Malaysia Permission Granted for COVID-19 Test Kit from China for Emergency Use; Homegrown Holista Colltech Receives Initial Order for 15,000 Units for Deployment

KUALA LUMPUR, Jun 18, 2021 – (ACN Newswire) – Amid rising concerns about the threat and economic impact of COVID-19, Holista Colltech Limited has been granted permission for Special access under the Medical Device (Exemption) Order 2016, from the Medical Devices Authority ("MDA") of Malaysia's Ministry of Health ("MOH") to import and distribute for an antigen rapid test kit (RTK-AG) developed and manufactured by Guangdong Hecin Scientific Inc. ("Hecin") of China. With this approval, the Company has secured an initial order for 15,000 units in Malaysia.

Holista Colltech Limited ("Holista"), a natural wellness and health products specialist headquartered in Petaling Jaya and listed on the Australian Securities Exchange ("ASX: HCT"), said the Hecin(TM) 2019-nCOV diagnostic test kits will be used to detect the presence of the SARS-CoV-2 viral antigen from nasal swabs within 15 minutes.

Antigen tests look for the coating or proteins of the virus while Polymerase Chain Reaction ("PCR") tests detect its nucleic acid, or genetic material (also known as RNA). The former can deliver results within minutes and generally cost less; the latter, while more accurate, can take up to several days and are generally more expensive.

The 15,000 units will be shipped by the end of this month to Klinik Mutiara, part of Amegajaya Sdn Bhd, a medical consultancy that works closely with MOH and related organizations. The maiden order secured by Holista's wholly owned Holista Biotech Sdn. Bhd. is worth approximately A$95,000 (US$73,000). The kits will be used by registered professionals at Klinik Mutiara for screening purposes.

MOH's Medical Devices Authority ("MDA") has granted Holista permission to import and distribute up to 45,000 units of the Hecin antigen test kit for emergency use within three months from the date of approval on 14th June 2021.

The clinical performance of Hecin RTK-Antigen test kit against PCR Comparator method using nasopharyngeal swabs specimens has obtained a sensitivity of 96.23% and specificity 99.07%. The trial was carried out in Daye City Center for Disease Control and Prevention within China. The results serve as the basis for obtaining the CE mark in Europe. The MDA also conducted its own clinical trials in Malaysia prior to this approval.

The MDA has also granted Holista similar import and distribution approval for Hecin Antibody Test kit which can test human serum, plasma or whole blood for levels of antibodies to assess immunity after vaccination.

Holista has rights to distribute the Hecin COVID-19 test kits in Brunei, Thailand, Indonesia, Philippines, Taiwan, Vietnam, Cambodia, Laos, Myanmar, Singapore and the United Kingdom.

The channel distribution will be handled by Holista's long-time partner, Zuellig Pharma.

Holista will build upon the approvals and commercial arrangements for these test kits to extend distribution rights and partnerships worldwide for pandemic-related infection control, testing and related healthcare solutions.

"The pandemic has impacted Malaysia severely with rising infections, deaths and prolonged movement controls which have disrupted business, education, social interaction and many other activities. Rapid testing is the key to controlling the spread of infection and revive economic activity with confidence," said Holista's CEO, Dato' Dr Rajen Manicka.

"An infected person can spread the virus for several days without showing symptoms. To counter this, regular antigen RTK testing can curb infections control in a very affordable manner. High frequency mass testing has been hugely successful in curbing infections in China, South Korea, Slovakia, Switzerland and the United Kingdom. We are glad that they are being introduced in Malaysia," he said.

"The Slovakia approach of testing brought infections down by more than 50%. Its success has been reported by British Medical Journal, The Lancet, Science and Scientific American earlier this year," Dato' Dr Rajen added.

Holista has also developed a mobile application that allows efficient tracking and tracing based on the 'Traffic Light' model that has been successfully deployed by the National Health Service in the United Kingdom.

About Holista CollTech Limited

Holista CollTech Ltd ("Holista") is a natural wellness company with the following divisions:
– Infection Control Solutions
– Dietary supplements
– Food Ingredients
– Ovine collagen

Holista has a global collaboration with Global Infection Control Consultants LLC to use Path-Away�, a plant-based solution that is proven to kill a broad spectrum of microbes. The all-natural alcohol-free active ingredient is used in Holista's range of sanitising products under the NatShield� brand.

Listed on the Australian Securities Exchange ("ASX"), Holista researches, develops, manufactures and markets health style products. Holista's suite of ingredients includes low GI baked products, reduced-sodium salts, low-fat fried foods and low-calorie sugar without compromising taste, odour and mouthfeel. Holista also produces sheep (ovine) collagen using patented extraction methods. For more information on Holista, please visit https://www.holistaco.com/

Media Contact:
WeR1 Consultants Pte Ltd
E: holista@wer1.net
M: +65 6721 7161

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

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.




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

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



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

USFDA recognized Antrodia cinnamomea mycelia (NDIN No.1170)

TAIPEI, May 20, 2021 – (ACN Newswire) – The history of Antrodia cinnamomea consumption by indigenous tribes in Taiwan dates back two hundred years ago, while people in the Western world know little about this ingredient. The USFDA NDI acknowledgement without objection to Greenyn's Antromax was the 1st notification after numerous attempts in the past 14 years. We are honored to establish a stepping-stone for the A. cinnamomea to the US health markets estimated at 10 billion US dollars.



Dr. Kao Shung-te (middle) of China Medical University Hospital and Dr. Houng Jer-yiing (left) of I-Shou University Medical School presented the study results of the randomized double-blind clinical trial and the bioavailability of Antromax in different dosages forms, respectively.


Antromax(R)– dripping pills, mycelia powder, emulsion powder (left to right).


Manufacturing site of Greenyn Biotechnology in Taichung


Health food of Antromax(R) in livercare in Taiwan (left) and Antromax(R) complex beverage (right).



USFDA acknowledged Antrodia cinnamomea as new dietary ingredients

On April 12th, Greenyn Biotechnology Corporation hosted a seminar – "The international development of Taiwan's Antrodia cinnamomea and its clinical application," and announced Antromax's acknowledgement without objection by USFDA NDI. It was a great feat for Greenyn, and will certainly boost the morale of the Antrodia industry to devote more resources in the US market.

A. cinnamomea is an edible fungus grows on the endangered Cinnamomum kanehirae tree which is found only in Taiwan. This indigenous fungus is traditionally used to ameliorate liver disorders, hangovers, fatigue, and enhance immunity. "Ruby of Taiwan" was given to this miracle fungus.

"We are surprised that this time we have obtained the USFDA NDI No. 1170 notification without objection for Antromax for marketing in the United States," pointed by Luo Hsuan, CEO of Greenyn. Over the past years, it was difficult to obtain such notification because A. cinnamomea is unknown to the western world; its' safety data, eating and application history is very limited. "It is a significant milestone and a good timing for us to step into the global market. We do hope that Taiwan's A. cinnamomea industry may take this opportunity to march into the global arena," Luo Hsuan added.

According to Dr. Hsu Pang-kuei, the R&D director of Geeenyn, A. cinnamomea is rare and grows very slowly in the wild. For medicinal purposes, you need to wait three years until it is fully grown and it is impossible to increase production/cultivate indoor as the tree Cinnamomum kanehirae is protected under the plant conservation laws. Fortunately, with Greenyn's solid-state fermentation technology, we are able to cultivate Antromax "A. cinnamomea mycelia" with active ingredients similar to the fully grown in just 3 months. This patented fermentation process will not only maintain the conservation of the tree, but will also lower the production cost, so the public may enjoy this natural healthy food at a reasonable price.

Clinical trials indicate Antrodia cinnamomea is effective as adjuvant treatment

During the seminar, Dr. Kao Shung-te, Attending Physician of China Medical University Hospital, shared the findings of Antromax in the clinical adjuvant treatment for hepatitis B. "Through medical trials, it is discovered that Antromax has an adjuvant treatment effect combined with the hepatitis B medicine. The liver function indexes are improved, and there are no adverse effect on the biochemical values in blood and urine."

In addition, Dr. Houng Jer-yiing, Associate Dean of the I-Shou University Medical School, shared that the bioavailability of Antromax in different dosage forms have similar adjuvant effects – lowering liver function indexes, liver fat accumulation and alcohol-related liver injuries, as well as enhancing activities of antioxidant enzymes.

Greenyn's facility is built to the international standards in the Central Taiwan Science Park with capacity of up-to 12 metric tons annually, which is sufficient for the global markets. Dr. Hsu says, "At present, we will focus on the US and Europe markets, and next we might start to promote in Asia such as Korea, Southeast Asian countries and Australia." In view of the US herbal supplements market worth USD 9.6 billion, Greenyn is honored to lead Taiwan's biotech industry to promote A. cinnamomea in the US markets. It is foreseeable that the health benefits of A. cinnamomea to the world during covid-19 will create another pride for Taiwan.

https://youtu.be/T1f84y2vzeY

Media Contact
Greenyn Biotechnology Co. Ltd.
Phone: +886-968-199-656
Contact: Nick Chen
Email: info@greenyn.com.tw
Website: http://en.greenynbio.com/index.php

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

APOLLOMICS INC. ANNOUNCES OFFICIAL OPENING OF SHANGHAI BRANCH

Foster City, CA, Shanghai and Hangzhou, China, May 20, 2021 – (ACN Newswire) – Apollomics Inc., an innovative biopharmaceutical company committed to the discovery and development of mono- and combination- oncology therapies, today announced that Apollomics Shanghai Branch has been officially opened and started its operations at Zhangjiang Hi-Tech Park, Pudong District, Shanghai.

Dr. Guoliang Yu, the company's Co-Founder, Chairman and CEO said, "In 2018, we established a Chinese company in Hangzhou, and our Chinese team has grown from a few people to dozens of people. The Shanghai branch is located in the Silicon Valley of bioinnovative drugs in China, Zhangjiang Medicine Valley, which has gathered top talent from research and development, clinical and commercialization. Many of our clinical trials in China are soon to be carried out. The establishment of the Shanghai branch will be more conducive to the construction of our diverse talent team and will also promote connection and communication with domestic and foreign partners."

About Apollomics, Inc.
Apollomics, Inc. is an innovative biopharmaceutical company committed to the discovery and development of monotherapies and combination therapies of tumor-targeting agents and immuno-oncology agents. It has operating entities in Foster City, California, USA and Hangzhou, China. The company's product pipeline has many projects at different stages of development, including novel, humanized monoclonal antibodies that restore the body's immune system to recognize and kill cancer cells, and targeted therapies against uncontrolled growth signaling pathways. For more information, please visit www.apollomicsinc.com.

Contact information of Apollomics:
Investor Contact:
Wilson W. Cheung
Chief Financial Officer
Telephone: +1-650-209-4436
Email: wcheung@apollomicsinc.com

Company Contact:
Liping Zhang
Telephone: +86-571-83521933
Email: liping.zhang@apollomicsinc.com

U.S. Media Contact:
Remy Bernarda
Corporate Communications
(415) 203-6386
remy.bernarda@apollomicsinc.com

China Media Contact:
Porda Havas International Finance Communications Group

Kelly Fung
General Manager
Telephone: (852) 3150 6763
Email: kelly.fung@pordahavas.com

Phoenix Fung
Assistant Vice President
Telephone: (852) 3150 6773
Email: phoenix.fung@pordahavas.com


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

Avance Clinical Expands Gene Technology Clinical Trial Services to Meet $17.4 billion Market Demand

ADELAIDE, AUS, May 7, 2021 – (ACN Newswire) – The leading Australian CRO for biotechs and Frost & Sullivan Asia-Pacific CRO Market Leadership Award winner, Avance Clinical, has expanded its gene technology clinical trial services to meet the increasing global demand predicted to reach $17.4 billion by 2023.





Avance Clinical is accredited as a gene technology CRO under the Office of the Gene Technology Regulator (OGTR).

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).

In Australia, dealings with GMOs in clinical research requires authorisation under the Gene Technology Act 2000. The OGTR administers the Gene Technology Act 2000, and has specific responsibility to protect the health and safety of people, and to protect the environment, by identifying risks posed by or as a result of gene technology, and by managing those risks through regulating dealings with GMOs.

The global market for genetic modification therapies is expected to grow from $2.3 billion in 2018 to reach $17.4 billion by 2023, growing at a compound annual growth rate of 49.9% (BCC Research, 2018). The utilization of gene modification technologies used in COVID-19 vaccine products is likely to translate in further growth in this field of therapeutics.

Avance Clinical CEO Yvonne Lungershausen said OGTR accreditation is important for our international clients. "Our clients need to know that their CRO has all the necessary credentials and is capable of delivering the highest of clinical research standards in this exciting and rapidly evolving sector," she said.

Avance Clinical currently has a number of GMO studies underway and is expanding its services further to accommodate increasing global demand.

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

About Avance Clinical

Australia's Avance Clinical has more than 20-years of experience and is now one of Australia's leading Contract Research Organizations. Avance Clinical facilitates quality drug development by aligning people, skills, and expertise in the pursuit of drug development for a healthier world.

Avance Clinical is committed to providing high-quality clinical research services with its highly-experienced team. The collective pool of knowledge and experience at Avance Clinical continually grows through the careful selection of experts who also demonstrate passion in their chosen field. Avance Clinical offers high-quality services in an established clinical trial ecosystem, that includes world-class Investigators and Sites able to access specialized patient groups. Visit http://www.avancecro.com for more information.

Other benefits include:
1. The Government R&D grant means up to 43.5% rebate on clinical trial spend
2. Telehealth pivot during COVID-19 pandemic – speed and continuity
3. Site Initiation Visit (SIV) and Study Start achieved in 5 – 6 weeks
4. No IND required for clinical trials
5. Full GMP material is not mandated for Phase I clinical trials
6. Established clinical trial environment with world-class Investigators and sites
7. Established healthy subject databases and specialized patient populations
8. Five independent Phase 1 facilities across Australia including hospital-based units for critical care
9. Major hospitals with world-class infrastructures and dedicated Clinical Trial Units with a long track-record in FDA compliant research
10. Seasonal studies: Northern hemisphere Sponsors can conduct their studies year-round by taking advantage of Australia's counter-flu and allergy seasons

Media Contact:
media@avancecro.com

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

Scivita Medical Raises Nearly RMB0.4 Billion in Series A Funding Round and Strives to Build A World-leading Platform for Innovative Products in Endoscope and Related Fields

HONG KONG, Apr 26, 2021 – (ACN Newswire) – Scivita Medical Technology Co., Ltd. ("Scivita Medical") today announced that it has raised nearly RMB0.4 Billion in Series A funding round, which has become one of the highest financing projects in the field of endoscope in China in recent years. The investment was jointly led by GL Ventures and Lilly Asia Ventures, with contribution from Matrix Partners China, Medtronic, Chengwei Capital and Shanghai Innochip Investment. The successful completion of the Series A funding round reflects the recognition of Scivita Medical in the field of endoscope and the expectation of its future development from the capital market and industrial strategic partners. Scivita Medical will strive to build the world's leading platform for innovative products in endoscope and related fields.





Founded by Dr. ZHANG Yi and Dr. CHEN Dong, Scivita Medical is headquartered in Suzhou Industrial Park with R&D centers in Suzhou, China, and Tokyo, Japan, focusing on the image processing R&D and technology innovation of endoscope. Scivita Medical is a high-tech enterprise engaged in the field of optical diagnosis and treatment, multidimensional images development, high-performance materials research and precision manufacturing with minimally invasive medical treatment. Scivita Medical's product covers both flexible endoscopy and rigid endoscopy, and has unique advantages in the research and commercialization of all cutting-edge technologies in the field of medical endoscopes. It has ultra-high-definition visualization technology (such as 4K UHD visualization), 3D visualization technology, special light visualization technology (such as fluorescence visualization), ultra-fine endoscopic visualization technology, single-use technology, etc.

According to Frost & Sullivan, it is estimated that by 2024, the overall scale of the global endoscope devices market will grow to USD26.98 billion, and the Chinese endoscope market size will reach RMB42.3 billion, becoming one of the fastest growing medical device sub-industries in the world. With the popularization of minimally invasive diagnosis and treatment technology worldwide, the endoscope industry has also entered a stage of rapid development.

The endoscope industry has higher technical barriers, involving multi-disciplinary and multi-fields, which integrates medicine, optics, materials, precision machinery, electronic engineering, software development and other disciplines, and has more technical content as compared to traditional mechanical manufacturing. At present, the endoscope equipment market presents an oligopolistic situation, with international brands occupying a large market share by relying on first-mover advantages and mature technological advantages. Scivita Medical has successfully achieved breakthroughs in key areas such as optical imaging and image processing of endoscopes, breaking down the technological monopoly of international brand products.

Scivita Medical accurately grasps the clinical needs, and combines innovative technologies in multi-disciplinary fields to develop excellent Chinese products that are recognized by clinical experts worldwide.World's first 2D to 3D " 3D Visualization System" developed by Scivita Medical obtained NMPA certification and CE certification in July 2018, and became the first domestic 3D Visualization System approved by the U.S. FDA launched in the United States in September 2019. The "4K UHD Camera System" independently developed by Scivita Medical obtained NMPA certification in June 2019. It was launched in China as the first domestic 4K UHD camera system and obtained CE certification in July 2019. In August 2020, the "4K UHD Camera System" became the first Chinese 4K product that was certified by the U.S. FDA.

In addition, Scivita Medical has various single-use endoscopy devices with international competitiveness, many of which have entered the clinical, registration, or sales stages in China, the United States, Europe and other countries and regions, respectively. Given that endoscope industry has entered into the era of consumables, Scivita Medical will compete with international brands in the global market with its disruptive single-use technology and leading technological advantages.

Dr. ZHANG Yi, Co-founder of Scivita Medical, said: "The company's founding management team expresses sincere gratitude to the industry's top investment institutions and industry strategic partners for their recognition and support. In the next few years, endoscope products will fully realize the iteration from 'HD' to 'Ultra HD', and from 'reuse' to 'single-use'. Relying on the world's leading technology and strong sustainable R&D strength, and with the support from investment institutions and the continuous attention from our peers, Scivita Medical will form a platform with a comprehensive layout of innovative products in endoscope and related fields. It is committed to using domestic high-quality innovative products to replace and compete with international brand products, and striving to build a world-leading endoscope R&D brand that are rooted in China. The original intention of Scivita Medical is to solve the clinical pain points, making diagnosis and treatment safer and more effective, and help every patient and their family. Scivita Medical will make unremitting efforts for it. "

Michael Nuoqing YI, Co-Chief Investment Officer of Hillhouse and Head of Biomedicine and Medical Devices of GL ventures, said: "With the advancement of hierarchical diagnosis and treatment, the development of minimally invasive surgery and the aging population, the clinical demand for endoscope is rising rapidly and there is a huge room for domestic substitute. Scivita Medical takes a leading position at home and abroad. Its products are independently developed, which covers electronic and optical endoscopes. It has ultra-high-definition visualization technology, 3D visualization technology, special light visualization technology, ultra-fine endoscopic visualization technology and single-use technology. Hillhouse would like to have a long-term companionship with outstanding entrepreneurs like Dr. ZHANG Yi and Dr. CHEN Dong, who are innovative and with excellent management experience. Hillhouse also aims to help Scivita Medical continue to make efforts on R&D and innovation, so as to using domestic high-quality innovative products to replace international brand products, and actively participate in international competition and to benefit more patients."

Dr. CHEN Fei, Managing partner of Lilly Asia Ventures, said: "The technical barrier of endoscope industry is very high. We are very optimistic about the strong technical experience and innovative R&D capabilities of Scivita Medical team in terms of rigid and flexible endoscopes. The 4K UHD Camera System independently developed by Scivita Medical was the first one approved by China National Medical Products Administration and FDA, and it is highly recognized by clinical experts. Leverage on its distinctive product solutions and forward-looking industrial layout, we believe Scivita Medical can become the leader in technological innovation in the field of endoscopy in China and even in the world.

Dr. Eric YU, Partner of Matrix Partners China, said: "Endoscope has a high technical barrier, and the domestic market has long been monopolized by foreign giants. Scivita Medical has strong technical strength in the next generation of 3D, ultra HD and single-use endoscopes, which have all reached or surpassed foreign giants. We look forward to the company's further performance and clinical promotion of the products, which will bring clinical benefits to Chinese doctors and patients.

Dr. SHI Yonghui, Managing Director of the Corporate Development and Venture Capital Department (Greater China) of Medtronic, said: "It is Medtronic's global mission to relieve pain, restore health, and extend life for patients around the world. Medtronic China has always been committed to supporting the application of innovative medical technology in the local market. Since the establishment of the Venture Capital Fund and Innovation Accelerator after 2016, it has invested in and incubated more than 10 medical technology companies. By strategically investing in Scivita Medical, we hope that both parties could carry out multi-level strategic cooperation in the field of endoscope, and finally bring prime medical solutions to thousands of Chinese patients."

YAN Di, Vice president of Chengwei Capital, said: "The current localization rate in the endoscopy industry is less than 10%, and the demand for domestic substitution is strong. We are very pleased to see that Scivita Medical's endoscope products can break through the monopoly of foreign technology and solve the current handicap that local products cannot enter the high-end market. It fills the gap in the high-end endoscope market. It is a domestic brand with rigid and flexible endoscopy technology. We believe that Scivita Medical will become a leader in the field of endoscope and help further development of clinical medicine."

WANG Zhi, Partner of Shanghai Innochip Investment Management Co., Ltd., said: "We are very optimistic about the trend of ultra HD and single-use evolution of medical endoscope systems under the background of the miniaturization of CMOS image sensor chips. This trend is expected to break the monopoly situation occupied by European, American and Japanese companies, and provides Chinese companies with international vision and innovative technology capabilities, represented by Scivita Medical, with opportunities to surpass competitors within the same filed. I believe that Chinese companies will make innovative and high-quality endoscopes, which will benefit to more patients."


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