Peptomyc Announces the Approval of Its Phase 1b Trial Testing OMO-103 in Combination With Standard of Care in PDAC Patients

BARCELONA, Jul 28, 2023 – (ACN Newswire) – Peptomyc S.L., a biotech company specialized in the development of protein therapeutics for cancer treatment, announces that it has received full study approval for its new Phase 1b clinical trial, which will evaluate the combination of the first-in-class MYC inhibitor, OMO103, together with the standard of care (SoC) regimen Gemcitabine and Nab-Paclitaxel in metastatic Pancreatic Ductal Adenocarcinoma (PDAC) patients in first line. PDAC is the most common form of pancreatic cancer. Currently, it is the fourth highest cause of cancer mortality worldwide and its incidence is rising steeply. Current therapies offer limited chance of a lasting cure and the five-year survival rate is one of the lowest among the most commonly occurring cancers.

MYC is an oncoprotein deregulated in most -if not all- types of cancers. It is activated in many PDAC cases, where it contributes to aggressiveness of the disease and resistance to treatments. The company recently completed a FIH Phase 1 study of OMO103 in all-comers solid tumor patients, demonstrating excellent safety and promising anti-tumor activity.

Manuela Niewel, MD, PhD, Chief Medical Officer of the company, leading Peptomyc's clinical development, regulatory and medical affairs activities, says: "I am excited to be able to start our new Phase 1b study in PDAC patients. With OMO-103, we hope to address this devastating disease and one of the highest unmet medical needs in the oncology field".

This Phase 1b combination study will be conducted in four sites in Spain. The lead PI will be Dr. Teresa Macarulla at the Vall d'Hebron Institute of Oncology in Barcelona, and she will collaborate with Dr. Andres Munoz at the Hospital Gregorio Maranon in Madrid, Dr. Mariona Calvo at the ICO-Hospitalet in Barcelona, and Dr. Roberto Pazo at the Hospital Miguel Servet in Zaragoza. The study is planned to start in Q3/2023.

About Peptomyc

Peptomyc (www.peptomyc.com) is a spin-off from VHIO – the Vall d'Hebron Institute of Oncology – and ICREA – the Catalan Institute of Research and Advanced Studies – founded in December 2014 in Barcelona, Spain. The company is focused on the development of innovative cell penetrating peptides (CPPs) targeting the Myc oncoprotein for cancer treatment and based on Dr. Soucek's scientific research in Omomyc (the best direct Myc inhibitor known to date) over the last twenty years. It is the first company to have successfully completed a Phase I clinical trial with a direct MYC inhibitor.

Contact Information
Laura Soucek
CEO
lsoucek@peptomyc.com
+34695207869

Copyright 2023 ACN Newswire. All rights reserved. http://www.acnnewswire.com

The phase 1/2 clinical trial of Bevacizumab for treatment of Ophthalmic Diseases completed

HONG KONG, Jul 26, 2023 – (ACN Newswire) – Essex Bio-Technology Ltd ("Essex" or the "Group", Stock Code: 1061.HK) today announced that a phase 1/2 clinical trial of EB12-20145P (HLX04-O), a recombinant anti-VEGF humanised monoclonal antibody injection jointly developed by the Group and Shanghai Henlius Biotech, Inc. ("Henlius", Stock Code: 2696.HK), has been completed in patients with wet age-related macular degeneration (wAMD). The results of this study demonstrated the good safety and tolerability of EB12-20145P (HLX04-O).

This single-arm, open-label, multicentre, phase I/II study aimed to evaluate the safety and preliminary efficacy of EB12-20145P (HLX04-O) via intravitreal injection (IVT) in patients with active wet age-related macular degeneration (wAMD). The study consisted of two parts. Part 1 was a safety run-in stage which enrolled 6 patients. Part 2 was a single-arm, open-label, multicentre, phase II study and 20 patients (including 6 patients from part 1) were enrolled in this part. All patients received EB12-20145P (HLX04-O) IVT (1.25 mg/0.05 mL) every four weeks until death, withdrawal of informed consent, loss to follow-up, study termination by the sponsor, or completion of one-year treatment. For part 1, the primary endpoint was a safety event related to EB12-20145P (HLX04-O) that occurred within four weeks after the first dose of EB12-20145P (HLX04-O); secondary endpoints were the systemic pharmacokinetic characteristics of EB12-20145P (HLX04-O) after the first and fourth IVT administration. For part 2, the primary endpoint was the mean change of letters from baseline in best corrected visual acuity (BCVA) at week 12; secondary endpoints included other efficacy measures, safety, immunogenicity, and systemic pharmacokinetic characteristics. The results showed that EB12-20145P (HLX04-O) was safe and well tolerated in wAMD patients, and preliminary efficacy was observed.

EB12-20145P (HLX04-O) is a recombinant anti-VEGF humanized monoclonal antibody injection constructed using genetic engineering technology independently developed by Henlius. EB12-20145P (HLX04-O) can inhibit VEGF's binding to its receptor Flt-1 (VEGFR-1) and KDR(VEGFR-2) on endothelial cells to inhibit the activation of its tyrosine kinase signaling pathway, inhibit endothelial cell proliferation and reduce angiogenesis, thereby treating eye diseases associated with angiogenesis. According to the requirements of ophthalmic drugs, Henlius has developed EB12-20145P (HLX04-O) which optimizes the prescription, specifications, and production processes of HANBEITAI, assuming that the active ingredients remain unchanged. Through a series of comparability analyses, it is proved that the changes in the production process and prescription of the preparation have no adverse impact on the quality, safety and efficacy of the preparation.

As of now, the clinical trial applications of EB12-20145P (HLX04-O) have been approved in Singapore and other countries and regions. Moreover, the first patients in the United States (US), China, the European Union (EU) and Australia were dosed in phase 3 clinical trials of EB12-20145P (HLX04-O) for the wAMD. Essex and Henlius will jointly manage progressively the global multi-centre clinical trials of EB12-20145P (HLX04-O) and apply marketing authorization in China, Australia, the EU, and the US around the globe based on the research results. EB12-20145P (HLX04-O) has the potential to be one of the first bevacizumab approved for use in ophthalmic diseases, benefiting more patients with eye diseases worldwide.

About wAMD
Age-related macular degeneration is one of the leading causes of visual impairment and blindness in the elderly worldwide[1]. According to the World Health Organization (WHO), about 30 million people have suffered from AMD globally, and about half a million people become blind due to AMD each year[2]. Wet age-related macular degeneration (wAMD) is characterized by the formation of subretinal choroidal neovascularization (CNV) and is responsible for approximately 90% of cases of AMD-related blindness. Due to an aging population, wAMD has become a serious social medical problem and indicated a huge burden of unmet needs [3]. With the development of treatment for fundus diseases, anti-VEGF drugs are becoming the first-line therapy for the management of wAMD[4], and the efficacy and safety of vitreous injection of bevacizumab for wAMD have been verified in multiple clinical studies[5-11].

About Essex (1061.HK)
Essex Bio-Technology Limited is a biopharmaceutical company that develops, manufactures and commercialises genetically engineered therapeutic b-bFGF (FGF-2), having six commercialised biologics marketed in China since 1998. Additionally, it has a portfolio of commercialised products of preservative-free unit-dose eye drops and Shilishun (Iodized Lecithin Capsules), etc. The products of the Company are principally prescribed for the treatment of wound healing and diseases in Ophthalmology and Dermatology, which are marketed and sold through approximately 10,900 hospitals and managed directly by its 43 regional sales offices in China. Leveraging on its in-house R&D platform in growth factor and antibody, the Company maintains a pipeline of projects in various clinical stages, covering a wide range of fields and indications.

Reference
[1] Ouyang Lingyi, Xing Yiqiao. Advances in the use of anti-VEGF drugs in wet age-related macular degeneration[J]. International Eye Science, IES,2020(1).
[2] Resnikoff S, Pascolini D, Etya'ale D, Kocur I, Pararajasegaram R, Pokharel GP, Mariotti SP. Global data on visual impairment in the year 2002. Bull World Health Organ. 2004 Nov;82(11):844-51.
[3] Wong WL, Su X, Li X, et al. The global prevalence of age-related macular degeneration and disease burden projection for 2020 and 2040: a systematic review and meta-analysis. Lancet Glob Health. 2014;2(2):e106-116.
[4] Li X R , Liu J P . Recognition of anti-VEGF therapy based on the mechanism of VEGF in wet age-related macular degeneration[J]. Zhonghua Shiyan Yanke Zazhi/Chinese Journal of Experimental Ophthalmology, 2012, 30(4):289-292.
[5] Tufail A, Patel PJ, Egan C, Hykin P, da Cruz L, Gregor Z, Dowler J, Majid MA, Bailey C, Mohamed Q, Johnston R, Bunce C, Xing W; ABC Trial Investigators. Bevacizumab for neovascular age-related macular degeneration (ABC Trial): multicentre randomized double-masked study. BMJ. 2010 Jun 9;340:c2459.
[6] Martin DF, Maguire MG, Ying GS, Grunwald JE, Fine SL, Jaffe GJ. Ranibizumab and bevacizumab for neovascular age-related macular degeneration. N Engl J Med. 2011 May 19;364(20):1897-908.
[7] Chakravarthy U, Harding SP, Rogers CA, Downes SM, Lotery AJ, Wordsworth S, Reeves BC. Ranibizumab versus bevacizumab to treat neovascular age-related macular degeneration: one-year findings from the IVAN randomized trial. Ophthalmology. 2012 Jul;119(7):1399-411.
[8] Kodjikian L, Souied EH, Mimoun G, Mauget-Faysse M, Behar -Cohen F, Decullier E, Huot L, Aulagner G; GEFAL Study Group. Ranibizumab versus Bevacizumab for Neovascular Agerelated Macular Degeneration: Results from the GEFAL Noninferiority Randomized Trial. Ophthalmology. 2013 Nov;120(11):2300-9.
[9] Krebs I, Schmetterer L, Boltz A, Told R, Vecsei-Marlovits V, Egger S, Schonherr U, Haas A, Ansari-Shahrezaei S, Binder S; MANTA Research Group. A randomized double-masked trial comparing the visual outcome after treatment with ranibizumab or bevacizumab in patients with neovascular age-related macular degeneration. Br J Ophthalmol. 2013 Mar;97(3):266-71.
[10] Berg K, Pedersen TR, Sandvik L, Bragadottir R. Comparison of ranibizumab and bevacizumab for neovascular age-related macular degeneration according to LUCAS treat-and-extend protocol. Ophthalmology. 2015 Jan;122(1):146-52.
[11] Schauwvlieghe AM, Dijkman G, Hooymans JM, Verbraak FD, Hoyng CB, Dijkgraaf MG,Peto T, Vingerling JR, Schlingemann RO. Comparing the Effectiveness of Bevacizumab to Ranibizumab in Patients with Exudative Age-Related Macular Degeneration. The BRAMD Study. PLoS One. 2016 May 20;11(5):e0153052.

Investor Enquiry:
Investor Relations: investors@essex.com.cn

Copyright 2023 ACN Newswire. All rights reserved. http://www.acnnewswire.com

BioGX Candida Auris PCR Assay Global Adoption Accelerates

BIRMINGHAM, AL, Jul 25, 2023 – (ACN Newswire) – BioGX, a global provider of easy molecular diagnostic solutions, announced accelerated adoption of their high performance Sample-Ready(TM) PCR assay* for detection of Candida auris, a rapidly spreading, hard to treat fungus with a growing presence in hospitals and long-term care facilities. A complete PCR mix is provided in a single lyophilized tube format to be validated by laboratories on a variety of real-time PCR instruments including the BD MAX, ThermoFisher QuantStudio, BioRAD CFX Touch and the new BioGX pixl(TM) platform.

"Our platform agnostic Candida auris PCR assay has been successfully validated and implemented by numerous public health laboratories and hospitals," said Shahin Iqbal, PhD, BioGX President & COO." He further added, "We are grateful that laboratories trust us to address their unmet needs for detection of emerging pathogens."

Dr. Margie Morgan, Director, Clinical Microbiology Pathology and Laboratory Medicine at Cedars Sinai Hospital in California said "the BioGX Candida auris PCR assay provides a rapid and sensitive method to perform surveillance testing for our patient population. The real time results have been used by our Epidemiology team to institute timely isolation precautions to successfully prevent C. auris transmission in our medical center."

BioGX's Sample-Ready(TM) line of products offer custom manufactured or Research Use Only PCR assays, lyophilized in a single vial and fine-tuned to ensure high performance across multiple platforms that are commonly used in laboratories today.

Additional information can be requested by contacting BioGX at info@biogx.com.

*Research Use Only, Not intended for human or animal diagnostic use.

Sample-Ready, Just Add Water, Xfree and pixl are trademarks of BioGX, Inc.

Contact Information
Bill Standwill
Head of Marketing
marketing@biogx.com
(205) 250-8055

Copyright 2023 ACN Newswire. All rights reserved. http://www.acnnewswire.com

HanchorBio Announces Taiwan FDA IND Approval for the Multi-Regional Clinical Trial of HCB101 to Treat Solid and Hematological Malignancies

TAIPEI, TAIWAN and SAN FRANCISCO, CA, Jul 24, 2023 – (ACN Newswire) – HanchorBio Inc., a global clinical-stage biotechnology company developing innovative immuno-biomedicines, announced today that the Taiwan Food and Drug Administration (TFDA) has approved its investigational new drug (IND) application to initiate a multi-regional clinical trial of its independently-developed novel drug candidate, HCB101, for the treatment of patients with advanced solid tumors or relapsed and refractory non-Hodgkin lymphoma.

"HCB101 is our first program in our pipeline which recently received IND clearance by US FDA and now obtained IND approval from TFDA of this multi-regional, multi-center clinical trial. HCB101 project was initiated in December 2021, and the U.S. IND was submitted in March 2023; the 2.3 year from inception to IND was a record for a biotech company of our size. The opportunity to bring this potential fusion protein to cancer patients who have such a high unmet medical need is at the core of what drives us as a company," said Scott Liu, Ph.D., Founder, Chairman, and Chief Executive Officer of HanchorBio. "With a strong pipeline targeting both the adaptive and innate immunity and the Fc-based designer biologics (FBDB(TM)) platform we have built, HanchorBio is well positioned to make important impacts in delivering innovative, cutting-edge immunotherapies."

Sean Juo, Ph.D., President and Chief Scientific Officer of HanchorBio, commented, "Leveraging the 'do not eat' signal pathway, HCB101 has demonstrated superior anti-tumor efficacy in our extensive preclinical studies of murine xenograft tumor models when comparing head-to-head with other agents currently being investigated in clinical trials that target the same pathway." "IND approval from TFDA within 23 working days (a speed record) is a testament to our in-house drug development capabilities and strong clinical operations through our partnership with global CRO companies. Our team already initiated this clinical trial in the US, and I look forward to enrolling the first subject soon," said Dora Weng, R.N., M.B.A., Clinical Operations Head of HanchorBio.

About HCB101

Using structure-guided protein design and engineering supplemented with relevant screening technologies, HCB101 is an engineered extracellular domain of SIRPa fused to the Fc region of IgG4. HCB101 triggers phagocytic activity of the macrophages by blocking the "do not eat" signal between macrophages and tumor cells. Based on the extensive in-vitro and in-vivo preclinical data, HCB101 is potentially a safer and more potent biologic than the anti-CD47 monoclonal antibodies and SIRPa fusion proteins currently being investigated in clinical trials. Furthermore, quantitative RNA transcriptional analysis indicated that HCB101 triggered distinct gene expression profiles inside the tumor and in the tumor microenvironment comparing to other relevant clinical candidates, suggesting that HCB101 might exhibit unique mechanisms of action. Using HCB101 as the foundation, our pipeline will include other arms targeting both adaptive and innate immunity to help revolutionize the treatment of patients with cancer and other debilitating diseases.

About Multi-Regional Clinical Trial of HCB101

HCB101-101 is a multi-regional, multi-center, open-label, dose-finding, first-in-human (FIH) study of adults with advanced solid tumors or relapsed and refractory non-Hodgkin lymphoma in the United States and Taiwan. The purposes of the study are to evaluate the safety, tolerability, pharmacokinetics, and clinical anti-tumor activity of weekly HCB101 intravenous injections. The US sites initiation of the HCB101-101 is on track within Q3-2023.

About HanchorBio

Based in Taipei, Shanghai, and San Francisco Bay Area, HanchorBio is a global clinical-stage biotechnology company focusing on immuno-oncology. The Company is led by an experienced team of pharmaceutical industry veterans with proven track-record of success in biologics discovery and global development to transcend current cancer therapies. Committed to reactivating the immune system to fight against diseases, the proprietary Fc-based designer biologics (FBDB(TM)) platform enables unique biologics with diverse multi-targeting modalities to unleash both innate and adaptive immunity to overcome the current challenges of anti-PD1/L1 immunotherapies. The FBDB(TM) platform has successfully delivered proof-of-concept data in several in vivo tumor animal models. By making breakthroughs in multi-functional innovative molecular configurations in R&D and improving the manufacturing process in CMC, HanchorBio develops transformative medicines to address unmet medical needs. For more information, please visit: www.HanchorBio.com or follow us on LinkedIn at www.linkedin.com/company/hanchorbio-inc

Contact Information
Scott Liu
Founder, Chairman and CEO
scott_liu@hanchorbio.com

Yi Du
Sr. Director of Business Development
yi_du@hanchorbio.com

Copyright 2023 ACN Newswire. All rights reserved. http://www.acnnewswire.com

DC Healthcare Debuts on ACE Market with a Premium of RM0.15 over IPO Price

SHAH ALAM, Malaysia, Jul 17, 2023 – (ACN Newswire) – DC Healthcare Holdings Berhad, an aesthetic medical services provider specialising in the provision of non-invasive and minimally invasive procedures, today debuted on the ACE Market of Bursa Malaysia Securities Berhad, opening at RM0.40 per share representing a premium of 60% over the initial public offering (IPO) price of RM0.25 per share.

DC Healthcare is listed under the stock name of "DCHCARE" and stock code of "0283".

DC Healthcare currently operates 13 aesthetic clinics in the central and southern regions of Peninsular Malaysia. The Group provides aesthetic medical services such as facial sculpting and body contouring and, general medical services focusing on skin diseases such as psoriasis and eczema, as well as blood test health screening.

The Group raised a total of RM49.81 million through the IPO, from which RM9.44 million is allocated for the establishment of 8 new clinics across the northern and southern regions of Peninsular Malaysia. Another RM13.12 million of the proceeds will be used to purchase medical machinery and equipment while RM6.24 million of the proceeds is allocated for repayment of borrowings. Another RM17.01 million of the proceed is allocated for working capital purposes The remaining RM4.0 million has been allocated for listing expenses.

Chairman of DC Healthcare, Datuk Dr. Mohd Noor Bin Awang said, "The listing of DC Healthcare, an established aesthetic medical services provider specialising in the provision of non-invasive and minimally invasive procedures, will allow us to benchmark ourselves as the first aesthetic medical services provider to be listed on Bursa Securities."

Managing Director of DC Healthcare, Dr. Chong Tze Sheng said, "This is a significant milestone for the Group and evidence of how far we have come as a business to be a leading provider of aesthetic services in Malaysia. Through this listing, we not only cement our success, but we can also continue to build on what we have to bring more value to shareholders".

Managing Director of Corporate Finance, M&A Securities Sdn Bhd, Datuk Bill Tan said, "We would like to commend the hard work and dedication of Dr. Chong and the DC Healthcare team. The prospects for DC Healthcare are on a positive uptrend based on the rapid growth, demand and success of aesthetic services in Malaysia."

According to the independent market report attached to DC Healthcare's prospectus, the Malaysian aesthetic medicine market was valued at RM468.8 million in 2022, up from RM366.3 million in 2021. It is projected to register a CAGR of 18.8% from 2021 to 2027 to RM1.03 billion.

The report noted that demand for aesthetic medical services stems from higher disposable income for Malaysians due to continued economic recovery, and a growing ageing population. These services are further supported by social media culture that has largely removed the stigma associated with aesthetic medical procedures.

M&A Securities Sdn Bhd, is the Principal Adviser, Sponsor, Underwriter and Placement Agent for the IPO exercise.

DC Healthcare Holdings Berhad: http://dchealthcareholdings.com/

Image
Ms. Sim Lee San, Independent Non-Executive Director, DC Healthcare Holdings Berhad
Datuk Dr. Mohd Noor Bin Awang, Independent Non-Executive Chairman, DC Healthcare Holdings Berhad
Dr. Chong Tze Sheng, Managing Director, DC Healthcare Holdings Berhad
Dr. Lai Ngan Chee, Executive Director, DC Healthcare Holdings Berhad
Ms. Rekha A/P Palanysamy, Independent Non-Executive Director, DC Healthcare Holdings Berhad
Ms. Yap Ee Ling, Independent Non-Executive Director, DC Healthcare Holdings Berhad [L-R]
( https://photos.acnnewswire.com/tr:n-650/20230717.DCHealthcare.jpg )

Copyright 2023 ACN Newswire. All rights reserved. http://www.acnnewswire.com

One More IPO of Legend Capital: Medical Device Supply Chain Service Provider GKHT Medical Goes Public Successfully

HONG KONG, Jul 14, 2023 – (ACN Newswire) – On July 12, Legend Capital's portfolio company, GKHT Medical Technology Co., Ltd. ("GKHT Medical"; Stock Code: 301370.SZ), was successfully listed on the ChiNext Market of the Shenzhen Stock Exchange.

GKHT Medical is a leading comprehensive digital supply chain service provider for medical devices in China. Focusing on the field of medical devices, the company specializes in providing customized supply chain solutions to manufacturing enterprises, distributors/dealers, and medical institutions based on its entire supply chain service-covered platform for every medical device product from original manufacturers to operating rooms.

Starting with high-value medical consumables, GKHT Medical has innovatively created a brand-new business model of the "one-stop distribution platform + hospital-end service platform", enabling the company to provide the industry with comprehensive digital supply chain services from original manufacturers to operating rooms through intensively integrating key elements such as funds, warehousing, logistics, and circulation process information.

As one of the company's earliest investors, Legend Capital participated in GKHT Medical's fundraising rounds in 2016 and 2019 and has kept helping enhance the company's management and operational capabilities and connect upstream and downstream customer resources since the investments. Over the seven years of investment cooperation, GKHT Medical's revenue has increased by more than 600%, and it has grown into a tier-one company in the field of high-value consumables for medical devices.

Joe ZHOU, Managing Director of Legend Capital, said: "GKHT Medical has an aspiring and dedicated team whose members have extensive experience in business operations and marketing and jointly drive pragmatic progress through the bonding of each other's talents. The high-value medical consumables market in China is worth over RMB100 billion, but most supply chain links, such as distribution, are still dominated by traditional agency models. The market is still open to be explored by disruptive innovators, and we believe that GKHT Medical will stand out in the future and continue to support innovation in the field of medical devices."

"It is believed that the listing will help GKHT Medical to further strengthen its cooperation with upstream and downstream partners, expand the coverage of its direct sales business to more terminal medical institutions, enhance operational funding, and improve its information systems and logistics warehousing system. With improved comprehensive service support capabilities and risk control capabilities, the company is well prepared to meet the changing needs of customers in different markets. At the same time, by deepening the links between the upstream and downstream of the industrial chain and expanding the supply chain business, GKHT Medical is capable of providing customers with digital supply chain services covering high-value consumables, low-value consumables, IVD, and equipment in the medical devices field. The company has established a channel of "manufacturers-GKHT Medical-hospitals" to continuously strengthen its core competitiveness as a comprehensive digital supply chain service provider for medical devices." Joe Zhou added.

At present, GKHT Medical has provided professional services for more than 100 leading original manufacturers of medical devices and more than 4,000 hospitals worldwide, and it has achieved high-quality and scale development with the capability of delivering to more than 80% of Chinese tertiary hospitals within 2 hours.

Legend Capital has long been paying attention to the investment in the field of medical devices and diagnostics with a focus on three major themes: first, major diseases, especially the unmet clinical needs of chronic diseases; second, the first and uniqueness in technology, which enables a company to become or have the potential to become a leading player in subdivided industries; the third is the "device +" investment opportunities brought by the integration of medical devices and interdisciplinary technologies such as AI, IoT and Big Data. At present, Legend Capital has invested in numerous leading companies in the subdivided industries, including GKHT Medical (301370.SZ), Careray Digital Medical Technology (688607.SH), Axonics (AXNX), New Horizon Health (06606.HK), Wuhan Easy Diagnosis Biomedicine (002932.SZ), Berry Genomics (000710.SZ), Aohua Photoelectricity Endoscope (688212.SH), Chemclin Diagnostics (688468.SH), Bio-heart Biological (02185.HK), STAR Sports Medicine, ET Healthcare, Hailai Xinchuang Medical Technology, and Dearer Medical.

Legend Capital has been actively investing in the healthcare industry since 2007 and has built a distinctive and valuable healthcare ecosystem. The company has created a powerful investment base on the strength of many pillar enterprises it invested in multiple subdivided healthcare industries. In response to changes in the external environment, Legend Capital has proposed a new "healthcare ecosystem +" strategy aiming at the new development pattern of the healthcare industry. By taking capital as the link and focusing on "innovation" and "ecosystems", Legend Capital intends to build a more extensive ecosystem that connects resources from various sectors, including the industry, academia, and society, to accelerate the transformation of R&D results, promote industrial upgrading, and achieve high-quality development.

About Legend Capital

Founded in 2001, Legend Capital is a leading VC&PE investor focusing on the early-stage and growth-stage opportunities in China, with offices across Beijing, Shanghai, Shenzhen, Hong Kong, and Seoul, Korea.

It currently manages USD and RMB funds of over US$10 billion in commitments, and has invested in around 600 companies, covering technology, healthcare, consumer, enterprise service and intelligent manufacturing sectors. Rooted in China, Legend Capital participated in the rise of many world-leading companies by solid investment coverage and systematic post-investment value-add. Over the years, Legend Capital has also become a widely recognized name in bridging key resources in China and overseas through cross-border activities, and a valuable partner to Chinese and overseas investors.

Legend Capital values long-term sustainable investment and incorporates ESG into its long-term development strategy. As a UNPRI signatory since November 2019, Legend Capital is among the first group of top VC/PE firms in China to join the initiative.

For more information, please visit www.legendcapital.com.cn/index_en.aspx and follow us on LinkedIn @Legend Capital ( https://www.linkedin.com/company/legend-capital ).

Copyright 2023 ACN Newswire. All rights reserved. http://www.acnnewswire.com

Veteran Healthcare Communicator Lea Sims Appointed to Lead CGFNS Marketing and Communications

PHILADELPHIA, PA, Jul 11, 2023 – (ACN Newswire) – CGFNS International announced today that it has appointed Lea Sims, a veteran executive who has held both private and public sector marketing leadership roles, as its Chief Marketing and Communications Officer. Sims will join the CGFNS senior leadership team and play an integral role in driving the organization's brand transformation strategy.

Lea Sims, Chief Marketing and Communications Officer, CGFNS International

Sims has 35 years' experience in healthcare, most recently as the Global Marketing Lead for Verizon's healthcare and life sciences practice, where she also led vertical marketing for Verizon Business Group. Prior to that, she served as Director of Professional Practices for the Association for Healthcare Documentation Integrity, a role that required strategic oversight of the association's marketing, communications, print and digital publications, professional credentialing, government affairs, and advocacy programs. An early career in clinical roles within health systems – including 15 years in healthcare documentation – led to teaching, writing, and ultimately marketing and communications for allied health professions and health technology.

"With her deep experience at the intersection of healthcare, technology and workforce development, Lea Sims is uniquely qualified to help lead CGFNS into a new era of boosting global mobility for health workers worldwide," said Dr. Peter Preziosi, the organization's President and CEO. "She will play an outsized role in promoting key innovations in global competency-based digital credentials, career development and redesigned care delivery models on a global scale."

"I'm thrilled to be joining CGFNS at such an important inflection point in its notable history and at an equally critical time in the evolution of nursing and allied health careers globally," said Sims. "Decentralization of care, clinician shortage and burnout, care model evolution, and the accelerated adoption of technologies like artificial intelligence (AI) are transforming the landscape of care and shifting the training and scope of practice of clinical teams. There's never been a more important moment in time for this organization to advocate for streamlined credentialing and career mobility for this essential workforce. And I look forward to helping CGFNS tell its story."

About CGFNS International, Inc.

Founded in 1977 and based in Philadelphia, CGFNS International is an immigration-neutral not-for-profit organization proudly serving as the world's largest credentials evaluation organization for the nursing and allied health professions. CGFNS International is an NGO in Consultative Status with the United Nations Economic and Social Council (ECOSOC) and is a member of the Conference of NGOs in Consultative Relationship with the United Nations (CoNGO). For more information, visit https://www.cgfns.org.

Contact Information
Mukul Bakhshi, Esq.
Chief of Strategy and Government Affairs
mbakhshi@cgfns.org
(215) 243-5825

Copyright 2023 ACN Newswire. All rights reserved. http://www.acnnewswire.com

Avantor Inaugurates Expanded Singapore Hub

One-Stop Facility with cGMP Manufacturing to Bolster AMEA’s Biopharma Industry

SINGAPORE, July 11, 2023 – (ACN Newswire) – Avantor, Inc. (NYSE: AVTR), a leading global provider of mission-critical products and services to customers in the life sciences, advanced technologies, and applied materials industries, today inaugurated its expanded Singapore Hub which includes newly added cGMP manufacturing and a world class quality control laboratory. The hub is a one-stop facility serving the needs of customers across Asia, Middle East, and Africa (AMEA), strengthening the region’s innovation and biopharma ecosystems.

Avantor today officially inaugurated its expanded Singapore Manufacturing & Distribution Hub. Standing from left to right: Christophe Couturier (EVP, Asia Middle East Africa, Avantor), Elaine Teo (SVP & Head, Investment Facilitation, Singapore EDB) and Narayana Rao Rapolu (VP, Biopharma, Asia Middle East Africa, Avantor).

*Avantor’s expanded Singapore Hub to bolster Asia Pacific’s Biopharma ecosystem with enhanced manufacturing and distribution.*

Strategically located in Singapore, the hub enables quicker turnaround times and expedites customers’ access to raw materials that are essential in AMEA’s drug discovery and development whilst upholding stringent quality standards.

“At Avantor, we recognize the growing complexities around customer requirements and regulatory standards across AMEA’s biopharma industry,” said Christophe Couturier, Executive Vice President, AMEA. “By enhancing our regional capabilities through the launch of our Singapore Manufacturing and Distribution Hub, we tap into our legacy of serving the evolving needs of customers, demonstrating our commitment to advancing life-changing science.”

The inauguration ceremony today was officiated by Avantor executives, Christophe Couturier, and Narayana Rao, Vice President, Biopharma – AMEA, and the Singapore Economic Development Board (EDB), represented by Elaine Teo, Senior Vice President and Head, Investment Facilitation at EDB.

“Avantor’s latest expansion of its Singapore hub enhances the supply of key materials and services required by biopharma manufacturers in Singapore and the region. This strengthens supply chain resilience for businesses and enhances the competitiveness of Singapore’s biomedical sciences industry, an integral part of Singapore’s manufacturing sector. Avantor’s successive investments in Singapore demonstrate confidence in our manufacturing and supply chain capabilities. These expansions are in line with EDB’s commitment to work with businesses to deepen their footprint and create new job opportunities in Singapore,” said Elaine Teo, Senior Vice President, EDB.

Building onto Avantor’s 2022 investment, the integration of the current distribution hub with new manufacturing operations features cGMP suites, quality testing, warehousing of certified products, batch-to-batch traceability and customized palletization capabilities. These state-of-the-art facilities allow the hub to drive innovation and efficiency to address the immediate challenges in AMEA’s biopharma industry.

About Avantor

Avantor^®, a Fortune 500 company, is a leading global provider of mission-critical products and services to customers in the biopharma, healthcare, education & government, and advanced technologies & applied materials industries. Our portfolio is used in virtually every stage of the most important research, development and production activities in the industries we serve. Our global footprint enables us to serve more than 300,000 customer locations and gives us extensive access to research laboratories and scientists in more than 180 countries. We set science in motion to create a better world. For more information, visit avantorsciences.com and find us on LinkedIn, Twitter and Facebook.

Regional Media Contact
Christina Koh
Director – Communications AMEA
Avantor
65-9720 0169
Christina.Koh@avantorsciences.com

Q&M Free Dental Clinic launched to provide free essential dental treatments for underprivileged individuals and families

SINGAPORE, Jul 10, 2023 – (ACN Newswire) – Q&M Free Dental Clinic Limited, a registered charity under the Commission of Charities, has opened its first Q&M Free Dental Clinic in Chai Chee dedicated to delivering essential dental treatment for underprivileged individuals and families in need.

Dr Ng Chin Siau, Group CEO of Q&M Dental Group, Mr Ong Ye Kung, Minister for Health, Mr Tan Chuan
Jin, Speaker of Parliament, Dr Mohanarajah, Chairman of Q&M Free Dental Clinic Limited [L-R]

The opening ceremony at 26 Chai Chee Rd was witnessed by Guest-of-Honour Ong Ye Kung, Minister for Health; and Tan Chuan-Jin, Speaker of Parliament, and Adviser to Marine Parade GRC Grassroots Organisations (Kembangan-Chai Chee).

In its first phase of operations, the free clinic will be staffed by more than 50 volunteer dentists from Q&M Dental Group, on a rotational basis and is expected to serve up to 1,400 patients each year. Eligible patients will be initially referred by grassroots organisations within Kembangan-Chai Chee Division and will receive free dental consultation and treatments that are essential to oral health, such as scaling and polishing, fillings, and extractions.

Mr Tan Chuan-Jin, Speaker of Parliament, and Adviser to Marine Parade GRC Grassroots Organisations (Kembangan-Chai Chee), said, "In Kembangan-Chai Chee, preventive healthcare has been an essential pillar of our social initiatives, besides food security and education. While we have made inroads with health screening, vaccinations, and general health management, we realise that oral health has often been overlooked, especially for our underprivileged residents.

"Hence, the idea of a free dental clinic was mooted over lunch with Dr Ng and I in August 2021 and we are grateful to have Q&M Dental Group partnering with us in this meaningful journey. This initiative is also timely as it fits perfectly into our nationwide Preventive Healthcare Program – Healthier SG," he added.

Dr Ng Chin Siau, Group CEO of Q&M Dental Group said, "With the continued support of our generous donors and volunteer staff, we aim to ramp up the current capacity to serve up to 5,000 patients per year in the free clinic's next phase of operations, in line with our goal to make dental care accessible to all."

Q&M Dental Group led the fundraising efforts to fully equip and set up the free dental clinic, donating S$500,000 to fund the initial costs of renovations and equipment. In total, close to S$1 million was raised together with the support of other key donors including Quan Min Holdings, Straumann, Belmont, Prof Hwang Yee Cheau, Madam Kong Siew Yin, Ng Kok Mee, Navi Corporate Advisory Pte Ltd and Dr Ng Chin Siau, in his personal capacity.

"The generosity of our donors will make a lasting impact on the lives of the underprivileged, providing essential dental care for them and creating a healthier community overall. We look forward to collaborating with other stakeholders to reach out to more patients in need and galvanise the medical community to contribute their expertise and resources to ensure everyone has access to essential healthcare services," added Dr Ng.

Dr Mohanarajah s/o S. Senathirajah, Chairman of Q&M Free Dental Clinic Limited, said, "We are really excited to launch the Q&M Free Dental Clinic knowing that we will make a meaningful contribution in the lives of the underprivileged amongst us. This initiative marks the latest milestone in our longstanding commitment in giving back to society, and what better way than to contribute our professional expertise in a sustained manner to help those in need."

Q&M Dental Group was recently awarded The President's Certificate of Commendation (COVID-19) for its contributions during the pandemic which include Q&M Dental Group volunteers, comprising of dentists and nurses administering swabbing procedures to migrant workers at factory-converted dormitories and government quarantine facilities, donating 200,000 medical grade surgical masks to 51 migrant worker dormitories and setting-up satellite Covid-19 testing facilities throughout its island-wide clinic network.

Q&M Free Dental Clinic
To donate and find out more, please visit: www.qmfdc.sg

Media contacts:
Q&M Dental Group
Jess Chang, jess@qnm.sg, +65 8388 6240
Lloyd Chan, lloydchan@qnm.sg, +65 9385 5702

Waterbrooks Consultants
Wayne Koo, wayne.koo@waterbrooks.com.sg, +65 9338 8166
Elliot Siow, elliot@waterbrooks.com.sg, +65 8375 0417

Copyright 2023 ACN Newswire. All rights reserved. http://www.acnnewswire.com

Moderna Announces Global Regulatory Submissions for Its Respiratory Syncytial Virus (RSV) Vaccine, MRNA-1345

Cambridge, MA, Jul 5, 2023 – (ACN Newswire) – Moderna, Inc. (Nasdaq:MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today provided an update on regulatory submissions for mRNA-1345, a vaccine for the prevention of RSV-associated lower respiratory tract disease (RSV-LRTD) and acute respiratory disease (ARD) in adults aged 60 years or older.

The Company has submitted marketing authorization applications for mRNA-1345 with the European Medicines Agency (EMA), Swissmedic in Switzerland, and the Therapeutic Goods Administration (TGA) in Australia and has initiated the rolling submission process for a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for the licensure of the mRNA-based RSV vaccine.

"We are proud to announce these filings for the use of our RSV vaccine candidate, mRNA-1345, in the European Union, Switzerland, Australia, and the U.S. RSV is a major cause of lower respiratory tract infections in older adults and can cause a significant burden to health systems through hospitalizations and emergency care admissions," said Stephane Bancel, Chief Executive Officer of Moderna. "Our mRNA platform has allowed us to move from initial clinical testing to our first international Phase 3 trial to initiation of regulatory submissions for mRNA-1345 in just two years, enabling us to tackle this pervasive public health burden with speed and clinical rigor. mRNA-1345 represents the second product coming from our mRNA platform to seek global approval, and with recent positive data in rare disease and cancer, we expect more in the future – further demonstrating the tremendous potential of mRNA to combat disease."

The regulatory applications are based on positive data from a prespecified interim analysis of the pivotal ConquerRSV study, a randomized, double-blind, placebo-controlled study of approximately 37,000 adults 60 years or older in 22 countries. The primary efficacy endpoints were based on two definitions of RSV-LRTD, defined as either two or more symptoms or three or more symptoms of disease. The trial met both its primary efficacy endpoints, with a vaccine efficacy (VE) of 83.7% (95.88% CI: 66.1%, 92.2%; p<0.0001) against RSV-LRTD as defined by two or more symptoms, and a VE of 82.4% (96.36% CI: 34.8%, 95.3%; p=0.0078) against RSV-LRTD defined by three or more symptoms. The vaccine was well tolerated with a favorable safety profile. Most solicited adverse reactions were mild or moderate, and the most commonly reported solicited adverse reactions in the mRNA-1345 group were injection site pain, fatigue, headache, myalgia, and arthralgia. The ConquerRSV study is ongoing, and additional efficacy analyses are planned as cases accrue, including for severe RSV. In addition to older adults, mRNA-1345 is being investigated in a fully enrolled, ongoing Phase 1 trial in pediatric populations.

In January 2023, the U.S. FDA granted mRNA-1345 Breakthrough Therapy Designation for the prevention of RSV-LRTD in adults aged 60 years or older, and mRNA-1345 was previously granted Fast Track designation by the U.S. FDA in August 2021. In Australia, the TGA submission will be evaluated under the Priority Pathway, following approval of the Priority Determination application for mRNA-1345 in April 2023.

Moderna's respiratory disease vaccine pipeline includes Phase 3 trials against influenza and a next-generation COVID-19 candidate. The pipeline also includes four additional influenza vaccines with expanded antigens, vaccines against other respiratory pathogens, and five combination vaccine programs.

About mRNA-1345

mRNA-1345 is an investigational RSV vaccine that consists of a single mRNA sequence encoding for a stabilized prefusion F glycoprotein. The vaccine uses the same lipid nanoparticles (LNPs) as in the Moderna COVID-19 vaccines. The F glycoprotein is on the surface of the virus and is required for infection by helping the virus to enter host cells. It exists in two states, prefusion and postfusion. The prefusion conformation is a significant target of potent neutralizing antibodies, and the protein sequences are largely similar across both RSV-A and RSV-B subtypes.

About Moderna

In over 10 years since its inception, Moderna has transformed from a research-stage company advancing programs in the field of messenger RNA (mRNA), to an enterprise with a diverse clinical portfolio of vaccines and therapeutics across seven modalities, a broad intellectual property portfolio and integrated manufacturing facilities that allow for rapid clinical and commercial production at scale. Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both groundbreaking science and rapid scaling of manufacturing. Most recently, Moderna's capabilities have come together to allow the authorized use and approval of one of the earliest and most effective vaccines against the COVID-19 pandemic.

Moderna's mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases, and auto-immune diseases. Moderna has been named a top biopharmaceutical employer by Science for the past eight years. To learn more, visit www.modernatx.com.

Moderna Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including regarding: the regulatory process with respect to mRNA-1345, including the potential for regulatory approval; Moderna's plans for further regulatory submissions for mRNA-1345 worldwide; the efficacy and safety and tolerability profile of mRNA-1345; the ongoing ConquerRSV study; and Moderna's expectations regarding future potential products, including in the areas of rare disease and cancer. The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond Moderna's control and which could cause actual results to differ materially from those expressed or implied by these forward-looking statements. These risks, uncertainties, and other factors include those other risks and uncertainties described under the heading "Risk Factors" in Moderna's Annual Report on Form 10-K for the fiscal year ended December 31, 2022, filed with the U.S. Securities and Exchange Commission (SEC) and in subsequent filings made by Moderna with the SEC, which are available on the SEC's website at www.sec.gov. Except as required by law, Moderna disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments, or otherwise. These forward-looking statements are based on Moderna's current expectations and speak only as of the date of this press release.

Moderna Contacts

Media:
Luke Mircea-Willats
Senior Director, International Communications
Luke.mirceawillats@modernatx.com

Investors:
Lavina Talukdar
Senior Vice President & Head of Investor Relations
617-209-5834
Lavina.Talukdar@modernatx.com

Copyright 2023 ACN Newswire. All rights reserved. http://www.acnnewswire.com