Essex and Gunze Shenzhen Entered into Exclusive Agency Agreement for PELNAC Absorbable Dressing in Mainland China

HONG KONG, Apr 11, 2023 – (ACN Newswire) – Essex Bio-Technology Ltd. ("Essex" or the "Group", Stock Code: 1061.HK) is pleased to announce that its wholly-owned subsidiary, Essex Medipharma (Zhuhai) Co., Ltd. ("Essex Medipharma"), has entered into an Agency Agreement ("Agency Agreement") with Gunze Medical Devices (Shenzhen) Ltd. ("Gunze Shenzhen"), a wholly-owned subsidiary of Gunze Limited ("Gunze") in Japan, for PELNAC Absorbable Dressing ("PELNAC"), for a product manufactured by Gunze. Pursuant to the Agency Agreement, Essex Medipharma will be the exclusive agent of PELNAC in Mainland China for a period of 5 years, starting from 2023 to 2027.

PELNAC, the world's leading artificial dermis product, consists of a collagen sponge layer, which provides a scaffold for cellular invasion and capillary growth, and a silicone film layer, which is reinforced with non-adhesive gauze. It is suitable for full skin defects: (1) Full-thickness burns, (2) Traumatic skin defect wounds, (3) Skin defects after tumor or nevus removal, (4) Sites of skin flap extraction. PELNAC is not only available in Mainland China and Japan, but has also obtained the CE marking in the EU and FDA approval in the US.

PELNAC works well with Essex's bFGF formulated products, the combination of the two products has a synergistic effect that would accelerate the vascularization and improve the viability rate in wounds repair and healing.

The Group believes that with its strong marketing system and extensive distribution network, this cooperation will accelerate the market expansion of PELNAC in Mainland China and will further strengthen the Group's development in the field of wounds healing for the clinical needs of more patients.

About Gunze Shenzhen
Gunze Medical Devices (Shenzhen) Limited was established in 2010 as a wholly owned subsidiary of Gunze Limited in China, focusing on the development, production and sales of regenerative medicine, and is responsible for the registration, marketing and after-sales management of Gunze Limited's absorbable medical materials in China. Its main products include absorbable dressing, PLLA bioabsorbable bone fixation devices, absorbable reinforcement felt and absorbable artificial dura mater, which are widely used in various departments such as thoracic surgery, orthopedics, burn surgery and neurosurgery.

About Essex
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 Shilishun (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 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.

Media Enquiry:
Strategic Financial Relations Limited (Website: http://www.sprg.com.hk)

Shelly Cheng +852 2864 4857 shelly.cheng@sprg.com.hk
Yan Li +852 2114 4320 yan.li@sprg.com.hk
June Tuo +852 2864 4848 june.tuo@sprg.com.hk
Angela Shen +852 2864 4870 angela.shen@sprg.com.hk
Media: media@essex.com.cn

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


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

TrialWire Patient Recruitment Platform Launches AI Pre-recruit to Cut Recruitment Time by 50%

ADELAIDE, AUS, Apr 11, 2023 – (ACN Newswire) – The award-winning TrialWire(TM) Patient Recruitment Platform, the most secure and rapid digital patient recruitment solution to reverse failing recruitment, today announced the rollout of Pre-recruit, the pre-recruitment solution that guarantees success before your study starts.

Pre-recruit ensures study sites have patients to contact as soon as the sites are activated, saving weeks or even months on a clinical program. Real-world data shows Pre-recruit cuts recruitment time by more than 50% saving costs and de-risking studies from the start. Using Pre-recruit sites can have a specific number of AI-Match screened eligible patients ready to contact. Sponsors, CROs, or sites can decide on how many patients each site can manage on activation which is pre-set on the Platform. With Pre-recruit, eligible patients are found online, AI-Match screened, and sent to dedicated and secure study site portals in Salesforce Health Cloud ready to be contacted by Study Coordinators when sites are activated.

Our SMS/Text Patient Engagement System ensures patients are retained by managing patient expectations around contact time with auto-reminders saying a Study Coordinator will contact them shortly. The SMS/Text Patient Engagement System is a world first in speed, security, and compliance for Study Coordinators contacting patients to discuss their study application and site bookings. It is primarily designed to speed up the contact process which is typically delayed using phone or email. Up to 50% of patients can be lost due to contact failure because they often don't answer an unknown number call from a site. In addition, study coordinators often can't afford the time to call more than 3-4 times in the hope of connecting with the patient.

TrialWire has found from patient responses that 92% want to be contacted by SMS/Text so this was a driving force behind the development and rollout of the service. This includes studies for older people. The SMS/Text Patient Engagement System can support all languages and keeps a record in the study coordinator's Dashboard of all conversations.

Most study coordinators are using the contact system to arrange then confirm times for screening calls, or site screening visits.

TrialWire recruitment can start in under 24-hours because the Platform doesn't require approvals.

The TrialWire Technology Platform includes:

– Dedicated secure portal dashboards for each Study Coordinator where they can review patient details and medical information
– Multiple dashboards per site so all Study Coordinators can connect with patients and see real-time progress
– Dashboards for sponsors and CROs where they can see de-identified referral status data
– Secure SMS/Text Patient Engagement System for SCs inside their dashboards for instant communications with the patient – book calls and screening visits
– Automated AI-Match and algorithm-driven "find and screen" patients process
– Minute-by-minute metrics for Study Coordinators showing numbers referred, contacted, screened, and enrolled at their site
– Minute-by-minute metrics for sponsors and CROs showing numbers referred, contacted, screened, and enrolled – across all sites on a study
– HIPAA compliance and all patient privacy security
– Built on the Salesforce Health Cloud
– Unlimited number of sites globally
– Available in all languages
– ScreenMatch – the SC support system that helps contact and phone screen patients

With more than 80% of clinical trials failing to recruit patients on time, and 30% of research sites not able to meet enrollment goals – 10% of sites don't enroll any patients – TrialWire offers peace of mind for sponsors and their CROs.

TrialWire is ideal for sponsors and CROs wanting to avoid extended recruitment delays.

Request more information here – starts in 24 hours https://trial-wire.com/contact/
Learn more here https://www.trial-wire.com/

About TrialWire www.trial-wire.com

TrialWire is a privately held technology company that leverages 25 years of experience in the clinical trial patient recruitment sector. TrialWire, which is solving the most serious problem in the drug development sector.

Its mission is to end the patient recruitment crisis delaying the development of new therapies which is costing drug companies billions of dollars a day due to problems finding the right people quickly and enrolling them at the site level.

The TrialWire Platform is the most secure service (powered by Salesforce Health Cloud) that uses advanced algorithms to find the right people who are online that might be suitable for studies available on the Platform. They are invited into the Platform and taken through the AI-Match screener to determine an exact match to a study – site-based or remote/virtual. No account sign-up is required to find and apply for a study. The Platform ingests study data from approved trial registries like ClinicalTrials.Gov. It uses advanced online algorithms to find patient/trial matches based on detailed demographic and location profiles.

Key to the TrialWire success is that it finds motivated people who are actively online trying to find out more about their conditions. They can be connected to a site in under 2 minutes. These people have high retention rates. Unlike all other digital recruitment firms, TrialWire does NOT keep patient details once a study is completed – no databases so no potential privacy breaches. Sponsors are not paying for database building where patients are sent to other studies.

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

Apollomics, a Company Developing Novel Oncology Therapies to Address Difficult-to-Treat Cancers, Announces Closing of Business Combination and Listing on Nasdaq

FOSTER CITY, Calif., Mar 30, 2023 – (ACN Newswire) – Apollomics Inc. ("Apollomics" or the "Company"), a clinical-stage biopharmaceutical company developing multiple oncology drug candidates to address difficult-to-treat and treatment-resistant cancers, today announced the completion of its business combination (the "Business Combination") with Maxpro Capital Acquisition Corp. ("Maxpro", Nasdaq: JMAC). Apollomics' Class A ordinary shares and public warrants are expected to commence trading today, March 30, 2023, on the Nasdaq Capital Market (Nasdaq) under the symbols "APLM" and "APLMW," respectively. The Business Combination, which was approved by Maxpro's shareholders on March 20, 2023, along with a $23.65 million private investment in public equity (PIPE) financing raised in connection with the Business Combination, provides access to capital that is expected to enable the Company to advance its pipeline of drug candidates.

Apollomics' mission is to improve treatment options for patients diagnosed with difficult-to-treat, high mortality cancers. Apollomics' pipeline includes nine novel oncology drug candidates, six of which are currently in clinical stage of development. By using targeted therapy, immuno-oncology agents, and other innovative approaches, Apollomics' novel drug candidates have the potential to address a range of cancers, including lung cancer, brain cancer, acute myeloid leukemia, and other solid tumors.

Apollomics expects results from its global Phase 2 multi-cohort clinical trial of vebreltinib (APL-101), a highly specific cMet inhibitor, in non-small cell lung cancer and other solid tumors with cMet dysregulation, this year, which the Company believes may support its first new drug application with the U.S. Food and Drug Administration (FDA) while generating clinical data on other indications. Apollomics is also developing uproleselan (APL-106), an E-selectin inhibitor, in China as an adjunct to chemotherapy to enhance its anti-cancer effects for adult patients with relapsed or refractory acute myeloid leukemia. The FDA granted Breakthrough Therapy Designation to GlycoMimetics, Apollomics' collaboration partner in the United States, for uproleselan, and the China National Medical Products Administration (NMPA) designated it as a breakthrough therapy in China. The Company expects to complete patient recruitment of its Phase 3 study for uproleselan (APL-106) in China this year.

"Becoming a public company represents a major milestone in our journey to provide solutions for patients with difficult-to-treat cancers worldwide," said Dr. Guo-Liang Yu, Ph.D., Chairman and Chief Executive Officer of Apollomics. "The funds now available to us are expected to facilitate development of our oncology pipeline and further our mission to provide patients with effective therapies and hope."

Moses Chen, Chief Executive Officer of Maxpro, said, "We are thrilled to have completed the Business Combination with Apollomics. We're confident that the Company's cutting-edge drug candidates will deliver value to investors while advancing the Company's ability to provide treatment options for patients diagnosed with difficult-to-treat, high mortality cancers."

Apollomics will continue to be led by Dr. Yu, a serial entrepreneur and pharmaceutical researcher with more than 300 patents, as its Chief Executive Officer and Chairman of the Board of Directors.

The Apollomics executive leadership team will also consist of:
— Dr. Sanjeev Redkar, Ph.D., MBA, Apollomics' Co-Founder, who will continue to serve as President and will serve as a Director;
— Dr. Jane Wang, Ph.D., who will continue to serve as Chief Scientific Officer; and
— Dr. Peony Yu, MD, who will continue to serve as Chief Medical Officer.

In addition to Dr. Yu and Dr. Redkar, Apollomics' Board of Directors will also consist of: Dr. Jonathan Wang, Ph.D., MBA; Dr. Kenneth C. Carter, Ph.D.; Dr. Hong-Jung (Moses) Chen, Ph.D.; Wendy Hayes, MBA; and Glenn S. Vraniak, MBA.

Advisors

EF Hutton, division of Benchmark Investments, LLC served as capital markets advisor and exclusive placement agent to Maxpro. Nelson Mullins Riley & Scarborough LLP served as legal advisor to Maxpro. White & Case LLP served as legal advisor to Apollomics.

About Apollomics Inc.

Apollomics Inc. is an innovative clinical-stage biopharmaceutical company focused on the discovery and development of oncology therapies with the potential to be combined with other treatment options to harness the immune system and target specific molecular pathways to inhibit cancer. Apollomics currently has a pipeline of nine drug candidates across multiple programs, six of which are currently in the clinical stage of development. Apollomics' lead programs include investigating its core product, vebreltinib (APL-101), a potent, selective c-Met inhibitor for the treatment of non-small cell lung cancer and other advanced tumors with c-Met alterations, which is currently in a Phase 2 multicohort clinical trial in the United States, and developing an anti-cancer enhancer drug candidate, uproleselan (APL-106), a specific E-Selectin antagonist that has the potential to be used adjunctively with standard chemotherapy to treat acute myeloid leukemia and other hematologic cancers, which is currently in Phase 1 and Phase 3 clinical trials in China.

Cautionary Statement Regarding Forward-Looking Statements

This press release includes statements that constitute "forward-looking statements" within the meaning of the federal securities laws, including Section 27A of the Securities Act of 1933, as amended (the "Securities Act"), and Section 21E of the Securities Exchange Act of 1934, as amended (the "Exchange Act"). All statements, other than statements of present or historical fact included in this press release, regarding the Company's future financial performance, as well as the Company's strategy, future operations, revenue guidance, projected costs, prospects, plans and objectives of management are forward-looking statements. When used in this press release, the words "could," "should," "will," "may," "believe," "anticipate," "intend," "estimate," "expect," "project," the negative of such terms and other similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain such identifying words. These forward-looking statements are based on management's current expectations and assumptions about future events and are based on currently available information as to the outcome and timing of future events. Apollomics cautions you that these forward-looking statements are subject to numerous risks and uncertainties, most of which are difficult to predict and many of which are beyond the control of Apollomics. In addition, Apollomics cautions you that the forward-looking statements contained in this press release are subject to unknown risks, uncertainties and other factors, including: (i) the impact of any current or new government regulations in the United States and China affecting Apollomics' operations and the continued listing of Apollomics' securities; (ii) the inability to achieve successful clinical results or to obtain licensing of third-party intellectual property rights for future discovery and development of Apollomics' oncology projects; (iii) the failure to commercialize product candidates and achieve market acceptance of such product candidates; (iv) the failure to protect Apollomics' intellectual property; (v) breaches in data security; (vi) risks related to the ongoing COVID-19 pandemic and response; (vii) the risk that Apollomics may not be able to develop and maintain effective internal controls; (viii) unfavorable changes to the regulatory environment; and those risks and uncertainties discussed in the Form F-4 (as amended) filed by Apollomics, Inc. with the U.S. Securities and Exchange Commission ("SEC") under the heading "Risk Factors" and the other documents filed, or to be filed, by the Company with the SEC. Other unknown or unpredictable factors also could have material adverse effects on the Company's future results and/or could cause our actual results and financial condition to differ materially from those indicated in the forward-looking statements. Should one or more of the risks or uncertainties described in this press release materialize or should underlying assumptions prove incorrect, actual results and plans could differ materially from those expressed in any forward-looking statements. New risk factors that may affect actual results or outcomes emerge from time to time and it is not possible to predict all such risk factors, nor can Apollomics assess the impact of all such risk factors on its business, or the extent to which any factor or combination of factors may cause actual results to differ materially from those contained in any forward-looking statements. Forward-looking statements are not guarantees of performance. You should not put undue reliance on these statements, which speak only as of the date hereof. Additional information concerning these and other factors that may impact the operations and projections discussed herein can be found in the reports that Apollomics has filed and will file from time to time with the SEC. These SEC filings are available publicly on the SEC's website at www.sec.gov. Apollomics undertakes no obligation to update publicly any of these forward-looking statements to reflect actual results, new information or future events, changes in assumptions or changes in other factors affecting forward-looking statements, except to the extent required by applicable laws. If Apollomics updates one or more forward-looking statements, no inference should be drawn that Apollomics will make additional updates with respect to those or other forward-looking statements.

CONTACTS

Investor Relations
Peter Vozzo
ICR Westwicke
Peter.Vozzo@westwicke.com
443-213-0505

Media Relations
Sean Leous
ICR Westwicke
Sean.Leous@westwicke.com
646-866-4012


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

Singapore family cord blood bank Cryoviva upgrades to AXP II System for cord blood processing

  • Widely recognised as a benchmark for volume reduction of cord blood processing, this FDA-cleared, functionally closed automated system allows for high recovery rate of mono-nuclear cells (MNCs) with greater safety and better quality, benefiting families storing their child’s cord blood.

Singapore, Mar 21, 2023 – (ACN Newswire) – Cryoviva Singapore, reputed to be among the top family cord stem cell banking companies in Southeast Asia, is making a significant upgrade to its cord blood processing capability with a switch to the AXP® II system.



The fully automated and programmable cell separation and recovery system, that allows for a fast and reproducible separation of cord blood in a sterile environment, reduces human error, accurate processing without damage to the cells and delivers consistent results. The AXP® II system, which has received both the CE mark and FDA 510K clearance, complies with good tissue practices (cGTP) and good manufacturing practices (cGMP). Globally, the system has already processed over a million cord blood units (CBU).

Designed to provide high-quality stem cell concentration from cord blood, the AXP® II system has demonstrated viable CD34+ stem cell recovery of >97% that is higher than most other known available systems. Moreover, CBUs processed with this system are seen to be richer in MNC than units that are conventionally processed with similar total nucleated cells (TNC).

“We are excited to be upgrading to the AXP® II system, which we believe provides the best outcomes for both our customers and us. Not only will our customers benefit from the quality and consistency of cord blood processing, but the system will also enhance the efficiency of our lab operations significantly with complete automation and software-driven tracking capabilities,” said Dr.Toh Keng Kiat, Medical Director.

“Cryoviva Singapore is committed to provide our customers with quality that is of the highest standard. Our upgrade to the AXP® II system is another investment towards that goal. The faster speed and efficiency accorded by the system’s capabilities will also improve our scalability and help us serve even more families. We will continue to invest in technologies and systems that will help us fulfil our mission to enable every family to discover the miracle of cord stem cells,” said Rajesh Nair, CEO of Cryoviva Singapore.

About Cryoviva Singapore

Established in 2014, Cryoviva Singapore (https://cryoviva.com.sg) is a reputed home-grown family cord blood bank in Singapore. The company is backed by reputed multinational investor organisations like RJ Corp, Indorama and MMI Singapore. The Cryoviva group has successfully stored over 160,000 umbilical cord blood units. Cryoviva Singapore’s cord blood storage facility is MoH-licensed, AABB accredited for both cord blood and cord tissue and ISO 9001:2015 QMS Certified. Cryoviva Singapore adheres to stringent processes and quality standards. Thanks to being centrally located and proximity to most major maternity hospitals in Singapore, cord blood samples reach its facilities very quickly and efficiently to ensure top quality maintenance upon storage.

Media Contact:
Natalie Lim
Marketing Manager
Tel: +65-83398482
E-mail: marketing@cryoviva.com.sg



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

Essex Bio-Technology Announces 2022 Annual Financial Results

HONG KONG, Mar 8, 2023 – (ACN Newswire) – Essex Bio-Technology Ltd ("Essex" or the "Group", Stock Code: 1061.HK) today announced the annual results for the year ended 31 December 2022.

Financial Performance

During the year under review, the financial results of the Group, have been negatively impacted and ongoing clinical trial programmes have been delayed due to disruptions resulted from sporadic emergence and persistent spread of COVID-19 and the ensuing lockdowns instituted under the "zero-COVID policy" in the PRC. As of the date of the results announcement, the clinical operations of hospitals and outpatient clinics progressively resumed to normalcy.

For the year ended 31 December 2022, the Group achieved a consolidated revenue of approximately HK$1,318 million, with a net profit of approximately HK$225 million. The net profit was weighed down by an impairment loss of approximately HK$ 25.8 million on goodwill arising from the acquisition of YesDok Pte Ltd and its wholly-owned subsidiary in Indonesia.

As of 31 December 2022, the Group had cash and cash equivalents of approximately HK$544 million (2021: approximately HK$671 million). The Board is pleased to propose a final dividend of HK$0.025 (2021: HK$0.055) per ordinary share to be approved at the upcoming annual general meeting of the Group. Together with the interim dividend of HK$ 0.04 per ordinary share paid on 21 September 2022, the total dividend for 2022 would be HK$ 0.065 (2021: HK$ 0.095) per ordinary share.

Revenue of Ophthalmology and Surgical Segments

The Group's revenue is primarily made up of the segments of Ophthalmology and Surgical (wound healing). The revenue of Ophthalmology is approximately HK$554 million, accounted for approximately 42.0% of the Group's revenue, while the revenue of Surgical is approximately HK$764 million, representing approximately 58.0% 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 Shilishun (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 and Yi Xue An Granules.

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, significant milestones achieved under business development activities are outlined as follows:

Through acquisition, Shilishun became the company's new added core product

On 8 March 2022, the acquisition of intellectual property rights relating to technologies and process of product R&D, production and right of Marketing Authorisation Holder of Shilishun (Iodized Lecithin Capsules) was completed and Shilishun (Iodized Lecithin Capsules) is being regarded as one of the Group's core products since then.

Secured Exclusive Global Rights and Interests of SkQ1 in the field Ophthalmology from Mitotech

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 allow the Group to explore further the development of products for other ophthalmic indications to meet the clinical and commercial needs of the Global (as defined below) market, on 13 October 2022, the Group successfully secured (i) a patent assignment deed (the "Patent Assignment Deed"); and (ii) a patent and know-how licence agreement (the "Patent and Know-how Licence Agreement", together with the Patent Assignment Deed, the "Agreements") relating to SkQ1 in the field of ophthalmology from Mitotech.

Pursuant to the Patent Assignment Deed, Mitotech agreed to assign to the Group all the rights of a list of inventions and patents relating to SkQ1 in the field of ophthalmology and all ophthalmic indications.

Pursuant to the Patent and Know-how Licence Agreement, Mitotech agreed to grant the Group an exclusive, transferable and irrevocable Global licence to use a list of patents owned by Mitotech relating to SkQ1 to develop, manufacture, sell and supply any therapeutic products or therapies applied to the eye and its adnexa (the "Products"), including the full global (excluding Armenia, Belarus, Kazakhstan, Kyrgyzstan and Russia) ("Global") right to apply for and obtain patents, to apply for and obtain Global regulatory approval for clinical trials, and to obtain marketing authorisation in relation to the Products.

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. 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 number of patients with moderate-to-severe dry eye disease alone was around 120 million in the PRC in 2020.
The potential market size of the SkQ1 Product is enormous.

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

In 2020, the Group entered into a co-development and exclusive license agreement with Shanghai Henlius Biotech, Inc. to co-develop a pharmaceutical product EB12-20145P, a recombinant anti-vascular endothelial growth factor ("anti-VEGF") humanized monoclonal antibody injection for the treatment of exudative (wet) age-related macular degeneration ("wet-AMD"). During the period under review, the product has been approved to commence the phase 3 clinical trial in Australia, the United States, Singapore, Russia, Serbia and European Union countries such as Hungary, Spain, Latvia, the Czech Republic and Poland. Also, the first patient has been dosed in the phase 3 clinical study of EB12-20145P for the treatment of wet-AMD in the PRC, Latvia, Australia and the United States.

In February 2023, the Group entered into an amendment agreement with Henlius to amend certain terms of the Co-Development License Agreement, which include 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 of these 4 categories of disease is over 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, the potential market size of the product is enormous.

Honors and Awards Obtained In 2022

The Group has been included in 2022 Forbes Asia's Best Under A Billion list, a testimony to the Group's achievements to date. Forbes Asia's Best Under A Billion list spotlights 200 top-performing publicly listed small and mid-sized companies in the Asia-Pacific region with annual sales under US$1 billion. In addition, the Group was conferred with China Excellent IR – The Best Shareholder Relationship Award and The Best ESG Award. In addition, Zhuhai Essex Bio-Pharmaceutical Company Limited, a wholly-owned subsidiary of the Group, has been recognised as one of the 2021 top 10 pharmaceutical and health manufacturing companies in Zhuhai, and has also been recognised as one of the 2021 top 100 chemical pharmaceutical companies in the PRC. The Group's Beifushu has been awarded as one of the Chinese reputable medicine brands in four 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 of 31 December 2022, the Group maintains a network of 43 regional sales offices in the PRC and a total number of about 1,240 sales and marketing representatives, covering more than 10,900 hospitals and medical providers, coupled with approximately 2,130 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 the date of the announcement, there are 16 R&D programmes in the pre-clinical to clinical stage, out of which the following 4 ophthalmology programmes (inclusive of a new addition of EB11-21148P in 2022) are in late clinical stage and 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 experts (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 69 patent certificates or authorisation letters, which include 50 invention patents, 14 utility model patents and 5 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, "Despite yet another difficult year inflicted by the pandemic of COVID-19 on us all, the tenacity, drive and leadership in our DNA were able to deliver sustained stakeholder value. 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."

Full version of Essex's FY2022 Annual Results Announcement can be downloaded at:
https://www1.hkexnews.hk/listedco/listconews/sehk/2023/0308/2023030800766.pdf

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 Shilishun(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 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.

Media Enquiry:
Strategic Financial Relations Limited (Website: http://www.sprg.com.hk)
Shelly Cheng +852 2864 4857 shelly.cheng@sprg.com.hk
Yan Li +852 2114 4320 yan.li@sprg.com.hk
June Tuo +852 2864 4848 june.tuo@sprg.com.hk
Angela Shen +852 2864 4870 angela.shen@sprg.com.hk
Media: media@essex.com.cn

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


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

Essex and Henlius signed amendment agreement for Global Co-Development and Exclusive License Agreement for treatment of age-related macular degeneration

HONG KONG, Feb 22, 2023 – (ACN Newswire) – Essex Bio-Technology Ltd ("Essex" or the "Group", Stock Code: 1061.HK) today announced that two of its wholly-owned subsidiaries, Essex Bio-Investment Limited ("Essex Bio-Investment") and Zhuhai Essex Bio-Pharmaceutical Co. Ltd ("Zhuhai Essex"), signed an amendment agreement (the "Amendment Agreement") with Shanghai Henlius Biotech, Inc. ("Henlius", Stock Code: 2696.HK) in relation to a global Co-Development and Exclusive license Agreement signed in October 2020 (the "Agreement"). Pursuant to the Agreement, Essex Bio-Investment and Henlius will co-develop the bevacizumab HLX04 (the "Product" or "EB12-20145P") for treatment of ophthalmic diseases such as exudative (wet) Age-related Macular Degeneration (wAMD). Essex Bio-Investment has an exclusive global license to develop, manufacture, and commercialise the Product in the field of human ophthalmic therapeutic use and/or therapies.

Reasons for, and benefits of, the entering into the Amendment Agreement

As a result of the (i) increased cost of clinical trial operations; (ii) increased cost of patient recruitment for the clinical trial programme; (iii) general inflation in the global economy and manpower shortage in the healthcare sector during and following the COVID-19 pandemic; and (iv) increased cost associated with the establishment of new clinical trial sites in the United States and Europe to support and balance requirements imposed by various regulatory authorities for the clinical trials, the development costs of the Product have materially increased since the signing of the Agreement. Therefore, to tackle the increasing development costs and to support the continuous research and development of the Product further, Essex Bio-Investment has agreed to provide additional funding towards Henlius by entering into the Amendment Agreement.
Amended terms

(i) Payments for regulatory and commercial sales milestones

(a) The regulatory milestone payment from Essex Bio-Investment to Henlius payable upon the completion of the clinical trial programme has been adjusted from US$10,000,000 (equivalent to approximately HK$78,400,000) or its Renminbi equivalent to US$8,000,000 (equivalent to approximately HK$62,720,000) or its Renminbi equivalent.

(b) The amount to be paid by the Licensee to the Licensor after the commercialisation of the Licensed Products, in the event where the Licensee commercialises the Licensed Product by itself only, shall be adjusted as follows:

Commercial sales milestone payments (which shall be paid once only) of US$1,500,000 (adjusted downwards from US$3,000,000 in the Agreement, equivalent to approximately HK$11,760,000), and US$7,500,000 (adjusted downwards from US$15,000,000 in the Agreement, equivalent to approximately HK$58,800,000).

(ii) Development costs

The arrangement of development costs will be amended as follows:

Subject to the terms of the Agreement and the Amendment Agreement, the Licensee has agreed to share the development costs with the Licensor in the aggregate amount up to US$55,000,000 (adjusted upwards from US$30,000,000, equivalent to approximately HK$431,200,000) as to 80% by the Licensee (i.e., up to US$44,000,000 (equivalent to approximately HK$344,960,000) ("Amended Essex Funding")) and as to 20% by the Licensor. The Amended Essex Funding shall be payable in accordance with the funding schedule agreed with reference to the achievement of the specified milestones.

All other principal terms of the Agreement remain unchanged.

Current status

Currently, the EB12-20145P (HLX04-O) project has completed first patient dosing in the EU, Australia, and the US, and has been licensed for clinical trials in Singapore and other countries and regions. Essex and Henlius will progressively jointly manage the global multi-centred clinical trials of EB12-20145P (HLX04-O) and apply marketing authorisation in China, Australia, the EU, the US, and ASEAN around the globe based on the research results. EB12-20145P (HLX04-O) has the potential to be one of the first bevacizumab products approved for use in ophthalmic diseases, benefiting more patients with eye diseases worldwide.

Essex's Board believes that Essex Bio-Investment entering the Amendment Agreement with Henlius will provide assurance that the clinical trial programme under the Agreement will remain undisrupted under Essex and Essex Bio-Investment's control with the intent of moving towards progressive completion of the clinical trial programme within the scope of the clinical trial programme.

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 Shilishun(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 10,710 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.

Media Enquiry:
Strategic Financial Relations Limited (Website: http://www.sprg.com.hk)
Shelly Cheng +852 2864 4857 shelly.cheng@sprg.com.hk
Yan Li +852 2114 4320 yan.li@sprg.com.hk
June Tuo +852 2864 4848 june.tuo@sprg.com.hk
Angela Shen +852 2864 4870 angela.shen@sprg.com.hk
Media: media@essex.com.cn

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


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

The Evolving Global Landscape in Vaccine Development: Novotech and Endpoints News Webinar

SYDNEY, AU, Feb 15, 2023 – (ACN Newswire) – Novotech, the leading Asia Pacific centred biotech CRO with extensive experience in vaccine trials, is convening an expert panel webinar covering the evolving landscape in vaccine development.

Register here https://webinars.endpts.com/keeping-pace-with-the-evolving-global-landscape-in-vaccine-development/

Between 2017 and 2021, there were close to 1,400 industry-sponsored single country vaccine based clinical trials globally, with the Asia Pacific involved in over 45% of the trials. Download our latest data report here: Vaccines – Asia Pacific Clinical Trial Landscape. https://novotech-cro.com/whitepapers/vaccines-asia-pacific-clinical-trial-landscape

The webinar, Keeping pace with the evolving global landscape in vaccine development, will hear from a panel of life science experts on the latest advancements and innovative modalities paving the way in the global vaccine development space including:

– The COVID-19 impact on drug development and the regulatory landscape.
– Key factors contributing to Asia Pacific being recognised as the hub for vaccine development and opportunities for biotech's to leverage.
– Key considerations for pre-clinical and clinical planning to accelerate vaccine development, supporting a robust global strategy.

Date/Time: March 09 11:00 am – 12:00 pm EST
Register here https://webinars.endpts.com/keeping-pace-with-the-evolving-global-landscape-in-vaccine-development/

Panelists:

SUSHANT SAHASTRABUDDHE
ASSOCIATE DIRECTOR GENERAL, INTERNATIONAL VACCINE INSTITUTE (IVI)
Dr. Sushant Sahastrabuddhe, Associate Director General at the International Vaccine Institute (IVI), joined in July 2010, leading the clinical trials of IVI's typhoid vaccine and process to achieve its licensure, the global clinical development of and licensure of SK bioscience's COVID-19 vaccines and Phase 1 and 2 trials of Bharat Biotech's Chikungunya vaccine. As a vaccine enthusiast with more than 17 years of experience in multiple countries across diverse projects, he continues to lead collaborative efforts with companies and partners in Korea, India and globally to get these vaccines through early- to late-stages of their clinical development. Dr. Sahastrabuddhe is also the Associate Editor for Vaccines for tropical diseases and associated with Yonsei University as Research Professor and with Universite Claude Bernanrd, Lyon France as Research Fellow. In 2021, Dr. Sahastrabuddhe was named an 'Honorary Citizen of Seoul' for his contributions to the joint efforts with Korean companies and international partners to develop vaccines against COVID-19 and other diseases.

PAUL GRIFFIN
ASSOCIATE PROFESSOR, INFECTIOUS DISEASES PHYSICIAN, MICROBIOLOGIST, UNIVERSITY OF QUEENSLAND
An Infectious Diseases Physician and Microbiologist, Dr. Paul Griffin was appointed as the Director of Infectious Diseases at Mater Health Services in 2013 and continues an appointment as an Associate Professor of Medicine at the University of Queensland Medical School. Additionally, Dr. Griffin chairs the Advanced Training Committee in Infectious Diseases with the Royal Australasian College of Physicians, the committee that oversees the training of Infectious Diseases specialists in Australia.
Previously, Dr. Griffin was the Principal Investigator (PI) and Medical Director at Nucleus Network, a contract research organization specializing in infectious diseases trials, which included a PI role on in excess of 125 clinical trials predominantly in Infectious Diseases including novel vaccines and COVID-19 vaccines. With fellowships in Infectious Diseases from the Royal Australasian College of Physicians, in Clinical Microbiology from the Royal College of Pathologists of Australasia and from the Australasian College of Tropical Medicine, Dr. Griffin has an active interest in vaccine education and advocacy and has become a trusted media authority and spokesperson across the nation during the COVID-19 pandemic.

BABAJI YADAV
SENIOR CONSULTANT, NOVOTECH DRUG DEVELOPMENT CONSULTING
Babaji Yadav is a Senior Consultant with over eight years of academic experience in pre-clinical oncology drug development and eight years of industry experience in drug development. Babaji has a strong background in pharmaceutical sciences with a Ph.D. in Pharmacology and Toxicology from the University of Otago, New Zealand. Previously he has worked as a Research Project Manager to oversee IND-enabling toxicology studies for lead oncology drugs and, prior to joining Novotech, was a Clinical Project Manager for early-phase oncology trials. Babaji is a UK Registered Toxicologist and at Novotech he is focused on providing technical toxicology advice and product development strategies to facilitate the entry of client's compounds into clinical trials. Babaji has experience in small molecules, combination products, and biologicals including vaccines, proteins, monoclonal antibodies, and advanced cell and gene therapies.

JENNIFER ARELLANO
DIRECTOR OF CLINICAL SERVICES (PHILIPPINES), NOVOTECH
Jennifer Arellano is the Director of Clinical Services in the Philippines with over 25 years of technical and leadership experience in managing clinical trial operations for sponsors and CROs. With a Bachelor of Industrial Pharmacy from the University of the Philippines and a Pharmacist license, Jennifer's research operations experience includes monitoring, auditing, project leadership, feasibility, study start-up, driving inspection readiness and hosting regulatory inspection, client engagement and business development, learning & development and organization SOP development/review. Jennifer has contributed to the transformation of the Philippine clinical research industry – bringing improvement to the local clinical research regulations and practices and is the founding President of a non-profit organization, the Philippine Clinical Research Professionals Inc, with more than 400 members from pharmaceutical and CROs, and has more recently, volunteered pro-bono services during the Covid-19 pandemic to provide trial management consultancy to the Philippine DOH-funded trials such as WHO Solidarity COVID-19 Treatment and Vaccine trials, Avigan COVID-19 treatment trial, and Philippine Heart Association funded cardiovascular outcome study.

Novotech has recently acquired EastHORN, a European CRO with clinical, medical and regulatory expertise in multiple strategically important locations across the continent. The acquisition is part of Novotech's global expansion program in Europe and the US.

Novotech has recently been benchmarked as a top 10 CRO among the world's leading CROs, is the recipient of the Asia Pacific Cell & Gene Therapy Clinical Trials Excellence award and the Asia-Pacific Contract Research Organization Company of the Year Award, and has signed 45 Leading Site Partnership agreements over the last 3 years.

Novotech offers biotechs a unique and unparalleled suite of early to late-phase CRO services across Europe and the US, with a specialist focus on Asia Pacific where the company has built a reputation for delivering high-quality expedited clinical trials.

About Novotech (Novotech-CRO.com)

Novotech is internationally recognized as the leading Asia Pacific centred biotech Contract Research Organization (CRO) with global execution capabilities. Novotech is a clinical CRO with labs, phase I facilities, drug development consulting services and FDA regulatory expertise and has experience in over 3,700 pre-clinical and clinical projects, including Phase I to Phase IV clinical trials and bioequivalence studies. Novotech is positioned to serve biotech clients conducting clinical trials in Asia Pacific, the US and Europe. Novotech has over 2,700 staff working across offices in 20 geographies. For more information visit https://novotech-cro.com/contact

Media Contact
David James
E: communications@novotech-cro.com
AU: +61 2 8218 2144
USA: +1 415 951 3228
Asia: +65 3159 3427

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

Novotech Global Report: Robust Phase 1 Trial Growth Across Asia Pacific

SYDNEY, AU, Feb 10, 2023 – (ACN Newswire) – Novotech, the leading Asia Pacific centred biotech CRO, has published a new global report on Phase 1 trial activity including current metrics on fast growth regions and therapeutic areas. The data analysis found that Asia Pacific has been the fastest-growing region for Phase 1 trials in the last ten years, reaching a share of 58% in 2022, with China leading the Phase I trials globally.

According to the report, titled "Phase I Global Clinical Trial Landscape – Focus on Asia Pacific", in 2022 Asia Pacific accounted for a 58% share of the approximately 3,600 Phase I trials initiated globally in 2022. The report found that Asia Pacific has been the fastest growing region for Phase 1 trials in the last ten years with a 10Y CAGR of 18%. Between 2018 and 2022, the region has had consistent performance and has been maintaining its majority share since 2018, with a peak of 61% share achieved in the year 2021. Mainland China, Australia, South Korea, Japan and India were the top five Asian locations, and together contribute over 50% of the global phase I trials.

One of the key reasons why Asia Pacific is in demand is that it has the shortest patient enrolment duration and fastest recruitment rate. Asia Pacific region has a much wider patient base which expedites the patient time recruitment process and shortens the trial duration enabling initiation and completion of trials.

The report found that Asia Pacific also leads phase I trials across the top therapeutic areas. Oncology, infectious disease, CNS, cardiovascular and metabolic disorders are the top therapeutic areas of Phase I trials across the top Asian locations of China, Australia, South Korea, Japan and India. Of all the five locations put together, China occupies the major share (>80%) of phase I trials in all the top therapeutic areas considered together.

View "Phase I Global Clinical Trial Landscape – Focus on Asia Pacific", the new report, on this link: https://tinyurl.com/novotech-global-report

See the report for Phase 1 location and therapeutic area analysis including:
– IMMUNOMODULATORY THERAPY
– IMMUNO-ONCOLOGY
– ADOPTIVE CELL THERAPY
– ALLOGENIC, AUTOLOGOUS, STEM CELL AND REGENERATIVE MEDICINE
– DNA AND RNA
– VACCINES
– MULTI-SPECIFIC MONOCLONAL ANTIBODY
– MICROBIOME

Cell & Gene

The latest data also shows Asia Pacific is the fastest-growing region globally for cell & gene therapy trials representing more than a third of all cell & gene studies, with China leading in the region. The region already accounts for over a third of cell & gene therapy trial activity and shows a nearly 50% faster growth rate in cell & gene therapy trials compared to ROW between 2016 and 2021. China shows a 15% faster growth rate than the ROW. After oncology, the majority of cell & gene trials are in infectious diseases, CNS, and cardiovascular diseases. In addition, the Asia Pacific is the leading location globally for CAR-T trials with China attracting ~60% of all CAR-T trials globally between 2015-2022.

European expansion – global footprint

Novotech offers a unique and unparalleled suite of early to late-phase CRO services across Europe and the US, with a specialist focus on Asia Pacific where the company has built a reputation for delivering high-quality expedited clinical trials. Novotech recently acquired EastHORN, a European CRO with clinical, medical and regulatory expertise in multiple strategically important locations across the continent. The acquisition is part of Novotech's global expansion program in Europe and the US.

Award recognition

Novotech has recently been benchmarked as a top 10 CRO among the world's leading CROs, has been awarded the Asia-Pacific Cell & Gene Therapy Clinical Trials Excellence award and selected for the Asia-Pacific Contract Research Organization Company of the Year Award. The company has signed 45 Leading Site Partnership agreements over the last 3 years.

View "Phase I Global Clinical Trial Landscape – Focus on Asia Pacific", the new report, on this link: https://tinyurl.com/novotech-global-report

About Novotech (Novotech-CRO.com)

Novotech is internationally recognized as the leading Asia Pacific centred biotech Contract Research Organization (CRO) with global execution capabilities. Novotech is a clinical CRO with labs, phase I facilities, drug development consulting services and FDA regulatory expertise and has experience in over 3,700 pre-clinical and clinical projects, including Phase I to Phase IV clinical trials and bioequivalence studies. Novotech is positioned to serve biotech clients conducting clinical trials in Asia Pacific, the US and Europe. Novotech has over 2700 staff working across offices in 20 geographies. For more information visit https://novotech-cro.com/contact

Media Contact
David James
E: communications@novotech-cro.com
AU: +61 2 8218 2144
USA: +1 415 951 3228
Asia: +65 3159 3427

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

Asia Pacific Cell & Gene Research: Novotech is Growing 50% Faster than ROW

SYDNEY, AU, Feb 3, 2023 – (ACN Newswire) – Novotech, the leading Asia Pacific focused biotech specialist CRO and recipient of the Asia Pacific Cell & Gene Therapy Clinical Trials Excellence award, said the number of cell & gene therapy trials in the region was growing 50% faster than ROW. The majority of trials are in oncology, specifically for blood cancers, viral infections, and solid tumors.

Novotech, which has extensive experience in cell & gene therapy clinical trials, is sponsoring the 6th Annual Cell And Gene Therapy Innovation Summit in Berlin, Germany (15-16 February 2023).

The company recently acquired EastHORN, a European CRO with clinical, medical and regulatory expertise in multiple strategically important locations across the continent. The acquisition is part of Novotech's global expansion program in Europe and the US.

The acquisition means biotech clients can access Novotech's unique and unparalleled suite of early to late-phase CRO services across Europe and the US, with a specialist focus on Asia Pacific where the company has built a reputation for delivering high-quality expedited clinical trials.

The latest data shows Asia Pacific is the fastest-growing region globally for cell & gene therapy trials representing more than a third of all cell & gene studies, with China leading in the region.

The region already accounts for over a third of cell & gene therapy trial activity and shows a nearly 50% faster growth rate in cell & gene therapy trials compared to ROW between 2016 and 2021. China shows a 15% faster growth rate than the ROW. After oncology, the majority of cell & gene trials are in infectious diseases, CNS, and cardiovascular diseases.

In addition, the Asia Pacific is the leading location globally for CAR-T trials with China attracting ~60% of all CAR-T trials globally between 2015-2022.

Novotech CEO Dr. John Moller said: "Cell & gene therapy research typically presents another level of complexity and regulatory processes which means an experienced CRO partner is vital. Our deep experience, exceptional site and investigator relationships – which also translates to patent access – our project management approach focused on problem-solving, ownership and flexibility, and our investments in data and technology combine to deliver the service biotechs need in this specialist sector for success."

Novotech has recently been benchmarked as a top 10 CRO among the world's leading CROs, selected for the Asia-Pacific Contract Research Organization Company of the Year Award, and has signed 45 Leading Site Partnership agreements over the last 3 years.

Download our latest data report:
Evolution of Clinical Trials in the Asia Pacific Region Compared to the US and the EU5
https://novotech-cro.com/whitepapers/evolution-clinical-trials-asia-pacific-region-compared-us-and-eu5

About Novotech (Novotech-CRO.com)

Novotech is internationally recognized as the leading Asia Pacific centred biotech Contract Research Organization (CRO) with global execution capabilities.

Novotech is a clinical CRO with labs, phase I facilities, drug development consulting services and FDA regulatory expertise and has experience in over 3,700 pre-clinical and clinical projects, including Phase I to Phase IV clinical trials and bioequivalence studies. Novotech is positioned to serve biotech clients conducting clinical trials in Asia Pacific, the US and Europe. Novotech has over 2,700 staff working across offices in 20 geographies. For more information visit https://novotech-cro.com/contact

Media Contact
David James
communications@novotech-cro.com
AU: +61 2 8218 2144
USA: +1 415 951 3228
Asia: +65 3159 3427

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

Novotech Acquires European CRO, Strengthens Global Operations

SINGAPORE, Jan 12, 2023 – (ACN Newswire) – Novotech announced today the acquisition of EastHORN, a European CRO with clinical, medical and regulatory expertise in multiple strategically important locations across the continent. The acquisition is part of Novotech's global expansion program. EastHORN was established in 2004 and has over 250 employees.

The acquisition means biotech clients can access Novotech's unique and unparalleled suite of early to late-phase CRO services across Europe and the US, with a specialist focus on Asia Pacific where the company has built a reputation for delivering high-quality expedited clinical trials.

Novotech CEO Dr. John Moller said: "This acquisition is a strategic move to further expand our CRO operations and provide biotech clients with in-country expertise across Asia-Pacific, North America, and Europe to deliver their global drug development programs. EastHORN and Novotech have been working together for many years and we share a culture of clinical excellence in biotech drug development. EastHORN which is retaining its brand, is now a Novotech company and will be integrated into our systems and processes so clients benefit from working with one CRO globally. Clients can now access our exceptional European infrastructure, local knowledge, site relationships and access to diverse patient populations."

EastHORN Executive Chairman Iain Gordon said: "I first started working on clinical projects with Novotech 15 years ago and have always been impressed by the quality of their services and their client-focused approach. EastHORN has been working closely with Novotech for over a decade now and have many friends within the Novotech team. This is a natural next step for our group and my colleagues and I are excited to become part of Novotech's global operations to support biotech clients' clinical programs. In particular, we can now offer our clients access to Novotech's team of experts across Asia-Pacific and the US including project management, regulatory, clinical, medical and biometrics, while our team's European expertise can advance clinical development in Europe for Novotech clients. We work with similar-sized biotechs and small to mid-size pharma companies and have experience across the same therapeutic areas, so this is an excellent cultural and strategic fit."

Novotech has decades of biotech drug development experience, exceptional site and investigator relationships, access to vast patient populations, and a project management approach focused on problem-solving, ownership and flexibility. Consistent investment in advanced training and technology combines to deliver an exceptional full-service biotech CRO solution.

Novotech has recently been recognised with significant CRO awards including the Asia-Pacific Biotech CRO of the Year by Frost & Sullivan, benchmarked as a top 10 CRO among the world's leading CROs, a finalist in the prestigious Scrip awards, and has just been awarded the Gene & Cell Therapy Excellence Award. In Asia Pacific Novotech has more than 50 Leading Site Partnership agreements with major medical research institutions which delivers exclusive benefits for sponsors.

About Novotech

Novotech is the leading Asia-Pacific centred biotech CRO. Novotech has integrated labs and phase I facilities and provides drug development consulting and clinical development services across all phases. Novotech is well-positioned to serve biotech clients conducting clinical trials in Asia-Pacific, the US, and Europe. For more information visit https://novotech-cro.com/contact

Media Contact
David James
E: communications@novotech-cro.com
AU: +61 2 8218 2144
USA: +1 415 951 3228
Asia: +65 3159 3427

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