HONG KONG, Aug 24, 2022 – (ACN Newswire) – Zhaoke Ophthalmology Limited ("Zhaoke Ophthalmology" or the "Company", SEHK: 6622), a leading ophthalmic pharmaceutical company dedicated to the research and development, manufacturing and commercialization of therapies that address significant unmet medical needs, today announced its interim results for the six months ended 30 June 2022 ("Reporting Period").

Zhaoke Ophthalmology is strategically focused on treatments that cover a wide range of ophthalmic diseases, with one of the largest and most comprehensive drug portfolios of innovative and generic treatments covering the six major eye diseases across both the front-and back-of-the-eye, including dry eye disease ("DED"), myopia, presbyopia, wet age-related macular degeneration ("wAMD"), diabetic macular edema ("DME") and glaucoma. The Company's portfolio includes several potential blockbuster innovative drug candidates.

Dr. Li Xiaoyi (Benjamin), Chairman of the Board, Executive Director and CEO of Zhaoke Ophthalmology, said, "Innovation and commercialization are Zhaoke Ophthalmology's dual focuses for 2022. We are proud to say that in the first half of 2022, we accomplished multiple milestone achievements in both areas, despite the challenging environment in China and globally."

The first highlight has been the completion of patient recruitment for concurrent Phase III clinical trials for one of the Company's core innovative drug candidates, NVK002, significantly ahead of schedule. In July 2022, NVK002, a treatment for myopia progression in children and adolescents, completed the recruitment for its concurrent two-year Phase III clinical trial ("China CHAMP") and one-year Phase III bridging trial ("Mini-CHAMP"). The China CHAMP trial involves 19 centers and 770 patients, and the Mini-CHAMP involves 18 centers and 526 patients. The former completed enrolment on 21 July 2022, two months ahead of schedule, while the latter completed enrolment on 28 July 2022, three months ahead of schedule.

Dr. Li continued, "Completing patient recruitment for these clinical trials so far ahead of schedule reflects both the strong capabilities and expertise of Zhaoke Ophthalmology's clinical operations team, as well as the immense demand for a safe and efficacious treatment for myopia progression in China."

The second highlight is the launch of Zhaoke Ophthalmology's first commercialized product, "Baodeshi" the Heat Compress Eyepatch, a category 2 medical device for reducing symptoms of mild cases of dry eye. The Eyepatch launch, will accelerate the Company's efforts to establish an omnichannel commercial strategy

Dr. Li added, "We are excited about the recent launch of the "Baodeshi" Heat Compress Eyepatch with an official flagship store on Tmall. The launch of the eyepatch exemplifies our core belief that a combination of drug regimen therapy and medical device will ultimately deliver the best treatment options for many patients. Moreover, the eyepatch also helps to increase the general public's awareness and knowledge of eye diseases and treatment solutions in China."

During the Reporting period, Zhaoke Ophthalmology achieved several milestones across its comprehensive drug pipeline. The Company's self-developed innovative drug, CsA Ophthalmic Gel for DED, submitted a New Drug Application (NDA) to the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) in China. The submission was accepted in June 2022 and is now under review by the CDE. In May 2022, Zhaoke Ophthalmology announced a new partnership with Visus, a US pharmaceutical company, to license BRIMOCHOL(TM) PF and Carbachol PF, innovative drugs for presbyopia. The introduction of the two innovative assets enabled Zhaoke Ophthalmology to become the first ophthalmic pharmaceutical company in China with innovative drugs in advanced clinical development covering the three major front-of-the-eye diseases – dry eye, myopia, and presbyopia. Also, TAB014, the company's first drug for the treatment of back-of-the-eye diseases, initiated a Phase III clinical trial and the first patient was enrolled for wAMD in June 2022.

Zhaoke Ophthalmology continues to focus on enhancing the Company's innovative omni-channel strategy through expanding its partnership network and strengthening digital engagement The strategy was kick-started with the launch of the Zhaoke Boshi WeChat platform in September 2021, in response to the demand from the ophthalmologist community for high quality content focusing on cutting-edge ophthalmology research in China and globally. This platform not only showcases outstanding content, but also allows leading KOLs to share their knowledge and best practices and facilitates discussions in the Chinese ophthalmologist community. Less than a year after its launch, the Zhaoke Boshi platform has attracted close to 10,000 followers. At the same time, over 60 leading KOLs in various fields of ophthalmology have contributed content or participated in livestream discussions on the platform.

Following the momentum established by Zhaoke Boshi, the launch of "Baodeshi" Heat compress eyepatch on Tmall with its own flagship store, marks the next milestone in our omni-channel commercialization strategy by establishing a direct channel of interaction with dry eye patients and eye-health-conscious consumers alike.

In February 2022, the Company established a corporate gift agreement with John Hopkins University, one of the world's leading private research institutes, to support translational research and academic exchange. In March 2022, Zhaoke Ophthalmology signed strategic partnership agreements with three of China's leading pharmaceutical supply chain service companies, Sinopharm Group Distribution Co., Ltd, Shanghai Pharmaceuticals Co., Ltd., and China Resources Pharmaceutical Commercial Group Limited to collaborate in areas including procurement models, logistics management, market developments, joint projects and information communication.

Turning to financial performance, Zhaoke Ophthalmology recorded a total loss of approximately RMB161.0 million for the six months ended 30 June 2022, compared to an approximately RMB1,987.7 million for the same period in 2021. During the period, the Company's R&D expenses reached approximately RMB100.9 million, compared to approximately RMB123.4 million for the six months ended 30 June 2021. Whilst the decrease in R&D expenses is mostly a result of the timing of various clinical programs, the Company is strictly focused on exercising discipline towards capital expenditure in light of overall financial market conditions.

As at the end of the Reporting Period, Zhaoke Ophthalmology recorded cash, cash equivalents and time deposits of approximately RMB1,860.3 million.

Dr. Li continued, "Looking forward, we anticipate the second half of 2022 will be an exciting period for Zhaoke Ophthalmology. Several milestones are expected to be completed in the coming months, including our partner Vyluma Inc. announcing the clinical results of their global three-year Phase III trial for NVK002. This will be an important step towards making this drug potentially the first US FDA-approved low-dose atropine for the treatment of myopia progression in children and adolescents."

He added, "Meanwhile, we will continue to adhere to our strategy ando combine our strong R&D capabilities, comprehensive asset portfolio and innovative commercialization approach to capture the huge unmet medical need not only in China, but also globally. With the dedication and unwavering passion of our employees, we are well positioned to capture the tremendous market opportunity."

Zhaoke Ophthalmology highlighted several pipeline updates as a part of the results announcement:

CsA Ophthalmic Gel for DED (self-developed)
Overview
CsA Ophthalmic Gel is an innovative drug being developed by us for the treatment of moderate to severe DED. It is a single, daily dose hydrogel which eliminates daytime administration and the associated discomfort and inconvenience and aims to dramatically improve patients' treatment compliance and quality of life. It is a proprietary hydrogel with patent approval in China and internationally. This novel formulation enhances the pharmacokinetic profiles of CsA on the ocular surface allowing efficacy similar to that of Cyclosporine A products currently available for DED. However, unlike the current treatment, CsA Ophthalmic Gel's unique formulation stays on the eye for longer, requiring only once-a-day dosing (compared with traditional twice-a-day dosing). In the Phase III clinical trial for CsA Ophthalmic Gel, the treatment also showed a faster onset of action by demonstrating efficacy at around a two-week period, while other CsA drugs normally take around seven to eight weeks.

Updates during the Reporting Period
On June 8, 2022, the NDA for CsA Ophthalmic Gel was accepted for review by the CDE.

Our Company continues to target the commercialization of CsA Ophthalmic Gel in China as early as 2023. Due to the treatment's potential to benefit millions of people globally, we are also exploring opportunities outside of China.

NVK002 (Atropine) for Myopia (partnered with Vyluma)
Overview
To date, low concentration atropine is the only medication that is consistently effective in myopia progression control among children and adolescents. Our innovative treatment, NVK002, is currently positioned as the first clinically-proven pharmaceutical product approved for treating the progression of myopia globally. This treatment has a proprietary formulation that successfully addresses the instability of low-concentration atropine and is preservative-free with an expected shelf life of more than 24 months. The clinical development of NVK002 involves two different concentrations of preservative-free atropine (0.01% and 0.02%) to determine the efficacy, safety and tolerability in children and adolescents with myopia, offering a distinct choice for doctors and patients.

Our Company's licensing partner for NVK002 is Vyluma, a wholly owned subsidiary of US-based Nevakar. Vyluma is currently conducting the Phase III clinical trial for NVK002 in the US and Europe. The results of the three-year trial are expected to be available by the end of 2022 and will be followed by an NDA submission to the FDA in 2023.

In September 2021, we received approval from the CDE to initiate two concurrent Phase III clinical trials, including China CHAMP and Mini-CHAMP. Combined with global data from Vyluma's Phase III clinical trial in the US and Europe, the overall trial for NVK002 will be one of the most comprehensive and robust Phase III clinical trials for low dose atropine use in the world.

Updates during the Reporting Period
The main objective of China CHAMP and Mini-CHAMP is to evaluate the efficacy and safety of NVK002 in the treatment of myopia progression in children and adolescents from 3 to 17 years old.

Led by Professor Wang Ningli from Beijing Tongren Hospital as the principal investigator, the China CHAMP trial involves 19 centers and has completed the enrollment of 777 patients. Co-led by Professor Qu Xiaomei from the Eye and ENT Hospital of Fudan University and Professor Yang Xiao from the Zhongshan Ophthalmic Center of Sun Yat-Sen University as the principal investigators, the Mini-CHAMP trial involves 18 centers and has completed the enrollment of 526 patients.

Both the China CHAMP and Mini-CHAMP have completed patient recruitment in July 2022, representing two and three months significantly ahead of schedule respectively. The early completion of patient recruitment across both trials gives our Company a strong head start in moving towards the goal of leading the market in launching a myopia progression treatment.

The drug could be available in the PRC market as early as 2024, potentially making Zhaoke Ophthalmology one of the first companies to commercialize a myopia drug in the PRC market.

BRIMOCHOL(TM) PF and Carbachol PF (partnered with Visus)
Overview
BRIMOCHOL(TM) PF and Carbachol PF are pupil-modulating eye drops designed to be once-daily, preservative-free therapeutics to correct the loss of near vision associated with presbyopia. BRIMOCHOL(TM) PF is a fixed-dose combination of carbachol (a cholinergic agent) and brimonidine tartrate (an alpha-2 agonist). Carbachol PF is a proprietary, preservative-free formulation of carbachol monotherapy. Both investigational therapies reduce the size of the pupil resulting in a "pinhole effect" so that only centrally focused light rays are able to enter the eye, thereby sharpening both near and intermediate images.

In the VIVID Phase II study conducted by Visus in the US, both formulations met primary and secondary endpoints, demonstrating a three-line improvement in near visual acuity with no loss of distance vision out to nine hours. Both BRIMOCHOL(TM) PF and Carbachol PF were well tolerated with no serious adverse events. Phase III pivotal trials commenced in March 2022, with interim topline data expected in the fourth quarter of 2022.

Corresponding to the ongoing Phase III clinical study of BRIMOCHOL(TM)PF and Carbachol PF in the US, we plan to launch a clinical study in China for presbyopia in the near future.

TAB014 (Bevacizumab) for wAMD (partnered with TOT BIOPHARM)
Overview
TAB014 is the first clinical-stage bevacizumab-based antibody indicated for wAMD in China. Bevacizumab is a clinically validated anti-VEGF drug. Globally, bevacizumab is approved for oncology treatment through intravenous infusion. However, there has been increasing off label use of bevacizumab via intravitreal
injection for the treatment of wAMD.

Updates during the Reporting Period
In March 2022, Zhaoke Guangzhou, a wholly-owned subsidiary of our Company, and TOT BIOPHARM Co., Ltd. Suzhou, a wholly owned subsidiary of TOT BIOPHARM, entered into a supplemental agreement – pursuant to which Zhaoke Guangzhou will have full control in the execution of clinical trials and the ultimate decision-making power in the development and commercialization of TAB014 in China, Hong Kong and Macau. Zhaoke Guangzhou has also been given the right to develop TAB014 for other ophthalmic indications besides wAMD or novel formulations for ophthalmic indications.

On June 28, 2022, we completed the recruitment of the first patient for the Phase III clinical trial of TAB014.

The Phase III clinical trial of TAB014 is a randomized, double-blind and noninferiority study. The main objective of the study is to evaluate the change from baseline in best corrected visual acuity (BCVA) at week 52 in TAB014-treated subjects group compared with Lucentis(R)-treated subjects group. The study will involve up to approximately 60 centers and enroll a total of 488 patients, led by Professor Chen Youxin from Peking Union Medical College Hospital as the principal investigator.

ZKY001 (self-developed)
Overview
ZKY001 is a seven-amino acid peptide derived from the functional fragment of Thymosin beta4 that binds actin, a type of protein that plays a central role in cell structure and movement. We are exploring multiple indications as we believe this asset can potentially be applied to multiple disease indications.

ZKY001 has broad applications in the healing of corneal wounds and can potentially be used in multiple indications. We are currently exploring four indications for ZKY001, including CED, corneal epithelial defect, TPRK, a surgical treatment for myopia, pterygium, a growth in the cornea or the conjunctiva, and NK, a rare degenerative corneal disease.

Updates during the Reporting Period
We completed treatment for the last patient in the Phase II clinical trial of ZKY001 for CED in February 2022. On March 16, 2022, the first patient was enrolled for Phase II clinical trial for pterygium disease. On August 5, 2022, the first patient was enrolled for the Phase II clinical trial for TPRK. We will refine our clinical development strategy for this asset once we have the trial results across multiple indications.

NTC010
Overview
NTC010 is a fixed dose combination of antibiotics and steroids to prevent infection and inflammation for patients undergoing cataract surgery. The drug belongs to a new generation of antibiotics, which increase efficiency and cover a wider range of bacteria. The drug also shortens the duration of the treatment by half – from 14 to seven days – making it beneficial to patients' overall health and helping to prevent antibiotic overuse. The drug has already been approved in seven European countries. We plan to submit an NDA to the NMPA in the near future.

PAN-90806 (VEGFR2 inhibitor) for wAMD and DME (partnered with PanOptica)
Overview
PAN-90806 is an innovative drug indicated in the treatment of wAMD, as well as DME, the leading cause of blindness in diabetic patients worldwide.

PAN-90806 is a novel eye drop formulation, which decreases the number of injections required. If approved as a maintenance therapy, PAN-90806 will bring significant convenience and a less invasive treatment alternative for patients. This will reduce the frequency of intravitreal injections and other treatment issues associated with mainstream anti-VEGF therapies while at the same time maintaining visual stability. PAN-90806 is expected to significantly reduce treatment discontinuation, and therefore slow underlying disease progression through improved patient comfort, acceptance, convenience and compliance.

We are currently focused on optimizing the formulation of PAN-90806. Subject to regulatory approvals, our Company plans to commence human trials after completion of requisite animal studies.

Generic Drugs
We follow a balanced approach in designing our drug pipeline. In addition to innovative drug candidates, our Company has several key generic drugs in the pipeline. Generic drugs address a substantial portion of ophthalmic medical needs in China. From a market demand perspective, our generic pipeline complements our innovative pipeline and better positions us to become an efficient one-stop comprehensive solution provider. From a supply perspective, our generic programs also offer several strategic benefits.

During the Reporting Period, we continue to focus on commercializing Bimatoprost Timolol, a generic drug for glaucoma, as our first commercialized drug asset. The launch of this treatment will position us in the under-served glaucoma market and prepare us for the future commercial launch of our innovative drugs.

About Zhaoke Ophthalmology
Founded in 2017, Zhaoke Ophthalmology (SEHK: 6622) is a leading ophthalmic pharmaceutical company dedicated to the research and development, manufacturing and commercialization of therapies that address significant unmet medical needs in the world. The company was listed on the Main Board of the Hong Kong Stock Exchange on 29 April 2021.

Zhaoke Ophthalmology has a comprehensive drug portfolio of innovative and generic treatments covering six major eye diseases across both the front and back of the eye. Many of the drugs are being produced in its state-of-the-art and fully functional development and production facility in Nansha, Guangzhou.

Zhaoke Ophthalmology is focusing on advancing towards the goal of product commercialisation, and achieving the objective of improving visual health in China through scientific research as soon as possible.

Through its ambitious growth strategy, including partnering with domestic and international pharmaceutical companies, Zhaoke Ophthalmology's goal is to become a leader in ophthalmology in the world.

For more information, please visit: www.zkoph.com

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HONG KONG, Aug 24, 2022 – (ACN Newswire) – SinoMab BioScience Limited ("SinoMab" or the "Company", together with its subsidiaries, the "Group", stock code: 3681.HK), a Hong Kong-based biopharmaceutical company dedicated to the research, development, manufacturing and commercialization of therapeutics for the treatment of immunological diseases, is pleased to announce that, on 23 August 2022, an Investigational New Drug application ("IND", for neuromyelitis optica spectrum disorder ("NMOSD")) for SN1011 was approved by the National Medical Products Administration of China (the "NMPA"). The IND approval would enable the Company to initiate the Phase II/III clinical study in China to evaluate the efficacy and safety of SN1011 for the treatment of NMOSD in China. The planned first patient enrollment is in the first quarter of 2023.

SN1011 is the Company's third generation, covalent reversible BTK inhibitor designed for higher selectivity, superior efficacy, and improved safety for the long-term treatment of systemic lupus erythematous ("SLE"), pemphigus ("PV"), multiple sclerosis ("MS"), neuromyelitis optica spectrum disorder("NMOSD") and other rheumatoid or immunological diseases. SN1011 differentiates from existing BTK inhibitors currently available in the market, such as Ibrutinib, in terms of mechanism of action, affinity, selectivity and safety. The Phase I study (first-in-human clinical trial) of SN1011 was conducted in Australia and China in 2019 and completed in July 2021, which has demonstrated good safety and pharmacokinetics profile.

Currently, four IND applications of SN1011 for the treatment of SLE, PV, MS and NMOSD have been approved by NMPA respectively. At the same time, the Company is planning an IND submission for MS in the U.S.

NMOSD is an autoimmune-mediated inflammatory demyelinating disease of the central nervous system with predominant involvement of the optic nerve and spinal cord. The pathogenesis of NMOSD is mainly associated with aquaporin-4 (AQP4) antibodies and is a separate disease entity from multiple sclerosis, with severe optic neuritis and longitudinal extensive transverse myelitis as the main clinical features. However, the cause of NMOSD is unknown, with a combination of environmental factors such as smoking, low vitamin D levels, EBV infection and genetic susceptibility contributing to the development of the disease.

Dr. Shui On LEUNG, Chairman, Executive Director and Chief Executive Officer of SinoMab said that: "The IND application of SN1011 for the treatment of NMOSD was accepted by the NMPA at the beginning of June, and approved within three months, fully reflecting the potential of SN1011 as well as the efficient execution of the Company's new drug R&D program. The clinical study for the treatment of NMOSD is the fourth indication of SN1011 approved in China following the approval of IND application for SLE, PV and MS, fully demonstrating the great potential of the innovative BTK inhibitor towards multiple indications in the field of the treatment of autoimmune diseases. Currently, numerous of Company's main candidate products, covering indications in the field of autoimmune diseases, have entered clinical stage gradually. Among which, our flagship product SM03 (Suciraslimab) is approaching the endpoint in its Phase III clinical study for rheumatoid arthritis. As the clinical studies of our key candidates moving forward, we will continue to expand the potential indications of the products, promote the global R&D progress and constantly improve our production facility and expand capacity to enhance our commercialization capability. SinoMab is devoting to becoming a biopharmaceutical company, with R&D headquartered in Hong Kong and production based in Mainland China, with whole industry chain layout from R&D to production as well as a global leader in the innovation of therapeutics for immunological and other debilitating diseases.

About SinoMab BioScience Limited
SinoMab BioScience Limited (stock code: 3681.HK) is dedicated to the research, development, manufacturing and commercialization of therapeutics for the treatment of immunological diseases. The Company's flagship product SM03 is a potential global first-in-target mAb against CD22 for the treatment of rheumatoid arthritis (RA) and is currently in Phase III clinical trial for rheumatoid arthritis in China, which has been recognized as one of the significant special projects of Significant New Drugs Development of the Twelfth Five-Year Plan Period and the Thirteenth Five-Year Plan Period. In addition, the Company possesses other potential first-in-target and first-in-class drug candidates, some of which are already in clinical stage, with their indications covering rheumatoid arthritis (RA), systemic lupus erythematosus (SLE), pemphigus, non-Hodgkin's lymphoma (NHL), asthma, and other diseases with major unmet clinical needs.


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LAUSANNE, Switzerland, Aug 23, 2022 – (ACN Newswire) – Oculis S.A., ('Oculis') a global ophthalmology company developing life-changing treatments to save sight and improve eye care with breakthrough innovations, announces that the results of the double blinded, multicenter and placebo controlled Phase 2 clinical trial assessing the effect of topical licaminlimab (OCS-02) on global ocular discomfort in patients with severe dry eye disease (DED) (NCT02365519) has been published by the Clinical Ophthalmology journal. The publication is accessible on the National Institutes of Health (NIH) website here. ( https://pubmed.ncbi.nlm.nih.gov/35821785/ )

The results from the study show that the change from baseline to Day 29 in the global ocular discomfort score, the primary efficacy endpoint, was statistically significantly greater for topical ocular licaminlimab (OCS-02) (-7.9) than for vehicle (-3.6) (90% CI -7.7, -0.8; p = 0.041). The percentage of patients with an improvement in global ocular discomfort score >20 from baseline to treatment day 29, one of the main secondary efficacy endpoints, was statistically greater for licaminlimab (17.9%) compared to vehicle (4.7%) (p=0.018).

Licaminlimab (OCS-02) was well tolerated in this study, with no major safety differences between licaminlimab (OCS-02) and vehicle treatment groups, and no increase in intra-ocular pressure was observed.

Licaminlimab (OCS-02) is a single-chain antibody fragment (scFv) that binds to and neutralizes the activity of human TNFa, with dual mechanism of action (MoA), anti-inflammation and anti-necrosis. Unlike full-length monoclonal antibodies, scFv fragments can penetrate ocular surface tissues when used as eye drops, due to the smaller size of the molecule giving it the potential to become the first approved topical biologic for DED.

Dry Eye is a multifactorial disease in which inflammation rapidly takes on a central role in sustaining the pathological state(1). The global prevalence of DED has been reported at 11.59%(2) , representing approximately 900 million people worldwide. In the US alone, there is currently between 16 million and 49 million people who have dry eye disease(3) . Significant unmet medical needs remain for this large and growing patient population with only 9% of diagnosed patients in the US receiving treatment(4) and despite current options, only 13% of patients are achieving lasting relief(5) .

Licaminlimab (OCS-02) is currently being investigated by Oculis in Phase 2 clinical trials for the treatment of dry eye disease and uveitis.

Pr Christophe Baudouin, M.D., Professor of Ophthalmology and Chairman of Ophthalmology III in Quinze-vingts National Ophthalmology Hospital, Paris, commented: "There is a true unmet medical need for the development of drugs with new MOA to treat the inflammation involved in the pathogenesis of DED. OCS-02 is certainly one that could fill that gap. As compared to currently available treatment options and other product candidates in the DED pipeline, OCS-02 could play a role in the treatment of the underlying causes of the disease given its anti-inflammatory and anti-necrosis benefits. I certainly look forward to the continued development and approval of OCS-02 in severe dry eye disease as these patients currently have limited treatment options."

Riad Sherif, M.D., CEO of Oculis, said: "The Phase 2 data further reinforce our confidence in the potential of OCS-02 as a novel anti-inflammatory treatment for the effective management of Dry Eye Disease, but also for other inflammatory eye diseases. With Phase 2b clinical trials of OCS-02 for the treatment of dry eye disease and uveitis which are planned to start in the coming months, along with on-going Phase 3 clinical trials of OCS-01 in diabetic macular edema and inflammation and pain following ocular surgery and a proof-of-concept (POC) trial of OCS-05 in acute optic neuritis, we look forward with confidence to the further development of the Oculis Ophthalmology Franchise to address significant unmet medical needs in key areas of ophthalmology."

About Oculis
Oculis is a global biopharmaceutical company purposefully driven to save sight, improve eye care and address significant unmet medical needs with breakthrough innovations. Oculis's highly differentiated pipeline includescandidates for topical retinal treatments, topical biologics and disease modifying treatments. With a presence in key international markets, Oculis is poised to deliver life-changing treatments to patients worldwide. Headquartered in Lausanne, Switzerland and with operations in Europe, the U.S. and China, Oculis is led by an experienced management team with a successful track record and supported by leading international healthcare investors.

For more information, please visit: www.oculis.com

Notes:
(1) Baudoin C. Dry Eye Disease, the complex interactions of vicious cycles. EuDESEuropean Dry Eye Society https://www.dryeye-society.com/resources/dry-eye-disease-complex-interactions-vicious-cycles
(2) Eric B Papas "The global prevalence of dry eye disease: A Bayesian view" 2021
(3) https://dryeyedirectory.com/dry-eye-statistics/
(4) DRG Dry Eye Disease Landscape and Forecast 2020
(5) Mukamal, R. Why is Dry Eye So Difficult to Treat? 2021 https://www.aao.org/eye-health/tips-prevention/fix-dry-eye-treatment-eyedrops


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HONG KONG, Aug 23, 2022 – (ACN Newswire) – Sino Biopharmaceutical Limited ("Sino Biopharmaceutical" or the "Company", together with its subsidiaries, the "Group") (HKEX:1177), a leading innovation-driven pharmaceutical conglomerate in the PRC, has announced its unaudited Interim results for the six months ended 30 June 2022 (the "Period").

Development Highlights
— The Group achieved considerable sales growth from a number of new products and oncology products, with sales of new products launched within five years accounted for approximately 43.5% of the Group's total revenue in the first half of 2022, up from approximately 36.9% for the same period last year.

— As of 30 June 2022, the Group had a total of 40 innovative drug candidates in the oncology field, 8 innovative drug candidates in the field of liver disease, 9 innovative drug candidates in the respiratory system field in development process for clinical application, and 1 innovative drug candidate in the field of surgery/analgesia in phase III clinical trial. Furthermore, the Group had a total of 23 biosimilar or generic drug candidates in the oncology field, 9 other biosimilar or generic drug candidates in the surgical/analgesic field, 5 biosimilar or generic drug candidates in the field of liver disease and 20 biosimilar or generic drug candidates in the respiratory system field in development process for clinical application.

— Focus V (Anlotinib Hydrochloride Capsules) was approved for the fifth indication-differentiated thyroid cancer in the first half of 2022. To date, Anlotinib 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.

— TDI01 is a highly selective inhibitor of ROCK2 and is currently in development process of phase I clinical trial for the target indications of pneumoconiosis, pulmonary fibrosis and graft versus host disease. There is no approved drug for pneumoconiosis worldwide, TDI01 is expected to fill this gap and be a boon to pneumoconiosis patients.

— SFT-1001 and SFT-1003 are two soft mist inhalation products that are currently in late clinical stage. As of 2021, there are only five soft mist inhalation products available worldwide, with a global market size of over US$3 billion and a compound growth rate of over 35% in the past five years, and the global soft mist market is expected to each US$7 billion by 2030.

During the Period, the Group recorded revenue of approximately RMB15.19 billion, an increase of approximately 5.9% against last year. Profit attributable to the owners of the parent company was approximately RMB1.92 billion. Earnings per share attributable to the owners of the parent company were approximately RMB10.30 cents. Excluding the share of profits and losses of associates and a joint venture (net of related tax and non-controlling interests), certain non-cash items and one-off adjustments, adjusted non-HKFRS profit attributable to the owners of the parent was approximately RMB1.66 billion, an increase of approximately 4.5% over that in the same period last year. Sales of new products accounted for approximately 43.5% of the Group's total revenue for the period, while it was approximately 36.9% for the same period last year. The Group's liquidity remains strong, with cash and bank balances classified under current assets of approximately RMB7.77 billion, bank deposits classified under non-current assets of approximately RMB6.84 billion, and wealth management products of approximately RMB7.64 billion in aggregate, the Group's total fund reserve was approximately RMB22.25 billion at the period end.

The Board of Directors has declared the payment of an interim dividend of HK6 cents per share. (2021: HK4 cents).

Sales: Harvested years of R&D results, sales of new products as a percentage to revenue climbed
The Group has obtained significant benefits from years of high research and development, and continues to focus on development of related products in the areas of specialist therapeutic. During the period, the sales revenue of new products launched within five years was approximately RMB6.61 billion, accounting for approximately 43.5% of the total revenue of the Group from approximately 36.9% last year.

During the Period, the Group's oncology, liver disease and cardio-cerebral vascular medicines continued to lead in sales contribution. Sales of oncology medicines increased by 16.7% year-on-year to approximately 4.96 billion, accounting for approximately 32.6% of the Group's revenue. Sales of liver disease (hepatitis) medicines and cardio-cerebral vascular medicines increased by approximately 11.1% and 13.8% year-on-year to approximately 2.01 billion and 1.55 billion, respectively, accounting for approximately 13.2% and 10.2% of the Group's revenue. In addition, the sales contributions of products in various areas such as surgery/analgesia, respiratory system and others went up hand-in-hand. Sales of surgery/analgesia and respiratory system medicines accounted for approximately 16.6% and 10.0% of the Group's revenue, respectively.

In the area of oncology, since its launch in 2018, the revenue from sales of Anrotinib has continued to grow rapidly and is expected to grow at a compound rate of 46% in the period between 2018 and 2022. During the Period, sales of Annike (Penpulimab monoclonal antibody injection) increased significantly against the same period last year. F-627 (Efbemalenograstim alpha, long-acting granulocyte colony-stimulating factor) is currently under marketing application stage. It provides a safety advantage over mainstream second generation products currently on the market, is expected to be approved in China in the first half of 2023.

In the area of surgery/analgesia, the Group focused on hospital access and high-potential area development, specifically on developing and increasing coverage of secondary hospitals and community healthcare facilities, driving the rapid growth of Debaian (Flurbiprofen) Cataplasms in the first half of the year.

In the area of liver disease, the Group made efforts to strengthen academic promotion so as to expand doctor coverage and enhance expert recognition, as well as actively identified new patients and new market to develop, driving the rapid growth of sales revenue of Tianqing Ganmei Injection during the Period.

R&D: Continued to focus on new products in specialist therapeutic areas
The Group has continued to focus R&D efforts on new oncology, surgery/analgesia, hepatitis, respiratory system and cardio-cerebral vascular medicines. As of 30 June 2022, a total of 418 pharmaceutical products had obtained clinical trial approval, or were under clinical trial or applying for production approval. Of them, 29 were for under hepatitis, 230 for oncology, 31 for respiratory system medicines, 9 for endocrine, 16 for cardio-cerebral medicines, 3 for surgery, 4 for analgesia and 96 for other medicines.

Prospects: Two-pronged approach of independent research and development, focusing more on products with high innovation and market potential
In the future, the Group will build a healthier, more diversified and sustainable revenue structure by continuing to build on traditional public hospital sales, invest more resources in new marketing channels and new marketing tools, and gradually expanding their share of revenue. In view of the potential impact of the national volume-based procurement policy on generic drugs, the Group has re-evaluated and optimised its product lines under development from the perspective of innovation and market value, focusing more on products highly innovative and with market potential.

The Group will continue to invest more resources in innovative R&D facilities, personnel and projects. Innovation has become a key driver of growth for the Group, with the share of revenue from innovative medicines expected to reach 24% by 2022. Looking ahead, the Group plans to attain revenue exceeding the RMB10 billion mark from innovative medicines by 2023, further increasing the share of revenue from them in the Group's total. The Group aims to become a world-class innovative pharmaceutical group by 2030, with a revenue target of HK$100 billion, of which over 60% is expected to be contributed by innovative drugs.

Looking ahead, the Group is focusing on four therapeutic areas, namely oncology, surgery/analgesia, liver disease and respiratory system, and will strive to achieve its 2030 target by adopting a two-pronged approach – pursuing independent research and development and innovation-driven business 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 oncology, surgery/analgesia, hepatitis, and respiratory system.

Sino Biopharmaceutical 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.



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HONG KONG, Aug 22, 2022 – (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 interim results for the six months ended June 30, 2022 (the "Period").

Performance Summary:
— Revenue was RMB118.8 million, representing an increase of 129.8% from the same period of 2021.
— Gross profit (excluding the amortization cost from purchase price allocation) was RMB87.6 million, representing an increase of 133.5% from the same period in 2021, and gross margin (excluding the amortization cost from purchase price allocation) reached 73.7%.

Key Operational Statistics:
— Even under the impact of Covid-19, revenue from theTranscatheter Valve Therapeutic Business and Neurointerventional Business were RMB52.1 million and RMB66.7 million, representing an increase of 455.4% and 57.6% from the same period in 2021, respectively.
— For the Transcatheter Valve Therapeutic Business, both product adoption by new hospitals and the utilization rate of its products in the adopted hospitals exceeded expectation. As of July 31, 2022, within a short period of about one year after TaurusOne(R) and TaurusElite(R) received NMPA approvals, a total of 209 hospitals were entered and the implantation volume repeatly reached monthly highs, accounting for close to 20% of the market share in July. The total implantation volume of the six months ended June 30, 2022 has far exceeded that of the whole year of 2021. The pipeline for the Transcatheter Valve Therapeutic Business was progressing smoothly as scheduled.
— The Group's registration applications of four ischemic products have been approved by the NMPA, and the product portfolio for the ischemic product line has been preliminarily established. The Group can provide a complete set of solutions for hemorrhagic and ischemic stokes. In the first half of 2022, the Group continued expanding its share in the sizable hemorrhagic market, constantly consolidating its leading position in the neurointerventional industry.
— The Group made continuous efforts to optimize the supply chain and optimize the production process to achieve long-term success, and continued to maintain stable production to meet the rapid sales demand growth in the first half of the year.

During the period, the Group recorded a revenue of RMB118.8 million, representing an increase of 129.8% as compared to the same period in 2021. Revenue from the Transcatheter Valve Therapeutic Business and Neurointerventional Business were RMB52.1 million and RMB66.7 million , representing a substantial increase of 455.4% and 57.6% as compared to the same period in 2021, respectively. The increase in revenue was primarily attributable to: (i) commercialization of the second-generation retrievable TAVR product TaurusElite(R); (ii) increased sales revenue from existing neurointerventional products including Tethys(R) Intermediate Catheter and SacSpeed(R) Balloon Dilation Catheter; and (iii) commercialization of multiple new neurointerventional products including Jasper(R) SS Detachable Coil, etc. Gross profit (excluding the amortization cost from purchase price allocation) was RMB87.6 million, representing an increase of 133.5% from the same period in 2021, and gross margin (excluding the amortization cost from purchase price allocation) reached 73.7%.

The impact of Covid-19 in the first half of 2021 further validated the Group's execution capability and operational efficiency. Both business lines exceeded their respective commercialization targets. The Group's pipeline projects progressed smoothly and its production operation and supply chain were well managed. Production fulfillment rate of core products reached around 60% (50% as the baseline) in the first half of the year.

Transcatheter Valve Therapeutic business: The commercialization platform was preliminarily established, setting up a strong foundation for commercialization success. Pipeline products also progressed smoothly, bringing sustainability to the long-term business development.

For the Transcatheter Valve Therapeutic Business, the Group had five registered products and nine product candidates at various development stages. The sales of TaurusOne(R) and TaurusElite(R) products were in good progress. The revenue of the Transcatheter Valve Therapeutic Business increased by 455.4% as compared to the same period in 2021 despite the impact of the pandemic. As of June 30, 2022, the Group had a sales and marketing team of 151 employees dedicated to the sales and marketing of its Transcatheter Valve Therapeutic Business.

Thanks to its outstanding product performance and professional market education and promotion, both product adoption by new hospitals and the utilization rate of our products in the adopted hospitals have accelerated for our Transcatheter Valve Therapeutic Business. As of July 31, 2022, the products of the Group entered 209 hospitals, repeatedly setting new monthly highs in implantation volume. The implantation volume reached close to a market share of 20% in July. For the seven months ended July 31, 2022, the total implantation volume reached close to 650 units, more than twice the implantation volume for the whole year 2021. The second half of the year started with strong momentum. The Group are steadily increasing our market share and striving to outperform other players. The Group have become the top player in certain cities and hospitals, with huge development potential.

The Transcatheter Valve Therapeutic Business has progressed rapidly since its commercial launch, thanks to its cross functional teams comprised of marketing, sales and medical professionals. The all-round support ranges from academic promotion to new technology cooperation, from patient identification to physician training, and from preoperative, intraoperative and postoperative clinical support to meticulous sales service. The rapid development of commercialization has built a solid cash foundation for the long-term development of the Company.

The Group has developed a competitive product pipeline through external acquisitions and internal development, with a wide range of innovative products in development covering major valvular diseases and next-generation technologies. As of August 19, 2022, the Group has four BD projects, which are deployed in the fields of aortic valve replacement for AR, mitral valve replacement, tricuspid valve replacement and mitral valve coaptation augmentation, respectively. In addition to BD projects, its internally developed projects are also widely recognized. Areas of the Group are exploring include improving the durability of prosthetic valves, creating non-implant treatment solution for valve diseases and developing innovative mitral valve repair products.

Among them, three projects are entering into significant clinical trial stages: GeminiOne(R) and MonarQ will enter the registration clinical trial and overseas FIM clinical trial stages, respectively, and HighLife(R) will enter the registration clinical trial stage.

Neurointerventional Business: With the Group's successive launch of four ischemic products, the product portfolio for the ischemic product line has been preliminarily established. The Group are able to provide a complete set of solutions for hemorrhagic and ischemic strokes. With increasing sales from hemorrahagic products and upcoming commercialization of recently approved ischemic products, the revenue composition of the Neurointerventional Business will further diversify.

In the first half of 2022, the registration applications of four products have been approved by the NMPA, namely, Syphonet(R) Stent Retriever, Tethys AS(R) Aspiration Catheter, Fastunnel(R) Delivery Balloon Dilation Catheter and Fluxcap(R) Balloon Guide Catheter. The product portfolio for the ischemic product line has been preliminarily established, with all major devices readily in place, forming a complete solution for patients with AIS and ICAD.

As of now, for the Neurointerventional Business, the Group had fourteen registered products and seven product candidates at various development stages. The Group have a comprehensive portfolio of registered and pipeline products that target both hemorrhagic and ischemic stroke markets, providing one-stop solution for both hemorrhagic and ischemic strokes with a complete line of core products. This will not only build its resilience in times of change and uncertainty, but also enhance the attractiveness and synergy of its product portfolio among physicians and distributors.

Thanks to the superior product performance, strong marketing capability as well as stable and in-depth distributor network, revenue from the Neurointerventional Business increased by 57.6% during the period, as compared to the same period in 2021. The revenue generated from the sales of hemorrhagic, ischemic and vascular access products accounted for 44.2%, 25.0% and 30.6% of the total revenue of the Neurointerventional Business, respectively. With increasing sales from hemorrahagic products and upcoming commercialization of recently approved ischemic products, the revenue composition of its Neurointerventional Business will further diversify.

As of June 30, 2022, the Group had 177 distributors, covering more than 1,800 hospitals in 31 provinces nationwide. The Group will continue to build on its sales team and distributor coverage in response to its expanding ischemic product portfolio. As of June 30, 2022, the Group had a sales and marketing team of 74 employees focusing on the sales and marketing of neurointerventional products.

As of June 30, 2022, the Group had a robust intellectual property portfolio, consisting of a total of 89 granted and valid patents and 100 patents under application. Specifically, there are 53 granted and valid patents and 74 patents under application for our Transcatheter Valve Therapeutic Business, and 36 granted and valid patents and 26 patents under application for its Neurointerventional Business.

Dr. Yi Zhang, Executive Director, Chairman of the Board and Chief Executive Officer of Peijia Medical Limited, said "As one of the world-class medical device leader rooted in China, Peijia Medical will strive to strengthen the Group's leading position in the industry by implementing a series of future strategies and plans. Looking forward, the company will continue to develop and commercialize interventional solutions for structural cardiac and neurovascular diseases in China and globally in line with its corporate vision. Meanwhile, the Group will continue to actively promote the clinical trials of pre-clinical products in development, and try our best to bring positive and effective treatment options to patients as soon as possible."


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HONG KONG, Aug 22, 2022 – (ACN Newswire) – IVD Medical Holding Limited ("IVD Medical" or the "Group"), a leading distributor of In Vitro Diagnostic ("IVD(1)") products in the PRC, has announced its interim results for the six months ended 30 June 2022 ("Period").

During the Period, although hospitals were closed and other quarantine and social distancing measures were put in place in mainland China due to the COVID-19 pandemic, which resulted in a temporary decrease in end customers' demand for IVD product. With the help of its competitive and diverse product portfolio, extensive distribution network and growing maintenance services business, the Group still recorded revenue of RMB1,176,557,000 (six months ended 30 June 2021: RMB1,186,791,000), a similar level to that in the same period last year. Gross profit increased by 11% year-on-year to RMB266,423,000 and gross profit margin was up 2.4 percentage points year-on-year to 22.6%. The increases were mainly attributable to the decrease in purchase price of IVD analysers and the increase in maintenance services revenue with relatively stable maintenance cost. Driven by rising profit margin, the Group's adjusted profit for the period amounted to RMB96,773,000, 6.7% more year-on-year. The Board resolved to declare the payment of an interim dividend of HK2.729 cents per share for the six months ended 30 June 2022.

Mr. Ho Kuk Sing, Chairman of IVD Medical, said, "In 2022, although the business environment of the medical industry has been tough under the pandemic, we have worked hard to overcome challenges and optimize our business operations. For distribution business, we signed a five-year exclusive distribution agreement with Sysmex in April this year. We have expanded our distribution network and hospital coverage to consolidate our position in the industry. Furthermore, our maintenance services business has been developing steadily with the notable growth in revenue, gross profit and gross profit margin. Looking ahead, we are prepared to capture potential growth opportunities in the industry and committed to bring better and long-term returns to shareholders."

Business Review
The Group is a leading distributor of IVD products in the People's Republic of China ("PRC"). It has also engaged in research, development, manufacturing and sales of its self-branded IVD products.

Distribution Business
The distribution of IVD products forms the cornerstone of the Group's business. It primarily involves the trading of IVD analysers, reagents and other consumables to customers such as distributors, hospitals and healthcare institutions and logistics providers. During the Period, revenue from this segment was RMB1,097,468,000, with gross profit up 3.1% to RMB216,907,000.

Through years of operation, the Group has established an expansive distribution network across 29 provinces, municipalities and autonomous regions in the PRC with an extensive hospital coverage. As of 30 June 2022, the Group has 204 direct customers, including hospitals and healthcare institutions, and 908 distributors in its established distribution network.

The Group distributes IVD products through its wholly-owned subsidiary Vastec Medical Limited ("Vastec"). Vastec has been the sole nationwide distributor of Sysmex haemostasis products with exclusive distribution rights in the PRC since 1997, and also procures a diversified portfolio of IVD products from other leading international brands for distribution in the PRC. On 1 April 2022, Vastec signed a five-year distribution agreement of Sysmex haemostasis products with exclusive distribution rights which is valid till 31 March 2027. The agreement has helped to strengthen the long-term and quality cooperation between Vastec and Sysmex.

Moreover, the Group has provided four Thrombotic Markers(2) products manufactured by Sysmex to the market. These products adopt highly sensitive chemiluminescence technology, which may facilitate early diagnosis of thrombosis and fibrinolysis.

The Group also provides solution services to clinical laboratories of hospitals, as such, it has enabled the Group to establish and maintain direct relationships with local medical practitioners so as to keep the Group close to the frontline of the medical practice and the demand of IVD products. In the first half of 2022, the Group provided solution services to eight Class III hospitals in the PRC.

Maintenance Services
The Group provides maintenance services to end customers of Sysmex' haemostasis analysers. In 2017, Vastec entered into a maintenance services agreement with Sysmex to provide maintenance services to haemostasis analysers procured by its end customers. The maintenance services provided by Vastec generally include maintenance and repair services, installation services and end customer trainings. And, it primarily provides its maintenance services to hospitals and healthcare institutions. During the Reporting Period, the maintenance services business has been sustainably and steadily developing, with revenue amounted to RMB77,286,000, up by 27.8% against the same period last year. Gross profit of this segment increased by 70.2% to RMB48,388,000 and gross profit margin was up 15.6 percentage points to 62.6% for the period.

Self-Branded Products Business
The Group has also engaged in the research and development, manufacturing and sales of IVD analysers and reagents under its own brand. The Group's self-branded IVD reagents were manufactured by Suzhou DiagVita Biotechnology Co., Ltd. and Bazoe Medical Co., Ltd., and the Group's IVD analysers were produced by its equipment manufacturers, IVD Medical Equipment (Shanghai) Ltd. and Langmai Biotechnology (Shandong) Co., Ltd. In addition, the Group distributes self-developed IVD products under its own brand which includes IVD analysers and reagents primarily under the IVD testing category of Point-of-care testing ("POCT"), mass spectrometry and microbiology.

Outlook
In the future, the Group will continue to consolidate its leading position in the IVD industry in the PRC. To realise this goal, the Group aims to continuously expand its product portfolio by diversifying product categories, increasing brand coverage, and further expanding the breadth of its distribution network and hospital coverage. In this way, the Group will be able to capitalise on the high growth potential in the IVD market.

Furthermore, the Group will continue to develop its distribution business by enhancing its capacity in providing solution services. By being the general supplier of the clinical laboratory department in such hospitals, the Group participates in the design of laboratory layout, provides centralised procurement of IVD products, conducts real-time inventory monitoring and provides other after-sale services to clinical laboratories. It also plans to hire more sales personnel to promote and market its solution services and to stock sufficient IVD products of various brands to strengthen its advantages in centralized procurement. To enhance brand awareness, it will continuously participate in national and local IVD symposiums, as well as academic conferences.

In addition, the Group believes that strong research and development ("R&D") capabilities are critical to securing its future development and sustainable growth. It will therefore invest more resources to further improve its R&D capabilities by acquiring equipment, instruments and hiring experts in the relevant fields. The Group will also engage in research projects to further develop self-branded IVD products that holding promising market potential. The Group is keen to further strengthen product quality management and optimize the performance and applicability of self-developed products to improve market competitiveness.

Mr. Leung King Sun, Chief Operation Officer of the Group, said, "Given the growing medical expenses per capita and government support to the industry pursuing technological development, the Group remains optimistic about the development prospects of the medical market in the PRC, particularly the medical equipment market. Priding competitiveness, a diverse product portfolio, an expansive distribution network and extensive hospital coverage, we are confident of seizing every potential opportunity. Meanwhile, we will continue to strengthen solution services for hospitals and enhance R&D capabilities for our own brands, and ultimately consolidate our leading position in the industry."

About IVD Medical Holding Limited
IVD Medical Holding Limited ("IVD Medical" or the "Group") is a leading distributor of IVD products in the PRC. Its key subsidiaries include Vastec Medical Limited, Dacheng Medical Equipments (Shanghai) Co., Ltd., IVD China Limited, Suzhou DiagVita Biotechnology Co., Ltd., Langmai Biotechnology (Shandong) Co., Ltd and Bazoe Medical Co., Ltd. The Group's distribution network covers 29 provinces, municipalities and autonomous regions across the PRC. It is the sole national distributor of Sysmex' haemostasis products in the PRC and provides maintenance services to its end customers. It also engages in the R&D, manufacturing and sales of self-branded IVD analysers and reagents and provides solution services to clinical laboratories of hospitals for centralised procurement.

Notes:
(1) IVD, "In Vitro Diagnostic", which encompasses tests done on samples such as blood or tissue taken from the human body
(2) 4 Thrombotic Markers refer to: 1)TAT: Thrombin-antithrombin complex, 2)PIC: Plasmin – a2-plasmin inhibitor complex, 3)TM: Thrombomodulin, 4)t-PAI-C: Tissue plasminogen activator/plasminogen activator inhibitor-1 complex.

Media Enquiries:
Strategic Financial Relations Limited
Heidi So Tel: (852) 2114 4320 Email: heidi.so@sprg.com.hk
Yan Li Tel: (852) 2864 4826 Email: yan.li@sprg.com.hk
Cherry Chen Tel: (852) 2114 4309 Email: cherry.chen@sprg.com.hk
Fax: (852) 2527 1196


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HANGZHOU, Aug 19, 2022 – (ACN Newswire) – New Horizon Health (6606.HK), China's leading biotechnology company for early cancer screening, announced its half-year results for the year ended June 30, 2022 today.

Based on the financial information before the audit as of June 30, 2022, New Horizon Health achieved total revenue of RMB226 million in the first half of 2022, an increase of 414% over the same period in 2021; achieved a gross profit of RMB185 million, an increase of 650% over the same period in 2021; gross profit margin climbed to 82.0% from 56.2% in the first half of 2021. The Company's adjusted net loss for the half-year was RMB106 million and the adjusted net loss rate(1) narrowed significantly from 221% to 47%; the ratio of expenses to sales(1) dropped significantly from 161% to 86%, and the ratio of management expense to sales(1) dropped significantly from 80% to 23%. The Company's total cash, including time deposits, cash, and cash equivalents, amounted to RMB1.65 billion.

The Company announced its cervical cancer screening product, CerviClear(TM), which had been launched in a large-scale prospective multi-center registered clinical trial in June 2022. CerviClear(TM) is the world's first HPV cervical cancer screening product that provides painless and non-invasive urine self-sampling at home, covering a comprehensive range of 14 high-risk HPV viruses. The clinical trial for LiverClear(TM) is progressing well and is expected to be launched in the fourth quarter of 2022 or the first quarter of 2023. As of June 30, 2022, the Company's R&D expenses(1) were RMB39.4 million, an increase of 111% over the same period in 2021.

"The results of the interim report were not easy to get. New Horizon Health's team is faithful to its promise that it is able to do what it says and do what it does. The Company's revenue in the first half of the year has exceeded last year's full-year revenue. The performance growth is mainly attributed to the increase in revenue and gross profit of ColoClear and Pupu Tube, as well as the listing of UU Tube. The underlying logic of the high growth and high gross profit of the three products is that more and more people with high risk are accelerating the change of concept, attaching importance to the risk prevention and control of high incidence cancer in personal and family health management, recognizing the important value of cancer early screening product compliance and willing to pay for it", the Chairman and CEO of New Horizon Health, YeQing ZHU, said, "Cancer early screening products are both serious medical and consumer products, and the huge market opportunity is backed by the high barrier of research and development and compliance as well as the high investment in market education. The necessary condition for the approval of cancer early screening products under New Horizon Health is solid prospective large-scale multi-center registration clinical validation, which is the strong barrier of our diversified business strategy and the foundation of user trust."

Normalization of COVID-19 epidemic accelerates the market education process for early screening at home: ColoClear and Pupu Tube continue to see 3-digit revenue growth

ColoClear achieved revenue of RMB73.6 million in the first half of 2022, representing an increase of 419% over the same period in 2021. The shipment volume in the first half of the year was approximately 294,600 kits, representing an increase of 143% over the same period in 2021. The increase in revenue of ColoClear was mainly due to the increase in volume sold and recognized as revenue and the increase in average recognition unit price.

China's first at-home self-testing FIT test product, Pupu Tube, achieved revenue of RMB68.5 million in the first half of 2022, an increase of 132% over the same period in 2021; and achieved shipment of 2,929,700 units, an increase of 54% over the same period in 2021. The increase in revenue recognized by Pupu Tube was mainly due to the increase in sales volume and the increase in the average unit price (including the increase in the unit price of direct-to-consumer pipeline and the increase in the unit price of health check centers).

Other than New Horizon Health, no domestic player has yet announced the launch of a large-scale prospective multi-center registration clinical trial for colorectal cancer screening. ColoClear is the only product approved by the National Medical Products Administration of China for screening cancer. Pupu Tube is the only approved product for at-home self-testing of FIT in China. In February 2022, ColoClear's multi-target stool FIT-DNA technology was recommended by the latest version of the Cancer Foundation of China's "China Integrated Cancer Treatment Guidelines", making it the only molecular early screening technology in China to be included in all national guidelines for colorectal cancer prevention and treatment.

In the first half of 2022, the policy of early screening of cancer at home was intensively favorable. The "14th Five-Year Medical Equipment Industry Development Plan ", the "14th Five-Year National Health Plan " and the "14th Five-Year Bio-economic Development Plan " all focus on "early screening and health management of key diseases" such as cancer and in vitro diagnosis in home scenes. The normalization of the detection of COVID-19 epidemic has accelerated the public's awareness of home screening and healthy "symptom-free" people.

The only consumer self-test for H. pylori testing: $83.5 million in half-year sales revenue for UU Tube
As of June 30, 2022, the sales revenue of UU Tube since its listing on January 18, 2022, was RMB83.5 million.

On December 31, 2021, UU Tube was approved for registration as a Class III medical device by the National Medical Products Administration of China and is the only product in China that is suitable for "consumer self-testing" for H. pylori detection, for which we have the exclusive patented design of the "pregnancy test stick" which is an integrated design for sampling and testing.

Data show that more than half of the users of UU Tube are women, nearly 50% are aged 31-40, and people aged 24-30 and 40-50 are also the main users. Jiangsu, Guangdong and Zhejiang have ranked the top three provinces in terms of the number of UU Tube users, and household users are more concerned about the detection and prevention of H. pylori.

The prevention and control of H. pylori is a major focus of the science of gastric cancer prevention and has been receiving widespread attention from the media and the public. Data show that in the first half of 2022, the epidemic prevention and control led to a significant decline in the measurement of H. pylori breath tests in hospitals and health checkups, while the number of online and offline gastroenterology consultations continued to rise during the same period, effectively boosting consumer demand for home testing of H. pylori and strongly supporting the rapid promotion of H. pylori.

Diversification of 2C quality pipes in tandem: ColoClear, Pupu Tube and UU Tube have excellent profitability performance

In the first half of 2022, all the three marketed products demonstrated excellent profitability, with the gross margins of ColoClear and Pupu Tube continuing to increase significantly compared to the same period in 2021. As of June 30, 2022, the gross margin of ColoClear reached 75.7%, the gross margin of Pupu Tube reached 80.0% and the gross margin of UU Tube reached 90.0%. Compared to the same period in 2021, the gross margins of ColoClear and Pupu Tube were 56.6% and 59.0%, respectively.

The Company's sales volume of the core pipeline increased steadily in the first half of 2022, and the new pipeline continued to make efforts to take advantage of the favorable macro and micro home inspection policies in the first half of the year with "Resilient" marketing and firmly implementation. The high gross margin of the three products benefited from the Company's continuous and in-depth diversified business strategy, which optimized the pipeline mix for product sales, increased the revenue of single test for direct-to-consumer pipelines and brought about scale production through operational leverage benefits, which further reduced the operating cost of a single test.

In the first half of the year, the Company has been making progress online and offline, both inside and outside the hospital. As of June 30, 2022, the Company has completed access and sales to over 800 hospitals in the first half of the year. During the "618" period, New Horizon Health continued to be the champion in sales of JD in three categories: medical devices, consumer medical and genetic testing. UU Tube won the top selling category of Tmall test paper. The Company's total sales in JD and Tmall exceeded RMB40 million, representing a 400% increase in total sales compared to the same period in 2021, and a 300% increase in sales of ColoClear YoY.

Based on the mainland market, start international marketing: ColoClear debuted in Hong Kong and will advance to Southeast Asia in phases

2022 is a milestone year for the internationalization of New Horizon Health. On May 23rd, the Company and Prenetics (Nasdaq: PRE) made a joint announcement that the two parties have launched in-depth cooperation to fully integrate the quality resources in market and pipeline development and product and service operation, and jointly promote the market coverage of ColoClear in Hong Kong, Macau and Taiwan, China, and explore the market opportunities in countries or regions in Southeast Asian at the same time. On June 8, ColoClear by Circle was officially launched in Hong Kong with an official price of HK$3,000. During the cooperation period, ColoClear is the colorectal cancer early screening product that Prenetics has exclusively partnered with.

At the same time as ColoClear's debut in the Hong Kong market, New Horizon Health announced the establishment of the Company's first international R&D center in the Hong Kong Science and Technology Parks to attract global talent and focus on multi-omics cancer screening technology innovation and product development, including NGS, and to drive overseas commercialization and synchronized global clinical trials.

About New Horizon Health

Founded in 2015, New Horizon Health is a pioneer and leader in China's cancer screening market, focusing on early home screening of high-incidence cancers, aiming to promote innovation in cancer screening technology and accelerate the popularity of cancer screening technology in China. On February 18, 2021, New Horizon Health was successfully listed on the SEHK with stock code 6606.HK, which became "the first listed Chinese cancer early screening company".

New Horizon Health has three marketed products. ColoClear, Pupu Tube and UU Tube have all been approved by the National Medical Products Administration of China and are officially commercialized. ColoClear is the only cancer screening product approved by the National Medical Products Administration of China for people aged 40-74 who are at high risk of colorectal cancer. UU Tube is the only consumer self-test product for Helicobacter pylori approved by the National Medical Products Administration of China. Pupu Tube is the first FIT at-home self-test device approved in China. In addition, the Company has three pipelines of products in development for liver cancer (LiverClear), cervical cancer (CerviClear ) and nasopharyngeal cancer screening. The Company has global rights to all of its marketed and pipeline products. New Horizon Health works extensively with hundreds of hospitals, health check-ups, insurance companies, pharmacies and online channels. The Company has a class 100,000 clean production workshop that meets ISO13485 and ISO9001 international certification standards. The third parties medical testing laboratories in Beijing, Hangzhou and Guangzhou have been certified by international quality standards and the local health care commission and issued licenses to practice, with an annual testing capacity of 2 million people.

(1) Excluding equity incentive-related expenses

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