Latest news with #BTD
RTÉ News
22-06-2025
- Business
- RTÉ News
How secure is your banking app?
Mobile banking is one of the most popular internet activities in Ireland. During the first six months of last year, 87% of internet users used internet banking or mobile banking, according to the Central Statistics Office. This trend tells us that many people now use their phones to manage their accounts and make payments. But fraudulent payments are a growing concern in Europe, especially in the rapidly evolving digital marketplace. Earlier this year, the Central Bank of Ireland published a new Behind the Data (BTD) paper on Irish payment fraud statistics. However, there are no stats to identify how many scams or frauds happen specially through interactions with apps. Head of Financial Crime with Banking and Payments Federation Ireland (BPFI) Niamh Davenport warns that app scams usually happen because a phone or device has been hacked. "Everyone thinks they're banking app scams, it's generally your phone that has been compromised rather than the app itself," said Ms Davenport. "Summer last year is probably the first time we really saw app scams come into force and they're still low volume in Ireland from what members are telling us, but they're only going to increase," she said. In March, the BPFI hosted the first Cross-Sector Anti-Fraud Forum which was established as a key action under the Department of Finance's National Payments Strategy. BPFI will chair the Forum for the initial period of two and half years and work with industry partners, the Government and An Garda Siochana to ensure a robust framework for fraud prevention, detection, and disruption. How secure are banking apps? Biometric logins, such as facial recognition, are becoming increasingly common within mobile banking apps to ensure they are secure. Our banking apps are "in general" secure, according to independent expert and Chief Technical Officer at Wayne Morgan. "Most banking apps have to undergo diligent tests and ongoing tests for the security vulnerabilities. So, in general, yes, I would say banking apps are secure," said Mr Morgan. He advises users to adopt a trust nothing and check everything attitude when it comes to keeping your personal information safe. "Cyber security and your approach to security starts the moment you sit in a chair or turn on your device," said Mr Morgan. "It's not good enough to action after the fact, you have to be diligent from the moment you pick up your device," he said. What are the main risks of banking apps as a consumer? They include phishing attacks, malware, fake apps or rogue apps or spoof apps; people reusing credentials in their banking that they would use in multiple other places; and man in the middle attack (MITM). MITM attackers sometimes create their own malicious public wifi networks to lure unsuspecting users and harvest their personal data. The attacker places themselves between a user and the app or website to eavesdrop on the communication. This can be done through a piece of software installed on a phone, tablet or computer and the attackers uses it to steal or manipulate information. This is why it is important not to use the same password for multiple accounts, as it makes it easier for attackers to compile more of your personal information. "People have a habit of using a password that's easy to remember. It could be a family member's name, an anniversary, the name of a pet," said Mr Morgan. "They will reuse that password across the spread of their apps, it could be their Facebook or Instagram, their banking, it could be many, many things, and reusing the password is definitely something we would advise against." Is technology or human error more susceptible to fraudsters? Typically, human error is the main path to a breach. Phishing and smishing are the most common attacks used by fraudsters to socially engineer customers into giving away their credentials. When downloading any apps, consumers should only use the official Apple and Android app stores. BPFI's Niamh Davenport warns that fraudsters are targeting people directly, and consumers need to take extra steps to check the legitimacy of an app. "We just click on things so quickly or we trust information that's put in front of us so easily. Irish people would have questioned everything, and I think we've just become a very trusting nation and just take everything at face value on particular when it comes to social media," she said. In an effort to tackle text scams the Communications Regulator has developed an SMS Sender ID system. From 3 July this year, unregistered SMS Sender IDs will be modified to "Likely Scam" to alert the recipient to be cautious of the content of those text messages. While from 3 October 2025, text messages from unregistered SMS Sender IDs will be blocked. What happens if you download a fake banking app? Fraudsters can trick people into sharing their logins and sensitive financial information with fake banking apps that imitate legitimate mobile banking. However, any fake app that is downloaded inadvertently through unofficial links or phishing websites poses a threat to the security of your information. And the fraudsters can play the long game, as you will have no idea that they have access to your phone or device. By installing an app from an untrusted source, there is the same risk as an email breach. The hackers can install a Trojan piece of software, and somebody will be sitting with full uninterrupted access to the device; and they'll just sit there. "It could be for days, for weeks, months, monitoring the traffic, waiting for the opportunity of you to use your banking app and enter your password," said Mr Morgan. "If you have two factor authentication, they will be sitting there waiting for the access code or token from your two-factor authentication session to go across," he said. "They would then use that token to gain access to your banking app. These things are a long game, they're not necessarily good in the short term, so diligence over time is critical," he explained. If a device is hacked in this way, deleting the fake app is unlikely to solve the problem. The initial piece of Trojan software that was installed is likely to install something else in the background such as a port or access path to a third party to access the device and the user's information. How are the banks in Ireland working to protect banking app customers? The EU is working on a new legislative framework the Payment Services Regulation (PSR) as well as a third Payment Services Directive (PSD). Both aim to modernise payment services, enhance consumer protection, and promote competition in the payments market. Banks in Ireland are not automatically liable for losses due to scams, but it is likely they will investigate the incident and could potentially refund the customer. This will depend on the type of scam or unauthorised payment, if the customer promptly reported the incident and a bank's own policy regarding scam refunds. Banks also have a range of security measures from the app itself being security protected, to one of the bigger ones which is transaction monitoring and its own internal systems. Here is a look at six of the top banking apps used in Ireland. AIB said its mobile banking service provides the highest level of industry standard security. The bank has 2.2 million active users on its digital channels and said it is continuously making significant investments to enhance its fraud monitoring systems. In the bank's 2024-2026 strategic update it included spending of around €300m per year period to ensure a "future fit" platform, but did not give a specific breakdown on spending on the app. AIB Head of Financial Crime, Mary McHale, noted the ongoing investment is to enhance cyber security protection and broaden the range of mobile payments capability, while adhering to new and emerging regulation. "We released 'Selfie Check' which uses facial biometrics to verify a customer's identity via our AIB Mobile app, using the latest technology to recognise the things that make a customer's face unique, so we know it's you in control of your money", Ms McHale said. "In the event of a customer mislaying their card, they can put a temporary freeze on it through the mobile app, on our internet banking service, or through the kiosk in our branch. There is the ability to unfreeze the card if found, which can then be used again as normal," she said. AIB said it cannot comment on individual customer cases, however it noted that when a customer initiates and authorises a payment that they later realise was fraudulent, they advise them to report it to the Gardaí and to them as soon as possible to give them the best chance of retrieving the payment. It added that once a fraudulent payment is reported to them, they can then report the fraud to the receiving bank and request for the funds to be returned, unfortunately in some cases it may be too late. Revolut Digital finance Provider Revolut is a fully licensed bank in 30 EEA countries, including Ireland where it has three million customers. It is authorised by the European Central Bank and regulated by the Bank of Lithuania. Revolut said that in 2024 alone it prevented approximately €750m in potential fraud against its customers. It said it continually enhances the app's security features, this year launching in-app calls to help customers quickly expose impersonation scams, as well as implementing real-time AI fraud detection systems, transaction limits, biometric authentication requirements, and providing educational resources to help consumers remain informed about potential risks. The Revolut app security features include strict identity checks, biometric security, a dedicated control centre where customers can personalise their security settings across more than 10 features, complete card control (a customer's physical card must be activated in their app), Wealth Protection (an additional layer of biometric security), in-app calls, and 24/7 customer support. A Revolut spokesperson said: "Our financial crime experts, who now make up more than a third of our 10,000-strong workforce, are continuously innovating to stay one step ahead of scammers, implementing real-time AI fraud detection systems, transaction limits, biometric authentication requirements, and providing educational resources. This thereby ensures that our customers are increasingly less exposed to the industry-wide risk of fraud." Bank of Ireland Bank of Ireland said the standard for security measures is set by the PSD 2 Regulation and the regulatory technical standards. A dedicated team of around 200 people are employed by the bank to work 24/7 to address fraud attempts. Last year Bank of Ireland announced an investment of €50m in customer fraud prevention and protection, with €15m specifically allocated to new fraud prevention technology. The investment includes implementing voice biometric technology and enhancing self-service features on the mobile app. The bank operates device monitoring with a range fraud measures across the Bank of Ireland app and online channels, including fraud detection tools across customer activity, payment limits, effective warnings, strong customer authentication, in-channel messaging, and push notifications. Head of Fraud at Bank of Ireland, Nicola Sadlier, said where they have a suspicion, they will reach out to a customer by text or phone call. "Essentially that team is working 24/7 to manage alerts, reach out to customers and attempt to stop any fraud either on our channel or whether a customer's being caught up unknown to themselves," she said. If an app scam is reported the bank will investigate fully and report it to the Gardai unless the customer has already done so. Bank of Ireland said it may have to get on to beneficiary banks to look to recover funds and will keep customers informed at all stages of the investigation. As member of the BPFI working groups, industry forums, and the Cyber Defence Alliance, Ms Sadlier said understanding what other banks are experiencing is a key focus area. "The UK often start experiencing fraud attacks ahead of us, it's really important that we share trend information and learn what's happening and to get ready and respond," she said. An Post An Post is continually focused on ensuring that its An Post Money app is secure by constantly enhancing it based on market intelligence and its own fraud experiences and systems monitoring. Product Management Consultant at An Post, Bruce Richardson, said they have not seen a rise in app fraud among its customers. He credits this with An Post's back-end security measures and educating customers, including the Fraud "Stop & Think" notifications in the app. "The weakest point is the customer because we're socially engineered to believe if somebody phones you and says they're from the fraud department or whoever it might be, we're socially conditioned to accept that," said Mr Richardson. "Also the fraudsters have become more clever about how they do it, people think they're going to phone up and ask for your bank details but they've already done that they already have your information, they're only looking normally for that verification code that will be sent to your mobile device and that's the piece that they really want," he stated. One feature that An Post credits with being instrumental in protecting customers is its Dynamic CVV. This is a security feature that replaces the static three-digit CVV number on the back of your debit card with a new, one-time-use code generated within the An Post Money app for each online purchase. This measure makes the CVV number useless to fraudsters after it's been used. "The fraudsters buy databases of card details off the dark web but the key piece that they don't have then is the CVV, and then because it changes every five minutes on the app it has been a key part for us to help curtail the fraudulent activity from a numbers perspective, he added. N26 German online bank N26 operates primarily through a mobile app and is a fully licenced digital bank. It is in operation in multiple countries across Europe, including Ireland. Governed by the same regulations as all traditional banks, N26 adheres to strict regulations on security, compliance, and financial crime prevention. It said it uses state-of-the-art systems to ensure its app is highly secure, to stay ahead of fraudsters and eliminate possible human error. The key security processes it uses are the "Know-Your-Customer" process which verifies a customer's identity and confirms that they are who they claim to be. N26 also carries out ongoing transaction monitoring to detect suspicious activity, and reauthentication which protects against identity and password theft. The secure features include but are not limited to a single paired device, two factor authentication, fingerprint and facial recognition, instant notifications, in-app card locking and pin change, location tracking and smart payment blocks The current trends the digital bank has identified in the last two years following reports by N26users in Europe are: - Authorised Push Payment (APP) fraud, where malicious actors convince victims to authorize payments themselves - digital wallet fraud, where criminals link users' cards to wallets to make unauthorised transactions - marketplace scams - where fraudsters entice customers with attractive offers for goods that never are received - postal fraud - which typically contain phishing messages to obtain sensitive customer information PTSB PTSB said it has robust security and fraud protection features in-built in its app to provide customers with a safe and convenient channel to meet their banking needs on the go. In a global banking first, the bank introduced "PTSB Protect", a feature to its mobile app which helps prevent customers falling victim to fraudulent scams and is continuously investing in this feature. PTSB Protect alerts customers if they receive a text message containing a fraudulent link or block them from accessing a suspicious website on their mobile device. It compares links received or accessed on a customer's phone against a known blocklist of links which pose as legitimate websites to deceptively obtain a customer's personal or banking details. Where a link matches an entry on the blocklist – which is maintained and updated daily by the bank – the website will either be blocked or an alert will be sent to the customer. The bank's dedicated fraud team carries out 24/7/365 real-time fraud monitoring of all app activity and transactions and provides 24/7/365 Agent support. A PTSB spokesperson said: "We have invested, and continue to invest, significantly in security and fraud prevention and detection across all our channels, including our mobile app and desktop banking services". "This includes the 'PTSB Protect; feature on our mobile app which has supported a 64% reduction in customer account exposure year on year," the spokesperson said. "As fraudsters are becoming more sophisticated, we communicate with our customers on an ongoing basis on how to avoid fraud and scams across all of our channels, in addition to our participation in the banking industry's FraudSMART programme," the spokesperson added.
The Star
16-06-2025
- Entertainment
- The Star
K-pop sensation Jang Dong Woo of Infinite to thrill the fans in his solo concert at Zepp KL on Aug 15
KUALA LUMPUR: The powerhouse performer and beloved member of K-pop sensation Infinite, Jang Dong Woo, is making a highly anticipated return to Kuala Lumpur — this time as a solo artist. The multi-talented rapper and dancer will meet fans through his 2025 JANG DONG WOO FAN-CON TOUR IN KUALA LUMPUR on August 15th at 8pm at the ZEPP Kuala Lumpur. Organized by Star Planet, this marks Dong Woo's first solo fan-con in Malaysia, promising an evening of heartfelt performances, personal interactions, and an immersive atmosphere that celebrates the deep bond between artist and fans. Since his debut with Infinite in 2010, Dong Woo has stood out as one of the group's most dynamic and multifaceted members. Known for his high-energy stage presence and unmistakable rap style, he has contributed significantly to INFINITE's success through hit tracks like 'BTD,' 'The Chaser,' and 'Last Romeo.' In 2019, Dong Woo unveiled his first solo album, 'BYE,' featuring seven tracks that highlight his artistic versatility—from hard-hitting rap and vibrant rhythms to soulful, introspective melodies. The album includes standout tracks such as 'I Am,' 'News,' 'Gun,' 'Romeo,' 'Party Girl,' 'Perfect,' and 'Something Between.' Beyond music, Dong Woo continues to shine across dance, variety, and creative platforms—an embodiment of artistic passion and growth. His constant evolution has solidified his standing in the K-POP world, earning him unwavering admiration from fans worldwide. The tour spans five major cities—Seoul, Taipei, Kuala Lumpur, Manila, and Hong Kong—and promises an intimate fan experience through powerful performances and meaningful interactions. Each stop serves as a platform to connect deeply with fans, celebrating a shared journey through music and emotion. Ticketing Information Tickets for the 2025 JANG DONG WOO FAN-CON TOUR IN KUALA LUMPUR will go on sale June 20, 2025, at 12:00 PM, exclusively via Don't miss this opportunity to form a unique connection with Dong Woo — a night of unforgettable memories, powerful music, and heartfelt moments awaits. For further details, visit
National Business Review
14-06-2025
- Business
- National Business Review
Buying the dip: why it's not as simple as it seems
Two weeks ago, I reviewed the strategy of, and rationale for, buying the dip (BTD). Today, I will continue that topic, speculating that recent 'dips' may not offer a good indication of future 'dips' both in terms of duration and amplitude. I will also examine why the BTD strategy has become so Want to read more? It's easy. Choose your subscription Already have an account? Login Smartphone Only Subscription NZ$29.95 / monthly Monthly Premium Online Subscription NZ$49.95 / monthly Smartphone Only Annual Subscription NZ$299.00 / yearly Yearly Premium Online Subscription NZ$499.00 / yearly Premium Group Membership 10 Users NZ$385 +GST / monthly $38.5 per user - Pay by monthly credit card debit Premium Group Membership 20 Users NZ$660 +GST / monthly $33 per user - Pay by monthly credit card debit Premium Group Membership 50 Users NZ$1375 +GST / monthly $27.5 per user - Pay by monthly credit card debit Premium Group Membership 100 Users NZ$2100 +GST / monthly $21 per user - Pay by monthly credit card debit Yearly Premium Online Subscription + NBR Marketplace NZ$999.00 / yearly Individual Group membership NBR Marketplace Student Exclusive FREE offer for uni students studying at a New Zealand university (valued at $499). View terms and conditions.
Yahoo
20-05-2025
- Business
- Yahoo
Viridian Therapeutics Announces Positive Long-Term Durability Data from the Veligrotug Phase 3 THRIVE Clinical Trial in Patients with Active Thyroid Eye Disease (TED)
- 70% of patients treated with veligrotug in THRIVE who were proptosis responders at week 15 maintained their response at week 52 - - Veligrotug recently received Breakthrough Therapy Designation (BTD), supporting eligibility for Priority Review; the BTD request was based on veligrotug's (i) consistent and robust improvement and resolution of diplopia in chronic TED, and (ii) rapid onset of proptosis response - - Biologics License Application (BLA) submission for veligrotug is on track for second half 2025 - - Actively preparing organization for planned U.S. commercial launch in 2026 - WALTHAM, Mass., May 20, 2025--(BUSINESS WIRE)--Viridian Therapeutics, Inc. (Nasdaq: VRDN), a biopharmaceutical company focused on discovering, developing, and commercializing potential best-in-class medicines for serious and rare diseases, today announced positive long-term durability data from the THRIVE phase 3 clinical trial of veligrotug ("veli"), an intravenously delivered anti-insulin-like growth factor-1 receptor (IGF-1R) antibody, in patients with active thyroid eye disease (TED). TED is an autoimmune condition characterized by inflammation, growth, and damage to tissues around and behind the eye. The THRIVE phase 3 clinical trial in active TED evaluated 5 infusions of veli or placebo every three weeks with primary topline analysis at week 15 and then followed patients through week 52. Positive Veligrotug Durability at 52 Weeks 70% of veligrotug patients (21/30) in THRIVE, who were proptosis responders at week 15 and continued follow-up to the end of the study at week 52, maintained their proptosis response. Maintenance of response is defined as responders at week 15 who still had at least a 2-millimeter (mm) reduction in proptosis compared to baseline at week 52, without worsening in the fellow eye (≥2 mm increase), as measured by exophthalmometry. There were no changes to the safety profile in the follow-up period. The vast majority of adverse events reported at the week 15 primary analysis had resolved by week 52. "We view the strength of today's durability and safety resolution data as reinforcing veli's strong and consistently robust clinical profile," said Steve Mahoney, Viridian's President and CEO. "We believe that the totality of veligrotug's clinical data continues to demonstrate its potential to be the treatment-of-choice for patients living with TED. We believe these data, together with a streamlined dosing regimen of five infusions, position veli to become a market leading TED therapeutic, if approved. We continue to make great progress towards submitting the BLA in the second half of this year and preparing for a potential launch in 2026." Robust Veligrotug Topline Clinical Profile for Active and Chronic TED As announced in late 2024, veligrotug met all of its primary and secondary endpoints and was generally well-tolerated in its pivotal phase 3 clinical trials, THRIVE and THRIVE-2, for active and chronic TED, respectively. Veligrotug demonstrated a rapid onset of treatment effect and statistically significant and clinically meaningful reduction and resolution of diplopia in both clinical trials. THRIVE-2 was the first data set from a global phase 3 clinical trial in chronic TED patients to demonstrate statistically significant diplopia response and resolution. Together, THRIVE and THRIVE-2 comprise the largest pivotal program to date in TED. About Veligrotug Veligrotug is an intravenously (IV) delivered, anti-insulin-like growth factor-1 receptor (IGF-1R) antibody in phase 3 development for thyroid eye disease, with the potential to be the IV treatment-of-choice for active and chronic TED patients. IGF-1R is a clinically and commercially validated target for thyroid eye disease (TED) with U.S. revenues of approximately $2 billion in 2024. Veligrotug has the potential to improve patient experience with a differentiated dosing regimen that features a shorter infusion time and fewer infusions compared to the currently approved and marketed IGF-1R inhibitor. In its pivotal phase 3 clinical trials, THRIVE and THRIVE-2, veligrotug met all of its primary and secondary endpoints. Veligrotug demonstrated a rapid onset of treatment effect and statistically significant and clinically meaningful reduction and resolution of diplopia in both clinical trials. THRIVE-2 was the first demonstration in a global phase 3 clinical trial of a statistically significant diplopia response and resolution in chronic TED patients. Veligrotug was generally well tolerated. Viridian believes that the robust veligrotug clinical profile has the potential to establish a strong position in the TED commercial market, if approved, and may help facilitate the introduction of VRDN-003, its potential best-in-class subcutaneous IGF-1R antibody for TED. About Viridian Therapeutics Viridian is a biopharmaceutical company focused on discovering, developing and commercializing potential best-in-class medicines for patients with serious and rare diseases. Viridian's expertise in antibody discovery and protein engineering enables the development of differentiated therapeutic candidates for previously validated drug targets in commercially established disease areas. Viridian is advancing multiple candidates in the clinic for the treatment of patients with thyroid eye disease (TED). The company is conducting a pivotal program for veligrotug (VRDN-001), including two global phase 3 clinical trials (THRIVE and THRIVE-2), to evaluate its efficacy and safety in patients with active and chronic TED. Both THRIVE and THRIVE-2 reported positive topline data, meeting all the primary and secondary endpoints of each study. Viridian is also advancing VRDN-003 as a potential best-in-class subcutaneous therapy for the treatment of TED, including two ongoing global phase 3 pivotal clinical trials, REVEAL-1 and REVEAL-2, to evaluate the efficacy and safety of VRDN-003 in patients with active and chronic TED. In addition to its TED portfolio, Viridian is advancing a novel portfolio of neonatal Fc receptor (FcRn) inhibitors, including VRDN-006 and VRDN-008, which has the potential to be developed in multiple autoimmune diseases. Viridian is based in Waltham, Massachusetts. For more information, please visit Follow Viridian on LinkedIn and X. Forward Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of words such as, but not limited to, "anticipate," "believe," "become," "continue," "could," "design," "estimate," "expect," "intend," "may," "might," "on track," "plan," "potential," "predict," "project," "should," "target," "will," or "would" or other similar terms or expressions that concern our expectations, plans and intentions. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based on our current beliefs, expectations, and assumptions. Forward-looking statements include, without limitation, statements regarding: clinical development and anticipated commercialization of Viridian's product candidates, including veligrotug (formerly VRDN-001) and VRDN-003; the potential utility, efficacy, potency, safety, clinical benefits, clinical response, convenience, and number of indications of veligrotug and VRDN-003, including Viridian's view of the strength of the THRIVE durability and safety resolution data and veligrotug's robust clinical profile; veligrotug's potential to be the IV treatment-of-choice for active and chronic TED; the impact of Breakthrough Therapy Designation, including eligibility for Priority Review, or any other FDA designations; regulatory interactions and anticipated timing of regulatory submissions, including the anticipated BLA submission for veligrotug in the second half of 2025; potential market sizes and market opportunities for Viridian's product candidates, including Viridian's belief that veligrotug is positioned to become a market leading TED therapeutic, if approved; Viridian's product candidates potentially being best-in-class; whether veligrotug will serve an unmet need; veligrotug's potential to improve patient experience over existing therapies; and Viridian's expectations regarding the potential commercialization of veligrotug and VRDN-003, if approved, including the potential U.S. launch of veligrotug in 2026. New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements. Such forward-looking statements are subject to a number of material risks and uncertainties including but not limited to: potential utility, efficacy, potency, safety, clinical benefits, clinical response, and convenience of Viridian's product candidates; that results or data from completed or ongoing clinical trials may not be representative of the results of ongoing or future clinical trials; that preliminary data may not be representative of final data; expectations and changes regarding the timing for regulatory filings; regulatory interactions; uncertainty and potential delays related to clinical drug development; the timing of and our ability to obtain and maintain regulatory approvals for our therapeutic candidates; competition from other therapies or products; estimates of market size; our future operating results and financial performance; Viridian's intellectual property position; that our product candidates may not be commercially successful, if approved; and other risks described from time to time in the "Risk Factors" section of our filings with the Securities and Exchange Commission (SEC), including those described in our most recent Annual Report on Form 10-K or Quarterly Report on Form 10-Q, as applicable, and supplemented from time to time by our Current Reports on Form 8-K. Any forward-looking statement speaks only as of the date on which it was made. Neither the company, nor its affiliates, advisors, or representatives, undertake any obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law. These forward-looking statements should not be relied upon as representing the company's views as of any date subsequent to the date hereof. View source version on Contacts IR@ Media@ Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
12-05-2025
- Business
- Yahoo
InnoCare's Mesutoclax Receives Breakthrough Therapy Designation from China's NMPA
BEIJING, May 12, 2025--(BUSINESS WIRE)--InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical company focusing on the treatment of cancer and autoimmune diseases, announced today that its B-cell lymphoma-2 (BCL2) inhibitor, Mesutoclax (ICP-248), has been granted Breakthrough Therapy Designation (BTD) by the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) for the treatment of BTKi-treated relapsed or refractory mantle cell lymphoma (R/R MCL). This marks the first BCL2 inhibitor to receive BTD recognition in China! Mesutoclax is a novel, orally bioavailable BCL2 selective inhibitor, developed as monotherapy or in combination with orelabrutinib for the treatment of chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL), mantle cell lymphoma (MCL), and other non-Hodgkin's lymphomas (NHLs), and as well as acute myeloid leukemia (AML). BCL2 is an important regulatory protein in the apoptosis pathway, and its abnormal expression is associated with the development of various hematologic malignancies. Mesutoclax exerts anti-tumor activity by selectively inhibiting BCL2 and restoring the normal apoptosis process in cancer cells. Dr. Jasmine Cui, the Co-founder, Chairwoman, and CEO of InnoCare, said, "We are delighted that mesutoclax has been granted Breakthrough Therapy Designation, which will help expedite multi-center, multi-indication clinical trials for mesutoclax in China and globally to benefit patients as early as possible." Clinical trials of mesutoclax are ongoing both in China and globally, including a Phase III registrational trial of mesutoclax in combination with orelabrutinib as a first line therapy for the treatment of CLL/SLL patients, as well as a clinical trial of mesutoclax for the treatment of AML. The Breakthrough Therapy Designation (BTD) by the CDE aims to accelerate the clinical development of new drugs that demonstrate significant clinical advantages. New drugs granted BTD are typically intended for diseases that are life-threatening or severely impair quality of life, and have demonstrated clear advantages in efficacy or safety during clinical trials. About InnoCare InnoCare is a commercial stage biopharmaceutical company committed to discovering, developing, and commercializing first-in-class and/or best-in-class drugs for the treatment of cancers and autoimmune diseases with unmet medical needs in China and worldwide. InnoCare has branches in Beijing, Nanjing, Shanghai, Guangzhou, Hong Kong, and the United States. InnoCare Forward-looking Statements This report contains the disclosure of some forward-looking statements. Except for statements of facts, all other statements can be regarded as forward-looking statements, that is, about our or our management's intentions, plans, beliefs, or expectations that will or may occur in the future. Such statements are assumptions and estimates made by our management based on its experience and knowledge of historical trends, current conditions, expected future development and other related factors. This forward-looking statement does not guarantee future performance, and actual results, development and business decisions may not match the expectations of the forward-looking statement. Our forward-looking statements are also subject to a large number of risks and uncertainties, which may affect our short-term and long-term performance. View source version on Contacts Media Chunhua Investors 86-10-66609999ir@ Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
