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Press Release: Sanofi and Regeneron’s Dupixent approved in Japan for children aged 6 to 11 years with bronchial asthma
Globenewswire· 2025-12-23 06:00
Core Viewpoint - Sanofi and Regeneron's Dupixent has received approval in Japan for treating bronchial asthma in children aged 6 to 11 years, expanding its previous approval for patients aged 12 and older [1][4]. Group 1: Approval and Clinical Data - The approval is based on data from the VOYAGE global phase 3 study, which showed Dupixent significantly reduced severe asthma exacerbations by 54% to 65% and improved lung function by 4.68% to 5.32% compared to placebo [2][8]. - Additional support for the approval came from the EXCURSION study, which included a sub-study of Japanese pediatric patients, demonstrating improved lung function and a low rate of severe exacerbations over one year [2][8]. Group 2: Asthma in Children - Asthma is a prevalent chronic disease in children, often leading to serious symptoms and impaired lung function, which can have long-lasting effects if not treated early [3]. - Uncontrolled asthma can disrupt daily activities such as sleeping, attending school, and playing sports [3]. Group 3: Dupixent Overview - Dupixent is a fully human monoclonal antibody that inhibits IL-4 and IL-13 signaling pathways, which are key drivers of type 2 inflammation [6][8]. - The drug is available in Japan as a 200 mg or 300 mg pre-filled syringe or pen, administered subcutaneously every two or four weeks based on weight [5]. Group 4: Broader Indications and Global Reach - In addition to asthma, Dupixent is approved for several other conditions in Japan, including atopic dermatitis and chronic rhinosinusitis with nasal polyposis [4]. - Dupixent has received regulatory approvals in over 60 countries and is currently being used to treat more than 1.3 million patients globally [7].
Dupixent® (dupilumab) Approved in Japan for Children Aged 6 to 11 Years with Bronchial Asthma
Globenewswire· 2025-12-23 06:00
Core Insights - The Ministry of Health, Labour and Welfare in Japan has granted marketing and manufacturing authorization for Dupixent (dupilumab) for treating bronchial asthma in children aged 6 to 11 years with severe or refractory disease [1][2] Group 1: Approval and Clinical Data - The approval is based on a global Phase 3 trial (VOYAGE) showing Dupixent significantly reduced severe asthma exacerbations by 54% to 65% and improved lung function by 4.68% to 5.32% compared to placebo [1][2] - Dupixent is the first biologic medicine to demonstrate improved lung function in children aged 6 to 11 years in a randomized Phase 3 trial [1][2] - Additional data from the EXCURSION trial, which included a sub-study of Japanese pediatric patients, supported the approval [2] Group 2: Treatment Context and Importance - Asthma is a prevalent chronic disease in children, and uncontrolled asthma can lead to serious symptoms and long-term health issues, including impaired lung function [3] - Current standard treatments may not adequately control symptoms, necessitating new therapeutic options like Dupixent [3] Group 3: Dupixent's Broader Indications - In addition to asthma, Dupixent is approved in Japan for several other conditions, including atopic dermatitis, chronic rhinosinusitis with nasal polyposis, and chronic obstructive pulmonary disease [4] - Dupixent has received regulatory approvals in over 60 countries for various indications, with more than 1.3 million patients treated globally [7] Group 4: Dupixent Administration and Technology - Dupixent is available in Japan as a 200 mg or 300 mg pre-filled syringe or pen, administered subcutaneously every two or four weeks based on weight [5] - The drug is developed using Regeneron's VelocImmune technology, which produces fully human monoclonal antibodies targeting IL-4 and IL-13 pathways [6][8]
Press Release: Sanofi and Regeneron's Dupixent approved in Japan for children aged 6 to 11 years with bronchial asthma
Globenewswire· 2025-12-23 06:00
Core Viewpoint - Sanofi and Regeneron's Dupixent has received approval in Japan for treating bronchial asthma in children aged 6 to 11 years, expanding its previous approval for patients aged 12 and older [1][4]. Group 1: Approval and Clinical Data - The approval is based on data from the VOYAGE global phase 3 study, which showed that Dupixent significantly reduced severe asthma exacerbations by 54% to 65% and improved lung function by 4.68% to 5.32% compared to placebo [2][8]. - Additional support for the approval came from the EXCURSION study, which included a sub-study of Japanese pediatric patients, demonstrating improved lung function and a low rate of severe exacerbations over one year [2][8]. Group 2: Asthma in Children - Asthma is a prevalent chronic disease in children, often leading to serious symptoms and impaired lung function, which can have long-lasting effects if not treated early [3]. - Uncontrolled asthma can disrupt daily activities such as sleeping, attending school, and playing sports [3]. Group 3: Dupixent Overview - Dupixent is a fully human monoclonal antibody that inhibits IL-4 and IL-13 signaling pathways, which are key drivers of type 2 inflammation [6][8]. - The drug is available in Japan as a 200 mg or 300 mg pre-filled syringe or pen, administered subcutaneously every two or four weeks based on weight [5]. Group 4: Broader Indications and Global Reach - In addition to asthma, Dupixent is approved for various conditions in Japan, including atopic dermatitis and chronic rhinosinusitis with nasal polyposis [4]. - Dupixent has received regulatory approvals in over 60 countries and is currently being used to treat more than 1.3 million patients globally [7].
Trump unveils major drug price deals with 9 Pharma giants, launches TrumpRx.gov to cut medicine costs in US
MINT· 2025-12-19 23:46
Core Insights - President Trump announced a set of drug-pricing agreements with nine major pharmaceutical companies, aiming to align U.S. medicine costs with those in Europe [1][2] - The initiative includes a new direct-to-consumer portal, TrumpRx.gov, allowing patients to purchase certain medicines directly from manufacturers [2][4] Group 1: Agreements and Participants - The agreements involve 14 out of 17 drugmakers that Trump previously urged to lower prices, including Amgen, GSK, and Merck [2][3] - Drug companies are motivated to negotiate to avoid potential regulatory measures that could impact their profits [3] Group 2: TrumpRx.gov Functionality - TrumpRx.gov will serve as a central directory for patients to access selected medicines directly from manufacturers' websites [4] - The portal is expected to be fully operational by January, following a promotional launch [4] Group 3: Pricing Details - Highlighted medicines include Amgen's Repatha at $239/month, GSK's Advair Diskus at $89/month, and Merck's Januvia at $100/month [6] - Gilead's Epclusa will be priced at $2,492/month, despite lower costs for insured patients [6] Group 4: Impact on Medicaid and Medicare - Companies committed to launching new medicines in the U.S. at prices comparable to those in other wealthy countries [8] - Medicaid programs are legally entitled to the lowest drug prices, with Bristol Myers Squibb offering Eliquis free to Medicaid [9] Group 5: Industry Response and Future Outlook - Health policy experts express skepticism about the agreements' impact on overall drug prices for most Americans [10] - The agreements do not impose mandatory price controls and leave many brand-name drug costs unchanged [15] - Ongoing discussions with additional manufacturers like AbbVie and Johnson & Johnson may lead to further agreements [14]
Trump strikes deal with US drugmakers to cut Medicaid medicine costs
The Guardian· 2025-12-19 20:14
Core Insights - Donald Trump and nine major pharmaceutical companies have reached agreements to significantly reduce drug prices for the Medicaid program and cash payers, aiming to align US costs with those in other wealthy nations [1][2] Group 1: Price Reductions and Agreements - Drugmakers will cut prices on most drugs sold to Medicaid, promising "massive savings" on commonly used medicines, although specific figures were not disclosed [2] - The deals include agreements to lower cash-pay prices for select drugs, launch drugs in the US at prices equal to those in other wealthy nations, and increase manufacturing [3] - Merck plans to sell its diabetes drugs at approximately 70% off list prices directly to US consumers, with potential for its experimental cholesterol drug to be offered through direct channels [4] Group 2: Previous and Current Deals - Five companies had previously made agreements with the administration to control prices, while three companies have yet to announce deals [6] - Drugmakers committed to "most-favored-nation" pricing for all new US drug launches across various markets, including Medicare [7] Group 3: Financial Commitments and Investments - Companies pledged to invest over $150 billion in US research and development and manufacturing, with Merck contributing $70 billion of that total [8] - A portion of revenues from foreign sales will be remitted to the US to help offset costs [8] Group 4: Medicaid and Market Impact - Medicaid, which represents about 10% of US drug spending, already benefits from significant price discounts, sometimes exceeding 80% [9] - Pfizer indicated that Medicaid discounts would lead to price and margin compression in the upcoming year [9]
Trump secures agreements with Merck, Amgen, Novartis and others to cut drug prices under Medicaid
MINT· 2025-12-19 20:04
Core Points - US President Donald Trump announced agreements with nine major pharmaceutical companies to reduce drug prices for Medicaid and cash-paying consumers, aiming to align US drug costs with those in other wealthy nations [1][4] - Trump emphasized that the US was previously subsidizing global drug costs and will no longer do so [2] Group 1: Drugmakers Involved - Participating companies include Bristol Myers Squibb, Gilead Sciences, Novartis, Amgen, Boehringer Ingelheim, Sanofi, GSK, Merck, and Roche's US unit Genentech [3] - Additional companies like Regeneron, Johnson & Johnson, and AbbVie are expected to join after the holidays [3] Group 2: Price Reductions and Commitments - Drugmakers will reduce prices on most medicines sold to Medicaid, promising "massive savings" on widely used drugs, although specific figures were not disclosed [4] - The agreements also include commitments to cut cash prices for select medicines and to launch new drugs in the US at prices equal to those in other wealthy countries [5] Group 3: Specific Drug Pricing - Merck plans to sell diabetes drugs Januvia, Janumet, and Janumet XR at discounts of about 70% off list prices [7] - Amgen will price its migraine drug Aimovig and arthritis treatment Amjevita at $299 per month, which is nearly 60% and 80% below current US list prices, respectively [7] Group 4: Investment and Revenue Sharing - Companies pledged to invest over $150 billion in US research, development, and manufacturing, with Merck alone committing $70 billion [8] - A portion of each company's overseas revenue will be remitted to the US to help offset domestic drug costs, and several companies agreed to donate drug ingredients to the US strategic reserve [9] Group 5: Industry Reaction - Five drugmakers, including Pfizer and Eli Lilly, had already struck similar deals with the administration, and AbbVie is expected to announce its agreement soon [10]
赛诺菲(SNY.O):协议不会影响三年期内的主导增长战略或财务展望。
Jin Rong Jie· 2025-12-19 19:37
Group 1 - The core viewpoint of the article is that Sanofi's agreement will not impact its dominant growth strategy or financial outlook over the next three years [1] Group 2 - Sanofi maintains a strong focus on its growth strategy despite the recent agreement [1] - The financial outlook remains stable and unaffected by the agreement [1]
Press Release: Sanofi reaches agreement with the US government to lower medicine costs while strengthening innovation
Globenewswire· 2025-12-19 19:21
Sanofi reaches agreement with the US government to lower medicine costs while strengthening innovation Agreement delivers on President Trump’s four requests, establishing a framework for lower prices for patients in the US and a tariff-free accord for SanofiShowcases commitment to US manufacturing, innovation, and economic growth Paris, December 19, 2025. Sanofi today announced an agreement with President Donald J. Trump's Administration to help ensure American patients have access to more affordable medici ...
“进博效应”持续释放,“进博好物”加速可及赛诺菲亮相首届进博优品交易会
Jing Ji Guan Cha Wang· 2025-12-19 14:55
Core Viewpoint - Sanofi is leveraging the China International Import Expo (CIIE) as a platform to showcase its innovative biopharmaceutical products, aiming to enhance the accessibility of global healthcare solutions in China [1][4]. Group 1: Participation in CIIE - Sanofi has been a consistent participant in the CIIE for eight years and has confirmed its participation in the upcoming ninth edition, emphasizing its commitment to connecting global innovation with China's healthcare needs [1][3]. - The company showcased several products at the inaugural CIIE, highlighting their journey from initial presentation to clinical application in China, referred to as "CIIE babies" [1][4]. Group 2: Product Innovations - Sanofi presented key products that have transitioned from previous CIIE showcases to clinical practice, including Dupixent (dupilumab injection), which has been approved for seven indications in China, covering skin and respiratory treatment areas [1][2]. - The company also introduced Nirsevimab, a long-acting monoclonal antibody for preventing respiratory syncytial virus (RSV) infections in infants, demonstrating a successful transition from international debut to local availability [1][2]. Group 3: Strategic Collaborations and Investments - Sanofi has signed a strategic cooperation agreement with local biotech company Yanshengchao at the CIIE, marking a shift from being merely an exhibitor to an investor, thereby deepening its local engagement [3]. - The company is investing €1 billion in a new insulin raw material project in Beijing, reinforcing its commitment to local production and supply chain stability [3][4]. Group 4: Future Commitment - Sanofi aims to continue its investment in China and enhance its "China solutions" to support the vision of "Healthy China," ensuring that innovative healthcare products reach patients more efficiently [4].
首届“小进博”来了,企业携全球好物直达消费者
Guo Ji Jin Rong Bao· 2025-12-19 13:27
Core Viewpoint - The first Import Expo Quality Products Trade Fair in Shanghai showcased over 700 companies from more than 60 countries, emphasizing the importance of quality products and consumer engagement in the post-Expo period [3][10]. Group 1: Event Overview - The trade fair took place from December 19 to 21 at the National Exhibition and Convention Center in Shanghai, serving as a key extension of the Import Expo [3]. - The event featured a variety of products, including health foods from Oceania, home appliances from Europe, personal care items from the Americas, and beauty products from Asia, all popular among consumers [5]. Group 2: Innovative Sales Approach - New Zealand's New Zealand Dairy Company transformed its booth into an immersive 360-degree live streaming space, allowing for real-time interaction and purchases, effectively merging online and offline sales [9][10]. - The company's star product, colostrum milk powder, sold out its initial batch of 25,000 cans within a month of its global debut at the previous Import Expo, highlighting its popularity [9][10]. Group 3: Consumer Engagement and Education - The trade fair served as a platform for companies to educate consumers about their products, with Medtronic showcasing advanced medical technologies aimed at enhancing health consumer choices [14]. - The event included a special area for health education, where innovative medical products were displayed, emphasizing the importance of consumer awareness in health technology [16]. Group 4: Brand Participation and Market Impact - Companies like Sanofi and Boston Scientific presented products that had previously debuted at the Import Expo, demonstrating a successful transition from exhibition to market availability [15][16]. - Shiseido adopted a direct sales model at the trade fair, allowing consumers to experience products firsthand and make immediate purchases, reflecting a shift towards consumer-centric marketing strategies [17][18].