Novotech Partners with South Korea’s Pusan National University Hospital

BUSAN, SOUTH KOREA, Jun 18, 2020 – (ACN Newswire) – The leading Asia-Pacific biotech specialist CRO Novotech has partnered with South Korea's world-class Pusan National University Hospital (PNUH) based in Busan, South Korea's second largest city.





The Partnership is designed to further support Novotech's biotech clients run their clinical trials in the region.

Dr. Jeong Zoo Lee, the President of PNUH, said: "The PNUH site team and Novotech have worked together on a number of studies already. Based on our strong relationship, we have progressed to a formal agreement to support Novotech biotech clients across all clinical research and patient recruitment areas.

"We are pleased to partner with a regional CRO leader with such an outstanding reputation internationally," said Dr. Lee.

Dr. Yooni Kim, Executive Director, Asia Operations said: "Novotech was very pleased to establish a Partnership with PNUH which has completed more than 340 clinical trials and is ranked 7th in terms of number of clinical trials in South Korea (GlobalData).

"The PNUH site offers biotechs quality infrastructure, world-class medical and hospital facilities, as well as South Korea's supportive rapid start-up environment. South Korea is the most active country in clinical research in Asia after China.

"The main therapeutic areas for clinical trials at PNUH have been oncology, infectious disease, cardiovascular and gastrointestinal," said Dr. Kim.

Novotech now has over 20 significant Partnerships with some of the leading medical institutions in the region. The Partnership Program is strategically designed to deliver unparalleled access to quality investigators, KOLs, and up to 4 million patients for its international biotech clients.

About Novotech – https://novotech-cro.com

Novotech is internationally recognized as the leading regional full-service contract research organization (CRO) in Asia-Pacific. Novotech has been instrumental in the success of over a thousand Phase I – IV clinical trials for biotechnology companies. Novotech was established in 1996, with offices in 11 locations across the region, and site partnerships with major health institutions.

Novotech provides clinical development services across all clinical trial phases and therapeutic areas including: feasibility assessments; ethics committee and regulatory submissions, data management, statistical analysis, medical monitoring, safety services, central lab services, report write-up to ICH requirements, project and vendor management. Novotech obtained the ISO 27001 certification which is the best-known standard in the ISO family providing requirements for an Information Security Management System. Together with the ISO 9001 Quality Management system, Novotech aims at the highest IT security and quality standards for patients and biotechnology companies.

For RFP enquiries: Please fill out the form available at https://novotech-cro.com/talk-to-an-expert

Media contact:
David James
communications@novotech-cro.com
AU: +61 2 8218 2144
USA: +1 415 951 3228
Asia: +65 3159 3427

Copyright 2020 ACN Newswire. All rights reserved. http://www.acnnewswire.com

Hua Medicine Successfully Completes SEED (HMM0301), Dorzagliatin’s Phase III Monotherapy Trial

SHANGHAI, CHINA, Jun 18, 2020 – (ACN Newswire) – Hua Medicine (the "Company", Stock Code: 2552.HK), a leading innovative drug development company focused on developing novel therapies for the treatment of diabetes, today announced topline results from SEED (also known as HMM0301), the first Phase III trial with dorzagliatin. Dorzagliatin is a first-in-class glucokinase activator administered orally, twice daily. The 52-week trial investigated the efficacy and safety of 75mg BID dorzagliatin in 463 patients with Type 2 diabetes, with an initial 24-week double blinded, placebo-controlled treatment, followed by an open label 28-week treatment. The primary efficacy and safety endpoints were evaluated at 24 weeks.



Figure 1


HbA1c Reduction *p<0.001 compared with baseline at 52 week



In November 2019, Hua Medicine announced the trial had achieved its primary efficacy and safety endpoints over the initial 24-week double blinded period. For the 52-week treatment period, the efficacy and safety profiles were sustained based on the topline data analysis. During the 28-week open-label period, patients initially receiving a placebo (i.e., the placebo group) were administered dorzagliatin for the first time. Figure 1 below illustrates the efficacy (as measured by HbA1c reduction) for the two-cohort groups for the entire 52-week period.

In the 28-week open-label treatment period, dorzagliatin continued to exhibit a safe and well-tolerated clinical profile. A safety analysis based on study safety population demonstrated that dorzagliatin was well tolerated and had a good safety profile. The incidence of adverse events was similar between the dorzagliatin-treated and placebo groups. There was less than 1% hypoglycemia with blood glucose < 3 mmol/L during the 52-week treatment period. During the 28-week open-label treatment, patients also saw a continued reduction of insulin resistance (insulin resistance is the hallmark of Type 2 diabetes).

"We are incredibly proud of our accomplishment. The Hua Medicine team and our partners have worked closely together over the last decade to advance the development of dorzagliatin," said Dr. Li Chen, CEO and founder of Hua Medicine. "With the successful completion of SEED, we become the first company globally to advance a glucokinase activator through clinical development. This is an incredible achievement for the Hua Medicine team, Chinese investigators, Hua's partners and supporters, and most importantly, for Type 2 diabetes patients globally." On Sunday, June 14th, 2020, Dr Chen presented more comprehensive data of the 24-week double blinded, placebo-controlled period of SEED study at the ADA 2020 80th Scientific Sessions. In addition to reduced glucose levels, the data presented at the ADA indicated improved beta cell function for the dorzagliatin-treatment group (as measured by the clinically meaningful biomarker HOMA2-beta). In contrast, the placebo group experienced reduced beta cell function during the same period. Dr. Chen added: "Hua Medicine will continue its efforts to develop a potential disease modifying therapy to treat diabetes."

SEED (Efficacy and Safety Evaluation of Dorzagliatin) study design
SEED is a randomized, double-blind, placebo-controlled Phase III study in 463 drug naive type 2 diabetes patients. Patients are treated with twice-daily doses of dorzagliatin (75 mg) or placebo, randomized 2:1. The clinical study evaluated the efficacy and safety of dorzagliatin during 24 weeks of double-blinded treatment, followed by a subsequent 28-week open-label treatment period, for a total of 52 weeks. During the 28-week open-label period, both patient groups were treated with twice-daily doses of dorzagliatin (75 mg). The trial was conducted in compliance with the guidelines of the Chinese Society of Endocrinology, which require physicians to educate patients and strictly enforce improved exercise and dietary control, as well as continuous self-monitoring, in treating Type 2 diabetes. The trial was conducted at 40 clinical sites across China led by Professor Dalong Zhu, President of the Chinese Diabetes Society.

About Dorzagliatin
Dorzagliatin is an investigational first-in-class, dual-acting glucokinase activator, designed to control the progressive degenerative nature of diabetes by restoring glucose homeostasis in patients with Type 2 Diabetes. By addressing the defect of the glucose sensor function of glucokinase, dorzagliatin has the potential to restore the impaired glucose homeostasis state of patients with Type 2 Diabetes and serve as a first-line standard-of-care therapy for the treatment of the disease, or as a cornerstone therapy when taken in combination with currently approved anti-diabetes drugs.

About Hua Medicine
Hua is a leading, clinical-stage innovative drug development company in China focused on developing novel therapies for the treatment of diabetes. Founded by an experienced group of entrepreneurs and international investment firms, Hua advanced a first-in-class oral drug for the treatment of Type 2 Diabetes into NDA-enabling stage and is currently evaluating the therapy in adults with diabetes in two Phase III trials in China and various earlier stage clinical trials in China and the United States. Dorzagliatin has achieved its first primary endpoint in a Phase III monotherapy trial. The Company has initiated product life-cycle management studies of this novel diabetes therapy and advanced its use in personalized diabetes care. Hua Medicine is working closely with disease experts and regulatory agencies in China and across the world to advance diabetes care solutions for patients worldwide.

For more information
Hua Medicine
Website: www.huamedicine.com
Investors
Email: ir@huamedicine.com
Media
Email: pr@huamedicine.com



Copyright 2020 ACN Newswire. All rights reserved. http://www.acnnewswire.com

Impact Biomedical Announces Publication of COVID-19 Research in Peer-Reviewed Journal

SINGAPORE, Jun 17, 2020 – (ACN Newswire) – SGX-listed Singapore eDevelopment Limited's (SeD; SGX:40V) wholly owned subsidiary Impact Biomedical Inc. ("Impact Biomedical") announced today that their COVID-19 research with Global Research and Discovery Group Sciences ("GRDG"), conducted in collaboration with Harvard Medical School and Vilotos Pharmaceutical, Inc. ("Vilotos"), was published in the peer-reviewed scientific journal Molecules on June 11, 2020. The research paper, titled "Potential of Flavonoid-Inspired Phytomedicines against COVID-19," reports that in advanced computational molecular docking GRDG's Equivir and Linebacker compounds and Vilotos's Caflanone bind with high affinity to the spike protein, helicase, and protease sites on the angiotensin-converting enzyme 2 (ACE2) receptor used by the SARS-CoV-2 to cause COVID-19. The paper reports that in vitro studies demonstrated Caflanone's potential to inhibit multiple virus entry factors. Additionally, the use of smart nanoparticle drones to deliver these medicines is discussed in the journal.

The ACE2 receptor found in the lung and respiratory tract is used by the virus to infect cells and cause COVID-19. Molecular docking of Equivir, Linebacker and Caflanone demonstrated high binding affinity on the ACE2 receptor on spike protein, helicase, and protease sites on the ACE2 receptor causing conformational change to inhibit viral entry of the virus. The molecular docking results indicate that Equivir, Linebacker and Caflanone may bind to the ACE2 receptor equally or better than Chloroquine, a drug currently under evaluation in clinical trials against COVID-19.

Smart nanodrones can enhance the bioavailability of these phytomedicines and could allow the ability for image guided targeting and monitoring. The flavonoids can be encapsulated in the nanodrones using microfluidic approaches or can be conjugated as targeting moieties.

Equivir was created by GRDG as an OTC medication/vitamin that works by impeding virulence and blocking downstream factors to treat and protect against diseases caused by not only SARS-CoV-2 but also Rhinoviruses, Influenzas, and other dangerous pathogens. Equivir has broad antiviral efficacy against multiple types of Influenza, Rhinovirus, Cholera, Ebola, and COVID-19.

Linebacker was designed by GRDG to shadow the Panacea Project, a US Defense Advanced Research Projects Agency (DARPA) program to provide novel, multi-target therapeutics for unmet physiological needs. Linebacker is a patented universal therapeutic medication with demonstrated effectiveness in neurological diseases including Parkinson's, many types of cancer, and multiple pathogens such as MRSA, E. coli, Cholera, A. baumannii, Influenza, SARS, MERS, Ebola, Malaria, and COVID-19.

Clark Swanson, Co-Founder and Executive Vice Chairman of Vilotos said, "We are very pleased with the results from our joint antiviral studies. Caflanone holds great potential for the future development of a novel drug for the treatment of COVID-19."

GRDG's Chief Scientific Advisor is Dr. Roscoe M. Moore, Jr., the former United States Assistant Surgeon General and former Epidemic Intelligence Service Officer at Centers for Disease Control and Prevention or CDC. Dr. Moore said, "The peer-review and publication of this research is significant and shows the potential of these compounds to be lifesaving tools in the fight against this and future pandemics."

GRDG is also advised by Lieutenant Colonel William H. Lyerly Jr., retired Career Senior Executive / Scientific Professional from the U.S. Department of Homeland Security and retired U.S. Army Medical Service Corps Officer. Lieutenant Colonel Lyerly also served as a senior official in the U.S. Department of Health and Human Services, the U.S. Agency for International Development, and the U.S. Executive Office of the President (White House). Lieutenant Colonel Lyerly said, "These studies show that Equivir, Linebacker, and Caflanone may be the novel approaches to unique solutions the world is looking for to combat the health threats posed by pandemics such as COVID-19."

"This collaborative effort endorses the direction we are heading towards and with the collective effort from the team, we can achieve great success to benefit everyone" said Mr. Chan Heng Fai, Chairman.

Daryl Thompson, Director of Scientific Initiatives and founder of GRDG said, "The findings of this study further support our collaborative efforts to identify, exploit and combat the infective nature of the SARS-CoV-2 virus."

This research indicates the strong potential for the development of these phytomedicines for use as prophylactics to prevent infection and as treatments to mitigate the disease saving many lives. The technologies can also be rapidly adapted to respond to future pandemics and emerging viral diseases.

Our intention in relation to the COVID-19 situation is to establish strong novel research data which will then be further developed and licensed to a major pharmaceutical company for integration and eventual deployment as treatments for diseases.

Shareholders and potential investors of SeD are advised to read this Press Release and any further announcements made by SeD carefully. Shareholders and potential investors of SeD are advised to refrain from taking any action with respect to their securities in SeD which may be prejudicial to their interests, and to exercise caution when dealing in the securities of SeD. Shareholders and potential investors of SeD should consult their stockbrokers, bank managers, solicitors or other professional advisers if they have any doubt about the actions they should take.

About Singapore eDevelopment Limited
Incorporated on 9 September 2009 and listed on the Singapore Exchange in July 2010, Singapore eDevelopment Limited is involved in (i) property development and investments primarily in the United States and Western Australia; (ii) information technology-related businesses; (iii) development, research, testing, manufacturing, licensing and distribution of biomedical products; and (iv) investment activities. For more information, please visit: www.SeD.com.sg or email contact@sed.com.sg.

About Impact BioMedical, Inc.
Impact BioMedical, Inc. ("Impact BioMedical") is a wholly-owned direct subsidiary of Global BioMedical Pte. Ltd., which in turn is a wholly-owned direct subsidiary of Singapore eDevelopment Limited, a company listed on the Singapore Exchange.

Impact BioMedical strives to leverage its scientific know-how and intellectual property rights to provide solutions that have been plaguing the biomedical field for decades. By tapping into the scientific expertise of GRDG Sciences, LLC. and Australian Exchange-listed Holista CollTech Limited, Impact BioMedical pledges to undertake a concerted effort in the R&D, drug discovery and development for the prevention, inhibition, and treatment of neurological, oncological and immuno related diseases.

About GRDG Sciences, LLC.
GRDG Sciences, LLC is an advanced research team formed in Florida by natural products discovery drug research scientist, Daryl Thompson. For more information, please visit: http://www.globalrdg.com.

About Vilotos Pharmaceutical, Inc.
Vilotos Pharmaceuticals is a Maryland based pharmaceutical company specialized in developing novel drugs for the prevention and treatment of endemic and emerging viruses. The company is currently focused on developing therapies against coronaviruses, hepatitis C, HIV and several other viruses. The lead molecule of the company is being developed to combat the current coronavirus (COVID-19) pandemic. (www.vilotospharma.com)

Copyright 2020 ACN Newswire. All rights reserved. http://www.acnnewswire.com

VerifyMe and Gohar Group’s Techind Form Strategic Relationship to Address Product Authentication and Brand Protection in India’s Large and Emerging Pharmaceutical Market

ROCHESTER, NY / ACCESSWIRE, Jun 15, 2020 – (ACN Newswire) – VerifyMe, Inc. (OTCQB:VRME), a digital technology solutions provider specializing in counterfeit prevention, authentication, serialization, data mining, track and trace, features for labels, packaging and products, is pleased to announce that it has entered into a strategic relationship with Techind Engineers & Consultants-Impex ("Techind"), part of the Gohar Group, of India.





Techind has experience in serialization and track and trace, having sold and installed more than 100 production line serialization systems for 10 clients in the Pharmaceutical industry over the past few years.

VerifyMe and Techind will work together in providing the VeriPAS(TM) serialization and track and trace solution to the broad range of industries and clients of Techind, with specific focus on the Pharmaceutical industry. Other project areas of Techind include: Bio-technology, Processed Food, Chemicals and Allied Packaging up to tertiary stage, on a turnkey basis. With 35+ years of presence in the market, Techind has earned its position, trust and goodwill in the region.

Techind's CEO A.J.S Gohar stated, "We have experience in serialization and track and trace over the past 9 years as our clients have asked for product authentication and brand protection solutions. VerifyMe's VeriPAS is an upgrade from what we were previously doing and something we believe our existing clients can integrate with and new clients will desire. We have already highlighted the areas of pharmaceutical, nutraceutical and consumer products, where we have clients and relationships that seek serialization and track and trace solutions. This partnership is particularly timely given our experience in the pharma industry and recent avenues to serialize and authenticate COVID-19 test kits. This will be an immediate area of focus. We look forward to rolling out VeriPAS to our client base in India, the SAARC region, and worldwide."

VerifyMe Chief Executive Officer Patrick White commented, "According to the World Health Organization, people are dying in the tens of thousands from the scourge of counterfeit drugs. See https://pr.report/ylAwH8q9. People want comfort that the drugs and medications they are taking are authentic. Our technologies allow both users and brand inspectors to perform a simple instant effective authentication test with their smart phone. We are thrilled to have our technologies chosen by the Gohar Group and Techind. Combining our counterfeit protection technologies with their expertise in building pharmaceutical manufacturing systems is a win not only for their pharmaceutical clients but for the people that need to be protected from harmful and deadly counterfeit drugs. Their business success and impeccable reputation, not only in India and the SAARC region, but worldwide, represent an opportunity for our serialization and track and trace solution, VeriPAS. Their client list is extremely impressive and particularly in pharma, represents great opportunity for us potentially with the likes of Sun Pharma, Cipla, Lupin, Panacea Biotec, Wockhardt, Intas, Apotex, Hospira, Johnson & Johnson, Daiichi Sankyo, Sanofi Aventis, Glaxo Smithkline, Novartis, Merck, Pfizer and AstraZeneca. We also look forward to working with Mr. Adhinayak Gohar – Director Technical of Techind in making our world a safer place."

For a list of highlight clients of Gohar Group, please visit: http://www.gohargroup.in/clients.php.

About Gohar Group and Techind Engineers & Consultants-Impex

Gohar Group was founded in 1945 and operates in a diverse range of activities with a broad spectrum of exclusive services, into various promising areas such as manufacturing. Information technology & telecommunications, healthcare, energy/oil & gas, banking & insurance, infrastructure & construction, education and environment conservation & re-cycling. For additional information, please visit: http://www.gohargroup.in.

Techind, with offices in Delhi and Mumbai, is carrying out the business of Turnkey Project Engineering & Consultancy, rendering services in the SAARC (The South Asian Association for Regional Cooperation) is the regional intergovernmental organization and geopolitical union of states in South Asia. Its member states are Afghanistan, Bangladesh, Bhutan, India, the Maldives, Nepal, Pakistan and Sri Lanka) region. Techind is also engaged in the representation of foreign principals, from Europe and the U.S., to market their machinery, equipment and know-how to various clients worldwide.

About VerifyMe, Inc.

VerifyMe, Inc., is a technology solutions company that markets products supported by patents, patent applications and trade secrets which provides identifiers and serialization for authenticating, tracking and tracing functions for labels, packaging and products. VerifyMe's technology authenticates packaging, labels and documents with a suite of proprietary security inks and pigments, which work in conjunction with serialization and track-and-trace software known as "VeriPAS(TM)" that allows both consumers and brand inspectors to verify authenticity with their smart phones. VeriPAS(TM) is a serialization software system that brand owners access thru a web portal to monitor, control and protect their products complete "Life cycle". To learn more, visit www.verifyme.com

Cautionary Note Regarding Forward-looking Statements

This release contains forward-looking statements regarding revenue opportunities, the use of our products in additional presses and locations, the results of ongoing tests, and roll-out of our products and authentication devices which involve uncertainty and risk. The words "believe," "may", "estimate," "continue," "anticipate," "intend," "should," "plan," "could," "target," "potential," "is likely," "will," "expect" and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our financial condition, results of operations, business strategy and financial needs. Important factors that could cause actual results to differ from those in the forward-looking statements include the company's ability to work with partners in selling its technologies to businesses, production difficulties, our inability to enter into contracts and deals with future partners, and issues which may affect the reluctance of large companies to change their purchasing of products, acceptance of our technologies, the efficiency of our authenticators in the field, our patents including potential litigation, and the ongoing novel COVID-19 pandemic. Further information on our risk factors is contained in our filings with the SEC, including the Form 10-K for the year ended December 31, 2019. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law.

For Licensing or Other Information Contact:
Company: VerifyMe, Inc.
Email: IR@verifyme.com
Website: http://www.verifyme.com

Investors:
ClearThink
nyc@clearthink.capital

SOURCE: VerifyMe

Copyright 2020 ACN Newswire. All rights reserved. http://www.acnnewswire.com

Agilex Biolabs Encourages Biotechs to Move Delayed Trials to Australia at BIO Digital 2020

Adelaide, AUS, Jun 11, 2020 – (ACN Newswire) – Agilex Biolabs, Australia's largest specialist bioanalytical laboratory for clinical trials, encouraged biotechs to consider Australia for their clinical trials during a presentation at BIO Digital 2020.

Watch the BIO Digital 2020 presentation here:
https://www.bio.org/events/bio-digital/sessions/search?name=Agilex

The presentation by CEO Jason Valentine and moderated by VP Business Development Julia Jones details the current trials landscape in Australia and why biotechs wanting to avoid delays caused by COVID-19, can move their trials to Australia.

Australia's impressive COVID-19 management and the world's most attractive rebate on clinical trials costs are just a few of the reasons that make it an ideal location to restart delayed trials, according to Agilex Biolabs.

CEO Jason Valentine said:

"Australia has a group of proven top-tier trial providers that regularly work together so are fully engaged and in sync with processes and each other's requirements and capabilities. We have worked with all the trials service provider companies so can advise on which ones are the best fit for each study.

"The Agilex Biolabs team can offer an unbiased approach and advice depending on specific trial requirements. Our world-class bioanalytical facilities have OECD GLP Recognition with NATA (Australian Government OECD GLP Compliance monitoring authority) and ISO 17025 Accreditation for global recognition."

Please Book a Briefing with us before you start your next clinical trial. https://calendly.com/agilexbiolabs/15min

Australia: +61 8 8302 8777 | China: +86 21 8036 9483 | South Korea: +82 80 812 1255 | USA: +1 800 247 1909

Agilex Biolabs has launched a News Video Update about COVID-19 and clinical trials in Australia. Watch it here: https://youtu.be/vZuHAYZ-GiE


About Agilex Biolabs https://www.agilexbiolabs.com

Agilex Biolabs, Australia's leading bioanalytical laboratory, has more than 20 years' experience in performing regulated bioanalysis, including quality method development, method validation and sample analysis services. We have successfully supported hundreds of preclinical and clinical trials around the world where customers choose Australia for the streamlined regulatory process and access to the world's most attractive R&D rebate of more than 40% on clinical trial work conducted in Australia.

Agilex Biolabs specialises in bioanalysis of small molecules and biologics for PK, immunogenicity, biomarkers and immunological pharmacodynamics assessments utilising LC-MS/MS, immunoassay (Mesoscale, Gurolab, Luminex) and flow cytometry (BD FACSymphony A3, 20 colour cell analyser). Agilex offers pharmacodynamics services including immunobiology services using the latest state-of-the-art technology to support immunology, cell biology and mode of action assays, incuding Immunophenotyping, Receptor occupancy, and Cytokine release assays (whole blood or PBMC stimulation assays) and cytokine/biomarker profiling PBMC assays and cellular mechanism of action assays (ie ADCC).

Agilex Biolabs, the only FDA-inspected lab of its type in the region, is located in Adelaide, South Australia in a science and biotech specialist hub. The biolabs has more than 65 dedicated laboratory staff, and annually support more than 80 clinical trials. This year they will analyse more than 60,000 samples for pharma/biotechs from US, Europe and APAC.
The company has just expanded its labs by more than 30% to accommodate biotech demand from APAC and the USA.

See us featured in Endpoints https://tinyurl.com/uqmkzcu

Media Contact:
Kate Newton
Media@AgilexBiolabs.com


Copyright 2020 ACN Newswire. All rights reserved. http://www.acnnewswire.com

SinoMab Announces Clinical Results on its First-in-target SM03 at EULAR 2020 Congress

HONG KONG, Jun 10, 2020 – (ACN Newswire) – SinoMab BioScience Limited ("SinoMab" or the "Company", stock code: 3681.HK), a Hong Kong-based biopharmaceutical company dedicated to the research, development, manufacturing and commercialization of therapeutics for the treatment of immunological diseases, made an oral presentation titled "Efficacy and safety of SM03, a Recombinant Anti-human CD22 Monoclonal Antibody in Chinese Patients with Rheumatoid Arthritis: A Phase II randomized, double-blind, multi-dose, placebo-controlled study" in the evening on 5th June, 2020 at the European League Against Rheumatology ("EULAR") 2020 Congress(the "Congress"). Professor Zhang Fengchun, the head of Internal Medicine Department of Peking Union Medical College Hospital (PUMCH) and the leading principal investigator of the Phase II clinical study of SM03, reported the results of the study as the keynote speaker.

Professor Zhang said that SM03 has shown significant efficacy for the treatment for RA without increase in adverse events. Been invited to announce the clinical results at the Congress showed the great emphasis and expectation worldwide for SM03. Professor Zhang also expressed his confidence in SM03's next stage study and marketing in the future. Moreover, Professor Zhang said B cells play an important role in immunological diseases. The positive results of SM03 for the treatment for RA will benefit the exploration of potential indications against other B cells-related diseases.

As a potential global first-in-target anti-CD22 mAb for the treatment of RA, SM03 has been recognized by the PRC's Ministry of Science and Technology as one of the significant special projects of Significant New Drugs Development of the Twelfth and Thirteenth Five-Year Plan Period for two consecutive times. SM03 has completed its Phase II clinical study for the treatment of RA led by the Peking Union Medical College Hospital, aiming to evaluate its efficacy and safety for patients with moderate to severe active RA. Phase II clinical study took a period of 24 weeks and enrolled 156 patients with a history of MTX treatment failure, who were randomly divided into three groups, namely Placebo, Low dose and High dose. The study design followed international standards for clinical trials of new drugs and conducted regular evaluation on efficacy and safety according to the requirements of international new drug applications. Statistics related to the oral presentation are as follow: the enrolled Chinese patients with active RA, SM03 in combination with methotrexate, demonstrated a good safety and tolerance, throughout 24 weeks of treatment, especially in terms of infusion-related reactions and treatment-related infections. No patient reported severe treatment-emergent infections or any secondary malignancies, during the study. Moreover, SM03 has demonstrated a good safety profile, especially in terms of treatment-related infection, secondary malignancy and low immunogenicity. (EULAR abstract number: OP0210)

Dr. Shui On Leung, the Executive Director, Chairman and Chief Executive Officer of SinoMab, said in the video interview, that SM03 is currently in Phase III clinical trials. Although the timeframe is extended due to the uncertainties brought by COVID-19, the enrolment is expected to be completed by the end of this year and the Biologics Licence Application is estimated to be filed by the end of 2021. Another drug developed by SinoMab, SN1011, which is one of the only two BTK inhibitor in clinical trials worldwide, is in Phase I clinical trial in Australia. The single arising dose study has completed and shown satisfying safety evaluation. The submission of Investigational New Drug("IND") in China is in preparation as well. Furthermore, SM17, SinoMab's first-in-class mAb against the receptor IL17BR, is developed for the treatment of potential indications including allergic asthma and idiopathic pulmonary fibrosis (IPF) and is expected to file IND in America or the European region. Dr. Leung said that SinoMab strives to become a global leader in the innovation of therapeutics for autoimmune diseases. Focusing on the development of novel drugs, in addition to the treatment of immunological diseases, SinoMab is also exploring therapeutics for cancers and other rare diseases in both domestic and overseas markets. To strengthen innovative R&D capability, the Company plans to introduce a target screening platform. And two to three drugs are estimated to initiate clinical trials in the next two years. At this stage, numerous international pharmaceutical giants have expressed cooperative intentions.

Professor Zhang added, SinoMab has found numerous targets for the treatment of immunological diseases and obtained the potential to develop more innovative therapeutics to contribute to the therapeutics for the treatment of immunological diseases.

About European League Against Rheumatology 2020 Congress

European League Against Rheumatology 2020 Congress is hosted by European League Against Rheumatology (EULAR) and enjoys an important role in global rheumatology research. The EULAR Congress initiated in 2000. Physicians, scientist and arthritis/rheumatism patients, health professionals and representatives from pharmaceutical industry from all over the world are gathered to share the cutting-edge research results in rheumatology field. Nowadays, the EULAR Congress has become an important platform for scientific and clinical information in Europe and a well-known forum for the communication between global rheumatologists. The scientific program of EULAR Congress covers topics including clinical innovation, clinical, transformation and fundamental science, dedicating to improving health condition of people suffering from rheumatic musculoskeletal disease.

About SinoMab BioScience Limited
SinoMab BioScience Limited ("SinoMab" or the "Company", stock code: 3681.HK) is dedicated to the research, development, manufacturing and commercialization of therapeutics for the treatment of immunological diseases. The Company's flagship product SM03 is a potential global first-in-target mAb against CD22 for the treatment of rheumatoid arthritis and is currently in Phase III clinical trial for rheumatoid arthritis in China, which has been recognized as one of the significant special projects of Significant New Drugs Development of the Twelfth Five-Year Plan Period and the Thirteenth Five-Year Plan Period. In addition, the Company possesses other potential first-in-target and first-in-class drug candidates, some of which are already in clinical stage, with their indications covering rheumatoid arthritis, systemic lupus erythematosus, non-Hodgkin's lymphoma, asthma, and other diseases with major unmet clinical needs.



Copyright 2020 ACN Newswire. All rights reserved. http://www.acnnewswire.com

Joonghun Pharmaceutical of Korea Targets Overseas Markets for Coronavirus Diagnostic Kits

SEOUL, KOREA, Jun 9, 2020 – (ACN Newswire) – With the worldwide spread of the Novel Coronavirus (COVID-19), orders for Korean diagnostic kits continue to roll in. As part of the effort to combat COVID-19, Joonghun Pharmaceutical announced that it was accelerating efforts to provide its JD COVID-19 qRT-PCR Kit for in vitro diagnostics internationally.





The JD COVID-19 qRT-PCR Kit uses Real-time RT-PCR (Real-time Reverse Transcription-Polymerase Chain Reaction), currently the main testing method for detecting SARS-CoV-2 virus in COVID-19, because of its excellent sensitivity and specificity.

Joonghun Pharmaceutical's diagnostic qRT-PCR Kit targets a single gene (N gene) of the coronavirus, based on the FDA and CDC response to COVID-19. Targeting the single gene accords with FDA Test Validation FAQs which note recent evidence suggesting appropriately validated single gene detection (single viral target SARS-CoV-2 assay) provides acceptable performance. Joonghun's targeting the N gene is based on the US CDC diagnostic kit 'CDC 2019-Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel' which targets N genes as well.

According to Joonghun Pharmaceutical, "We successfully conducted clinical trials using U.S. Food and Drug Administration (FDA) Emergency Use Authorization (EUA) clinical guidelines, in cooperation with university research institutes and government agencies." Furthermore, "Based on these clinical results, on April 17 we obtained an export license from the Korean Ministry of Food and Drug Safety, and received a European in vitro diagnostic (CE-IVD) certification, providing us with a foothold for meeting various needs around the world."

Joonghun Pharmaceutical is currently attending results of its FDA EUA application, submitted May 4th, 2020. The FDA approval process is expected to proceed smoothly as the product was verified in clinical trials. A spokesperson for Joonghun Pharmaceutical said requests for the supply of diagnostic kits are constantly coming from South America, Europe and parts of Asia where COVID-19 is still spreading, and obtaining EUA approval would provide another source of validation for these markets.

The company also produces the Joonghun Ribavirin capsule, one of 35 medicines recognized by the Korea Health Insurance Review and Assessment Service as a COVID-19 treatment. "Inquiries regarding Joonghun Ribavirin capsules surged from public institutions and distributors in countries across Europe and South America, and in March, at the request of Luxembourg, a total of 42,000 capsules were urgently exported."

"In order to contribute and help stabilize the global impact of COVID-19, we will increase the production of medicines, in order to respond quickly to urgent requests from domestic and international entities. Joonghun's JD COVID-19 qRT-PCR Kit is produced in a GMP facility for pharmaceuticals and medical devices, so we will be able to provide a stable supply." Joonghun Pharmaceutical also added, "In order to actively respond to the worldwide demand for diagnostic kits, we are also planning to release a rapid test kit in June."

Media contact
Joonghun Pharmaceutical Co., Ltd.
T: +82-2-2138-8114
E: COVID-19TF@joonghun.com
U: www.joonghun.com

Copyright 2020 ACN Newswire. All rights reserved. http://www.acnnewswire.com

TrialTrove Data Shows Australia is Open for Business says Avance Clinical at BIO Digital 2020

Adelaide, AUS, Jun 9, 2020 – (ACN Newswire) – The leading Australian CRO for biotechs, Avance Clinical announced at BIO Digital today that Australia currently has 2,413 trials planned or ongoing. Importantly in Australia, despite the global COVID-19 pandemic, no healthy volunteer studies have been suspended, and only 27 Phase 1 or 2 studies were temporarily put on hold for various reasons (TrialTrove, 9 June 2020).

Avance Clinical commended the Australian industry for exceptional COVID-19 management which has meant Australia leads the world in maintaining clinical trials business as usual.

Avance Clinical's Chief Strategy Officer, Ben Edwards presented at BIO Digital 2020 today on the many benefits of running trials in Australia.

Watch the Avance Clinical BIO Digital presentation On Demand here.
https://www.bio.org/events/bio-digital/sessions/search?name=Avance%20Clinical

Mr Edwards said: "Approximately 96% of our work is supporting small to medium-sized biotechnology companies executing Phase 1 and Phase 2 trials. Our client base currently extends across North America, Canada, New Zealand, Europe and Asia.

Australia is a well-established location for international clinical trials and our management of the COVID-19 crisis has made it an even more attractive trials destination."

Avance Clinical is a medium-sized full-service CRO known for its nimble and collaborative approach, with more than 20-years of experience in managing early phase trials.

In addition to the impressive COVID-19 management, a key factor in sponsor demand is the speed, access to high quality sites and attractive cost of running trials in Australia including:

– The Australian Government financial rebate of 43.5% on clinical trial spend
– No IND required for clinical trials and streamlined regulatory processes
– Advanced medical, research & scientific community, leading investigators & KOLs, modern medical facilities

Watch the video: How we work during the COVID-19 pandemic here. https://tinyurl.com/yc2z6kjj

Australia's reputation for FDA compliant scientific and research excellence, its advanced healthcare, and the opportunity to access patients in a less clinical trial competitive environment further reinforces its advantage as a destination for clinical trials.

For more information about the benefits of running your next study with Avance Clinical contact us: https://www.avancecro.com/contact-us/

About Avance Clinical

Australia's Avance Clinical has more than 20-years of experience and is now one of Australia's leading Contract Research Organisations. Avance Clinical facilitates quality drug development by aligning people, skills, and expertise in the pursuit of drug development for a healthier world.

Avance Clinical is committed to providing high-quality clinical research services with its highly-experienced team. The collective pool of knowledge and experience at Avance Clinical continually grows through the careful selection of experts who also demonstrate passion in their chosen field.

Avance Clinical offers high quality services in an established clinical trial ecosystem, that includes world-class Investigators and Sites able to access specialised patient groups. Other benefits include:

1. The Government R&D grant means up to 43.5% rebate on clinical trial spend
2. Telehealth pivot during COVID-19 pandemic – speed and continuity
3. Site Initiation Visit (SIV) and Study Start achieved in 5 – 6 weeks
4. No IND required for clinical trials
5. Full GMP material is not mandated for Phase I clinical trials
6. Established clinical trial environment with world-class Investigators and sites
7. Established healthy subject databases and specialised patient populations
8. Five independent Phase 1 facilities across Australia including hospital-based units for critical care
9. Major hospitals with world class infrastructures and dedicated Clinical Trial Units with a long track-record in FDA compliant research
10. Seasonal studies: Northern hemisphere Sponsors can conduct their studies year-round by taking advantage of Australia's counter-flu and allergy seasons

Media Contact:
media@avancecro.com
Chris Thompson


Copyright 2020 ACN Newswire. All rights reserved. http://www.acnnewswire.com

Blockchain Holdings Ltd. subsidiary TraceSafe and Toronto Wolfpack Sign Contract for Wearable Technology to Safely Reopen Lamport Stadium

Tortola, British Virgin Islands / ACCESSWIRE, Jun 2, 2020 – (ACN Newswire) – Blockchain Holdings Ltd. (Canadian Securities Exchange: BCX) ("BCX" or the "Company") is pleased to announce that its wholly-owned subsidiary, TraceSafe Technologies, Inc. ("TraceSafe") has executed a contract with Toronto Wolfpack Rugby League Football Club ("Toronto Wolfpack") to deploy its wearable tracking products and services to help safely reopen Lamport Stadium for training and future games, whether played behind closed doors or with fans, as and when the season resumes.

Under the terms of the agreement, TraceSafe has an exclusive contract for the 2020-2021 season to supply wearable tracing products for any staff and fans attending the Toronto Wolfpack's home games at Lamport Stadium while social distancing restrictions are in place.

Why Tracesafe's Wearable Technology can be Utilized to Improve Safety at Sports Stadiums during COVID-19

TraceSafe's iMSafe wristbands help ensure that each person is protected by having the smart wireless wristbands always on the person. Furthermore, while privacy is protected, there is no personal information stored on the wristbands. The wristbands effectively act as two-way radios that enable public health directives such as contact-tracing and social-distancing to be applied at large scale events such as at Lamport Stadium. It also enables other location-based services, such as guidance to seating areas, access control and loyalty programs, to be personalized and location-aware, that further enhances the enjoyment and safety for all fans. It does not require the use of the fans' mobile phones, thereby eliminating privacy concerns and any technical issues related to mobile phones' capabilities.

How it Works

The iMSafe wristbands transmit and receive signals from each other so that nearby contacts can be logged and data is seamlessly retrieved in the background via infrastructure local to the stadiums. Data can then be used for contact-tracing should it be required, to help ensure the health and safety of fans in a stadium. Potential exposures to a confirmed case can be traced and isolated to the area or the groups of individuals in contact with particular persons. Real-time monitoring of social-distancing violations can also be enabled so that the individuals concerned may be informed or authority alerted.

What Happens to the Data Collected?

Data can be automatically deleted after a predetermined time, for example 14 days after each game day. Individuals can be identified by a login ID created by the fans themselves, and any notifications can be sent anonymously to the persons involved without personal information involved.

"We are delighted to partner with Toronto Wolfpack to work on safely reopening Lamport Stadium and bringing back rugby to Toronto. This agreement is a testimony to the leading position of TraceSafe in the category of wearable safety tech," stated James Passin, Executive Chairman, BCX.

"TraceSafe products & software will greatly improve our re-opening operating procedures for Lamport Stadium by adding a verifiable, easy to use and affordable method to assist with social distancing. It is important that as we re-start our lives, this technology aids in re-opening stadiums, avoiding tracking apps loaded onto our mobile phones," stated Toronto Wolfpack Chairman & CEO, Robert Hunter.

About TraceSafe

TraceSafe is a full suite of real-time location management services and contact tracing solutions enabled through advanced bluetooth beacons in a variety of form factors. TraceSafe's leading cloud management solution ensures both user privacy and comprehensive administrative control. TraceSafe is deployed in mission critical quarantine applications around the world in partnership with leading governments. In addition to their government work, TraceSafe is developing leading edge solutions for Enterprise, Healthcare, and large-scale venue management. For more information visit tracesafe.io

For further information, please contact:
Malcolm Burke
+1 604 220 2000
mpb@primarycapital.net

Alan Tam, CFO
+1 604 377-7575
alantamca@gmail.com

Wayne Lloyd, CEO
+1 604 629-9975
wayne@blockchainholdingsltd.com

TraceSafe Media Inquiries:
Trey Ditto
trey@dittopr.co
+1 512 619-1343

About Toronto Wolfpack

Toronto Wolfpack is a professional Rugby team competing in the European Super League. It is the first North American team to play in the RFL and the world's first transatlantic professional sports team. The Wolfpack organization is driven by the belief that the world is a better place with more rugby balls in kids' hands. Toronto Wolfpack is committed to enriching the lives of the people who value proper care of their bodies. Toronto Wolfpack also aspires to create a global centre for rugby excellence in Toronto, to showcase the best of Ontario and Canada by supporting family run local businesses to actively promote transatlantic trade between North American and UK partners. Learn more about the Toronto Wolfpack at: www.torontowolfpack.com

Toronto Wolfpack UK Media Inquiries:
Martin Vickers +44 7808 556315 / martin@torontowolfpack.com

Toronto Wolfpack North America/Global Media Inquiries:
Jon Pallet +1 (647) 675-6301 / jon@torontowolfpack.com

The Canadian Securities Exchange has in no way passed upon the merits of the proposed transaction and has neither approved or disapproved the contents of this press release.

Statements in this news release may contain forward-looking statements that are based on Blockchain's expectations, estimates and projections regarding its business, operations, assets and the economic environment in which it operates, including with respect to expectations regarding the TRACEsafe technology, future developments in respect of COVID-19 and adoption of the Tracesafe technology by governments and orders of product therefrom. Although Blockchain believes the expectations expressed in such forward-looking statements are based on reasonable assumptions, such statements are not guarantees of future performance and involve risks and uncertainties that are difficult to control or predict, including the spread or containment of COVID-19, government responses thereto and the ability of the Tracesafe technology to assist government containment and monitoring programs. Therefore, outcomes and results may differ materially from those expressed in these forward-looking statements and readers should not place undue reliance on such statements. These forward-looking statements speak only as of the date on which they are made, and Blockchain undertakes no obligation to update them publicly to reflect new information or the occurrence of future events or circumstances unless otherwise required to do so by law.

Copyright 2020 ACN Newswire. All rights reserved. http://www.acnnewswire.com

Impact Biomedical and GRDG Sciences Announce Medical Technology Package Valued at USD 1.39 Billion (SGD 1.97 Billion) by Independent Experts

SINGAPORE, Jun 1, 2020 – (ACN Newswire) – SGX-listed Singapore eDevelopment Limited's (the "Company") (SeD; SGX:40V) wholly owned subsidiary, Impact Biomedical Inc. ("Impact Biomedical"), would like to update its stakeholders on its suite of antiviral and medical technologies ("Suite"). This Suite is valued at USD 1.39 Billion (SGD 1.97 Billion) as of 26 May 2020 by another independent valuation experts which are reputed for their expertise and skills in assessing the potential deal value of medical intellectual property. The Suite is mainly co-owned by Impact Biomedical and its scientific research partner, Global Research and Discovery Group Sciences ("GRDG Sciences"). Impact Biomedical's ownership in the Suite equates to a value of approximately USD 933 Million (SGD 1.32 Billion).

Impact Biomedical previously announced on 23 April 2020 that the Suite was valued at USD 592 million (SGD 841 million) by Destum Partners. Unlike the previous valuation, the new valuation of the Suite conducted, which was initiated by GRDG Sciences, takes into consideration numerous additional disease applications of the Suite. The scope of the new valuation of the Suite includes: 3F Mosquito and Antiviral Biofragrance; Equivir, an OTC medication with broad antiviral activity; Laetose, an advanced sugar replacement that is reduced calorie and low glycemic; and Linebacker, a broad-spectrum universal therapeutic.

The Company refers to its announcement on 4 May 2020 in relation to Impact Biomedical's entry into a share exchange agreement for a proposed US$50 million share swap. The Company wishes to state that as the terms of the share swap transaction has been finalized prior to the new valuation, the new valuation amount of the suite will not vary the terms and consideration of the share swap transaction.

Impact Biomedical and GRDG Sciences developed this Suite in a long-term research program adhering to the principles and initiatives established by the Panacea program, the Open Air Defense Initiative, Project Bioshield and the Biomedical Advanced Research and Development Authority ("BARDA") of the U.S. Department of Health and Human Services.

3F Biofragrance was designed for the Open Air Defense Initiative, a strategy to protect locations where large numbers of people gather or transit such as airports, containment areas, train stations, convention centers, hospitals, and other appropriate enclosed spaces, and ports of entry. 3F Mosquito Biofragrance and Mosquito Booster are a multi-aspect inhibitors of mosquito receptors that shut down the ability of the insects to detect human prey and they deactivate the feeding impulse. 3F Antiviral Biofragrance has proven to be successful against E. coli, MRSA, Influenza, Rhinovirus, Tuberculosis, and COVID-19. All three Biofragrance technologies are patent pending and were valued for their mosquito repellent, mosquito repellent boosting, and antimicrobial disinfectant applications.

Equivir was created as a solution for Project Bioshield, a U.S. government program to conduct and support research and development activities for countermeasures in biological emergencies. Equivir is a patented OTC medication/vitamin that has broad antiviral efficacy and was valued for its use as a prophylactic and treatment against multiple types of Influenza, Rhinovirus, Cholera, Ebola, and COVID-19.

Linebacker was modeled to shadow the Panacea program created by the US Defense Advanced Research Projects Agency ("DARPA"). Panacea was a research program designed to provide novel, multi-target therapeutics for unmet physiological needs. Linebacker is a patented universal therapeutic medication and was valued for its demonstrated effectiveness against neurological diseases including Parkinson's, 17 types of cancer, and multiple pathogens such as MRSA, E. coli, A. baumannii, K. penumoniae, S. flexneri, Cholera, Influenza, SARS, MERS, Malaria, and COVID-19.

Laetose is a reduced calorie and low glycemic sugar replacement created to address the rising global problem of metabolic disorders and associated conditions such as obesity and diabetes.

GRDG Sciences's Chief Scientific Advisor is Dr. Roscoe M. Moore, Jr., the former United States Assistant Surgeon General and former Epidemic Intelligence Service Officer at Centers for Disease Control and Prevention or CDC. He said, "GRDG's broad set of technology clearly shows a comprehensive approach to provide solutions to global healthcare that is poised to make a real impact and improve the lives of many people around the world."

Also advising GRDG Sciences is Lieutenant Colonel William H. Lyerly Jr., retired Career Senior Executive / Scientific Professional from the U.S. Department of Homeland Security and retired U.S. Army Medical Service Corps Officer. Lieutenant Colonel Lyerly also served as a senior official in the U.S. Department of Health and Human Services, the U.S. Agency for International Development, and the U.S. Executive Office of the President (White House). Lieutenant Colonel Lyerly states, "GRDG has a wide range of novel, unique capabilities which are reflected in this valuation. Each aspect is important on its own and the combination of assets is simply astounding."

Impact Biomedical accomplished this research and development in strategic partnership with GRDG Sciences led by Mr. Chan Heng Fai, Chairman. "I am greatly encouraged with the results and the team's contribution to this cause. We hope this will eventually prove to be beneficial to everyone and we look forward to more exciting discoveries" said Mr. Chan.

Daryl Thompson, Director of Scientific Initiatives and founder of GRDG Sciences said, "This valuation validates the 5-year project to prove the speed in which biomedical countermeasure research can be achieved, a major accomplishment especially in the present atmosphere of the COVID pandemic." GRDG Sciences is working with large global companies and organizations to license and integrate this technology into pipelines and programs for further validation, regulatory approval, and deployment to treat or prevent multiple threats to the health of people worldwide.

Shareholders and potential investors of SeD are advised to read this Press Release and any further announcements made by SeD carefully. Shareholders and potential investors of SeD are advised to refrain from taking any action with respect to their securities in SeD which may be prejudicial to their interests, and to exercise caution when dealing in the securities of SeD. Shareholders and potential investors of SeD should consult their stockbrokers, bank managers, solicitors or other professional advisers if they have any doubt about the actions they should take.

About Singapore eDevelopment Limited
Incorporated on 9 September 2009 and listed on the Singapore Exchange in July 2010, Singapore eDevelopment Limited is involved in (i) property development and investments primarily in the United States and Western Australia; (ii) information technology-related businesses; (iii) development, research, testing, manufacturing, licensing and distribution of biomedical products; and (iv) investment activities. For more information, please visit: www.SeD.com.sg or email contact@sed.com.sg.

About Impact BioMedical, Inc.
Impact BioMedical, Inc. ("Impact BioMedical") is a wholly-owned direct subsidiary of Global BioMedical Pte. Ltd., which in turn is a wholly-owned direct subsidiary of Singapore eDevelopment Limited, a company listed on the Singapore Exchange. Impact BioMedical strives to leverage its scientific know-how and intellectual property rights to provide solutions that have been plaguing the biomedical field for decades. By tapping into the scientific expertise of GRDG Sciences, LLC. and Australian Exchange-listed Holista CollTech Limited, Impact BioMedical pledges to undertake a concerted effort in the R&D, drug discovery and development for the prevention, inhibition, and treatment of neurological, oncological and immuno related diseases.

About GRDG Sciences, LLC.
GRDG Sciences, LLC is an advanced research team formed in Florida by natural products discovery drug research scientist, Daryl Thompson. For more information, please visit: http://www.globalrdg.com.

Copyright 2020 ACN Newswire. All rights reserved. http://www.acnnewswire.com