Luxembourg, Apr 5, 2023 – (ACN Newswire) – Moolec Science SA (NASDAQ:MLEC) ("Company" or "Moolec"), a Molecular Farming food-ingredient company, announced today that the Animal and Plant Health Inspection Service ("APHIS") of the U.S. Department of Agriculture ("USDA") has concluded that Moolec's GLA safflower plants pose no greater plant pest risk than non-genetically engineered safflower plants according to regulation found at 7 CFR part 340. To access the Regulatory Status Review ("RSR") response from USDA-APHIS, click here. https://pr.report/piWafISN

Moolec's CEO and co-founder Gaston Paladini stated, "This important milestone reinforces our go-to-market path and validates our proposed regulatory strategy. Also, it complements the FDA's food safety reviews and approvals already obtained for our GLA safflower oil (GLASO)." He finished by declaring, "The green light from USDA-APHIS bolsters the idea of the safe use of Molecular Farming technology to improve nutritional profile for end food products. Moolec is very excited that its innovative food ingredients are a key part of the bioeconomy."

Martin Salinas, Chief of Technology and co-founder of Moolec, expressed, "This will greatly increase the efficiency of our operations, including raw material procurement, downstream crushing, and processing. We will no longer need USDA-APHIS permits to import, move interstate or grow these plants in the field in the United States." He concluded, "We are positive that this achievement paves the way for our upcoming regulatory reviews in our pipeline."

According to USDA-APHIS regulation found at 7 CFR part 340, developers may submit a request for a RSR when they believe a genetically engineered ("GE") plant is not subject to the regulation. APHIS reviews the GE plant and considers whether it might pose an increased plant pest risk compared to its non-GE comparator. If APHIS does not identify a greater pest risk relative to the comparator, the GE plant is not subject to this regulation. Regulation 7 CFR part 340 governs the importation, interstate movement, and the environmental release of certain organisms that have been modified or produced by genetic engineering.

About Moolec Science SA

Moolec is a science-based food ingredient company focused on producing animal proteins in plants through Molecular Farming, a disruptive technology in the alternative protein landscape. Its purpose is to upgrade taste, nutrition, and affordability of alternative protein products while building a more sustainable and equitable food system. The Company's technological approach aims to have the cost structure of plant-based solutions with the organoleptic properties and functionality of animal-based ones. Moolec's technology has been under development for more than a decade and is known for pioneering the production of a bovine protein in a crop for the food industry. The Company's product portfolio and pipeline leverage the agronomic efficiency of broadly used target crops, like safflower, soybean, and pea. Moolec has a growing international patent portfolio (23, both granted and pending) for its Molecular Farming technology. The Company is run by a diverse team of Ph.Ds and Food Insiders, and operates in the United States, Europe, and South America. For more information, visit www.moolecscience.com.

Forward-Looking Statements

This press release contains "forward-looking statements." Forward-looking statements may be identified by the use of words such as "forecast," "intend," "seek," "target," "anticipate," "believe," "expect," "estimate," "plan," "outlook," and "project" and other similar expressions that predict or indicate future events or trends or that are not statements of historical matters. Such forward-looking statements with respect to performance, prospects, revenues, and other aspects of the business of Moolec Science S.A. ("Moolec") are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to risks and uncertainties. Although we believe that we have a reasonable basis for each forward-looking statement contained in this press release, we caution you that these statements are based on a combination of facts and factors, about which we cannot be certain. We cannot assure you that the forward-looking statements in this press release will prove accurate. These forward-looking statements are subject to a number of significant risks and uncertainties that could cause actual results to differ materially from expected results, including, among others, changes in applicable laws or regulations, the possibility that Moolec may be adversely affected by economic, business and/or other competitive factors, costs related to the scaling up of Moolec's business and other risks and uncertainties, including those included under the header "Risk Factors" in the Form F-1 Registration Statement filed with the U.S. Securities and Exchange Commission ("SEC"), as well as Moolec's other filings with the SEC. Should one or more of these risks or uncertainties materialize, or should any of our assumptions prove incorrect, actual results may vary in material respects from those projected in these forward-looking statements. We undertake no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required under applicable securities laws. Accordingly, you should not put undue reliance on these statements.

Contact Information
Catalina Jones
Chief of Staff & Sustainability
comms@moolecscience.com

Martin Taraciuk
Investor Relations
ir@moolecscience.com

Michael Bowen
ICR, LLC
moolecir@icrinc.com

Related Files
Moolec Science Achieves USDA-APHIS Regulatory Status Review Clearance for Molecular Farming Product
https://cdn.newswire.com/files/x/03/7c/bcbadb44190484d6da7107cf3b7c.pdf

SOURCE: Moolec Science

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

HEIDLEBERG, Germany, Apr 4, 2023 – (ACN Newswire) – BioMed X, an independent biomedical research institute, announces the start of its new research project – "New Strategies to Enhance the Immunogenicity of Tumors" – in collaboration with Merck. The focus of this new research group will be to develop novel approaches for enhancing tumor immunogenicity to broaden the population of patients who could benefit from cancer immunotherapy.

"What if we could overcome the immunosuppressive microenvironment of solid tumors with a novel targeted approach?" asks Dr. Christian Tidona, Founder and Managing Director of the BioMed X Institute. "This call for application is inviting original research proposals that explore new ways to enhance the immunogenicity of tumors and thus boost the efficacy of immune checkpoint inhibitors," explains Dr. Tidona.

A high mutational burden, as well as aberrant mRNA splicing, are sources of neoantigens: unique antigens presented by tumor cells capable of eliciting an effective anti-tumor immune response. The most recently completed BioMed X project was also a Merck collaboration investigating RNA splicing patterns in cancer. "Using a new bioinformatic approach, we were able to query splicing variants that are unique to certain cancers," said Dr. Alexandra Duarte, former group leader at the BioMed X Institute. "Such splicing abnormalities can shape the complex pathophysiology of cancer cells, including through the expression of immunogenic neoantigens," added Dr. Duarte, now a Senior Scientist in the Department of mRNA Cancer Immunotherapies of Prof. Dr. Ugur Sahin at HI-TRON in Mainz, Germany.

The new project launched today, marking the tenth joint research group between the two partners, expands this line of research by targeting tumor-specific DNA Damage Repair (DDR) mechanisms or exploiting tumor-intrinsic DDR defects to increase the tumor mutational burden and immunogenicity. Researchers who are interested in becoming part of this new BioMed X research team in Heidelberg are invited to respond to this international call for application by submitting a project proposal via the BioMed X Career Space at https://career.bio.mx/call/2023-BMX-C01 before May 28, 2023.

About BioMed X

BioMed X is an independent research institute located on the campus of the University of Heidelberg in Germany, with a worldwide network of partner locations. Together with our partners, we identify big biomedical research challenges and provide creative solutions by combining global crowdsourcing with local incubation of the world's brightest early-career research talents. Each of the highly diverse research teams at BioMed X has access to state-of-the-art research infrastructure and is continuously guided by experienced mentors from academia and industry. At BioMed X, we combine the best of two worlds – academia and industry – and enable breakthrough innovation by making biomedical research more efficient, more agile, and more fun.

Contact Information
Flavia-Bianca Cristian
Recruiting & Communications Manager
fbc@bio.mx
+49 6221 426 11 706

SOURCE: BioMed X Institute

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

HONG KONG, Apr 3, 2023 – (ACN Newswire) – Peijia Medical Limited ("Peijia Medical" or the "Company", together with its subsidiaries, the "Group", stock code: 9996), a leading domestic player in the high-growth transcatheter valve therapeutic and neurointerventional procedural medical device markets in China, announced its audited consolidated annual results for the year ended 31 December 2022 (the "Year").

During the Year, the Group realized revenue of RMB250.8 million, an increase of 83.7% over the same period in 2021. The increase in revenue was mainly attributable to: 1) the commercialization of the second generation retrievable TAVR product, TaurusElite and 2) the steady increase in sales volume of existing neurointerventional products, including Tethys Intermediate catheter, SacSpeed Balloon Dilatation Catheter and Jasper SS Detachable Coil. Additionally, as a result of the Group's continuous efforts in cost control, gross profit margin remaine stable at 70.2%, representing an improvement of 0.1% over the same period in 2021. The Group's net loss narrowed significantly by 29.0% to RMB407.8 million from RMB574.2 million in the same period in 2021.

Transcatheter Valve Therapeutic Business: Market share increased significantly; the commercial team began to scale

Peijia's commercialization efforts in the Transcatheter Valve Therapeutic Business advanced significantly, benefiting from professional market education and promotion and outstanding product performance despite the impact from COVID-19 on the volume of the TAVR procedures over the market. During the Year, revenue generated from the sales of Transcatheter Valve Therapeutic products amounted to RMB107.3 million, representing a year-over-year increase of 155.9%. After the initial year of commercialization in 2021, the number of hospital admissions and end-user implants continued to increase significantly in 2022. During the Year, the Group's first- and second-generation transcatheter aortic valve systems TaurusOne and TaurusElite were newly placed in 195 hospitals. As of December 31, 2022, a total of 290 hospitals have used TaurusOne and/or TaurusElite. During the Year, the number of end-use implants reached 1,200+, representing a market share of about 14%. The increase of about 10 percentage points over the same period of the previous year meets performance guidance of capturing 12-15% market share.

The strong commercialization results are due to the Group's efficient and professional marketing and sales teams. As of December 31, 2022, the Group's Transcatheter Valve Therapeutic Business' sales and marketing team has grown to 185 employees, with the commercialization team beginning to scale among the industry players.

Neurointerventional Business: Steady revenue growth, commercialization of 4 new ischemic products, further diversification of revenue

During the Year, the Group continued to consolidate its first-mover advantage in Neurointerventional Business by consistently increasing product coverage, adoption, and expanded market share. The Group recorded revenue of RMB143.5 million, an increase of 51.7% over the same period of the previous year, indicative of Peijia's commitment to performance growth. During the Year, the Group's registration applications for 4 ischemic products; Fastunnel Delivery Balloon Dilatation Catheter which combines balloon and microcatheter in one device, Syphonet Stent Retriever, Tethys AS Aspiration Catheter and Fluxcap Balloon Guide Catheter, were approved by the National Medical Products Administration of the PRC (NMPA). With the approval of these 4 products, the Group successfully established its product portfolio for the ischemic product line with all major devices readily in place. As of December 31, 2022, the Group's Neurointerventional Business has 14 commercialized products and 7 products at different research and development stages, which comprehensively cover the inverventional treatment solution of hemorrhagic stroke, acute ischemic stroke, and intracranial atherosclerotic disease. The development of Syphonet Stent Retriever also leads to the development of BASIS (Balloon AngioplaSty with the distal protection of Stent retriever) technology. This innovative technology, with Syphonet Stent Retriever as the core and the combination of balloon dilatation catheter and intermediate catheter, provides a safe and effective treatment option for patients with ICAS-LVO type of stroke. As of the date of the annul results announcement, 4 new products had been launched and were expected to contribute to revenue growth in the next fiscal year.

The ongoing development of the ischemic product line, coupled with the first mover advantage of its hemorrhagic product line, enables the Group to further diversify its revenue composition for the Neurointerventional Business. Revenue generated from hemorrhagic products, ischemic products and vascular access products accounted for 39.4%, 27.6% and 32.9% of the revenue from the Neurointerventional Business (2021: 54.2%, 20.6% and 24.9%) respectively. As of December 31, 2022, the Group's Neurointerventional Business had a sales and marketing team of 77 employees, and 205 distributors, covering around 2,000 hospitals in [31] provinces nationwide. The Group's well-established commercialization team and dealer network will contribute to increasing the market share of Neurointerventional products.

R&D: Developed a comprehensive and in-depth product portfolio; consecutive market entrance of multiple blockbuster products

As a pioneer in the industry, the Group has developed a strategy with a comprehensive and in-depth pipeline of the next-generation core technology for Valve Therapeutic through internal development and external business development that comprehensively covers AS, AR, MR, TR, via transcatheter approaches. Additionally, the Transcatheter Valve Therapeutic Business' main pipeline products have successively progressed to the human trial stage. As of December 31, 2022, the Group's Transcatheter Valve Business had launched 5 products and is developing an additional 9 products, covering cutting-edge solutions such as AR indication valve, durability-enhanced valve, polymeric valve and non-impant therapy.

During the Year, in addition to actively promoting the multi-center registration clinical trial of Third-Generation Non-glutaraldehyde Crosslinked Dry-tissue TAVR System TaurusNXT and FIM clinical trial of the interventional non-implantable Lithotripsy Valvuloplasty System TaurusWave, the Group successfully carried out the multi-center registration clinical trial for HighLife TSMVR System and GeminiOne TEER System. Additionally, in partnership with inQB8 Medical Technologies, LLC, the Group completed the first human plant of the FIM clinical trial of MonarQTM Transcatheter Tricuspid Valve Replacement (TTVR) system in Coapenhagen, Demnark.

In December 2021, the Group entered into a series of agreements with JenaValve Technology Inc., for the exclusive right of Trilogy(TM) Heart Valve System in the Greater China region (named TaurusTrio(TM) by Peijia). So far, the Trilogy(TM) Heart Valve System is the first and the only TAVR device of its kind to receive CE Mark, making it the only TAVR product with dual indications for AR and AS in the world. During the Year, the Group successfully facilitated the technology transfer of the project. As of the date of the annual results announcement, the Group is preparing for the commercial impant in Hong Kong and the registration clinical trials in the mainland China.

As of December 31, 2022, the Group had an internal research and development team of 133 employees, who focus on the R&D, and clinical registration of transcatheter valve therapeutic products and Neurointerventional products. The Group has a strong intellectual property portfolio, including a total of 101 granted and valid patents (transcatheter valve therapeutic business: 63; neurointerventional business: 38) and 126 patents under application (transcatheter valve therapeutic business:105; neurointerventional business:21).

International strategy: Formulating a differentiated product overseas strategy – MonarQTM overseas clinical first to expand internationally

"Based in China, Looking at the world" has been Peijia Medical's mission since it was established as a leading innovative medical device company. Facing fierce competition and market challenges in Europe and America, Peijia management is focusing on product innovation and increasing the number of internal patents as its core strategy to compete internationally. Additionally, the Group actively markets its innovative, proprietary pipelines, strives to achieve key technological breakthroughs, and customizes overseas strategy for its different products, such as overseas clinical practice, and out-license. At present, many of the Group's transcatheter valve therapeutic products have the strength to go overseas, including the technologically innovative TaurusNXT (Non-glutaraldehyde Crosslinked Dry-tissue TAVR system), TaurusWave (Lithotripsy Valvuloplasty system), TaurusApex (Polymer Leaflets TAVR system), MonarQTM (TTVR system) and GeminiOne (TEER system) with independent patent (Freedom-to-Operate). The overseas expansion for the MonarQTM during the year is the first step in Peijia Medical's overseas strategy. The Group owns the global rights to the product and will continue to promote its overseas clinical practice as it looks to expand in the future.

"Peijia Medical will always uphold its corporate vision as we bolster our commitment to the development and commercialization of interventional solutions for structural heart and neurovascular diseases in China and globally. With the completion and commissioning of the new headquarters in 2023, Peijia Medical will fully accelerate its product development, production and commercialization. In the future, the Group will deepen its professional marketing network to further expand its business in transcatheter valve therapeutic products and grow its neurointerventional market share, while strengthening in-house R&D capabilities, international patent portfolios, as it further advances its globalization strategy," said Dr. Yi Zhang, Executive Director, Chairman of the Board, and Chief Executive Officer of Peijia Medical Limited.

About Peijia Medical Limited
Peijia Medical, headquartered in Suzhou, Jiangsu Province, China, was established in 2012 and listed on the Main Board of the Hong Kong Stock Exchange in May 2020 (Stock Code: 9996. HK). Adhering to the corporate vision of "Dedication with Passion, Devotion for Life", always put life and safety first, cultivate technology deeply, persist in innovation, and do as much as it can for helping life and health. With the strategic layout of "Innovation-oriented, Simultaneous Treatment of Heart and Cerebrovascular Diseases" and focusing on the innovation, R&D and production of high-end medical devices for structural heart and cerebrovascular disease intervention, Peijia Medical covers the entire product pipeline for aortic, mitral and tricuspid valve replacements and surgical instruments and accessories, as well as diseases related to hemorrhagic, ischemic and vascular access in the field of neurointervention, built a relatively comprehensive product portfolio and solutions in the field of structural heart and neurovascular diseases in China.


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HONG KONG, Mar 31, 2023 – (ACN Newswire) – Sino Biopharmaceutical Limited ("Sino Biopharm" or the "Company", together with its subsidiaries, the "Group") (HKEX:1177), a leading innovation-driven pharmaceutical conglomerate in the PRC, has announced its audited financial results for the year ended 31 December 2022.

Development Highlights

Oncology Innovative Drugs
— Focus V (Anlotinib Hydrochloride Capsules) has been approved for five indications: third-line non-small cell lung cancer, third-line small cell lung cancer, soft tissue sarcoma, medullary thyroid cancer and differentiated thyroid cancer.
— The Phase III clinical trials of Anlotinib in combination with TQB2450 (PD-L1) for the treatment of first-line small cell lung cancer has completed interim analysis and met the pre-specified endpoint.
— In addition, 12 new indications for Anlotinib have also entered Phase III clinical trials, including the combination of Anlotinib with Penpulimab monoclonal antibody, Anlotinib with TQB2450 (PD-L1), Anlotinib with chemotherapy, and other treatment options, for which marketing applications are expected to be submitted progressively in the next one to two years.
— Annike (Penpulimab monoclonal antibody injection) injection was approved in January 2023 for the treatment of first-line locally advanced or metastatic squamous non-small cell lung cancer with chemotherapy. To date, the product has been approved for two indications: third-line classic Hodgkin's lymphoma and first-line squamous non-small cell lung cancer. In addition, it has one indication (third-line nasopharyngeal carcinoma) under marketing review.
— F-627 (Efbemalenograstim alpha, long-acting granulocyte colony-stimulating factor) is currently in the marketing application stage. F-627 is currently the only G-CSF drug on the market that has conducted simultaneous research head-to-head with both short-acting and long-acting G-CSF in large sample sizes. Phase III clinical trials have been completed with marketing applications submitted in China and the United States. The Group expects that the marketing application will be approved in China in 2023. With its strong oncology sales team, Sino Biopharm is confident in a smooth launch and rapid market penetration of the product.

Liver Disease Innovative Drugs
— Lanifibranor (pan-PPAR agonist) is an orally-available small molecule. The product is currently undergoing Phase III clinical trials globally, and is the first oral drug for NASH that has entered Phase III clinical trials in China, to address a large clinical unmet need in the China NASH market.

Respiratory System Innovative Drugs
— Ensitrelvir (3CL protease inhibitor) is a novel oral drug for the treatment of COVID-19. The drug has the potential to become a good oral drug for the treatment of COVID-19.

Surgery/Analgesia Innovative Drugs
— PL-5, an antimicrobial peptide product that is the first newly designed non-antibiotic antimicrobial drug with a broad antibacterial spectrum. The product has completed a Phase III clinical study in China for the treatment of secondary wound infections, and the Group expects to file a marketing application within this year. When the product is launched, it will be the first antimic robial peptide product available in China.

Generic Drugs
— As of the end of the reporting period, the Group's generic drug products, with annual revenue of more than RMB500 million (excluding exclusive products), have been included in the scope of centralized drug procurement. The stock of generic drugs that has not been included in the scope of centralized drug procurement has been cleared, hence, eliminating its risk exposure in centralized drug procurement.

During the year, the Group recorded revenue of approximately RMB28.78 billion, an increase of approximately 7.1% over last year. Profit attributable to the owners of the parent company was approximately RMB2.54 billion. Earnings per share attributable to the owners of the parent company were approximately RMB13.66 cents, a decrease of approximately 82.4% over last year. Excluding the share of profits and losses of associates and a joint venture (net of related tax and non-controlling interests), one-off adjustments for the impairment and fair value changes of certain assets and liabilities (net of related tax and non-controlling interests), fair value losses of current equity investments, share-based payments, loss on extinguishment of partial convertible bond, fair value gain of convertible bond embedded derivative component, effective interest expenses, exchange gain and fair value losses of derivative financial instruments in relation to foreign currency forward contracts of the convertible bond debt component, adjusted non-HKFRS profit attributable to the owners of the parent was approximately RMB2.99 billion, an increase of around 16.4% over last year. The Group's liquidity remains strong, with total fund reserve at approximately RMB22.96 billion, including cash and bank balances classified under current assets of approximately RMB12.07 billion, bank deposit classified under non-current assets of approximately RMB6.35 billion, and the wealth management products of approximately RMB4.54 billion in aggregate.

The Board of Directors has recommended a final dividend payment of HK6 cents per share. Together with the interim dividend of HK6 cents already paid, the total dividend for the year amounted to HK12 cents (2021: HK8 cents).

Sales: Sales revenue contributed by new products and innovative drug products rises relied on a strong sales system
The Group continues to focus on developing innovative medicines in four therapeutic areas and has benefited significantly from the continuous and huge investment it has made in R&D over the years. During the year, sales revenue from new products (products launched within five years) launched amounted to RMB12.51 billion, a 19.8% year-on-year increase, accounting for 43.5% of the Group's total revenue for the year, up from 38.9% for last year. Revenue from innovative drugs amounted to RMB6.75 billion, up by 20.0% year-on-year, and accounted for 23.5% of the Group's total revenue.

During the year, the Group's sales contribution continued to be led by drugs in the areas of oncology, surgery/analgesia, liver disease and respiratory system. Among them, the sales of oncology medicines amounted to approximately RMB9.19 billion, up by approximately 14.3% for last year, representing approximately 31.9% of the Group's revenue. The sales of surgery/analgesia and liver disease amounted to approximately RMB4.88 billion and RMB3.84 billion, respectively, representing approximately 17% and 13.3% of the Group's revenue, respectively. In addition, sales contributions from various areas such as respiratory, cardio-cerebral vascular medicines and others were comparable. Among them, the sales of respiratory and cardio-cerebral vascular medicines accounted for approximately 10.2% and 9.4% of the Group's revenue, respectively.

R&D: Continued to focus on R&D of innovative medicines, emphasizes protection of intellectual property rights
The Group has continued to focus its R&D efforts on new medicines in four therapeutic areas, namely
oncology, liver disease, respiratory system and the surgery/analgesia. As of the end of the reporting period, the Group has 103 products under development, including 53 oncology products, 12 liver disease products, 26 respiratory system products, and 12 surgery/analgesia products, involving a total of 58 Category I innovative products.

The Group also emphasizes the protection of intellectual property rights. It encourages its member enterprises to apply for patent applications as a means to enhance the Group's core competitiveness. During the year, the Group filed 1,006 new patent applications and received 280 authorized patent notices.

Prospects: Focus on main four therapeutic areas while the innovation and transformation have entered the harvest stage
As the pharmaceutical industry is likely to pick up rapidly. The Group has closely followed the development of the country, society and industry, and adjusted its development strategy in a timely manner. It has actively conducted organizational integration, optimized the internal organizational structure of the Group, and accelerated construction of business teams across different channels, in order to grow its business rapidly and deliver results in a stable manner.

According to important guidelines of the Country such as the "14th Five-Year Plan for Bioeconomy" and Key Tasks for Deepening the Reform of the Medical and Healthcare System in 2022. Sino Biopharma regards innovation and transformation as integral to its strategic development, and is focused on four main therapeutic areas: oncology, hepatitis, respiratory, and surgery/ analgesia. It has been mapping out innovative drug projects with best-in-class (BIC) and first-in-class (FIC) potential, and is driving innovative development through its dual engines: internal research and development, and commercial expansion. At present, the Group's innovation and transformation have entered the harvest stage. In the next three years, more than 10 innovative drug products will be launched, and over 40 innovative drugs in the pipeline may be launched by 2030, further promoting the high-quality development of the Group, realizing the revenue target of HK$100 billion by 2030, and becoming a leading innovative pharmaceutical group in the world. In addition, as the cornerstone of generic drugs, the Group will continue to deploy special generic drugs that have broad market prospects and are highly competitive, and through efficient and stable production maintain steady revenue growth from generic drugs.

Under the four main strategies of "organizational integration, comprehensive innovation, internationalization, and digitalization", the Group will further consolidate resources, improve operational efficiency, accelerate and facilitate cooperation at home and abroad, and promote global innovation and development.

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

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

For more information:
Strategic Financial Relations Limited
Vicky Lee +852 2864 4834 vicky.lee@sprg.com.hk
Sophie Du +852 2864 4815 sophie.du@sprg.com.hk
Website: www.sprg.com.hk


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

HONG KONG, Mar 30, 2023 – (ACN Newswire) – Ocumension Therapeutics ("Ocumension" or the "Company", together with its subsidiaries, collectively the "Group", stock code: 1477), a leading China ophthalmic pharmaceutical platform company, announced its annual results for the year ended 31 December 2022 today.

2022 was a year full of challenges and opportunities which the Company survived the ups and downs of the COVID-19. Courageous without hesitations is always the mission Ocumension Therapeutics committed to stick with. Given that, the Group achieved remarkable results during the year. It was attributable to the successful commercialization of multiple companies' core products which boosted the sale, plus the increase of revenue generated from the sales of ophthalmic products. During the year, operating revenue surged 183.1% to RMB159.0 million, as compared to RMB56.1 million in 2021. Consolidated gross profit margins was approximately 64.7%, total R&D expenses for the year amounted to RMB184.3 million, an increase of 9.0% as compared to 2021. Loss for the year attributable to the owners of the company was RMB402.6 million, mainly because no one-time gain was generated from the transaction with third parties, and the increase in share-based payments which the Group has further granted options, awards and RSUs under the share incentive schemes to our employees and consultant during the Reporting Period.

The Group continued to accelerate the penetration of the drugs in hospitals in the PRC ophthalmology market, achieving a coverage of 8,171 hospitals nationwide, 1,384 of which are Grade III hospitals, and a commercialization team of 191 people, thereby having completed the national commercialize network coverage. During the Reporting Period, the sales of Ou Qin and Emadine increased by 64% and 199%, respectively, as compared to the year ended December 31, 2021.

The Group continued to promote research and development progress during the year, the NDA for the Company's Core Product, Youshiying (OT-401), was approved by the NMPA in June 2022 for the treatment of chronic NIU-PS and commercialization in the PRC, ahead of the expected schedule. Youshiying was subsequently launched officially in December 2022 and completed the first patient injection, this is the first drug approved in China fully based on real-world study data and overseas clinical data, marked a milestone achievement in the history of drug registration in China and demonstrated the Company's research and development capabilities. At the same time, which in turn is also expected to boost the sales performance of the Company in 2023.

In addition, the phase III clinical trial of ZERVIATE (OT-1001), a potent and highly selective histamine-1 receptor antagonist with anti-allergic properties, has achieved its primary clinical endpoint and received positive results. The Company received approval from CDE for the phase III clinical trial of ILUVIEN (OT-703) for the treatment of diabetic macular edema (DME), having increased the total number of drug candidates in the stage of phase III clinical trial to six, giving the Company a significant lead over other competitors. OT-202 being one of the in-house developed new chemical entity (NCE) ophthalmic drugs with whole new targets and the fastest clinical progress in China for many years has drawn extensive attention from the medical community. As of now, the Company has successfully completed the phase I clinical trial of OT-202, and has initiated its phase II clinical trial on a researcher conference. The smooth progression of the project OT-202 served as concrete proof of the Company's solid innovation and research and development capabilities.

The research and development of the other pipeline products of the Company has also been continuously advancing in 2022. The completion of patients enrollment in China for the global phase III clinical trial of OT-101 (0.01% atropine sulfate eye drop), a self-developed new drug to treat the progression of myopia, signified the achievement of the milestone event of OT-101, which is expected to greatly accelerate the R&D and registration process of the such drug candidate, enabling patients in China suffering from myopia to have the opportunities to receive timely treatment.

The Company has established a comprehensive marketing and promotion system within the year. With the support of the system, Ocumension has met its aggregated sales goal of revenue of over RMB100 million in the fourth year since its inception. Meanwhile, the Company's sales efficiency has also further improved. Benefitting from its powerful commercialization network in the field of ophthalmic drugs, During the Reporting Period, the Company obtained the promotion right of all the ophthalmic pipeline products of Viatris in the hospitals nationwide in the PRC, further fortifying its leading position in the key fields such as glaucoma and antiallergy in the PRC, as well as increasing the number of commercialized pipeline products of the Company to 14.

Besides, our Suzhou manufacture site started pilot-scale and process validation batch production in May 2022. With the highly automated production lines, the production standard of our Suzhou manufacture site was able to reach the world-class manufacturing level and thus to ensure the quality and production efficiency of the products of the Company. The inauguration and start of operation of our Suzhou Xiaxiang manufacture site have not only firmly assured the Company's further improvement in sales, cost reduction, stable supply and enhanced profitability, but also demonstrated the manufacturing capabilities of the Company, lay a solid foundation for potential opportunities for international cooperation on the production of drug products in the future.

Looking forward to 2023, the Company will further advance and accelerate the process for registration and commercialization of the drug candidates under research and development, introduce more in-house developed products into clinical trial stage and maintain a wholesome product portfolio, so as to sustain its leadership among the peers in terms of the product pipeline. Pivoting the launch of the Core Product, Youshiying, the Company's commercialization team will further widen the scope and deepen the level of its promotion in the academic aspect, and strive to maintain the Company's exponential growth in sales.

In terms of research and development, at least two new products of the Company will enter the registration stage in 2023, keeping the pace of the continuous launch of new products. In terms of manufacture and production, our Suzhou Xiaxiang manufacture site will achieve commercialized mass production to ensure the stability of supply and the quality of products. At the same time, as the team stability and cohesion were finally achieved, be committed to building a unique corporate culture catering to Ocumension to safeguard our sustainable development and growth in the next stage in 2023.

Mr. Ye LIU, CEO and Executive Director of Ocumension, said: "As a young biopharma, Ocumension is marching into the fifth year since its inception. Leveraging the ameliorative market trend and favorable business environment in 2023, the Company will continue to grow at an exceptional pace as a pioneer, so as to repay the Shareholders' trust in and support to the Company. "

About Ocumension Therapeutics
Ocumension Therapeutics is a Chinese ophthalmology platform company dedicated to identifying, developing and commercializing pioneering or best-in-class ophthalmic therapies. The company's vision is to provide world-class drug solutions to meet the huge demand for ophthalmology treatments in China. We believe that our ophthalmology platform with its obvious first-mover advantage will give us a leading position in the ophthalmology industry in China. Up to now, the company has 24 kinds of drug assets in front of the eye and back of the eye, and has established a complete ophthalmic drug product line, six of which have entered phase III clinical trials in China. On July 10, 2020, Ocumension was listed on the main board of the Stock Exchange of Hong Kong Limited (stock code: 01477).

More information about Ocumension Therapeutics: https://www.ocumension.com/


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