Market Newsdesk

SHANGHAI, Nov. 27, 2020 /PRNewswire/ — Zoomlion Heavy Industry Science & Technology Co., Ltd. (Zoomlion) has presented its largest outdoor exhibition at bauma China 2020 in Shanghai and launched multiple high-end intelligent products during the three-day international trade fair.

Zoomlion is exhibiting over 50 sets of construction equipment products from nine product lines at bauma China 2020. Through new product releases and online livestreaming events to interact with global customers, Zoomlion has signed orders totaling CNY20 billion ($US3.04 billion) at bauma China as of 26 November.

“The exhibition highlights Zoomlion’s high-end 4.0 generation products and innovative achievements that represent a qualitative leap of intelligence,” said Mr. Guo Xuehong, Vice President of Zoomlion.

Taking the lead in the industry with high-end, innovative intelligent products

Zoomlion’s exhibition at bauma China 2020 offered a glimpse into the future of construction machinery with a demonstration of intelligent hoisting minus the operation cab but with a 5G remote control experience center giving the “intelligence” part of the equipment the ability to touch, sense and see.

The ZTC-250NEV is the world’s first electric truck crane which has integrated machine vision, artificial intelligence and 5G communication, it’s a cab-less crane but with “eyes and a brain” to complete smart hoisting tasks with the push of a button.

The ZCC18000 crawler crane has the highest tonnage at the trade fair, boasting great hoisting capacity that makes it a perfect model for wind power hoisting on land and at sea. It’s equipped with Zoomlion’s self-developed no-landing overloading counterweight technology that reduces the area of operation by 60% and delivers industry-leading lifting performance.

Zoomlion also released the ZT68J, a self-propelled straight-arm aerial work platform that sets a world record of 67.5 meters in height, while guaranteeing better performance in off-road operation and intelligent control.

The company’s dry-mix mortar equipment has adopted the patented ultra-high-precision automatic powder metering system Powerdos. The intelligent functions such as hollow boom technology, carbon fiber concrete pipe and man-machine voice interaction and a tower crane ETI smart control system were widely acclaimed by visitors to the fair and global livestreaming audiences alike.

As the global market recovers from the impacts of COVID-19, Zoomlion is persisting with innovative research and development and looks forward to creating and sharing with all partners. The exhibitor hosted a 24-hour livestream in Chinese and English allowing global customers to participate in bauma China 2020.

“Zoomlion has never changed its vision to share the industry’s achievements and co-build the industry’s ecosphere. We are expecting to shape an intelligent and ultimate future in the principles of extensive consultation, joint contribution and shared benefits,” said Mr. Guo.

About Zoomlion

Founded in 1992, Zoomlion Heavy Industry Science & Technology Co., Ltd. (01157.HK) is a high-end equipment manufacturing enterprise that integrates engineering machinery, agricultural machinery, and financial services. The company now sells more than 600 cutting-edge products from 56 product lines covering ten significant categories.

View original content to download multimedia:http://www.prnewswire.com/news-releases/zoomlion-wows-at-bauma-china-2020-exhibition-with-launch-of-next-gen-intelligent-construction-machinery-securing-over-us3-billion-in-orders-301181103.html

SOURCE Zoomlion

STOCKHOLM, Nov. 27, 2020 /PRNewswire/ — LeoVegas AB (publ) (“LeoVegas”) has mandated SEB and Swedbank as joint bookrunners to arrange investor meetings commencing on 30 November 2020 to explore the conditions to issue a senior unsecured bond with an expected volume of SEK 500m, within a framework of SEK 1,200m with a tenor of three years. Subject to market conditions, a capital markets transaction may follow. The proceeds from the potential bond issue will be used to facilitate LeoVegas’ expansion strategy, refinance existing debt and for potential acquisitions. In conjunction with the transaction, LeoVegas also enters into a new three-year revolving credit facility agreement of EUR 40m.

Financial targets – leverage target introduced

In conjunction with the transaction, LeoVegas publishes that the leverage ratio (net debt to adjusted EBITDA) shall not, over the long term, exceed 1.0x. However, LeoVegas may, under certain circumstances, choose to exceed this level during short time periods in connection with, for instance, larger acquisitions or other strategic initiatives.

LeoVegas’ existing long-term financial targets are unchanged which include:

• Long-term organic growth that outperforms the online gaming market
• Long-term EBITDA margin of at least 15 percent, under the assumption that 100% of the revenue is generated in locally regulated markets where gaming tax is paid
• To pay dividend, over time, of at least 50 percent of the profit after tax

“With this, we ensure a long-term and stable financing for LeoVegas. We strengthen the company’s financial flexibility and diversify our financing with the combination of a bond and new bank loans. This enables us to continue to deliver on our expansion strategy where we focus on regulated markets and markets soon to become regulated. Further, we continuously evaluate strategic and complementary acquisitions that may fit into the LeoVegas Group”, Gustaf Hagman, Group CEO

This information is such that LeoVegas AB (publ) is obligated to make public pursuant to the EU Market Abuse Regulation 596/2014. The information in this press release has been published through the agency of the contact persons set out below, at the time stated by LeoVegas AB’s (publ) news distributor Cision, upon publication of this press release. The persons indicated below can also be contacted for further information.

for further information, please contact:

Gustaf Hagman, Group CEO
+46 (0) 8 410 367 66, [email protected]

Stefan Nelson, Group CFO
+356 993 942 68, [email protected]

Philip Doftvik, Director of Investor Relations and Corporate Finance
+46 73 512 07 20, [email protected]

About leovegas mobile gaming group:

LeoVegas vision and position is “King of Casino”. The global group LeoVegas Mobile Gaming Group offers games on Casino, Live Casino, Bingo and Sport. The parent company LeoVegas AB (publ.) is located in Sweden and its operations are mainly located in Malta. The company’s shares are listed on Nasdaq Stockholm. www.leovegasgroup.com

This information was brought to you by Cision http://news.cision.com

https://news.cision.com/leovegas-mobile-gaming-group/r/leovegas-contemplates-to-issue-a-senior-unsecured-bond-and-communicates-a-leverage-target,c3243761

The following files are available for download:

View original content:http://www.prnewswire.com/news-releases/leovegas-contemplates-to-issue-a-senior-unsecured-bond-and-communicates-a-leverage-target-301181097.html

SOURCE LeoVegas Mobile Gaming Group

SHANGRAO, China, Nov. 27, 2020 /PRNewswire/ — JinkoSolar Holding Co., Ltd. (“JinkoSolar” or the “Company”) (NYSE: JKS), one of the largest and most innovative solar module manufacturers in the world, today announced that it plans to release its unaudited financial results for the third quarter ended September 30, 2020 before the open of U.S. markets on Monday, December 7, 2020.

JinkoSolar’s management will host an earnings conference call on Monday, December 7, 2020 at 7:30 a.m. U.S. Eastern Time (8:30 p.m.Beijing / Hong Kong the same day).

Dial-in details for the earnings conference call are as follows:

Please dial in 10 minutes before the call is scheduled to begin and provide the passcode to join the call.

A telephone replay of the call will be available 2 hours after the conclusion of the conference call through 23:59 U.S. Eastern Time, December 14, 2020. The dial-in details for the replay are as follows:

Additionally, a live and archived webcast of the conference call will be available on the Investor Relations section of JinkoSolar’s website at http://www.jinkosolar.com.

About JinkoSolar Holding Co., Ltd.

JinkoSolar (NYSE: JKS) is one of the largest and most innovative solar module manufacturers in the world. JinkoSolar distributes its solar products and sells its solutions and services to a diversified international utility, commercial, and residential customer base in China, the United States, Japan, Germany, the United Kingdom, Chile, South Africa, India, Mexico, Brazil, the United Arab Emirates, Italy, Spain, France, Belgium, and other countries and regions. JinkoSolar has built a vertically integrated solar product value chain, with an integrated annual capacity of 20 GW for silicon wafers, 11 GW for solar cells, and 25 GW for solar modules, as of June 30, 2020.

JinkoSolar has 9 production facilities globally, and 14 overseas subsidiaries in Japan, South Korea, Vietnam, India, Turkey, Germany, Italy, Switzerland, United States, Mexico, Brazil, Chile, and Australia, and global sales teams in China, United  Kingdom, France, Spain, Bulgaria, Greece, Ukraine, Jordan, Saudi Arabia, Tunisia, Morocco, Kenya, South Africa, Costa Rica, Colombia, Panama, Kazakhstan, Malaysia, Myanmar, Sri Lanka, Thailand, Vietnam, Poland, and Argentina.

To find out more, please see: www.jinkosolar.com

Safe Harbor Statement

This press release contains forward-looking statements. These statements constitute “forward-looking” statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and as defined in the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements can be identified by terminology such as “will,” “expects,” “anticipates,” “future,” “intends, “plans,” “believes,” “estimates” and similar statements. Among other things, the quotations from management in this press release and the Company’s operations and business outlook, contain forward-looking statements. Such statements involve certain risks and uncertainties that could cause actual results to differ materially from those in the forward-looking statements. Further information regarding these and other risks is included in JinkoSolar’s filings with the U.S. Securities and Exchange Commission, including its annual report on Form 20-F. Except as required by law, the Company does not undertake any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.

For investor and media inquiries, please contact:

In China:

Ms. Ripple Zhang
JinkoSolar Holding Co., Ltd.
Tel: +86 21-5183-3105
Email: [email protected]

Mr. Rene Vanguestaine
Christensen
Tel: + 86 178 1749 0483
Email: [email protected]

In the U.S.:

Ms. Linda Bergkamp
Christensen, Scottsdale, Arizona
Tel: +1-480-614-3004
Email: [email protected]

View original content:http://www.prnewswire.com/news-releases/jinkosolar-to-report-third-quarter-2020-results-on-december-7-2020-301181096.html

SOURCE JinkoSolar Holding Co., Ltd.

STOCKHOLM, Nov. 27, 2020 /PRNewswire/ —

Numbers in parentheses refers to outcomes during the corresponding period of the previous year.

• Revenues of SEK 0 million (0).
• Other operating income of SEK 0.3 million (0.9) mainly pertaining to grants.
• Operating costs decreased to SEK 0.7 million (1.3). Administrative expenses decreased to SEK 3.3 million (7.1). The comparable period last year was affected by IPO related costs.
• Profit (loss) for the period amounted to SEK -3.5 million (-8.2).
• Earnings per share of SEK -0.1 (-0.3).
• As of 30 September 2020, cash and cash equivalents amounted to SEK 93 million (108) and shareholders’ equity amounted to SEK 91 million (105). Total number of outstanding shares amounted to 35,194,844 (34,997,194).
• Cash flow from operating activities increased to SEK -5.3 million (-14.6) due to lower costs.
• Average number of employees of 17 (14).

Significant events in the quarter

• EWP EDF One Project- In a significant regulatory milestone, Eco Wave Power secured an engineering coordination permit from the Municipality of Tel-Aviv Jaffa (permit number 2020-4345) required for the deployment of the grid-connection works of the EWP-EDF One wave energy project in the Port of Jaffa, Israel.
• 
  Portugal– Eco Wave Power established EW Portugal – Wave Energy Solutions, Unipessoal lda, a wholly owned subsidiary in Porto, Portugal. The strategic decision will enable Eco Wave Power to commence official licensing procedures for its planned wave energy project in Portugal, as part of the company’s newly signed 20MW Concession Agreement with the Port Authority of Leixões, APDL.
• 
  Gibraltar– Eco Wave Power announced performance improvements and significant cost reductions from its Gibraltar wave energy project. In 2018-2019, power production performance of the array reached 70% of the forecasted output for the site, as compared to 31% in 2017-2018. Furthermore, direct maintenance and repair costs decreased from 18% of project cost in 2017, to 9% in 2018 and 4% in 2019. The results will undergo independent verification by Dr. Guang Li, an expert in ocean energy at the Queen Mary University of London.
• New Projects in the Pipeline- Eco Wave Power entered two new letters of Intent; a 2MW LOI with the Port of Shoreham in the UK and an LOI with Diamond Energy for an up to 20MW PPA in Australia. Given these new agreements, the company’s projects pipeline, expanded to 254MW, which is a 64MW increase from the projects pipeline communicated in 2019. This reinforces the growing global commitment and interest in the Eco Wave Power Technology.
• Patents- Patents number 254987 and 254990 were approved for registration.
• Awards and Recognitions- This quarter, Eco Wave Power continues to receive industry accolades. Fast Company, selected Inna Braverman, as one of the world’s 74 “Most Creative People in Business for 2020″, and Eco Wave Power was recognized by Sifted.eu as one of the “European tech pioneers shaping the post-pandemic world”, in addition to becoming the recipient of the Green Innovation Award by the UK Department of International Trade.

Significant events after the reporting date

•  In a EWP EDF One Project- Eco Wave Power announced the development of a new preventative-predictive and corrective smart Wave Power Verification (WPV) software. The software can speed up efficiency verification of the different sub systems of wave energy generation technologies, as well as detect failures in wave modules instantly. It will achieve its first trial launch in the EWP-EDF One project, which is financed by the Israeli Energy Ministry and EDF Renewables IL.
• 
  Portugal– Eco Wave Power announced a strategic collaboration with Painhas Engineering and Construction Company for the technical support for the licensing of 20MW Portugal Project. Painhas will take an integral part in the technical support needed for the official licensing procedures for the planned wave energy project in Portugal, as part of the newly signed 20MW Concession Agreement with the Port Authority of Leixões – APDL. Once licensing is obtained, the parties will work towards a continued collaboration for the execution of the project.
• New Projects in the Pipeline- Eco Wave Power has entered a 20MW Letter of Intent with the Port of Bilbao, in Spain. In addition, Eco Wave Power has entered an MOU Agreement with MSMART Future Technology. The collaboration between the parties shall be executed in milestones. In the first phase, Eco Wave Power will perform an in-depth feasibility study, at the selected site in Vietnam and once studies are completed, the companies will work towards the establishment of a Joint Venture company for the development of a 50MW wave energy array.
• Awards and Recognitions- Eco Wave Power has been invited to join 14 other leading entrepreneurs from across the UK & Europe for the first ever virtual iteration of the Unreasonable Impact programme, which aims to accelerate the growth of their companies. Unreasonable Impact is an innovative multi-year multi-geographic partnership between Barclays and Unreasonable Group to launch the world’s first global network focused on scaling up entrepreneurial solutions that will help employ thousands worldwide in the emerging green economy. In addition, Meaningful Business, a global platform for leaders combining profit and purpose, has recognised Eco Wave Power of as a Meaningful Business 100 (MB100) leader for 2020 and Eco Wave Power was shortlisted for the Falling Falls Science Breakthrough of the year in the Engineering and Technology Category. Falling Walls promotes ground-breaking ideas across borders and disciplines and brings together innovators from around the world. 
• Moreover, we were extremely honored to be featured on RE:TV by the Sustainable Markets Initiative, curated by editor-in-chief, His Royal Highness, Prince Charles of Wales. It showcases inspiring innovations and ideas that point towards a sustainable future.

A Word From the CEO

“We now at last have a hugely important opportunity to reimagine our world through the lens of Sustainable Markets, and to put people and planet at the heart of global value creation.” – HRH Prince Charles, Prince of Wales.

Prior to the pandemic, more than 800 million people worldwide lacked access to electricity. Billions more have their potential diminished by unreliable or insufficient energy access, predominantly provided by carbon-emitting fuels. The energy accessibility gap has further widened because of the pandemic. This year alone, more than 100 million people have seen their electricity access severed because they couldn’t pay their bills during the pandemic, with the toll falling disproportionately on the poor and most vulnerable. The World Bank estimates that the combined impact of climate change and the damage done by Covid-19 will push 132 million people into poverty.

“There’s no going back to the past, to before-Covid. We need to reimagine the future we want,” said Dr. Rajiv J. Shah, President of the Rockefeller Foundation. “To meet this moment, we must leverage all our resources and relationships to build an equitable, sustainable future, where everyone has the opportunity to realize their full potential and climate disaster is avoided. The time to act is right now to make sure vulnerable children and families are included in the pandemic response and recovery.”

The Rockefeller Foundation committed to invest 1 Billion USD over the next three years to catalyse a more inclusive, green recovery from the Covid-19 pandemic. Other prominent leaders, governments, and organizations are also rising to the occasion and have committed to advancing significant and ground-breaking green recovery plans. For example, in June 2020, the EU launched a €750bn coronavirus recovery package of which 37% of the funding was to be allocated towards green initiatives that improve energy efficiency, reduce dependence on fossil fuels, and invest in preserving and restoring nature.⁴ Also, The Sustainable Markets Initiative, was launched by HRH Prince Charles of Wales, in response to the increasing threats posed by climate change and biodiversity loss.

In this quarter, Eco Wave Power is proud to be profiled in the Sustainable Market Initiative by HRH Prince of Wales, The World Economic Forum, and the Bank of America. The initiative reinforces the rising commitment of global leaders for the implementation of clean and sustainable energy production solutions, to catalyse green recovery from the Covid-19 pandemic and stresses the fact that now more than ever, wave energy is being acknowledged as a significant part of the green recovery plan.

Here, at Eco Wave Power, we are humbly accepting such acknowledgment with the understanding that we hold great responsibility for the future of our planet. As a result, in Q3, Eco Wave Power’s team has performed an admirable and mission-driven work, thus making me identify this quarter with the acronym “PAIRS”. I deem the acronym “PAIRS” as suitable, as everyone worked together in great harmony, towards a joint mission.

Personally, I found it the team work remarkable, especially given the unexpected hardships presented by Covid-19. Our efforts this quarter, have resulted in the following:

1. Projects Progress
2. Awareness
3. Increasing Pipeline Projects Intake
4. Reinforcing Financial Position
5. Successfully Expanding the Company’s Product Offering

Projects Progress- In terms of our projects, we have seen important progress in our EWP-EDF One project (Israel) and our planned project in Portugal. During this quarter, our company has secured the engineering coordination permit necessary for the deployment of the grid-connection works and is working towards the finalization of the software for our second grid connected power station.

Whereas in Portugal we have established a local subsidiary and commenced collaboration with Painhas Engineering and Construction company in Portugal to accomplish the licensing for the APDL project in an efficient and timely manner.

Awareness- In terms of awareness and recognition, during this quarter, our company has enjoyed increased visibility in high profile media outlets and organizations; The company was  featured and recognized by Fast Company as “Most Creative People in Business”, by Sifted as “European tech pioneers shaping the post-pandemic world”, in addition to becoming the recipient of the Green Innovation Award by the UK Department of International Trade. Moreover, Meaningful Business, has recognised Eco Wave Power as a Meaningful Business 100 (MB100) leader for 2020 and Eco Wave Power was shortlisted for the Falling Falls Science Breakthrough of the year in the Engineering and Technology Category. Furthermore, we were extremely honored to be featured on RE:TV by the Sustainable Markets Initiative, curated by editor-in-chief, His Royal Highness, Prince Charles of Wales. It showcases inspiring innovations and ideas that point towards a sustainable future.

Increasing Pipeline Projects Intake- By working digitally over the past quarter we have been able to effectively respond to the continued heightened interest for our technology that we have been witnessing, due to  increase in awareness and recognition for the company’s work. Customers are vastly more accepting of digital meetings, allowing us to conduct multiple meetings with people on different continents in a single day. This resulted in three new letters of Intent; a 2MW LOI with the Port of Shoreham in the UK and an LOI with Diamond Energy for an up to 20MW PPA in Australia, as well as a 20MW LOI with the Port of Bilbao in Spain. This reinforces the growing global commitment and interest in the Eco Wave Power Technology.

Reinforcing Financial Position- During this quarter our business development team has worked towards the submission of several large-scale grants, aimed at supporting Eco Wave Power’s R&D efforts, as well as the company’s commercial roll-out plan. Securing these grants, will have significant value for the Eco Wave Power shareholders and for our commercialization process.

Successfully expanding the company’s products offering- In our annual report, we communicated that our company is planning to expand its product offering by providing increased project development products and services. One of the services presented in the report, was commencing feasibility studies for our potential clients, which will add costumer value and provide an additional revenue stream for the company. In this quarter, I am very pleased to present that we have achieved this goal, with the first MOU and Feasibility Study Agreement signed with MSMART Future Technology in Vietnam, and several additional such agreements on the way (to be announced soon). In addition, we are even further expanding our product portfolio through the development of our new preventative-predictive and corrective smart Wave Power Verification (WPV) software. As soon as we will finalize the software’s development, we will add it to our product portfolio and position Eco Wave Power not only as a technology provider, but also as a world-leader in a proprietary software for the growth of the whole industry.  We plan to release the software for use by third parties, such as other wave energy developers, as well as relevant research institutions and leading universities, through unique licensing agreements. We strongly believe that the production of clean electricity from the waves is an important segment for the fight against climate change and are looking forward to contributing to the sector’s rapid development and commercialization.

In summary, I feel content with the PAIRS quarter, as we have worked purposefully while continuously ticking off important interim goals along the way of our main objective, which is wave energy commercialization. 

Kind Regards
Inna Braverman
CEO

For the full interim report, please click here.

About EWPG Holding AB

EWPG Holding AB (publ) (“Eco Wave Power”) is a leading onshore wave energy technology company that developed a patented, smart and cost-efficient technology for turning ocean and sea waves into green electricity. Eco Wave Power’s mission is to assist in the fight against climate change by enabling commercial power production from sea and ocean waves.

EWP is recognized as a “Pioneering Technology” by the Israel’s Ministry of Energy and was labelled as an “Efficient Solution” by the Solar Impulse Foundation. Furthermore, EWP’s project in Gibraltar has received funding from the European Union Regional Development Fund and from the European Commission’s HORIZON2020 framework program. The company was also recently recognized by the United Nations in receiving the “Climate Action Award”, which was granted to the company during COP25 in Madrid, Spain.

The Eco Wave Power share (ECOWVE) is traded on Nasdaq First North Growth Market. Read more about Eco Wave Power at: www.ecowavepower.com.

FNCA Sweden AB is Certified Advisor of the Company (+46 8-528 00 399, [email protected]).

This information is information that the Company is required to disclose under the EU Market Abuse Regulation. The information was provided by the contact persons below for publication on 27 November 2020 at 08.00 CET.

For more information, please contact:

Inna Braverman, CEO
[email protected]
+972 350 940 17

Andreas Kihlblom, CFO
[email protected]
+46 (0)8 420 026 94

This information was brought to you by Cision http://news.cision.com

https://news.cision.com/ewpg-holding-ab–publ-/r/interim-report-for-the-period-1-january—30-september-2020,c3242235

The following files are available for download:

View original content:http://www.prnewswire.com/news-releases/ewpg-holding-ab-interim-report-for-the-period-1-january–30-september-2020-301181095.html

SOURCE EWPG Holding AB (publ)

TOKYO, Nov. 27, 2020 /PRNewswire/ — Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) and FibroGen, Inc. (Nasdaq: FGEN, CEO: Enrique Conterno, “FibroGen”) today announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) approved EVRENZO^® (roxadustat) for the treatment of anemia of chronic kidney disease (CKD) in adult patients not on dialysis. This marks the second approval in Japan for roxadustat through the Astellas and FibroGen collaboration, after the therapy was approved and launched for use in adult patients with anemia of CKD on dialysis last year.

“We are delighted roxadustat is now approved in Japan for adults with anemia of CKD not on dialysis, as it allows even more patients to access this important new treatment option,” said Bernhardt G. Zeiher, M.D., Chief Medical Officer, Astellas. “With its novel mechanism of action and oral administration, we hope roxadustat will alleviate some of the burden associated with anemia of CKD prior to the initiation of dialysis and deliver meaningful improvements in the lives of these patients.”

This approval is based on results obtained from three clinical studies in more than 500 Japanese patients with anemia of CKD not on dialysis. The first, an open-label Phase 3 conversion study versus active comparator, darbepoetin alfa, met the primary efficacy endpoint of non-inferiority and continued to demonstrate maintenance of hemoglobin (Hb) levels over time.¹ Roxadustat was generally well tolerated, and the safety profile was comparable with that of darbepoetin alfa.¹ The other two studies (one Phase 3 and one Phase 2) support the safety and efficacy of roxadustat in erythropoiesis-stimulating agent (ESA)-untreated patients.^2,3

“Today’s approval is another milestone achievement for both FibroGen and Astellas,” said K. Peony Yu, M.D., Chief Medical Officer, FibroGen. “By bringing roxadustat to adult patients living with anemia of CKD, both on dialysis and not on dialysis, we are continuing our efforts to meet the significant unmet medical need of patients in this community.”

The approval of the supplementary New Drug Application (sNDA) for roxadustat in Japan for the treatment of anemia of CKD in adult patients not on dialysis triggers a milestone payment of $15 million by Astellas to FibroGen.

As a first-in-class orally administered inhibitor of hypoxia-inducible factor (HIF) prolyl hydroxylase (PH), roxadustat increases Hb levels through a mechanism of action that is different from that of traditional ESAs. As a HIF-PH inhibitor, roxadustat activates the body’s natural protective response to reduced oxygen levels in the blood. This response involves the regulation of multiple, coordinated processes that lead to the correction of anemia.

Product Information

About Clinical Trials
For more information about the clinical trials associated with this approval (1517-CL-0310, 1517-CL-0314, 1517-CL-0303), please visit www.clinicaltrials.gov.

About CKD and Anemia
CKD is characterized by a progressive loss of kidney function caused by damage to the kidneys resulting from conditions such as hypertension, diabetes or immune-regulated inflammatory conditions.^4,5 Worldwide, 1 in 10 people are living with CKD.⁶ In Japan specifically, the prevalence of CKD has increased significantly over time.⁷ Although CKD can occur at any age, it becomes more common in aging populations and the prevalence is increasing.⁸ In addition, CKD is predicted to become the fifth most common cause of premature death by 2040 globally.⁹ It is a critical worldwide healthcare issue that represents a large and growing unmet medical need.

Anemia is a common complication of CKD,¹⁰ resulting from the failing kidneys’ ability to produce erythropoietin, reduced oxygen sensing, and increased hepcidin and iron deficiency resulting from chronic inflammation. Anemia affects approximately one-third of Japanese patients with Stage 3–5 CKD.¹¹ It is associated with significant morbidity and mortality in dialysis and non-dialysis populations, increasing in both prevalence and severity as kidney disease worsens.¹² Anemia of CKD increases the risk of adverse cardiovascular events, worsens renal outcomes and can negatively impact patients’ quality of life.^13-15

About Roxadustat
Roxadustat is a first-in-class orally administered inhibitor of HIF-PH, which increases hemoglobin levels through a mechanism of action that is different from that of traditional ESAs. As a HIF-PH inhibitor, roxadustat activates a response that occurs naturally when the body responds to reduced oxygen levels in the blood. Roxadustat promotes red blood cell production through increased endogenous production of erythropoietin; improved iron absorption, transport and mobilization; and downregulation of hepcidin, which helps to overcome the negative impact of inflammation on hemoglobin synthesis and red blood cell production.

Roxadustat is approved and launched for the treatment of anemia of CKD in Japan and China in adult patients on dialysis (DD) and not on dialysis (NDD). A New Drug Application for the treatment of anemia of CKD in patients both DD and NDD is under review by the U.S. Food and Drug Administration with a decision expected in December 2020. The marketing authorisation application for roxadustat for the treatment of anemia of CKD in patients both DD and NDD was accepted by the European Medicines Agency for review. Several other licensing applications for roxadustat have been submitted by Astellas and AstraZeneca to regulatory authorities across the globe, which are currently in review.

Astellas and FibroGen are collaborating on the development and commercialization of roxadustat for the potential treatment of anemia in territories including Japan, Europe, Turkey, Russia and the Commonwealth of Independent States, the Middle East and South Africa. FibroGen and AstraZeneca are collaborating on the development and commercialization of roxadustat for the potential treatment of anemia in the U.S., China and other markets in the Americas and in Australia/New Zealand as well as Southeast Asia.

About Astellas
Astellas Pharma Inc., is a pharmaceutical company conducting business in more than 70 countries around the world. We are promoting the Focus Area Approach that is designed to identify opportunities for the continuous creation of new drugs to address diseases with high unmet medical needs by focusing on Biology and Modality. Furthermore, we are also looking beyond our foundational Rx focus to create Rx+^® healthcare solutions that combine our expertise and knowledge with cutting-edge technology in different fields of external partners. Through these efforts, Astellas stands on the forefront of healthcare change to turn innovative science into value for patients. For more information, please visit our website at https://www.astellas.com/en.

About FibroGen
FibroGen, Inc. is a biopharmaceutical company committed to discovering, developing and commercializing a pipeline of first-in-class therapeutics. The company applies its pioneering expertise in hypoxia-inducible factor (HIF) and connective tissue growth factor (CTGF) biology to advance innovative medicines for the treatment of unmet needs. The Company is currently developing and commercializing roxadustat, an oral small molecule inhibitor of HIF prolyl hydroxylase activity, for anemia associated with chronic kidney disease (CKD). Roxadustat is also in clinical development for anemia associated with myelodysplastic syndromes (MDS) and for chemotherapy-induced anemia (CIA). Pamrevlumab, an anti-CTGF human monoclonal antibody, is in clinical development for the treatment of idiopathic pulmonary fibrosis (IPF), locally advanced unresectable pancreatic cancer (LAPC), Duchenne muscular dystrophy (DMD), and coronavirus (COVID-19). For more information, please visit www.fibrogen.com.

Astellas Cautionary Notes
In this press release, statements made with respect to current plans, estimates, strategies and beliefs, and other statements that are not historical facts are forward-looking statements about the future performance of Astellas. These statements are based on management’s current assumptions and beliefs in light of the information currently available to it and involve known and unknown risks and uncertainties. A number of factors could cause actual results to differ materially from those discussed in the forward-looking statements. Such factors include, but are not limited to: (i) changes in general economic conditions and in laws and regulations, relating to pharmaceutical markets, (ii) currency exchange rate fluctuations, (iii) delays in new product launches, (iv) the inability of Astellas to market existing and new products effectively, (v) the inability of Astellas to continue to effectively research and develop products accepted by customers in highly competitive markets and (vi) infringements of Astellas’ intellectual property rights by third parties.

Information about pharmaceutical products (including products currently in development) that is included in this press release is not intended to constitute an advertisement or medical advice.

FibroGen Forward-Looking Statements
This release contains forward-looking statements regarding FibroGen’s strategy, future plans and prospects, including statements regarding the development of the company’s product candidates, the potential safety and efficacy profile of our product candidates, our clinical and regulatory plans and the commercial plans of our partners. These forward-looking statements include, but are not limited to, statements about our plans, objectives, representations and contentions and are not historical facts and typically are identified by use of terms such as “may”, “will”, “should”, “on track”, “could”, “expect”, “plan”, “anticipate”, “believe”, “estimate”, “predict”, “potential”, “continue” and similar words, although some forward-looking statements are expressed differently. Our actual results may differ materially from those indicated in these forward-looking statements due to risks and uncertainties related to the clinical, regulatory and commercial operations and results, and other matters that are described in our Annual Report on Form 10-K for the fiscal year that ended December 31, 2019 and our quarterly report on 10-Q for the fiscal quarter that ended June 30, 2020 filed with the Securities and Exchange Commission, including the risk factors set forth therein. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release, and we undertake no obligation to update any forward-looking statement in this press release, except as required by law.

 

 

View original content to download multimedia:http://www.prnewswire.com/news-releases/astellas-receives-approval-of-evrenzo-roxadustat-in-japan-for-the-treatment-of-anemia-of-chronic-kidney-disease-in-adult-patients-not-on-dialysis-301181047.html

SOURCE Astellas Pharma Inc.

SHENZHEN, China, Nov. 26, 2020 /PRNewswire/ — OneConnect Financial Technology Co., Ltd. (NYSE: OCFT), the leading technology-as-a-service platform provider and an associate of Ping An Insurance Group, reaffirms its commitment as the trusted tech partner for financial institutions in Malaysia with the launch of its new entity, OneConnect Smart Technology (Malaysia) Sdn Bhd. In line with its Southeast Asia expansion strategy, Malaysia is a key growth engine where OneConnect plans to build a local team that stands ready to serve financial institutions across Malaysia and support its regional projects. The launch was graced by Dato’ Ng Wan Peng, Chief Operating Officer of the Malaysia Digital Economy Corporation (MDEC).

Malaysia’s fintech space is thriving

Bank Negara Malaysia (BNM) has launched several initiatives in a move to embrace financial inclusion and the shift in banking habits towards digital channels. These include the announcement last year that it will issue new digital banking licenses and the publication of an Electronic Know-Your-Customer (eKYC) guideline on 30 June 2020. The move has given a boost to the nation’s banking and fintech players that are ready to accelerate digital transformation and adopt fintech innovations.

“Fintech had garnered lots of attention for its astonishing potential in impacting lives and changing economies. Since it appeared, fintech helped enable ordinary people to access financial products securely and efficiently. At the same time, it also accelerated the economic growths of many countries. In order to enhance the development of the fintech ecosystem for this country, the Malaysia Digital Economy Corporation (MDEC) will continue to engage start-ups, investors and innovators from around the world to yield positive outcomes via its continuous efforts in expanding and innovating the fintech industry. As OneConnect has established a regional presence in Malaysia, it reinforces the fact that Malaysia is an attractive investment destination. In fact, many fintech and data ecosystem players come to Malaysia specifically for its vibrant testbed environment and the multi-cultural background of its talent pool and their digital savviness and language proficiency in technical subjects,” shared Dato’ Ng Wan Peng, Chief Operating Officer, MDEC.

According to the e-Conomy SEA 2020 Report^[1], consumers and SMEs have adopted digital financial services like never before. In Malaysia, over the various Movement Control Order periods, many turned to the Internet for solutions to their challenges. A significant number tried new digital services – 36 per cent of all digital service consumers were new – with 92 per cent of these new consumers intending to continue their behaviour post-pandemic. Year-to-date, Malaysia has also seen a 33 per cent monthly active user growth for select mobile banking apps.

The scene is an important preamble to the ongoing digital transformation taking place in the financial landscape and it signifies a positive sign for OneConnect who has market-ready solutions for insurtech and full-stack digital banking technologies including end-to-end frictionless account opening and onboarding, smart lending, and an eKYC solution that recognises MyKad.

Committed to the growth of Malaysia’s financial sector

OneConnect is committed to being the trusted tech enabler in digital transformation for financial institutions.

Backed by Ping An’s 32 years of experience in the financial industry and an extensive track record as the tech enabler, OneConnect is able to bring to Malaysia the breadth and depth of proven solutions, and journey with its clients through their digital transformation roadmap.

Echoing the same, Tan Bin Ru, CEO (Southeast Asia) of OneConnect Financial Technology, said, “Malaysia is of strategic importance to OneConnect. The country is home to five local banks that are 20 of Southeast Asia’s largest banks, enjoying strong regional presence. Bank Negara Malaysia’s decision to open its door to digital banking bodes well for our Southeast Asia expansion strategy. One of our unique value propositions that our clients value much is the breadth and depth of our solutions which becomes a breeze when they can have a single strategic tech partner to integrate a full suite of digital solutions and work alongside their team through phases of their transformation plan. We see a lot of potential in Malaysia and with our new office being set up, we will be able to contribute our deep market knowledge and ready solutions to the local banks and financial institutions in Malaysia.”

She added, “Having served all the major banks and more than half of the insurance companies in China, we have amassed extensive track records in enabling digital transformations for, and accumulated a wealth of bespoke experience in the banking, insurance and ecosystem realms. Since the setting up of our regional headquarters in Singapore in 2018, more than 50 clients across Southeast Asia and other parts of Asia, as well as the UAE and Europe have entrusted us to be their tech expert.” 

Serving the needs of leading financial institutions in Malaysia

OneConnect currently serves a global insurance player and three of the top five local banks in Malaysia It has collaborated with RHB Bank and another top five local bank where it collaborated on the development of two firsts-of-its-kind services that were launched in Malaysia recently. It is also collaborating with CIMB Philippines to enhance digital banking technologies in The Philippines.

OneConnect has partnered with RHB Bank to develop an omnichannel platform that fully digitalises the SME loan experience. The omnichannel platform – comprising the RHB Financing (SME) mobile app for customers, a sales app for the bank’s relationship managers and a seamless SME loan management website – utilises OneConnect’s artificial intelligence (AI) and eKYC technologies. Launched in August as Malaysia’s first AI-powered SME financing mobile app, the app automates and simplifies onboarding process where SMEs only need to submit two scanned documents – MyKad and a bank statement – via their mobile phones to apply for loans. The omnichannel platform lets RHB serve SMEs more efficiently by reducing the back-office processes and operating costs. The bank aims to provide RM500 million in financing facilities to support small businesses in the next year.

OneConnect also partnered with another top five local bank to develop a mobile banking app powered by its eKYC solution, making this the first eKYC solution approved by BNM to launch in Malaysia in October. The app is the first in Malaysia launched by a bank to deliver a truly digital onboarding experience without having to visit any physical branch. Customers can open an account and bank safely anytime and anywhere amidst the ongoing pandemic.

Yao Jing, Head of Strategy and Business Development (Singapore and Malaysia), OneConnect Financial Technology, said, “Our deep market knowledge and ready solutions for Malaysia aptly position us to meet the local needs. We are grateful for the trust and confidence that some of the largest financial institutions in Malaysia have given us and we will continue to deepen the relationships with our valued clients. We see ourselves as a strong tech player in this space, and are dedicated to supporting and enabling the digital banking ecosystem here. We will continue to forge collaborations and work closely with financial institutions and other stakeholders, including Bank Negara Malaysia, and nurture the local tech talents as we walk this journey of a transformational landscape together.”

OneConnect plans to hire local talents to grow a product and engineering team who will provide support for clients in Malaysia and have the opportunities to work on its regional projects.

About OneConnect Financial Technology

OneConnect (NYSE: OCFT) is a leading technology-as-a-service platform for financial institutions. The Company’s platform provides cloud-native technology solutions that integrate extensive financial services industry expertise with market-leading technology. The Company’s solutions provide technology applications and technology-enabled business services to financial institutions. Together they enable the Company’s customers’ digital transformations, which help them increase revenue, manage risks, improve efficiency, enhance service quality and reduce costs.

Our technology-as-a-service platform strategically covers multiple verticals in the financial services industry, including banking, insurance and asset management, across the full scope of their businesses – from sales and marketing and risk management to customer services, as well as technology infrastructure such as data management, program development, and cloud services.

Annex: Chinese Glossary

 

View original content:http://www.prnewswire.com/news-releases/oneconnect-financial-technology-cements-presence-in-malaysia-with-new-entity-launch-graced-by-mdec-301181093.html

SOURCE OneConnect

HELSINKI, Nov. 27, 2020 /PRNewswire/ — Strong momentum continues: first GMP campaign initiated, first dosing in humans to start before year-end, all near-term business targets set out in IPO to be achieved ahead of schedule, new global major pharma client signed, two new PoC projects started, one more non-GMP line commissioned and a new near-term business target introduced: “First Biologics PoC project in 2021”.

7-9/2020 key financials:

– Revenue was EUR 159 thousand, during 7-9/2019 there were no revenues.

– The gross profit and margin came in at EUR 101 thousand and 63%, during 7-9/2019 the gross profit was negative.

– The operating loss was EUR -3.8 million (operating loss was EUR -2.1 million in 7-9/2019).

– The loss for the period was EUR -4.2 million (EUR -2.2 million in 7-9/2019).

– Basic EPS was EUR -0.06(EUR -0.05).

– The number of employees grew to 68 at the end of 7-9/2020 (34 employees at the end of 7-9/2019).

– Cash position was EUR 66.6 million on September 30, 2020 (EUR 10.3m on September 30, 2019).

1-9/2020 key financials:

– Revenue was EUR 501 thousand and stemmed from nine different customer projects. In 1-9/2019 there were no revenues.

– The gross profit and margin came in at EUR 363 thousand and 72%, respectively. In 1-9/2019 the gross profit was EUR -182 thousand.

– The operating loss and the loss for the period were EUR -14.8 million and EUR -15.5 million, respectively. In 1-9/2019 the operating loss and the loss for the period were EUR -4.7 million and EUR -5.0 million, respectively.

– Basic EPS was EUR -0.29(EUR -0.12).

– EUR 79.9 million (gross) was raised in the IPO.

Significant events during 1-9/2020

– In January Nanoform USA Inc. (100% owned subsidiary in the US) was established.

– In March Nanoform signed two new agreements, one with a global major pharma company and one with Orion Corporation, a repeat customer.

 – In March two new non-GMP lines were commissioned.

– On April 7, at the AGM, Miguel Calado was appointed chairman of the Board of Directors, after being vice chairman for a year.

– In April Nanoform was awarded Good Manufacturing Practices (GMP) status by the Finnish Medicines Agency, FIMEA.

-In April the Company’s form was changed to a public limited liability company and the share capital was increased to EUR 80 thousand.

– Early June, EUR 79.9 million (gross) was raised in a successful IPO on Nasdaq First North Premier Growth Markets in Finland and Sweden. The considerably oversubscribed offering attracted strong interest from Global, European, and Nordic investors. Trading started on June 4, 2020.

– In June a proof-of-concept contract was signed with a UK Respiratory Biotech company.

– In June Nanoform expanded its US commercial team by appointing Eric Peter and Sergie Letser to drive the business development in the US, starting September 1, 2020.

– During 4-6/2020 one new non-GMP line was commissioned, taking our capacity to seven non-GMP lines and one GMP line on the small molecules side.

– In June Nanoform appointed Peter Hänninen as General Counsel, starting September 1, 2020.

– In July Nanoform’s near-term business target to acquire more new customers in 2020 than in 2019 was achieved, when Nanoform signed a contract with a West Coast US Biotech company.

– Cynthia Schwalm was appointed ordinary member of the Board of Directors at the EGM, September 1, 2020.

– In September, a new global major pharma customer was signed.

Significant events after 7-9/2020

– On October 20, a major milestone and mid-term business target was achieved when Nanoform announced that it had initiated its first GMP campaign for the first ever human trial of a drug candidate nanoformed using Nanoform’s proprietary CESS® technology. Dosing was announced to begin before year-end 2020 (previously: in 2021) and results are expected before the end of Q2/2021.

– In October Johanna Tuomisto was appointed HR Director, starting January 1, 2021. Johanna joins Nanoform from a position as HR Director for Thermo Fisher Scientific Oy in Finland. She holds a Master of Law degree from the University of Helsinki.

– In November, a new non-GMP line was commissioned, taking our capacity to eight non-GMP lines and one GMP line on the small molecules side.

– On November 27, a new near-term business target was announced: “First Biologics PoC in 2021”.

CEO’s review

In a fast-moving company where the focus is intensely on future goals and daily demands, the quarterly reports give me the opportunity to reflect on and measure what has been achieved since last reporting to you. These reports help me deliver on the annual goals.

During the last month Nanoform has reached two major milestones on its long-term trajectory:

(1) the first GMP campaign was initiated and before year-end dosing will start in the first-ever human trial of a drug candidate nanoformed using Nanoform’s proprietary CESS^® technology. This is something the founders of Nanoform and I have diligently worked towards for more than a decade. Results are expected before the end of Q2/2021 and we are waiting for them with excitement.

(2) our technology for Biologics is now ready to be introduced to pharma customers, hence our new near-term business target “First Biologics PoC in 2021”.Compared to the journey with our CESS^® technology for small molecules, I see a faster and clearer early path with lots of synergies and structures already in place (organization, GMP, QC, QA, PM, commercial etc.) and market position (brand awareness, client relationships etc.). Hence, we are all very excited, as the opportunities within Biologics are vast.

During Q3 Nanoform has continued to show strong momentum; in addition to the above mentioned, we have won additional clients, added line capacity, started new customer projects, doubled our sales force, strengthened our board, and continued to attract exceptional individuals from all over the world. For2020, the list of achievements is even longer: establishing a US subsidiary, getting a GMP certificate, dual-listing, raising EUR 80m, more than doubling the number of clients, more than tripling the number of projects running in parallel, almost doubling the number of employees and most importantly initiating our first GMP campaign and soon dosing in humans. And all this during the corona crisis tells something about our will to win.

Having met our near-term business targets set out ahead of the IPO, my focus is now on ensuring that Nanoform enters the next stage on its growth trajectory. By that I mean the world of GMP projects supplying material to clinical trials with the long-term vision to help a billion patients. We have added a new near-term business target and will in the coming months add a few more targets for 2021 and 2022. Our 2025 mid-term targets are unchanged.

None of this can be done without our amazing employees and great partners! My sincere THANK YOU to you all for your continued dedication to Nanoform and for the inspiring and innovative work for which we are known. Our journey has only begun, let’s make the next five years as exciting and fast paced as the first five have been!

Best Regards,

Prof. Edward Hæggström, CEO Nanoform

Company near-term business targets for 2020 and 2021

• to acquire more new customers in 2020 than in 2019 (achieved in July)
• to start its first GMP project before year-end 2020 (achieved on October 20th)
• first dosing in humans before year-end 2020 (changed from in 2021 on October 20^th)
• First Biologics PoC project in 2021 (new target)

Company mid-term business targets 2025 (unchanged)

• to nanoform at least 50 new Active Pharmaceutical Ingredients (API) annually
• to have in place 25 operating production lines of which 5 to 10 are expected to be GMP production lines
• over 90 percent gross margin
• approximately 200 employees
• to be cash flow positive

Nanoform’s complete Interim Report January – September 2020 can also be found at:
https://nanoform.com/en/financial-reports-and-presentations/

Nanoform 1-9/2020 Conference Call Friday November 27^th 15:00 p.m. Helsinki time (14:00 p.m.Stockholm time)

Nanoform will be represented by CEO Edward Hæggström, CFO Albert Hæggström, CTO Niklas Sandler, CCO Christian Jones and CBO Gonçalo Andrade. The presentation will be delivered in English.

The presentation will be broadcast live as a webcast available at: https://financialhearings.com/event/13383

Teleconference dial-in numbers:

Finland: +358981710521

Sweden: +46856642692

United Kingdom: +443333009263

United States: +18332498407

For further information, please contact:

Albert Hæggström, CFO
[email protected] / +358 29 370 0150

For investor relations queries, please contact:

Henri von Haartman, Director of Investor Relations
[email protected] / +46 7686 650 11

About Nanoform

Nanoform is an innovative nanoparticle medicine enabling company. Nanoform works together with pharma and biotech partners globally to provide hope for patients in developing new and improved medicines utilizing Nanoform’s platform technologies. The Company focuses on reducing attrition in clinical trials and on enhancing drug molecules’ formulation performance through its nanoforming services. Nanoform’s capabilities span the small to large molecule development space and the company focuses on solving key issues in drug solubility and bioavailability and on enabling novel drug delivery applications. Nanoform’s shares are listed on the Premier-segment of Nasdaq First North Growth Market in Helsinki (ticker: NANOFH) and Stockholm (ticker: NANOFS). Certified Adviser: Danske Bank A/S, Finland Branch, +358 40 562 1806. For more information please visit http://www.nanoform.com

Forward-Looking Statements

This press release contains forward-looking statements, including, without limitation, statements regarding Nanoform’s strategy, business plans and focus. The words “may,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “target” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, any related to Nanoform’s business, operations, clinical trials, supply chain, strategy, goals and anticipated timelines, competition from other companies, and other risks specified in Nanoform’s prospectus published (on May 22, 2020) in connection with Nanoform’s initial public offering (the “Prospectus”) under “Risk Factors” and in our other filings or documents furnished to the Finnish Financial Supervisory Authority in connection with the Prospectus. Nanoform cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. Nanoform disclaims any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. Any forward-looking statements contained in this press release represent Nanoform’s views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date.

This information was brought to you by Cision http://news.cision.com

https://news.cision.com/nanoform/r/nanoform-finland-plc–interim-report-january—september-2020–november-27-th–2020-at-08-00-a-m–fi,c3244568

The following files are available for download:

View original content:http://www.prnewswire.com/news-releases/nanoform-finland-plc-interim-report-january—september-2020-november-27th-2020-at-0800-am-finnish-time-301181091.html

SOURCE Nanoform