Pirfenidone

21 August 2025 PureTech Health plc PureTech Showcases Differentiated Development Strategy, Including New Patient Preference Insights, and Spotlights Phase 2b Data Positioning Deupirfenidone as a Potential New Standard of Care in IPF Deupirfenidone to be advanced by PureTech's newly launched Founded Entity, Celea Therapeutics PureTech Health plc (Nasdaq: PRTC, LSE: PRTC) ("PureTech" or the "Company"), a clinical-stage biotherapeutics company dedicated to changing the lives of patients with devastating diseases, demonstrated its growing leadership in idiopathic pulmonary fibrosis (IPF) at the 2025 IPF Summit this week in Boston. The Company highlighted the strength of its Phase 2b ELEVATE IPF trial data supporting the advancement of deupirfenidone (LYT-100) into Phase 3 by its newest Founded Entity, Celea Therapeutics ("Celea"), and shared new patient preference data and insights shaped by deep engagement across the IPF treatment ecosystem. "With deupirfenidone demonstrating compelling efficacy, we are taking a holistic approach to Phase 3 planning - one that is informed by a deep understanding of the needs of patients, clinicians, and payers alike," said Camilla Graham, MD, MPH, Senior Vice President of Medical Affairs at PureTech. "After more than a decade without meaningful therapeutic advancement, the IPF treatment landscape is beginning to shift. To deliver real impact, innovation must extend beyond the molecule - into clinical trial design, patient and provider education, and access. That's the bar we've set with deupirfenidone." Balancing Efficacy and Safety of Treatment: Perspectives of People Living with IPF As part of its commitment to developing therapies that address real-world needs, PureTech shared new findings from structured interviews with 16 individuals living with IPF, designed to understand how patients weigh the trade-offs between efficacy and tolerability when considering novel treatments. The data highlight that patients are not only open to new options, they are primarily motivated by the potential for better outcomes. Key findings included the following: · 69% of participants preferred a hypothetical treatment offering greater efficacy over one with improved tolerability. · 94% said they would proactively initiate a conversation with their physician if a new treatment offered a differentiated profile. "We've seen real hesitation around initiating currently available therapies - even among patients with progressive disease," said Tejaswini Kulkarni, MD, MPH, University of Alabama at Birmingham and co-author on the research. "These findings reflect a shift in mindset. People with IPF want better outcomes, and they're willing to accept manageable tolerability trade-offs in pursuit of a more effective treatment. That perspective is essential to designing trials and therapies that truly resonate with those who matter most." De-risking Late-Stage Development through Sophisticated Trial Design Across two expert panels at the IPF Summit, PureTech shared insights into the clinical development strategy behind deupirfenidone, emphasizing how the design of its Phase 2b ELEVATE IPF trial was purposefully built to address persistent challenges in the development of new IPF therapies. "The ELEVATE IPF trial stands out for its thoughtful design and execution," said Toby Maher, MD, PhD, Professor of Medicine and Director of Interstitial Lung Disease at Keck School of Medicine, University of Southern California, Los Angeles, and lead investigator in the ELEVATE IPF trial. "By selecting a 26-week treatment period, including an active comparator, and applying rigorous data quality controls, the study was designed to generate the type of robust and reliable data that has often been difficult to achieve in early-stage IPF therapeutic development. Just as importantly, deupirfenidone builds on more than a decade of clinical and real-world experience with pirfenidone, reinforcing confidence in the ELEVATE data and its potential to be replicated in Phase 3." The trial incorporated key features to generate high-confidence data that position deupirfenidone for a Phase 3 program with reduced clinical risk, including: · Trial Duration: Most Phase 2 IPF trials last just 12 weeks. While this design can help establish an early efficacy signal, it often fails to capture the strength and durability of a treatment effect over time. PureTech's Phase 2b ELEVATE IPF trial spanned 26 weeks, enabling a more robust assessment of lung function decline and a clearer view of long-term therapeutic potential. Importantly, open-label extension data further support the durability of deupirfenidone's treatment effect through at least 52 weeks while reinforcing safety and tolerability. · Data Quality: Spirometry, the primary efficacy measure in IPF trials, is inherently variable. To ensure data integrity, ELEVATE IPF employed training to 2019 ATS standards and centrally-read spirometry with rigorous quality control systems, resulting in clean, consistent data. · Active Comparator Arm: ELEVATE IPF was the first industry-sponsored trial to include an approved antifibrotic agent as an active comparator. In the trial, both pirfenidone and placebo performed in line with historical expectations, reinforcing the credibility and reproducibility of the deupirfenidone data. · Consistency of Development Plan: PureTech intends to discuss a Phase 3 trial design with the U.S. Food and Drug Administration that recapitulates key aspects of ELEVATE IPF, thereby minimizing technical risk from protocol changes. Together, these elements reinforce the strength and reliability of the Phase 2b data and underscore why deupirfenidone is poised to set a new benchmark as it advances into Phase 3. Deupirfenidone: A Potential New Standard of Care In a dedicated clinical update at the IPF Summit, PureTech presented data from its global, randomized, double-blind, active- and placebo-controlled Phase 2b ELEVATE IPF trial, which support the advancement of deupirfenidone into Phase 3 as a potential new standard of care. The trial met its primary endpoint and demonstrated a statistically significant and clinically meaningful reduction in lung function decline at 26 weeks with deupirfenidone 825 mg three times a day (TID) compared to placebo. Patients treated with deupirfenidone 825 mg TID experienced a slower rate of lung function decline, as measured by change from baseline of Forced Vital Capacity (FVC), at 26 weeks versus those who were treated with pirfenidone 801 mg TID or placebo (-21.5 mL vs. -51.6 mL vs. -112.5 mL, respectively).[1] Based on their respective reductions in lung function decline versus placebo, the treatment effect with deupirfenidone 825 mg TID was approximately 50% greater than that of pirfenidone 801 mg TID (80.9% vs. 54.1%). This effect is supported by pharmacokinetic data showing that treatment with deupirfenidone 825 mg TID achieved ~50% higher drug exposure than pirfenidone 801 mg TID, without a corresponding increase in tolerability challenges. Notably, initial data from the ongoing open-label extension (OLE) study showed that the treatment effect with deupirfenidone 825 mg TID was sustained out to at least 52 weeks. As of May 9, 2025, a total of 101 patients had received at least 52 weeks of treatment with deupirfenidone. Those in the deupirfenidone 825 mg TID arm experienced a decline in FVC of -32.8 mL over the 52-week period,[2] which is similar to the expected natural decline in lung function in healthy older adults over one year (approximately -30.0 mL to -50.0 mL).[3] These longer-term data support the durability of the treatment effect observed with this dose and reinforce its potential improvements over current IPF treatments to stabilize lung function decline over time, while maintaining favorable safety and tolerability. Additional data, including outcomes in participants who transitioned to deupirfenidone in the OLE after initially receiving placebo or pirfenidone during the blinded portion of the trial, will be presented at the upcoming European Respiratory Society (ERS) International Congress in September 2025. Celea, PureTech's newly launched Founded Entity focused on respiratory diseases, is advancing the development and potential commercialization of deupirfenidone. The company is led by Sven Dethlefs, PhD, who has played a central role in driving the program forward over the past year and brings deep expertise in respiratory therapeutics and commercial execution. "The ELEVATE IPF trial has delivered some of the most compelling data the IPF field has seen, and it's a privilege to now be leading the effort to advance deupirfenidone into Phase 3 through PureTech's newest Founded Entity, Celea Therapeutics," said Dr. Dethlefs. "With a foundation of rigorous science, differentiated efficacy, and strong stakeholder alignment, we believe deupirfenidone has the potential to become a new standard of care for people with IPF." About Deupirfenidone (LYT-100) Deupirfenidone (LYT-100) is in development as a potential new standard of care for the treatment of idiopathic pulmonary fibrosis (IPF). It is a deuterated form of pirfenidone, which - along with nintedanib - is one of the two FDA-approved treatments for IPF. Both approved therapies offer only modest efficacy in slowing lung function decline, largely due to tolerability challenges that limit the ability to achieve higher doses that could significantly improve patient outcomes. These limitations have contributed to low treatment uptake and poor adherence, with approximately 25% of people with IPF in the U.S. ever receiving either drug.[4] Despite this, combined peak global sales exceed $5 billion, representing a significant market opportunity in IPF and other fibrotic lung diseases. [5] Deupirfenidone may overcome these limitations. In the global Phase 2b ELEVATE IPF trial, deupirfenidone demonstrated the potential to stabilize lung function decline over at least 26 weeks as a monotherapy while maintaining a favorable safety and tolerability profile. Initial data from an ongoing open-label extension study suggest that this effect may be sustained through at least 52 weeks. These findings support the potential for deupirfenidone to offer a meaningful advance for people living with this progressive and deadly disease. Beyond IPF, deupirfenidone may also address multiple underserved fibrotic conditions, including progressive fibrosing interstitial lung diseases. About Idiopathic Pulmonary Fibrosis (IPF) Idiopathic pulmonary fibrosis (IPF) is a rare, progressive, and fatal lung disease characterized by irreversible scarring of lung tissue that leads to a steady decline in lung function. Median survival following diagnosis is estimated to be two to five years, and currently there is no cure.[6] About Celea Therapeutics Celea Therapeutics is dedicated to advancing transformative treatments for people with serious respiratory diseases. Drawn from the Latin word for "sky," the name reflects the company's mission to rise above the status quo and deliver therapies that change lives. The company's lead program, deupirfenidone (LYT-100), is a Phase 3-ready therapeutic candidate with the potential to set a new standard of care for idiopathic pulmonary fibrosis (IPF) and other fibrotic lung diseases. Celea was founded by PureTech Health plc (Nasdaq: PRTC, LSE: PRTC), a biotherapeutics company dedicated to giving life to science. PureTech's innovative R&D model drives the creation of Founded Entities like Celea, enabling the advancement of highly promising medicines to patients in a capital-efficient manner. For more information, please visit www.celeatx.com and www.puretechhealth.com. About PureTech Health PureTech is a clinical-stage biotherapeutics company dedicated to giving life to new classes of medicine to change the lives of patients with devastating diseases. The Company has created a broad and deep portfolio through its experienced research and development team and its extensive network of scientists, clinicians, and industry leaders that is being advanced both internally and through its Founded Entities. PureTech's R&D engine has resulted in the development of 29 therapeutics and therapeutic candidates, including three that have been approved by the U.S. Food and Drug Administration. A number of these programs are being advanced by PureTech or its Founded Entities in various indications and stages of clinical development, including registration-enabling studies. All of the underlying programs and platforms that resulted in this portfolio of therapeutic candidates were initially identified or discovered and then advanced by the PureTech team through key validation points. For more information, visit www.puretechhealth.com or connect with us on X (formerly Twitter) @puretechh. Cautionary Note Regarding Forward-Looking Statements This press release contains statements that are or may be forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation statements that relate to continued development of and regulatory interactions related to deupirfenidone, the potential of deupirfenidone in IPF and other indications, our expectations around our therapeutic candidates and approach towards addressing major diseases, our plans to advance our programs and deliver on our milestones, our future plans, prospects, developments, and strategies. The forward-looking statements are based on current expectations and are subject to known and unknown risks, uncertainties and other important factors that could cause actual results, performance and achievements to differ materially from current expectations, including, but not limited to, those risks, uncertainties and other important factors described under the caption "Risk Factors" in our Annual Report on Form 20-F for the year ended December 31, 2024 filed with the SEC and in our other regulatory filings. These forward-looking statements are based on assumptions regarding the present and future business strategies of the Company and the environment in which it will operate in the future. Each forward-looking statement speaks only as at the date of this press release. Except as required by law and regulatory requirements, we disclaim any obligation to update or revise these forward-looking statements, whether as a result of new information, future events or otherwise. PureTech Public Relations publicrelations@puretechhealth.com Investor Relations IR@puretechhealth.com UK/EU Media Ben Atwell, Rob Winder +44 (0) 20 3727 1000 puretech@fticonsulting.com US Media Justin Chen jchen@tenbridgecommunications.com [1] The efficacy analysis used a random coefficient regression model with absolute FVC including baseline as response variable and week, treatment, and interaction between week and treatment as fixed effect. The analysis was performed based on the predefined Full Analysis Set. The rate of FVC decline at week 26 with deupirfenidone 825 mg TID compared to placebo was statistically significant (-21.5 mL vs. -112.5 mL, respectively; p=0.02). p value is two-sided and has not been corrected for multiplicity. The rate of FVC decline at week 26 with pirfenidone 801 mg TID compared to placebo was consistent with previously reported pirfenidone clinical trial data (Roche). ELEVATE-IPF was not designed to demonstrate the superiority of deupirfenidone 825 mg TID vs. pirfenidone 801 mg TID. [2] Analysis conducted using the same methodology to assess rate of decline in FVC at 26 weeks from the double-blind portion of the trial. Efficacy analysis used a random coefficient regression model with absolute FVC including baseline as response variable and week, treatment and interaction between week and treatment as fixed effect. The analysis was performed based on the predefined Full Analysis Set. [3] Valenzuela, C., Bonella, F., Moor, C., Weimann, G., Miede, C., Stowasser, S., & Maher, T. (2024, September). Decline in forced vital capacity (FVC) in subjects with idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF) compared with healthy references [Poster presentation]. European Respiratory Society International Congress, Vienna, Austria; and Luoto, J., Pihlsgård, M., Wollmer, P., & Elmståhl, S. (2019). Relative and absolute lung function change in a general population aged 60-102 years. European Respiratory Journal, 53(3), 1701812. https://doi-org.libproxy1.nus.edu.sg/10.1183/13993003.01812-2017 [4] Dempsey, T. M., Payne, S., Sangaralingham, L., Yao, X., Shah, N. D., & Limper, A. H. (2021). Adoption of the antifibrotic medications pirfenidone and nintedanib for patients with idiopathic pulmonary fibrosis. Annals of the American Thoracic Society, 18(7), 1121-1128. [5] Esbriet peak sales (2020) per Roche 2021 Financial Results & Ofev peak sales (2024) per Boehringer Ingelheim 2024 Financial Results. Ofev sales include those for all approved indications - IPF, PF-ILD, and systemic sclerosis-associated interstitial lung disease (SSc-ILD). [6] Fisher, M., Nathan, S. D., Hill, C., Marshall, J., Dejonckheere, F., Thuresson, P., & Maher, T. M. (2017). Predicting life expectancy for pirfenidone in idiopathic pulmonary fibrosis. Journal of Managed Care & Specialty Pharmacy, 23(3-b Suppl), S17-S24. https://doi-org.libproxy1.nus.edu.sg/10.18553/jmcp.2017.23.3-b.s17

本周药品注册受理数据，分门别类呈现，一目了然。(8.11-8.17） 新药上市申请 药品名称 企业 注册分类 受理号 HY22017胶囊 长春海悦药业股份有限公司 2.3 CXHS2500095 海曲泊帕乙醇胺片 江苏恒瑞医药股份有限公司 2.4 CXHS2500094 海曲泊帕乙醇胺片 江苏恒瑞医药股份有限公司 2.4 CXHS2500093 海曲泊帕乙醇胺片 江苏恒瑞医药股份有限公司 2.4 CXHS2500092 新药临床申请 药品名称 企业 注册分类 受理号 MAX-001胶囊 安炎达医药技术(广州)有限公司 1 CXHL2500859 MAX-001胶囊 安炎达医药技术(广州)有限公司 1 CXHL2500858 HSK39297片 海思科医药集团股份有限公司 1 CXHL2500855 HSK39297片 海思科医药集团股份有限公司 1 CXHL2500854 HSK39297片 海思科医药集团股份有限公司 1 CXHL2500853 HSK39297片 海思科医药集团股份有限公司 1 CXHL2500852 TGRX-678片 深圳市塔吉瑞生物医药有限公司 1 CXHL2500850 D-2570片 益方生物科技(上海)股份有限公司 1 CXHL2500849 HRS-6209胶囊 江苏恒瑞医药股份有限公司 1 CXHL2500848 HRS-6209胶囊 江苏恒瑞医药股份有限公司 1 CXHL2500847 HRS-6209胶囊 江苏恒瑞医药股份有限公司 1 CXHL2500846 HRS-6209胶囊 江苏恒瑞医药股份有限公司 1 CXHL2500845 HRS-2189片 山东盛迪医药有限公司 1 CXHL2500844 HRS-2189片 山东盛迪医药有限公司 1 CXHL2500843 ARTS-023片 安锐生物医药科技(广州)有限公司 1 CXHL2500835 ARTS-023片 安锐生物医药科技(广州)有限公司 1 CXHL2500834 XZ022 山东新时代药业有限公司 2.2 CXHL2500860 紫杉醇软胶囊 美济生物医药(广州)有限公司 2.2 CXHL2500839 HWH217片 湖北生物医药产业技术研究院有限公司 2.3 CXHL2500857 HWH217片 湖北生物医药产业技术研究院有限公司 2.3 CXHL2500856 注射用戈舍瑞林微球 山东绿叶制药有限公司 2.4 CXHL2500851 阿贝西利片 齐鲁制药有限公司 2.4 CXHL2500840 阿贝西利片 齐鲁制药有限公司 2.4 CXHL2500842 阿贝西利片 齐鲁制药有限公司 2.4 CXHL2500841 结合雌激素乳膏 新疆新姿源生物制药有限责任公司 2.4 CXHL2500833 吡非尼酮胶囊 北京康蒂尼药业股份有限公司 2.4 CXHL2500836 PRT-062鼻喷雾剂 四川普锐特药业有限公司 2.4;2.2 CXHL2500838 PRT-062鼻喷雾剂 四川普锐特药业有限公司 2.4;2.2 CXHL2500837 重组呼吸道合胞病毒疫苗(CHO细胞) 北京华诺泰生物医药科技有限公司 1.2 CXSL2500691 吸附无细胞百白破(组分)联合疫苗(成人及青少年用) 北京智飞绿竹生物制药有限公司 2.6 CXSL2500705 SHR-1139注射液 广东恒瑞医药有限公司 1 CXSL2500704 注射用乙型脑炎溶瘤病毒 四川安可康生物医药有限公司 1 CXSL2500709 注射用乙型脑炎溶瘤病毒 四川安可康生物医药有限公司 1 CXSL2500708 注射用乙型脑炎溶瘤病毒 四川安可康生物医药有限公司 1 CXSL2500707 注射用乙型脑炎溶瘤病毒 四川安可康生物医药有限公司 1 CXSL2500706 ZX2021注射液 江苏中新医药有限公司 1 CXSL2500699 ZX2021注射液 江苏中新医药有限公司 1 CXSL2500698 ZX2021注射液 江苏中新医药有限公司 1 CXSL2500697 ZX2021注射液 江苏中新医药有限公司 1 CXSL2500696 ZX2021注射液 江苏中新医药有限公司 1 CXSL2500695 GenSci098注射液 长春金赛药业有限责任公司 1 CXSL2500703 Cizutamig注射液 上海坦蒂生物医药科技有限公司 1 CXSL2500702 注射用YP004 原菩生物技术(武汉)有限责任公司 1 CXSL2500701 VBC101 上海橙帆医药有限公司 1 CXSL2500700 AZD0901 阿斯利康全球研发(中国)有限公司 1 CXSL2500694 注射用QLC5513 齐鲁制药有限公司 1 CXSL2500690 仿制药申请 药品名称 企业 注册分类 受理号 盐酸卡替洛尔滴眼液 成都地奥九泓制药厂 3 CYHS2503016 洛索洛芬钠颗粒 辽宁海一制药有限公司 3 CYHS2503013 联苯苄唑溶液 中山万汉制药有限公司 3 CYHS2503009 盐酸多巴酚丁胺注射液 石家庄四药有限公司 3 CYHS2503006 联苯苄唑溶液 杭州上禾健康科技有限公司 3 CYHS2503005 盐酸西替利嗪口服溶液 海南万玮制药有限公司 3 CYHS2503004 布比卡因脂质体注射液 浙江博崤生物制药有限公司 3 CYHS2503003 布比卡因脂质体注射液 浙江博崤生物制药有限公司 3 CYHS2503002 氨磺必利口服溶液 河北义海医药科技有限公司 3 CYHS2503000 枸橼酸西地那非口溶膜 杭州和泽坤元药业有限公司 3 CYHS2502996 JP-1366片 丽珠医药集团股份有限公司 3 CYHS2502991 聚乙二醇4000散 西安安健药业有限公司 3 CYHS2502988 普瑞巴林口服溶液 江苏贝佳制药有限公司 3 CYHS2502986 普瑞巴林口服溶液 江苏贝佳制药有限公司 3 CYHS2502983 叶酸片 成都通德药业有限公司 3 CYHS2502973 枸橼酸苯海拉明布洛芬片 合肥恩瑞特药业有限公司 3 CYHS2502972 盐酸多西环素片 江苏润恒制药有限公司 3 CYHS2502969 盐酸多西环素片 江苏润恒制药有限公司 3 CYHS2502968 瑞舒伐他汀钙口崩片 广东万泰科创药业有限公司 3 CYHS2502966 瑞舒伐他汀钙口崩片 广东万泰科创药业有限公司 3 CYHS2502965 注射用硫酸多黏菌素B 国药集团国瑞药业有限公司 3 CYHS2502963 叶酸片 建昌帮药业有限公司 3 CYHS2502979 复方聚乙二醇(3350)电解质口服溶液 湖北午时药业股份有限公司 3 CYHS2502957 中性腹膜透析液(碳酸氢盐-G1.5%) 成都青山利康药业股份有限公司 3 CYHS2502955 中性腹膜透析液(碳酸氢盐-G1.5%) 成都青山利康药业股份有限公司 3 CYHS2502954 中性腹膜透析液(碳酸氢盐-G1.5%) 成都青山利康药业股份有限公司 3 CYHS2502953 中性腹膜透析液(碳酸氢盐-G2.5%) 成都青山利康药业股份有限公司 3 CYHS2502952 中性腹膜透析液(碳酸氢盐-G2.5%) 成都青山利康药业股份有限公司 3 CYHS2502951 中性腹膜透析液(碳酸氢盐-G2.5%) 成都青山利康药业股份有限公司 3 CYHS2502950 复方磷酸盐颗粒 江苏润恒制药有限公司 3 CYHS2502947 草酸艾司西酞普兰口服溶液 浙江领创优品药业有限公司 3 CYHS2502944 维生素B12注射液 江苏润恒制药有限公司 3 CYHS2502943 中性低钙腹膜透析液(碳酸氢盐-G2.5%) 成都青山利康药业股份有限公司 3 CYHS2502930 中性低钙腹膜透析液(碳酸氢盐-G2.5%) 成都青山利康药业股份有限公司 3 CYHS2502929 中性低钙腹膜透析液(碳酸氢盐-G2.5%) 成都青山利康药业股份有限公司 3 CYHS2502928 磷/碳酸氢钠血滤置换液(4mmol/L钾、1.25mmol/L钙) 宁波天益药业科技有限公司 3 CYHS2502922 帕拉米韦注射液 哈尔滨三联药业股份有限公司 3 CYHS2502916 色甘酸钠滴眼液 苏州乐珠制药有限公司 3 CYHS2502936 帕拉米韦氯化钠注射液 哈尔滨三联药业股份有限公司 4 CYHS2503015 帕拉米韦氯化钠注射液 哈尔滨三联药业股份有限公司 4 CYHS2503014 注射用磷酸特地唑胺 安徽省先锋制药有限公司 4 CYHS2503008 阿达帕林凝胶 东阳祥昇医药科技有限公司 4 CYHS2503007 盐酸曲唑酮缓释片 合肥力成药业有限公司 4 CYHS2503001 双氯芬酸钠盐酸利多卡因注射液 四川健林药业有限责任公司 4 CYHS2502999 阿法骨化醇滴剂 石家庄科仁医药科技有限公司 4 CYHS2502998 聚乙烯醇滴眼液 北京汇恩兰德制药有限公司 4 CYHS2502981 氧(液态) 准格尔旗鼎承气体有限责任公司 4 CYHS2502980 蒙脱石混悬液 浙江百代医药科技有限公司 4 CYHS2502997 左氧氟沙星氯化钠注射液 四川太平洋药业有限责任公司 4 CYHS2502995 洛索洛芬钠贴剂 苏州弘森药业股份有限公司 4 CYHS2502994 洛索洛芬钠贴剂 苏州弘森药业股份有限公司 4 CYHS2502993 骨化三醇软胶囊 江苏万高药业股份有限公司 4 CYHS2502992 聚乙二醇4000散 西安安健药业有限公司 4 CYHS2502990 瑞舒伐他汀依折麦布片(I) 山东新华制药股份有限公司 4 CYHS2502989 氟轻松玻璃体内植入剂 苏州欧康维视生物科技有限公司 4 CYHS2502987 乳果糖口服溶液 浙江震元制药有限公司 4 CYHS2502985 乳果糖口服溶液 浙江震元制药有限公司 4 CYHS2502984 乳果糖口服溶液 浙江震元制药有限公司 4 CYHS2502982 磷酸芦可替尼片 齐鲁制药有限公司 4 CYHS2503012 磷酸芦可替尼片 齐鲁制药有限公司 4 CYHS2503010 磷酸芦可替尼片 齐鲁制药有限公司 4 CYHS2503011 甲磺酸沙非胺片 扬子江药业集团有限公司 4 CYHS2502946 碘佛醇注射液 福安药业集团宁波天衡制药有限公司 4 CYHS2502971 灌注用盐酸氨酮戊酸己酯 江苏联环药业股份有限公司 4 CYHS2502970 伏立康唑干混悬剂 河北嵘霖制药有限公司 4 CYHS2502967 泊那替尼片 成都硕德药业有限公司 4 CYHS2502964 盐酸曲唑酮缓释片 中曦(福建)药业有限公司 4 CYHS2502978 盐酸曲唑酮缓释片 中曦(福建)药业有限公司 4 CYHS2502977 沙库巴曲缬沙坦钠片 江西施美药业股份有限公司 4 CYHS2502976 沙库巴曲缬沙坦钠片 江西施美药业股份有限公司 4 CYHS2502975 沙库巴曲缬沙坦钠片 江西施美药业股份有限公司 4 CYHS2502974 甲磺酸沙非胺片 扬子江药业集团有限公司 4 CYHS2502945 塞来昔布胶囊 吉林亚泰永安堂药业有限公司 4 CYHS2502959 塞来昔布胶囊 吉林亚泰永安堂药业有限公司 4 CYHS2502958 达格列净片 青岛百洋制药有限公司 4 CYHS2502956 美阿沙坦钾片 福建东瑞制药有限公司 4 CYHS2502949 美阿沙坦钾片 福建东瑞制药有限公司 4 CYHS2502948 卡铂注射液 南京泽恒医药技术开发有限公司 4 CYHS2502942 替普瑞酮胶囊 广东迈德珐医药科技有限公司 4 CYHS2502941 巴瑞替尼片 江苏万高药业股份有限公司 4 CYHS2502940 巴瑞替尼片 江苏万高药业股份有限公司 4 CYHS2502939 瑞维那新吸入溶液 复星医药(徐州)有限公司 4 CYHS2502938 瑞维那新吸入溶液 遂成药业股份有限公司 4 CYHS2502937 艾普拉唑肠溶片 广东君康药业有限公司 4 CYHS2502961 沙库巴曲缬沙坦钠片 国药集团致君(深圳)坪山制药有限公司 4 CYHS2502960 巴瑞替尼片 浙江华海药业股份有限公司 4 CYHS2502962 阿达帕林凝胶 河北三禾实创生物科技有限公司 4 CYHS2502934 甲钴胺片 天津柏海药业有限责任公司 4 CYHS2502933 盐酸伐昔洛韦片 浙江浙北药业有限公司 4 CYHS2502932 非奈利酮片 重庆莱美药业股份有限公司 4 CYHS2502931 苯磺酸左氨氯地平片 山西汾河制药有限公司 4 CYHS2502927 苯磺酸左氨氯地平片 山西汾河制药有限公司 4 CYHS2502926 非诺贝特片(III) 深圳格莱恩生物医药科技有限公司 4 CYHS2502925 乙酰半胱氨酸颗粒 武汉远大弘元股份有限公司 4 CYHS2502924 溴芬酸钠滴眼液 盈科瑞(珠海金湾)制药有限公司 4 CYHS2502923 注射用氨苄西林钠舒巴坦钠 山东安信制药有限公司 4 CYHS2502921 注射用氨苄西林钠舒巴坦钠 山东安信制药有限公司 4 CYHS2502920 注射用氨苄西林钠舒巴坦钠 山东安信制药有限公司 4 CYHS2502919 门冬氨酸钾镁注射液 裕松源药业有限公司 4 CYHS2502918 洛索洛芬钠凝胶贴膏 浙江恒研医药科技有限公司 4 CYHS2502917 蒙脱石散 重庆康刻尔制药股份有限公司 4 CYHS2502935 注射用硫酸艾沙康唑 石药集团欧意药业有限公司 4 CYHS2502915 沙库巴曲缬沙坦钠片 苏州第三制药厂有限责任公司 4 CYHS2502914 沙库巴曲缬沙坦钠片 苏州第三制药厂有限责任公司 4 CYHS2502913 奥利司他胶囊 湖南本草制药有限责任公司 4 CYHS2502912 奥利司他胶囊 湖南本草制药有限责任公司 4 CYHS2502911 乙酰半胱氨酸注射液 重庆康刻尔制药股份有限公司 4 CYHS2502910 达格列净二甲双胍缓释片(III) 重庆博腾药业有限公司 4 CYHS2502909 达格列净二甲双胍缓释片(II) 重庆博腾药业有限公司 4 CYHS2502908 达格列净二甲双胍缓释片(I) 重庆博腾药业有限公司 4 CYHS2502907 低钙腹膜透析液(乳酸盐-G4.25%) 辰欣药业股份有限公司 4 CYHS2502906 贝伐珠单抗眼内注射液 珠海亿胜生物制药有限公司 3.2 CXSS2500082 司美格鲁肽注射液 惠升生物制药股份有限公司 3.3 CXSS2500084 司美格鲁肽注射液 惠升生物制药股份有限公司 3.3 CXSS2500083 瑞卢戈利片 山东朗诺制药有限公司 3 CYHL2500147 异硫蓝注射液 康哲(湖南)制药有限公司 3 CYHL2500146 盐酸羟甲唑啉滴眼液 北京汇恩兰德制药有限公司 3 CYHL2500145 甲磺酸酚妥拉明滴眼液 浙江视方极医药科技有限公司 3 CYHL2500143 呫诺美林曲司氯铵胶囊 江苏恩华药业股份有限公司 3 CYHL2500142 呫诺美林曲司氯铵胶囊 江苏恩华药业股份有限公司 3 CYHL2500141 呫诺美林曲司氯铵胶囊 江苏恩华药业股份有限公司 3 CYHL2500140 茚达特罗格隆溴铵吸入粉雾剂 山东京卫制药有限公司 4 CYHL2500144 冻干人用狂犬病疫苗(人二倍体细胞) 成都康华生物制品股份有限公司 3.3 CXSL2500692 QL2302注射液 齐鲁制药有限公司 3.3 CXSL2500693 进口申请 药品名称 企业 注册分类 受理号 塞普替尼片 Eli Lilly Nederland B.V. 5.1 JXHS2500087 塞普替尼片 Eli Lilly Nederland B.V. 5.1 JXHS2500086 塞普替尼片 Eli Lilly Nederland B.V. 5.1 JXHS2500085 塞普替尼片 Eli Lilly Nederland B.V. 5.1 JXHS2500084 艾沙妥昔单抗注射液(皮下注射) Sanofi Winthrop Industrie 2.1 JXSS2500108 乙磺酸LY4066434片 Eli Lilly and Company 1 JXHL2500216 乙磺酸LY4066434片 Eli Lilly and Company 1 JXHL2500215 乙磺酸LY4066434片 Eli Lilly and Company 1 JXHL2500214 Icotrokinra片 Janssen Research & Development, LLC 1 JXHL2500213 Rilzabrutinib片 Sanofi-Aventis Recherche & Developpement 2.4 JXHL2500217 马立巴韦干混悬剂 Takeda Pharmaceuticals U.S.A., Inc. 2.4;2.2 JXHL2500212 马立巴韦干混悬剂 Takeda Pharmaceuticals U.S.A., Inc. 2.4;2.2 JXHL2500211 AZD0486 AstraZeneca AB 1 JXSL2500154 AZD0486 AstraZeneca AB 1 JXSL2500153 AZD0486 AstraZeneca AB 1 JXSL2500152 AZD0486 AstraZeneca AB 1 JXSL2500151 AZD0486 AstraZeneca AB 1 JXSL2500150 BCD-261注射液 SPH-BIOCAD (HK) LIMITED 1 JXSL2500149 MEDI5752 AstraZeneca AB 1 JXSL2500148 Lunsekimig注射液 Sanofi-Aventis Recherche & Developpement 1 JXSL2500146 Lunsekimig注射液 Sanofi-Aventis Recherche & Developpement 1 JXSL2500145 注射用SAR446523 Sanofi-Aventis Recherche & Developpement 1 JXSL2500144 注射用替奈普酶 Boehringer Ingelheim International GmbH 2.2 JXSL2500155 DS-1062a AstraZeneca AB 2.2 JXSL2500147 中药相关申请 药品名称 企业 注册分类 受理号 小儿胆青双解颗粒 海南葫芦娃药业集团股份有限公司 1.1 CXZL2500065 苏黄止咳胶囊 杨凌科森生物制药有限责任公司 4 CYZS2500009 注：绿色字体部分为潜在首仿品种； 不包含原料药、医用氧、注射用水、氯化钠或葡萄糖注射液等申请，不包含再注册、一次性进口、技术转移、复审申请。