged vacation providers and leisure travel distribution platforms in North America serving the United States, Mexico and the Caribbean
• Amstar, a leading destination services management company
• Trisept Solutions®, a unique leisure travel technology platform

Hyatt is determining ways in which the World of Hyatt® loyalty program and ALG’s Unlimited Vacation Club® can bring added value and unique loyalty benefits to their respective member bases. Hyatt plans to integrate the AMR™ Collection into World of Hyatt in 2022 so that members can earn and redeem World of Hyatt points at more than 100 AMR™ Collection hotels and resorts.

“Hyatt’s acquisition of ALG represents a brand-defining moment in our more than 60-year history and builds on our legacy as a hospitality leader,” said Mark Hoplamazian, president and chief executive officer, Hyatt. “Hyatt and ALG have highly complementary brand portfolios and share a deep commitment to colleague and guest experiences focused on care. Having first entered the fast-growing luxury all-inclusive space in 2013, we are ideally positioned to capture the significant and rising demand for leisure travel and extend the world-class hospitality we provide to a wide range of new travelers. We are excited to welcome the ALG team to the Hyatt family, and look forward to working together to achieve new levels of growth and value creation for all stakeholders – including our shareholders, owners, customers, guests, members and colleagues.”

“Today marks the beginning of ALG’s next chapter, in which we will continue to build on the strong loyalty and reputation we have established through our luxury travel brands and services, now as part of Hyatt,” said Alejandro Reynal, chief executive officer and president, Apple Leisure Group. “We strongly believe we can achieve more together and are excited by the opportunities ahead for our expanded family, including our ALG team members, who are excited to join a larger global organization. With Hyatt’s added expertise, we expect to accelerate our expansion as we welcome more travelers and turn vacation dreams into life-long memories.”

ALG’s business will continue to be led by Alejandro Reynal and the current ALG leadership team. ALG will operate as a distinct business unit within Hyatt. Mr. Reynal has joined Hyatt’s executive leadership team and reports to Mr. Hoplamazian.

In September of 2021, Hyatt fulfilled its asset disposition commitment announced in 2019 of $1.5 billion resulting in a total of more than $3 billion of proceeds realized since its asset-disposition strategy was launched in 2017, at a combined multiple of over 17x EBITDA. Hyatt also reaffirms its commitment to generate an additional $2 billion in proceeds from asset dispositions by the end of 2024.

Advisors
In connection with the transaction, BDT & Company, LLC and J.P. Morgan served as financial advisors to Hyatt, and Latham & Watkins LLP acted as its legal advisor. PJT Partners served as financial advisor to ALG, and Simpson Thacher & Bartlett LLP acted as its legal advisor. Credit Suisse and Deutsche Bank Securities Inc. served as financial advisors to KKR and KSL Capital Partners.

The term “Hyatt” is used in this release for convenience to refer to Hyatt Hotels Corporation and/or one or more of its affiliates.

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DuitNow QR Programme by Payments Network Malaysia Sdn Bhd (PayNet) in collaboration with TNG Digital (TNGD)
KUALA LUMPUR, Nov 1 (Bernama) — As part of its ongoing commitment to build an inclusive, accessible, and efficient payments and financial eco-systems for Malaysia, Payments Network Malaysia Sdn Bhd (PayNet) in collaboration with TNG Digital (TNGD) has expanded the interoperable national QR standard to Langkawi through its DuitNow QR Programme.

From 25 October till 12 December 2021, the DuitNow QR Programme will provide cash incentive to the first 2,000 merchants in Langkawi who successfully register for the Touch ‘n Go eWallet DuitNow QR to enable them to access seamless payment collection for their operations.

The programme aims to support businesses impacted by the Covid-19 pandemic, particularly in the tourism sector. To support the government’s travel bubble initiative, the DuitNow QR Programme will focus on merchants in Langkawi with hopes to kick start their business through the acceptance and acceleration of digital payment instruments.

Khairuan Abdul Rahman, Director of Retail Payment Services of PayNet said “As the national payments operator, PayNet is fully committed to support our country’s shift towards a cashless future in an inclusive manner. DuitNow QR offers interoperability and standardised QR payments, so that customers can make QR payments via any of the 32 banks and eWallets at over 900,000 touch points across the country. Our collaboration with TNG Digital will enable merchants to join our fast-growing ecosystem which will hopefully accelerate their recovery from the pandemic and revive the economy in Langkawi.”

Meanwhile, Ignatius Ong, Chief Executive Officer of TNG Digital said, “The pandemic has accelerated the adoption and usage of digital payments as consumers’ daily habits, consumption patterns and ways of thinking have changed. This collaboration with PayNet allows us to extend this seamless, fast, convenient, and safe platform with DuitNow QR for both merchants and consumers in Langkawi. We hope this endeavour will help revitalise the merchants as well as the economy on the island.”

An integrated, comprehensive solution for business, TNGD simplifies the merchant onboarding process with its merchant dashboard within the Touch ‘n Go eWallet app. Dedicated to managing and tracking sales transactions, the merchant dashboard provides merchants with the convenience and tools to manage their business at their fingertips. The benefit for merchants is that they would only need to maintain one acquirer account to accept QR transactions. This simplifies their operations especially for small businesses as they would only need to refer to one statement to view all QR-code transactions.

With nearly 90,000 visitors recorded since the Langkawi travel bubble commenced as of mid-October, the expansion of DuitNow QR to Langkawi is expected to benefit merchants as tourist arrivals increases. Apart from addressing hygiene concerns in handling cash, merchants no longer need to display multiple QR codes at payment counters. Customers can scan with their bank mobile app or eWallet of choice to pay via a single DuitNow QR code.

For more information and updates, visit www.touchngo.com.my and log on to https://www.facebook.com/touchngoewallet/. The Touch ‘n Go eWallet is available for download on the Apple App Store and Google Play Store respectively.

About Payments Network Malaysia Sdn Bhd (PayNet)
PayNet is Malaysia’s premier payments network and central infrastructure for financial markets. We innovate, build, and operate world-class payment systems and financial market infrastructures that safely, reliably, and efficiently enable the functioning and development of Malaysia’s financial system as well as the economy as a whole. Bank Negara Malaysia (BNM) is PayNet’s single largest shareholder, with eleven Malaysian’s Banks as joint shareholders.

About DuitNow QR
DuitNow QR is Malaysia’s National QR Standard established by PayNet under Bank Negara Malaysia’s Interoperable Credit Transfer Framework which allows interoperability between all participating Banks and eWallets. For more information, please visit www.paynet.my
 
About TNG Digital Sdn Bhd
TNG Digital Sdn Bhd (“TNGD”) founded by Touch ‘n Go Sdn Bhd and Ant Group (“Ant”), parent company of Alipay, China’s largest digital payments platform. Established in 2017, TNGD is the owner and operator of Touch ‘n Go eWallet, Malaysia’s number one eWallet company, with over 16 million registered users. Combining Touch ‘n Go’s strong domestic brand, dominance in toll, transit and parking use cases and nationwide user base, together with Ant’s deep domain expertise and leading the development of open platforms for technology-driven inclusive financial services, the Touch ‘n Go eWallet provides financial services and payments services to both retail users and small to mid-sized businesses, across physical and online infrastructure. For more information, please visit www.touchngo.com.my   

Source: Payments Network Malaysia Sdn Bhd (PayNet)

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