Adelaide, AU & North Carolina, USA, Feb 28, 2024 – (ACN Newswire) – Avance Clinical, the award-winning Australian and North American market-leading CRO for biotechs, has today spoken with SCRIP about their positive outlook for the US biotech sector following the J.P. Morgan Healthcare Conference and Biotech Showcase meetings. (read the full article here)

Avance Clinical CEO, Yvonne Lungershausen was interviewed by SCRIP Intelligence about the current biotech financial and drug development climate in the US and signs of growth.

Lungershausen noted there was a positive shift in sentiment compared to the previous year, with some companies even announcing their Series A funding during the conference. However, she emphasized that investors remained cautious, demonstrating a low-risk appetite in their investment decisions.

“We’re seeing green shoots in terms of funding coming through now in the US, but I think it’s still a bit of a tough road ahead. Investors are really being super cautious about where they’re investing and relatively, there’s not a high-risk appetite,” Lungershausen said to SCRIP in the interview.  

The Avance Clinical team engaged with industry leaders at the J.P. Morgan Healthcare Conference and Biotech Showcase, sharing insights into the evolving landscape of biotech funding, their strategic partnerships in the AI sector, and ground-breaking developments in oncology study design. 

The interview also covered AI saying “Lungershausen indicated that Avance had taken the position of having an innovation and technology group specifically to look at how the CRO can best support clients to get the data that they need for their trials as quickly as possible.

Avance Clinical, she said, is looking at partnerships with companies developing AI and making the assessment of “whether or not that’s something that we should bring in-house and offer to our clients”. It is also keen to work with some of those companies in terms of helping them “understand what the landscape requires”.

According to the interview “Avance’s CEO maintained that Australia also featured “high on the agenda” for a lot of the biopharma companies at JPM “because time is money”.

“That came through over and over again and the ability to start fast with high-quality data that is readily accepted by the US Food and Drug Administration and other regulatory agencies was very important,” she explained.

While a 43.5% rebate on clinical trial costs in Australia provides biopharma clients “a longer runway with their money”, there’s also the exchange rate advantage that typically comes into play.

Importantly, sponsors also don’t require to have an active own-country IND to initiate trials in the island continent. That, Lungershausen stated, is the “biggest advantage” and is possible because Australia has a streamlined and efficient regulatory process.”

According to the interview she said “that amid the generally tight funding environment what also came through strongly…was the need for biotechs to find the right partner”.

SCRIP Intelligence noted that Avance Clinical presented at JPM and Biotech Showcase a new analysis by market research leader, Frost & Sullivan on the biotech sector and the challenges they have finding the right fit or size CRO (See report here).

The analysis has shed light on critical hurdles faced by more than 60% of US biotechs seeking the right CRO partner to propel their drug development programs forward.

SCRIP Intelligence said Lungershausen believes that Avance Clinical “is ideally positioned being able to support biopharma with the advantages of Australia for early phase trials and “start fast but then pivot back to the US very quickly”.

“They’re looking for a partner that can seamlessly help transition them and there’s a lot of excitement about that,” she said.

The comprehensive report underscores the increasing preference of biotechs to collaborate with mid-sized, agile, and responsive CROs with a proven track record of swiftly advancing high-quality clinical programs. The findings suggest that large multinational CROs may be perceived as less responsive and less adept at adapting to the fast-paced nature of biotech demands.

Key insights from the analysis:

1. Challenges in Partner Selection: The analysis reveals that 60 to 65% of US biotechs encounter challenges in identifying the right-sized CRO partner capable of delivering at every phase of their drug development program.

2. Perception of Large Multinational CROs: There is a notable perception among biotechs that large multinational CROs may be less responsive and adaptable to the dynamic requirements of the biotech industry.

3. Biotech Funding Decline: The report highlights challenges faced by biotechs, including a decline in biotech funding, increased drug development complexity, evolving FDA regulatory review processes, and costly delays due to slow patient recruitment.

4. Engagement with Multiple CROs: More than 50% of biotechs engage with more than one CRO during their clinical program, leading to increased costs, delays, and challenges in knowledge and data transfer.

Find out more:

Learn about the GlobalReady model here https://www.avancecro.com/avance-clinical-north-america-operations/

For more information about the benefits of running your next study with Avance Clinical contact us: enquiries@avancecro.com

Media Contact:
Avance Clinical
Kate Thompson
media@avancecro.com 

About Avance Clinical

Avance Clinical is the largest premium full-service Australian and North American CRO delivering quality clinical trials, with globally accepted data, in Australia, New Zealand and the US for international biotechs. The company’s clients are biotechs completing Phase I to Phase III of their drug development program that requires fast, agile, and adaptive solution-oriented clinical research services.

Frost & Sullivan Awards
Avance Clinical, a Frost & Sullivan Asia-Pacific CRO Market Leadership Award recipient for the past four years, has been providing CRO services in the region for more than 26 years.

Pre-clinical through to mid to late phase
Avance Clinical offers pre-clinical services with their experienced ClinicReady team right from pre-clinical through to Phase III clinical services leveraging significant Australian Government incentive rebates of up to 43.5% and rapid start-up regulatory processes.

With experience across more than 120 indications, the CRO can deliver world-class results and high-quality internationally accepted data for FDA and EMA review.

Technology
Avance Clinical uses state-of-the-art technology and gold standard systems across all functional areas to provide clients with the most effective processes. Medidata, Oracle, TrialHub, Certinia, Salesforce, Zelta and Medrio are just some of the technology partners.

www.avancecro.com

Copyright 2024 ACN Newswire. All rights reserved. http://www.acnnewswire.com

SAN FRANCISCO, CA, Jan 9, 2024 – (ACN Newswire) – Avance Clinical, the leading Australian and North American CRO for biotechs announced today that new industry analysis shows 60-65% of US biotechs face challenges identifying the right sized CRO partner that can deliver at every phase of their drug development program. The report found this directly affected clinical programs and budgets.

View the report here

The report also found that 50% of biotechs engaged with more than one CRO over the course of their clinical program potentially impacting knowledge transfer, timelines and budget.

The new analyst report from Frost & Sullivan examined the challenges biotechs face during the CRO selection process saying “biotechs are increasingly wanting to partner with mid-sized, agile, and responsive CROs with a proven ability to rapidly advance quality clinical programs”.

“There is a perception among biotechs that large multinational CROs are less responsive and unable to adapt to the fast-paced nature of biotech demands,” according to the report.

Additionally, it noted that biotechs currently faced multiple challenges including a decline in biotech funding, a rise in drug development complexity, evolving FDA regulatory review processes, and costly delays caused by slow patient recruitment.

The report concluded that biotechs, especially those aiming to meet investor milestones, need to select the right CRO from the start.

The report outlined the key criteria US-biotechs use to identify the right CRO including:

1.    Established site relationships
2.    Scientific excellence 
3.    Quality compliance and data excellence
4.    Cost competitive
5.    Patient recruitment solutions
6.    Agile and responsive 
7.    Accelerated timelines
8.    Regulatory approval track-record
9.    Ability to expand to multi-regional global phases
10.    Access to latest technologies (including Artificial Intelligence & Machine Learning)

The report emphasized that biotechs were seeking CROs with established site relationships and highlighted that Avance Clinical now has more than 1,250 US-based sites in their GlobalReady Site Partnership Program to support US biotechs accelerate their clinical trials.

Each site has been accredited by Avance Clinical for data quality, patient centricity, and streamlined processes designed meet rigorous clinical timelines.

In addition, the report found a regulatory affairs track-record was a key selection criteria saying in-house regulatory expertise was the most attractive option for biotechs. It found that Avance Clinical is one of the only Australian/US mid-sized CRO with an inhouse regulatory affairs team experienced in FDA, EMA and China FDA approval processes.

Avance Clinical presented the report at JPM and Biotech Showcase 2024 where the team is taking meetings.

Avance Clinical has been recognised by Frost & Sullivan for the past 4 years with the prestigious Frost & Sullivan Asia-Pacific CRO Best Practices Leadership Award.

CEO Yvonne Lungershausen said “We have shown, with our high growth and industry-leading repeat business rates that our focus on gold standard technology paired with solution-orientated clinical experts is the mix our biotech clients need for clinical success”.

“Avance Clinical’s GlobalReady model is designed to extend biotechs’ investments so they can achieve greater clinical development milestones with reduced spend, all with the assurance of FDA accepted data,” she said.

GlobalReady gives our biotech clients conducting their early phase studies in Australia and New Zealand a seamless journey into the US to continue their clinical development programs, retaining the same high-quality CRO, which reduces time and cost and delivers quality FDA accepted data.

GlobalReady also enables US biotechs to conduct their mid to late phase studies in the US and expand to multi-regional locations.

In addition, the attractive 43.5% rebate on clinical spend in Australia, offers clients the opportunity to utilize our North American operations expertise and team, whilst maintaining services in Australia to maximise their rebate potential.

Find out more:

• Learn about the GlobalReady model here https://www.avancecro.com/avance-clinical-north-america-operations/
• For more information about the benefits of running your next study with Avance Clinical contact us: enquiries@avancecro.com 

About Avance Clinical

Avance Clinical is the largest premium full-service Australian and North American CRO delivering quality clinical trials, with globally accepted data, in Australia, New Zealand and the US for international biotechs. The company’s clients are biotechs completing Phase I to Phase III of their drug development program that requires fast, agile, and adaptive solution-oriented clinical research services.

Frost & Sullivan Awards

Avance Clinical, a Frost & Sullivan Asia-Pacific CRO Market Leadership Award recipient for the past four years, has been providing CRO services in the region for more than 26 years.

Pre-clinical through to mid to late phase

Avance Clinical offers pre-clinical services with their experienced ClinicReady team right from pre-clinical through to Phase III clinical services leveraging significant Australian Government incentive rebates of up to 43.5% and rapid start-up regulatory processes.

With experience across more than 120 indications, the CRO can deliver world-class results and high-quality internationally accepted data for FDA and EMA review.

Technology

Avance Clinical uses state-of-the-art technology and gold standard systems across all functional areas to provide clients with the most effective processes. Medidata, Oracle, TrialHub, Certinia, Salesforce, Zelta and Medrio are just some of the technology partners.

www.avancecro.com

Media Contact:
Avance Clinical
Kate Thompson
media@avancecro.com

Copyright 2024 ACN Newswire. All rights reserved. http://www.acnnewswire.com

Adelaide, Australia & North Carolina, USA, Oct 19, 2023 – (ACN Newswire) – Avance Clinical, the Australian and North American market-leading CRO for biotechs, was asked to present their GlobalReady drug development solution to more than 45 Korean biotechs and pharmaceutical companies in Seoul, Korea last week as part of a special symposium at KoNECT Korea Conference. 

Avance Clinical’s Korean CRO partner Dt & SanoMedics initiated the Global Clinical Trial Strategy Symposium and invited Avance Clinical to co-host. 

The Avance Clinical team, including CEO Yvonne Lungershausen, and Vice President, Commercial Business Development, Liahna Toy discussed drug development options including conducting clinical trials across South Korea, Australia, New Zealand, and the United States to support fast tracking clinical trial development programs. 

Yvonne Lungershausen said Avance Clinical offers two critical solutions for biotechs.

“Avance Clinical in Australia can maximise the 43.5% rebate on clinical trial spend, and in the United States can provide high quality trials following the FDA pathway. Both approaches were received as attractive propositions for biotechs wanting to maximise their data captured and conserve funding,” she said.

“Our Avance Clinical teams in Australia and the United States offer world-class quality data and cultural alignment for Korean biotech clients designed to make their drug development programs seamless and successful.” 

“Avance Clinical’s study data is accepted by all the main regulatory authorities including the MFDS and FDA; and conversely the Therapeutic Goods Administration (TGA) in Australia recognises data generated in Korea.” 

Yvonne Lungershausen thanked Korean CRO partner Dt & SanoMedics for arranging the Global Clinical Trial Strategy Symposium.

“This was an impressive group of biopharma companies and we are extremely excited to be part of their clinical program as they expand to the United States.”

“Thank you to Chairman of the Dt&C group, Charles Park and Yujin Lee, Vice-President of Dt & SanoMedics, and the entire team for welcoming and hosting Avance Clinical in South Korea.” 

Dt & SanoMedics VP Yujin Lee said the partnership with Avance Clinical has been further strengthened with the team providing valuable international drug development strategies for the Korean biotech community. 

“We are pleased to introduce the Avance Clinical team because we know they stand for quality. Importantly, they have the experience and track-record especially in the United States which is where most biotechs will be conducting their later phase trials.” 

“We believe this has been an important visit which has enabled us to enhance our partnership and actively help Korean companies enter the US and Australian pharmaceutical markets,” she said. 

About Avance Clinical 

Avance Clinical is a full-service CRO for biotechs with a proven track-record for delivering clinical excellence in Australia, New Zealand, and North America. As the largest premium full-service CRO in Australia and North America, Avance Clinical specializes in delivering top-tier clinical trials that yield globally accepted data.  

Award-winning CRO for Biotechs 

Avance Clinical has been recognised for the fourth consecutive year by Frost & Sullivan in 2023, being awarded the Best Practices Customer Value Leadership for Biotech’s award, for its continuous exceptional performance. 

Pre-clinical through to Phase I and Beyond 

Avance Clinical offers pre-clinical consultancy services with their experienced ClinicReady team right through to Phase I and beyond clinical services leveraging significant Government incentive rebates of up to 43.5% and rapid start-up regulatory processes that are available in Australia and highly qualified sites and networks within the United States. With experience across more than 110 therapeutic indications, Avance Clinical can deliver world-class, high-quality, internationally accepted data suitable for FDA and EMA review. 

Technology 

Avance Clinical uses state-of-the-art technology and gold-standard systems across all functional areas to provide clients with the most effective processes. Medidata, Oracle, Zelta, Veeva and Medrio are just some of Avance Clinical’s technology partners. 

www.avancecro.com 

Media Contact:
Avance Clinical
Kate Thompson
media@avancecro.com

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

SHANGHAI, CHINA and TAIPEI, TAIWAN, Aug 28, 2023 – (ACN Newswire) – HanchorBio Inc., a global clinical-stage biotechnology company focusing on the discovery and development of innovative immuno-biomedicines, and Shanghai Henlius Biotech, Inc., a global biopharmaceutical company developing biologic medicines with a focus on oncology, autoimmune diseases, and ophthalmic diseases, today announced that the two companies have entered into a strategic framework agreement for collaboration to combine HanchorBio's protein engineering expertise and proprietary Fc-based designer biologics (FBDB(TM)) technology platform with Henlius' integrated product development and commercialization capabilities. The collaboration aims to expand the application of each company's platform by developing novel cancer immunotherapies, including those tumors resistant to anti-PD-1/L1 immunotherapies, to accelerate their respective pipeline of innovative immunotherapy medicines.

"FBDB(TM)-based innovative products may offer effective cancer immunotherapies to patients suffering from cancers which are resistant or refractory to PD-1/PD-L1 blockade therapies and having significant unmet medical needs on a global scale," said Scott Liu, Ph.D., Founder, Chairman, and Chief Executive Officer of HanchorBio. "This collaboration represents a foundational recognition and investment in our platform science and capabilities, which strengthens our pipeline and accelerates our research to providing novel therapies to patients globally. We are thrilled to collaborate with Shanghai Henlius to jointly address the inadequacies of the current anti-PD-1/L1 therapies and to navigate new frontiers in immuno-oncology through the design and development of novel multi-functional modalities that synergistically modulate and re-engage immune systems to fight cancers."

Mr. Jason Zhu, Chief Executive Officer, President, and Chief Financial Officer of Henlius, said, "Henlius is dedicated to providing affordable and innovative biologics for patients around the world. Today, we have achieved great success in marketing 5 products to the global market. Focusing on unmet clinical needs, Henlius actively collaborates with our global leading partners to pursue discovery and technology advance. HanchorBio was founded by Dr. Scott Liu, one of the co-founders of Henlius, and the Company possesses an experienced management team with a great mission and vision. Taking innovation as a driver, HanchorBio has quickly built its differentiated advantages and stands out in the field of onco-immunotherapy. This collaboration will allow Henlius to further accelerate our practice of affordable innovation and benefit more patients worldwide by fully leveraging HanchorBio's leading-edge technology and R&D platform."

About the Collaboration

With this collaboration, Henlius will consider early licensing and/or establish research collaboration of promising products from HanchorBio's pipeline that are complementary to Henlius' current portfolio (e.g., FBDB(TM) platform molecules, engineered immunocytokines etc.). This will be detailed in a separate agreement upon successful presentation of relevant efficacy/safety data. Under the terms of the agreement, Henlius will also have the opportunity to opt-in and co-develop the selected products with HanchorBio.

About Henlius

Henlius is a global biopharmaceutical company with the vision to offer high-quality, affordable, and innovative biologic medicines for patients worldwide with a focus on oncology, autoimmune diseases, and ophthalmic diseases. Since its inception in 2010, Henlius has built an integrated biopharmaceutical platform with core capabilities of high-efficiency and innovation embedded throughout the whole product life cycle including R&D, manufacturing, and commercialization. It has established global innovation centers and Shanghai-based manufacturing facilities in compliance with global Good Manufacturing Practice (GMP), including Xuhui Plant certificated by China and the EU GMP and Songjiang-I Plant certificated by China GMP. Apart from the launched biosimilar products HANLIKANG (rituximab), HANQUYOU (trastuzumab) for injection, trade name in Europe: Zercepac(R); trade names in Australia: Tuzucip(R) and Trastucip(R), HANDAYUAN (adalimumab) and HANBEITAI (bevacizumab), the innovative product HANSIZHUANG (anti-PD-1) has been approved by the NMPA for the treatment of MSI-H solid tumors, squamous non-small cell lung cancer (sqNSCLC), and extensive-stage small cell lung cancer (ES-SCLC), making it the world's first anti-PD-1 monoclonal antibody for the first-line treatment of SCLC. Its NDA for the treatment of esophageal squamous cell carcinoma (ESCC) is under review. What's more, Henlius has conducted over 30 clinical trials for 16 products, expanding its presence in major and emerging markets.

About HanchorBio

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

For more information, please visit: www.HanchorBio.com or follow us on LinkedIn at www.linkedin.com/company/hanchorbio-inc

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

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

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

LONDON, Aug 18, 2023 – (ACN Newswire) – WholisticResearch, a leading authority in the realm of cognitive enhancement research, has recently unveiled its list of the top nootropic supplements for 2023. Following rigorous testing and comprehensive analysis, the organization has identified the most effective cognitive enhancers available on the market today. Authored by Jacob Kovacs, the head researcher at WholisticResearch, the article delves into the top nootropics that may enhance cognitive abilities.

Understanding Nootropics

Nootropics, often referred to as "brain boosters," have gained significant attention for their potential to boost focus, productivity, memory, and mood. As the article states, "Nootropics are a new class of brain enhancers that may increase focus and productivity, enhance memory, and improve mood." With a plethora of options available on the market, the article serves as a guide to understanding which nootropics are truly effective.

Jacob Kovacs emphasizes the importance of making informed choices. He notes, "There are several cognitive enhancers that are being researched for their potential to increase mental performance, cognitive function, and mental health." The article further elaborates on how these nootropics function, their pros and cons, and what makes them stand out.

Methodology

WholisticResearch employed a meticulous testing and review process to determine the top-quality nootropics. This process encompassed factors such as effectiveness, ingredients, brand reputation, transparency, production method, user feedback, price, and value.

A Comprehensive Approach

WholisticResearch's article is not just a list but a comprehensive guide. It details the mechanism of action of nootropics, stating, "Nootropics are substances that may improve cognitive function, memory, and focus. They may also help to increase intelligence and creativity." The article also addresses frequently asked questions about nootropics, ensuring readers are well-informed.

The Challenges of Cognitive Enhancement

Cognitive enhancement is not a straightforward process. The brain is a complex environment for compounds, and intricate cognitive enhancement strategies are required. WholisticResearch acknowledges that new compounds are increasingly adopting complicated strategies. They emphasize that hands-on research is crucial to determining the correct product and its manufacturing process.

About WholisticResearch

Founded in 2019, WholisticResearch has been at the forefront of cognitive enhancement research. Their primary focus is on the latest nootropics and peptides that can potentially improve cognitive function. The organization also reviews the most recent research on vitamins and supplements that may boost cognition. WholisticResearch continues to be a beacon of information and research in the realm of cognitive enhancement, driven by a team of dedicated professionals.

Contact Information
Jacob Kovacs
Author
jacob@wholisticresearch.com

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

NEW YORK, Aug 17, 2023 – (ACN Newswire) – PCG Digital — Driving towards its goal of continued global growth in the surgical robotics sector, Asensus Surgical (NYSE American: ASXC) provided a positive update on both recent accomplishments and the company's projected outlook for the coming year. Asensus' trajectory shows strong promise and interest, with marked advancements in the adoption of its state-of-the-art products and a clear vision for future innovations.

Q2 in Review:

– Progress across Key Areas: The company reported meaningful progress across its key areas, including the broader utilization of the Intelligent Surgical Unit(TM) (ISU(TM)), the advancement of their clinical body of evidence, and the continued optimization of their flagship product, Senhance(R) Surgical System.

– Robust Worldwide Growth: A 27% year-over-year growth was observed in the second quarter, with more than 1,000 Senhance procedures performed globally. This consistent growth rate of around 10% sequentially underscores the firm's commitment to expansion and stability.

– Global Reach: Asensus Surgical continues to make international inroads. Notably, the initiation of the Senhance program at Fukuoka Tokushukai Hospital in Kasuga City, Japan, and the successful establishment of an exclusive Senhance program within the pediatric surgery department of a leading U.S. hospital indicates its expanding global footprint and trajectory.

– Pediatric Space Advancements: Pediatric surgeons are drawn to the Senhance system's specialized features, smaller instruments, and real-world data demonstrating safety and effectiveness in the wake of Asensus obtaining FDA clearance in March 2023.

– Clinical Registry Expansion: The TRUST(TM) clinical registry, which collects both intraoperative and postoperative follow-up data, has expanded to include data from over 2,500 patients. This data supports quality clinical publications and aids in the company's market development strategy.

– Active Participation in Industry Events: Asensus Surgical participated in several key industry events, including the Society of Robotic Surgery Annual Meeting in Australia and the joint meeting of IPEG and ESPES, to generate excitement and showcase the capabilities of Senhance, LUNA, and the ISU.

Financial Overview:

Asensus reported revenue of $1.1 million for Q2 2023, a slight increase from $1 million in Q2 2022. This includes lease revenue, instruments, and accessories as well as services. Although there was a reported net loss of $20.7 million for Q2 2023, the company's strong cash position, bolstered by a recent offering that generated approximately $10 million, extends the company's cash runway through the second quarter of 2024.

Strategic and Surgical Precision

– LUNA Surgical System: The upcoming LUNA Surgical System is a significant development. By the end of 2023, the company aims to complete full system integration and testing for LUNA. Regulatory filings are anticipated in late 2024, with hopes of FDA clearance by mid-2025. This would pave the way for a commercial launch in the second half of 2025.

– Economic Flexibility: With LUNA, Asensus is considering a subscription-based model for hospitals, offering an innovative approach to ensure broader adoption without increasing procedure costs.

– Expansion of ISU and Senhance: 2023 will also see Asensus entering into an agreement with a strategic graphics hardware provider and ramping up pilot manufacturing for the future ISU. Furthermore, a total of 10 to 12 new Senhance programs are expected to be initiated throughout the year.

A Closer Look:

Anthony Fernando, President and CEO at Asensus, attributes ongoing growth to two key factors: 1) More surgeons within the same hospital adopting the system and 2) Additional installations coming up to speed.

Fernando has previously stated that from a pipeline point of view, Asensus feels very bullish and that it can deliver on its commitment of 10 to 12 systems. Fernando further commented on the timing of the additional systems that the decision cycle is a long one because hospitals are doing the diligence and trying to get as much consensus internally as they can with surgeons so they can make the program successful.

Fernando added that pediatrics is "somewhat of an underserved space" and that the value of smaller instruments, haptic feedback, and innovative digital capabilities is becoming more and more attractive to pediatric surgeons, particularly in the United States.

Finally, the team is making excellent progress on the LUNA R&D front. They continue to receive positive feedback from surgeons who are looking forward to utilizing both 3- and 5-millimeter instruments as well as eye-tracking features and independent arms: "They can see the improvements, and that's what's driving a high level of interest," Fernando added.

Asensus Surgical's recent achievements and future plans suggest a company that is not only growing but also driving significant innovations in digital surgery. With their commitment to delivering better outcomes for patients and continuous advancements, the company's trajectory of sustained growth and leadership in its domain is drawing surgeons, patients, and investors alike.

Disclaimer

This communication was produced by PCG Digital Holdings, LLC, an affiliate of PCG Advisory Inc., (together "PCG"). PCG is not a registered or licensed broker-dealer nor investment adviser. No information contained in this communication constitutes an offer to sell, a solicitation of an offer to buy, or a recommendation of any security. PCG may be compensated by respective clients for publicizing information relating to its client's securities. See www.pcgadvisory.com/disclosures.

PCG Digital
info@pcgadvisory.com
646-863-6341

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

HONG KONG, Aug 16, 2023 – (ACN Newswire) – Essex Bio-Technology Ltd ("Essex" or the "Group", Stock Code: 1061.HK) today announced the interim results for the six months ended 30 June 2023 ("the period under review").

Financial Performance Returned to Pre-COVID-19 Operating Level

During the period under review, the Group achieved a consolidated revenue of approximately HK$899 million, with an increase of 37.1% as compared to the same period last year, indicating normalcy in business to the pre-COVID-19 operating level. The profit of the Group increased by 22.0% to approximately HK$170 million as compared to approximately HK$139.2 million for the same period last year.

As of 30 June 2023, the Group had cash and cash equivalents of approximately HK$506 million (31 December 2022: approximately HK$543 million). The Board is pleased to propose an interim dividend of HK$0.045 (For the six months ended 30 June 2022: HK$0.04) per ordinary share for the six months ended 30 June 2023.

Revenue Growth in Ophthalmology and Surgical Segments

The Group's revenue is primarily made up of the segments of Ophthalmology and Surgical (wound care and healing). For the six months ended 30 June 2023, the revenue of Ophthalmology increased by 41.6% to approximately HK$382 million, accounting for approximately 42.4% of the Group's revenue, while the revenue of Surgical up 34.0% to approximately HK$518 million, representing approximately 57.6% of the Group's revenue. The core products that are as current growth driver under each segment are:

1. Ophthalmology – Beifushu series (Beifushu eye drops, Beifushu eye gel and Beifushu unit-dose eye drops), Tobramycin Eye Drops, Levofloxacin Eye Drops, Sodium Hyaluronate Eye Drops and Iodized Lecithin Capsules; and

2. Surgical (Wound care and healing) – Beifuji series (Beifuji spray, Beifuji lyophilised powder and Beifuxin gel), Carisolv dental caries removal gel, Dr. YaDian mouth wash,Yi Xue An Granules and PELNAC collagen-based artificial dermis.

Significant Business Development Activities

The Group is committed to pragmatically investing in new products and technologies to strengthen the Group's product and research and development ("R&D") pipeline as near to mid-term growth driver in ophthalmology and long-term plan for new therapeutics in oncology. During the period under review, major investments in ophthalmic products that are currently in an advanced stage of clinical development are outlined as follows:

Re-establishing the VISTA programme after the acquisition of SkQ1's intellectual property rights

In order to provide the Group with flexibility and independence in the continuing development of the US FDA VISTA programme in the field of dry eye disease and to allow the Group to explore further the development of products for other ophthalmic indications, the Group successfully secured a patent assignment deed and a patent and know-how licence agreement relating to SkQ1 in the field of ophthalmology from Mitotech.

Following the acquisition of the intellectual property rights relating to SkQ1 on 13 October 2022, the Group's priority is to complete the transfer of chemistry, manufacturing and controls (CMC), know-how and intellectual property rights relating to SkQ1 from Mitotech. Concurrently, the Group is re-establishing the VISTA programme with regulators for mitigating any identifiable risks before continuing with the clinical trial. According to Frost & Sullivan, the estimated number of patients with moderate-to-severe dry eye disease was around 119.7 million in the PRC in 2020. It is expected that the size of the potential market of the SkQ1 product will be significant.

EB12-20145P (HLX04-O) global phase 3 clinical study makes significant progress

In 2020, the Group entered into a co-development and exclusive licence agreement with Shanghai Henlius Biotech, Inc. to co-develop a pharmaceutical product (EB12-20145P), a recombinant anti-vascular endothelial growth factor ("anti-VEGF") humanised monoclonal antibody injection for the treatment of exudative (wet) age-related macular degeneration ("wet-AMD"). As at the date of this announcement, the product has been approved to commence phase 3 clinical trials in Australia, the United States, Singapore, Russia, Serbia and European Union countries such as Hungary, Spain, Latvia, the Czech Republic and Poland. So far, the first patient has been dosed in a phase 3 clinical study for EB12-20145P for the treatment of wet-AMD in the PRC, Latvia, Australia and the United States. Also, the phase 1/2 clinical study for EB12-20145P for the treatment of wet-AMD has shown its safety and tolerability and demonstrated preliminary efficacy.

In February 2023, the Group entered into an amendment agreement with Henlius to amend certain terms of the co-development and exclusive license agreement, which included payments for regulatory and commercial sales milestones and development costs in respect of the Anti-VEGF licensed product, details of which are in the announcement dated 22 February 2023 and the annual results announcement on 8 March 2023.

The Anti-VEGF Licensed Product can be used for treating wet-AMD, diabetic macular edema, macular edema caused by retinal vein occlusion and myopic choroidal neovascularisation. According to Frost & Sullivan, the estimated number of patients with these 4 categories of disease was around 15.8 million in the PRC in 2020. Assuming each patient applies 4 doses in the first year of treatment and 2 to 3 doses in subsequent years, it is expected that the size of the potential market of the Anti-VEGF licensed product will be significant.

Honors and Awards Obtained In 2023

Zhuhai Essex Bio-Pharmaceutical Company Limited, a wholly-owned subsidiary of the Group, has been recognised as one of the 2022 top 100 innovative companies in Zhuhai, and has also been recognised as one of the 2022 top 100 chemical pharmaceutical companies in the PRC. The Group's Beifushu has been awarded as one of the Chinese reputable medicine brands in five consecutive years. This is a testament to the recognition by the industry for the efficacy and quality of our flagship biologic drug.

Market Development Entrenched Market Access Capability

The Group has been relentlessly investing in establishing and strengthening its market access capability. As at 30 June 2023, the Group maintains a network of 43 regional sales offices in the PRC with a total number of more than 1,200 sales and marketing representatives, covering more than 12,100 hospitals and medical providers, coupled with more than 2,100 pharmaceutical stores, which are widely located in the major cities, provinces and county cities in the PRC. Sales to lower-tier cities is supplemented by on-line platform for medical consultation and e-prescription, the on-line platform is further deployed for serving patients with chronic diseases.

The Group's expansion of its market access into Southeast Asian countries via its base in Singapore has been gaining good development traction since 2020.

Research and Development

During the period under review, the Group remains focused executing its 5-year (2021 to 2025) R&D's development plans. As at 30 June 2023, there are 16 R&D programmes in the pre-clinical to clinical stage, out of which the following 4 ophthalmology programmes are as mid-term growth drivers:

— EB11-18136P: SkQ1 eye drops, second phase 3 clinical trial (US FDA) (VISTA-2) topline data released on 24 February 2021
— EB11-15120P: Azithromycin eye drops, ongoing review by external key opinion leaders (National Medical Products Administration ("NMPA") in the PRC)
— EB12-20145P: Bevacizumab for wet age-related macular degeneration ("wet-AMD"), phase 3 clinical trial (US FDA, European Medicines Agency, Therapeutic Goods Administration and NMPA in the PRC)
— EB11-21148P: Cyclosporine eye drops, phase 2 clinical trial (NMPA in the PRC)

The Group holds a total of 73 patent certificates or authorisation letters, which include 52 invention patents, 14 utility model patents and 7 design patents. The Group currently has diversified its R&D resources to multiple research sites in Zhuhai (PRC), Boston (United States), London (United Kingdom) and Singapore which support not only our pursuit of new therapeutics but also our recruitment of global talents.

Mr. Patrick Ngiam, Chairman of Essex, said, "With tenacity and strength, we are pleased to return our business performance to the pre-COVID-19 operating level. Barring any unforeseen circumstances, being resilient, relevant and growth ready, the Group is optimistic of delivering progressive results.

I would like to take this opportunity to express my sincere gratitude to all stakeholders, business associates and valued customers for the trust, support and cooperation accorded to us, and each and every member of the Group for their relentless efforts rendered in shaping the Group into being a progressive and promising pharmaceutical player."

About Essex (1061.HK)
Essex Bio-Technology Limited is a bio-pharmaceutical company that develops, manufactures and commercialises genetically engineered therapeutic b-bFGF (FGF-2), having six commercialised biologics marketed in China since 1998. Additionally, it has a portfolio of commercialised products of preservative-free unit-dose eye drops and Iodized Lecithin Capsules etc.. The products of the Company are principally prescribed for the treatment of wounds healing and diseases in Ophthalmology and Dermatology, which are marketed and sold through approximately 12,100 hospitals and managed directly by its 43 regional sales offices in China. Leveraging on its in-house R&D platform in growth factor and antibody, the Company maintains a pipeline of projects in various clinical stages, covering a wide range of fields and indications.


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

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

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

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

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

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

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

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

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

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

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

About HCB101

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

About Multi-Regional Clinical Trial of HCB101

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

About HanchorBio

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

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

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

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