Tag: Healthcare & Pharm

World-first Hip Fracture Registry Toolbox striving to improve care for the 1 million+ who fracture a hip in Asia Pacific each year

MALAYSIA, Jun 15, 2021 – (ACN Newswire) – An innovative world-first Hip Fracture Registry Toolbox has been launched today (June 15) to address the alarming deaths and disabilities caused by the more than 1 million hip fractures sustained in the Asia Pacific each year.


Developed by the Asia Pacific Fragility Fracture Alliance (APFFA) in collaboration with the Fragility Fracture Network (FFN), the practical and informative resource explains the fundamental need, and how to best advocate for, the establishment of a national hip fracture registry.

Tailored to clinicians, hospital administrators, healthcare systems and governments alike, the Toolbox covers pertinent topics, including stakeholder engagement and consolidation, building a case for change, and planning and funding a registry, to setting up a pilot registry, and navigating governance and ethics approval. Examples of current registries and other useful resources also feature in the Toolbox.

Concerningly, one-in-four patients who sustain a hip fracture die within a year, and less than half of those who survive, regain their previous level of function. The expected direct incurred cost associated with the more than 1.1 million hip fractures estimated to have occurred in nine countries and regions in APAC, including China, Chinese Taipei, Hong Kong SAR, India, Japan, Malaysia, Singapore, South Korea and Thailand in 2018, amounts to USD 7.5 billion. This cost is projected to increase to almost USD 13 billion by 2050.

According to Professor Jacqui Close, Consultant Ortho-Geriatrician, and Clinical Director of the Falls, Balance and Injury Research Centre at Neuroscience Research Australia (NeuRA) and APFFA Hip Fracture Registry Working Group Co-Chair, widescale implementation of hip fracture registries worldwide can facilitate vast improvements in care for the millions of people who sustain a hip fracture each year.

"Hospitals can utilise hip fracture registries to benchmark their provision of care against best practice clinical standards for acute care, rehabilitation, and secondary fracture prevention. Hip fracture registries can transform patient-level data into information that both equips and empowers hospital teams to identify, and develop solutions for key challenges within their respective institutions, and to strive for ongoing improvement in care," said Prof Close.

By 2050, one in four people in APAC will be aged over 60. This portion of the population is expected to triple between 2010 and 2050, reaching close to 1.3 billion people. Within the same timeframe, between 4.5 to 6.3 million hip fractures are predicted to occur worldwide, half of which will occur in Asia.

Dr Hannah Seymour, Consultant Geriatrician and Medical Director, Fiona Stanley Fremantle Hospitals Group in Australia, and APFFA Hip Fracture Registry Working Group Co-Chair argues that given the exponential increase in both the incidence and costs associated with hip fractures to date, and those anticipated globally, hip fracture registries serve as a vital tool underpinning quality improvement initiatives in the Asia Pacific region, and globally.

"As of April 2021, 18 countries across Asia Pacific, Europe, Latin America and North America had established a hip fracture registry, at different stages of maturation, participation and development. Notably, only three registries are currently operating in the Asia Pacific.

"The Hip Fracture Registry Toolbox explains how timely, reliable and constructive feedback to clinical teams, coupled with the engagement and participation of key stakeholders, improves the impact of hip fracture registries," Dr Seymour said.

Registries can contribute to government initiatives designed to manage rapidly ageing populations, and can further help governments to promote the equitable provision of care. With adequate operational efficiency and funding, registries can improve healthcare, and are likely to prove significantly cost-effective.

According to Dato' Dr Joon-Kiong Lee, Orthopaedic Surgeon in Malaysia and APFFA co-Chair, today's release of the Toolbox coincides with the launch of APFFA's YouTube channel: "The APFFA YouTube channel will house a series of educational videos featuring interviews with leading clinicians from the Asia Pacific arena, reflecting on important considerations for each of the seven key steps involved in establishing a hip fracture registry.

"We trust our APFFA and FFN Toolbox, and supporting videos, will arm our colleagues throughout Asia Pacific, and the rest of the world, with the necessary inspiration, knowledge and guidance on how to successfully establish a national hip fracture registry in their respective countries," said Dato' Dr Lee.

About APFFA
Formed in November 2018, APFFA comprises seven global and regional member organisations from the geriatrics, orthopaedics, osteoporosis and rehabilitation sectors, with the primary purpose of driving policy change, improving awareness and changing political and professional mindsets, to facilitate optimal fragility fracture management across Asia Pacific. www.apfracturealliance.org.

About the APFFA HFR Working Group
The APFFA Hip Fracture Registry Working Group is a principal action group within APFFA, comprising global experts in hip fracture treatment and management, charged with driving the development of the HFR Toolbox. The HFRWG report on hip fracture epidemiology and outcomes across Asia Pacific aims to frame the problems facing the region, and outline APFFA-related projects capable of providing a partial solution to these issues. The HFRWG is also responsible for a feasibility study examining the costs and practicalities of establishing new hip fracture registries in specific countries throughout Asia Pacific.

About the Fragility Fracture Network (FFN)
The FFN is a global organisation comprising a multidisciplinary network of experts charged with improving the treatment and secondary prevention of fragility fractures. The organisation strives to optimise multidisciplinary management of a patient with a fragility fracture, to ensure maximum recovery, quality of life, and no further fractures, worldwide.

The Hip Fracture Audit Special Interest Group (HFA SIG) comprises a multidisciplinary network of clinicians
well-versed in hip fracture audits, striving for global adoption of a Minimum Common Dataset (MCD), and a worldwide platform to share HFA knowledge, learning and research.

To learn more about APFFA and download the Hip Fracture Registry Toolbox head to: www.apfracturealliance.org/HFR-toolbox/, follow APFFA on LinkedIn: asia-pacific-fragility-fracture-alliance, and YouTube: www.youtube.com/channel/UCpb3uxbr8BQ1vz2KAp8imxw.

For more information, contact:
Kirsten Bruce or Mel Kheradi, VIVA! Communications, Sydney, AUSTRALIA
T. +61 401 717 566 / +61 2 421 551 257
E. kirstenbruce@vivacommunications.com.au / melorin@vivacommunications.com.au

Download the Hip Fracture Registry Toolbox Digital Media Kit:
www.apfracturealliance.org/hfr-toolbox-media-kit/

References:
See all references at https://acnnewswire.com/press-release/english/67278/.

Copyright 2021 ACN Newswire. All rights reserved. http://www.acnnewswire.com

Strategic collaboration Memorandum between EC Healthcare and China Medical System Utilize the Synergy of Upstream and Downstream of the Aesthetic Medical Industry, Jointly Promote the Development of Medical Products and Talents

HONG KONG, Jun 11, 2021 – (ACN Newswire) – EC Healthcare (the "Company", which together with its subsidiaries is referred to as the "Group", SEHK stock code: 2138), the largest non-hospital medical group in Hong Kong* and China Medical System Holdings Limited (the "CMS", SEHK stock code: 867), jointly announce that the Group and a subsidiary of the CMS entered into a memorandum in relation to the strategiccollaboration, including but not limited to setting up an aesthetic medical marketing centre for distribution and marketing of aesthetics medication and related products initially in Hong Kong , and exploring to set up an aesthetic medical training and education platform for registered practitioners, and further exploring the formation of a nationwide aesthetic medical doctor partnership business platform.

The Group is the largest non-hospital medical service provider in Hong Kong based in the Greater Bay Area, providing medical, aesthetic medical and healthcare services. The CMS Group is an innovation-driven specialty pharma with a focus on sales and marketing in China, with more than two decades proven record of experience in successful drug promotion in multi departments. Of vertical development in the specialist field, the CMS Group is consistently expanding its horizontal boundary at the same and deploy product matrix in leading skin management and medical aesthetic technology. According to the memorandum, the Group and CMS will set up and operate an aesthetic medical marketing centre in Hong Kong as starting point for distribution, sales and marketing of aesthetics medication and related products in Hong Kong, set up an aesthetic medical training and education platform for registered practitioners to provide aesthetic medical services, and further explore the formation of a nationwide aesthetic medical doctor partnership business platform, in order to strategically link up upstream and downstream of aesthetic medical industry to maximize the industry synergy, promote the compliance of aesthetic medical products, foster the commercialisation of aesthetic medical professionals, and standardize aesthetic medical services.

Under the strategic collaboration, CMS intends to inject the medication resources on its research and development platform and the distribution rights of aesthetic medication or related products in Hong Kong; EC Healthcare intends to inject its digital marketing system, team of registered practitioners, resources of key opinion leaders and celebrity spokespersons and its branding influence as a market leader in the industry. Besides, by leveraging CMS's vast network of medical practitioners in the China and EC Healthcare's aesthetic medical education expertise, the parties will establish as an education and training centre for cultivating and certifying a new generation of aesthetic medical talents, and actively explore the formation of a nationwide aesthetic medical doctor partnership business platform.

Mr. Eddy Tang, Chairman, Executive Director and Chief Executive Officer of EC Healthcare said, "The Group is honored to establish a long-term strategic partnership with CMS. Both parties will fully exploit their respective advantages to realize a strong alliance. In the past few years, EC Healthcare's outstanding performance continued to prove the Group's brand power and operational capabilities in the Greater Bay Area and across the country. Through the collaboration, we hope to facilitate the Group's precise layout in mainland market and scale the aesthetic medical business to a new height through replicating the successful operation system. In light of the strong growth potential of China's aesthetic medical services market, as well as the shortage of compliant aesthetics medication and talents, the Group believes that the collaboration can promote valuable synergies between the upstream and downstream of the industry, thereby leading the development of pharmaceuticals and medical talents in order to reform the industry and resolve the pain points in response to the strong domestic demand for high-quality compliant aesthetic medical services."

About EC Healthcare
EC Healthcare is Hong Kong's largest non-hospital medical service provider*, leveraging its core businesses of preventive and precision medicine, and committed to developing medical artificial intelligence by integrating its multi-disciplinary medical services. The move, which is supported by the Group's high-end branding and quality customer services, is aimed at offering customers safe and effective healthcare and medical services with professionalism.

The Group principally engages in the provision of one-stop medical and health care services in Greater China. The Group provides a full range of services and products under its well-known brands, including those of its one-stop aesthetic medical solutions provider DR REBORN which has ranked first in Hong Kong by sales for years, primary care clinics jointly established with Tencent Doctorwork, chiropractic services centre SPINE Central, New York Spine and Physiotherapy Center NYMG, health management centre re:HEALTH, a vaccine centre Hong Kong Professional Vaccine HKPV, a comprehensive dental centre UMH DENTAL CARE, a diagnostic and imaging centre HKAI, an oncology treatment centre reVIVE, a day procedure centre HKMED, a specialty clinic SPECIALISTS CENTRAL and NEW MEDICAL CENTER, obstetrics and gynaecology specialist ZENITH MEDICAL CENTER AND PRENATAL DIAGNOSIS CENTRE, specialists central, a paediatric center PRIME CARE, cardiology center HONG KONG INTERNATIONAL CARDIOLOGY CENTER, PathLab Medical Laboratories and a professional hair care center HAIR FOREST.

*According to an independent research conducted by Frost and Sullivan in terms of revenue in 2019 and 2020

About China Medical System
China Medical System Holdings Limited is an innovation-driven specialty pharma with a focus on sales and marketing in China, dedicated to offering competitive products and services to meet China's unmet needs for health and beauty.

CMS focuses on innovative products that are global first-in-class, or with the best efficacy, safety or cost-effectiveness in the class due to their innovative formulations or drug delivery systems, and has built an innovative product pipeline with relatively high innovation level, good market potential and competitive differentiation advantages. Meanwhile, CMS has proven and successful experience in drug commercialization and strong capability in professional academic promotion, having created a leading market position for many existing drugs. Jointly driven by the strong product competence, the powerful academic promotion capability, and the refined internal management system, CMS has become one of the Chinese pharmaceutical companies with the highest operating efficiency.

Capitalizing on its own advantages, CMS constantly expands the business boundaries and rapidly promotes the development of new businesses, which consist of the dermatology and medical aesthetic business (CMS Aesthetics) and the healthcare business (CMS Health), while making in-depth development in multiple fields of expertise. CMS Aesthetics specializes in the development of dermatological drugs and medical aesthetic solutions, dedicated to becoming the largest and most professional company in the field of dermatology, medical aesthetics and health management in China. CMS Health stringently selects functional quality healthcare products with unique ingredients globally according to medical concept and high standards, and forms one-stop cross-border e-commerce platforms, to help Chinese consumers improve their sub-health status.

For further information, please contact:
iPR Ogilvy Limited
Callis Lau / Lorraine Luk / Shana Li / Ada Chew
Tel: (852) 2136 6952 / 2169 0467 / 3920 7649 / 3920 7650
Fax: (852) 3170 6606
Email: ech@iprogilvy.com


Copyright 2021 ACN Newswire. All rights reserved. http://www.acnnewswire.com

Strategic collaboration Memorandum between EC Healthcare and China Medical System

HONG KONG, Jun 11, 2021 – (ACN Newswire) – EC Healthcare (the "Company", which together with its subsidiaries is referred to as the "Group", SEHK stock code: 2138), the largest non-hospital medical group in Hong Kong* and China Medical System Holdings Limited (the "CMS", SEHK stock code: 867), jointly announce that the Group and a subsidiary of the CMS entered into a memorandum in relation to the strategiccollaboration, including but not limited to setting up an aesthetic medical marketing centre for distribution and marketing of aesthetics medication and related products initially in Hong Kong , and exploring to set up an aesthetic medical training and education platform for registered practitioners, and further exploring the formation of a nationwide aesthetic medical doctor partnership business platform.

The Group is the largest non-hospital medical service provider in Hong Kong based in the Greater Bay Area, providing medical, aesthetic medical and healthcare services. The CMS Group is an innovation-driven specialty pharma with a focus on sales and marketing in China, with more than two decades proven record of experience in successful drug promotion in multi departments. Of vertical development in the specialist field, the CMS Group is consistently expanding its horizontal boundary at the same and deploy product matrix in leading skin management and medical aesthetic technology. According to the memorandum, the Group and CMS will set up and operate an aesthetic medical marketing centre in Hong Kong as starting point for distribution, sales and marketing of aesthetics medication and related products in Hong Kong, set up an aesthetic medical training and education platform for registered practitioners to provide aesthetic medical services, and further explore the formation of a nationwide aesthetic medical doctor partnership business platform, in order to strategically link up upstream and downstream of aesthetic medical industry to maximize the industry synergy, promote the compliance of aesthetic medical products, foster the commercialisation of aesthetic medical professionals, and standardize aesthetic medical services.

Under the strategic collaboration, CMS intends to inject the medication resources on its research and development platform and the distribution rights of aesthetic medication or related products in Hong Kong; EC Healthcare intends to inject its digital marketing system, team of registered practitioners, resources of key opinion leaders and celebrity spokespersons and its branding influence as a market leader in the industry. Besides, by leveraging CMS's vast network of medical practitioners in the China and EC Healthcare's aesthetic medical education expertise, the parties will establish as an education and training centre for cultivating and certifying a new generation of aesthetic medical talents, and actively explore the formation of a nationwide aesthetic medical doctor partnership business platform.

Mr. Eddy Tang, Chairman, Executive Director and Chief Executive Officer of EC Healthcare said, "The Group is honored to establish a long-term strategic partnership with CMS. Both parties will fully exploit their respective advantages to realize a strong alliance. In the past few years, EC Healthcare's outstanding performance continued to prove the Group's brand power and operational capabilities in the Greater Bay Area and across the country. Through the collaboration, we hope to facilitate the Group's precise layout in mainland market and scale the aesthetic medical business to a new height through replicating the successful operation system. In light of the strong growth potential of China's aesthetic medical services market, as well as the shortage of compliant aesthetics medication and talents, the Group believes that the collaboration can promote valuable synergies between the upstream and downstream of the industry, thereby leading the development of pharmaceuticals and medical talents in order to reform the industry and resolve the pain points in response to the strong domestic demand for high-quality compliant aesthetic medical services."

About EC Healthcare
EC Healthcare is Hong Kong's largest non-hospital medical service provider*, leveraging its core businesses of preventive and precision medicine, and committed to developing medical artificial intelligence by integrating its multi-disciplinary medical services. The move, which is supported by the Group's high-end branding and quality customer services, is aimed at offering customers safe and effective healthcare and medical services with professionalism.

The Group principally engages in the provision of one-stop medical and health care services in Greater China. The Group provides a full range of services and products under its well-known brands, including those of its one-stop aesthetic medical solutions provider DR REBORN which has ranked first in Hong Kong by sales for years, primary care clinics jointly established with Tencent Doctorwork, chiropractic services centre SPINE Central, New York Spine and Physiotherapy Center NYMG, health management centre re:HEALTH, a vaccine centre Hong Kong Professional Vaccine HKPV, a comprehensive dental centre UMH DENTAL CARE, a diagnostic and imaging centre HKAI, an oncology treatment centre reVIVE, a day procedure centre HKMED, a specialty clinic SPECIALISTS CENTRAL and NEW MEDICAL CENTER, obstetrics and gynaecology specialist ZENITH MEDICAL CENTER AND PRENATAL DIAGNOSIS CENTRE, specialists central, a paediatric center PRIME CARE, cardiology center HONG KONG INTERNATIONAL CARDIOLOGY CENTER, PathLab Medical Laboratories and a professional hair care center HAIR FOREST.

*According to an independent research conducted by Frost and Sullivan in terms of revenue in 2019 and 2020

About China Medical System
China Medical System Holdings Limited is an innovation-driven specialty pharma with a focus on sales and marketing in China, dedicated to offering competitive products and services to meet China's unmet needs for health and beauty.

CMS focuses on innovative products that are global first-in-class, or with the best efficacy, safety or cost-effectiveness in the class due to their innovative formulations or drug delivery systems, and has built an innovative product pipeline with relatively high innovation level, good market potential and competitive differentiation advantages. Meanwhile, CMS has proven and successful experience in drug commercialization and strong capability in professional academic promotion, having created a leading market position for many existing drugs. Jointly driven by the strong product competence, the powerful academic promotion capability, and the refined internal management system, CMS has become one of the Chinese pharmaceutical companies with the highest operating efficiency.

Capitalizing on its own advantages, CMS constantly expands the business boundaries and rapidly promotes the development of new businesses, which consist of the dermatology and medical aesthetic business (CMS Aesthetics) and the healthcare business (CMS Health), while making in-depth development in multiple fields of expertise. CMS Aesthetics specializes in the development of dermatological drugs and medical aesthetic solutions, dedicated to becoming the largest and most professional company in the field of dermatology, medical aesthetics and health management in China. CMS Health stringently selects functional quality healthcare products with unique ingredients globally according to medical concept and high standards, and forms one-stop cross-border e-commerce platforms, to help Chinese consumers improve their sub-health status.

For further information, please contact:
iPR Ogilvy Limited
Callis Lau / Lorraine Luk / Shana Li / Ada Chew
Tel: (852) 2136 6952 / 2169 0467 / 3920 7649 / 3920 7650
Fax: (852) 3170 6606
Email: ech@iprogilvy.com



Copyright 2021 ACN Newswire. All rights reserved. http://www.acnnewswire.com

Dingdang Health raises US$220 million in new financing round

BEIJING, Jun 8, 2021 – (ACN Newswire) – China's leading integrated online healthcare platform Dingdang Health announced today that it has raised US$220 million in its latest financing round. This round was led by TPG Capital Asia and co-led by OrbiMed and Redview Capital. Other investors included, Valliance, Travis Global Limited (which is an affiliate of Orchid Asia), Summer Capital, and Yingke PE.


Mr. Yang Wenlong, founder and chairman of Dingdang Health, said: "With this round of financing, Dingdang Health will press ahead with its online-to-offline strategy to cover services including medical care, medicine delivery and medical insurance. Riding on the new trend of online medical care and medication services amid Covid-19, we aim at providing all-encompassing online services catering to various needs including consultation, drug purchase, chronic disease management and psychological consultation through product upgrades and technological innovation."

"I would like to express my heartfelt gratitude to our existing and new shareholders for their recognition. Investors such as TPG, OrbiMed and Redview Capital have extensive investment experience in the health field. Moving forward, with their support, we will remain devoted to accelerating the digitalization of medical care and medication, providing comprehensive service for customers," Mr. Yang said.

With a deep understanding of the industry and user insights, Dingdang Health has continued to invest in product upgrades to grow the business. As a pioneer of online healthcare products and service provider, Dingdang Health's online-to-offline model enables it to supply drugs from the pharma manufacturers and offline pharmacies to meet users' urgent medical needs. The company has also expanded its business to more areas such as medical care, medicine delivery and medical insurance. The strategy has helped the platform remain competitive in China's digital health and wellness market.

Lydia Cai, Managing Director at TPG Capital Asia, said: "The public demand for digitalization and healthcare has become increasingly acute under the new normal due to Covid-19. Dingdang Health's business model perfectly combines both digitalization and healthcare. Leveraging big data and internet technologies, the company has created a pioneering self-operating model that provides online medical care and medicine delivery services. It links pharmaceutical companies, pharmacies and users in an all-encompassing ecosystem with timely and caring services. As the company evolves into an integrated healthcare provider, TPG is optimistic about its technology, model and potential, and will fully support its rapid growth to benefit more users."

TPG is a leading global alternative asset firm founded in 1992 with more than US$91 billion of assets under management. It is one of the early international private equity investment giants that created a dedicated healthcare investment team. It has extensive investment experience in this space globally.

Iris Wang, Partner of OrbiMed, said: "Dingdang Health empowers the local healthcare system and gives new momentum to the industry's development by employing efficient information technologies including AI, big data, 5G and Internet of Things. Its capabilities in both technological innovation and professional healthcare allow ordinary people to have medical consultation and purchase medicines without leaving their homes. We are excited to join hands with the company at an important stage of its development, and continue to create value in terms of protecting people's health and pushing for the development of the industry."

OrbiMed has been focusing on investments in the global biomedical field for over two decades, with assets under management exceeding US$17 billion. The team has a deep understanding of China's grassroots healthcare market and continues to identify companies that can provide professional services in that field.

Xin Wang, Partner of Redview Capital, said, "Redview Capital is committed to collaborating with industry-leading companies with innovative capabilities. Dingdang Health has been engaged in online medical care and pharmacy field for many years. With a comprehensive blueprint of online consultation and medicine ordering platform as well as offline smart pharmaceutical retail stores, it provides one-stop healthcare services including online consultation, medication advice, home delivery and health management, showcasing strong innovation, technological capabilities and competitiveness. We will fully support the continuous development of Dingdang Health and work with it to promote people's health."

Redview Capital is a China-focused private equity fund that invests in industries including emerging consumer goods and services, health, new materials, clean energy, consumer services, and high-end manufacturing sectors.

About Dingdang Health
Dingdang Health Technology Group is a pioneer and leader in the field of digital healthcare service in China, leveraging the Internet solutions/ technologies to transform and reshape China's healthcare system including pharmaceutical retail and medical consultation. As a leading digital new pharmaceutical retail company, it has established a new pharmaceutical retail model that integrates online and offline operations of "online ordering for delivery from stores", providing users a series of products and services, including 7*24 hours, 28 minutes to deliver medicines to users in core area of cities. With the innovative "Internet + Healthcare" model, it is able to address the unmet needs in the medication and health management effectively and efficiently. Its pharmaceutical retail, online medical consultation, chronic diseases management and other businesses cooperate with each other to form a broader health ecology, transform and lead the development of China's healthcare market. It has received several rounds of investment from well-known investment institutions such as SBCVC, CMBI, CICC Capital, Sinopharm-CICC Capital, Taikang Insurance Group, Longmen Investments and Haier Biomedical.

About TPG
TPG is a leading global alternative asset firm founded in 1992 with more than $91 billion of assets under management and offices in Beijing, Fort Worth, Hong Kong, London, Luxembourg, Melbourne, Mumbai, New York, San Francisco, Seoul, Singapore, and Washington D.C. TPG's investment platforms are across a wide range of asset classes, including private equity, growth equity, impact investing, real estate, secondaries, and public equity. TPG aims to build dynamic products and options for its investors while also instituting discipline and operational excellence across the investment strategy and performance of its portfolio. For more information, visit www.tpg.com or @TPG on Twitter.



Copyright 2021 ACN Newswire. All rights reserved. http://www.acnnewswire.com

Avance Clinical’s USA Biotech Survey Finds 21% Not Aware Australian Clinical Data is Accepted by the FDA and Other Major Regulatory Authorities

ADELAIDE, AUS, Jun 4, 2021 – (ACN Newswire) – The leading Australian CRO for biotechs and Frost & Sullivan Asia-Pacific CRO Market Leadership Award recipient Avance Clinical announced the results of their Australian Clinical Trials Knowledge Survey with Endpoints News as part of their presence at BIO Digital 2021.



Results from the survey found:
– 21% were not aware Australian data is accepted by the FDA and other major regulatory authorities
– less than half of respondents were aware of Australia's 43.5% rebate on clinical research spend
– only 52% knew that studies could achieve regulatory approval in under 5 weeks in Australia

The survey was sent to Endpoints News subscribers in biotech hubs on the USA east and west coasts.

The Avance Clinical team is attending BIO Digital 2021 virtually and is available on the BIO One-on-One Partnering(TM) platform to discuss the benefits of conducting trials in Australia.

Avance Clinical CEO Yvonne Lungershausen, said the survey was designed to determine awareness levels among biotech companies around the key benefits of conducting clinical trials in Australia. "Sponsors are well aware of the quality of research from Australia however it seems from the survey that some key benefits including data acceptance, the rebate, and accelerated regulatory approval are still not widely known," said Yvonne Lungershausen. "The clinical trial environment in Australia supports rapid regulatory approval and includes one of the most attractive rebates on clinical costs as part of the Australian Government's clinical trial attraction incentive program."

Avance Clinical has recently won the BDO Excellence in Business Award 2021 for rapid managed growth and attracting and nurturing experienced staff in a competitive global environment. The mid-sized CRO has a reputation for going beyond the industry standard time and support for Sponsors and providing staff the training and resources needed to deliver excellence in clinical research management.

About Avance Clinical

Avance Clinical, Australia's CRO for biotechs, has more than 20-years of experience providing excellence in clinical research services for biotech companies from around the globe. Avance Clinical facilitates quality drug development by aligning people, skills, and expertise in the pursuit of drug development for a healthier world. The collective pool of knowledge and experience at Avance Clinical continually grows through the careful selection of experts who also demonstrate passion in their chosen field. Avance Clinical offers high-quality services in an established clinical trial ecosystem, that includes world-class investigators and sites able to access specific patient groups. Visit http://www.avancecro.com for more information.

Recent Awards:
Excellence in Business Award 2021
Frost & Sullivan Asia-Pacific CRO Market Leadership Award 2020

Other benefits of working with Avance Clinical include:
1. The Government R&D grant offers up to 43.5% rebate on clinical trial spend
2. COVID-19 clinical continuity
3. Site Initiation Visit (SIV) and Study Start achieved in 5 – 6 weeks
4. No IND required for clinical trials
5. Full GMP material is not mandated for Phase I clinical trials
6. Established clinical trial environment with world-class investigators and sites
7. Access to sites/Phase I facilities with established healthy subject databases and specific patient populations
8. Major hospitals with world-class infrastructures and dedicated Clinical Trial Units with a long track-record in FDA compliant research
9. Seasonal studies: Northern hemisphere sponsors can conduct their studies year-round by taking advantage of Australia's counter-flu and allergy seasons
10. Avance Clinical is accredited as a gene technology CRO under the Office of the Gene Technology Regulator (OGTR) so it can manage gene technology trials in Australia.

Media Contact:
media@avancecro.com

Copyright 2021 ACN Newswire. All rights reserved. http://www.acnnewswire.com

Avantor Acquires RIM Bio; Expands Bioproduction Footprint into China

RADNOR, Pa. and SHANGHAI, June 2, 2021 – (ACN Newswire) – Avantor, Inc. (NYSE: AVTR), a leading global provider of mission-critical products and services to customers in the life sciences and advanced technologies & applied materials industries, announced today that it has acquired RIM Bio, a leading China-based manufacturer of single-use bioprocess bags and assemblies for biopharmaceutical manufacturing applications.

RIM Bio provides a complete range of single-use products manufactured in ISO 7 Class 10,000 cleanroom facilities

Rim Bio’s proprietary technology provides single use bioprocess customers with differentiated product offerings

RIM Bio’s Changzhou, China facility is Avantor’s first single-use production plant in the AMEA region, building on the company’s existing global single-use manufacturing network in the Americas and Europe and greatly increasing capacity to meet growing global demand in bioprocessing. Avantor will leverage RIM Bio’s proprietary technologies and best-in-class lead times to provide single-use customers with a differentiated offering.

Dr. Ger Brophy, Executive Vice President, Biopharma Production at Avantor, said, “Adding RIM Bio enables Avantor to better serve our customers by expanding our single-use manufacturing, distribution, and cleanroom capabilities to the AMEA region. RIM serves as an anchor for us to build our presence in this key region, as we better position Avantor to capture long-term opportunities in the growing, global Bioproduction space.”

Established in 2009, RIM Bio provides a complete range of single-use 2D bags, 3D bags, tank liners, bag assemblies and multi-bag manifolds used in the manufacturing of biologics including monoclonal antibodies (mAbs), vaccines, cell and gene therapies, and recombinant proteins.

This acquisition marks another major investment in China. In December 2019, the company opened its Shanghai Innovation & Customer Support center, a dedicated bioprocessing facility focused on research, application development and process optimization solutions for biopharma companies across AMEA.

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 225,000 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, please visit http://www.avantorsciences.com.

Forward-looking statements

This press release contains forward-looking statements. All statements other than statements of historical fact included in this press release are forward-looking statements. Forward-looking statements discuss our current expectations and projections relating to our announced transaction with Ritter as well as our financial condition, results of operations, plans, objectives, future performance and business. These statements may be preceded by, followed by or include the words “aim,” “anticipate,” “believe,” “estimate,” “expect,” “forecast,” “intend,” “likely,” “outlook,” “plan,” “potential,” “project,” “projection,” “seek,” “can,” “could,” “may,” “should,” “would,” “will,” the negatives thereof and other words and terms of similar meaning.

Forward-looking statements are inherently subject to risks, uncertainties and assumptions; they are not guarantees of performance. You should not place undue reliance on these statements. We have based these forward-looking statements on our current expectations and projections about future events. Although we believe that our assumptions made in connection with the forward-looking statements are reasonable, we cannot assure you that the assumptions and expectations will prove to be correct. Factors that could contribute to these risks, uncertainties and assumptions include, but are not limited to, the factors described in “Risk Factors” in our 2020 Annual Report on Form 10-K for the year ended December 31, 2020, which is on file with the U.S. Securities and Exchange Commission (“SEC”) and available in the “Investors” section of Avantor’s website, ir.avantorsciences.com, under the heading “SEC Filings,” and in any subsequent Quarterly Reports on Form 10-Q and other documents Avantor files with the SEC.

All forward-looking statements attributable to us or persons acting on our behalf are expressly qualified in their entirety by the foregoing cautionary statements. In addition, all forward-looking statements speak only as of the date of this press release. We undertake no obligations to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise other than as required under the federal securities laws.

Media Contact

Christina Koh
Director Communications – AMEA
+65 9720 0169
christina.koh@avantorsciences.com

Investor Relations Contact

Tommy Thomas
Vice President, Investor Relations
+1 781 375-8051
Tommy.Thomas@avantorsciences.com

SOURCE: Avantor and Financial News



Copyright 2021 ACN Newswire. All rights reserved. http://www.acnnewswire.com

Agilex Biolabs and Gyros Protein Technologies Partner for BioAnalysis Zone Webinar on Singlicate Analysis

ADELAIDE, AUS, May 31, 2021 – (ACN Newswire) – Agilex Biolabs, Australia's largest and most technologically advanced specialist bioanalytical laboratory for clinical trials is partnering with Gyros Protein Technologies and BioAnalysis Zone to share the latest on singlicate analysis on the Gyrolab platform.



Register Here https://tinyurl.com/puwwj9zp
Singlicate analysis on the Gyrolab platform
Wednesday 2 June 2021
18:00 [EDT] 23:00 [BST] | Thursday 3 June 06:00 [CST] 08:00 [AEST]

Agilex Biolabs' Principal Method Development Scientist, Morgan Evans will present with Gyros Protein Technologies' Application & Service Director EMEA and Asia Pacific, John Chappell for a comprehensive webinar titled Singlicate analysis on the Gyrolab platform.

The webinar topic was inspired by the Agilex Biolabs poster presentation Development and Validation of a PK Method for Tocilizumab in Both Singlicate and Duplicate on the Gyrolab Platform presented at the 13th EBF open symposium.

Over the last several years singlet analysis has become a hot topic within the world of LBA non-regulated and regulated bioanalysis. A number of studies have demonstrated positive outcomes on both replicate precision assessment and PK/TK parameters.

Due to the highly automated and robust nature of the instrument, Gyrolab has become a front runner in LBA technologies for singlicate analysis.

This webinar will look at the overall landscape of singlet analysis and through Agilex Biolabs case studies discuss the use of the Gyrolab technology. It will also look at how lessons learned can inform prospects of singlicate analysis on other technological platforms keeping in mind 'speed to patient' to ensure efficiency in bioanalytical laboratories.

Agilex Biolabs' world-class laboratories feature state-of-the-art equipment including Gyrolab Xplore, MSD Quickplex 120, Luminex Magpix, BD FACSymphony A3 flow cytometer and soon to be released, digital droplet quantitative real-time RT-PCR.

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

Australian clinical trials have remained open for business and Agilex Biolabs is a designated essential service so clients can be assured of study continuity.

Agilex Biolabs has more than 120 staff which includes 85 dedicated laboratory staff, and supports client pharma and biotech companies from US, Europe and APAC.

Book a confidential briefing with our scientists before you start your next clinical trial. https://calendly.com/agilexbiolabs/15min

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

Agilex Biolabs, Australia's leading bioanalytical laboratory, has more than 24 years' experience in performing regulated bioanalysis, including quality method development, method validation and sample analysis services. It has successfully supported hundreds of preclinical and clinical trials from around the world where customers choose Australia for the streamlined regulatory process and access to the world's most attractive R&D rebate of more than 40% on clinical trial work conducted in Australia. Agilex Biolabs also offers toxicology services through its company TetraQ, an established GLP rodent toxicology facility in Australia.

Agilex Biolabs has the leading certifications including OECD GLP Recognition with NATA (Australian Government OECD GLP Compliance monitoring authority) and ISO 17025 Accreditation for global recognition. The company has recently expanded its main labs by more than 30% to accommodate biotech demand from APAC and the USA. Watch the new lab video walkthrough at https://www.agilexbiolabs.com/new-labs-video

Agilex Biolabs specialises in bioanalysis of small molecules and biologics for PK, immunogenicity, biomarkers and immunological pharmacodynamics assessments utilising LC-MS/MS, immunoassay (Mesoscale, Gyrolab, Luminex) and flow cytometry (BD FACSymphony A3, 20 colour cell analyser).

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

Agilex Biolabs Media Contact:
Kate Newton
Media@AgilexBiolabs.com

Copyright 2021 ACN Newswire. All rights reserved. http://www.acnnewswire.com

Avance Clinical Releases Industry Survey Results at BIO Korea 2021

ADELAIDE, AUS, May 27, 2021 – (ACN Newswire) – The leading Australian CRO for biotechs and Frost & Sullivan Asia-Pacific CRO Market Leadership Award recipient Avance Clinical shared results of a recent industry survey conducted by the company that found data quality to be the most important criteria for selecting a CRO for Phase ll studies in Australia.

Results from the survey found 63.64% of respondents selected data quality as the Key operational consideration when planning Phase II, followed by access to patients, then CRO therapeutic area expertise, cost, and access to KOLs.

Avance Clinical is attending BIO Korea 2021 virtually and is available via the Partnering platform to discuss the benefits of conducting trials in Australia. Avance Clinical has extensive experience in conducting trials in oncology, CNS, cardiovascular, infectious diseases and dermatology.

Avance Clinical CEO, Yvonne Lungershausen, said South Korea is recognised globally for its thriving biotech sector and the CRO is keen to connect with companies wanting regional alternatives for their clinical development. "As Australia's CRO for biotechs, we are seeing an increasing number of South Korean biotechs selecting Australia to accelerate their Phase I and II trials," she said. "The high-quality of our data for FDA and other regulatory authority approvals is a key factor in the decision-making process."

The clinical trial environment in Australia supports rapid startup and a rebate of more than 40% on clinical costs as part of the Australian Government's clinical trial attraction incentive program.

In addition, Avance Clinical is accredited by the Office of the Gene Technology Regulator (OGTR) so it can manage gene technology trials in Australia.

This accreditation recognizes that Avance Clinical has the CRO resources and internal processes in place to effectively manage pre-clinical and clinical trials for products involving genetically modified organisms (GMOs).

Take the Quiz: Test your Knowledge about Australian Clinical Trials here. https://www.surveymonkey.com/r/Australian-Clinical-Trials

About Avance Clinical

Avance Clinical, Australia's CRO for biotechs, has more than 20-years of experience providing excellence in clinical research services for biotech companies from around the globe. Avance Clinical facilitates quality drug development by aligning people, skills, and expertise in the pursuit of drug development for a healthier world. The collective pool of knowledge and experience at Avance Clinical continually grows through the careful selection of experts who also demonstrate passion in their chosen field. Avance Clinical offers high-quality services in an established clinical trial ecosystem, that includes world-class investigators and sites able to access specific patient groups. Visit http://www.avancecro.com for more information.

Recent Awards:
Excellence in Business Award 2021
Frost & Sullivan Asia-Pacific CRO Market Leadership Award 2020

Other benefits of working with Avance Clinical include:
1. The Government R&D grant offers up to 43.5% rebate on clinical trial spend
2. COVID-19 clinical continuity
3. Site Initiation Visit (SIV) and Study Start achieved in 5 – 6 weeks
4. No IND required for clinical trials
5. Full GMP material is not mandated for Phase I clinical trials
6. Established clinical trial environment with world-class investigators and sites
7. Access to sites/Phase I facilities with established healthy subject databases and specific patient populations
8. Major hospitals with world-class infrastructures and dedicated Clinical Trial Units with a long track-record in FDA compliant research
9. Seasonal studies: Northern hemisphere sponsors can conduct their studies year-round by taking advantage of Australia's counter-flu and allergy seasons

Media Contact:
media@avancecro.com

Copyright 2021 ACN Newswire. All rights reserved. http://www.acnnewswire.com

Sino Biopharmaceutical 2021 First Quarterly Profit attributable to Owners of the Parent Soars 118.5% to RMB1.91 Billion

HONG KONG, May 24, 2021 – (ACN Newswire) – Sino Biopharmaceutical Limited ("Sino Biopharmaceutical" or the "Company", together with its subsidiaries, the "Group") (HKEX:1177), a leading and innovation-driven pharmaceutical conglomerate in the PRC, has announced its unaudited first quarterly results for the three months ended 31 March 2021.

Development Highlights
— Chia Tai – Tianqing Pharmaceutical Group Co. Ltd. ("CT Tianqing"), a member company of the Group, and Beijing-based Genetron Holdings Limited (NASDAQ: GTH) signed a strategic cooperation agreement on early screening of liver cancer. The two parties will work together in the next three years in selected areas in the country to serve those at high risk of developing liver cancer, including Hepatitis B carriers and other liver disease patients, thereby establishing industry benchmarks for early liver cancer screening in China and for the world.
— The Group's 6 products, namely Esomeprazole Magnesium Enteric-coated Capsules, Empagliflozin Tablets, Emtricitabine and Tenofovir Disoproxil Fumarate Tablets, Canagliflozin Tablets, Bortezomib for Injection and Ticagrelor Tablets, were included in the fourth batch of centralized procurement drugs. Of them, 4 products including Esomeprazole Magnesium Enteric-coated Capsules, are newly approved products which, being qualified for centralized procurement, are expected to quickly gain market share.
— The Group, through its subsidiary C-Lab International Limited, had acquired 100% equity interest in the Belgian private company SOFTHALE NV. SOFTHALE's soft mist inhalation device (SMI) operating on differentiated technology allows more efficient drug deposition in the lungs. It is the next generation transpulmonary drug delivery technology and has good application prospects in treating a board range of diseases such as chronic obstructive pulmonary disease. The Group also plans to through the acquisition build a key strategic hub for development in Europe.
— Fosaprepitant Dimeglumine for Injection, a drug developed by CT Tianqing for prevention of nausea and vomiting caused by chemotherapy, secured approval from the U.S. Food and Drug Administration (FDA). This is another entry pass to international markets obtained by the product, following that from the European Union. It is also another product developed by CT Tianqing that has been granted approval for launch from three mainstream international markets, namely China, the U.S. and Europe.
— Under the guidance of the Beijing Municipal Science and Technology Commission, the Management Committee of the Beijing Economic-Technological Development Area, the Chinese Academy of Medical Sciences and Sino Biopharm, the first "Future Stars" Innovation Achievement Transformation Project Competition hosted by the Institute of Materia Medica at Chinese Academy of Medical Sciences and Beijing Tide Pharmaceutical Co. Ltd., a member company of the Group, was held in Beijing between 6 and 7 January, 2021. The competition has helped enhance mutual understanding between R&D institutions and enterprises, and also presented enterprises an effective mechanism to transform R&D institutions' projects into products.

Sales of new products as a percentage to revenue increased to 47.4%, driving revenue up 16.4%; profit attributable to the owners of the parent climbed by 118.5%
During the period, the Group recorded revenue of approximately RMB7.24 billion, an increase of approximately 16.4% over the same period last year. Among them, sales of new products amounted to RMB3.43 billion, accounting for approximately 47.4% of the Group's total revenue for the period, up from approximately 32.9% last year. Profit attributable to the owners of the parent was approximately RMB1.91 billion, representing a year-on-year increase of approximately 118.5%. Earnings per share attributable to the owners of the parent were approximately RMB10.19 cents, an increase of approximately 118.7% over the same period last year.

The Group's financial position remains strong and stable, cash and bank balances totaled approximately RMB7.93 billion at the period end.

The Board of Directors declares a quarterly dividend of HK2 cents per share (Q1 2020: HK2 cents).

Building effective marketing by leveraging emerging online platforms amid the pandemic, which in turn boosted product sales; sales of oncology medicines doubled
During the period, the Group's marketing and sales team was able to accurately grasped opportunities arising from hospitals resuming service with the pandemic under control and more and more patients going to the hospital for consultation. Abiding strictly with pandemic prevention and control policies, marketing activities fully resumed and an effective marketing and service system was formed by integrating the online academic promotion and patient education and service platforms set up during the pandemic.

Sales of oncology medicines amounted to approximately RMB2.64 billion, representing an increase of 31.8%. Its contribution has quickly increased to approximately 36.4% and become the Group's largest product category in terms of revenue. With the well-known innovative drug Anlotinib giving the push, and newly launched products in good number and boasting wide coverage of indications, and by giving support to clinical experts in exploring various combined treatment options, Anlotinib as well as other products continued to see fast growth in sales. These products included Qingkeshu (Abiraterone), a prostate cancer drug on the national drug procurement list, the targeted therapy drugs for myeloma, namely Qianping (Bortezomib for injections), Andxian (Lenalidomide capsules), Anyue (Pomalidomide) and Leweixin (Bendamustine Hydrochloride for Injection), the first generic drug Qingkeyi (Fulvestrant Injection) for treating breast cancer, the first generic drug Weishou (Azacitidine for Injection) for treating leukaemia, and the antiemetic drug Shanqi (Fosaprepitant Dimeglumine for Injection).

In the cardiovascular and cerebrovascular segment, 8 products developed by the Group were selected in the past 4 rounds of national procurement. To make the best of those related opportunities, the Group worked hard on ensuring smooth production, logistics and supply of its products. As such, products including Tuotuo, Beilishu and Anxinfen reported satisfactory growth.

In the field of orthopedic and analgesia, the Group applied its chronic disease management system, well-established and strengthened during the pandemic period, to enhance services for doctors and patients. Gaisanchun (Calcitriol Capsules), Debaian/Zepolas (Flurbiprofen Cataplasms), Yigu (Zoledronic Acid Injection), Kaifen (Flurbiprofen Axetil Injection), Chia Tai Jiuli (Glucosamine Hydrochloride Tablets), Taiyan (Tofacitinib Citrate Tablets), Fenkexin, Yu An (Parecoxib Sodium for Injection), and Sulibao (Celecoxib Capsules) all achieved remarkable sales performance.

In the field of respiratory, the Group's first generic drug for allergic asthma, Tianqingsuchang (Budesonide Suspension for Inhalation), was launched, helping enrich the Group's respiratory product line and providing local patients with a new option for the first time other than imported products. At the prompt decision of the medical and marketing departments to set up a hospital service system pinpointing asthma patients, sales of the product increased markedly. Currently, the Group still has a number of respiratory products under development and the area will be one of its main foci in the future.

Digestive products, such as Getai (Diosmin Tablets) and Deyou (Pronase), infusion products Fenghaina (Compound Sodium Acelate Ringer's Injection), and contrast products, such as Qingliming (Iodixanol Injection) and Xianai (Gadoxetate Disodium Injection), performed far better than expected during the period.

Strong R&D capabilities has been the key profit driver
Over the years, the Group has put immense resources into bolstering its R&D capability to turn it into a key profit driver. It has 50 products on sale launched in or after 2018 and their total revenue grew over 90% during the period. The Group's product lines under development have strong reserves of new products to add to every year.

During the period, the Group obtained 7 production approvals: 3 specifications of Anlotinib Capsules' New Indication for Medullary Thyroid Carcinoma, 2 specifications of Esomeprazole Magnesium Enteric-coated Capsules, and 2 specifications of Empagliflozin Tablets; and 12 passes of Consistency Evaluation (or are deemed to have passed): 2 specifications of Esomeprazole Magnesium Enteric-coated Capsules (or are deemed to have passed), 2 specifications (or are deemed to have passed) of Empagliflozin Tablets, 2 specifications for Bortezomib for Injections, Parecoxib Sodium for Injection, Docetaxel Injection, 3 specifications of Decitabine for Injection, Alfacalcidol Soft Capsule. 7 pharmaceutical products obtained clinical trial approvals and 8 filed applications for clinical trial. 2 filed applications for production approval and 4 made application for Consistency Evaluation. The Group obtained 39 new invention patent approvals, and made 212 applications for invention patents. Cumulatively, the Group has obtained 963 invention patent approvals.

During the period, the total R&D expenditure was approximately RMB1.06 billion, accounting for approximately 14.7% of the Group's revenue.

Prospects: deploy the Internet and big data riding on the "Internet + healthcare" national policy
According to forecasts, the global economic recovery is likely to continue in the second quarter, with further divergence among economies depending on epidemic control, vaccine supply, economic fundamentals and stimulus policies. China's economic activity will continue to show a higher year-on-year growth rate after a full recovery due to its relatively low performance in the same period last year. Health care reform has entered deeper waters. The dynamic adjustment of the National Reimbursement Drug List and the normalization of centralized drug procurement will pave the way for the restructuring of the pharmaceutical industry. R&D innovation capability, production and operational efficiency will be the key to the survival and competitive success of pharmaceutical companies.

The Group has been aware of the trend of encouraging and promoting "Internet + healthcare" by national policy, and has started to deploy and will continue to make good use of the Internet and big data to efficiently and cost-effectively conduct academic activities while provide better services to patients through chronic disease management.

About Sino Biopharmaceutical Limited (HKEX:1177)
Sino Biopharmaceutical Limited is a leading, innovative R&D driven pharmaceutical conglomerate in the PRC. Its business encompasses a fully-integrated chain which covers an array of R&D platforms, a line-up of intelligent production and a strong sales system. The Group's products have gained a competitive foothold in various therapeutic categories with promising potentials, comprising a variety of biopharmaceutical and chemical medicines for tumors, liver diseases, cardio-cerebral diseases, orthopedic diseases, respiratory system diseases and parenteral nutrition.

Sino Biopharm is a constituent stock of the following indices: MSCI Global Standard Indices – MSCI China Index, Hang Seng Index, Hang Seng China Enterprises Index, Hang Seng Composite Index, Hang Seng Healthcare Index, Hang Seng SCHK Mainland China Healthcare Index, Hang Seng Composite LargeCap Index, Hang Seng Composite LargeCap & MidCap Index, Hang Seng China (Hong Kong-listed) 100 Index and Hang Seng Stock Connect Hong Kong Index, etc.. Sino Biopharm was ranked as one of "Asia's Fab 50 Companies" by Forbes Asia for three consecutive years in 2016, 2017 and 2018.




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Two Products of Zhaoke Ophthalmology (6622.HK) Passed The On-Site Inspection for Drug Registration of The National Medical Products Administration and The GMP Compliance Inspection of The Guangdong Medical Products Administration

HONG KONG, May 24, 2021 – (ACN Newswire) – Zhaoke Ophthalmology Limited ("Zhaoke Ophthalmology" or the "Company"; stock code: 6622), an ophthalmic pharmaceutical company dedicated to the research, development and commercialization of therapies that address significant unmet medical needs, announced that on 13 May 2021, two pharmaceutical products of the Company, namely Bimatoprost Timolol eye drop (a potential first-to-market generic drug in China targeting glaucoma, a fixed dose combination of a prostaglandin analogue and a beta-blocker) and Epinastine HCl eye drop (a potential first-to-market generic drug in China targeting allergic conjunctivitis with a dual mechanism of action of anti-histamine and mast cell stabilization), passed the on-site inspection for drug registration of the Greater Bay Area Center for Drug Evaluation of NMPA. The inspection verified the original records and information on the research and development as well as the manufacturing processes of the above two drug products.

The Company also passed the Good Manufacturing Practice (GMP) compliance inspection conducted by the Guangdong Medical Products Administration. It confirms that the Company has put in place a GMP management framework, a core team, a complete set of analytical instruments, equipment and facilities, a well-managed documentation system and proper operations of the production and quality systems.

Passing the on-site inspection for drug registration and GMP compliance is a major milestone for the Company. The positive result of the on-site inspection for drug registration of the Company as the first by any enterprise to complete such inspection conducted by the Greater Bay Area Center for Drug Evaluation of NMPA signifies NMPA's approval of the capacity of the Company's drug research and development system as well as the quality management system. It also validates that such systems can produce products compliant with the registration requirements in a sustained and consistent fashion.

The Company's manufacturing facility occupies approximately 7,600 sq.m. in Nansha New District, Guangzhou. It is designed and built for ophthalmic drugs in compliance with cGMP requirements of China, the United States and the EU with full manufacturing capability and ready for commercial-scale production. The Company is currently expanding its manufacturing capacity and expects to complete the expansion by the end of 2022.

Dr. Li Xiaoyi, Chairman of the Board, Executive Director and CEO of Zhaoke Ophthalmology, said, "The eye is a very sensitive organ of the human body, so we attach great importance to our production quality and safety, and strive to provide patients with the safest and highest quality products. Quality manufacturing is one of the core pillars of Zhaoke, passing the on-site inspection by the NMPA is a strong accreditation for the Company. It affirms all the hard work that we have put in over the years to ensure a quality manufacturing system."

The Company has submitted the abbreviated new drug application (ANDA) for both of the aforementioned generic drugs (Bimatoprost Timolol eye drop and Epinastine HCl eye drop) to NMPA. The Company expects to commence commercialization of these two products upon receiving their regulatory approvals in 2022. Their commercialization is expected to address the unmet needs by glaucoma patients and help the Company forge a close bond with downstream strategic channels such as partners, key opinion leaders, ophthalmologists and hospitals.

About Zhaoke Ophthalmology Limited
Zhaoke Ophthalmology Limited is an ophthalmic pharmaceutical company dedicated to the research, development and commercialization of therapies that address significant unmet medical needs in China. The Company has built a comprehensive ophthalmic drug pipeline of 25 candidates, comprising 13 innovative drugs and 12 generic drugs, that covers most major ocular indications affecting the front and the back of the eye, through either in-house development or in-licensing. The Company has developed internal capabilities in key aspects of ophthalmic drug development. The Company's specialized in-house research, development, clinical and regulatory capabilities have enabled it to concurrently advance multiple innovative and generic drug candidates through the preclinical and clinical stages. The Company has established a commercial-scale advanced manufacturing facility, which is designed and built for ophthalmic drugs in compliance with cGMP requirements of China, the United States and the European Union. The Company is led by an international management team with decades of industry experience and a track record of research and development, clinical operations, manufacturing, regulatory communications, business development and commercialization of ophthalmic therapies.

Zhaoke Ophthalmology has received strong endorsement from blue-chip pre-IPO investors, including GIC, Hillhouse Capital, TPG, Loyal Valley Capital, Orbimed and Aier Eye Hospital. The Company recently completed its HK IPO with cornerstone investors including CaaS Capital, GIC, Golden Valley, Jennison, Mass Ave, Matthews Asia, OrbiMed and VMS Investment.

Issued by Porda Havas International Finance Communications Group for and on behalf of Zhaoke Ophthalmology Limited. For further information, please contact:

Porda Havas International Finance Communications Group
Zhaoke.hk@pordahavas.com



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