Category: Pharma

NMPA Accepted Essex’s Biologics License Application for EB12-20145P (HLX04-O) for the Treatment of Wet Age-Related Macular Degeneration

Essex Bio-Technology Limited (Essex or the Group, HKG: 1061) is pleased to announce that a Biologics License Application (BLA) for EB12-20145P (HLX04-O), a recombinant anti-VEGF humanized monoclonal antibody injection, has recently been accepted by the Centre for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) in China. The product is jointly developed by the Group and Shanghai Henlius Biotech, Inc. (Henlius, HKG: 2696) for the treatment of wet age-related macular degeneration (wet-AMD) in China.

The phase 3 clinical trial of EB12-20145P (HLX04-O) among Chinese patients (“AURA-1”) has successfully reached the primary endpoint in April this year. AURA-1 is a multi-centre, randomised, double-blind, active-controlled, and non-inferiority phase 3 clinical trial which aimed to compare the efficacy and safety of EB12-20145P (HLX04-O) with that of ranibizumab administered by intravitreal injection (“IVT”) in newly diagnosed wet-AMD patients.

In addition to AURA-1, the BLA of which has been validated by the NMPA, an international, multi-centre phase 3 clinical study of EB12-20145P (HLX04-O) in patients with wet-AMD is ongoing successively in several European countries, Australia, the United States, and China (“AURA-2”) with last patient last visit completed by January 2025. Moving forward, Essex will continue to strive for excellence by embracing innovation to develop first-in-class and best-in-class products, providing solutions for Tomorrow’s healthcare problems, Today.

About wet-AMD
Age-related macular degeneration (“AMD”) is one of the leading causes of visual impairment and blindness in the elderly worldwide [1]. According to the World Health Organization (WHO), about 30 million people have suffered from AMD globally, and about half a million people become blind due to AMD each year [2]. Wet age-related macular degeneration (“wet-AMD”) is characterised by the formation of subretinal choroidal neovascularization (CNV) and is responsible for approximately 90% of cases of AMD-related blindness. Due to an aging population, wet-AMD has become a serious social medical problem and indicated a huge burden of unmet need [3]. With the development of treatment for fundus diseases, anti-VEGF drugs are becoming the first-line therapy for the management of wet-AMD [4], and the efficacy and safety of vitreous injection of bevacizumab for wet-AMD have been verified in multiple clinical studies [5-11].

About Essex
Essex is a bio-pharmaceutical company that develops, manufactures, and commercialises genetically engineered therapeutic b-bFGF, with six commercialised biologics currently marketed in China. Additionally, the Company has a diverse portfolio of commercialised preservative-free unit-dose eye drops, Shilishun (Iodized Lecithin Capsules) and others, which are principally prescribed for wound healing and diseases in Ophthalmology and Dermatology.

These products are marketed and sold through approximately 14,000 hospitals, supported by the Company’s 44 regional offices in China. Leveraging its in-house R&D platform in growth factor and antibody technology, Essex maintains a robust pipeline of projects in various clinical stages, covering a wide range of fields and indications.

Reference
[1] 2020(1).
[2] Resnikoff S, Pascolini D, Etya’ale D, Kocur I, Pararajasegaram R, Pokharel GP, Mariotti SP. Global data on visual impairment in the year 2002. Bull World Health Organ. 2004 Nov;82(11):844-51.
[3] Wong WL, Su X, Li X, et al. Global prevalence of age-related macular degeneration and disease burden projection for 2020 and 2040: a systematic review and meta-analysis. Lancet Glob Health. 2014;2(2): e106-116.
[4] Li X R, Liu J P. Recognition of anti-VEGF therapy base on the mechanism of VEGF in wet age-related macular degeneration[J]. Zhonghua Shiyan Yanke Zazhi/Chinese Journal of Experimental Ophthalmology, 2012, 30(4):289-292.
[5] Tufail A, Patel PJ, Egan C, Hykin P, da Cruz L, Gregor Z, Dowler J, Majid MA, Bailey C, Mohamed Q, Johnston R, Bunce C, Xing W; ABC Trial Investigators. Bevacizumab for neovascular age related macular degeneration (ABC Trial): multi-centre randomized double masked study. BMJ. 2010 Jun 9;340:c2459.
[6] Martin DF, Maguire MG, Ying GS, Grunwald JE, Fine SL, Jaffe GJ. Ranibizumab and bevacizumab for neovascular age-related macular degeneration. N Engl J Med. 2011 May 19;364(20):1897-908.
[7] Chakravarthy U, Harding SP, Rogers CA, Downes SM, Lotery AJ, Wordsworth S, Reeves BC. Ranibizumab versus bevacizumab to treat neovascular age-related macular degeneration: one-year findings from the IVAN randomized trial. Ophthalmology. 2012 Jul;119(7):1399-411.
[8] Kodjikian L, Souied EH, Mimoun G, Mauget-Faÿsse M, Behar -Cohen F, Decullier E, Huot L, Aulagner G; GEFAL Study Group. Ranibizumab versus Bevacizumab for Neovascular Age-related Macular Degeneration: Results from the GEFAL Noninferiority Randomized Trial. Ophthalmology. 2013 Nov;120(11):2300-9.
[9] Krebs I, Schmetterer L, Boltz A, Told R, Vécsei-Marlovits V, Egger S, Schönherr U, Haas A, Ansari-Shahrezaei S, Binder S; MANTA Research Group. A randomized double-masked trial comparing the visual outcome after treatment with ranibizumab or bevacizumab in patients with neovascular age-related macular degeneration. Br J Ophthalmol. 2013 Mar;97(3):266-71.
[10] Berg K, Pedersen TR, Sandvik L, Bragadóttir R. Comparison of ranibizumab and bevacizumab for neovascular age-related macular degeneration according to LUCAS treat-and-extend protocol. Ophthalmology. 2015 Jan;122(1):146-52.
[11] Schauwvlieghe AM, Dijkman G, Hooymans JM, Verbraak FD, Hoyng CB, Dijkgraaf MG, Peto T, Vingerling JR, Schlingemann RO. Comparing the Effectiveness of Bevacizumab to Ranibizumab in Patients with Exudative Age-Related Macular Degeneration. The BRAMD Study. PLoS One. 2016 May 20;11(5): e0153052.

Kangji Medical Receives Privatisation Proposal from a Consortium Led by Kangji Medical’s Chairman, Zhong Ming, TPG and QIA to Advance Long-Term Strategic Vision

Kangji Medical Holdings Limited and Knight Bidco Limited today jointly announced the pre-conditional proposal for the privatisation of Kangji Medical Holdings Limited by way of a scheme of arrangement (the Proposal).

Proposed privatisation of Kangji Medical Holdings Limited

  • The Cancellation Price of HK$9.25 per share represents a 21.7% premium over the closing price on 30 June, 2025, being the Undisturbed Date, a 47.3% premium over the 360-trading day average closing price up to and including the Undisturbed Date, and exceeds the highest closing price as quoted on the Stock Exchange since 2022
  • The proposed privatisation will be effected by way of a scheme of arrangement; the Offeror Concert Parties collectively hold 74.75% shares in the Company; an Irrevocable Undertaking has been received from one institutional shareholder to vote in favour of the Proposal
  • The Proposal presents shareholders with certainty over their ability to monetise their interests in Kangji Medical Holdings Limited, following a period of sustained pressure on trading prices and limited liquidity

Aug 12 2025, Kangji Medical Holdings Limited (Kangji Medical or the Company, HKG: 9997.HK) and Knight Bidco Limited (the Offeror) today jointly announced a privatisation proposal. The parties intend to implement the privatisation of the Company by way of a scheme of arrangement, with a view to enabling the Company to focus on long-term strategic decisions, such as longer-term business investment in R&D and operations enhancements.

Upon completion of the Proposal, the Company will become a wholly-owned subsidiary of the Offeror, and the listing of the Shares will be withdrawn from the Stock Exchange.

The Offeror is owned by a consortium comprising Mr. Zhong and Ms. Shentu (the Founders), the TPG Entities, NewQuest V and Al-Rayyan Holding.  

Rationale for the Proposal

Due to the long-term underperformance in the trading prices and trading liquidity of the Shares, the ability of the Company to raise funds from the equity market has been significantly limited. In addition, the Company has to incur administrative, compliance and other listing related costs and expenses for maintaining the listing status. Accordingly, there are limited benefits for the Company to maintain its listing status.

In light of intensifying competition in domestic market and ongoing regulatory uncertainties, and in order to achieve sustainable growth, the Company’s long-term strategy requires significant investment which could create short-term pressure on the Company’s financial performance. It is anticipated that additional resources need to be allocated to areas including sales and marketing, investment in research, development, and commercialisation, and the Company’s market expansion outside of China.

Considering this, and the listing-related costs, there are limited benefits for Kangji Medical to maintain its listing status. In addition, the implementation of the Proposal will alleviate pressure on Kangji Medical’s short-term financial performance, which enables better focus on strategic objectives. It is anticipated that additional resources will need to be allocated for its future sustainable growth.

Furthermore, the Proposal provides minority shareholders an attractive opportunity to realise compelling returns amid market volatility, industry and macro uncertainties, and the limited liquidity of the Shares.

Knight Bidco Limited’s proposal offers a timely solution to Kangji Medical and its shareholders. Its proposal to privatise Kangji Medical will:

(a) reduce Kangji Medical’s administrative, compliance and other listing related costs;
(b) relieve Kangji Medical from the pressure associated with short-term performance metrics and enable Kangji Medical to focus on long-term strategic decisions (such as longer-term investment in R&D and operations enhancements which might incur short-term losses); and
(c) present shareholders with certainty over their ability to monetise their interests in Kangji Medical at an attractive premium to the undisturbed share price.

In summary, the Offeror believes that a take-private transaction is the strategic alternative that provides immediate and most compelling value for all shareholders, while also avoiding exposure to uncertain market conditions.

Overview of the Proposal

The proposal sets out a Cancellation Price of HK$9.25 per share, valuing the company at approximately US$1.4 billion on an equity value basis.[1]

The Offeror has indicated the Cancellation Price is final and will not be increased further.

The Cancellation Price reflects:

  • A 21.7% premium over the closing price on the Undisturbed Date (being 30 June, 2025).
  • A 47.3% premium over the closing price of 360-trading day average price up to and including the Undisturbed Date.
  • An 84.6% premium over the 52-week closing low (HK$5.01) up to and including the Undisturbed Date.
  • A Cancellation Price above the highest closing price as quoted on the Stock Exchange since 2022 (HK$8.66).

The Cancellation Price has taken into account, among other things, the recent and historical prices of the Shares traded on the Stock Exchange, publicly available financial information of the Company and with reference to other similar privatisation transactions in Hong Kong in recent years.

The Proposal is subject to satisfaction of the Pre-Conditions by the Pre-Condition Long Stop Date (being 31 January, 2026) and the Conditions by the Long Stop Date (being 30 April, 2026). The Company will appoint an independent financial adviser (the “IFA”) to advise the committee of directors who are considered independent for the purposes of the Proposal (the “Independent Directors”) for the purposes of making a recommendation to shareholders in connection with the Proposal. Details of the Proposal including the Independent Directors’ final recommendation on the Proposal and the IFA’s advice will be included in the Scheme Document, expected to be dispatched to shareholders in due course.

Scheme Meeting

Details of the Scheme Meeting to be convened will be contained in the Scheme Document which is expected to be dispatched to shareholders in due course.

There are several pre-conditions and conditions as set out in the Joint Announcement, including regulatory approvals, shareholders approval and compliance with other legislative requirements.

Irrevocable Undertaking

An Irrevocable Undertaking has been received from one institutional shareholder to vote in favour of the Proposal. Further details are available in the Joint Announcement.

Trading in the Shares of the Company has been suspended on the Stock Exchange since 9:00 a.m. on 18 July, 2025, pending the release of this Announcement. The Company has applied to the Stock Exchange for the resumption of trading of Shares with effect from 9 a.m. on August 13, 2025.

J.P. Morgan acted as the exclusive financial advisor to the Offeror.

Kangji Medical Holdings Limited

Kangji Medical is a medical device group founded in 2004 with headquarters at Hangzhou, Zhejiang Province, China. It was listed at the mainboard of the Stock Exchange of Hong Kong in June 2020 (Stock Code: 9997.HK). The Company specializes in the design, development, manufacture and sale of minimally invasive surgery instruments and accessories (“MISIA”). It strives for the mission of “providing physicians with high-quality products and services, and dedicating to improve people’s health”. The Company offers a comprehensive product portfolio to provide physicians and hospitals one-stop and tailored surgical solutions primarily for four major surgical specialties, including obstetrics and gynecology, general surgery, urology, and thoracic surgery. It is also committed to developing an internationally recognized minimally invasive surgery instruments and accessories platform with global coverage.

About Knight Bidco Limited

Each of the Offeror, MidCo and TopCo is a newly incorporated company in the Cayman Islands with limited liability and an investment holding company set up solely for the purposes of implementing the Proposal. As at the date of the announcement, the Offeror is wholly owned by MidCo, which in turn is wholly owned by TopCo. As at the date of this announcement, TopCo is held by the Consortium Members, as to approximately 25.53% by Fortune Spring ZM, approximately 14.47% by Fortune Spring YG, approximately 24.38% by TPG Asia VII, approximately 5.01% by Keyhole, approximately 5.69% by Knight Success, approximately 4.56% by NewQuest V and approximately 20.36% by Al-Rayyan Holding. As at the date of this announcement, save as disclosed in the section headed “Shareholding Structure of the Company” in the Joint Announcement, none of TPG Asia VII, Keyhole, Knight Success, NewQuest V and Al-Rayyan Holding is a Shareholder.

Kangji Medical is controlled by Mr. Zhong and his spouse Ms. Shentu who together hold 52.98% of the shares in Kangji Medical. Following the privatisation of Kangji Medical, Mr. Zhong and Ms. Shentu will remain the largest shareholders in the ultimate parent company of the Offeror, holding 40.00% of the shares in TopCo via Fortune Spring ZM and Fortune Spring YG. Further details are available in the Joint Announcement.

Each of the Founder Entities is a business company incorporated in the British Virgin Islands.

Knight Success is a newly incorporated company in Singapore with limited liability and an investment holding company. Keyhole is an exempted company incorporated in the Cayman Islands with limited liability and an investment holding company. TPG Asia VII is a company incorporated in Singapore with limited liability. Each of Knight Success and Keyhole is either wholly owned or controlled by TPG Asia VII, which is in turn controlled by TPG Asia GenPar VII Advisors, Inc. and ultimately controlled by TPG Inc., a publicly traded Delaware corporation (NASDAQ).

TPG is a leading global alternative asset management firm founded in 1992 with more than US$269 billion of assets under management as of 30 June 2025. For many years, TPG has been investing in transformation, growth, and innovation and aims to build dynamic products and strategies for its investors while also instituting discipline and operational excellence across its investment strategies and performance of its portfolios.

NewQuest V is a company incorporated in Singapore with limited liability and an investment holding company. NewQuest V is wholly owned by NewQuest Asia Fund V, L.P., which is in turn controlled by NewQuest Asia Fund V GP Ltd. and ultimately controlled by TPG Inc., a publicly traded Delaware corporation (NASDAQ).

Established in 2011, NewQuest is one of Asia’s leading secondary private equity platforms with the most experienced secondary team in Asia across five offices. Since its founding, NewQuest has focused on working with GPs to create bespoke, tailored solutions to meet liquidity and other strategic needs of private asset owners and their stakeholders. Starting from a strategic partnership forged in 2018, NewQuest became wholly owned by TPG in January 2022.

Al-Rayyan Holding is a limited liability company established in 2012 under the regulations of the Qatar Financial Centre Authority in the State of Qatar, and is a 100%-owned indirect subsidiary of QIA, the sovereign wealth fund of the State of Qatar. QIA was founded in 2005 to invest and manage the state reserve funds. QIA is among the largest and most active sovereign wealth funds globally. QIA invests across a wide range of asset classes and regions as well as in partnership with leading institutions around the world to build a global and diversified investment portfolio with a long-term outlook. As at the date of this announcement, Al-Rayyan Holding and its concert parties (other than those who are, or deemed to be, acting in concert with Al-Rayyan Holding solely in connection with the Consortium) are not interested in any Shares.

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[1] Based on  HK$9.25 Cancellation Price per share, 1,207,994,000 shares outstanding, and USD/HKD of 7.85

All capitalized terms which are used in this press release but not otherwise defined herein shall have the meanings ascribed to them in the Joint Announcement dated 12 August, 2025. This press release should be read in conjunction with the Joint Announcement, a copy of which is available on https://www1.hkexnews.hk/listedco/listconews/sehk/2025/0812/2025081201338.pdf.

AsiaMedic Reports 26% Revenue Growth to S$16.6 million in 1H2025, Led by Strong Diagnostic Imaging Performance

SGX Catalist-listed AsiaMedic Limited (the “Company” and, together with its subsidiaries, the “Group”) announced its unaudited financial results for the six months ended 30 June 2025 (“1H2025”), delivering 26% year-on-year revenue growth to S$16.6 million, up from S$13.2 million in 1H2024.

This performance was led by the Group’s diagnostic imaging business, which contributed over 60% of total revenue, supported by strong demand at its flagship Shaw Centre clinic and contributions from the newly opened Novena imaging centre.

Financial Highlights:

  • Revenue up 26% to S$16.6 million, from S$13.2m in 1H2024, driven by strong growth in diagnostic imaging and steady performance in medical wellness.
  • EBITDA attributable to owners of the Company was maintained at S$1.3 million, reflecting consistent contributions from core businesses, even as the new Novena centre incurred ramp-up losses.
  • Net loss attributable to owners of the Company narrows significantly to S$38,603 from S$104,431 in 1H2024.
  • Cash and cash equivalents stood at S$4.9 million, with an additional S$3.6 million in financial assets, reflecting strong underlying liquidity despite investments into Novena centre.

Profitability was significantly affected by the new Novena imaging centre as it remains in its ramp-up phase. However, the Group’s financial performance reflects solid execution of its core business strategy amidst expansion.

Mr Arifin Kwek (郭致宾), Chief Executive Officer of AsiaMedic Limited, said, “Our performance in the first half of 2025 reflects the continued strength of our diagnostic imaging business. Shaw Centre remained our primary growth engine with sustained patient volumes, while the newly opened Novena Centre, though still ramping up, has already begun contributing. These investments will further position us as a trusted provider of early detection and preventive care in Singapore.

Our health screening and medical wellness segment remained stable, underpinned by the government awarded Grow Well SG programme and steady corporate wellness demand. While the opening of Novena has added to our cost, these are deliberate investments in capacity, technology, and skilled professionals in a key medical geographical location in Singapore, that position us for long term growth.

We will continue to build on this foundation, focusing on scaling our imaging and health screening businesses while ensuring we deliver high quality, patient-centred care. With expanded capacity and prudent cost management, AsiaMedic is well placed to capture growth opportunities in Singapore’s healthcare sector.”

As Singapore continues to position itself as a regional healthcare hub, AsiaMedic is well-placed to meet growing demand for accessible, high-quality diagnostic and preventive healthcare services. With established centres in Orchard and Novena — two of the country’s key medical precincts — the Group is strategically expanding its reach to serve a broader patient base. This geographic presence, supported by ongoing investments in technology, infrastructure, and clinical talent, positions AsiaMedic to play a meaningful role in advancing Singapore’s preventive care and early detection agenda.

This media release should be read in conjunction with the financial statements announced on SGXNet.

About AsiaMedic Limited

AsiaMedic Limited together with its subsidiaries (“AsiaMedic” or the “Group”) is a leading healthcare provider in Singapore which provides holistic solutions through integrated application of the latest medical technologies to preventand detect early illnesses to achieve positive experiences and clinical outcomes for patients. AsiaMedic is listed on the Catalist Board of the Singapore Exchange Securities Trading Limited (SGX-ST).

The Group is committed to helping clients through practical and personalised solutions delivered with the highestprofessional standards of service and expertise in a timely, safe and consistent manner.

With convenient locations at Orchard and Novena, AsiaMedic is a preferred one-stop centre for:

  • Diagnostic imaging and radiology services
  • Medical wellness and health screening services
  • Primary healthcare services
  • Medical aesthetic services and products

For more information, please visit www.asiamedic.com.sg

For media and analysts’ queries, please contact:
Waterbrooks Consultants
Wayne Koo
T: (65) 9338 8166 / (65) 8901 9780
E: wayne.koo@waterbrooks.com.sg / query@waterbrooks.com.sg


This announcement has been reviewed by the Company’s Sponsor, Xandar Capital Pte Ltd. It has not been examinedor approved by the Singapore Exchange Securities Trading Limited (the “SGX-ST”) and the SGX-ST assumes no responsibility for the contents of this announcement, including the correctness of any of the statements or opinions made or reports contained in this announcement. The contact person for the Sponsor is Ms Pauline Sim (Registered Professional) at 3 Shenton Way, #24-02 Shenton House, Singapore 068805. Telephone number: (65) 6319 4954.

Formerra Becomes North American Distributor for Syensqo PVDF

New agreement reinforces Formerra’s strategy to support high-performance applications with advanced polymer solutions across multiple markets.

Formerra, a leader in performance materials distribution, has signed an agreement with Syensqo to distribute its Solef® Polyvinylidene Fluoride (PVDF) materials in North America. The agreement expands access to this critical material known for its combination of chemical resistance and flexibility. Solef® PVDF joins a growing list of high-performance materials in Formerra’s portfolio designed to advance product development and innovation.

“With this new agreement, Formerra will be able to support customers across multiple markets with the materials they need to meet demanding application requirements,” said Bob Long, Business Development Manager at Formerra. “In addition, this reinforces our commitment to delivering unmatched access, application support, and advanced materials for customers navigating complex performance and regulatory challenges.”

PVDF is positioned near the top of the performance pyramid for its outstanding chemical and heat resistance. Its inherent flexibility further enhances its suitability for demanding applications in chemical processing, healthcare, and automotive industries. Key properties* include:

  • Heat resistance: Continuous use temperatures up to 150 degrees C (302 degrees F), bursting pressures of up to 139 bar (2,017 psi) at room temperature
  • Chemical purity: Ultra-pure water resistivity, meeting SEMI F-57 specifications for the semiconductor industry
  • Balance of strength and flexibility: Tensile yield strength up to 55 MPa (8,000 psi) with elongation at break up to 100%

“We chose Formerra as our distribution partner for Solef® PVDF in North America because of their technical and commercial reach,” said Rose Catherin, Sales Director Americas, Channel partners, Distribution and Digital Sales at Syensqo Specialty Polymers. “Their commitment to excellence and long-standing presence in critical markets make them an ideal fit to help expand the availability and use of Solef® PVDF.”

*As measured by TDS

Caption: Formerra Becomes North American Distributor for Syensqo Solef®PVDF.

Key Details:

  • Formerra is an authorized distributor of Solef® PVDF from Syensqo in North America.
  • The agreement includes support for high-performance applications across a broad spectrum of industries.
  • PVDF offers excellent chemical resistance, thermal stability, and flexibility.
  • Formerra provides technical guidance and supply chain expertise to support material selection and application development.

About Formerra
Formerra is a preeminent distributor of engineered materials, connecting the world’s leading polymer producers with thousands of OEMs and brand owners across healthcare, consumer, industrial, and mobility markets. Powered by technical and commercial expertise, it brings a distinctive combination of portfolio depth, supply chain strength, industry knowledge, service, leading e-commerce capabilities, and ingenuity. The experienced Formerra team helps customers across multiple industries to design, select, process, and develop products in new and better ways – driving improved performance, productivity, reliability, and sustainability. To learn more, visit www.formerra.com.

Media Contact
Jackie Morris
Marketing Communications Manager, Formerra
jackie.morris@formerra.com
+1 630-972-3144

SOURCE: Formerra

Everest Medicines Announces Full Approval of NEFECON(R) in Taiwan

Everest Medicines (HKG: 1952) recently announced the Taiwan Food and Drug Administration (TFDA) has approved the supplementary application for NEFECON(R). NEFECON(R) is indicated to reduce the loss of kidney function in adults with primary immunoglobulin A nephropathy (IgAN) who are at risk for disease progression, irrespective of proteinuria levels.

With this label update, the previous requirement in accelerated approval stage to submit full confirmatory trial analysis to demonstrate clinical benefit has been formally removed. Additionally, data demonstrating NEFECON(R)’s efficacy in delaying kidney function decline has been included in the approved product label. IgAN is highly prevalent among Asian populations, with a 56% higher risk of progression to end-stage renal disease compared to other groups and often progresses more rapidly.

Taiwan region became the last region across all Everest’s territories to grant full approval for NEFECON(R), together with Mainland China, Singapore, Macao SAR, Hong Kong SAR and South Korea. This further demonstrates NEFECON(R)’s foundational first-line cornerstone treatment for IgAN patients.

“NEFECON(R) has received full approval in Taiwan, further validating its outstanding clinical value and offering physicians a more solid clinical foundation for treatment decisions.” Rogers Yongqing Luo, Chief Executive Officer of Everest Medicines, said. “As the first and only fully approved etiological treatment for IgAN, NEFECON(R) has now achieved full approval across Asia. This milestone will benefit a broader patient population by enabling more individuals with IgAN to access this etiological treatment earlier, helping to slow disease progression and improve quality of life. We will continue to expand the accessibility and affordability of NEFECON(R) across Asia, aiming to benefit more IgAN patients and improve their quality of life.”

The approval is based on the global Phase 3 NefIgArd clinical trial, which showed that compared to placebo, it not only brought about a durable reduction in proteinuria and reduced the frequency of microscopic hematuria but also demonstrated clinically relevant and statistically significant treatment benefits in estimated glomerular filtration rate (eGFR), reducing the decline in kidney function by 50% over a period of 2 years, comprising 9 months of treatment and 15 months of observation, and potentially delaying the progression to dialysis or kidney transplantation by 12.8 years.

Additionally, the complete 2-year data of the NefIgArd study further analyzed the potential differences in the response to NEFECON(R) treatment between Asians (n=83) and Caucasians (n=275). The results showed that compared to placebo, treatment with NEFECON(R) for 9 months in both Asians and Caucasians can significantly delay the decline of eGFR, protect kidney function, and bring about a sustained reduction in proteinuria and reduce the risk of microscopic hematuria.

NEFECON(R) has been recommended by several authoritative treatment guidelines, including the “KDIGO 2024 Clinical Practice Guideline for the Management of Immunoglobulin A Nephropathy (IgAN) and Immunoglobulin A Vasculitis (IgAV) (Public Review Draft)”, and the “Clinical Practice Guideline for IgA Nephropathy and IgA Vasculitis in Chinese Adults (For Public Review)”. NEFECON(R) was included in China’s National Reimbursement Drug List (NRDL) in November 2024, and the supplemental application for the production expansion of NEFECON(R) has been officially approved by NMPA in August 2025.

NEFECON(R) is currently the world’s first IgAN treatment to have received full approval from the National Medical Products Administration (NMPA) in China, the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), the Medicines and Healthcare products Regulatory Agency（MHRA）in the United Kingdom , as well as in other Asian territories where Everest Medicines holds the rights, including Hong Kong SAR, Macao SAR, Taiwan region (China), Singapore, and South Korea.

Cornerstone Robotics Completes World’s First Clinical Validation of Autonomous Surgery Performed by Robot-Assisted Surgery

A major breakthrough in surgical embodied intelligence in Robot-Assisted Surgery (RAS) has been achieved in Hong Kong, China. At a press conference held on 5 August, the Chinese University of Hong Kong (CUHK) officially announced that its multidisciplinary research team, in collaboration with Cornerstone Robotics, a leading global innovator and unicorn enterprise in surgical robotics, has successfully developed the world’s first embodied intelligence platform for multitask surgical automation. The team also completed the world’s first clinical validation of autonomous surgery using this platform on Cornerstone Robotics’ self-developed Sentire® Endoscopic Surgical System.

The research paper, titled “Surgical Embodied Intelligence for Generalized Task Autonomy in Laparoscopic Robot-assisted Surgery“, has been published in Science Robotics, a prestigious research journal in the field of robotics and a flagship publication under the Science family. With a current impact factor of 27.5 and a five-year impact factor of 32.9, Science Robotics is one of the most influential journals in the global robotics field. This marks the first successful in vivo animal testing using a Chinese-developed laparoscopic surgical robot equipped with AI-powered embodied intelligence, validating its multitask autonomy and human-robot collaboration capabilities. It demonstrates the generalisability of the algorithms and the system’s clinical feasibility, paving the way for a future of smarter, more collaborative, and more accessible robotic surgery.

A Breakthrough Framework: VPPV Embodied Intelligence
The research introduced a novel paradigm for surgical task automation, encompassing visual parsing, a perceptual regressor, policy learning, and a visual servoing controller (VPPV). This framework combines robust visual foundation models, the generalisation capability of reinforcement learning, and integration of data-driven policy and classic controller to achieve breakthroughs in autonomous performance of robot-assisted surgery, particularly regarding stability, flexibility, and repeatability. Unlike traditional methods in autonomous surgery that rely on additional sensors or pre-defined models and rules, this research is the world’s first purely vision-based surgical embodied intelligence framework, featuring full perception, multitask applicability, precise closed-loop servo control, and human-robot cooperation functions. It significantly lowers the barrier for R&D and clinical adoption, setting a new benchmark for next-generation intelligent surgical assistants.

The research team trained multiple AI frameworks with generalized task autonomy using their independently developed open-source surgical embodied intelligence simulator, SurRoL, and successfully achieved zero-shot sim-to-real transfer. SurRoL integrates multimodal sensing, built-in physics engine modelling, and multi-task operation training, encompassing the robot-assisted surgery control interface, simulation environment, and reinforcement learning engine.

Ex and In Vivo Validation on the Sentire® Endoscopic Surgical System
To simulate real surgical settings, the research team conducted rigorous experiments using ex vivo porcine stomach tissue (preserving the left and right gastroepiploic arteries) and an in vivo ~30kg pig. Both tests were completed using the Sentire Endoscopic Surgical System, fully developed by Cornerstone Robotics. During the in vivo validation phase, an innovative supervised autonomy safety mode was adopted. Without any external sensors and relying solely on the Sentire Endoscopic Surgical System’s high-definition stereoscopic endoscope system, the robot autonomously executed several surgical assistive tasks, such as gauze picking, soft tissue retraction, and blood vessel clipping. The system demonstrated robust adaptability to environmental changes, reliable control stability, and clinical translation potential, offering tangible support for the surgical embodied intelligence mode driven by human-robot collaboration.

A Vertically Integrated, AI-Ready Robotic Platform
Dr. Jerry Wang, Co-Founder, Chief Technology Officer, and Chief Operating Officer of Cornerstone Robotics, and the corresponding author of the study, stated, “The Sentire Endoscopic Surgical System, as a core platform in this research, is built on a fully self-developed infrastructure-including mechanical, electrical, software architecture, robotic algorithms, imaging systems, and advanced energy control. This commercial-grade integrated robotic system provides the technical robustness and precision needed for stable deployment of AI autonomy in dynamic surgical environments.”

He added, “At Cornerstone Robotics, we remain committed to the R&D strategy of full-stack independent research and vertical integration. Our proprietary technology, independently developed software, hardware and system integration, benefits our core platforms with exceptional scalability, with built-in AI-readiness and AI-friendly architecture. This not only enables rapid adaptation and deployment of AI algorithms but also allows the system to flexibly address diverse surgical tasks and scenarios, laying a solid foundation for the evolution of intelligent surgery.”

From Lab to Operating Room: A Leap Toward Clinical Translation
As a key technology partner in the research, the Cornerstone Robotics team worked closely with CUHK researchers to complete the successful deployment of algorithms and their in vivo validation on the Sentire® Endoscopic Surgical System. This achievement not only validates the open-source infrastructure and high compatibility of Cornerstone Robotics’ platform but also marks a significant advance in accelerating AI-powered surgical assistance from the lab to the forefront of clinical translation.

Professor Samuel Au, Founder and CEO of Cornerstone Robotics, commented, “We firmly believe that deep integration between research and industry is the driving force behind breakthroughs in advanced medical technologies. This collaboration not only validates the real-world application of embodied AI on a commercial robotic surgical platform but also showcases their vast potential in surgical automation. We will continue to work with international researchers and clinical partners to explore new eras in task automation, human-robot collaboration, and intelligent system monitoring mechanisms, to accelerate the path toward real clinical application of smart surgical robots.”

About Cornerstone Robotics Limited (CSR)
Cornerstone Robotics (CSR) is a unicorn enterprise, leading medical innovations to create a healthier world. It advances surgical care with cutting-edge robotic systems that make high-quality healthcare more accessible and efficient globally. Founded in 2019, CSR has assembled a global team of surgical robotics experts, clinical professionals, and multidisciplinary innovators, driving rapid growth with key hubs in Hong Kong, Shenzhen, Beijing, Shanghai, and Boston (US), alongside an R&D collaboration hub in Portsmouth (UK). With multiple development pipelines, we are pioneering robotic solutions for soft tissue and other surgical specialties.

To find out more information, please visit our website at https://en.csrbtx.com/.

TruMerit Launches Global Credential for First-Level, General Nurses

TruMerit, a worldwide leader in international credentials evaluation to support health worker careers, today introduced the Certified Global Nurse (CGN), the world’s first truly global credential for first-level, general nurses (RNs).

TruMerit | Global careers. Care anywhere.

TruMerit | Global careers. Care anywhere.

The new, merit-based credential is available to any qualified nurse – from any country – to recognize their competencies, regardless of where they choose to live and work. It is awarded upon passage of TruMerit’s Nurse Qualifying Exam (NQE), which applicants may take after verification of their nursing education and licensure.

Previously known as the CGFNS Qualifying Exam and used by nurses migrating to the United States, the NQE was reinvented with a global focus to support the ongoing evolution of nursing practice worldwide and particularly the emergence of key challenges such as digital health, mental health, and climate change. This was achieved through a collaborative process involving more than 70 nursing experts from 50 countries, with all World Health Organization regions and World Bank country income levels represented. The experts agreed upon a core set of nursing practice standards after analyzing nursing competency frameworks from 37 countries.

In addition to its role as a key requirement for the CGN credential, the upgraded exam continues to support other TruMerit programs – such as the VisaScreen® Visa Credentials Assessment Service and the Certification Program® – as a shared global framework for validating the applied knowledge and practice competence of nurses worldwide.

“The Certified Global Nurse credential offers nurses everywhere a common framework for meeting globally agreed-upon essential nursing practice standards,” said Dr. Peter Preziosi, TruMerit’s President and CEO. “When nurses carry the credential, their employers and colleagues will know that their applied nursing knowledge and skills are validated against a global benchmark, attesting to their qualifications for delivering quality healthcare.”

The credential is ultimately intended to provide nurses with greater mobility within the profession, within their native countries, and across geopolitical boundaries throughout their careers.

“By signifying work-readiness on an international scale, and thereby helping expand the pool of readily identifiable qualified nurses worldwide, global credentialing will become part of the solution to the challenges health systems are facing around the world,” said Preziosi.

“We hope this credential can contribute to a sustained, collaborative effort involving many stakeholders-health ministries, international agencies, health systems, nursing schools, and nursing associations worldwide-to harmonize nursing education and practice and support the future growth of the global nursing workforce,” he said.

The Nurse Qualifying Exam is a proctored examination that will be offered four times a year at more than 1,000 Kryterion testing centers located around the world, with the first test window scheduled for November 10-14, 2025. Nurses who wish to earn a CGN credential and sit for the NQE in November must apply by September 30 at the TruMerit website, where they will find more information on the credential and how to prepare for the exam.

The testing schedule for 2026 will be announced later this year.

About TruMerit
TruMerit is a worldwide leader in healthcare workforce development. Formerly known as CGFNS International, the organization has a nearly 50-year history supporting the career mobility of nurses and other healthcare workers – and those who license and hire them – by validating their education, skills, and experience as they seek authorization to practice in the United States and other countries. As TruMerit, this mission has been expanded to building workforce capacity that meets the needs of people in a rapidly evolving global health landscape. Through its Global Health Workforce Development Institute, the organization is advancing evidence-based research, thought leadership, and advocacy in support of healthcare workforce development solutions, including globally recognized practice standards and certifications that will enhance career pathways for healthcare workers. www.trumerit.org

Contact Information
David St. John
dstjohn@trumerit.org

SOURCE: TruMerit

NEFECON(R) Receives NMPA Approval for Production Expansion in China,as Everest Medicines Accelerates Accessibility and Capacity Efforts

Everest Medicines (HKG: 1952) today announced that the supplemental application for the production expansion of NEFECON® has been officially approved by China’s National Medical Products Administration (NMPA). This approval for production expansion will further boost capacity and increase product supply, enabling a more efficient response to the growing clinical demand in China and across Asia.

NEFECON® is the first and only etiological treatment for IgA nephropathy (IgAN) to receive full approval in China, the United States, and Europe, serving as a foundational first-line therapy for patients with IgAN. Since its initial approval in China in November 2023, NEFECON® was subsequently included in the National Reimbursement Drug List (NRDL) in November 2024, and received full approval from the NMPA in May 2025, irrespective of proteinuria levels, benefiting most individuals living with IgAN.

NEFECON® specifically modulates the mucosal immune system in the gut to reduce the formation of pathogenic galactose-deficient IgA1 (Gd-IgA1) that trigger IgAN. Results from the Phase 3 clinical study NefIgArd demonstrated that NEFECON® reduces the decline in kidney function by 50%. Results from Phase 3 clinical study NefIgArd of the Chinese population shows that NEFECON® reduces kidney function decline by 66%, and delays disease progression to dialysis or kidney transplantation by 12.8 years.

“The expansion of our NEFECON® production capacity will help better meet the growing clinical treatment needs of IgAN patients in China.” Said Rogers Yongqing Luo, Chief Executive Officer of Everest Medicines. “China has one of the highest rates of primary glomerular disease in the world, with more than 5 million patients estimated to be living with IgAN and over 100,000 new cases diagnosed each year. Chinese IgAN patients generally experience faster disease progression and poorer prognosis, highlighting a significant unmet medical need.

As the only etiological treatment for IgAN currently recommended by both international and Chinese guidelines, the expansion of NEFECON® production will further accelerate the uptake of etiological treatment, enabling more patients to access standardized treatment earlier to delay disease progression and protect kidney function. We will continue to enhance the accessibility and affordability of NEFECON®, supporting its advancement from ‘changing the treatment landscape’ to ‘redefining the standard of care’.”

NEFECON®, as the only in-disease IgAN treatment has been included in the KDIGO 2024 Clinical Practice Guideline for the Management of Immunoglobulin A Nephropathy (IgAN) and Immunoglobulin A Vasculitis (IgAV) (public review draft), making it the only targeted therapy endorsed by both international and Chinese guidelines. NEFECON® has been approved across all Everest Medicines’ territories, including mainland China, Hong Kong SAR, Macau SAR, Taiwan region, China, as well as Singapore and South Korea, and continues to expand its therapeutic impact across Asia.

As production capacity continues to grow and supply capabilities improve, NEFECON® is well positioned to benefit a broader patient population by accelerating the uptake of etiological treatment, enabling more patients to access standardized care earlier to delay disease progression and preserve kidney function.

Everest Medicines Expands Strategic Investment in I-MAB to Advance the Global Value of Its Proprietary Next-Generation Cancer Immunotherapies

Everest Medicines (HKG: 1952) today announced a strategic equity investment in I-Mab (NASDAQ: IMAB), under which Everest will invest US$30.9 million (equivalent to approximately HK$242.6 million) in cash. Upon completion of the subscription and inclusive of shares already held, Everest will own approximately 16.1% of I-Mab’s total outstanding shares.

Under the terms of the agreement of this offering, Everest will subscribe for 15,846,154 newly issued American depositary shares (ADSs) of I-Mab at a price of US$1.95 per ADS, for a total consideration of US$30.9 million. Upon completion, Everest will hold a total of 15,846,154 ADSs and 6,078,571 ordinary shares, representing approximately 16.1% of I-Mab’s total issued share capital, inclusive of 6,078,571 ordinary shares it already owns. In addition to Everest, several leading global institutional investors are participating in this offering, including Janus Henderson Investors, Adage Capital Partners LP, Woodline Partners, and Exome Asset Management.

This strategic investment marks a significant step in Everest’s ongoing efforts to strengthen its position in next-generation cancer immunotherapy. It also reflects the strong clinical and business development complementarity and synergy between the two companies. I-Mab’s Claudin 18.2 x 4-1BB bispecific antibody, givastomig, demonstrated an impressive overall response rate (ORR) of 83% in combination with immunotherapy in a Phase 1b trial for first-line gastric cancer. I-Mab’s differentiated 4-1BB receptor-targeting platform and bispecific antibody pipeline are highly complementary with Everest’s existing mRNA cancer vaccine and in vivo CAR-T platforms.

In addition, I-Mab’s unique clinical translational capabilities, particularly in the U.S., combined with Everest’s clinical capabilities in Asia, could help accelerate the development and global expansion of pipeline products for both companies.

“This strategic equity investment furthers our plan to be an active player in next-generation oncology programs across global markets. Everest and its Board of Directors believe this investment recognizes I-Mab’s unique clinical translational capabilities in the U.S., which are complementary and synergistic with the Company’s strong Asia presence,” said Rogers Yongqing Luo, Chief Executive Officer of Everest Medicines. “As a biotech pioneer in China, Everest has built internally developed pipeline assets including mRNA therapeutic cancer vaccines and in vivo CAR-T therapies targeting cancer and autoimmune diseases. Our areas of focus meaningfully intersect with I-Mab’s differentiated 4-1BB platform and bispecific antibody pipeline, including oncology candidates Givastomig (Claudin 18.2 x 4-1BB bispecific antibody) and Ragistomig (PD-L1 x 4-1BB bispecific antibody), both promising programs that we are closely watching. Furthermore, both companies may be able to leverage their combined expertise to run clinical programs in both China and the U.S. Everest is proud to develop innovative and valuable therapies that can benefit cancer patients globally.”

The strategic equity investment not only strengthens Everest Medicines’ position in next-generation immuno-oncology, but also extends the global development path of its proprietary AI-powered mRNA platform. As a key pillar of Everest’s “dual-engine” strategy of in-licensing and internal innovation, the company has made solid progress in building and internationalizing its AI+mRNA platform. Multiple pipeline programs are advancing in preclinical research, with a strong focus on oncology and autoimmune diseases. Looking ahead, Everest will accelerate global clinical development and regulatory efforts, while actively exploring collaborations with leading international biopharmaceutical companies to maximize the value of its platform and bring breakthrough therapies to patients worldwide.

Traveler Care Launches Global Medical Dispatch Platform to Help Travel Insurance Companies Cut ER Claims by 80%

Traveler Care, a breakthrough medical dispatch platform that brings urgent care directly to travelers in hotels, Airbnbs, and vacation rentals, has officially launched worldwide – offering travel insurance companies a high-impact solution to reduce avoidable emergency room and hospital claims.

Traveler care

Traveler care traveler.care home page

A Concierge Alternative to the Emergency Room

Traveler Care connects travel insurers and their policyholders to a network of licensed, on-call providers who visit travelers in their accommodations – typically within 60-90 minutes. Conditions such as flu, food poisoning, dehydration, allergic reactions, UTIs, sprains, and wound care are treated on-site, eliminating the need for an ER visit.

“In most cases, travelers just need a doctor – not a hospital admission,” said Eli Ofel, founder of Traveler Care. “We’ve built a scalable, insurer-ready solution that saves money and delivers a far better traveler experience.”

Reduce Claims by $10,000+ Per Visit
On average, a non-emergency ER visit costs travel insurers $13,000 to $17,000. Traveler Care treats the same conditions in-room for $1,700 to $3,000 – including diagnostics like mobile X-ray, ultrasound, IV therapy, and wound treatment.

Pilot results have shown:- 83% reduction in ER claim volume- $10,000+ savings per case avoided- Higher satisfaction scores among travelers

Built for Travel Insurance Partners
Traveler Care is fully designed for insurance integration – with white-label and API options available for TPAs, underwriters, and global assistance networks.

Platform features:- Nationwide U.S. coverage (with international expansion underway)- A robust dispatch network, for example companies like Leaa Health, Sickday, Heal, DocGo and more, any location that the travel insurance is experiencing high volume travel care will create a solution for that particular location within 60 days.- HIPAA-compliant documentation + one-click claims integration- Supports care delivery to hotels, Airbnbs, resorts, and serviced apartments

Now Onboarding Insurance Companies Worldwide
“We believe travel insurance companies shouldn’t just pay for care – they should deliver it smarter,” said Ofel. “With Traveler Care, you lower claims without compromising care.”

Insurance providers, TPAs, and global assistance companies are invited to partner and deploy in-room urgent care as part of their medical benefit stack.

Contact
To schedule a private demo or receive our ROI case study:
Visit www.traveler.care
Email: partners@traveler.care
Phone: +1 (347) 733-0563

About Eli Ofel
Eli Ofel is a serial entrepreneur and visionary behind multiple AI- and tech-powered platforms in healthcare, finance, and transportation. He is the founder and CEO of Traveler Care, Run.Vet, Leaa Health, 02.Market, and Lender.Market. With over 20 years of experience in healthcare operations, insurance workflows, and mobile logistics, Ofel brings a proven ability to bridge patient needs with scalable platform solutions – saving time, money, and lives.

Contact Information
Eli Ofel
CEO
eli@traveler.care
3477330563.

SOURCE: Traveler care