BANGKOK � Southeast Asia, seeking a long term agreement to settle disputes in the South China Sea, faces new challenges as China moves to extend its regional influence with plans for a scientific station on islets close to the Philippines.
The concerns come as analysts say the United States' Asia policy is currently focused on rising tensions on the Korean Peninsula.
Philippine President, Rodrigo Duterte, currently chairman of the Association of South East Asian Nations (ASEAN), this week held talks with regional partners Myanmar and Thailand.
Freedom of navigation
Following talks in Bangkok with Thailand's Prime Minister Prayut Chan-o-cha, the countries agreed to promote freedom of navigation in the South China Sea as a core value in securing peace and prosperity in the region.
Maintaining peace, stability and security as well as respecting freedom of navigation and over-flight in the South China Sea, are in the interests of all countries, within an outside the region, as they are fundamental conditions for growth, development and prosperity, Duterte said.
Thai analyst Kavi Chongkittavorn said Thailand and the Philippines hope to have a code of conduct framework completed by July, to then add nuts and bolts to the agreement.
Code of conduct
ASEAN's long time goal has been to press ahead with implementation of a 2002 declaration on the conduct of parties in the South China Sea or code of conduct. But Beijing has long resisted completing a legally binding code, leading to divisions within ASEAN.
However, China is to host a meeting of ASEAN in May on the Code of Conduct framework, with diplomats hoping on progress towards a legally-binding document to manage regional disputes.
Environmental monitoring station
But the talks in Bangkok follow official Chinese media reports saying Beijing may be preparing to install an environmental monitoring station at Scarborough Shoal, which sits inside the Philippines' 200 nautical mile exclusive economic zone. The Chinese foreign ministry denied those reports Wednesday.
In 2016 China pressed ahead with consolidating its military position on the Spratly Islands, including runways on Fiery Cross, Subi and Mischief Reefs, reinforced hangers to accommodate fighter jets as well as other defenses, improving port facilities and installing radar.
The U.S., which has carried out military exercises near Scarborough Shoal, strongly opposed any Chinese construction there under former President Obama.
US attention now focused on North Korea
But analysts say President Donald Trump's administration is preoccupied with tensions on the Korean peninsula, where North Korea has been testing rockets.
Carl Thayer, a defense analyst at Australia's University of New South Wales, said Washington's attention has shifted from the South China Sea issue.
The South China Sea has been lost. It's just not on the radar. It is there but it's like a pot that's been put on the burner and the heat has been turned down. Everybody else is looking at not moving a fire on the main cooking pot � and that's North Korea, Thayer said.
China is strengthening claims
Analysts say uncertainties over the U.S. policy towards the South China Sea and a comprehensive strategy for Asia generally has enabled China to adopt a stronger position to its claims to the region.
James Chin, director of the Asia Institute at the University of Tasmania, said the uncertainties over the U.S. policy have led to disappointment within ASEAN.
Now they think it's going to be a stalemate and people are thinking that the Americans only worry about North Korea and the North Korean crisis. They don't worry about the South China Sea, Chin said.
Now all bets are off. The problem with this approach it that the longer you leave the South China Sea alone, it means to give more time to the Chinese to keep building military bases, he said.
China nears de-facto control
Once China builds on reclaimed land on the Scarborough Shoal, it means they will have de-facto control of the South China Sea.
Thayer said a Chinese airfield on the Shoal would be strategically significant completing a triangle linking Woody Island in the Parcels, the occupied features in the Spratly Islands, giving China the ability to monitor all aircraft and surface ships passing over or through the South China Sea.
[But] they will allow freedom of navigation because China is essentially a trading nation. So they will not disturb the freedom of navigation � so that's the positive, said Chin.
China claims much of the South China Sea through the so-called nine dash line that extends near Malaysia, Brunei, the Philippines and Vietnam.
Source: Voice of America
RedHill Biopharma Announces First Patient Dosed in the Open-Label Extension Study to the Phase III Study with RHB-104 for Crohn’s Disease
- A first randomized, double-blind, placebo-controlled Phase III clinical study with RHB-104 for the treatment of Crohn’s disease (the MAP US study) is ongoing in the U.S. and additional countries
- The open-label extension study (the MAP US2 study) is intended to assess the safety and efficacy of RHB-104 in patients who have completed 26 weeks of treatment in the ongoing MAP US Phase III study and remain with active Crohn’s disease (CDAI>150); these patients have the opportunity to receive treatment with RHB-104 for a 52-week period in the open-label extension study
- The MAP US2 open-label extension study is considered separate from the ongoing MAP US Phase III study and data collected will be supplemental to the MAP US study data
- A second independent DSMB meeting for the MAP US Phase III study is expected in mid-2017, including an interim efficacy analysis and an evaluation of an option for early stop for success for overwhelming efficacy
- RHB-104 is a proprietary, orally-administered, potentially groundbreaking antibiotic combination therapy with potent intracellular, antimycobacterial and anti-inflammatory properties
TEL-AVIV, Israel, March 21, 2017 (GLOBE NEWSWIRE) — RedHill Biopharma Ltd. (NASDAQ:RDHL) (Tel-Aviv Stock Exchange:RDHL) (“RedHill” or the “Company”), a specialty biopharmaceutical company primarily focused on the development and commercialization of late clinical-stage, proprietary, orally-administered, small molecule drugs for gastrointestinal and inflammatory diseases and cancer, today announced dosing of the first patient in the open-label extension study to the Phase III study with RHB-104 for the treatment of Crohn’s Disease (the MAP US study).
RHB-104 is a proprietary, orally-administered, potentially groundbreaking antibiotic combination therapy with potent intracellular, antimycobacterial and anti-inflammatory properties.
The MAP US study is a randomized, double-blind, placebo-controlled first Phase III study, intended to evaluate the safety and efficacy of RHB-104 in patients with moderately to severely-active Crohn’s disease (defined as Crohn’s Disease Activity Index (CDAI) between 220 and 450). To date, 266 patients out of a planned total of 410 patients have been enrolled in the study, which is being conducted in up to 150 clinical sites in the U.S, Canada, Europe, Israel, Australia and New Zealand. A long-term population pharmacokinetic (pop-PK) study is also ongoing as part of the MAP US study. Additional studies will be required to support a U.S. New Drug Application (NDA) for RHB-104.
The open-label extension study (the MAP US2 study) is intended to assess the safety and efficacy of RHB-104 in patients who have completed 26 weeks of treatment in the ongoing MAP US Phase III study and remain with active Crohn’s disease (CDAI>150) at week 26, the MAP US study’s primary endpoint. These patients have the opportunity to receive treatment with RHB-104 for a 52-week period in the open-label extension study. This study is considered separate from the ongoing MAP US Phase III study, and data collected will be supplemental to the MAP US study data. The open-label extension study’s primary endpoint is disease remission at week 16, defined as CDAI less than 150. The open-label extension MAP US2 study is planned to enroll approximately 100 subjects in up to 150 clinical sites in the U.S., Canada, Europe, Israel, Australia and New Zealand. Additional open-label studies with RHB-104 for Crohn’s disease are being planned by RedHill, to provide further supportive clinical data for potential future marketing applications.
A second independent Data and Safety Monitoring Board (DSMB) meeting of the MAP US Phase III study, expected in mid-2017, will include an interim efficacy analysis and will evaluate the option for an early stop for success for overwhelming efficacy, according to a pre-specified statistical significance threshold. Assuming the study is not stopped for success or inefficacy following the DSMB meeting in mid-2017, completion of recruitment for the MAP US study is expected by the end of 2017. In December 2016, a first, pre-planned independent DSMB meeting reviewed safety data from the ongoing MAP US study and provided a unanimous recommendation to continue the study as planned.
The development of RHB-104 is based on increasing evidence supporting the hypothesis that Crohn’s disease, and potentially other autoimmune diseases, are related to Mycobacterium avium subspecies paratuberculosis (MAP) infection in susceptible patients. The development of RHB-104 is consistent with the growing awareness of the possibility that a bacterially-induced dysregulated immune system may contribute to the pathogenesis of various autoimmune diseases of unknown etiology.
The MAP US Phase III study is registered on www.ClinicalTrials.gov, a web-based service of the U.S. National Institutes of Health, which provides access to information on publicly and privately supported clinical studies.
Currently in a first Phase III study for the treatment of Crohn’s disease (the MAP US study), RHB-104 is a proprietary, orally-administered, potentially groundbreaking oral antibiotic combination therapy, with potent intracellular, antimycobacterial and anti-inflammatory properties. RHB-104 is based on increasing evidence supporting the hypothesis that Crohn’s disease is caused by Mycobacterium avium subspecies paratuberculosis (MAP) infection in susceptible patients. Clinical trials conducted with earlier formulations of RHB-104 include an Australian Phase III study conducted by Pharmacia/Pfizer. RedHill has conducted several supportive studies with the current formulation of RHB-104 and a long-term population pharmacokinetic (pop-PK) study is ongoing as part of the Phase III MAP US study. Additionally, an open-label extension study (the MAP US2 study) is ongoing to assess the safety and efficacy of RHB-104 in patients who have completed 26 weeks of treatment in the ongoing Phase III MAP US study and remain with active Crohn’s disease (CDAI>150) at week 26. RHB-104 is covered by several issued and pending patents. RedHill has also completed a Phase IIa, proof-of-concept clinical study, evaluating RHB-104 as an add-on therapy to interferon beta-1a in patients treated for relapsing-remitting multiple sclerosis (the CEASE MS study). Top-line final results from the CEASE MS study suggest meaningful positive safety and clinical signals upon 24 weeks of treatment with RHB-104 as an add-on therapy, thereby supporting further clinical development.
About RedHill Biopharma Ltd.:
RedHill Biopharma Ltd. (NASDAQ:RDHL) (TASE:RDHL) is a specialty biopharmaceutical company headquartered in Israel, primarily focused on the development and commercialization of late clinical-stage, proprietary, orally-administered, small molecule drugs for the treatment of gastrointestinal and inflammatory diseases and cancer. RedHill has a U.S. co-promotion agreement with Concordia for Donnatal®, a prescription oral adjunctive drug used in the treatment of IBS and acute enterocolitis. RedHill’s clinical-stage pipeline includes: (i) RHB-105 – an oral combination therapy for the treatment of Helicobacter pylori infection with successful results from a first Phase III study; (ii) RHB-104 – an oral combination therapy for the treatment of Crohn’s disease with an ongoing first Phase III study, a completed proof-of-concept Phase IIa study for multiple sclerosis and QIDP status for nontuberculous mycobacteria (NTM) infections; (iii) BEKINDA® (RHB-102) – a once-daily oral pill formulation of ondansetron with an ongoing Phase III study for acute gastroenteritis and gastritis and an ongoing Phase II study for IBS-D; (iv) RHB-106 – an encapsulated bowel preparation licensed to Salix Pharmaceuticals, Ltd.; (v) YELIVA® (ABC294640) – a Phase II-stage, orally-administered, first-in-class SK2 selective inhibitor targeting multiple oncology, inflammatory and gastrointestinal indications; (vi) MESUPRON – a Phase II-stage first-in-class, orally-administered protease inhibitor, targeting pancreatic cancer and other solid tumors and (vii) RIZAPORT® (RHB-103) – an oral thin film formulation of rizatriptan for acute migraines, with a U.S. NDA currently under discussion with the FDA and marketing authorization received in Germany in October 2015. More information about the Company is available at: www.redhillbio.com.
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words. Forward-looking statements are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control, and cannot be predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) the initiation, timing, progress and results of the Company’s research, manufacturing, preclinical studies, clinical trials, and other therapeutic candidate development efforts; (ii) the Company’s ability to advance its therapeutic candidates into clinical trials or to successfully complete its preclinical studies or clinical trials; (iii) the extent and number of additional studies that the Company may be required to conduct and the Company’s receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings, approvals and feedback; (iv) the manufacturing, clinical development, commercialization, and market acceptance of the Company’s therapeutic candidates; (v) the Company’s ability to successfully market Donnatal®, (vi) the Company’s ability to establish and maintain corporate collaborations; (vii) the Company’s ability to acquire products approved for marketing in the U.S. that achieve commercial success and build its own marketing and commercialization capabilities; (viii) the interpretation of the properties and characteristics of the Company’s therapeutic candidates and of the results obtained with its therapeutic candidates in research, preclinical studies or clinical trials; (ix) the implementation of the Company’s business model, strategic plans for its business and therapeutic candidates; (x) the scope of protection the Company is able to establish and maintain for intellectual property rights covering its therapeutic candidates and its ability to operate its business without infringing the intellectual property rights of others; (xi) parties from whom the Company licenses its intellectual property defaulting in their obligations to the Company; and (xii) estimates of the Company’s expenses, future revenues capital requirements and the Company’s needs for additional financing; (xiii) competitive companies and technologies within the Company’s industry. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 20-F filed with the SEC on February 23, 2017. All forward-looking statements included in this Press Release are made only as of the date of this Press Release. We assume no obligation to update any written or oral forward-looking statement unless required by law.
Company contact: Adi Frish Senior VP Business Development & Licensing RedHill Biopharma +972-54-6543-112 [email protected] IR contact (U.S.): Marcy Nanus Senior Vice President The Trout Group +1-646-378-2927 [email protected]
FuelCell Energy and Korean-based POSCO Energy Announce Strategic Agreement to Globalize the Stationary Fuel Cell Market
- FuelCell Energy to commence market activities for Asian market development offering entire portfolio of SureSource™ solutions
- POSCO Energy to support existing South Korean fuel cell installations and operate local manufacturing facility
- Parties expect to finalize detailed definitive agreements by fall 2017
DANBURY, Conn., March 21, 2017 (GLOBE NEWSWIRE) — FuelCell Energy, Inc. (Nasdaq:FCEL), a global leader in delivering clean, innovative and affordable fuel cell solutions for the supply, recovery and storage of energy, today announced a memorandum of understanding with partner POSCO Energy to use an existing FuelCell Energy subsidiary to directly develop the Asian fuel cell business for the purpose of expanding Asian market opportunities. Under this agreement, FuelCell Energy will immediately commence marketing the entire suite of SureSource™solutions in Korea as well as the broader Asian markets for the supply, recovery and storage of energy. POSCO Energy will continue to service the existing installed base of fuel cell plants in South Korea and will commit to a specified level of module purchases from FuelCell Energy to supplement its own local manufacturing for servicing their existing fleet. Definitive agreements are expected to be finalized by fall 2017 subject to completion of due diligence, regulatory approvals, and customary closing conditions.
“Offering our entire portfolio of solutions throughout Asia aligns well with our growing list of global customers as well as sizeable projects with existing customers of POSCO Energy,” said Chip Bottone, President and Chief Executive Officer FuelCell Energy. “This revised relationship is structured to rapidly grow market opportunities and enable project-level investment by third parties while leveraging the deep relationships of POSCO Energy.”
“We believe FuelCell Energy will be successful in the significant Asian utility-scale stationary fuel cell market by now directly marketing its high quality products,” said Dong Jun Yoon, President and Chief Executive Officer, POSCO Energy.
The installed fleet in South Korea consists of 18 sites, totaling more than 170 megawatts with a customer base that includes 15 of Korea’s largest utilities and independent power producers. The backlog for the underlying service agreements for these installations includes over 300 megawatts of future fuel cell module production under existing service agreements.
“We have the capabilities in place for the development, construction, operation and maintenance of fuel cell projects in Korea as we leverage our decade-plus working relationship with POSCO Energy; utilize our global monitoring and control center to remotely operate and monitor plants worldwide; continue to manage the joint purchasing from our shared global supply chain; and we helped design the production process and procured manufacturing equipment on behalf of POSCO Energy for the fuel cell manufacturing facility in South Korea,” commented Tony Rauseo, Chief Operating Officer, FuelCell Energy. “We see this as a natural evolution for growing the Asian market.”
Fuel cells are well suited for addressing the energy, environmental and economic goals of the Korean government. High population density, limited land, and scarce natural resources that lead to the importation of more than 90 percent of the fuel needed to generate power and heat requires highly efficient and affordable power that can be located near where the power is used. The virtual lack of criteria pollutants and low carbon footprint of fuel cells combined with affordable economics and minimal space needs have led to significant fuel cell adoption by Korean utilities and independent power producers. With high availability and capacity factors, fuel cell power plants make meaningful contributions to Renewable Portfolio Standard targets.
Cautionary Language Regarding Forward-Looking Statements
This news release contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including, without limitation, statements with respect to the Company’s plans and expectations regarding the memorandum of understanding. All forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those projected. Factors that could cause such a difference include, without limitation, changes to projected deliveries and order flow, changes to production rate and product costs, general risks associated with product development, manufacturing, changes in the regulatory environment, customer strategies, unanticipated manufacturing issues that impact power plant performance, changes in critical accounting policies, potential volatility of energy prices, rapid technological change, competition, and the Company’s ability to achieve its sales plans and cost reduction targets, as well as other risks set forth in the Company’s filings with the Securities and Exchange Commission. The forward-looking statements contained herein speak only as of the date of this press release. The Company expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any such statement to reflect any change in the Company’s expectations or any change in events, conditions or circumstances on which any such statement is based.
About FuelCell Energy
FuelCell Energy (NASDAQ:FCEL) delivers efficient, affordable and clean solutions for the supply, recovery and storage of energy. We design, manufacture, undertake project development, install, operate and maintain megawatt-scale fuel cell systems, serving utilities, industrial and large municipal power users with solutions that include both utility-scale and on-site power generation, carbon capture, local hydrogen production for transportation and industry, and long duration energy storage. With SureSource™ installations on three continents and millions of megawatt hours of ultra-clean power produced, FuelCell Energy is a global leader with environmentally responsible power solutions. Visit us online at www.fuelcellenergy.com and follow us on Twitter.
SureSource, SureSource 1500, SureSource 3000, SureSource 4000, SureSource Recovery, SureSource Capture, SureSource Hydrogen, SureSource Storage, SureSource Service, SureSource Capital, FuelCell Energy, and FuelCell Energy logo are all trademarks of FuelCell Energy, Inc.
FuelCell Energy, Inc.
Kurt Goddard, Vice President Investor Relations
Source: FuelCell Energy
3D Systems เปิดตัวแพลตฟอร์มการผลิตสารเติมแต่งแบบครบวงจรที่สามารถปรับขนาดได้เป็นครั้งแรกในวงการอุตสาหกรรม
ยนแปลงการผลิตชิ้นส่วนที่ กำหนดเองและมีความซับซ้อนในปริ มาณที่มาก ขณะที่ตอบสนองความต้องการในเรื่ องความคงทนและความซ้ำซ้ อนของสภาพแวดล้อมการผลิต
ษัทอุตสาหกรรม Fortune 50
CHICAGO, March 21, 2017 (GLOBE NEWSWIRE) — ด้วยการส่งมอบกลยุทธ์
ด้วยเทคโนโลยี Figure 4 ที่มีความเป็นนวัตกรรม แพลตฟอร์มใหม่ของ 3D Systems ช่วยให้ลูกค้าสามารถปรับแต่
“เราเชื่อว่าแพลตฟอร์ม Figure 4 อันก้าวหน้าของเราจะทำให้เกิ
|ตัวอย่าง – Figure 4 vs. SLA แบบเดิม*|
|ตัวเลขการผลิตของ Figure 4 ด้วยเครื่องยนต์16 ตัว||การพัฒนา|
|ปริมาณงานต่อปีต่อเครื่องพิมพ์ (พิมพ์)||225 x||สูงกว่า|
|TCO – 5 ปี, ทั้งชุด||3.5 x||ต่ำกว่า|
|ชิ้นส่วน (1 พันล้านชิ้นต่อปี)||การพัฒนา|
|เวลาเฉลี่ยต่อหนึ่งชิ้น (เป็นชั่วโมง)||14.1 x||เร็วกว่า|
|วัสดุที่เป็นขยะ (เป็นกรัม)||1.5 x||ต่ำกว่า|
อยกว่าแต่มีผลการผลิตที่ดีขึ้น ส่งผลให้ต้องใช้ต้นทุนที่น้ อยลงและการใช้วัสดุที่คุ้มค่ ามากขึ้น
- ต้นทุนต่อชิ้นส่วนที่ผลิตโดย Figure 4 เท่ากับประมาณร้อยละ 30 ของ SLA แบบดั้งเดิม
เมื่อเวลาผ่านไป บริษัทฯ ตั้งใจที่จะขยายแอพพลิเคชันแต่
เกี่ยวกับ 3D Systems
3D Systems ให้บริการด้านผลิตภัณฑ์และบริ
ข้อมูลติดต่อของนักลงทุน: Stacey Witten Email: [email protected]
com ติดต่อประชาสัมพันธ์: Diane Parrish Email: [email protected]
แพลตฟอร์มปฏิวัติรูป Figure 4 รวมกับวัสดุ NextDent ทำให้ลดต้นทุนของการดำเนินงานทั้
CHICAGO, March 21, 2017 (GLOBE NEWSWIRE) — 3D Systems (NYSE:DDD) วันนี้ได้ทำการเปิดตัวแพลตฟอร์
3D Systems มีความชำนาญเชิงลึกในตลาดทั
“เครื่องตัดแบบเดิม ๆ จะสามารถตัดครอบฟันได้เพียงหนึ่
3D Systems จะนำเสนอแพลตฟอร์มเครื่องพิมพ์
เกี่ยวกับ 3D Systems
3D Systems ให้บริการผลิตภัณฑ์และบริการ 3 มิติแบบครบวงจร ซึ่งได้แก่ เครื่องพิมพ์ 3D วัสดุการพิมพ์ บริการผลิตสินค้าอุปโภคบริโภค และเครื่องมือออกแบบระบบดิจิตอล ระบบนิเวศของพวกเขาสนับสนุ
ข้อมูลติดต่อของนักลงทุน: Stacey Witten Email: [email protected]
com ติดต่อประชาสัมพันธ์: Diane Parrish Email: [email protected]