MP Biomedicals and A*STAR Co-Develop Rapid Antibody Point-of-care Test Kit for SARS-CoV-2

SINGAPORE, Jul 24, 2020 – (ACN Newswire) – MP Biomedicals Asia Pacific Pte Ltd, a diagnostic corporation which has been operating for over 30 years focusing on various infectious disease testing development and manufacturing, today announced the successful development of a rapid antibody test kit for COVID-19, in collaboration with the Agency for Science, Technology and Research (A*STAR).

ASSURE(R) SARS-CoV-2 IgG/IgM Rapid Test Kit
(Photo credit: MP Biomedicals)

MP Biomedicals Diagnostics division's Research and Development team with their ASSURE(R) SARS-CoV-2 IgG/IgM Rapid Test kits. Two devices shown reflects positive IgG antibodies result (marked, on right) and a negative reading (unmarked, on left)
From left: Ivy Teoh; Delynn Xu; Zee Hong Goh
(Photo credit: MP Biomedicals)

Scientists from A*STAR's Institute of Molecular and Cell Biology (IMCB) who were involved in the development of the ASSURE(R) rapid antibody test kit for COVID-19. From L-R: Ms Carol Leong, Research Officer; Associate Professor Tan Yee Joo, Joint Senior Principal Investigator; Dr Wang Yaju, Senior Research Officer (Photo credit: A*STAR)

Named the ASSURE® SARS-CoV-2 IgG/IgM rapid test, or ASSURE® in short, the test kit detects antibodies produced by the human immune system in response to exposure to SARS-CoV-2. It produces accurate results in as little as 15 minutes, and employs a lateral flow format similar to those used in home pregnancy tests. ASSURE® was developed and manufactured in Singapore. It can be deployed at or near the point of patient care, and has been distributed to regions such as Europe, Africa and South America. MP Biomedicals intends to file for Emergency Use Authorization (EUA) from the US FDA for this product as well.

The test kit detects IgG and IgM antibodies, which are produced by the body to combat SARS-CoV-2, from samples of human blood, plasma or serum. Studies have shown that levels of IgG and IgM appear to be correlated with the severity of COVID-19, thus they are good biomarkers for confirming positive or past infection.

Aligned with the current recommendation by the World Health Organization, point-of-care or rapid serology tests including ASSURE® rapid antibody test kit should not be used in the clinical diagnosis of COVID-19 infections or in the evaluation of persons with acute respiratory symptoms, especially within the first 14 days of illness. This is to avoid giving patients false reassurance that they do not have the infection, arising from a negative result. However, ASSURE® rapid antibody test kit can help to determine whether an individual has been previously exposed to the virus and generated antibodies as a result. This can help identify asymptomatic individuals or those with only mild symptoms who were not subjected to RT-PCR testing.

The technology behind the ASSURE® rapid antibody test kit utilises proprietary synthetic SARS-CoV-2 proteins. These proteins bind to the IgG and IgM antibodies if the antibodies are present in the specimen samples. MP Biomedicals used it to develop the product based on their lateral flow platform. The Diagnostics Development (DxD) Hub, a national platform hosted by A*STAR's commercialisation arm, A*ccelerate, co-developed the validation protocols and quality controls. The ASSURE® rapid antibody test kit was evaluated by the National University Hospital's (NUH) Department of Laboratory Medicine, and demonstrated good results for both serum and whole blood. The sensitivity of the kit performed well as compared to commercial immunoassays, when tested with convalescent blood from recovered COVID-19 patients in the clinic.

The ASSURE® rapid antibody test kit has been granted Provisional Authorisation by the Health Sciences Authority (HSA) for its intended use in Singapore.

Dr Delynn Xu, Senior R&D Manager, MP Biomedicals, said: "The development and manufacture of ASSURE® is a successful collaboration between MP Biomedicals and A*STAR through tremendous joint work. We are not the first one in the market but chasing the best performance is always our primary goal. With this rapid antibody test kit, we are proud to contribute to the global fight against COVID-19."

"We identified a human monoclonal antibody which binds to SARS-CoV-2, and it proved to be useful during the early development phase of this rapid test kit," said Associate Professor Tan Yee Joo, Joint Senior Principal Investigator, Institute of Molecular & Cell Biology (IMCB), A*STAR, and National University of Singapore's Yong Loo Lin School of Medicine. "IMCB is glad to assist our industry partner in their COVID-19 product development," she added.

Dr Sidney Yee, Chief Executive Officer, DxD Hub, A*STAR, said: "It is absolutely critical that we continue to transfer R&D know-how to biotech companies, to scale up and let more labs tap on this diagnostics test kit to screen patients. This rapid serological point-of-care test kit for COVID-19 by MP Biomedicals and A*STAR will complement global efforts to develop more efficient diagnostics, as the COVID-19 situation continues to evolve."

Mr Ng Boon Heong, Chief Executive Officer, Temasek Foundation, said: "We seek to actively pilot innovative solutions for community care. This project is an opportunity for us to work together with companies with a local presence, such as MP Biomedicals; R&D institutions such as A*STAR; medical partners such as NUH to enable development and access to point of care rapid serological test kits. These kits help identify segments of our communities that are recovering from or previously infected by SARS-CoV-2 to ensure their safe return back to work. This is one of the cases where we placed an initial commitment to help MP Biomedicals scale up their production locally, and piloted its use in our local community."

Relevant images can be downloaded from this link: https://tinyurl.com/y2ckta7w
Fact Sheet: http://www.acnnewswire.com/clientreports/598/FactSheet.pdf

For media queries and clarifications, please contact:
Haris Ong
Diagnostics Product Manager, MP Biomedicals Asia Pacific
DID: +65 6394 7678
E-mail: haris.ong@mpbio.com

Mr Owen Sia
Corporate Communications, A*STAR
HP: +65 9273 7432
E-mail: owen_sia@hq.a-star.edu.sg

About MP Biomedicals Asia Pacific Pte Ltd

MP Biomedicals is a global corporation, with headquarters in California, USA, and MP Biomedicals Asia Pacific Pte Ltd is its APAC regional headquarters as well as the hub for diagnostic product line. With over 50 years of experience in life science and diagnostics, the company is dedicated to give innovative, quality tools to aid in research for ground breaking discoveries and disease control. For more information about MP Biomedicals, please visit this link: https://www.mpbio.com/about-us

About the Agency for Science, Technology and Research (A*STAR)

The Agency for Science, Technology and Research (A*STAR) is Singapore's lead public sector R&D agency, spearheading economic-oriented research to advance scientific discovery and develop innovative technology. Through open innovation, we collaborate with partners in both the public and private sectors to benefit society.

As a Science and Technology Organisation, A*STAR bridges the gap between academia and industry. Our research creates economic growth and jobs for Singapore, and enhances lives by contributing to societal benefits such as improving outcomes in healthcare, urban living, and sustainability.

We play a key role in nurturing and developing a diversity of talent and leaders in our Agency and research entities, the wider research community and industry. A*STAR's R&D activities span biomedical sciences and physical sciences and engineering, with research entities primarily located in Biopolis and Fusionopolis. For ongoing news, visit www.a-star.edu.sg. For more information about the DxD Hub, please visit this link: https://tinyurl.com/y2zgz7wj

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

SinoMab entered into Strategic Collaboration with D2M

HONG KONG, Jul 23, 2020 – (ACN Newswire) – SinoMab BioScience Limited ("SinoMab" of 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, is pleased to announce that SinoMab and D2M Biotherapeutics Limited ("D2M") have entered into a Research, Development and Commercialization Agreement ("R&D Agreement") for long term collaboration for the identification of novel drug targets. Other than the R&D agreement, the Company is also going to invest totally USD 5 million in D2M as pre-A1 round investment.

Dr. Nan BING, one of the founders of D2M, served as a Senior Director of Immunogenetics of Pfizer Inc., (U.S.A.). Dr. BING was a founding team member of the genetic data department of Pfizer and has extensive experience in discovering biomarkers through clinical data and identifying drug treatment targets through various genetic data.

Under the R&D Agreement, SinoMab and D2M enter into long-term collaboration where SinoMab is entitled to conduct research, development and commercialization of qualified drug targets, which are chosen by the Company from the original results of D2M's target identification works according to a prioritized target-selection mechanism ("Collaboration"). D2M shall identify novel drug targets for the Company to consider further development upon satisfactory evaluation by the Company on the scientific merits and commercial potential of these discoveries.

Dr. Shui On LEUNG, the Executive Director, Chairman and Chief Executive Officer of SinoMab, remarked: "Our Collaboration and investment in D2M are intended to expand the scope of SinoMab's existing capabilities and values by ramifying into areas of novel target identification against which antibodies can be developed for the treatment of diseases of unmet medical needs. We are optimistic that through the synergies created by our Collaboration, D2M can contribute to the success of our future business development. The newly added drug target identification platform will make SinoMab in line with most other well-known biopharmaceutical companies which have had substantial investment in this area. It is a suitable timing for SinoMab to strategically collaborate with D2M for novel drug target identification and move-up its value chain."

With the additional value created by D2M on the upstream research and development process in the biotech industry, such as target identification and therapeutics and therapies discovery, contributed to the Company. A strategic collaboration will be established by the parties, where SinoMab and D2M can combine their strengths and resources to create greater business value. The Company believes that the Collaboration marks a major step forward for the Company to fulfill the Company's commitment to research, development, manufacturing and commercialization of therapeutics for the treatment of immunological and other debilitating disease.

About D2M Biotherapeutics Limited
D2M Biotherapeutics Limited ("D2M") is a company specialized in the development of a genetics-driven target identification platform and the discovery, development and commercialization of therapeutics and therapies against those targets for treatment or prevention of human diseases.

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

Agilex Biolabs and Endpoints News Present ‘How to Move Trials to Australia’ Webinar

Adelaide, AUS, Jul 22, 2020 – (ACN Newswire) – Agilex Biolabs, Australia's largest specialist bioanalytical laboratory for clinical trials, and Endpoints News launched a new webinar "How Easy is it to Move Your Trials to Australia" at BIO Taiwan 2020.

Watch here: https://tinyurl.com/y2ktufhv.

Register here: https://tinyurl.com/y2ktufhv.

The webinar details step-by-step guidance for moving new or delayed trials to Australia, and Agilex Biolabs' clients discuss how they made the decision and the benefits, and any challenges.

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.

Australia's relatively moderate COVID-19 impact due to rapid localised lockdowns for case clusters, combined with the world's most attractive 43.5% rebate on clinical trials costs, makes it the ideal destination for re-booting clinical trials, according to Agilex Biolabs.

Agilex Biolabs and all the early phase units have been open throughout the global COVID-19 pandemic.

CEO Jason Valentine said the key to success was engaging with Agilex Biolabs early.

"By contacting Agilex Biolabs first, for any new trial or trial transition process from another region, we can facilitate the scoping exercise for sponsors by assessing compatible service providers to ensure a good streamlined fit.

Our 20 years of experience working with all the service providers means we understand the nuances of the Australian trial landscape and can recommend the right partners to accelerate start up and save on costs. Getting the right fit for size and experience is vital for success.

This includes everything from CROs, Phase 1 units, sites, Ethics Committees, Government authorities, setting up an Australian affiliate and legal support. Considerations also include later phase plans and continuity.

Australia is well known as an early phase trials destination and at Agilex Biolabs we have a powerful network of early phase units, sites and other providers with whom we work regularly.

In addition, our R&D team need at least 1-2 months to properly develop the assays, and conduct feasibility studies if required."

Biotechs are particularly attracted by Agilex Biolabs' FDA-inspected status, and the 43.5% rebate on clinical trial spend that applies in Australia.

Agilex Biolabs' world-class bioanalytical facilities have OECD GLP Recognition with NATA (Australian Government OECD GLP Compliance monitoring authority) and ISO 17025 Accreditation for global recognition.

The company has just expanded its labs by more than 30% to accommodate biotech demand from APAC and the USA. Watch the New Labs Walkthrough Video Here https://www.agilexbiolabs.com/new-labs-video

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 also offers pharmacodynamics services that include immunobiology services using the latest state-of-the-art technology to support immunology, cell biology and mode of action assays, including:
– Immunophenotyping
– Receptor occupancy
– Cytokine release assays (whole blood or PBMC stimulation assays) and cytokine/biomarker profiling
– PBMC assays and cellular mechanism of action assays (eg: ADCC)

The biolabs has more than 90 staff including 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.

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

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.

We offer services for both small molecules and biologics for PK, immunogenicity (PD) and biomarker bioanalysis utilising the two platforms of LC-MS/MS and Immunoassay.

Agilex Biolabs operates a fully quality-assured laboratory ensuring that, within the principles of GLP, assays are validated to the latest FDA/EMA guidance and study samples are assayed and reported to the sponsor's desired format using WATSON LIMS. Laboratory certifications include OECD GLP and ISO/IEC17025.

Our highly experienced team consists of over 65 dedicated laboratory staff with over 15 years average industry experience across senior scientists. Expertise includes development of robust compliant PK and PD assays de novo or by method transfer.

Our laboratory is fitted with 7 SCIEX tandem mass spectrometers, 6 API 4000 and 1 QTRAP 5500 as our standard platform for LC-MS/MS analysis. For immunoassay, we employ the state-of-the-art systems of Meso Scale Discovery (MSD) and Gyrolab xPlore.

Agilex Biolabs owns a suite of validated biosimilar assays that have already supported biosimilar studies executed in the region. These assays include Avastin/Bevacizumab, Lucentis/Ranibizumab, Actemra/Tocilizumab, Xolair/Omalizumab, Herceptin/Trastuzumab and Solaris/Eculizumab. We would like to discuss how we can support companies with biosimilar pipelines looking to conduct trials in the region. Our validated biosimilar assays require less setup saving time and money.

Agilex Biolabs also have a suite of biomarker assays that have been developed to support studies in the areas of endocrinology (estrone, estradiol, progesterone, testosterone and others).

Recently, Agilex Biolabs has added a comprehensive cannabinoid assay to its suite of validated assays to support clinical trials. The fully validated assay includes the five cannabinoids THC, CBD, CBN and the two THC-metabolites OHTHC and COOHTHC.

Our LC-MS/MS experience includes NCEs, sugars, nucleotides, enantiomers, steroids, prodrugs, peptides, immunosuppressants, nanoparticles, neurotransmitters, oligonucleotides and polymeric mixtures.

Our biologics experience entails PK analysis using colorimetric, fluorescence or chemiluminescence detection for recombinant or fusion proteins, monoclonal antibodies, ADCs, immunogenicity testing, biomarker analysis and PBMC blood stimulation assays.

Media Contact:
Media@AgilexBiolabs.com
Kate Newton

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

Dorsett Hospitality International partners with Prenetics to provide government-recognised Covid-19 testing to combat the third wave

HONG KONG, Jul 22, 2020 – (ACN Newswire) – As part of Dorsett Hospitality International's ongoing commitment to the local community under #DorsettCares, the Hong Kong-based hospitality group is the first hotel group to partner with leading global genetic testing and digital health company Prenetics to offer the local community, associates and hotels guests in Hong Kong a peace of mind with 24/7 access to the Project Screen by Circle COVID-19 test, recommended by the World Health Organisation and officially recognised by the Hong Kong government, as we collectively fight to contain the city's third wave.

Hong Kong-based Prenetics is one of three laboratories who have been assigned by the government to help with mass community testing. Their 'Do-It-Yourself' test kit has an analytical accuracy of 99.9% based on validated studies by the National Health Commission and the US FDA. They also provide all the testing for the English Premier League and have carried out over 40,000 COVID-19 tests for players and coaches without which the season would not have resumed. The largest private laboratory in Hong Kong, Prenetics have boosted its capacity up from 5,580 to 22,000 tests in Hong Kong per day.

Dorsett has test kits available for purchase at its 9 hotels in Hong Kong for only HK$785 with results available within just one to two business days. Furthermore, the hotel group will be sponsoring over 50% off of each COVID-19 test for all their associates and in some instances, full sponsorships of COVID-19 test kits should testing be required from any hotel staff to ensure we continue to do everything we can to make our employees feel safe.

Since the first outbreak back in February, all nine of Dorsett Hospitality International's hotels in Hong Kong – and worldwide – have implemented preventive and anti-epidemic control measures, including use of hospital-grade Ecolab disinfectant cleaner 2.0, increased cleaning and disinfection frequency of public areas and facilities every hour and temperature screening for those coming in and out of the hotels.

To date, Dorsett Hospitality International has provided accommodation for healthcare workers and frontliners in London, Hong Kong and China and donated supplies used in hospitals and quarantine centres in Malaysia. We will continue to support the communities in each city where we have a presence as part of our #DorsettCares' commitment to our esteemed associates and guests around the world.

The COVID-19 test kit is being sold at HK$985, with the cost breakdown and features listed below:

– Prenetics PCR COVID-19 test: HK$785
– Sample Pick-Up to Laboratory Fee: HK$200
– Private, secure digital results provided within 24 to 48 hours of receipt in their laboratory
– Individuals with positive results will be provided a telehealth physician consultation

About Dorsett Hospitality International

Dorsett Hospitality International is one of Asia's fastest-growing hotel groups. As a Hong Kong hospitality brand, we are proud to have an international footprint in 25 major cities worldwide with a total of 56 properties with our strategic partners TWH and AGORA Hospitality, including Dorsett Hospitality International's 3 core brands: Dorsett Hotels & Resorts, d.Collection, and Silka, each with their own distinct identity and offerings to cater to diverse travel needs. Since the group's establishment in Hong Kong in January 2007, we have grown by leaps and bounds with hotels across China, Malaysia, Singapore, Japan, Australia, the United Kingdom, and Continental Europe; more properties are planned in the development pipeline. For more information on Dorsett Hospitality International, visit: www.dorsett.com.

About Prenetics

Prenetics is a leading global genetic testing and digital health company. Prenetics operates its direct to consumer genomics business via its two brands, CircleDNA in Asia and DNAFit in Europe. The company has a team of over 150 people and is spread across ten offices in Asia, Europe and South Africa.

Prenetics has received over USD 50-million in strategic funding from Alibaba Hong Kong Entrepreneurs Fund, Ping An and more. Prenetics' mission is to help people lead healthier, more active lives by empowering them with personalised, predictive, and preventive measures in the form of the latest, proven innovations in DNA and mobile technology. For more information, visit www.prenetics.com and www.circledna.com.

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

Avance Clinical Contracted for Atossa Therapeutics AT-301 Nasal Spray Clinical Study, Atossa’s Second COVID-19 Therapeutic Development Program

Adelaide, AUS, Jul 22, 2020 – (ACN Newswire) – The leading Australian CRO for biotechs and Frost & Sullivan 2020 Asia-Pacific CRO Market Leadership Award winner Avance Clinical has been contracted to conduct a clinical study of Atossa Therapeutics' proprietary drug candidate AT-301, to be administered by nasal spray. Avance has successfully completed multiple clinical studies of Atossa's proprietary Endoxifen.

Atossa Therapeutics, Inc. (Nasdaq: ATOS) is a clinical-stage biopharmaceutical company seeking to discover and develop innovative medicines in areas of significant unmet medical need with a current focus on breast cancer and COVID-19.

Yvonne Lungerhausen, CEO, Avance Clinical said:

"Avance Clinical is very pleased to be working with Atossa Therapeutics again on their second COVID-19 Therapeutic Development Program. Atossa is a valued long-term client that clearly understands the excellence in clinical research available in Australia, and the many benefits of conducting studies in the region."

According to Atossa Therapeutics:

AT-301 is Atossa's proprietary formula intended for nasal administration in patients immediately following diagnosis of COVID-19 but who have not yet exhibited symptoms severe enough to require hospitalization. It is intended for at-home use to proactively reduce symptoms of COVID-19 and to slow the infection rate so that a person's immune system can more effectively fight SARS-CoV-2 (coronavirus). Atossa also intends to conduct testing to determine whether AT-301 can be used as a prophylaxis to prevent or mitigate SARS-CoV-2.

The study is a double-blinded, randomized, and placebo-controlled safety study of AT-301 nasal spray in 32 healthy adult subjects divided into two study groups. Part A consists of two single-dose cohorts receiving either active therapy, AT-301B, or the placebo comparator AT-301A. Part B is a multiple dose arm with cohorts receiving either AT-301A or AT-301B for 14 days. The primary objective of the study is to evaluate the safety and tolerability of single and multiple doses of AT-301 administered via nasal instillation to healthy volunteers. Secondary objectives are to assess the incidence and severity of local irritation and bronchospasm following administration of AT-301 via nasal instillation.

"Our AT-301 nasal spray program is being developed for COVID-19 patients who are not hospitalized, which complements our AT-H201 program being developed for COVID-19 patients on ventilators," commented Steven Quay, M.D., Ph.D., President and CEO of Atossa. "Many COVID-19 patients are infected via the nasal passage, which makes a nasal spray therapy potentially very attractive. Collectively, the components of AT-301 are believed to replicate a 'vaccine-like mechanism' to help maintain a protective mucosal barrier within the nasal cavity with anti-viral properties that may lead to lower infectivity and reduced symptoms in COVID-19 patients due to their interference with the spike protein of the virus in the nasal cavity and upper respiratory tract. We may eventually develop AT-301 as a prophylaxis to reduce risk of being infected with COVID-19. For example, it could be taken as a daily vaccine-like treatment for people at higher-risk, such as TSA workers, emergency medical professionals and hospital personnel," concluded Dr. Quay.

An application to commence the study has been submitted to the relevant institutional review board (IRB) and local regulatory authority in Australia which must be approved before commencement of the study. Pending these approvals, Atossa expects that the study will commence this quarter. Adequate and well-controlled studies to demonstrate safety and efficacy must be successfully completed and regulatory approvals must be obtained before AT-301 may be commercialized. Atossa has filed provisional patent applications on AT-301 to treat patients diagnosed with, or to prevent, COVID-19 via nasal spray.

About Atossa Therapeutics

Atossa Therapeutics, Inc. is a clinical-stage biopharmaceutical company seeking to discover and develop innovative medicines in areas of significant unmet medical need with a current focus on breast cancer and COVID-19. For more information, please visit www.atossatherapeutics.com.

See full announcement here https://tinyurl.com/y46rcp33

About Avance Clinical

Australia's Avance Clinical has more than 20-years of experience and is now one of Australia's leading Contract Research Organizations. 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 specialized patient groups. Visit http://www.avancecro.com for more information.

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 specialized 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

Genor Biopharma Announced the Acceptance of New Drug Application for Geptanolimab and the Appointment of Mr. CHEN Wende as Chief Operation Officer

HONG KONG, Jul 21, 2020 – (ACN Newswire) – Genor Biopharma Co. Inc, a pre-commercial stage biopharmaceutical company focused on developing and commercializing oncology and autoimmune therapeutics, announced that the new drug application (NDA) for Geptanolimab, a novel PD-1 mAb drug candidate, has been accepted by the National Medical Products Administration ("NMPA") for the treatment of Peripheral T cell Lymphoma (PTCL).

On the same day, Genor Biopharma announced the appointment of Mr. CHEN Wende as Chief Operation Officer. In this role, Mr. CHEN will oversee commercialization and prepare for launches of late-stage drug candidates.

Mr. CHEN brings over 20 years of experience in biopharmaceutical industry, focusing on sales and marketing and business operation at Roche, AstraZeneca, and Pfizer in China. Mr. CHEN was most recently Chief Commercial Officer at a well-known biotech company. Before that, Mr. CHEN served as Vice President at Roche China, overseeing Corporate Affairs, Market Access and Channel Management for a number of key drugs including Herceptin, MabThera, Avastin, Tarceva and Zelboraf. Mr. CHEN also served as Senior Vice President at AstraZeneca from 2010 and as Senior Sales Director at Pfizer from 2000.

"We are excited to appoint Mr. CHEN as COO of Genor Biopharma. We are looking to file NDAs for a number of our late-stage drug candidates in the near term," commented Dr. GUO, Chief Executive Officer of Genor Biopharma, "With over 20 years of experience in drug commercialization and deep insight of the landscape, Mr. CHEN will build our in-house commercialization team and lead our drug launches with differentiated strategy and drive our transformation into a biopharma company."

About JHBP (CY) Holdings Limited ("Genor Biopharma")
Established in December 2007, JHBP (CY) Holdings Limited is a biopharmaceutical powerhouse focusing on developing and commercializing oncology and autoimmune drugs. The Company has been strategically focused on major therapeutic areas with substantial unmet medical needs. At present, the Company has more than 10 drug candidates, 10 of which have entered the clinical development stage. The Company's pipeline products are mainly deployed in the field of cancer and other major diseases and have established a series of mature technology platforms in antibody drug research, development and manufacturing to serve patients in China and around the world. The Company's leadership team boasts more than 20 years of industry experience in global biopharmaceutical companies such as Pfizer, Merck, Amgen and AbbVie with proven track record and a well-balanced combination of expertise. The Company currently has around 400 employees across 3 sites in China – Shanghai Zhangjiang, Yunnan Yuxi, and Beijing office, as well as lab in South San Francisco, US, among which 80% are R&D and clinical specialists.

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

Antengene Corporation Closes US$97 Million Series C Financing to Support Ongoing Drug Development and Preparations for Potential Commercialization

SHANGHAI, CHINA, Jul 20, 2020 – (ACN Newswire) – Antengene Corporation, a leading innovative hematology and oncology-focused biopharmaceutical company dedicated to discovering, developing and commercializing global first-in-class and best-in-class therapies, today announced that it has successfully closed US$97 million in Series C financing.

The financing was led by Fidelity Management & Research Company LLC with additional support from new investors including GL Ventures (an affiliate of Hillhouse Capital), GIC, and a large, reputable long-term investor. Existing investors including Qiming Venture Partners and Boyu Capital also participated.

"We appreciate the recognition and trust from these prestigious investment institutions. This round of financing has drawn support from among the world's largest asset managers, top-tier healthcare investors widely recognized in the capital markets, and strong continuous support from our existing investors. This is an important milestone to reinforce Antengene's capabilities to bring cutting-edge therapies to help patients with life-threatening diseases in the Asia Pacific regions and around the world." said Dr. Jay Mei, Founder, Chairman and CEO of Antengene.

Proceeds from the Series C financing will be primarily used to fund the continuing clinical development of Antengene's robust pipeline of hematology and oncology therapies, expanding in-house research and development capabilities and strengthening the commercial infrastructures in APAC markets. To date, Antengene has made significant progress with its broad pipeline of six clinical-stage programs and six pre-clinical stage oncology assets:

– ATG-010 (selinexor) is the first and only oral selective inhibitor of nuclear export (SINE) compound in the world. In July 2019, the U.S. FDA approved selinexor in combination with low-dose dexamethasone for the treatment of adult patients with relapsed/refractory multiple myeloma (RRMM). In June 2020, selinexor was approved by the U.S. FDA as a treatment for patients with relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL). Currently, the registration clinical trials of ATG-010 in RRMM and R/R DLBCL are ongoing in China. The compound is also in late clinical development for various other hematologic malignancies and solid tumors (including KRAS mutant tumors). Pre-clinical studies demonstrated that inhibition of nuclear protein export through XPO1 can effectively treat tumors with such mutation.

– ATG-008 (onatasertib) is a second-generation dual mTORC1/2 inhibitor presently studied in multi-regional clinical trials for the treatment of advanced hepatocellular carcinoma (HCC), as well as non-small-cell lung cancer (NSCLC), gynecological malignancies and other cancers as a single agent or in combination with an anti-PD-1 antibody.

– ATG-016 (eltanexor) is a second-generation oral selective inhibitor of nuclear export protein XPO1 presently studied in myelodysplastic syndrome (MDS) as well as various types of solid tumors, such as colorectal cancer (CRC) and prostate cancer (PrC).

– ATG-019 is a first-in-class PAK4/NAMPT dual-target inhibitor presently studied in a number of clinical trials including non-Hodgkin's lymphoma (NHL), colorectal cancer, NSCLC, and melanoma. In addition, pre-clinical studies have demonstrated that ATG-019 in combination with anti-PD-1 antibodies can effectively improve the anti-tumor activity and is effective in treating patients that become resistant to anti-PD-1 therapy.

– ATG-527 (verdinexor) is an innovative compound in clinical studies as a potential treatment for anti-viral infection and autoimmune diseases – such as Epstein-Barr virus (EBV), respiratory syncytial virus (RSV) infection, cytomegalovirus (CMV) infection, systemic lupus erythematosus (SLE). Phase I healthy volunteer study of the compound has been completed.

– ATG-017 is a potent and selective small molecule extracellular signal-regulated kinases 1 and 2 (ERK1/2) inhibitor in clinical development for the treatment of various solid tumors, non-Hodgkin's lymphoma, acute myeloid leukemia (AML) and multiple myeloma.

In addition, the Antengene drug discovery team is focused on the research and pre-clinical development of innovative small molecules, monoclonal and bi-specific antibodies to treat cancer.

About Antengene

Antengene is a biopharmaceutical company with integrated drug discovery, clinical development, manufacturing and commercialization anchored in the Asia Pacific regions and with a global layout, aiming to provide the most advanced first-in-class/best-in-class anti-cancer drugs and other treatments for patients in China, the rest of Asia and around the world. In April 2017, Celgene (now officially acquired by Bristol-Myers Squibb, and become the world's top ten pharmaceutical company after the merger), a global leading innovative biopharmaceutical company became a founding partner and obtained an equity position as an investor in Antengene. Over the past 3 years, Antengene has built a product pipeline of 12 clinical and pre-clinical stage programs, obtained 7 IND approvals with 10 ongoing cross-regional clinical trials in the Asia Pacific regions. The vision of Antengene, "Treating Patients Beyond Borders", is to meet the unmet medical needs of patients in the Asia Pacific regions and around the world through research & development and commercialization of first-in-class/best-in-class drugs. For more information, please visit www.antengene.com.

About Fidelity

Fidelity's mission is to inspire better futures and deliver better outcomes for the customers and businesses we serve. With assets under administration of $8.1 trillion, including discretionary assets of $3.3 trillion as of May 31, 2020, we focus on meeting the unique needs of a diverse set of customers: helping more than 32 million people invest their own life savings, 22,000 businesses manage employee benefit programs, as well as providing more than 13,500 institutions with investment and technology solutions to invest their own clients' money. Privately held for more than 70 years, Fidelity employs more than 40,000 associates who are focused on the long-term success of our customers. For more information about Fidelity Investments, visit https://www.fidelity.com/about-fidelity/our-company.

About GL Ventures (an affiliate of Hillhouse Capital)

GL Ventures focuses on innovative companies in healthcare, software services, consumer Internet, emerging consumer brands and services. The GL Ventures team is passionate about partnering with visionary entrepreneurs to create industry leaders that stand the test of time. GL Ventures is an affiliate of Hillhouse Capital, and we have been investing with innovators across the world since 2005. We were one of the earliest investors into some of the largest global companies today, including Beigene, Zoom, Meituan, JD, Woowa Brothers and many more.

About GIC

GIC is a leading global investment firm established in 1981 to manage Singapore's foreign reserves. A disciplined long-term value investor, GIC is uniquely positioned for investments across a wide range of asset classes, including real estate, private equity, equities and fixed income. GIC has investments in over 40 countries and has been investing in emerging markets for more than two decades. Headquartered in Singapore, GIC employs over 1,500 people across 10 offices in key financial cities worldwide. For more information about GIC, please visit www.gic.com.sg.

About Qiming Venture Partners

Founded in 2006, Qiming Venture Partners is a leading China venture capital firm with offices in Shanghai, Beijing, Suzhou, Shenzhen, Hong Kong, Seattle, Boston and San Francisco Bay Area. Currently Qiming Venture Partners manages nine US Dollar funds and five RMB funds with $5.3 billion assets under management. Since our establishment, we have invested in outstanding companies in the TMT and healthcare industries at the early and growing stages.

Since our debut, we have backed over 350 fast-growing and innovative companies. Over 110 companies are already listed on NYSE, NASDAQ, HKEx, Gretai Securities Market, Shanghai Stock Exchange and Shenzhen Stock Exchange, or achieved exit through M&A and other means. There are also over 30 portfolio companies that have achieved unicorn status. Many of our portfolio companies are today's most influential firms in their respective sectors, including Xiaomi (SEHK:1810), Meituan Dianping (SEHK:3690), Bilibili (NASDAQ:BILI), Roborock (SHSE:688169), Gan & Lee (SHSE: 603087), Tigermed (SZSE:300347), Zai Lab (NASDAQ:ZLAB), Venus MedTech (SEHK:2500), CanSino (SEHK:6185), Schrodinger (NASDAQ:SDGR), Sanyou Medical (SHSE:688085), AmoyDx (SZSE:300685), Berry Genomics (SZSE:000710), SinocellTech (SHSE: 688520), WeDoctor Group, UBTech among many others.

About Boyu Capital

Boyu Capital is one of the largest private investment firms in China. With offices in Beijing, Shanghai and Hong Kong, Boyu has provided long-term capital and operational expertise to some of the best-managed and most innovative companies across the media/technology, healthcare, consumer/retail, and financial services industries.

Forward-looking 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.

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

Cariflex to Double its Polyisoprene Latex Capacity at the Paulinia Facility in Brazil

SINGAPORE, Jul 17, 2020 – (ACN Newswire) – Cariflex PTE. Ltd. (Cariflex) today announced that it will be constructing a new large-scale polyisoprene latex plant at its Paulinia, Brazil, facility to meet the strong market demand from its medical and consumer product customers.

"Cariflex is excited to be making a sizeable investment in the growth of the polyisoprene latex business. Cariflex polyisoprene latex is a unique synthetic alternative to natural rubber latex for dipped goods and various specialty products. With the current strong demand for medical protective equipment such as surgical gloves, we recognize our customers' needs to have more material available," said Philippe Henderson, Cariflex Sales & Marketing leader.

With Cariflex's increased production capacity and unmatched global service network, its customers can be assured of secure supplies anywhere in the world. Following the addition of this polyisoprene latex unit, the new resulting capacity in Paulinia, Brazil, combined with the existing capacity in Himeji, Japan, will strengthen Cariflex's position as the global leader of polyisoprene latex with unmatched quality and supply diversity. Customers will benefit from Cariflex IR0401 latex volumes sourced from four distinct production lines.

The addition of this new production line is replicating the technology of the current fully utilized unit and will double the polyisoprene latex capacity of the site.

Daelim Industrial Co., Ltd named Prakash Kolluri as Chief Executive Officer of Cariflex Pte Ltd, for the global business. Sean Kim, Chief Executive Officer for Daelim Industrial Co., Ltd, said, "We are delighted to have appointed Mr. Prakash Kolluri who is a huge asset to the company. We are confident Prakash will move Cariflex Pte Ltd forward and bring a wealth of experience which will be extremely valuable in driving our future growth globally."

"Our strategic decision of capacity expansion, in support of organic growth, separates us from competition. Our industry-leading polyisoprene latex capacity acts as a catalyst for our valued customer base to make inroads in new geographies. Cariflex is strategically positioned and has a bright future serving medical and other high-value markets," Prakash Kolluri, Chief Executive Officer mentioned.

ABOUT Cariflex

Cariflex is a global leader of isoprene rubber latex ("IR Latex") and isoprene rubber ("IR") for medical end markets and other high-value markets with strong growth drivers. Cariflex produces high value-added synthetic rubbers and latexes used for medical materials such as surgical gloves and rubber stoppers and seals for drug delivery devices. Cariflex is a wholly owned subsidiary of Daelim Industrial Co., Ltd.

For Press Inquiries
Sang-woo Ryu, Cariflex: sangwoo.ryu@cariflex.com
Eric Byun, KorCom Porter Novelli (Daelim Industrial's PR agency): eric@korcom.com

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

Dr. Burkhard Dick Joins the EuroEyes International Medical Advisory Board

HONG KONG, Jul 15, 2020 – (ACN Newswire) – EuroEyes International Eye Clinic Limited ("EuroEyes" or the "Company", stock code: 1846), a well-established leading ophthalmic medical group, is pleased to announce that Dr. Burkhard Dick ("Dr. Dick") has joined The EuroEyes International Medical Advisory Board. In the future. He will strive to promote continued medical education for European staff of the Group, foster innovation in technology and raise the quality and service standard of the refractive field.

Dr. Burkhard Dick

As one of the most influential surgeons who pioneered bladeless laser cataract surgery in Europe, Dr. Dick has a renowned reputation in the global ophthalmology community, serving as a regular lecturer at international meetings, such as the European Society of Cataract & Refractive Surgeons, the Deutsche Ophthalmologische Gesellschaft, the Deutschen Ophthalmochirurgen (DOC), the Deutschsprachige Gesellschaft fur Intraokularlinsen-Implanation und Refraktive Chirurgie, and the American Society of Cataract and Refractive Surgery. He has instructed fellows from 38 different countries in state-of-the-art cataract, refractive, glaucoma, and vitreoretinal surgery. In the "Power List 2018" ranking of the world's most influential ophthalmologists by the publication, The Ophthalmologist, Dr. Dick was listed among the Top 20, and he has been in the Top 50 several times before.

As the most influential ophthalmologist in the world, Dr. Dick joined the eye hospital of the University of Mainz in 1996 where he became a professor in 2003. In 2006, Dr. Dick was appointed as the chair of the department of ophthalmology at the University of Bochum and director of the University Eye Clinic, conducting R&D and promoting the cataract and refractive treatment, and leading the team to establish an internationally renowned ophthalmology clinic with outstanding achievements.

During his 30 years of practice, Dr. Dick persistently pursued more advanced and effective surgical techniques to promote the development of ophthalmology medical education.

Dr. Jorn Slot Jorgensen, executive director, chairman of the board of directors, and chief executive officer of EuroEyes, said: "We are excited that Dr. Burkhard Dick joins the EuroEyes international medical advisory board. EuroEyes plans to introduce more advanced vision correction technologies and equipment in the future. Leveraging Dr. Dick's, one of the pioneers in the industry, excellent and rich experience in surgery and R&D, we are confident to enhance the Group's comprehensive strength, promote technological innovation, and improve medical quality and service standards, as well as provide European and Chinese customers with the world's leading vision correction surgery, brings the best returns to our shareholders and investors."

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

Novotech Webinar: Why the Asia-Pacific is Attracting 10,000 Oncology Trials and How Biotechs Can Tap the Region

SYDNEY, Jul 13, 2020 – (ACN Newswire) – The leading Asia-Pacific biotech specialist CRO Novotech is again collaborating with the prestigious biotech and pharma news platform Endpoints News. This webinar focusses on how to advance oncology clinical trials in the Asia-Pacific which is currently attracting 10,000 oncology studies (GlobalData).

The webinar will be led by Endpoints News Publisher Arsalan Arif. Participants will include leading experts from the Asia-Pacific region and a US biotech sponsor.

Webinar title: Advancing Oncology Trials in Asia-Pacific
Broadcast time: July 14th 2PM EST
Click to register: https://www2.novotech-cro.com/l/223242/2020-06-30/mttpv

There are currently about 10,000 oncology clinical trials, either ongoing or planned, in Asia-Pacific and about 50% of all industry-sponsored oncology trials in 2019 globally have an Asia-Pacific component (GlobalData).

Meanwhile, the number of industry-sponsored oncology trials initiated in Asia-Pacific has grown by over 10% on average annually between 2017 and 2019 (GlobalData).
Novotech has completed over 200 oncology trials.

According to Novotech:

"A growing number of biotechnology companies are looking at the Asia-Pacific region to run their clinical trials in oncology. While Australia and New Zealand are preferred locations to run early phase trials, sponsors often look at Asia for large late phase clinical studies. Moreover, clinical trials are often the only channel through which patients can get access to new oncology treatments in Asia which ultimately stimulates patient recruitment rates."

The webinar will also cover:
– The latest research and trends of oncology clinical trials globally and in Asia-Pacific
– The reasons why oncology clinical research sites in Asia have been less affected by the COVID-19 crisis than in other regions
– The benefit for biotechnology companies to involve sites in Asia-Pacific for oncology trials
– Feedback from sponsors and investigators

Novotech has teams on the ground in the key Asia-Pacific countries and has just signed its 30th Partnership agreement which is a program with leading medical institutions throughout the Asia-Pacific giving Novotech clients unique access to some of the top researchers, investigators and key opinion leaders.

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