Workflow
Lenacapavir(来那帕韦)
icon
Search documents
吉利德四赴进博会,两款新药进迎来亚洲“首秀”
Cai Jing Wang· 2025-11-08 08:13
Core Insights - Gilead showcased its commitment to health innovation at the China International Import Expo, presenting two significant products: the long-acting HIV pre-exposure prophylaxis drug Lenacapavir and the new drug for primary biliary cholangitis (PBC), Seladelpar [1][2][3] Product Highlights - Lenacapavir is a long-acting HIV capsid inhibitor that requires administration only twice a year, demonstrating over 99.9% efficacy in preventing HIV in global Phase III clinical trials [2] - Seladelpar is an innovative drug for PBC, a chronic autoimmune liver disease, which was approved in August 2023 and is the first therapy to improve biochemical markers and alleviate itching symptoms in PBC patients [3] Market Impact - Gilead has launched 13 innovative drugs in China, benefiting approximately 1.8 million patients, and aims to deepen its local strategy while enhancing drug accessibility and health equity [4] Collaborative Efforts - Gilead is actively pursuing collaborations to support the "Healthy China 2030" initiative, focusing on improving public health through academic exchanges, enhancing treatment capabilities in rural areas, and expanding innovative partnerships in oncology [6]
吉利德科学携亚洲首发重磅展品亮相第八届进博会
Guo Ji Jin Rong Bao· 2025-11-08 05:35
Core Insights - Gilead showcased two significant products at the China International Import Expo: the long-acting HIV pre-exposure prophylaxis drug Lenacapavir and the new drug for primary biliary cholangitis (PBC) Seladelpar, emphasizing its commitment to creating a healthier world [1][3] Product Highlights - Lenacapavir is a groundbreaking long-acting HIV capsid inhibitor that requires administration only twice a year, demonstrating over 99.9% efficacy in preventing HIV in global Phase III clinical trials [3][4] - Seladelpar is the first innovative therapy that improves biochemical markers and alleviates itching symptoms for PBC patients, which was included in the National Health Commission's list of rare diseases in 2023 [4] Market Entry and Approval - Lenacapavir received approval for HIV pre-exposure prophylaxis in Hainan Boao Lecheng International Medical Tourism Pilot Zone, almost simultaneously with FDA approval, marking a significant milestone for domestic drug approval processes [4] - Seladelpar was approved in Beijing under the urgent clinical need policy, providing new treatment hope for PBC patients in China [4] R&D Initiatives - Gilead is actively advancing local R&D with 16 ongoing projects in China, including 10 in oncology and 6 in non-oncology, aiming for synchronized global development to benefit Chinese patients [5] Access to Innovative Medicines - Over the past eight years, Gilead has launched 13 global innovative drugs in China, benefiting approximately 1.8 million patients, including notable products for HIV treatment and hepatitis [8] - The company emphasizes collaboration with various sectors to enhance access to innovative medicines and promote health equity [9]
吉利德科学携两款亚洲首发展品亮相进博会
Xin Jing Bao· 2025-11-07 09:57
Core Insights - Gilead Sciences showcased multiple products at the 8th China International Import Expo, including two Asia debut products: long-acting HIV pre-exposure prophylaxis drug Lenacapavir and a new drug for primary biliary cholangitis (PBC) named Seladelpar [1][2] Group 1: Lenacapavir - Lenacapavir is a globally first-of-its-kind long-acting HIV capsid inhibitor that requires administration only twice a year, demonstrating over 99.9% effectiveness in preventing HIV based on global Phase III clinical studies [1] - Lenacapavir has received several prestigious recognitions, including being ranked first in Science magazine's "Top 10 Scientific Breakthroughs of 2024" and being included in Time magazine's "Best Inventions of 2025" [1] - The drug was approved for HIV pre-exposure prophylaxis in Hainan Boao Lecheng International Medical Tourism Pilot Zone in late June, almost simultaneously with the approval from the U.S. FDA [1] Group 2: Seladelpar - Seladelpar is an innovative drug targeting patients with primary biliary cholangitis, a chronic autoimmune liver disease recognized as a "silent killer" and included in the National Health Commission's list of rare diseases in 2023 [2] - The drug is the first global therapy that can improve biochemical indicators in PBC patients while alleviating itching symptoms, which significantly impact the quality of life [2] - Seladelpar was approved in August under Beijing's clinical urgent import policy, marking a significant step in addressing the needs of PBC patients [2] Group 3: Gilead's Market Presence - Gilead Sciences has launched 13 global innovative drugs in China over the past eight years, benefiting approximately 1.8 million patients [2] - At the expo, Gilead plans to deepen collaborations with various parties to enhance the accessibility of innovative drugs and promote standardized diagnosis and treatment [2]
探访第八届进博会医疗馆:“中国创新”浓度飙升,健康生活科技感扑面而来
Cai Jing Wang· 2025-11-07 07:16
Group 1 - The China International Import Expo (CIIE) has become a significant platform for global companies to showcase innovations and deepen international cooperation, particularly in the healthcare sector [1] - The eighth CIIE opened on November 5, 2025, in Shanghai, featuring a record number of global product launches and highlighting China's strategic position in the global health industry [1] - Major international medical companies like Siemens Healthineers, GE Healthcare, and Pfizer showcased numerous innovative products, with a focus on "China R&D, global debut" [1][2] Group 2 - GE Healthcare presented nearly 40 innovative products, with 60% led by Chinese teams, marking a record high for the expo [2] - Medtronic's first heart pacing catheter developed in China exemplifies the "local innovation, global sharing" model, with significant local procurement and investments in startups [3] - Pfizer aims to accelerate the approval of 60 innovative drugs in China by 2030, having already achieved over half of this goal [3] Group 3 - AI has become an essential feature in medical products, with Siemens showcasing AI-driven innovations that enhance clinical decision-making and patient care [5][6] - Philips emphasized its commitment to local innovation, with over 95% of its products developed and manufactured in China [4] - The integration of AI in healthcare is expanding from hospitals to home care, with Philips investing significantly in AI and data science [7] Group 4 - The expo highlighted innovative drugs for rare diseases, with Sanofi launching two significant cardiovascular drugs [8] - Gilead Sciences introduced a long-acting HIV prevention drug, achieving a record for global synchronization in its launch [9] - The CIIE has become a vital platform for the rapid introduction of new therapies to benefit Chinese patients [9]
吉利德金方千:以创新为钥,解锁中国市场增长新空间
Core Insights - The China International Import Expo (CIIE) serves as a significant platform for global companies to showcase their innovations and engage with key decision-makers in the Chinese pharmaceutical market [1][2][3] - Gilead Sciences has experienced the benefits of the CIIE, particularly in accelerating the approval and market entry of innovative therapies in China [1][2][3] Policy and Regulatory Environment - China's continuous policy reforms in drug approval processes have created a favorable environment for innovative drugs, enhancing the attractiveness of the Chinese market for multinational pharmaceutical companies [1][2] - The establishment of expedited approval channels for breakthrough therapies and conditional approvals has significantly reduced the time for innovative drugs to enter the Chinese market [2][3] Market Dynamics and Opportunities - The CIIE has become a "policy windfall" and "information hub" for new drugs entering China, allowing companies to effectively communicate with regulatory bodies and enhance product recognition among healthcare professionals and patients [2][3] - Gilead's innovative drugs, such as Lenacapavir and Seladelpar, have demonstrated rapid approval and market entry following their showcases at the CIIE, highlighting the event's role in expediting access to new treatments [3][4][7] Collaboration and Local Partnerships - Gilead is actively pursuing collaborations with local pharmaceutical companies and healthcare platforms to strengthen its supply chain and enhance product accessibility in China [9][10] - The company is also focusing on educational initiatives to reduce stigma around diseases like HIV, thereby fostering a more informed patient population and improving market conditions [9][10] Future Directions - Gilead plans to continue its focus on both treatment and prevention in the HIV space, exploring innovative dosing regimens to improve patient adherence [8][9] - The company is engaged in multiple clinical studies globally, with a significant emphasis on advancing HIV treatment and prevention strategies [8][11] - Gilead's ongoing partnerships and collaborations with local innovators reflect a broader trend of multinational companies seeking to capitalize on China's growing pharmaceutical market [12]
紧握进博机遇、合作共赢未来 吉利德科学携亚洲首发重磅展品亮相第八届进博会
Core Insights - Gilead Sciences showcased its commitment to innovation and health equity at the 2025 China International Import Expo, highlighting two Asian debut products: Lenacapavir and Seladelpar [1][2][3] - The company aims to enhance drug accessibility and promote health equity through collaboration with various stakeholders, including governments and healthcare professionals [1][6] Product Highlights - Lenacapavir is a groundbreaking long-acting HIV capsid inhibitor that requires administration only twice a year, recognized as a top scientific breakthrough and awarded the 2025 Galen Prize for Best Pharmaceutical Product [2] - Seladelpar is an innovative treatment for primary biliary cholangitis (PBC), recently approved in Beijing, providing new hope for patients suffering from this chronic autoimmune liver disease [3] Market Presence and Achievements - Gilead has launched 13 innovative drugs in China, benefiting approximately 1.8 million patients, and continues to expand its local research and development efforts with 16 ongoing projects [4][10] - The company emphasizes its role as a reliable partner in China's public health sector, contributing to the "Healthy China 2030" initiative through various collaborative projects [6][9] Community Engagement - Gilead actively supports disease awareness and patient support initiatives, including charitable donations to schools for HIV-infected children, enhancing their access to innovative treatments [5] - The company promotes public understanding of diseases and advocates for better social support for patients, aiming to create a more inclusive environment [5][6]
进博观察:开放平台引“凤”来,医疗药械焕新健康动能
Core Insights - The 8th China International Import Expo (CIIE) opened in Shanghai, attracting 155 countries and regions, with 4,108 overseas enterprises showcasing their latest innovations across 43,000 square meters of exhibition space, marking a new high in the expo's scale [1] - The expo has strengthened its role as a platform for international procurement, investment promotion, cultural exchange, and open cooperation since its inception in 2018, becoming a key venue for multinational companies to showcase products and understand the Chinese market [1] Medical Devices and Healthcare - The medical devices and healthcare exhibition area, covering over 70,000 square meters, focuses on the theme "Healthy China, Healthy Life," showcasing cutting-edge medical technologies and innovations aimed at promoting the "Healthy China 2030" strategy [1] - Sanofi's new indication for Dupixent (dupilumab) for chronic rhinosinusitis with nasal polyps made its debut in China, addressing a significant unmet medical need for approximately 30 million patients suffering from this condition [2] - Gilead Sciences presented two major products, Lenacapavir and Seladelpar, at the expo, with Lenacapavir being a long-acting HIV prevention drug that requires administration only twice a year, marking a significant advancement in HIV prevention [3] Innovations in Cardiovascular and Kidney Treatments - Novartis showcased breakthrough innovations in cardiovascular and kidney treatments, emphasizing the importance of the CIIE in accelerating the availability of innovative drugs in China [4] - The company aims to enhance patient accessibility to cutting-edge therapies and continues to collaborate with government and industry partners to improve the prevention and treatment of cardiovascular and kidney diseases [4] Local Production and Investment - AstraZeneca announced an additional investment of approximately $136 million to expand its production capacity in Qingdao, focusing on inhalation aerosol products for respiratory diseases [9] - Alcon plans to localize the production of its Wavelight excimer laser surgical equipment in China, responding to the growing demand for eye health services in the country [11] - Medtronic highlighted its commitment to local innovation and collaboration in China, showcasing its advanced surgical robotics and precision radiation solutions at the expo [8][12] Industry Trends and Future Outlook - The expo serves as a vital platform for foreign medical companies to deepen their commitment to the Chinese market, with many firms increasing investments and localizing production to meet the growing healthcare demands [9][10] - The focus on high-end medical devices and intelligent upgrades is seen as crucial for improving diagnostic and treatment quality in line with the "Healthy China 2030" strategy [5][6] - The increasing collaboration between global companies and local partners is expected to drive innovation and enhance healthcare services in China, reflecting the country's role as a significant growth engine in the global market [13]
“一年两次” 长效预防药物落地博鳌,加速终结HIV流行
Core Insights - The ongoing battle against HIV/AIDS has persisted for over 40 years, with no cure available, making it a significant global public health issue [1] - In China, over 95% of reported HIV cases are transmitted through sexual contact, with a notable increase in the proportion of cases attributed to sexual transmission in recent years [1] - The introduction of Lenacapavir, a long-acting HIV pre-exposure prophylaxis (PrEP) drug, marks a significant advancement in HIV prevention strategies [2][7] Group 1: Current Situation of HIV/AIDS in China - The proportion of HIV cases transmitted through sexual contact reached 97.6% in 2022, with heterosexual transmission accounting for 72.0% and homosexual transmission for 25.6% [1] - The Chinese government has recognized the importance of HIV prevention, emphasizing a strategy that combines prevention and treatment [2][4] - Despite public awareness of HIV transmission routes, many individuals still perceive HIV as a distant issue, leading to a significant number of undiagnosed cases [1] Group 2: Challenges in HIV Prevention - The effectiveness of PrEP is not widely understood, and there is a significant gap in public knowledge regarding its necessity and proper usage [2][3] - Adherence to daily medication regimens for PrEP, such as Truvada, poses challenges, leading to many individuals discontinuing use or never starting [5] - The market for HIV treatment drugs in China has shown substantial growth, with projections indicating a market size of 4.96 billion yuan by 2023, reflecting a compound annual growth rate of 18.6% from 2019 to 2023 [5] Group 3: Innovations in HIV Prevention - Lenacapavir, requiring only two doses per year, represents a significant innovation in HIV prevention, providing a long-lasting protective effect [2][7] - The drug works by directly targeting the HIV capsid protein, effectively blocking critical steps in the virus's replication process [7] - Clinical studies have demonstrated that Lenacapavir maintains over 99.9% efficacy in preventing HIV infection among high-risk populations [7][8]
一年给药两次的艾滋预防药落地博鳌了,但暴露前预防知晓率低问题待解
Di Yi Cai Jing· 2025-07-25 08:52
Core Viewpoint - The introduction of Lenacapavir, a groundbreaking HIV pre-exposure prophylaxis (PrEP) drug requiring only two doses per year, marks a significant advancement in HIV prevention efforts in China, addressing a critical public health issue with over 100,000 new infections annually in the country [1][3]. Group 1: Product Launch and Availability - Gilead China announced the official launch of Lenacapavir in the Boao Lecheng International Medical Tourism Pilot Zone, with approval received on June 30 for use in adults and adolescents weighing at least 35 kg at risk of HIV-1 infection [1]. - Starting July 25, individuals can make appointments for Lenacapavir through designated institutions such as Boao Super Hospital and Boao Yiling Life Care Center [1]. Group 2: Public Health Context - HIV remains a major public health challenge globally, with China projected to account for 7.8% of new HIV infections worldwide in 2024 [1]. - The World Health Organization has set a target to end the AIDS epidemic by 2030, emphasizing the need for comprehensive prevention strategies to cover 95% of those at risk by 2025 [3]. Group 3: Importance of Pre-Exposure Prophylaxis - Experts highlight that transitioning from treatment-centered approaches to proactive prevention strategies is crucial for effectively controlling HIV spread in China [3][4]. - The introduction of Lenacapavir, which has shown nearly 100% efficacy in preventing HIV in various populations, is expected to improve adherence among high-risk individuals due to its less frequent dosing schedule [4]. Group 4: Challenges and Future Directions - Despite the availability of long-acting prevention drugs like Lenacapavir, there is a need for increased awareness and education about pre-exposure prophylaxis to enhance its uptake among at-risk populations [4]. - The ongoing stigma surrounding HIV may hinder individuals from seeking preventive care, necessitating innovative approaches to resource allocation and outreach in healthcare settings [4].
全球同类首创、一年给药两次的HIV预防药物落地海南博鳌乐城使用
news flash· 2025-07-25 05:18
Core Viewpoint - Gilead China has officially launched Lenacapavir, a groundbreaking HIV pre-exposure prophylaxis (PrEP) drug that requires administration only twice a year, in the Boao Lecheng International Medical Tourism Pilot Zone in Hainan [1] Group 1 - Lenacapavir has been approved for use in the United States since June, aimed at reducing the risk of HIV transmission through sexual contact for adults and adolescents weighing at least 35 kilograms [1]