iTolerance, Inc. and Northway Biotech Announce Partnership Agreement for Manufacturing of Streptavidin-FasL Fusion Protein for Innovative iTOL-100 Immunomodulatory Technology

MIAMI, FL & VILNIUS, LITHUANIA, Aug 1, 2023 – (ACN Newswire) – iTolerance, Inc. ("iTolerance" or the "Company"), an early-stage regenerative medicine company developing technologies to enable tissue, organoid or cell therapy without the need for life-long immunosuppression, and Northway Biotech, an end-to-end biologics Contract Development and Manufacturing Organization (CDMO), today announced they have entered into a partnership agreement for the manufacturing of iTolerance's Streptavidin-FasL (SA-FasL) fusion protein, a crucial component of the proprietary iTOL-100 platform technology. The SA-FasL fusion protein has shown great potential in pre-clinical studies, establishing durable, localized immune tolerance and enabling implanted tissue, organoid, or cell therapy to function as a viable replacement for damaged native cells.

Under the terms of the agreement, Northway Biotech will leverage its expertise to develop a robust manufacturing process for the SA-FasL fusion protein. This involves producing a Master Cell Bank (MCB), developing and qualifying analytical methods, optimizing the formulation, development and scaling up of the production process, and manufacturing a cGMP drug substance batch for clinical studies.

"We believe this strategic partnership is not only a significant step for iTolerance, but also in developing advanced regenerative medicine technologies. We are incredibly delighted to establish this important partnership with Northway Biotech, a pre-eminent CDMO, to manufacture the clinical supplies necessary for our first in human clinical study for our lead program, iTOL-102," commented Dr. Anthony Japour, Chief Executive Officer of iTolerance. "We look forward to working closely with the Northway Biotech team to advance our iTOL-100 technology and progress towards providing treatment options that have the potential to cure diseases without the need for chronic immunosuppression."

"We are excited to be working with Northway Biotech on this critical component of our iTOL-100 technology. Northway has unique experience working with our cell line which we believe will accelerate our ability to prepare cGMP protein to support our planned first in human clinical study," added Dennis M. Hester, PhD, SVP of Chemistry, Manufacturing and Controls at iTolerance, Inc.

Prof. Vladas Algirdas Bumelis, Chief Executive Officer and Chairman of the Board at Northway Biotech expressed his enthusiasm, stating, "We are delighted to embark on this dynamic project focused on producing the SA-FasL fusion protein for iTolerance. We believe this partnership is an exciting development in the regenerative medicine field, and we are honored to play a role in advancing this important work. With a commitment to meeting contractual timelines, our primary objective is to ensure the punctual delivery of these crucial materials to our esteemed partners at iTolerance."

Andre Markmann, PhD, VP of Business Development at Northway Biotech, added, "The partnership with iTolerance has been smooth sailing from the start. We are pleased to commence this project built on mutual trust and a collaborative spirit that drives both companies to perform at the highest level and deliver exceptional results."

About iTOL-100

iTolerance's iTOL-100 immunomodulatory technology is a biotechnology-derived Streptavidin-FasL fusion protein, a synthetic form of the naturally occurring protein FasL, mixed with a biotin-PEG microgel (SA-FasL microgel) that potentially allows convenient and effective co-administration with implanted cells or organoids to induce local immune tolerance without the need for life-long immunosuppression. This proprietary technology has broad applicability and can be applied to allogenic and stem cell-derived organoids across several diseases.

About iTolerance, Inc

iTolerance is an early-stage privately-held regenerative medicine company developing technologies to enable tissue, organoid or cell therapy without requiring life-long immunosuppression. Leveraging its proprietary biotechnology-derived Streptavidin-FasL fusion protein/biotin-PEG microgel (SA-FasL microgel) platform technology, iTOL-100, iTolerance is advancing a pipeline of programs using both allogenic pancreatic islets and stem cells that have the potential to cure diseases. The Company's lead program, iTOL-102, leverages significant advancements in stem cells to derive pancreatic islets, which allows an inexhaustible supply of insulin-producing cells. Utilizing iTOL-100 to induce local immune tolerance, iTOL-102 has the potential to be a cure for Type 1 Diabetes without the need for life-long immunosuppression. Additionally, the Company is developing iTOL-201 for treating liver failure by utilizing hepatocytes and iTOL-401 as a nanoparticle formulation for large organ transplants without the need for life-long immunosuppression. For more information, please visit www.itolerance.com.

About Northway Biotech

Northway Biotech is a leading contract development and manufacturing organization (CDMO) supporting customers worldwide. Its highly experienced, professional team executes projects at any stage, from cell line construction and process development to cGMP manufacturing of biopharmaceutical products. The company's wide-ranging expertise and vertically integrated service offering translate to the ability to rapidly execute multiple projects from its state-of-the-art GMP facilities while ensuring complete process and product compliance at all stages of research, development and commercial manufacturing. Northway Biotech is a privately owned company founded in 2004 and located in Vilnius, Lithuania, London, United Kingdom, and Waltham, MA, US. Further information can be found on Northway's website at www.northwaybiotech.com.

Forward-Looking Statements

This press release contains "forward-looking statements" within the meaning of the "safe-harbor" provisions of the Private Securities Litigation Reform Act of 1995. When used herein, words such as "anticipate", "being", "will", "plan", "may", "continue", and similar expressions are intended to identify forward-looking statements. In addition, any statements or information that refer to expectations, beliefs, plans, projections, objectives, performance or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking.

All forward-looking statements are based upon iTolerance's current expectations and various assumptions. The Company believes there is a reasonable basis for its expectations and beliefs, but they are inherently uncertain. The Company may not realize its expectations, and its beliefs may not prove correct. Actual results could differ materially from those described or implied by such forward-looking statements as a result of various important factors, including, without limitation, anticipated levels of revenues, future national or regional economic and competitive conditions, and difficulties in developing the Company's platform technology. Consequently, forward-looking statements should be regarded solely as the Company's current plans, estimates and beliefs. Investors should not place undue reliance on forward-looking statements. The Company cannot guarantee future results, events, levels of activity, performance or achievements. The Company does not undertake and specifically declines any obligation to update, republish, or revise any forward-looking statements to reflect new information, future events or circumstances or to reflect the occurrences of unanticipated events, except as may be required by law.

Northway Biotech Contacts:
Vladas Algirdas Bumelis
CEO and Chairman of the Board
vladas.bumelis@northwaybiotech.com

iTolerance Contacts:
Investor Contact
Jenene Thomas
Chief Executive Officer
JTC Team, LLC
T: 833.475.8247
iTolerance@jtcir.com

Media Contact
Susan Roberts
T: 202.779.0929
sr@roberts-communications.com

Contact Information:
Vladas Bumelis
CEO and Chairman of the Board
vladas.bumelis@northwaybiotech.com

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

China Medical System Once Again Received MSCI-ESG ‘AA’ Rating, Leading the Industry in ESG Management

SHENZHEN, CHINA, Jul 31, 2023 – (ACN Newswire) – Recently, MSCI (Morgan Stanley Capital International), the world's largest index company, announced the latest Environmental, Social, and Governance (ESG) evaluation report for China Medical System Holdings limited ("CMS" or the "Group"), who achieved an "AA" rating and surpassed 75% of global peers with leading ESG management practices.

MSCI is one of the most widely used, influential, and referenced rating companies in the global market. Based on a scientifically rigorous evaluation system, it evaluates companies' risk control performance and sustainable development potential comprehensively from various aspects such as environment, human capital, health accessibility, product safety and quality, and corporate governance. MSCI-ESG rating results have been regarded by global investors as an important non-financial basis for investment decision-making. Being back to the "AA" rating, reflects the full recognition of the Group's ESG management practices by the international authoritative rating company.

The Group deeply integrates the concept of sustainable development into its operations with a development perspective, continuously improves its internal governance under the guidance of its ESG strategy, and actively assumes its responsibilities as a corporate citizen. Based on years of continuous investment in sustainable development, CMS's ESG management has been widely recognized: over the past three years, the Group's MSCI-ESG rating has maintained an "A" or "AA; its S&P Global ESG score surpassed 92% of the global peers with a score of 53, and successfully stood out from approximately 1,600 Chinese companies to be included in the first "Sustainability Yearbook (China)" of S&P Global.

In the future, CMS will always keep in mind its mission of being a responsible citizen, and work together with its stakeholders to promote healthy, harmonious, and sustainable development of the industry, society, and environment.

About CMS:

CMS (0867.HK) is a platform company linking pharmaceutical innovation and commercialization with strong product lifecycle management capability, dedicated to providing competitive products and services to meet unmet healthcare needs.

CMS focuses on developing first- or best-in-class innovative products and has made the layout of 30 differentiated pipeline products with strong market potential. CMS deeply engages in specialty therapeutic fields, and has developed proven commercialization capabilities, extensive networks and expert resources, resulting in leading academic and market positions for its major marketed products. CMS continues to strengthen the competitiveness of its cardio-cerebrovascular/gastroenterology business, and independently operated dermatology and medical aesthetic business, and ophthalmology business, whilst enhancing the scale and efficiency. CMS also entered into the Southeast Asian market to create new opportunities to further enhance the sustainable development of the Group.

Media Contact
Brand: China Medical System Holdings Ltd.
Contact: CMS Investor Relations
Email: ir@cms.net.cn
Website: https://web.cms.net.cn/en/home/

Source: China Medical System Holdings Ltd.

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

Exploring New Collaborative Opportunities! The Indonesia-China Healthcare and Biotech Investment Forum Successfully Held

HONG KONG, Jul 31, 2023 – (ACN Newswire) – On 27 July 2023, on the eve of the highly anticipated Chengdu FISU World University Games, the Minister of Health Indonesia Budi Gunadi Sadikin accompanied Indonesian President Joko Widodo on a visit to China. The Indonesia-China Healthcare and Biotech Investment Forum, co-hosted by the Embassy of the Republic of Indonesia in China and the Indonesian Chamber of Commerce and Industry Bilateral Committee for China (KIKT), and supported by Legend Capital and Indonesia Chamber of Commerce in China (INACHAM), was successfully held at the Shangri-La Hotel in Chengdu. A total of 120 people, including Indonesian government officials, scholars, business people and leading Chinese healthcare companies, attended the event to jointly discuss the direction and opportunities for the development of healthcare and biotech in China and Indonesia.

Jafar WANG, Co-Chief Investment Officer of Legend Capital

Frank HONG, Managing Director of Legend Capital

The forum was chaired by Mr. Jafar WANG, Co-Chief Investment Officer of Legend Capital, who mentioned Legend Capital's latest "Ecosystem plus" strategy in healthcare, and hoped to collaborate with the excellent healthcare enterprises in China and Indonesia to build an open, innovative, and international ecosystem through this forum. Mr. Garibaldi Thohir, Chairman of Indonesia Chamber of Commerce and Industry Bilateral Committee of China (KIKT), Mr. H.E. Djauhari Oratmangun, Indonesian Ambassador to the People's Republic of China, and Mr. Arsjad Rasjid, Chairman of Indonesia Chamber of Commerce and Industry (KADIN), each delivered opening speeches for the forum. They warmly welcomed Chinese healthcare companies investing and developing in Indonesia, combining innovative technologies, advanced concepts, and China's experience with Indonesia's national conditions, to promote the development of Indonesian healthcare and medical services.

The Minister of Health Indonesia, Budi Gunadi Sadikin, delivered a keynote speech on "Healthcare Policy and Planning in Indonesia". The speech systematically sorted out and discussed the overall health system in Indonesia from various perspectives, such as the current situation of Indonesian healthcare, the number and capabilities of medical personnel, the distribution of medical resources, and the coverage of universal health insurance. He indicated that the Indonesian healthcare system urgently needs to transform and develop, hoping to promote the transformation and upgrading of the healthcare system through the establishment of a nationwide disease prevention and control monitoring network, improving the level of primary healthcare services in Indonesia, training medical professionals and medical staffs, making rational use of funds from all parties, as well as cooperating deeply with Chinese companies through national projects. At last, He warmly welcomed Chinese companies to invest and develop in Indonesia and explore new opportunities and potentials for the development of the healthcare industry in both countries.

Mr. Frank HONG, Managing Director of Legend Capital, then delivered a speech on "Trends in Investment and Industrial Cooperation in Indonesia", sharing Legend Capital's investment strategies and choice of approaches in Southeast Asia, especially in Indonesia. He also elaborated on the current situation and upgrade demands of the Indonesian healthcare industry and suggested that excellent Chinese healthcare companies go abroad, increase investment in Indonesia and create more value for the two countries.

Subsequently, under the witness of the Minister of Health Indonesia and relevant government officials, the Ministry of Health Indonesia and Tsinghua University signed a strategic cooperation agreement. At the same time, a signing ceremony was also held between Chinese and Indonesian companies, whereby Chinese companies, including Sansure Biotech, Walvax Biotech, CanSino Bio, BGI, Sinovac Biotech, Zhifei Biological, and Wondfo Biotech, together with Indonesian companies such as UBC Medical, ETANA, Kalbe Farma, BioFarma, and Kimia Farma, reached partnership agreements, jointly supporting the coordinated development of the healthcare fields in China and Indonesia.

Mr. LI Ning, Vice President of BGI Group, gave a speech on "Trends in Life Science Technology", stating that BGI Group hopes to lead the innovative development of genomics with the integrated development model of "industry, university, and R&D", promote the transformation of gene technology achievements, and realize the benefits of gene technology to humankind.

During the panel discussion, Mr. Bonanza Perwira, Director of Centre for Global Health and Technology Policy of the Indonesian Ministry of Health, chaired a discussion on the "Prospects for Industrial Cooperation between China and Indonesia", which the Minister of Health Indonesia Mr. Budi Gunadi Sadikin, Director General of Pharmaceuticals and Medical Devices of the Indonesian Ministry of Health Ms. Lucia Rizka Andalucia, Chairman of Indonesia Chamber of Commerce and Industry Mr. Arsjad Rasjid, Kimia Farma's President Director Mr. David Utama, and Kalbe Farma's President Mr. Vidjongtius participated in and responded to questions raised by the audience regarding Indonesian healthcare policies, Indonesian health insurance payment methods, foreign company access and commercialization, and partner selection, and expressed a warm welcome to more open cooperation with Chinese companies.

Subsequently, Mr. QI Fei, Executive Director of Legend Capital, presided over the panel discussion of "Attempts for Chinese Company Collaborating in Indonesia", which Mr. DAI Lizhong, Chairman and Founder of Sansure Biotech, Mr. WU Xiaobin, President and Chief Operations Officer of BeiGene, Mr. DONG Shaozhong, Vice President of Walvax Biotech, Ms. WANG Jing, Chief Commercial Officer and Executive Director of CanSino Bio, Mr. XIA Jusong, President of International Business at United Imaging Healthcare, and Mr. CHEN Kai, Executive Director of AstraZeneca China participated in and shared and discussed topics such as the trend of China-Indonesia cooperation, development opportunities in Indonesia, practical experience of entering the Indonesian market, and cooperation models between the two countries. It is hoped that Chinese healthcare enterprises can carry out broader and deeper cooperation with more countries to benefit more people around the world.

2023 is the 10th anniversary of the establishment of the China-Indonesia Comprehensive Strategic Partnership and is also a year of opportunities for both countries. With the joint efforts of both sides, it is believed that the collaborative development of China-Indonesia in healthcare fields will undoubtedly contribute to the building of a community with a shared future for human health.

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

LAC FullCal and LAC Joint Protec: Stronger Bones and Healthier Joints for Pregnant/Postpartum Mothers

SINGAPORE, Jul 31, 2023 – (ACN Newswire) – Gazing at the pregnancy test kit, as the faint double-lines slowly appear, can be an emotional rollercoaster of happiness and trepidation. Pregnancy is a beautiful journey, but it also comes with its fair share of physical challenges, especially within the joints and bones, as the body adjusts itself to accommodate a new life growing within.

As pregnancy progresses, development of symptoms like the Pelvic Girdle Pain often becomes a constant companion, causing nagging pain in the back and hips, ranging from mild ache to severe limitations in daily activities, no thanks to the influx of the relaxin hormone within the body, along with the extra weight that a pregnant mother carries.

The developing fetus also requires a considerable amount of calcium to form bones and teeth, and with a deficiency in the mother's calcium metabolism, the baby will draw what it needs from the mother's bones, leading to sudden drops in bone density and an increased risk of fractures even without falling.

To reduce the painful and potentially lasting effects of pregnancy, it is important for women to consume a balanced diet rich in calcium, vitamin D, and other nutrients that support bone health, which brings us to the latest developments by LAC – LAC FullCal and LAC Joint Protec to help optimise musculoskeletal health.

The LAC FullCal and LAC Joint Protec are perfect forms of supplements to add to a new mother's daily diet. With a gold standard 2:1 calcium to magnesium ratio for optimal calcium absorption and metabolism, LAC FullCal is also enriched with other beneficial co-nutrients like fish collagen, and Vit C & E to support joint health, making it an all-rounded calcium supplement.

Alongside LAC FullCal, LAC Joint Protec is a complementary supplement to help boost joint health, and alleviate the symptoms brought about by joint weakness. Consisting of key ingredients like glucosamine, chondroitin and collagen to promote cartilage repair, Joint Protec minimises friction between the joints for increased mobility. Enhanced with a blend of other beneficial ingredients, such as the cat's claw, bromelain, and calcium lactate to ease joint discomfort and strengthen joints.

LAC FullCal and Joint Protec not only benefit a mother's bone and joint health but also support the healthy growth and development of the growing baby. These supplements aid in preventing bone loss, reducing inflammation, and improving joint function and mobility, leading to relief from joint pain and restricted movements in mothers.

About LAC Global

Headquartered in Singapore, LAC Global is one of Asia's largest speciality retailers in nutritional supplements, vitamins, minerals, herbal, and other speciality supplements in Anti-ageing and Beauty, Immunity, Weight Management, Sports Nutrition, and Energy.

The Company owns the LAC brand, short for Leader in Antioxidative Control(TM), a leading health and wellness supplement brand with a global presence. Since its founding, LAC has embarked on a pioneering journey to develop scientifically based formulas, harnessing the best of eastern wisdom and western technology to fight free radicals, combat ageing brought forth by oxidative stress, and support you daily in looking, feeling, and functioning at your best. Having established a global presence since 1997, LAC's reach includes Singapore, Malaysia, Taiwan, Philippines, China, Japan, Vietnam, Myanmar, USA, Central & South Americas, and the Middle East. Currently, there are more than 220 LAC branded stores in Singapore, Malaysia, Philippines and Taiwan ROC. LAC stringently sources ingredients from around the globe, such as USA, Japan, France, Australia, New Zealand and Switzerland to ensure utmost quality, and works only with the most specialised partners in developing and manufacturing health solutions.

Its other brands include Xndo Food For Health. LAC Global is dedicated to ensuring consumers stay well, and live life to the fullest.

Website: LAC.sg
Instagram: @LACGlobalSingapore
Facebook: @LACGlobalSingapore

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

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

OSIM Unveils South Korean Actor Hyun Bin as Ambassador for Next Generation uDream Pro Well-Being Chair

MALAYSIA, Jul 24, 2023 – (ACN Newswire) – OSIM, the leading innovator of Wellness Tech products and solutions, has unveiled South Korean actor Hyun Bin as its ambassador for the next generation flagship product – the uDream Pro well-being chair. Imbued with the latest Wellness Tech innovations and designed as a sophisticated style statement, the next generation uDream Pro is the latest articulation of OSIM's best in class well-being solutions.

OSIM solutions span the health, fitness, beauty and gaming sectors and are all designed to enable customers to feel good, stress less, sleep better and live heathier and happier lives. The acclaimed actor is partnering OSIM as the company continues to expand its ecosystem of Wellness Tech solutions.

Ms Chia Sook Fun, General Manager of OSIM Malaysia said, "We are delighted to welcome Hyun Bin as our ambassador. His dedication to his craft and commitment to excellence resonate strongly with our mission to inspire and improve the world's well-being."

OSIM has sought out and partnered with like-minded global brand partners and artistes based on shared values such as innovation and creative excellence – exemplified by this latest partnership with Hyun Bin.

Hyun Bin said, "A perfect day to me is one that strikes a good balance between work and rest. With OSIM's uDream Pro, I am able to enjoy personalized massage techniques with a single touch through artificial intelligence (AI) analysis and relax while stabilizing the various senses of my body with the '5-Senses Experience'. It is a technology that provides suitable management for the condition of each day and helps to lead a healthy daily life."

Focus On Continuing Innovation for The Next Generation Well-being Chair

In its ongoing mission to introduce new innovations to consumers around the world, OSIM has pioneered the use of leading-edge Wellness Tech in its ecosystem of solutions. This move has successfully elevated the traditional massage chair to a new standard in well-being chairs.

Better than a massage chair, the uDream Pro is the world's first well-being chair to incorporate AI in the measuring, monitoring, and managing of stress and fatigue for users. It also features an industry-first innovation designed to enhance an immersive stress relief experience. With just one touch of a button, users are transported to one of three different paradise experiences – Aurora Night, Sunset Beach or Nature Bliss. Senses are awakened through guided massage programs synchronized with relaxing imagery, soothing voice guidance, enchanting music and mood-enhancing ambient lighting. Users can also opt to engage their olfactory sense by using the DreamScent Aroma Pods to complete the five-senses stress relief experience.

Seamlessly weaving OSIM's latest innovations such as AI features with elegantly executed design motifs inspired by nature, the uDream Pro is artfully created with technology and design excellence. It is also integrated with the OSIM Well-Being App to provide users with a total well-being experience that can be measured, monitored and managed in the comfort of their homes.

OSIM Wellness Tech Deploys AI to Deliver Truly Customised De-Stress Programmes

With 14 patented features that combine to create a unique OSIM stress relief experience that cannot be replicated, the uDream Pro harnesses best-in-class technology from OSIM's own R&D labs to address the harmful effects of long-term stress on the human body.

Collaborating with internationally renowned professionals such as cardiothoracic surgeon Dr Thomas Burdon from Stanford University and Japanese chiropractic massage expert Sato Tsuyoshi-san, the uDream Pro uses electrocardiogram technology to accurately measure stress signals of the body, as well as deploys AI-powered biometric algorithms to determine body tension scores. These signals and scores are then analysed to deliver individually customised stress relief programmes that are effective.

Data From uDream Pro Users Indicates Improved Mental And Physical Health

Anonymised body tension scores collected from uDream Pro users before and after each well-being session show a general decline in tension felt[1]. The scores revealed that:

– 78.72% (about 8 in 10 users) experienced an immediate reduction in short-term stress and improved state-of-mind after one use; and
– 87.23% (about 9 in 10 users) experienced a decline in long-term stress and improved overall mental and physical health with repeated use over a period of 6 months.

Hyun Bin Embodies The uDream Pro Vision Of Sophisticated Wellness Technology

A respected, award-winning actor in the entertainment industry and a household name, Hyun Bin is among the most influential actors in South Korea and has captivated audiences with his striking onscreen presence and versatile range of performances. His career spans more than two decades and includes leading roles in internationally popular dramas such as Crash Landing On You and Memories of the Alhambra as well as movies such as Confidential Assignment and The Negotiation.

Hyun Bin shares more about his philosophy to work-life balance and overall well-being in an exclusive OSIM video feature on Youtube.

The new generation OSIM uDream Pro retails in Malaysia at a promotional price from RM436.47 per month with zero interest instalments up to 60 months and it is available at osim.com.my and at all OSIM stores. Visit OSIM stores now to enjoy an extraordinary wellness experience.

OSIM https://www.osim.com.my/

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

International Self-Care Day: Better Self-Care, Better Healthcare; Better Welfare Globally

NYON, SWITZERLAND, Jul 24, 2023 – (ACN Newswire) – International Self-Care month 2023 opened with an ambitious joint statement of intent from the United for Self-Care Coalition: "It's time to put self-care at the front of the healthcare debate". And today, on International Self-Care Day, the Global Self-Care Federation (GSCF) is calling for all stakeholders to back the urgent adoption of a WHO resolution on self-care. A rise in chronic conditions, an aging population, and the COVID-19 pandemic have all impacted already-overstretched resources over the past few years and proven how crucial it is to codify self-care at international level. It is imperative to preserve the momentum and empower individuals to manage their own health while while lessening burdens on health systems globally. The resolution would drive a significant increase in the expansion of self-care both within the WHO and at the national level and accelerate the achievement of universal health coverage (UHC). There is no time to waste.

International Self-Care month is recognised annually between June 24th – July 24th, is part of the WHO's global health calendar. It symbolically culminates on July 24th, as a demonstration that individuals can practice self-care 24 hours a day, 7 days a week. Self-care is any action an individual takes to look after their own health either alone or in collaboration with healthcare professionals.

At the end of 2021, GSCF and 17 like-minded organizations formed the United for Self-Care Coalition. This global coalition includes NGOs, academic institutions and health workers' associations, and is united by the shared desire to advance progress towards UHC. This goal that can only be achieved by working at a global level in order to formally recognise the value that self-care can bring in terms of access to care, quality of treatment and resilience of health systems.

Judy Stenmark, Director General of GSCF said, "With the growing cost of living crisis and increasing pressures on global supply chains, health systems are continually under-resourced as health workers become overworked. Evidence-based research has already clearly showed that self-care is often the only option for vulnerable people to engage with health services. Our own reports have further confirm that current self-care practices contribute to a gain of 22 million quality-adjusted life years, and health system annual savings of $120 billion."

Universal health care cannot be achieved without high quality and wide-spread self-care. Self-care puts individuals at the center of health policy. The United for Self-Care Coalition is calling for all supporters to take up the call for a WHO resolution on self-care:

https://www.unitedforselfcare.org

Contact Information
Catherine Laverty
claverty@selfcarefederation.org

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