Latest news with #IDS
Korea Herald
2 days ago
- Health
- Korea Herald
GC Biopharma's Phase 3 Clinical Trial Results for Hunterase Published in SCIE-Indexed Journal
YONGIN, South Korea, May 30, 2025 /PRNewswire/ -- GC Biopharma, a South Korean pharmaceutical company, announced that the Phase 3 clinical trial results for Hunterase (idursulfase beta), its investigational drug for Hunter Syndrome (MPS II), have been published in Genetics in Medicine, an SCIE-indexed journal. Conducted at Samsung Medical Center, the Phase 3 clinical trial enrolled 24 newly diagnosed Hunter Syndrome patients with no prior treatment. It evaluated the efficacy and safety of Hunterase over a one-year treatment period. Hunter Syndrome is a rare genetic disorder caused by a deficiency of iduronate-2-sulfatase (IDS), an enzyme critical for glycosaminoglycan (GAG) catabolism. This deficiency leads to the progressive accumulation of GAGs in various organs and tissues, resulting in multisystemic dysfunction, including joint stiffness and hepatosplenomegaly. The clinical trial results demonstrated that Hunterase significantly enhanced functional mobility, reduced urinary GAG concentrations, and markedly alleviated hepatosplenomegaly. In the 6-Minute Walk Test (6-MWT), the primary endpoint of the study, patients treated with Hunterase walked an average of 62.2 meters more after treatment. This improvement was more than eight times greater compared to the placebo group, which saw an average increase of just 7.3 meters. The 6-MWT measures the distance a patient can walk on a flat surface within 6 minutes. It is a widely used clinical measure for evaluating functional mobility, cardiopulmonary function, muscle strength, and overall physical health. In the context of Hunter syndrome, it serves as a standardized and meaningful indicator of disease progression and quality of life. In addition to the primary endpoint, the study also achieved positive outcomes in secondary endpoints, including changes in urinary total glycosaminoglycan (GAG) levels, as well as heparan sulfate (HS) and dermatan sulfate (DS) levels. The GAG levels decreased by 71%, while HS and DS levels decreased by 89% and 88%, respectively. Moreover, liver and spleen volumes were reduced by 27% and 26%, respectively, demonstrating the drug's effectiveness in addressing organ enlargement commonly associated with the disease. Hunterase also demonstrated a favorable safety profile. Most adverse events were mild or moderate, and no patients discontinued treatment due to side effects. Notably, only 19% of the patients had neutralizing antibodies detected three or more consecutive times, which is significantly lower than the 62.5% observed with the existing treatments. This suggests that Hunterase may offer a more sustained therapeutic effect compared to other currently available therapy. "This clinical trial is especially meaningful as it represents the first Phase 3 study in Asian patients to validate the clinical efficacy of Hunterase", said Professor Young Bae Sohn of Ajou University School of Medicine and Ajou University Hospital, the journal's first author. "The results showed significant clinical improvement not only in metabolic markers but also in organ size normalization and restoration of physical mobility." "We are thrilled to publish our encouraging phase 3 clinical trial results", stated Jae Uk Jeong, Head of R&D at GC Biopharma. "Hunterase, developed in Korea using our proprietary technology, has the potential to significantly improve the lives of patients with Hunter syndrome." Hunter Syndrome is an X-linked lysosomal storage disorder, affecting approximately 1 in 100,000 male births. In severe cases, the patients experience early death before they reach adulthood, highlighting the need for early diagnosis and treatment. Currently, two treatments are widely available worldwide for Hunter Syndrome: GC Biopharma's Hunterase and Takeda's Elaprase. About GC Biopharma GC Biopharma (formerly known as Green Cross Corporation) is a biopharmaceutical company headquartered in Yong-in, South Korea. The company has over half a century of experience in the development and manufacturing of plasma derivatives and vaccines, and is expanding its global presence with successful US market entry of Alyglo™(intravenous immunoglobulin G) in 2024. In line with its mission to meet the demands of future healthcare, GC Biopharma continues to drive innovation by leveraging its core R&D capabilities in engineering of proteins, mRNAs, and lipid nanoparticle (LNP) drug delivery platform to develop therapeutics for the field of rare disease as well as I&I (Immunology & Inflammation). To learn more about the company, visit This press release may contain biopharmaceuticals in forward-looking statements, which express the current beliefs and expectations of GC Biopharma's management. Such statements do not represent any guarantee by GC Biopharma or its management of future performance and involve known and unknown risks, uncertainties, and other factors. GC Biopharma undertakes no obligation to update or revise any forward-looking statement contained in this press release or any other forward-looking statements it may make, except as required by law or stock exchange rule.
Malaysian Reserve
3 days ago
- Health
- Malaysian Reserve
GC Biopharma's Phase 3 Clinical Trial Results for Hunterase Published in SCIE-Indexed Journal
YONGIN, South Korea, May 30, 2025 /PRNewswire/ — GC Biopharma, a South Korean pharmaceutical company, announced that the Phase 3 clinical trial results for Hunterase (idursulfase beta), its investigational drug for Hunter Syndrome (MPS II), have been published in Genetics in Medicine, an SCIE-indexed journal. Conducted at Samsung Medical Center, the Phase 3 clinical trial enrolled 24 newly diagnosed Hunter Syndrome patients with no prior treatment. It evaluated the efficacy and safety of Hunterase over a one-year treatment period. Hunter Syndrome is a rare genetic disorder caused by a deficiency of iduronate-2-sulfatase (IDS), an enzyme critical for glycosaminoglycan (GAG) catabolism. This deficiency leads to the progressive accumulation of GAGs in various organs and tissues, resulting in multisystemic dysfunction, including joint stiffness and hepatosplenomegaly. The clinical trial results demonstrated that Hunterase significantly enhanced functional mobility, reduced urinary GAG concentrations, and markedly alleviated hepatosplenomegaly. In the 6-Minute Walk Test (6-MWT), the primary endpoint of the study, patients treated with Hunterase walked an average of 62.2 meters more after treatment. This improvement was more than eight times greater compared to the placebo group, which saw an average increase of just 7.3 meters. The 6-MWT measures the distance a patient can walk on a flat surface within 6 minutes. It is a widely used clinical measure for evaluating functional mobility, cardiopulmonary function, muscle strength, and overall physical health. In the context of Hunter syndrome, it serves as a standardized and meaningful indicator of disease progression and quality of life. In addition to the primary endpoint, the study also achieved positive outcomes in secondary endpoints, including changes in urinary total glycosaminoglycan (GAG) levels, as well as heparan sulfate (HS) and dermatan sulfate (DS) levels. The GAG levels decreased by 71%, while HS and DS levels decreased by 89% and 88%, respectively. Moreover, liver and spleen volumes were reduced by 27% and 26%, respectively, demonstrating the drug's effectiveness in addressing organ enlargement commonly associated with the disease. Hunterase also demonstrated a favorable safety profile. Most adverse events were mild or moderate, and no patients discontinued treatment due to side effects. Notably, only 19% of the patients had neutralizing antibodies detected three or more consecutive times, which is significantly lower than the 62.5% observed with the existing treatments. This suggests that Hunterase may offer a more sustained therapeutic effect compared to other currently available therapy. 'This clinical trial is especially meaningful as it represents the first Phase 3 study in Asian patients to validate the clinical efficacy of Hunterase', said Professor Young Bae Sohn of Ajou University School of Medicine and Ajou University Hospital, the journal's first author. 'The results showed significant clinical improvement not only in metabolic markers but also in organ size normalization and restoration of physical mobility.' 'We are thrilled to publish our encouraging phase 3 clinical trial results', stated Jae Uk Jeong, Head of R&D at GC Biopharma. 'Hunterase, developed in Korea using our proprietary technology, has the potential to significantly improve the lives of patients with Hunter syndrome.' Hunter Syndrome is an X-linked lysosomal storage disorder, affecting approximately 1 in 100,000 male births. In severe cases, the patients experience early death before they reach adulthood, highlighting the need for early diagnosis and treatment. Currently, two treatments are widely available worldwide for Hunter Syndrome: GC Biopharma's Hunterase and Takeda's Elaprase. About GC Biopharma GC Biopharma (formerly known as Green Cross Corporation) is a biopharmaceutical company headquartered in Yong-in, South Korea. The company has over half a century of experience in the development and manufacturing of plasma derivatives and vaccines, and is expanding its global presence with successful US market entry of Alyglo™(intravenous immunoglobulin G) in 2024. In line with its mission to meet the demands of future healthcare, GC Biopharma continues to drive innovation by leveraging its core R&D capabilities in engineering of proteins, mRNAs, and lipid nanoparticle (LNP) drug delivery platform to develop therapeutics for the field of rare disease as well as I&I (Immunology & Inflammation). To learn more about the company, visit This press release may contain biopharmaceuticals in forward-looking statements, which express the current beliefs and expectations of GC Biopharma's management. Such statements do not represent any guarantee by GC Biopharma or its management of future performance and involve known and unknown risks, uncertainties, and other factors. GC Biopharma undertakes no obligation to update or revise any forward-looking statement contained in this press release or any other forward-looking statements it may make, except as required by law or stock exchange rule. GC Biopharma Contacts (Media) Sohee Kimshkim20@ Yelin Junyelin@ Yoonjae Nayjy6520@
Borneo Post
4 days ago
- Business
- Borneo Post
MADANI government fiscal consolidation on the right track
Malaysia's economy grew by 4.4 percent in the first quarter of 2025, supported by among others, the tourism industry. – File photo KOTA KINABALU: The strong fiscal performance of the MADANI Government indicates that Malaysia's fiscal consolidation efforts are on the right track despite ongoing global economic challenges. Institute for Development Studies Sabah (IDS) Chief Executive Officer Datuk Dr Ramzah Dambul said the national fiscal deficit was successfully reduced by 17 percent to RM21.9 billion in the first quarter of 2025, compared to RM26.4 billion in the same period last year. In addition,government revenue rose by three per cent to RM72.1 billion in the first quarter of 2025, driven by the collection of sales and service tax (SST) and individual income tax, he said. He added that a 2.5 per cent reduction in expenditure to RM94.2 billion – achieved through subsidy rationalisation and savings from lower global oil prices – also contributed to the improved fiscal performance. 'This reflects the success of the tax base expansion strategies and revenue reforms implemented through the MADANI Budget.' 'Moreover, the government plans to introduce capital gains tax and luxury goods tax as new sources of revenue without burdening the people.' 'Discipline in expenditure management is also evident, including through the restructuring of diesel subsidies, which has significantly reduced costs without compromising the welfare of low-income groups. 'Targeted aid initiatives such as the Rahmah Cash Contribution (STR), Basic Rahmah Aid (SARA), and rice seed subsidies are maintained,' he said. 'Spending efficiency has also been improved by optimising grants to statutory bodies,' he said. Datuk Dr Ramzah Dambul Ramzah, who is also an economic researcher, said the enactment of the Public Finance and Fiscal Responsibility Act 2023 sets a target to reduce the fiscal deficit to 3.8 per cent of Gross Domestic Product (GDP) by 2025 and to three per cent by 2028. Similar efforts are also being implemented at the state level, such as the Sabah Government's move to introduce taxes on silica sand and palm biomass products starting in April 2024, he said. 'This proves that governments at all levels are applying strong and disciplined strategies to strengthen revenue and fiscal sustainability. 'This performance also reflects fiscal discipline and the effectiveness of the government's economic reforms, with the 2024 deficit reduced to 4.1 percent of GDP – surpassing the 4.3 percent target – and a commitment to further lower it to 3.8 percent in 2025 under the Act. 'This clearly shows the government's ongoing efforts to strengthen the country's fiscal sustainability,' he said, adding that Malaysia's economic strengthening efforts are in line with its latest fiscal achievements. Ramzah, who is also former Deputy Vice-Chancellor (Research and Innovation) of Universiti Malaysia Sabah (UMS), said Malaysia recorded its highest-ever approved investments in 2024, amounting to RM378.5 billion – a 14.9 percent increase from the previous year – spanning over 6,700 projects and creating 207,000 job opportunities. As such, he said this reflects investor confidence in stable and business-friendly economic policies. He added that the economy grew by 4.4 percent in the first quarter of 2025, supported by household spending, a strong labour market, private investment, and increased exports – especially in the electrical and electronics (E&E) and tourism sectors. He also noted that government efforts to stimulate growth, including strategic industry incentives and skills upgrading programmes, have contributed to this momentum. 'However, the government remains aware that external risks such as trade tensions can have an impact.' 'Hence, efforts to diversify sources of growth, improve productivity, expand export markets, and enhance spending efficiency, and the tax base must continue to be strengthened proactively,' he said. Ramzah also refuted claims that the country's economy is deteriorating, saying they are inconsistent with current facts, especially considering the government's success in reducing the fiscal deficit. He said the national economy continued to grow at a rate of 4.4 percent in the first quarter of 2025, while inflation remained low at around 1.5 to 1.9 percent, with projections remaining below three percent for the year. He added that Malaysia's record-high approved investments of RM378.5 billion also affirm strong confidence from both domestic and foreign investors. 'In fact, the American Malaysian Chamber of Commerce (AmCham) has described this growth as a sign of economic resilience and a stable business environment.' 'Therefore, these fiscal and economic achievements are the best response to negative claims suggesting the country's economy is worsening.' 'The current administration must continue to present verified data, communicate real successes, and be transparent about challenges and solutions.' 'With this approach, public perception can be corrected, and confidence in government policies can be strengthened,' he said.
Daily Express
25-05-2025
- Politics
- Daily Express
IDS' research on Sabah's role in federation
Published on: Sunday, May 25, 2025 Published on: Sun, May 25, 2025 Text Size: Kota Kinabalu: The Institute for Development Studies (Sabah) (IDS) is holding second Focus Group Discussion (FGD) on its ongoing policy research aimed at enhancing Sabah's role within the Malaysian Federation. It would gather representatives from government agencies, academia, civil society, legal experts and the private sector to review and provide feedback on the first draft of the policy brief entitled 'Strengthening Sabah's Position in the Federation: A Strategic Approach to Federalism'. IDS Chief Executive, Datuk Ts. Dr. Ramzah Dambul said the discussion is part of IDS' continued efforts to produce inclusive, forward-looking policies grounded in Sabah's realities within the Federation. This paper explores sector-by-sector strategies spanning education, health, tourism, regional diplomacy, multimedia governance, and Sabah's official status, where the state can pursue greater administrative autonomy through legal, institutional, and policy-based reforms. The discussion aims to refine the draft in preparation for formal presentation to state-level policymakers. The final version of this brief will be published and made publicly accessible. It is intended to serve not only as a reference for the government, but also as a lasting platform for public understanding, stakeholder engagement, and sustained advocacy ensuring that the conversation does not conclude with the paper's completion, but rather begins with it. Advertisement IDS Sabah invites all interested stakeholders, from civil society to public officials, to engage with the findings, contribute to the discourse, and help shape a governance future that reflects the aspirations and realities of Sabah. For further information about this programme, please contact the IDS researcher, Mr. Ariff Adi Putera Anwar (the brief's lead author and policy researcher at IDS), via e-mail at [email protected] or call 088- 450 500. * Follow us on our official WhatsApp channel and Telegram for breaking news alerts and key updates! * Do you have access to the Daily Express e-paper and online exclusive news? Check out subscription plans available. Stay up-to-date by following Daily Express's Telegram channel. Daily Express Malaysia
Yahoo
24-05-2025
- Business
- Yahoo
RVTY Stock Falls Despite the Latest Launch of Automated Instrument
Revvity, Inc. RVTY announced the launch of its new IDS i20 analytical random-access platform from EUROIMMUN. Per management, it is expected to enable full automation of chemiluminescence immunoassays (ChLIA). The IDS i20 instrument is equipped with the ability to process up to 140 tests per hour (assay dependent) and is the latest addition to RVTY's well-established IDS i-device series. The latest product availability is expected to boost Revvity's Immunodiagnostics product line under the broader Diagnostics segment. Following the announcement, shares of the company lost nearly 2.9% till yesterday's closing. Historically, the company has gained a top-line boost from its various product launches. Although the latest product availability is likely to be beneficial for RVTY's top-line growth going forward, the stock declined overall. Revvity currently has a market capitalization of $10.67 billion. It has an earnings yield of 5.3%, favorable than the industry's 4.1%. In the last reported quarter, RVTY delivered an earnings surprise of 5.2%. Per Revvity, the IDS i20 platform is a CE-marked and FDA-listed device that will likely allow laboratories to consolidate multiple specialty tests on a unique single instrument with greater reagent capacity and higher test throughput compared to existing offerings. The IDS i20 platform is expected to offer fully automated processing of specialty assays in endocrinology, allergy, autoimmune and infectious diseases, Alzheimer's disease and therapeutic drug monitoring. Management believes that the IDS i20 instrument will be able to support Revvity's customers in transitioning from manual and semi-automated processing to a fully automated solution for enhanced immunodiagnostics workflows. Per a report by Grand View Research, the global ChLIA market was estimated at $11.71 billion in 2023 and is anticipated to witness a CAGR of 4.6% between 2024 and 2030. Factors like the growing emphasis on early disease detection and increased efforts by pharmaceutical companies in drug discovery and development are likely to drive the market. Given the market potential, the latest product launch is expected to be a significant milestone for Revvity and boost its business. Last month, Revvity announced its first-quarter 2025 results, wherein its Diagnostics segment recorded a robust year-over-year revenue growth both on a reported and organic basis. In March, Revvity announced the launch of EUROIMMUN's CE-marked Anti-Measles Virus ELISA 2.0 (IgG) to support the diagnosis of a measles virus infection or to determine the immune status against measles virus. In January, Revvity received the FDA's 510(k) clearance for EUROIMMUN's automated chemiluminescence-based immunoassay test for free testosterone. Shares of the company have lost 20.2% in the past year compared with the industry's 20.9% decline. The S&P 500 has gained 10% in the same time frame. Image Source: Zacks Investment Research Currently, RVTY carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the broader medical space are Hims & Hers Health, Inc. HIMS, Cencora, Inc. COR and Integer Holdings Corporation ITGR. Hims & Hers, carrying a Zacks Rank #2 (Buy) at present, has an estimated long-term growth rate of 36.5%. HIMS' earnings surpassed estimates in two of the trailing four quarters, missed once and broke even in the other, the average surprise being 19.6%. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. Hims & Hers' shares have surged 217.1% compared with the industry's 13.5% growth in the past year. Cencora, carrying a Zacks Rank of 2 at present, has an estimated long-term growth rate of 12.8%. COR's earnings surpassed estimates in each of the trailing four quarters, the average surprise being 6%. Cencora has rallied 32.5% against the industry's 20.9% decline in the past year. Integer Holdings, sporting a Zacks Rank of 1 at present, has an estimated long-term growth rate of 18.4%. ITGR's earnings surpassed estimates in three of the trailing four quarters and missed once, the average surprise being 2.8%. Integer Holdings' shares have lost 3.7% compared with the industry's 14.7% plunge in the past year. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Cencora, Inc. (COR) : Free Stock Analysis Report Integer Holdings Corporation (ITGR) : Free Stock Analysis Report Hims & Hers Health, Inc. (HIMS) : Free Stock Analysis Report Revvity Inc. (RVTY) : Free Stock Analysis Report This article originally published on Zacks Investment Research ( Zacks Investment Research
