Category Archives: PRNews

VolitionRx Limited Signs Memorandum of Understanding with Fosun Long March in China

ISNES, Belgium, March 28, 2019 /PRNewswire/ — VolitionRx Limited (NYSE AMERICAN: VNRX) (“Volition”) has executed a nonbinding Memorandum of Understanding (“MOU”) with Shanghai Fosun Long March Medical Science Co., Ltd. (“Fosun Long March”) with an expectation of negotiating and entering into a binding agreement to help facilitate the entrance of the Nu.QTM platform into China. Based on recent promising proof-of-concept data using Volition’s product-grade Nu.Q assays, particularly in lung cancer, subject to reaching agreement on the terms and conditions of the proposed relationship, the parties intend to conduct three clinical studies in China in colorectal cancer, lung cancer and ovarian cancer.

Fosun Long March is a high tech in-vitro diagnostics enterprise active in manufacturing, marketing and research and development of diagnostic and laboratory instruments and reagents. Fosun Long March is a wholly owned company of Shanghai Fosun Pharmaceutical (Group) Co., Ltd. (“Fosun Pharma”), a China Fortune 500 company. Fosun Pharma is a leading healthcare company in China and is listed on Shanghai Stock Exchange and on the Main Board of the Hong Kong Stock Exchange.

Fosun Long March’s network and expertise will assist Volition with the facilitation and coordination of the collection, provision and testing of blood samples using Volition’s proprietary Nu.QTM assays for the clinical studies, with Fosun’s hospitals, research institutions and clinics, as well as other third-party hospitals, universities, research institutions and clinics in China.

Dr. Jasmine Kway, Chief Executive Officer of Singapore Volition, commented: “We are happy to be able to announce this MOU with Fosun Long March because, in addition to our plans to undertake three clinical studies, we are also planning to jointly explore the development of Nu.Q assays utilizing Fosun’s LUMIART-II Automated Chemiluminescence Immunoassay System, which could provide us with an additional platform for the Chinese market.”

Dr. Yuejian Zhang, Chairman of Fosun Long March remarked: “We were impressed with Volition’s preliminary data, particularly in lung cancer, and would like to explore if we can work together in China, beginning with the proposed clinical studies. Whilst China represents a little under 20% of the world’s population it accounts for almost 24% of cancer diagnoses and 30% of cancer-related deaths worldwide in 2018, almost a third of which are due to lung cancer and colorectal cancer. We look forward to proceeding with the collaboration with Volition on these important studies and working together to launch Nu.Q in China.”

“We are excited about the possibility of commencing our work in China in 2019 and look forward to a successful collaboration with Fosun Long March,” commented Cameron Reynolds, Chief Executive Officer of Volition. “The need for a simple, easy to use, cost effective test for cancer is truly universal and we hope very much that our Nu.Q tests can help revolutionize the way cancer is diagnosed worldwide. We see Asia, and particularly lung cancer in China, as a key market for Volition going forward. We believe that this MOU with Fosun Long March is a significant step in working towards the launch of Nu.Q in China.”

About Fosun Long March

Established in 1989, Fosun Long March is the investment platform of in-vitro diagnostics division of Fosun Pharma Group and has since accelerated merger and acquisition of new products introduction into China. With its wide range of in-vitro diagnostics products, strength in manufacturing and strong nation-wide sales network, Fosun Long March is one of the most influential brands in in-vitro diagnostics in China.

About Volition

Volition is a multi-national life sciences company developing simple, easy to use, cost effective blood tests to help diagnose a range of cancers and other diseases. Early diagnosis has the potential to not only prolong the life of patients, but also to improve their quality of life. The tests are based on the science of NucleosomicsTM, which is the practice of identifying and measuring nucleosomes in the bloodstream or other bodily fluid – an indication that disease is present.

Volition’s research and development activities are currently centered in Belgium, with additional offices in London, Texas and Singapore, as the company focuses on bringing its diagnostic products to market.

For more information about Volition, visit Volition’s website (http://www.volitionrx.com) or connect with us via:

Twitter: https://twitter.com/volitionrx
LinkedIn: https://www.linkedin.com/company/volitionrx  
Facebook: https://www.facebook.com/VolitionRx/  
YouTube: https://www.youtube.com/user/VolitionRx

The contents found at Volition’s website address, Twitter, LinkedIn, Facebook, and YouTube are not incorporated by reference into this document and should not be considered part of this document. The addresses for Volition’s website, Twitter, LinkedIn, Facebook, and YouTube are included in this document as inactive textual references only.

Media / Investor Contacts

Safe Harbor Statement

Statements in this press release may be “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, that concern matters that involve risks and uncertainties that could cause actual results to differ materially from those anticipated or projected in the forward-looking statements. Words such as “expects,” “anticipates,” “intends,” “plans,” “aims,” “targets,” “believes,” “seeks,” “estimates,” “optimizing,” “potential,” “goal,” “suggests,” “could,” “would,” “should,” “may,” “will” and similar expressions identify forward-looking statements. These forward-looking statements relate to the negotiation and execution of a binding agreement with Fosun Long March, the effectiveness of Volition’s blood-based diagnostic tests as well as Volition’s ability to develop and successfully commercialize such test platforms for early detection of cancer and other diseases. Volition’s actual results may differ materially from those indicated in these forward-looking statements due to numerous risks and uncertainties. For instance, if Volition fails to develop and commercialize diagnostic products, it may be unable to execute its plan of operations. Other risks and uncertainties include Volition’s failure to obtain necessary regulatory clearances or approvals to distribute and market future products in the clinical IVD market; a failure by the marketplace to accept the products in Volition’s development pipeline or any other diagnostic products Volition might develop; Volition will face fierce competition and Volition’s intended products may become obsolete due to the highly competitive nature of the diagnostics market and its rapid technological change; and other risks identified in Volition’s most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q, as well as other documents that Volition files with the Securities and Exchange Commission. These statements are based on current expectations, estimates and projections about Volition’s business based, in part, on assumptions made by management. These statements are not guarantees of future performance and involve risks, uncertainties and assumptions that are difficult to predict. Forward-looking statements are made as of the date of this release, and, except as required by law, Volition does not undertake an obligation to update its forward-looking statements to reflect future events or circumstances.

NucleosomicsTM, and Nu.QTM and their respective logos are trademarks and/or service marks of VolitionRx Limited and its subsidiaries. All other trademarks, service marks and trade names referred to in this press release are the property of their respective owners. Additionally, unless otherwise specified, all references to “$” refer to the legal currency of the United States of America.

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WAT Medical Interviewed by NHK, Japan’s National Broadcasting Organization

VANCOUVER, British Columbia, March 27, 2019 /PRNewswire/ — WAT Medical was recently interviewed by NHK, one of the largest broadcasting corporations in Japan. The interview was held in Vancouver, where WAT Medical’s CEO, Raymond Ji, discussed the development, use, and advancements of neuromodulation technologies.The interview will be broadcasted to the Japanese audience in March 2019.

During the interview, focus was given to Raymond’s background as a hospital pediatrician and how this has influenced his work at WAT Medical. Working at WAT Medical not only helps him treat individual patients but also influence the style of healthcare treatments that would ultimately benefit patients of future generations. As the CEO of Wat Medical, he is able to work specifically on developing therapies in the field of transcutaneous electrical nerve stimulation (TENS) that are more helpful in the following ways:

1.  Specificity: WAT Medical focuses on specific conditions instead of trying to solve all the problems. One device is designed to offer a solution for one kind of issue. Patients get exactly what they need.

2.  Wearability: By making the devices wearable, the therapies become available anywhere, anytime. It’s possible for consumers to enjoy evidence-based, safe and effective therapies with affordable prices.

Raymond also discussed how WAT Medical takes inspiration and knowledge from acupuncture while designing its devices. Acupuncture is considered an early type of neuromodulation which can be divided into 3 stages.

1. Acupuncture: Acupuncture has been around for thousands of years as a way to relieve pain and promote qualify of life for people. To be effective, however, the treatment needs to be performed by specially trained individuals. The effect of the therapy is different from day to day and person to person.

2.  TENS: TENS technology industrializes and digitalizes this type of treatment. This transforms the skills of the trained individuals into physical products, allowing them to be much more accessible. The devices can put out measurable and repeatable treatments, free from potential fluctuations or inconsistencies between healthcare providers.

3.  Targeted TENS: While traditional TENS is used to solve a wide range of issues, WAT Medical took it to the next level and turned it into targeted-neuro modulation, which focuses on specific medical conditions. This is how WAT Medical’s devices are designed. EmeTerm and HeadaTerm each put out electrical currents at a particular frequency that are meant to stimulate specific areas of the brain and nerve nuclei.

Peter W.F. Ji, Co-Founder of WAT Medical and doctorate degree candidate at UC Berkeley, was also interviewed by the NHK team. Peter introduced the mechanisms of EmeTerm anti-nausea and vomiting wristband and HeadaTerm anti-migraine head patch and demonstrated the devices. Peter also introduced WAT Medical’s ongoing projects, including the solution for vision weakness and its new device, eEspresso, which could keep people awake and might be launched at 2020 CES in Las Vegas.

References:

https://www.watmedical.com/ 
https://www.nhk.or.jp/ 
http://science.sciencemag.org/content/150/3699/971 Pain Mechanisms: a New Theory
https://www.neuromodulation.com/for-medical-providers Neuromodulation Therapies
https://www.health.harvard.edu/blog/acupuncture-for-headache-2018012513146

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Source: WAT Medical Enterprise Ltd.

EquipNet Raises Fund for Acquisition Strategy as Next Phase in Growth Plan

CANTON, Massachusetts, March 27, 2019 /PRNewswire/ — EquipNet Inc., the global leader in surplus asset management today announced that it has raised an acquisition fund to be used to acquire companies that meet its selection criteria.

“We have excelled at organically building our current infrastructure to deliver a best-in-class value proposition to our customer base,” said Roger Gallo CEO of EquipNet.  “The next phase in our growth plans include the strategic acquisition of select companies that compliment and diversify our existing operations.”

EquipNet currently offers several hundred million dollars of laboratory instrumentation, manufacturing equipment, and industrial assets on the secondary market through its e-Commerce Marketplace (www.equipnet.com). The company also provides numerous surplus capital asset services that deliver maximum financial return while maintaining positive corporate image, adhering to safety standards, and contributing to sustainability initiatives. It will now actively seek to acquire operations that expand and/or offer value-added solutions connected to the vertical markets that it services.

About EquipNet-EquipNet is a global leader of surplus asset management solutions. It is recognized for its proprietary asset management platform, revolutionary industrial equipment marketplace and results-driven project management services. Clients include Fortune 500 multi-national corporations, leading regional manufacturers, financial institutions, and corporate renewal professionals.

For Media Inquiries Contact:

Ben Potenza
VP Sales and Marketing
bpotenza@equipnet.com
781-821-3482 x2180

For Business Inquires Contact:

Tom Noonan 
VP Corporate Development
tnoonan@equipnet.com
781-821-3482 x2152

Logo – https://mma.prnewswire.com/media/562949/EquipNet_Logo.jpg

Source: EquipNet Inc.

Shineco, Inc. Receives Regional Government Merchants Invitation for its Industrial Hemp Business Line

BEIJING, March 26, 2019 /PRNewswire/ — Shineco, Inc. (“Shineco” or the “Company”) (NASDAQ: TYHT), a producer and distributor of Chinese herbal medicines, organic agricultural produce, specialized textiles, and other health and well-being focused plant-based products in China, announced today that the Company received a merchant’s invitation (the “Invitation”) for its industrial hemp business line from Xingshan District People’s Government of Hegang City of Heilongjiang province (the “Government”) on March 20, 2019.

As previously disclosed in a press release dated March 20, 2019, the Company has established a wholly owned subsidiary, Beijing Tenjove Newhemp Biotechnology Co., Ltd. (“TNB”) on March 13, 2019, to capture growth in the industrial hemp market.

According to the Invitation, the Government has invited TNB to cooperate with Heilongjiang Zhenye Agricultural Technology Development Co., Ltd. for industrial hemp business in the Xingshan District of Hegang City of Heilongjiang province. Local land resources are abundant in Hegang city which has an economic development zone planning area of 54.22 square kilometers. In addition, the geographical conditions are particularly suitable for the growth of medicinal industry cannabis. The Government is willing to discuss proposals in detail with TNB.

Mr. Yuying Zhang, Chairman and Chief Executive Officer of Shineco, commented, “Heilongjiang and Yunnan provinces are currently the only provinces in China where industrial hemp is allowed to grow. We are excited for this opportunity to leverage our technical expertise in advanced agricultural production techniques to develop operations in Heilongjiang. We plan to develop industrial hemp processing and CBD related products capacity in Heilongjiang. We believe we have identified an area with the appropriate soil and water conditions for industrial production.”

About Shineco, Inc.

Incorporated in Delaware in August 1997 and headquartered in Beijing, China, Shineco, Inc. (“Shineco” or the “Company”) is a holding company, through its subsidiaries and variable interest entities, undertakes vertically- and horizontally-integrated production, distribution and sales channels to provide health and well-being focused plant-based products in China. Utilizing modern engineering technologies and biotechnologies, Shineco produces, among other products, Chinese herbal medicines, organic agricultural produce and specialized textiles. For more information about the Company, please visit www.tianyiluobuma.com.

Forward-Looking Statements

This press release contains information about Shineco’s view of its future expectations, plans and prospects that constitute forward-looking statements. Actual results may differ materially from historical results or those indicated by these forward-looking statements as a result of a variety of factors including, but not limited to, risks and uncertainties associated with its ability to raise additional funding, its ability to maintain and grow its business, variability of operating results, its ability to maintain and enhance its brand, its development and introduction of new products and services, the successful integration of acquired companies, technologies and assets into its portfolio of products and services, marketing and other business development initiatives, competition in the industry, general government regulation, economic conditions, dependence on key personnel, the ability to attract, hire and retain personnel who possess the technical skills and experience necessary to meet the requirements of its clients, and its ability to protect its intellectual property. Shineco encourages you to review other factors that may affect its future results in Shineco’s registration statement and in its other filings with the Securities and Exchange Commission.

For more information, please contact:

Tina Xiao
Ascent Investor Relations LLC
Phone: +1-917-609-0333
Email: tina.xiao@ascent-ir.com

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Health2Sync, CTBC Bank and Bitmark Launch World’s First Diabetes Data Trust

-Groundbreaking blockchain trust enhances diabetes research by securing patient medical records, speeding data access and streamlining payments.

TAIPEI, Taiwan, March 26, 2019 /PRNewswire/ — Health2Sync, a leader in diabetes management, has partnered with CTBC Bank and Bitmark to establish the world’s first diabetes data trust; an extremely secure, yet transparent ecosystem which streamlines diabetes research projects while ensuring the privacy of patients’ data.

The Health2Sync diabetes data trust separates itself from conventional medical research databases by:

  • Giving patients full control and ownership of medical records.
  • Securing patient data on a distributed blockchain instead of a private company server.
  • Speeding up payments to patients for research performed with their data.

Diabetes research participants can now use Health2Sync’s HealthPass mobile app, armored by Bitmark’s blockchain-secured technology, to securely upload their medical data into the diabetes data trust. Patients can control who gets access to medical records while researchers benefit by having access to a new worldwide patient record database. CTBC Bank’s technology speeds the processing of payments to patients from researchers accessing the aggregated dataset.

“In our work helping over 300,000 diabetes sufferers, patients have told us they are open to helping medical research,” said Ed Deng, CEO at Health2Sync. “However, they are greatly concerned about their privacy and cannot risk any situation in which their personal information can be used against them through data leaks or hacks. Because of this, many patients remain inaccessible to researchers.”

Health2Sync’s diabetes data trust provides a private, equitable way for individuals, researchers and companies to exchange diabetes health data. Patients and researchers from any diabetes healthcare app, care provider, institution or advocacy group can apply to participate.  

“Our vision is to enable an ecosystem of diabetes patients helping researchers in all parts of the world,” said Deng. “Diabetes affects over 400 million people and is considered the fastest-growing health crisis of our time. Creating this trust using Bitmark’s blockchain technology allows us to present research opportunities to new participants by giving them control over their personal privacy and ownership over their data.”

Bitmark’s technology allows data-science computations, including artificial intelligence (AI) and machine learning (ML), to be run on the data within the trust while ensuring participant privacy. By using blockchain, costs that institutions typically pay to legal administrators are reduced, with savings passed on to research participants. Bitmark has already used its technology to speed royalty payments to musicians by developing a paper-free blockchain system which enforces the property rights to their music and tracks when royalty payments are billed and received.

Sean Moss-Pultz, CEO at Bitmark said, “Bitmark’s mission is to help individuals and institutions define data as property in order to facilitate legal transactions at costs accessible to anyone around the world. Nobel Prize winner Ronald Coase postulated that clear and easily transferable property rights allow economic activity to take place by removing the friction of negotiating and enforcing contracts — this trust for health data is a perfect example of Coase’s theorem actualized in the real world.”

Currently, many datasets are available in healthcare, put together by governments, institutions, or data resellers. These datasets are typically limited in scope and expensive to aggregate. With the new Health2Sync diabetes data trust, however, researchers can now draw from diverse worldwide research populations participating via mobile phone — a rarity in such studies. Combining health records with new health-sensor and internet-of-things (IOT) data such as from Apple Watch and Fitbit wearables provides a broader view of the individual over longer periods of time.

CTBC Bank was proud to partner with Health2Sync and Bitmark to help patients receive payments for their participation in research. As the first financial institution in Taiwan to use blockchain technology for transaction verification, value recognition and payment, CTBC Bank was excited about the potential of blockchain to spur innovation and improve healthcare outcomes.

About Health2Sync

Founded in 2013, Health2Sync provides a comprehensive health-management platform for people with diabetes. Its products combine mobile, cloud, and data analytics, enabling patients to obtain personalized care and allows care providers and family to care for patients remotely. With the largest network of clinics and hospitals, it is the leading solution in Asia that brings an effective, yet scalable solution to diabetes management.  It was selected as one of the “Best Diabetes Apps” in 2017 and 2018 by Healthline, one of the world’s largest health information networks.

https://www.health2sync.com

About CTBC Bank Co., Ltd. 

Established in 1966, CTBC Bank Co., Ltd. started business as China Securities Investment Corp. and soon grew into China Investment and Trust Co., Ltd. In 1992, it was restructured into a commercial bank. The bank’s commitment to principles of integrity and caring has guided it to become Taiwan’s financial industry leader with an extensive network of 152 branches domestically and 114 overseas. As of 2018, consolidated assets totaled NT$3.96 trillion, the most of any privately owned bank in Taiwan.

https://www.ctbcbank.com/english

About Bitmark

Bitmark defines digital property, defends it, and makes it economically divisible. Bitmark is the property system for establishing value and legal control over the world’s data. Before Bitmark, no property system facilitated economic activity around data and other digital assets. Under Bitmark’s decentralized property registry, individuals, institutions, and corporations gain control of their digital property; they can register titles to establish property rights, prove provenance and chain of ownership, and benefit from cross-border and local legal compliance.

Institutions like Pfizer and UC Berkeley and individuals trust us today to defend the property rights to their health data, music copyrights, financial products, and more. Bitmark is now closing in on one million digital properties registered all over the world. The team is distributed in the Silicon Valley, Taiwan, Vietnam, and Iceland.

https://bitmark.com

Media Contact

Michael Nguyen
Bitmark
press@bitmark.com

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Source: Bitmark Inc.

Ciming Boao International Hospital Fertility Center Begins First Trial Operations

BOAO, China, March 25, 2019 /PRNewswire/ — Ciming Boao International Hospital and Fertility Center, a state-of-the-art 5,000sq meter facility has begun trial operations. Built on 16.5 acres of land located within the “Boao Lecheng Medical Tourism Pilot Zone,” the hospital has received the support of the National Health Commission’s Women and Children Department and will offer standard fertility services, as well as screening and diagnostic services.


Ciming Boao International Hospital Assisted Reproduction Center Medical Team

Ciming Boao International Hospital Fertility Center belongs to the Dr. Han Medical Group and is the first international center for assisted reproductive medicine in the Pilot Zone to partner with the America-based HRC and GFG.USA reproductive medical groups to introduce a leading model of assisted reproductive treatments and services to address the problem of decreasing birth rates in China. Every year 40 million people experience infertility, and there are 900 000 babies with defects. Fortunately, these problems can be solved by using pre-implantation genetic screening and diagnosis (PGS/PGD) technology developed by the fertility center. Furthermore, this PGS/PGD technology can help high-risk parents to give birth to healthy babies and assist in preventing congenital disabilities.

The 5,000 sqm high-end private medical facility, built to American standards, includes private consultation rooms with advanced gene detection equipment. In total, there are 12 American assisted reproductive physicians and embryologists on-site with more than 30 years of experience including leading academic Dr. John G. Wilcox, and the President of the Society for Assisted Reproduction Technology as well as  Dr. Vidali who will be part of this unique team to design one-to-one personalized and efficient diagnosis and treatment programs for patients.

About Ciming Boao International Hospital

Ciming Boao International Hospital is part of the Dr. Han Medical Group, which cooperates with a national network of 500 health checkup centers (SZ002044) – the most extensive network of centers in the world with a turnover of 30 million customers a year in China alone. The hospital is a Class Three general hospital that has its own IVF center as well as nine other departments including chronic disease management and stem cell treatment department.


The phase one building of Ciming Boao International Hospital

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VolitionRx Limited to Present at Conferences in March & April 2019

ISNES, Belgium, March 25, 2019 /PRNewswire/ — VolitionRx Limited (NYSE AMERICAN: VNRX) (“Volition”) today announced that its Executive Vice President, Investor Relations, Scott Powell, is scheduled to present at three conferences in March and April 2019.

During the conferences, Dr. Powell will outline Volition’s business, clinical, regulatory and operational milestones, as well as the Company’s recently announced clinical data and upcoming 2019 milestones.

Details of the conference presentations are as follows:

        Conference:     The MicroCap Spring Invitational
        Date:                 Wednesday, March 27, 2019
        Time:                 6:00 p.m. – 9:00 p.m. EDT
        Location:          The Cornell Club, New York, NY

        Conference:      Sidoti & Company Spring 2019 Investor Conference
        Date:                  Thursday, March 28, 2019
        Location:           The Marriott Marquis, New York, NY

        Conference:      Spring Investor Summit ’19
        Date:                  Monday, April 1, 2019
        Time:                 10:30 a.m. EDT
        Location:          J.W. Marriott Essex House New York, New York, NY

Persons attending any of the above-referenced conferences who would like to schedule a 1-on-1 meeting with Volition management during such conference may do so by contacting Joseph Green of Edison Advisors at JGreen@edisongroup.com or Scott Powell, Head of Investor Relations at investorrelations@volitionrx.com

We are also hosting a Capital Markets Day at the New York Stock Exchange on Tuesday April 9, 2019, with presentations from Scientific Advisory Board Member, Professor Axel Imhof of the Biomedical Center of the Ludwig-Maximilians University of Munich and from Associate Professor Heather Wilson-Robles of Texas A&M Veterinary School.  We hope to provide further updates of results, ongoing projects and of plans for the potential new paths to revenues, most notably in lung cancer, Nu.Q Vet and in Nu.Q Capture.

For further details please contact mediarelations@volitionrx.com.

About Volition

Volition is a multi-national life sciences company developing simple, easy to use, cost effective blood tests to help diagnose a range of cancers and other diseases. Early diagnosis has the potential to not only prolong the life of patients, but also to improve their quality of life. The tests are based on the science of NucleosomicsTM, which is the practice of identifying and measuring nucleosomes in the bloodstream or other bodily fluid – an indication that disease is present.

Volition’s research and development activities are currently centered in Belgium, with additional offices in London, Texas and Singapore, as the company focuses on bringing its diagnostic products to market.

For more information about Volition, visit Volition’s website (http://www.volitionrx.com) or connect with us via:

Twitter: https://twitter.com/volitionrx
LinkedIn: https://www.linkedin.com/company/volitionrx
Facebook: https://www.facebook.com/VolitionRx/
YouTube: https://www.youtube.com/user/VolitionRx

The contents found at Volition’s website address, Twitter, LinkedIn, Facebook, and YouTube are not incorporated by reference into this document and should not be considered part of this document.  The addresses for Volition’s website, Twitter, LinkedIn, Facebook, and YouTube are included in this document as inactive textual references only.

Media / Investor Contacts

NucleosomicsTM and Nu.QTM  and their respective logos are trademarks and/or service marks of VolitionRx Limited and its subsidiaries.

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CStone receives approval in China to initiate Phase 1 clinical trial for RET inhibitor BLU-667 (CS3009)

SUZHOU, China, March 21, 2019 /PRNewswire/ — CStone Pharmaceuticals (“CStone”; HKEX: 2616) today announced that China’s National Medical Products Administration (NMPA) has approved the clinical trial application to begin a Phase 1 trial in China for BLU-667 (CS3009), a highly selective and potent RET inhibitor discovered by CStone’s partner Blueprint Medicines. The study is part of Blueprint Medicines’ ongoing, global Phase 1 ARROW clinical trial for patients with RET-altered non-small cell lung cancer (NSCLC), medullary thyroid cancer (MTC) and other advanced solid tumors. Trial objectives include overall clinical response, duration of response, pharmacokinetics, pharmacodynamics and safety.

In June 2018, CStone and Blueprint Medicines entered into a license and collaboration agreement in which Blueprint Medicines granted CStone exclusive rights to develop and commercialize BLU-667 and two other drug candidates in Mainland China, Hong Kong, Macau and Taiwan.

Recently, BLU-667 was granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration (FDA) for the treatment of RET-mutation-positive MTC that requires systemic treatment and for which there are no acceptable alternative treatments.

Based on the early clinical data and regulatory feedback, Blueprint Medicines has announced plans to submit a New Drug Application (NDA) to the U.S. FDA for BLU-667 in the first half of 2020.

“BLU-667 has already demonstrated its potential to produce clinical responses in several RET-altered tumor types, and there are currently no selective RET inhibitors approved globally,” noted CStone Chairman and CEO Dr. Frank Jiang. “If the data generated in Chinese patients are consistent with global results, we plan to use the global and China data from the ARROW study to support NDA filings in China.”

CStone’s Chief Medical Officer Dr. Jason Yang commented: “Currently available data show that non-small cell lung cancer and medullary thyroid cancer patients with RET altered tumors may benefit from BLU-667, with the potential to advance standards of care in these genetically defined populations. We will move forward on development of BLU-667 in China and hope to make this drug candidate available to Chinese patients as quickly as possible.”

About BLU-667

BLU-667 is an investigational, once-daily oral precision therapy specifically designed for highly potent and selective targeting of oncogenic RET alterations. In preclinical studies, BLU-667 consistently demonstrated sub-nanomolar potency against the most common RET fusions, activating mutations and predicted resistance mutations. In addition, BLU-667 demonstrated markedly improved selectivity for RET compared to approved multi-kinase inhibitors, including more than 80-fold improved potency for RET versus VEGFR2. By suppressing primary and secondary mutants, BLU-667 has the potential to overcome and prevent the emergence of clinical resistance. This approach is expected to enable durable clinical responses across the range of RET alterations, with a favorable safety profile.

BLU-667 was designed by Blueprint Medicines’ research team, leveraging the company’s proprietary compound library. Blueprint Medicines is developing BLU-667 for the treatment of people with RET-altered NSCLC, MTC and other solid tumors. The U.S. FDA has granted Breakthrough Therapy Designation to BLU-667 for the treatment of RET-mutation-positive MTC.

About CStone

CStone Pharmaceuticals (HKEX: 2616) is a biopharmaceutical company focused on developing and commercializing innovative immuno-oncology and precision medicine to address the unmet medical needs of cancer patients in China and worldwide. Established in 2015, CStone has assembled a world-class management team with extensive experience in innovative drug development, clinical research, and commercialization. The company has built an oncology-focused pipeline with a strategic emphasis on immune-oncology combination therapies. Currently, 4 late-stage candidates are at or near pivotal trials. With an experienced team, a rich pipeline, a robust clinical development-driven business model, and substantial funding, CStone’s vision is to become globally recognized as a leading Chinese biopharmaceutical company by bringing innovative oncology therapies to cancer patients worldwide.

For more information about CStone Pharmaceuticals, please visit: www.cstonepharma.com.

Statement

The forward-looking statements made in this article relate only to the events or information as of the date on which the statements are made in this article.  Except as required by law, we undertake no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, after the date on which the statements are made or to reflect the occurrence of unanticipated events.  You should read this article completely and with the understanding that our actual future results or performance may be materially different from what we expect.  In this article, statements of, or references to, our intentions or those of any of our Directors or our Company are made as of the date of this article.  Any of these intentions may alter in light of future development.

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Sanofi Chief Executive Officer Olivier Brandicourt attended the China Development Forum and spoke at the Economic Summit

-Showing commitment to help promote the rapid implementation of rare diseases treatment in China

BEIJING, March 24, 2019 /PRNewswire/ — Sanofi Chief Executive Officer Olivier Brandicourt expressed yesterday that he is very glad to be able to participate in the 2019 edition of the China Development Forum, particularly as it marks the 20th anniversary of the Forum.


Sanofi Chief Executive Officer Olivier Brandicourt attended the China Development Forum and spoke at the Economic Summit

Hosted by the Development Research Centre of the State Council (DRC), the China Development Forum (CDF) is being held at the Diaoyutai State Guesthouse in Beijing from 23rd to 25th March, with the theme of “Greater Opening-up for Win-Win Cooperation.”

“Since the Healthy China blueprint was adopted two years ago, we realized how much policy has been adopted and the government has incredible ability to keep pace and continuously draft, adopt and then implement health policies. So it is clearly one of the key successes of China in reforming the healthcare system.” At the Economic Forum of CDF, Mr. Brandicourt spoke highly of Chinese authorities for having made significant strides to accelerate the listings of special care and rare disease medicines to address critical life-threatening conditions.

Sanofi stands by the millions of people battling long-term chronic conditions and the few sufferings from rare diseases. Mr. Brandicourt commented, “Considering our experience in developing groundbreaking rare diseases treatments and our strong experience in working with governments around the world, we, at Sanofi, are committed to working alongside the Chinese government to swiftly implement these policies and increase awareness among the public and healthcare actors.”

According to the organizers, 2019 marks the 70th anniversary of the establishment of People’s Republic of China. Its development over 70 years has strengthened China’s determination to adhere to the opening-up policy. China will continue to focus on its opening-up and innovative development, which are key concepts embedded in its new development plan.

More than 150 official representatives from foreign businesses attended the forum, including a total of 96 chairmen and CEOs of the world’s leading companies. The companies represented various industry sectors, including energy and minerals, financial insurance, aerospace, and information communications technology, equipment manufacturing, biopharmaceutical, and many more.

About Sanofi

Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.

With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.

Sanofi, Empowering Life

About Sanofi China

In 1982, Sanofi opened its first office in China. Sanofi China has a diversified business that ranges from pharmaceuticals and human vaccines to consumer healthcare. Sanofi’s China headquarters in Shanghai are supported by 11 offices in Beijing, Tianjin, Shenyang, Jinan, Hangzhou, Nanjing, Wuhan, Chengdu, Guangzhou, Fuzhou and Urumqi. Sanofi has around 9,600 employees in China.

Sanofi has three manufacturing facilities in China to meet the increasing demand of the domestic market. These plants are located in Beijing, Hangzhou and Shenzhen.

Sanofi operates the China R&D Center and Asia Pacific R&D Hub in Shanghai, Global R&D Operations in Chengdu, and Global Research Institute in Suzhou. Sanofi’s R&D focuses on unmet medical needs, such as oncology, immunology, and metabolic diseases in China and the rest of the world.

For more information, please visit www.sanofi.cn or subscribe to the Sanofi China official WeChat account: SanofiChina.

Sanofi Forward-Looking Statements

This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. Forward-looking statements are generally identified by the words “expects”, “anticipates”, “believes”, “intends”, “estimates”, “plans” and similar expressions. Although Sanofi’s management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labeling and other matters that could affect the availability or commercial potential of such product candidates, the absence of guarantee that the product candidates if approved will be commercially successful, the future approval and commercial success of therapeutic alternatives, the Group’s ability to benefit from external growth opportunities, trends in exchange rates and prevailing interest rates, the impact of cost containment policies and subsequent changes thereto, the average number of shares outstanding as well as those discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under “Risk Factors” and “Cautionary Statement Regarding Forward-Looking Statements” in Sanofi’s annual report on Form 20-F for the year ended December 31, 2017. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.

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AAHRPP Accredits Three More Research Organizations

Two in the U.S., one in Taiwan attain the gold standard

WASHINGTON, March 22, 2019 /PRNewswire/ — The Association for the Accreditation of Human Research Protection Programs today announced its first accreditations for 2019: a research institute in Massachusetts, a health care delivery system in California and a hospital in Taiwan.

The three newly accredited organizations are:

  • Harvard Pilgrim Health Care Institute, LLC, of Harvard Pilgrim Health Care, Inc., Boston, Massachusetts
  • Memorial Health Services, Fountain Valley, California
  • National Cheng Kung University Hospital, Tainan, Taiwan

“These organizations join more than 600 entities worldwide in committing to shared high standards for safe, ethical research,” AAHRPP President and CEO Elyse I. Summers said. “Their AAHRPP designation offers assurances—to potential partners, the scientific community and the general public—that study participants are protected and research results can be trusted.”

The emphasis on universal standards is intensifying, in part, because of the trend toward multisite, multi-institutional research. In this environment, the common ground of AAHRPP accreditation can ease the way for successful collaboration.

“The benefits of a common standard are significant and, as the gold standard, AAHRPP accreditation is the logical choice,” Summers said. “We continue to work toward one standard worldwide—one accreditation at a time.”

To earn AAHRPP accreditation, organizations must show that they have built extensive safeguards into every level of their research operation and that they adhere to high standards for research.

AAHRPP has accredited organizations across the United States and in Belgium, Brazil, Canada, mainland China, India, Mexico, Republic of Korea, Saudi Arabia, Singapore, South Africa, Taiwan and Thailand.

All major U.S. independent institutional review boards have earned AAHRPP accreditation. In addition, 70 percent of U.S. medical colleges and 85 percent of the top National Institutes of Health-funded academic medical centers are either AAHRPP accredited or have begun the accreditation process. NIH, the world’s largest public funder of research, has earned accreditation, as has Pfizer, Inc., the largest industry sponsor of clinical research.

About AAHRPP: A nonprofit organization, AAHRPP provides accreditation for organizations that conduct or review human research and can demonstrate that their protections exceed the safeguards required by the U.S. government. To learn more, visit www.aahrpp.org.

FOR MORE INFORMATION CONTACT:
Michelle Feige
Executive Vice President
mfeige@aahrpp.org 
(202) 783-1112

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