phase – PressAP

ACN Newswire

HighTide Therapeutics Raises $107 Million in Series C/C+ Financing to Advance Innovative Pipeline and Business Collaborations

January 5, 2023

ROCKVILLE, MD and SHENZHEN, CHINA, Jan 5, 2023 - (ACN Newswire via SEAPRWire.com) - HighTide Therapeutics Inc. ("HighTide"), a globally integrated clinical-stage biopharmaceutical company developing novel multifunctional therapies for metabolic and digestive diseases, today announced the closing of a $107 million Series C/C+ financing led by the TCM Healthcare Fund of Guangdong, managed by China Development Bank Capital. Other investors included Yuexiu Fund and Yuthai Fund. Proceeds of the financing will be used to advance multiple global development programs, including mid-to-late-stage clinical trials, and the commercialization and business development of the company's robust pipeline. HighTide's lead candidate HTD1801, is a novel multifunctional molecule, being developed for the treatment of patients suffering from complex metabolic and digestive diseases. HighTide has successfully completed multiple clinical trials of HTD1801 and continues to advance its global development programs as follows:-- A Phase 2 clinical study in type 2 diabetes (T2DM) is near completion;-- A Phase 2b clinical study in nonalcoholic steatohepatitis (NASH) has been initiated; and -- A successful End-of-Phase 2 (EOP2) meeting was held with the U.S. Food and Drug Administration (FDA) based on the positive findings from the Phase 2 clinical study in primary sclerosing cholangitis (PSC)."After completing a successful $60 million Series B+ round at the end of 2020, we are thrilled to have well-recognized investors participate in our C/C+ round. We are grateful that our investors have such strong confidence in HighTide's team, the commercial value of our pipeline, and future development prospects," said Liping Liu, Ph.D., founder and Chief Executive Officer of HighTide. "The Series C/C+ financing is a significant milestone for HighTide. It will enable us to move aggressively to accelerate the clinical and commercial development of our innovative pipeline and external business collaborations."About HighTide TherapeuticsHighTide is a globally integrated clinical-stage biopharmaceutical company focusing on the discovery and development of novel multifunctional therapies for metabolic and digestive diseases with significant unmet medical needs. The company's lead drug candidate, HTD1801, is a first-in-class new molecular entity, currently in clinical development for the treatment of type 2 diabetes (T2DM), nonalcoholic steatohepatitis (NASH), severe hypertriglyceridemia (SHTG), and primary sclerosing cholangitis (PSC). The U.S. Food and Drug Administration (FDA) granted Fast Track designation to HTD1801 for both NASH and PSC, as well as Orphan Drug designation for PSC. In China, HTD1801 has been included in the National Major New Drug Innovation Program. For more information, please visit www.hightidetx.com.Contacts:InvestorsNadia Gaoir@hightidetx.com+86-134-8219-0265MediaKarl Schmiederkarl@messaginglab.com+1-646-515-3392 Copyright 2023 ACN Newswire. All rights reserved. (via SEAPRWire)

SeaPRwire

New it.com Domain Name Goes into Sunrise Phase on 2nd January 2023

December 31, 2022

London, UK, December 30, 2022 – (SEAPRWire) – UK Intis Telecom LTD announces the launch of the new top-level domain name zone (TLD) – it.com. This new domain name extension represents a new & intelligent solution to the ever-depleting availability of great, short, and easy-to-remember domain names in other zones. The domain name has been in Conditional General Availability (CGA) phase over the past few months before announcing its official Sunrise phase, a period for brand & trademark owners from all over the world to access the registry and reserve the domain name before anyone else. The it.com domain was acquired in 2021 for $3.8 million, marking it as the biggest domain sale of the year. It was purchased by UK-based Intis Telecom, which has been operating globally in the telecommunications and technology sphere for over 14 years, its operations spanning 180 countries across the globe. All websites that use the it.com extension will have an opportunity to reach a global audience, thanks to its resemblance to the IT & Internet industries and the various technological abbreviations that IT represents. Last but not least, it’s also a good opportunity for businesses that target the Italian market, being short for Italy. it.com Launch Schedule The launch schedule includes a special phase for registered trademark holders and additional phases for the most-interested and active parties before it is made globally available to all. Phases start and end at 00:00 UTC as per the below timetable:Sunrise Phase: January 2 – January 30, 2023 (28 days) – A phase for all trademark holders to register domains matching their approved trademarks in any country.Settlement Phase: January 31 – February 2, 2023 (2 days) – A period to review the trademark registration objections & disputes.Landrush Phase: February 3 – February 18, 2023 (15 days) – An early access phase for those tempted to be the first among the registrants to get a catchy domain name before the rest of the registrations. General Availability (GA): Starting on February 19, 2023 – Registration will be open to the public. Anyone who wishes can register a name ending in it.com on a first-come, first-served basis. The domain name can be registered via various well-known international domain name registrars. Official accredited registrars include 101domain.com, CentralNic Group, Domgate.com, Marcaria, CSC Global, Encrica, AEserver.com, dotNICE, INWX, Nomeasy, MarkMonitor, SafeBrands SAS, Route Africa, HostingSolutions.it & Webnic. Many other registrars are currently in the accreditation process and will be announced soon. Media contact Brand: UK Intis Telecom LTD Contact: Joe Alagna E-mail: joe@it.com Website: https://get.it.com/ Telephone: +44 7392000000 SOURCE: UK Intis Telecom LTD The article is provided by a third-party content provider. SEAPRWire ( https://www.seaprwire.com/ ) makes no warranties or representations in connection therewith. Any questions, please contact cs/at/SEAPRWire.com Sectors: Top Story, Daily News SEA PRWire: PR distribution in Southeast Asia (Hong Kong: AsiaExcite, EastMud; AsiaEase; Singapore: SEAChronicle, VOASG; NetDace; Thailand: SEAsiabiz, AccessTH; Indonesia: SEATribune, DailyBerita; Philippines: SEATickers, PHNotes; Malaysia: SEANewswire, KULPR; Vietnam: SEANewsDesk, PostVN)

JCN Newswire

Mazda: Mid-Term Management Plan Update and Management Policy up to 2030

November 22, 2022

HIROSHIMA, Japan, Nov 22, 2022 - (JCN Newswire via SEAPRWire.com) - Mazda Motor Corporation today announces an update to its Mid-Term Management Plan and basic management policies up to 2030. Taking into account the significant changes that have occurred in the business environment including countries' environmental regulatory trends, heightened geopolitical risks, and rapid development of advanced technologies represented by CASE, Mazda sets forth the basic policies for management stated below and will promote key initiatives.Basic Management Policies up to 2030Mazda believes it is the duty of every company to conduct its business responsibility for the earth and society and we continue to pursue research based on our human-centered philosophy. We are committed to engineering and manufacturing, creating human connections and developing people in a way that uplifts the mind and body.1. Contribute to resolving the social challenge of curbing global warming through our electrification strategy appropriate to regional characteristics and environmental needs2. Conduct in-depth research of people and shed light on their relationship with cars with a view toward realizing a safe and secure automotive society.3. Maintain Mazda's brand value management, offer our unique values, and continue to be the brand preferred by customers.Key InitiativesBased on the idea of "co-creating with others," Mazda will promote collaborative projects with a broad range of partners, hone our unique values, and adapt to significant environmental changes. In addition, we will invest in people who are the fountainhead of our company.1. Initiatives for Carbon NeutralityTo achieve carbon neutrality by 2050, we have set an interim target of making Mazda factories carbon neutral worldwide by 2035. We will pursue this initiative on three pillars: energy conservation, shift to renewable energies, and use of carbon neutral fuels. In this effort, we will contribute to realizing a sustainable circular society while coexisting with local communities and residents.2. Electrification StrategyWe have set out a three-phase approach through 2030 and will flexibly address electrification. In the first phase, we will make use of our technology assets comprising multiple electrification technologies to achieve both a reduction in our environmental footprint and produce attractive products. In the second phase, we will introduce new hybrid system and, in China where electrification is advancing, introduce EV-dedicated vehicles as well as launch battery EV vehicles globally. In the third phase, we will promote the full-fledged launch of battery EVs and consider investing in battery production. We estimate Mazda's EV ratio in global sales to rise to a range between 25 percent and 40 percent as of 2030.3. Value Creation through Co-creation between People and ITMazda will conduct in-depth research of people to understand and create models of mechanisms between the human body and brain in our aim to accelerate the development of human-centered advanced driver assistance technology and eliminate new Mazda vehicles as a cause of fatal accidents avoidable with automotive technologies by 2040. In addition, we will facilitate investment to train digitally-proficient personnel capable of easily utilizing AI and IT.4. Cost Reduction and Supply Chain EnhancementFrom a comprehensive viewpoint, we will look into both value chains and supply chains to thoroughly eliminate waste, irregularities, and overburdens to refine our costs, thereby enhancing our capability to reduce costs and resilience to reductions in production.In moving toward 2030, Mazda will aim to continue our research based on our human-centered philosophy, create more moving experiences for people to enjoy while driving in their daily life, and deliver more enjoyment to everyday life which will uplift and energize people. Copyright 2022 JCN Newswire. All rights reserved. (via SEAPRWire)

ACN Newswire

80-160 year building use rights in IKN to attract investors: Minister

October 12, 2022

JAKARTA, Oct 12, 2022 - (ACN Newswire via SEAPRWire.com) - The Ministry of Agrarian and Spatial Planning/National Land Agency (ATR/BPN) is offering building use rights (HGB) of up to 80 and extendable to 160 years to attract investors to the new capital (IKN) Nusantara.Balang Island Short Span Bridge in Penajam North Paser Regency, East Kalimantan (ANTARA/HO-ATR BPN/rst)"The efforts will benefit all parties, both to the welfare of those who live in the city or the business actors themselves," ATR Minister and BPN head, Hadi Tjahjanto, said to Antara here on Monday evening.The 80-year HGB permit is meant as an incentive for investors to invest in IKN Nusantara, he added. The 80-year HGB will be divided into three stages: the first phase will span 30 years, the second phase 30 years, and the third phase 20 years.In the first phase, the ministry will ask the investor to submit a report assessment. "The permit will continue up to 80 years," he said. The permit can be extended if it is profitable to the community. "If it is still used properly and beneficial to the community, we can still extend it for another 80 years, up to 160 years," the minister informed.He further said that his ministry has completed four regional spatial planning plans (RDTR) for IKN Nusantara, which will be submitted to the IKN Authority for immediate approval. Furthermore, RDTRs are being prepared for five regions and are targeted to be completed by the end of 2022.The ministry will provide facilities related to land, spatial planning, and business licensing in the IKN Nusantara area, which will then be submitted to the IKN Authority, he stated."We will facilitate it, and we will hand it over to the head of the IKN Authority, including RDTR, spatial planning, and land issues. We will help the process," he added.Written by: Rini Utami, Aditya Ramadhan, Resinta S, Editor: Suharto (c) ANTARA 2022 Copyright 2022 ACN Newswire. All rights reserved. (via SEAPRWire)

ACN Newswire

Avance Clinical Announces North American CRO Acquisition to Expand Later Phase Services for Biotechs

September 6, 2022

SYDNEY, AU, Sep 6, 2022 - (ACN Newswire via SEAPRWire.com) - Avance Clinical, the Australian CRO for biotechs, has expanded into North America with the acquisition of CRO partner company C3 Research Associates, enabling biotech clients a seamless journey from early phase to later phase studies. Avance Clinical has backing from private equity group Riverside Company for their global expansion program.Watch the video here: https://www.avancecro.com/avance-clinical-north-america-operations/Avance Clinical is the largest and most established full-service Australian and New Zealand CRO with a proven track-record of data acceptance by the FDA and all other major regulatory bodies.The combined Avance Clinical Australia, New Zealand, and North American operations deliver a unique GlobalReady drug development model for biotechs.Avance Clinical's CEO Yvonne Lungershausen said: "Avance Clinical has been working with C3 Research Associates in recent years and they share a similar culture and focus on customer service and clinical excellence. This strong relationship made C3 Research Associates a natural acquisition choice for Avance Clinical's expansion plans into North America. The due diligence process has taken more than 6 months and we are excited to now welcome our US team and offer the GlobalReady model for our clients. "This acquisition gives our biotech clients conducting their early phase studies in Australia and New Zealand a seamless journey into the US to continue their clinical development programs, retaining the same high-quality CRO, which reduces time and cost and delivers quality FDA-accepted data. This GlobalReady model is designed to extend biotechs' investments so they can achieve greater clinical development milestones with reduced spend, all with the assurance of FDA accepted data. "In addition, the attractive 43.5% rebate on clinical spend in Australia, offers our clients the opportunity to utilize our North American operations expertise and team, whilst maintaining services in Australia to maximise their rebate potential. "We often point to the fact that there are currently more than 280 Phase III global trials that have conducted their Phase I study in Australia, which again demonstrates Australian data acceptability with the FDA and other major regulatory authorities."We will be making significant investments in our US operations including growing the team to more than 120 people and leveraging their deep industry experience across a broad range of therapeutic areas, in particular oncology.Clients can be assured the world-class best practice technologies, systems and processes will be integrated across all regions."This seamless GlobalReady journey is designed for success whereby biotechs can:- Take advantage of the Australian early phase clinical trial landscape (No IND and 43.5% tax rebate)- Transition or expand into North America for later phases - without changing CROs (retain study knowledge and processes/team)- Seamlessly operationalise global dose-escalation and dose-expansion trials across the two regions- Harness significant speed and cost advantages- Be assured of quality data - transferable and readily acceptable by the FDA and other regulatory authorities The Avance Clinical team offers exceptional study approval and success rates which can be attributed to its deep scientific expertise, advanced data technologies, knowledge of the Australian, New Zealand and North American regulatory environment, and its extensive relationships with sites and KOLs.The company is also accredited as a gene technology CRO under the Office of the Gene Technology Regulator (OGTR) which allows it to manage pre-clinical and clinical trials for vaccines and GMO therapies.Avance Clinical's has achieved high growth and industry-leading repeat business rates with its focus on gold standard technology paired with solution-orientated clinical experts. This is the mix that biopharma clients clearly require in this fast-moving, competitive and high-stakes sector.Avance Clinical has been recognised for the past two consecutive years with the prestigious Frost & Sullivan CRO Best Practices Award.Learn about the Australian Advantage here: https://www.avancecro.com/the-australian-advantage/Meet the North American leadership team here: https://www.avancecro.com/avance-clinical-north-america-operations/For more information about the benefits of running your next study with Avance Clinical contact us https://www.avancecro.com/contact-us/About Avance ClinicalAvance Clinical is the largest premium full-service Australian CRO with operations across Australia, New Zealand and North America delivering quality clinical trials with globally accepted data for international biotechs. The company's clients are biotechs in their early phases of drug development that need fast, agile, and adaptive solution-oriented clinical research services.Frost & Sullivan AwardsAvance Clinical, a Frost & Sullivan Asia-Pacific CRO Market Leadership Award recipient for the past two years, has been providing CRO services in the region for 24 years.Pre-clinical to Later Phase Avance Clinical offers pre-clinical services with their experienced ClinicReady team right through to later phase clinical services leveraging significant Government incentive rebates of up to 43.5% and rapid start-up regulatory processes. With experience across more than 110 indications, the CRO can deliver world-class results and high-quality internationally accepted data for FDA and EMA review.State-of-the-art TechnologyAvance Clinical uses state-of-the-art technology and gold standard systems across all functional areas to provide clients with the most effective processes. Medidata, Oracle, IBM and Medrio are just some of the technology partners.Media Contacts: Avance ClinicalChris Thompsonmedia@avancecro.com Copyright 2022 ACN Newswire. All rights reserved. (via SEAPRWire)

ACN Newswire

Zhaoke Ophthalmology Announces 2022 Interim Results

August 24, 2022

HONG KONG, Aug 24, 2022 - (ACN Newswire via SEAPRWire.com) - 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)OverviewCsA 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 PeriodOn 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)OverviewTo 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 PeriodThe 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)OverviewBRIMOCHOL(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)OverviewTAB014 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 intravitrealinjection for the treatment of wAMD.Updates during the Reporting PeriodIn 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)OverviewZKY001 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 PeriodWe 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.NTC010OverviewNTC010 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)OverviewPAN-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 DrugsWe 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 OphthalmologyFounded 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 Media Contact:Artemis Associates Diana Footitt, CEOM: +852 9183 0667E: diana.footitt@artemisassociates.comBowen Chui, DirectorM: +852 9783 0643E: bowen.chui@artemisassociates.comIris Pei, DirectorM: +86 15000 465 016E: iris.pei@artemisassociates.com Copyright 2022 ACN Newswire. All rights reserved. (via SEAPRWire)

SeaPRwire

Nakamoto Games Entering New Growth Phase

June 25, 2022

Play-to-earn disruptor to finalize private sale token distribution ahead of schedule Mahe, Seychelles, June 25, 2022 – (SEAPRWire) -Nakamoto Games ($NAKA), the token powering the industry’s fastest-growing play-to-earn gaming ecosystem, is entering a new growth phase with exciting prospects. On Monday, June 27th, 2022, Nakamoto Games will release the last $NAKA token allocation batch to private sale investors. The latest release comes ahead of schedule and follows a favorable turnaround in crypto market conditions. It also marks the beginning of a new phase where secondary market investors can confidently back the exciting ecosystem they are building at Nakamoto Games without worrying about private sale exits. Nakamoto Games is easily the industry’s fastest-growing and exciting play-to-earn ecosystem. Within the past seven months, they have released 17 gaming titles and grown our platform from zero to over 110,000 registered users. Nakamoto Games has also recorded impressive progress towards the full release of the NAKAVERSE, a Metaverse environment that unlocks a new level of fun for players on our platform. The team greatly appreciates the immense support from our high-profile investors and beloved community, which has made these milestones possible. They are also stoked about what lies ahead as they enter this new growth phase with no token distributions. The absence of selling pressure makes it increasingly more straightforward for the rapid gaming releases and platform improvement to accrue value to $NAKA. Nakamoto Games is already disrupting the play-to-earn gaming landscape and welcomes the chance to do so with developments closely aligned with the interest of our long-term backers. The team is greatly pleased to reach this milestone and eagerly look forward to $NAKA reaching its full potential in the blockchain gaming space. Social Links Medium: https://medium.com/@nakamotogames Twitter: https://twitter.com/NakamotoGames Media Contact Company: NAKA Technologies Limited Contact: Chawalit Rugsasri Email: play@nakamoto.games Website: https://nakamoto.games/ SOURCE: NAKA Technologies Limited The article is provided by a third-party content provider. SEAPRWire ( https://www.seaprwire.com/ ) makes no warranties or representations in connection therewith. Any questions, please contact cs/at/SEAPRWire.com Sectors: Top Story, Daily News SEA PRWire: PR distribution in Southeast Asia (Hong Kong: AsiaExcite, EastMud; AsiaEase; Singapore: SEAChronicle, VOASG; NetDace; Thailand: SEAsiabiz, AccessTH; Indonesia: SEATribune, DailyBerita; Philippines: SEATickers, PHNotes; Malaysia: SEANewswire, KULPR; Vietnam: SEANewsDesk, PostVN)

ACN Newswire

SinoMab Dosed First Healthy Subject in Phase I Clinical Trial of SM17 in the U.S.

June 15, 2022

HONG KONG, Jun 15, 2022 - (ACN Newswire via SEAPRWire.com) - 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, today announced that, the first healthy subject has been dosed in the Phase I clinical trial of SM17 in the U.S. SM17 is a First-in-Class (FIC) humanized anti-IL-17RB monoclonal antibody. The subject is currently in a normal condition.SM17 is the world's first humanized IgG4-k monoclonal antibody targeting IL-17RB. SM17 is currently under development by SinoMab, and was engineered by LifeArc (a leading medical research charity based in the United Kingdom). SM17 was originally developed by Dr. Andrew McKenzie, FRS, who also serves as a member of the Company's Scientific Advisory Board, at the MRC Laboratory of Molecular Biology (LMB).SM17 could suppress Th2 immune responses by binding to IL-17RB on Type 2 Innate Lymphoid cells (ILC2s), blocking a cascade of responses induced by interleukin-25 (IL-25). IL-25 is a critical cytokine classified as "alarmin", which has shown to be implicated in the pathogenesis of airway viral responses and allergic diseases, such as uncontrolled severe asthma. Uncontrolled severe asthma is associated with increased mortality/ morbidity, diminished quality of life and increased health expenditures. These patients are at a risk of recurrent asthma exacerbations and hospitalizations. The Company expected that targeting upstream mediators of the Th2 inflammatory cascade, such as IL-17RB on ILC2s, will have a broad effect on airway inflammation. The Company believes the huge potential of SM17 could satisfy unmet medical needs in asthma treatment. The Phase I study is a Single Ascending Dose (SAD) and Multiple Ascending Doses (MAD) to investigate the safety, tolerability and pharmacokinetics of SM17 in healthy subjects.SM17 received Investigational New Drug (IND) approval from U.S. Food and Drug Administration (FDA) on 11 March 2022. Despite the pandemic, SinoMab have soon initiated the first-in-human dose in the Phase I clinical trial. This marks a significant milestone on the collaboration between SinoMab and LifeArc, and demonstrates the efficient implementation of SinoMab's new drug R&D programs.Melanie Lee, Chief Executive Officer of LifeArc, said: "We applied our antibody capabilities when working with Dr. Andrew McKenzie at the LMB, to firstly generate and select a clinical candidate antibody targeting IL-17RB, and then humanise it. After evaluating and choosing the lead candidate, it was licensed to SinoMab to take forward into clinical development and towards patients. It's so rewarding to know that this antibody is going into trials and could eventually make a difference to people with severe asthma."Dr. Shui On LEUNG, Chairman, Executive Director and Chief Executive Officer of SinoMab said that: "SM17's successful first-in-human dosing in Phase I clinical trial marked another milestone in our pipeline development. Following our flagship product, SM03 and key product, SN1011, we now have another key asset entering the clinical trial stage. This further assures our potential commercialization prospects and proves our capability for progressing multiple assets of R&D concurrently. We are confident of the enormous prospects for SM17's clinical development as well as our commercialization opportunities in general. Moving forward, we will accelerate implementation of our projects, adhere to our vision of independent innovation to bring benefits to patients and create value for shareholders."About LifeArcLifeArc is a self-financing and leading UK medical research charity. It partners and works with academics, industry, charities and patient groups to unlock the potential of early stage science. It has an office in London and scientific research facilities in Stevenage and Edinburgh. It also has a specialist science team working at the Francis Crick Institute in London.About SinoMab BioScience LimitedSinoMab 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 vulgaris (PV), non-Hodgkin's lymphoma (NHL), asthma, and other diseases with major unmet clinical needs. Copyright 2022 ACN Newswire. All rights reserved. (via SEAPRWire)