HONG KONG, Mar 22, 2022 - (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 2021.

Highlights
-- The group's turnover surged 67.4% to HK$1,637.7 million, Profit-After-Tax lifted 58% to HK$346.0 million;

-- Sales coverage increased to around 10,500 hospitals and 2,110 pharmaceutical stores in the PRC;

-- Obtained an approval for the registration and commercialisation of the preservative-free unit-dose Moxifloxacin Hydrochloride Eye Drops in the PRC;

-- Significant progress in R&D program, 15 R&D programs in the pre-clinical to clinical stage, out of which 3 ophthalmology programs are in clinical stage as the below:
SkQ1 eye drops, second phase 3 clinical trial (US FDA) (VISTA-2) topline data released on 24 February 2021;
Azithromycin eye drops, ongoing review by external key opinion leaders (National Medical Products Administration ("NMPA") in the PRC);
Bevacizumab intravitreal injection for wet-AMD, phase 3 clinical trial (US FDA, European Medicines Agency, Therapeutic Goods Administration and NMPA in the PRC);

-- Holds a total of 44 patent certificates or authorisation letters: 35 invention patents, 4 utility model patents and 5 design patents;

-- Completed the acquisition of IP rights relating to R&D, production and MAH of Shilishun Iodized Lecithin Capsules.

Significant progression in Financial Performances

Essex achieved significant progression and encouraging performances amid the COVID-19 pandemic and macro uncertainties. For the year ended 31 December 2021, the Group recorded a turnover growth of 67.4% to approximately HK$1,637.7 million as compared to approximately HK$978.1 million in 2020, indicating a strong recovery to the pre-COVID-19 operating level. In tandem with the increase of turnover, the Group achieved an increase of 58% in after-tax profit to approximately HK$346.0 million as compared to approximately HK$218.9 million in 2020.

Turnover of Ophthalmology and Surgical Segments Surged 60.6% and 72.6% respectively
The Group's turnover is primarily made up from the segments of Ophthalmology and Surgical (wound care and healing). The core products that are of 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, Moxifloxacin Hydrochloride 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.

The sectoral turnover of Ophthalmology and Surgical is approximately 41.1% and 58.9% of the Group's turnover, respectively. The combined turnover of the Group's flagship biologics, Beifushu series and Beifuji series, the basic fibroblast growth factor (bFGF) based biologic drugs, represented about 84.3% of the Group's total turnover, of which Beifushu series and Beifuji series accounted for 26.1% and 58.2% of the Group's turnover, respectively. The remaining 15.7% of the Group's turnover is mainly contributed from sales of Tobramycin Eye Drops, Levofloxacin Eye Drops, Sodium Hyaluronate Eye Drops, Moxifloxacin Hydrochloride Eye Drops, Shilishun Iodized Lecithin Capsules, Carisolv dental caries removal gel, Dr. YaDian mouth wash and Yi Xue An Granules, collectively. Ophthalmology segment contributed approximately HK$673.3 million to the Group's turnover for the year ended 31 December 2021, representing an increase of 60.6% as compared to approximately HK$419.2 million in 2020. Surgical segment recorded a total turnover of approximately HK$964.4 million for the year ended 31 December 2021, representing an increase of 72.6% as compared to approximately HK$558.9 million in 2020. The increase was attributable to the resumption of clinical operations in hospitals to normalcy in the PRC and the expansion of sales.

The selling of Xalatan Eye Drops and Xalacom Eye Drops would be discontinued in 2022 that contributed approximately 2% to the Group's gross profit for the year ended 31 December 2021.

The Board proposed a final dividend of HK$0.055 (2020: HK$0.05) per ordinary share to be approved at the upcoming annual general meeting of the Company.

Mr. Patrick Ngiam, Chairman of Essex, said, "2021 has been a year full of diverse challenges. Our part of the world has been affected by extended lockdowns and border closures under COVID zero regime, even as other regions begun to reopen. Despite yet another difficult year inflicted by the pandemic of COVID-19 on us all, the tenacity, drive and leadership in our DNA was able to deliver greater stakeholder value. The Group has achieved significantly improved financial performances in the financial year ended 31 December 2021. This is a testament that the Group's business is resilient and was able to recover swiftly to the pre-COVID-19 level after the normalcy of the clinical operations of hospitals resumed in the PRC since September 2020."

Significant Business Development Activities

The Group is committed to pragmatically investing in new products and technologies to strengthen the Group's product and R&D pipeline as near to mid-term growth driver in ophthalmology and long-term plan for new therapeutics in oncology. During the year under review, major investments in ophthalmic products are outlined as follows:

Investment in Ophthalmology

Significant progress for SkQ1's second phase 3 clinical trial
In 2018, the Group entered into a co-development agreement with Mitotech S.A. ("Mitotech") and Mitotech LLC for the United States Food and Drug Administration (the "US FDA") phase 3 clinical trial of an ophthalmic solution containing SkQ1 for dry eye disease. As disclosed in the announcement of the Company dated 24 February 2021, positive outcome was achieved during second phase 3 clinical trial (VISTA-2). The clinical trial study repeated statistically significant positive results on key predefined secondary end-point (Central Corneal Fluorescein Staining). The Board is enthusiastic about the read-out of clearing of central staining of the cornea (defined as zero staining in central cornea), which reveals the potential of SkQ1 in addressing oxidative stress in dry eye diseases. Following the positive trial outcome of VISTA-2, Mitotech has planned a pivotal trial (VISTA-3), which will commence once Mitotech's management team has fully assessed there is no potential disruption to trial centres and patient recruitment during the ongoing COVID-19 pandemic. However, recent developments in Ukraine have led to governments and industries reacting to business relationships with Russia in a way that could potentially induce delays in Mitotech's VISTA clinical trial program.

HLX04-O approved for phase 3 clinical trial
In 2020, the Group entered into a co-development and exclusive license agreement with Shanghai Henlius Biotech, Inc. to co-develop a pharmaceutical product that contains an anti-vascular endothelial growth factor ("anti-VEGF") as a drug substance, which is intended for the treatment of exudative (wet) age-related macular degeneration ("wet-AMD"). As at the date of 22 March 2022, the recombinant anti-VEGF humanised monoclonal antibody injection HLX04-O ("HLX04-O") for the treatment of wet-AMD has been approved to commence the phase 3 clinical trial in Australia, the United States, Singapore, Russia, Serbia and European Union countries such as Hung ary, Spain, Latvia, the Czech Republic and Poland. Also, the first patient has been dosed in a phase 3 clinical study for HLX04-O for the treatment of wet-AMD in the PRC.

Ophthalmology business is expected to be further strengthened by the acquisition of Shilishun Iodized Lecithin Capsules

The successful acquisition of IP rights relating to R&D, production and MAH of Shilishun Iodized Lecithin Capsules will enable the Group to strengthen its ophthalmology business.

Market Development

Robust Market Access Capability
Over the years, the Group has been relentlessly investing in establishing and strengthening its market access capability. As at 31 December 2021, the Group maintains a network of 43 regional sales offices in the PRC and a total number of about 1,265 sales and marketing representatives, out of which 64% are full-time employees and 36% are on contract basis or from appointed agents.

More Extensive Healthcare Network for Product Prescription
During the year under review, the Group's therapeutic products are being prescribed in more than 10,500 hospitals and medical providers, coupled with approximately 2,110 pharmaceutical stores, which are mainly located in the major cities, provinces and county cities in the PRC.

Further Investments to Strengthen Competitiveness and Customer Base
For achieving a sustainable traction on growth for currently marketed products as well as for near-term to mid-term new products being commercialised, the Group initiated investments to improve its competitiveness and widen its customer base under the following plans:

-- Investing in clinical observation programs for affirming additional clinical indications of its commercialised products;
-- Reaching out to market in lower-tier cities;
-- Cultivating pharmaceutical stores, where possible, as complementary sales channel; and
-- Building on-line platform for medical consultation and e-prescription for patients with chronic diseases under its healthtech initiative.

The Group has initiated its market access expansion to Southeast Asian countries by setting up a base and expanded its presence in Singapore since 2020.

Research and Development

The Group renewed its R&D's vision, emphasising the dedication to science and innovation, with a mission to develop therapeutics that would meet unmet clinical and/or commercial needs. The Group concurrently kick-started a 5-year (2021 to 2025) R&D's development plan to further strengthen its R&D capability and its position in Ophthalmology.

As at 31 December 2021, there are 15 R&D programs in the pre-clinical to clinical stage, out of which 3 ophthalmology programs are in clinical stage. The 3 ophthalmology programs listed below are targeted as mid-term growth driver.

1. EB11-18136P: SkQ1 eye drops, second phase 3 clinical trial (US FDA) (VISTA-2) topline data released on 24 February 2021

2. EB11-15120P: Azithromycin eye drops, ongoing review by external key opinion leaders (National Medical Products Administration ("NMPA") in the PRC)

3. EB12-20145P: Bevacizumab intravitreal injection for wet-AMD, phase 3 clinical trial (US FDA, European Medicines Agency, Therapeutic Goods Administration and NMPA in the PRC)

As at the date of this announcement, the Group has obtained a total of 44 patent certificates or authorisation letters: 35 invention patents, 4 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 supports not only our pursuit for new therapeutics but also our acquisition of global talent.

Prospects

Looking ahead, the Group will continue to monitor the circumstances under the uncertainty of COVID-19 in 2022. Its strong team spirit and dynamic leadership have provided it with the capacity to navigate these turbulent times, and capture any opportunities in the ever changing world. The Group remains highly dynamic in delivering positive results in the coming year.

"COVID-19 remains a major concern in 2022 globally. We continue to monitor the situation and will take appropriate actions to overcome any unforeseen challenges. Barring the unforeseen circumstance, the Group remains focus on executing its plans and 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.", said Mr. Patrick Ngiam.

Full version of Essex's FY2021 Annual Results Announcement can be downloaded at: https://www1.hkexnews.hk/listedco/listconews/sehk/2022/0322/2022032200780.pdf

About Essex Bio-Technology Limited (Stock Code: 1061.HK)
Essex Bio-Technology Limited is a bio-pharmaceutical company that develops, manufactures and commercialises genetically engineered therapeutic rb-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 10,500 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
Jill Cheung +852 2114 4870 jill.cheung@sprg.com.hk
Media: media@essex.com.cn

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


Copyright 2022 ACN Newswire. All rights reserved. www.acnnewswire.comEssex Bio-Technology Ltd ("Essex" or the "Group", Stock Code: 1061.HK) today announced the annual results for the year ended 31 December 2021.

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Cambridge, MA, Feb 17, 2022 - (ACN Newswire) - Moderna, Inc., (NASDAQ:MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that the Therapeutic Goods Administration (TGA) in Australia has granted provisional registration for the use of Moderna's mRNA COVID-19 vaccine, Spikevax, in a 50 ug dose, two-dose series, for active immunization to prevent COVID-19 caused by SARS-CoV-2 in children aged 6-11 years.

"The TGA authorization for the use of our COVID-19 vaccine in children 6-11 years old in Australia is an important milestone for Moderna as it is the first regulatory authorization for the use of our vaccine in this age group. We are grateful to the TGA for their diligence and the Government of Australia for its continued confidence in our mRNA platform," said Stephane Bancel, Chief Executive Officer of Moderna. "We are grateful for the opportunity to provide protection against COVID-19 to this important age group, keeping children safe and able to continue life as normally as possible."

Professor Robert Booy from the Immunisation Coalition commented, "I welcome this decision by the TGA and look forward to the uptake of vaccination in children increasing even more to provide protection of children and maximize school attendance."

Moderna's vaccine was investigated in the ongoing Phase 2 "KidCOVE" study, a randomized, observer-blind, placebo-controlled expansion study to evaluate the safety, tolerability, reactogenicity, and effectiveness of two 50 ug doses of Spikevax (mRNA-1273) given to healthy children 28 days apart. The study population was divided into three age groups (6 to under 12 years, 2 to under 6 years, and six months to under 2 years).

Data submitted to the TGA demonstrated that vaccination of children 6 to under 12 years of age with a 50 ug mRNA-1273 primary series is associated with non-inferior anti-SARS-CoV-2 neutralizing antibody responses when compared to that in individuals 18-25 years old from the Phase 3 Cove study. The geometric mean ratio (GMR) comparing the response in children to the response in young adults from the Phase 3 COVE study was 1.5 (95% CI: 1.3, 1.8), with a seroresponse rate of 99.3%. Two 50 ug doses of mRNA-1273 were generally well tolerated.

The study is being conducted in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH) and the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services (HHS). The ClinicalTrials.gov identifier is NCT04796896.

Moderna's vaccine has already received regulatory approval for adults and adolescents in Australia. On 9 August 2021, the TGA granted provisional registration to the Moderna COVID-19 Vaccine for active immunization to prevent COVID-19 caused by SARS-CoV-2 virus in individuals 18 years of age and older. On 3 September 2021, the provisional registration was extended to individuals 12 years of age and older.

About Moderna

In 10 years since its inception, Moderna has transformed from a research-stage company advancing programs in the field of messenger RNA (mRNA), to an enterprise with a diverse clinical portfolio of vaccines and therapeutics across seven modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for both clinical and commercial production at scale and at unprecedented speed. Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both groundbreaking science and rapid scaling of manufacturing. Most recently, Moderna's capabilities have come together to allow the authorized use and approval of one of the earliest and most-effective vaccines against the COVID-19 pandemic.

Moderna's mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases, and auto-immune diseases. Moderna has been named a top biopharmaceutical employer by Science for the past seven years. To learn more, visit www.modernatx.com.

AUTHORIZED USE

The Therapeutic Goods Administration (TGA) in Australia has granted provisional registration for the use of Moderna's mRNA COVID-19 vaccine, Spikevax for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals six years of age and older.

Forward Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including regarding: the Company's development of a vaccine against COVID-19 (mRNA-1273, or Spikevax); the ability of Spikevax to trigger a neutralizing antibody response in children similar to that in older populations and to protect against COVID-19; and the safety and tolerability profile for Spikevax. The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond Moderna's control and which could cause actual results to differ materially from those expressed or implied by these forward-looking statements. These risks, uncertainties, and other factors include those risks and uncertainties described under the heading "Risk Factors" in Moderna's most recent Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission (SEC) and in subsequent lings made by Moderna with the SEC, which are available on the SEC's website at www.sec.gov. Except as required by law, Moderna disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. These forward-looking statements are based on Moderna's current expectations and speak only as of the date hereof.

Moderna Contacts:
Media:
Luke Mircea Willats
Director, Corporate Communications
Luke.Mirceawillats@modernatx.com

Investors:
Lavina Talukdar
Senior Vice President & Head of Investor Relations
617-209-5834
Lavina.Talukdar@modernatx.com

SOURCE: Moderna, Inc.

Copyright 2022 ACN Newswire. All rights reserved. www.acnnewswire.comModerna, Inc., (NASDAQ:MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that the Therapeutic Goods Administration (TGA) in Australia has granted provisional registration for the use of Moderna's mRNA COVID-19 vaccine, Spikevax, in a 50 ug dose, two-dose series, for active immunization to prevent COVID-19 caused by SARS-CoV-2 in children aged 6-11 years.

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