Tag: BioTech

Bayer and Hua Medicine announce commercialization agreement and strategic partnership for investigational first-in-class novel diabetes treatment dorzagliatin in China

Beijing and Shanghai, China, Aug 17, 2020 – (ACN Newswire) – Bayer and Hua Medicine, a leading innovative drug development company, today announced a commercialization agreement and strategic partnership for dorzagliatin, a novel diabetes treatment, in China. The agreement aims to provide Chinese diabetes patients with access to a new treatment option, building on Bayer's existing strength and leadership in diabetes management in China and the innovation capabilities of Hua Medicine.
On behalf of Bayer and Hua Medicine, Wei Jiang (Left) and Dr. Li Chen (Right) signed agreement on strategic partnership in China



"Bayer has been long committed to Chinese patients living with diabetes and diabetic macular edema (DME) by offering innovative treatment options including Glucobay and Eylea," said Wei Jiang, Executive Vice President and President of Bayer Pharmaceuticals Region China & APAC and President of Bayer Group Greater China. "In the face of significantly increasing challenges caused by diabetes to public health in China, our collaboration with Hua Medicine will further address unmet medical needs of Chinese patients living with diabetes. By leveraging Bayer's well-established products as well as the upcoming continuous glucose monitoring system under the partnership with WaveForm, we will be able to provide integrated solutions ranging from prevention, diagnosis, treatment and complication management."

Type 2 diabetes continues to be an important health challenge. According to the China Mainland National Cross Sectional Study in the British Medical Journal, the prevalence rate of T2DM for adults in China is 11.2%, but the proportion of patients who have their hemoglobin A1c (HbA1c) levels controlled is 49.4%(1). Among patients taking oral anti-diabetic drugs, fasting plasma glucose and 2-hour postprandial plasma glucose level lower than or equal to target were only achieved by 51.3% and 53.4%, respectively. These observations from real-world data highlights the unmet medical needs in diabetes, and are the reasons why biotech companies continue to explore novel therapies to improve diabetes management. With a novel mechanism of action, dorzagliatin is an investigational first-in-class glucokinase activator ("GKA") targeting the restoration of glucose homeostasis in T2DM patients by addressing the defect of the glucose sensor function in the pancreas. A recently completed phase III clinical study of dorzagliatin monotherapy by Hua Medicine showed positive 52-week efficacy data. In addition, 24-week topline results were announced recently: The phase III metformin combination clinical trial met the primary efficacy endpoint.

"We are very excited to have this great opportunity, joining forces with Bayer to bring a first-in-class diabetes medicine, dorzagliatin, to Chinese patients," said Dr. Li Chen, CEO of Hua Medicine. "Bayer has been a leader in diabetes treatment for the past 10 years in China and will be a great partner for Hua Medicine to advance diabetes care. T2DM currently affects approximately 463 million patients worldwide, 116 million of which are in China(2). Over the last ten years, Hua Medicine has translated the novel concept of glucose homeostasis management into a breakthrough T2DM therapy that aspires to cure diabetes. For the first time, a drug has demonstrated, in clinical trials, the potential ability to improve glucose metabolism and Bata-cell function in T2DM patients. The partnership between Hua Medicine and Bayer will bring this medical innovation to a broader patient population in China even faster."

Under the terms of the agreement, Hua Medicine as the market authorization holder shall be responsible for clinical development, registration, product supply and distribution, whilst Bayer as the promotion service provider shall be responsible for marketing, promotion and medical education activities in China. Hua Medicine will receive an upfront payment of RMB 300 million and additional payments could reach up to RMB 4.18 billion if certain milestones are met. Bayer receives the exclusive rights to commercialize the product in China and will receive tiered service fee based on the net sales. Initially, both parties will share equally in sales derived from China net sales, with adjusting sales percentages based on agreed China net sales thresholds.

"China is a key focus of Bayer's partnering efforts and we are continuously looking for assets and health technologies to help address significant unmet medical needs of patients," said Marianne De Backer, PhD, Member of the Executive Committee and Head of Strategy and Business Development & Licensing, Pharmaceuticals Division of Bayer AG. "Through this new partnership, we further expand treatment options for millions of Type 2 diabetes patients in China by leveraging our commercial expertise and diabetes leadership position in China and combining it with the external know-how of a strong partner."

The Pharmaceuticals Business Development & Licensing team of Bayer facilitated this collaboration.

(1). British Medical Journal. Prevalence of diabetes recorded in China using 2018 diagnostic criteria from the American Diabetes Association: national cross sectional study. https://www.bmj.com/content/369/bmj.m997
(2). International Diabetes Federation. 9th Edition of IDF Diabetes Atlas. https://www.diabetesatlas.org/en/

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 T2DM. 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 T2DM and serve as a standard-of-care therapy for the treatment of the disease, or as a combination therapy with currently approved anti-diabetes drugs. For more information, please go to www.huamedicine.com

About Bayer
Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. Its products and services are designed to benefit people by supporting efforts to overcome the major challenges presented by a growing and aging global population. At the same time, the Group aims to increase its earning power and create value through innovation and growth. Bayer is committed to the principles of sustainable development, and the Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2019, the Group employed around 104,000 people and had sales of 43.5 billion euros. Capital expenditures amounted to 2.9 billion euros, R&D expenses to 5.3 billion euros. For more information, go to www.bayer.com.

About Hua Medicine
Hua Medicine is a leading, clinical-stage innovative drug development company in China focused on developing novel therapies for the treatment of diabetes to satisfy unmet medical needs. Founded by an experienced group of entrepreneurs and international investment firms, Hua Medicine advanced a first-in-class oral drug for the treatment of T2DM 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 primary endpoint in both of its Phase III monotherapy and combination trials in China over the 24-week trial period, and completed its 52-week 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.

Contact Bayer:
Bayer China Communications – Pharmaceuticals
Tel No.: (86)10-5921-8499
Email: pharma.china.comm@bayer.com

Contact Hua Medicine
Investors: ir@huamedicine.com
Media: pr@huamedicine.com

Bayer Forward-Looking Statements
This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer's public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

Hua Forward-Looking Statements
This press release may contain statements that constitute "forward-looking statements", including, but not limited to, statements relating to the implementation of strategic initiatives, and other statements relating to Hua Medicine's future business development and economic performance. While these forward-looking statements represent Hua Medicine's judgments and future expectations concerning the development of business, a number of risks, uncertainties and other statutory requirements may render actual developments and results to differ materially from our expectations. For more information, go to www.huamedicine.com.


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

China Medical System Holdings Limited 2020 Interim Results Announcement

HONG KONG, Aug 13, 2020 – (ACN Newswire) – China Medical System Holdings Limited ("CMS", or the "Company", SEHK:867), together with its subsidiaries (the "Group"), a well-established, innovation-driven specialty pharma with a focus on sales and marketing in China, announced its unaudited results for the 6 months ended 30 June 2020 ( the "Reporting Period").

In the first half of 2020, the Group recorded a turnover of RMB3,108.1 million (H1 2019: RMB2,964.4 million), an increase of 4.8% over the same period last year; excluding the effect of the "two-invoice system", turnover was up 4.6% to RMB3,557.1 million (H1 2019: RMB3,401.5 million). Profit for the period recorded an increase of 11.4% to RMB1,300.5 million (H1 2019: RMB1,167.5 million). Declared interim dividend was up 11.8% compared with the same period last year to RMB0.2105 per share (H1 2019: RMB0.1883).

Mr. Lam Kong, Chairman and Chief Executive of CMS, said: "Sustainable product competence is the key competitive factor for future development of enterprises. Adhering to the development strategy with innovative products as the core, the Group constantly expanded the innovative pipeline, while accelerating the registration progress of innovative products in China, so as to fulfill the unmet medical needs in China pharmaceutical market. Meanwhile, the Group continued to optimize the professional promotion system as well as the compliant and refined management system. Empowered by the product competence, promotion capability and efficient management system, the Group achieved steady and good growth."

Product Pipeline
The Group concentrates on the innovative products that are global first-in-class or with the best efficacy or best cost-effectiveness in the same class due to their innovative formulations or drug delivery systems. Capitalizing on its resources of global product development accumulated for more than two decades, as well as the market reputation earned, the Group has established strategic cooperation relationships with a number of leading pharmaceutical companies around the world and made equity investments in innovative R&D companies from the U.K., France, the U.S. and Switzerland. The Group's product pipeline includes 20 innovative products with great market potential and competitive differentiation advantages at relatively high innovation level, covering therapeutic fields including nervous system, ophthalmology, dermatology, endocrine system, oncology, nephrology, immune system, digestive system, anti-infection, etc.

During the Reporting Period, the Group's innovative pipeline continued to expand. The Group successively acquired exclusive licenses of the innovative product Desidustat (a patented new molecular entity for the treatment of anemia in patients with chronic kidney disease) and PLENITY (the U.S. FDA-cleared safe and effective orally-administered weight management product made from naturally derived materials) in Mainland China, HK SAR, Macau SAR, TWN and/or other countries in Asia. Meanwhile, the registration and clinical work of innovative products was accelerated. Two blockbuster innovative products (Diazepam Nasal Spray and Cyclosporine Eye Drops 0.09%) have been granted clinical trial notices issued by China NMPA for comparative PK study and confirmatory clinical trial respectively; the confirmatory clinical trial application of one blockbuster innovative product (Tildrakizumab) has been accepted by China NMPA; and the Phase II clinical trial of one innovative product (CF102) in Israel has yielded positive top line results.

Meanwhile, the Group deployed complex generics and competitive generics and actively worked on their registration in China, so as to capitalize on the opportunities brought by the National Volume-based Procurement to capture additional driving forces for the future development of the Group. As at 30 June 2020, two generics were under the review for marketing approval in China and one was granted clinical trial notice in China.

Existing Product Development
The Group's existing products mainly involve products under cardio-cerebrovascular line (mainly include Plendil, XinHuoSu and Deanxit), digestion line (mainly include Ursofalk, Salofalk, Bioflor and Combizym), ophthalmology line (mainly include Augentropfen Stulln Mono Eye Drops) and dermatology line (mainly include Hirudoid). Through deeply exploring and enhancing the evidence-based medical evidence and reinforcing the expert network construction and academic platform integration, the Group constantly increased products' academic influence and solidified the competitive advantages of the existing products. During the Reporting Period, the Group recorded solid growth across core product lines. The revenue of products under cardio-cerebrovascular line would increase by 4.4% to RMB2,026.6 million if excluding the effect of the "two-invoice system"; the revenue of products under digestion line increased by 12.7% to RMB1,157.9 million; the revenue of products under ophthalmology line decreased by 1.2% to RMB113.8 million; the revenue of products under dermatology line decreased by 0.9% to RMB85.2 million.

Promotion System
During the Reporting Period, the Group focused on the expansion of the promotion network and strengthened the market segmentation as well as the lower-tier market penetration. The Group actively explored the improvement and innovation of the promotion model while solidifying the existing promotion system, so as to accumulate experiences and make deployments in advance for the academic promotion of innovative products. In the meantime, aiming to building a more professional and compliant promotion team with higher execution capability, the Group further perfected the job qualification and employee training system, optimized the remuneration and incentive system, and intensified the compliance training and inspection. In addition, the Group capitalized on digital tools to hold online academic conferences with high frequency. Complying with the industry trend, the Group steadily promoted the construction of the retail network, expanded the coverage of retail chains and terminal stores, and further strengthened the cooperation with e-commerce platforms.

During the Reporting Period, the Group's promotion network covered about 57,000 hospitals and medical institutions in China.

Manufacturing Facilities
As at 30 June 2020, the Group owned pharmaceutical manufacturing sites in Hunan, Hebei and Shenzhen, occupying a total area of more than 110,000 square meters. The Group has the Pharmaceutical Production License and the Pharmaceutical GMP Certificate for various dosage forms such as powder, oral solution, small-volume injections, tablets, hard capsules, etc. With more than two decades of pharmaceutical production experiences, the Group has instituted stringent quality management standards and regulations to guarantee the product quality, ensuring the localized preparation manufacturing of overseas innovative products in China.

Mr. Lam Kong concluded, "The Group focuses firmly on the two core values in the pharmaceutical industry chain: product competence and promotion capability. Capitalizing on our extensive global resources, the Group will continue to expand the innovative pipeline and facilitate the further development and commercialization of drugs in China, so as to enhance product competence. At the same time, the Group will continuously strengthen the professional, compliant and efficient promotion system to achieve sustainable and steady growth. Adhering to the mission of "Offering competitive products and services to meet China's unmet medical needs", CMS will benefit and provide Chinese patients with more effective, safer, and more cost-effective drugs."


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

QBiotics Announces Clinical Collaboration with MSD Targeting Unresectable Melanoma

BRISBANE, AUSTRALIA, Aug 13, 2020 – (ACN Newswire) – QBiotics Group Limited (QGL), a life sciences company developing novel anticancer and wound healing pharmaceuticals, is pleased to announce that it has entered into an agreement with MSD (tradename of Merck & Co., Inc., Kenilworth, NJ, USA), to evaluate use of its lead molecule tigilanol tiglate, in combination with Keytruda(R) (pembrolizumab) in patients with unresectable melanoma.

Dr Victoria Gordon, Managing Director and CEO of QBiotics, said, "We are delighted to announce this collaboration with MSD. Patients with unresectable melanoma who have received prior checkpoint inhibitors currently have limited effective treatment options. Through this program we hope to see that when combined, tigilanol tiglate and Keytruda may produce additive anti-tumour immune responses, and improve outcomes for patients."

The Phase I/II open label 'QBC46-H06' study is a dose escalation and expansion study with the primary objective of determining the maximum tolerated dose or maximum feasible dose of the combination therapy. Secondary measures include assessing tumour responses in both injected tumours and uninjected tumours, as well as clinical efficacy parameters. Patients with unresectable melanoma and who have had exposure to immune checkpoint inhibitors are eligible for the study.

Dr Gordon continued, "This study follows on from encouraging Phase I data where tigilanol tiglate as a monotherapy showed a 27% treatment response rate*, including an 18% complete response with full tumour destruction across a wide variety of solid tumour types(2). Two patients with melanoma that had complete responses also had an abscopal (anenestic) response. Melanoma is the second human application we are pursuing for tigilanol tiglate following on from our Phase I/II clinical trial in patients with Head and Neck Squamous Cell Carcinoma (HNSCC) which commenced in December 2019".

Tigilanol tiglate is a small molecule administered by intratumoural injection directly into the solid tumour mass. Once injected, it has a multi-modal action including (i) rapid, but highly localised, inflammatory responses, (ii) increased permeability and destruction of tumour vascular endothelium, and (iii) rapid tumour cell death by oncosis(1).

*27% treatment response rate (n=6); 18% complete response rate (n=4)2.

Issued by QBiotics Group Limited – www.qbiotics.com

For further information
Dr Victoria Gordon, CEO & Managing Director, QBiotics Group
victoria.gordon@qbiotics.com or + 61 418 453 737

For media enquiries
Jane Lowe, IR Department
jane.lowe@irdepartment.com.au or +61 411 117 774

About QBiotics
QBiotics is a public unlisted Australian life sciences company which discovers, develops and commercialises novel anticancer and wound healing products for human and veterinary markets. Its lead product, tigilanol tiglate, is an anticancer pharmaceutical targeting a range of solid tumours across multiple species. QBiotics' business model is to develop products that have application in both veterinary and human markets. Success in the veterinary programs validates QBiotics technology and de-risks human development, while generating early, non-diluting revenues. https://qbiotics.com

About Tigilanol tiglate
Tigilanol tiglate is a small molecule that is being tested as an intratumoural treatment for solid tumours. Its effect on tumours is multimodal and involves injected tumour responses as well as distal responses in non-injected tumours. Complete destruction of the injected tumour is mediated via tumour vascular disruption as well as death of tumour cells by oncosis1. Following tumour destruction, rapid wound healing has been shown to ensue.

A single injection of tigilanol tiglate has been shown in canine patients to ablate (completely destroy) 75% of treated tumours(3). Veterinary use of tigilanol tiglate (branded STELFONTA(R)) has received marketing authorisation by the European Medicines Authority and the Veterinary Medicines Directorate in the United Kingdom as a treatment for canine mast cell tumours. STELFONTA(R) is also under review by the US Food and Drug Administration – Center for Veterinary Medicine and the Australian Pesticides and Veterinary Medicines Authority. STELFONTA(R) is partnered with Virbac, a global animal health company and launched in Europe in April 2020.

References
1. Boyle et al., (2014) Intra-tumoural injection of the novel PKC activator EBC-46 rapidly ablates tumours in mouse models. PLoS One 9:e1068887. DOI: 10.1371/journal.pone.0108887.
2. Panizza et al., (2019) Phase I dose-escalation study to determine the safety, tolerability, preliminary efficacy and pharmacokinetics of an intra tumoural injection of tigilanol tiglate (EBC-46). EBioMedicine 50: 433-441.
3. De Ridder et al., (2020). Randomized controlled clinical study evaluating the efficacy and safety of intratumoral treatment of canine mast cell tumors with tigilanol tiglate (EBC-46). Journal of Veterinary Internal Medicine. 1-15. DOI: 10.1111/jvim.15806

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

Made-in-Singapore Cancer Drug ETC-159 Advances Further in Clinical Trials

SINGAPORE, Jul 30, 2020 – (ACN Newswire) – Made-in-Singapore cancer drug, ETC-159, has achieved a new developmental milestone in achieving "First Patient First Visit[1]" in Phase 1B. The first dose of ETC-159 has been administered to patients in this new phase of clinical testing, which for the first time, will look at efficacy in addition to assessing the safety of ETC-159 in treating different types of cancers.
Scientists from the Experimental Drug Development Centre, A*STAR, preparing ETC-159 clinical samples for real-time Reverse Transcription-Polymerase Chain Reaction (RT-PCR) which amplifies the genetic material. (Photo credit: A*STAR)


Scientists from the Experimental Drug Development Centre, A*STAR, using centrifuges to bring ETC-159 clinical sample reactions down. (Photo credit: A*STAR)


Scientists from the Experimental Drug Development Centre, A*STAR, performing real-time Reverse Transcription-Polymerase Chain Reaction (RT-PCR) to amplify the genetic material from ETC-159 clinical samples.
From L-R: Ms Sylvia Gan, Senior Research Manager; Ms Nurul Rozaini, Research Associate (Photo credit: A*STAR)



This clinical study will include subgroups of colorectal, endometrial and ovarian cancer patients from two sites in Singapore (National University Cancer Institute, Singapore and National Cancer Centre Singapore) and up to seven clinical sites in the United States, including four confirmed sites, The University of Texas MD Anderson Cancer Center (Houston, Texas); University of Colorado (Aurora, Colorado); Washington University in St. Louis (Missouri); and Duke University (Durham, North Carolina). The trial is expected to be completed by 2023 at the latest.

ETC-159 was jointly developed by Duke-NUS Medical School (Duke-NUS) and the Agency for Science, Technology and Research (A*STAR), and first entered clinical trials in June 2015[2]. ETC-159 targets a range of cancers including colorectal, endometrial, ovarian and pancreatic cancers, which contribute to a significant fraction of Singapore's cancer burden. A subset of these cancers are caused by hyperactivity in a cell signalling pathway known as the Wnt pathway.

ETC-159 is an upstream inhibitor of the Wnt pathway and the clinical trial will determine to what extent this drug can slow or halt the growth of Wnt-high cancers or if ETC-159 can enhance the activity of immunotherapy in those patients that normally do not respond to immunotherapy. It has previously been shown that increased expression of Wnt pathway related genes is associated with drug resistance and exclusion of tumour-killing immune cells in the targeted types of cancers. The clinical trial uses ETC-159 to block the Wnt pathway so that immune cells can infiltrate the tumour. The trial will also combine ETC-159 with the immune checkpoint inhibitor pembrolizumab to stimulate the immune cells to kill tumour cells.

The Experimental Drug Development Centre (EDDC), a national platform for drug discovery and development, brought ETC-159 to the successful completion of Phase 1A clinical trials in July 2018. In that phase, proof of the drug's mechanism of action was achieved and a safe dose level established in 32 patients with advanced solid tumours.

EDDC, together with POLARIS[3] at A*STAR's Genome Institute of Singapore (GIS), and the Diagnostics Development (DxD) Hub, have also developed a novel diagnostic test in agreement with the US FDA, to identify a particular subgroup of colorectal cancer patients predicted to respond well to ETC-159 due to the presence of gene fusions involving R-spondin genes (RSPO2 or RSPO3) in their tumours. Such patients comprise only about 8% of colorectal cancers and will be identified upfront, based on left-over tumour tissue to be included in Phase 1B of the study. The test will be performed at POLARIS for all clinical samples from this trial.

"A significant milestone for EDDC and Singapore has been achieved with the progression of ETC-159 into Phase 1B clinical trials. We are grateful for the collaboration and input of our partners, such as Duke-NUS, POLARIS, clinical investigators and others within Singapore and beyond, which has enabled the successful completion of the Phase 1A trial and led us to initiate this next critical stage of ETC-159 development. We are optimistic about rapidly recruiting patients for the next phase of the clinical trial given the unmet need and opportunity ETC-159 brings to these patients, and will continue leveraging great science to make great medicines." – Professor Damian O'Connell, CEO EDDC, A*STAR

"The progression of ETC-159 to this exciting new phase of study is the result of a tremendous Singapore team effort, spanning from basic bench science to international clinical trials. With this critical study, we will learn whether ETC-159, by targeting a set of cancers that has previously been untreatable, will indeed help patients in Singapore and internationally. This important milestone is yet another testament to the research excellence and strong collaborations Singapore can achieve with focused effort. I hope this is just one of many such achievements." – Professor David Virshup, Duke-NUS Medical School

"This study will help address a critical and unmet need in gastrointestinal cancers. The novel design to molecularly screening for R-spondin fusion colorectal cancers that may be driven by the Wnt pathway and to target them with ETC-159 and immunotherapy has never been done before. Furthermore, most gastrointestinal cancers particularly colorectal cancers do not respond to immunotherapy. This may be due to suppression of immune cells in the tumour by Wnt-related pathways. We hope that by combining ETC-159 and immunotherapy we can circumvent this problem and achieve long-lasting responses for our patients." – Dr Matthew Ng, Senior Consultant, National Cancer Centre Singapore (NCCS)

"The incidence of ovarian and endometrial cancers is rising in the developed world, with many patients presenting at advanced stages of the disease. Despite initial responses to chemotherapy, the majority of patients with advanced ovarian and endometrial cancer will experience disease recurrence and eventually develop treatment refractory disease. At the National University Cancer Institute, Singapore (NCIS), we have long recognised this unmet medical need and have consistently been working with various academic and industry partners to develop new therapeutic approaches for these hard to treat gynaecological cancers. This clinical trial represents a novel and exciting therapeutic concept for the treatment of ovarian and endometrial cancers. In our continual drive to find better treatments for our patients, we certainly look forward to adding this study to the burgeoning portfolio of early phase trials at the NCIS Developmental Therapeutics Unit." – Associate Professor David Tan, Senior Consultant, National University Cancer Institute, Singapore (NCIS)

For more information on the ETC-159 clinical trials, please visit:
https://clinicaltrials.gov/ct2/show/NCT02521844

Relevant images can be downloaded from:
https://tinyurl.com/y3kodlbk

For media queries and clarifications, please contact:
Mr Robin Chan
Head, Corporate Communications
Agency for Science, Technology and Research (A*STAR)
Tel: +65 6826 6281
HP: +65 9830 2610
Email: robin_chan@hq.a-star.edu.sg

Lekshmy Sreekumar, Ph.D.
Communications
Duke-NUS Medical School
Tel: +65 6516 1138
Email: lekshmy_sreekumar@duke-nus.edu.sg

About the Experimental Drug Development Centre (EDDC)

The Experimental Drug Development Centre (EDDC) is a national platform for drug discovery and development formed in 2019 from the integration of A*STAR drug discovery and development units, namely, the Experimental Therapeutics Centre (ETC), Drug Discovery and Development (D3), and Experimental Biotherapeutics Centre (EBC). Together, these three units have forged partnerships with more than 70 academic institutions and 25 companies, locally and internationally, with close to 20 licensing deals executed.

The Centre will continue to champion public-private partnerships in the drug development industry. EDDC will allow for better coordination and optimised use of public sector resources, giving industry partners and Singapore greater ability to translate discoveries into new medicines for patients.

EDDC possesses a full range of drug discovery capabilities, including assay development, high throughput screening, antibody cloning, medicinal chemistry and ADME/toxicology. These capabilities allow EDDC to identify drug hits and leads, and develop them to the preclinical candidate stage in-house. In addition, EDDC enables translational drug development activities by having the internal expertise to support candidates through First-in-Human/Patient Phase 1 studies as well as being able to conduct Proof-of-Mechanism or Proof-of-Concept Studies.

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 our 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.

Follow us on
– Facebook https://www.facebook.com/HQastar/
– LinkedIn https://www.linkedin.com/company/a-star
– Instagram https://www.instagram.com/astarsingapore/
– YouTube https://www.youtube.com/astartv

About Duke-NUS Medical School

Duke-NUS is Singapore's flagship graduate entry medical school, established in 2005 with a strategic, government-led partnership between two world-class institutions: Duke University School of Medicine and the National University of Singapore (NUS). Through an innovative curriculum, students at Duke-NUS are nurtured to become multi-faceted 'Clinicians Plus' poised to steer the healthcare and biomedical ecosystem in Singapore and beyond. A leader in ground-breaking research and translational innovation, Duke-NUS has gained international renown through its five signature research programmes and nine centres. The enduring impact of its discoveries is amplified by its successful Academic Medicine partnership with Singapore Health Services (SingHealth), Singapore's largest healthcare group. This strategic alliance has spawned 15 Academic Clinical Programmes, which harness multi-disciplinary research and education to transform medicine and improve lives. For more information, please visit www.duke-nus.edu.sg.

[1] "First Patient First Visit" is a term used in the pharmaceutical industry to refer to the administration of the first dose of a compound or drug product to the first patient at his or her first visit in a clinical trial.
[2] "First made-in-Singapore cancer drug enters clinical testing:" A*STAR press release, July 16, 2015. National Archives of Singapore.
[3] POLARIS (Personalized OMIC Lattice for Advanced Research and Improving Stratification) https://www.a-star.edu.sg/polaris/

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

Captiva Verde Announces Esmeralda Agreement with Mexican Health Care Workers Union for up to USD$142 Million per Year of Annual Product Sales

Coquitlam, British Columbia, Jul 28, 2020 – (ACN Newswire) – Captiva Verde Land Corp. (CSE: PWR) (OTC: CPIVF) (the "Company" or "Captiva Verde"), is pleased to announce that further to its news release of October 2, 2019, where Captiva Verde has executed a share exchange agreement to acquire Salud Esmeralda de Mexico SA de CV, ("Esmeralda") where Esmeralda holds a comprehensive pharmaceutical license to sell, market and distribute an entire suite of 300+ pharmaceutical, health, wellness and veterinarian products which include all narcotic, psychoactive and non-psychoactive drugs listed under Groups I, II & III in Mexico, Esmeralda has today executed an agreement with the Chairman of both the 380,000 member Health Care Workers Union in Mexico and the broader 1.2 Million member Union Federation, whereby Esmeralda can expressly distribute and sell medicinal health and wellness products to the Union Federation on a direct basis, with payment from the Union.



The Amount outlined in the agreement is for up to 1.2 Million members per month at between MXN $160 to MXN $220 per month, (between MXN $2.3 Billion to MXN $3.2 Billion per year) or up to USD $142,000,000 per year of product sales. (based on 30 day MXN-USD of 22.3) Captiva Verde is 75% complete in constructing its brand new drug manufacturing facility in Mexico for preparation of manufacturing and sales to the Union Federation this coming November. Anticipated Gross Profit is 40%. The complete cost of the new building is USD $750,000.

The Share Exchange Agreement between Esmeralda and Captiva Verde calls for the exchange of 80 Million shares subject to a strict pooling Agreement. Jeff Ciachurski, the CEO of Captiva Verde will receive 22.4 Million of those shares in this agreement. The Share Exchange Agreement and its resolutions are currently waiting for the filing of a signature verification process from the Mexican Consulate in Vancouver. Covid19 had previously delayed this basic administrative function. Final approval is then subject to the Canadian Securities Exchange once the Mexican Consulate has verified the Canadian resolutions including the corporate documents of Captiva Verde.

The exact wording in the Share Exchange Agreement reads:
https://tinyurl.com/yxvsvmdj

Jeff Ciachurski, the CEO of Captiva Verde, states: "This is an extremely significant milestone in the history of the Company. Without question, this agreement transforms Captiva Verde as a player in the legal health and wellness business, as we execute this function to one unified buyer, avoiding middlemen, agents, dealers and brokers, offering Mexican Union Members significant cost savings that are not available in the wholesale or retail market."

On Behalf of the Board of Directors
"Jeff Ciachurski"
Jeffrey Ciachurski
Chief Executive Officer and Director
Cell: (949) 903-5906
www.captivaverdecorp.com
E-mail: westernwind@shaw.ca

Cautionary Note Regarding Forward Looking Information

This release includes certain statements that may be deemed "forward-looking statements". All statements in this release, other than statements of historical facts, that address events or developments that the Company expects to occur, are forward-looking statements. Forward-looking statements are statements that are not historical facts and are generally, but not always, identified by the words "expects", "plans", "anticipates", "believes", "intends", "estimates", "projects", "potential" and similar expressions, or that events or conditions "will", "would", "may", "could" or "should" occur. Although the Company believes the expectations expressed in such forward-looking statements are based on reasonable assumptions, such statements are not guarantees of future performance and actual results may differ materially from those in the forward-looking statements. Factors that could cause the actual results to differ materially from those in forward-looking statements include regulatory actions, market prices, and continued availability of capital and financing, and general economic, market or business conditions. Investors are cautioned that any such statements are not guarantees of future performance and actual results or developments may differ materially from those projected in the forward-looking statements. Forward-looking statements are based on the beliefs, estimates and opinions of the Company's management on the date the statements are made. Except as required by applicable securities laws, the Company undertakes no obligation to update these forward-looking statements in the event that management's beliefs, estimates or opinions, or other factors, should change.

To view the source version of this press release, please visit https://www.newsfilecorp.com/release/60586

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Impact Biomedical initiates Quantum Research Program to solve the Patent Cliff

SINGAPORE, Jul 27, 2020 – (ACN Newswire) – SGX-listed Singapore eDevelopment Limited's (SeD; SGX:40V) wholly-owned subsidiary Impact Biomedical Inc. ("Impact"), announced today the initiation of Quantum, their research program designed to solve the impending pharmaceutical patent cliff threat.

Impact Biomedical's transition to the Quantum research program comes on the heels of the completion of the research and development stage of its existing biodefense intellectual portfolio, which is now moving to the licensing and commercialization phase. The portfolio, valued by independent experts at approximately US$1.39 billion as announced by the Group on 1 June 2020 includes: Linebacker, a universal therapeutic designed to shadow the Panacea Project, a US Defense Advanced Research Projects Agency (DARPA) program to provide novel, multi-target therapeutics for unmet physiological needs; 3F BioFragrance, designed for the Open Air Defense Initiative, a strategy to protect locations where large numbers of people gather or transit; and Equivir, an OTC medication designed as an antiviral treatment and prophylactic comprising polyphenols that are GRAS or Generally Recognized as Safe, meaning its safety and behaviour in humans is already well understood and therefore is designed to proceed directly to human trials.

The patent cliff is a severe threat to pharmaceutical companies. The patent cliff arises when patents for blockbuster drugs expire without being replaced with new drugs, pharmaceutical companies experience an abrupt decrease in revenue. This depletes financial resources needed for the development of new therapeutics, which in turn reduces overall pharmaceutical innovation globally including crucial research into new methods to prevent and treat illnesses. The global pharmaceutical market research firm EvaluatePharma estimates that the patent cliff puts approximately US$198 billion in revenue at risk between 2019 and 2024[1]. Typical drug development uses schemes that have become less and less tenable. For example, drugs based on molecules found in cannabis are largely unpatentable due to the vast body of published research on new molecules derived from cannabis. Most existing techniques have already been contemplated. Without the patentability of the foregoing, the resources needed to develop a new drug based on cannabis cannot be secured.

Impact, through their strategic partner Global Research and Discovery Group Sciences ("GRDG"), has created a solution called Quantum, a new frontier in pharmaceutical development. Quantum is a new class of medicinal chemistry that uses advanced methods to boost efficacy and persistence of natural compounds and existing drugs while maintaining the safety profile of the original molecules. Instead of modifying functional groups, as is typically done presently in drug discovery, this new technique alters the behavior of molecules at the sub-molecular level. GRDG estimates that 65% of the World Health Organization Essential Medicines List can be improved and re-patented using Quantum. This approach can be used to enhance and patent natural compounds which includes many substances used in traditional medicines around the world.

This research follows the success of GRDG's recently completed exploratory program to address biomedical threats including the current COVID-19 pandemic which produced the 3F Antimicrobial BioFragrance, the universal therapeutic Linebacker, and the antiviral OTC medication Equivir, which is moving to human clinical trials. These inventions form the core of Impact's suite of next generation medical technology that was recently valued at approximately US$1.39 Billion by independent experts.

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 the U.S. Centers for Disease Control and Prevention. Dr. Moore said, "A new direction in drug discovery is sorely needed and Quantum has the potential to revive innovation and development of lifesaving pharmaceuticals."

GRDG's Chief Strategy Advisor is Lieutenant Colonel William H. Lyerly Jr., a retired U.S. Army Medical Service Corps Officer, as well as a retired Career Senior Executive / Scientific Professional (ST), with decorated civilian service as a senior official within the U.S. Department of Homeland Security, 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, "Continued innovation in drug discovery is vital to combat new dangers to human health such as the current COVID-19 pandemic and beyond. Quantum can improve the drug development industry and enable scores of new solutions."

Impact Biomedical Chairman, Mr. Chan Heng Fai said, "Today, the difficulty in obtaining a pharmaceutical patent and retaining market exclusivity after it expires thwarts the momentum required by pharmaceutical companies to spur greater innovation. Backed by our newly established Quantum solution, we are proud to lead the field by bringing real and cutting-edge solutions to this immense global health challenge. In due time, we believe that Quantum will provide a practical solution for pharmaceutical companies to extend the patent life of their existing drug portfolio, thereby reducing abrupt declines in revenue following the expiration of patents. More importantly, they will be able to focus their resources on developing new, innovative drugs to treat and prevent illnesses for society at-large."

Daryl Thompson, Director of Scientific Initiatives and founder of GRDG, said, "The patent cliff represents a significant crisis in pharmaceutical innovation. The primary cause of the crisis is that most techniques for modifying natural molecules to pharmaceutical grade products are essentially 'played out.'

"Another way to explain this is that most of the methods to make drugs have already been published in scientific papers or rationalized in long expired patents. This means that these methods can render the development of new, novel compounds unpatentable. It is essential for a new drug in development qualify for patent protection due to the high costs of bringing a single compound to market. The medium cost of bringing a drug to market today is roughly US$985 million.

"Previous strategies for increasing the potency of a natural compound to pharmaceutically therapeutic levels employed the used of other molecular modification schemes. These techniques typically included standard practices such as altering functional groups, the addition or substitution of halogens and or the inclusion of lipid structures. The goal of these modifications would be to increase stimulation or inhibition of the molecule against its target site as well as increase bioavailability. Unfortunately, these effective techniques are being rendered moot due to lack of patentability due to prior disclosure.

"We have devised a method to break through this barrier and open a new path for drug development. We will be moving past macro-molecular techniques as mentioned above and will go deeper into the sub-atomic. Here we can look at molecular modification from the perspective of quantum physics. For instance, our previous work on the Linebacker program utilized halogenation to create electron rich portions in the molecule to increase its therapeutic potential. This technique, called sigma-hole generation or X-bonding, is well understood in the scientific community. However, once we disclose how we used this technique in a patent to create a new drug, it can never be patented again once the patents are expired.

"Quantum molecular modifications approach this problem from the perspective of manipulating the sub-atomic electron balance as a whole in consideration of the sum of both kinetic and potential energies within the molecular state. The exploitation of modification of this type by total energy configurations allows the use of quantum principles such as the Hamiltonian Operator as tools for understanding how to manipulate subatomic forces to increase a molecule's effectiveness as potential new life saving drug.

"This approach allows for a virtually endless array of methods that can lead to a new era in drug discovery possibilities. With our Biodefense mission complete, we will now move forward with the initialization of our Quantum Applications Research Platform. We expect to deliver the first 6 Quantum molecules to research institutes within three business quarters."

This new research will propel global drug discovery forward and foster increased innovation and ultimately better health worldwide.

There is currently no outlay of funds required for the initiation of Impact BioMedical's Quantum research program. Depending on the state of development of Quantum, SeD will fund its development through a variety of sources ranging from its internal source of funds and/or externally such as through funds generated from financial institutions as well as potential debt and/or equity fund raising.

Shareholders and potential investors of SeD should note that there is no certainty or assurance as at the date of this Press Release that Impact BioMedical's biodefense intellectual portfolio will be licensed or close to monetisation. 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.

[1] EvaluatePharma(R) World Preview 2019, Outlook to 2024 Report, 12th Edition, June 2019 https://tinyurl.com/y3lbhutm

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

Aptorum Group Becomes the First Nasdaq Listed Biopharmaceutical Company Admitted to Trading on Euronext Paris Stock Exchange Under the Ticker Symbol APM

HONG KONG, Jul 27, 2020 – (ACN Newswire) – Aptorum Group Limited (Nasdaq: APM) ("Aptorum Group"), a biopharmaceutical company focusing on the development of novel therapeutics to address global unmet medical needs, today is pleased to announce that its Class A Ordinary Shares has commenced trading on the Professional Compartment of Euronext in Paris under the Euronext ticker symbol "APM" and ISIN Code: KYG6096M1069. Aptorum Group's Class A Ordinary Shares continues to be listed on the Nasdaq Global Market under the symbol APM.



Mr. Darren Lui, President and Executive Director (left), at the Euronext Paris Stock Exchange ceremony



The 7,950,986 Class A Ordinary Shares of Aptorum Group got admitted to trading on Euronext market in Paris after Aptorum Group received a visa for its prospectus granted by the French Autorite des Marches Financiers on 16 July 2020.

Reed Smith LLP acts as Aptorum Group's legal advisor and listing agent. BNP Paribas Securities Services acts as Aptorum Group's trading agent.

About Aptorum Group
Aptorum Group Limited (Nasdaq: APM) is a pharmaceutical company dedicated to developing and commercializing novel therapeutics to tackle current unmet medical needs. Aptorum Group's current drug pipeline includes indications in orphan diseases, infectious diseases and metabolic diseases, a number of which are targeted to enter clinical trial phases. Aptorum Group is also launching a women's health supplement, dioscorea opposita bioactive nutraceutical tablets marketed under the brand name NativusWell.

For more information about Aptorum Group, please visit our website: www.aptorumgroup.com.

Disclaimer and Forward-Looking Statements

This press release does not constitute an offer to sell or a solicitation of offers to buy any securities of Aptorum Group.

This annoucement is not a prospectus within the meaning of the Regulation (EU) n 2017/1129 of 14 June 2017 as amended by Regulations Delegated (EU) n 2019/980 of 14 March 2019 and n 2019/979 of 14 March 2019.

This press release includes statements concerning Aptorum Group Limited and its future expectations, plans and prospects that constitute "forward-looking statements" within the meaning of the US Private Securities Litigation Reform Act of 1995. For this purpose, any statements contained herein that are not statements of historical fact may be deemed to be forward-looking statements. In some cases, you can identify forward-looking statements by terms such as "may," "should," "expects," "plans," "anticipates," "could," "intends," "target," "projects," "contemplates," "believes," "estimates," "predicts," "potential," or "continue," or the negative of these terms or other similar expressions. Aptorum Group has based these forward-looking statements, which include statements regarding projected timelines for application submissions and trials, largely on its current expectations and projections about future events and trends that it believes may affect its business, financial condition and results of operations. These forward-looking statements speak only as of the date of this press release and are subject to a number of risks, uncertainties and assumptions including, without limitation, risks related to its announced management and organizational changes, the continued service and availability of key personnel, its ability to expand its product assortments by offering additional products for additional consumer segments, development results, the company's anticipated growth strategies, anticipated trends and challenges in its business, and its expectations regarding, and the stability of, its supply chain, and the risks more fully described in Aptorum Group's Form 20-F and other filings that Aptorum Group may make with the SEC in the future and the prospectus that received the French Autorite des Marches Financiers visa n 20-352 on 16 July 2020. As a result, the projections included in such forward-looking statements are subject to change and could be materially different from those described herein. Aptorum Group assumes no obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.
This press release is provided "as is" without any representation or warranty of any kind.

Investor relations contacts
Aptorum Group limited
Investor Relations Department:
Tel: +852 3953 7700
Email: investor.relations@aptorumgroup.com

Actifin – Financial Communications Europe
Investor relations
Ghislaine Gasparetto
ggasparetto@actifin.fr
+33 1 56 88 11 22

Redchip – Financial Communications United States
Investor relations
RedChip Companies, Inc.
dave@redchip.com
+1 407 491 4498



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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.



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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.



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