Bevacizumab biosimilar (Bio-Thera Solutions)

GUANGZHOU, China and LONDON, May 27, 2025 /PRNewswire/ -- Bio-Thera Solutions, Ltd (688177:SH), a commercial-stage biopharmaceutical company developing a pipeline of biosimilars and innovative assets and Hikma Pharmaceuticals PLC, along with its wholly owned subsidiary Hikma Pharmaceuticals USA Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved STARJEMZA® (ustekinumab-hmny) Injection, a biosimilar referencing Stelara® (ustekinumab) Injection. STARJEMZA® is Bio-Thera's third FDA approved product. Bio-Thera and Hikma entered into a license and commercialization agreement for STARJEMZA® in August 2021. Under the terms of the agreement, Bio-Thera is responsible for the development and manufacturing of the product. Hikma is responsible for the commercialization of STARJEMZA® in the United States. "The approval of STARJEMZA® is another significant accomplishment for Bio-Thera, establishing Bio-Thera as a premier global biosimilar developer and manufacturer," said Shengfeng Li, CEO at Bio-Thera. "As our third FDA approved biosimilar, STARJEMZA® demonstrates Bio-Thera's commitment to developing more biosimilars, expanding patient access to important therapies." "This approval and our partnership with Bio-Thera enables us to strongly enter the U.S. biosimilar market, building on our well-established position as a top-three domestic provider of sterile injectable medicines to U.S. hospitals, healthcare providers, and patients," said Dr. Bill Larkins, President of Hikma Injectables. "Tapping into the robust ongoing growth of the U.S. biosimilar market is a priority for Hikma. We are eager to use our excellent U.S. commercial capabilities to launch this important product and provide it to the many patients who will benefit from using it." The FDA approval of STARJEMZA®, originally known as BAT2206, was based on a comprehensive analytical, non-clinical, and clinical data package submitted by Bio-Thera to the FDA. Extensive analytical characterization between STARJEMZA® and US and EU Stelara® was conducted on structural, physicochemical, and biological properties to support bio-similarity of STARJEMZA®. A randomized double-blind, single-dose, three-arm, parallel phase I study compared the pharmacokinetics, safety, and immunogenicity of STARJEMZA® with both the US and EU Stelara® in healthy volunteers. A multicenter, randomized, double-blind, parallel-arm, phase III study compared STARJEMZA® with Stelara® for efficacy, safety, and immunogenicity in patients with moderate to severe plaque psoriasis. The totality of the evidence demonstrated that STARJEMZA® has similar efficacy, safety, immunogenicity, and quality as the reference product ustekinumab. About STARJEMZA® (ustekinumab-hmny) Injection STARJEMZA® is a biosimilar to Janssen's Stelara® which is a human monoclonal antibody that inhibits the bioactivity of human IL-12 and IL-23 by preventing shared p40 subunit from binding to the IL-12Rβ1 receptor chain of IL-12 (IL-12Rβ1/β2) and IL-23 (IL-12Rβ1/23R) receptor complexes on the surface of immune cells. IL-12 and IL-23 are involved in inflammatory and immune responses, such as natural killer cell activation, CD4+ T-cell differentiation and following relative cytokines stimulated release. Abnormal regulation of IL-12 and IL-23 have been implicated as important contributors to chronic inflammation, including psoriasis, psoriatic arthritis (PsA), Crohn's disease (CD), and Ulcerative colitis (UC). Neutralizing human IL-12 and IL-23 by STARJEMZA® to prevent the relevant cell signaling in the Th1 or Th17 lineages can effectively block the pathologic processes of these immune disorders. About Bio-Thera Solutions Bio-Thera Solutions, Ltd., a leading innovative, global biopharmaceutical company in Guangzhou, China, is dedicated to researching and developing novel therapeutics for the treatment of cancer, autoimmune, cardiovascular, eye diseases, and other severe unmet medical needs, as well as biosimilars for existing, branded biologics to treat a range of cancer and autoimmune diseases. As a leader in next generation antibody discovery and engineering, the company has advanced multiple candidates into late-stage development, including five approved products: QLETLI® (adalimumab) and BETAGRIN® (bevifibatide citrate) Injection in China, STARJEMZA® in the US, and BAT1806/TOFIDENCE™ (tocilizumab) and AVZIVI® (bevacizumab-tnjn) in the US, a/k/a POBEVCY® in EU and China. In addition, the company has more than 20 promising candidates in clinical trials, focusing on immuno-oncology in the post-PD-1 era and targeted therapies such as antibody-drug conjugates (ADCs). For more information, please visit or follow us on X (@bio_thera_sol) and WeChat (Bio-Thera). About Hikma Pharmaceuticals (LSE: HIK) (NASDAQ Dubai: HIK) (OTC: HKMPY) (rated BBB/stable S&P and BBB-/positive Fitch) Hikma helps put better health within reach every day for millions of people around the world. For more than 45 years, we've been creating high-quality medicines and making them accessible to the people who need them. Headquartered in the UK, we are a global company with a local presence across North America, the Middle East and North Africa (MENA) and Europe, and we use our unique insight and expertise to transform cutting-edge science into innovative solutions that transform people's lives. We're committed to our customers, and the people they care for, and by thinking creatively and acting practically, we provide them with a broad range of branded and non-branded generic medicines. Together, our 9,500 colleagues are helping to shape a healthier world that enriches all our communities. We are a leading licensing partner, and through our venture capital arm, are helping bring innovative health technologies to people around the world. For more information, please visit: Cautionary Note Regarding Forward-Looking Statements This news release contains certain forward-looking statements relating to STARJEMZA® /BAT2206 or the product pipelines in general of Bio-Thera Solutions and Hikma. Readers are strongly cautioned that reliance on any forward-looking statements involves known and unknown risks and uncertainties. The forward-looking statements include, among others, those containing "could," "may," "should," "will," "would," "anticipate," "believe," "plan," "promising," "potentially," or similar expressions. They reflect the company's current views with respect to future events that are based on what the company believes are reasonable assumptions in view of information currently available to Bio-Thera Solutions and Hikma and are not a guarantee of future performance or developments. Actual results and events may differ materially from information contained in the forward-looking statements as a result of a number of factors, including, but not limited to, risks and uncertainties inherent in pharmaceutical research and development, such as the uncertainties of pre-clinical and clinical studies, for example, the development processes could be lengthy and high in vitro affinity may not translate to desired results in vivo or successful clinical studies. Other risks and uncertainties include challenges in obtaining regulatory approvals, manufacturing, marketing, competition, intellectual property, product efficacy or safety, changes in global healthcare situation, changes in the company's financial conditions, and changes to applicable laws and regulations, etc. Forward-looking statements contained herein are made only as of the date of their initial publication. Unless required by laws or regulations, Bio-Thera Solutions and Hikma undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, changes in the company's views or otherwise. 1) STARJEMZA® is a registered trademark of Hikma Pharmaceuticals USA Inc. 2) STELARA® is a registered trademark of Johnson and Johnson 3) QLETLI® is a registered trademark of Bio-Thera Solutions, Ltd. 4) BETAGRIN® is a registered trademark of Bio-Thera Solutions, Ltd. 5) TOFIDENCE™ is a trademark of Organon LLC 6) AVZIVI® is a registered trademark of Sandoz 7) POBEVCY® is a registered trademark of Bio-Thera Solutions, Ltd. Bio-Thera Contacts Bio-Thera Solutions, Ltd.: Bert E. Thomas IV +1.410.627.1734 [email protected] Hikma Pharmaceuticals PLC Susan Ringdal +44 (0)20 7399 2760/ +44 7776 477050 EVP, Strategic Planning and Global Affairs Steven Weiss +1 732 788 8279 US Communications Important Safety Information for STARJEMZA® (ustekinumab-hmny) Injection CONTRAINDICATIONS STARJEMZA is contraindicated in patients with clinically significant hypersensitivity to ustekinumab products or to any of the excipients in STARJEMZA. WARNINGS & PRECAUTIONS Infections - Ustekinumab products may increase the risk of infections and reactivation of latent infections. Serious bacterial, mycobacterial, fungal, and viral infections were observed in patients receiving ustekinumab products. Avoid initiating treatment with STARJEMZA in patients with any clinically important active infection until the infection resolves or is adequately treated. Consider the risks and benefits of treatment prior to initiating use of STARJEMZA in patients with a chronic infection or a history of recurrent infection. Serious infections requiring hospitalization, or otherwise clinically significant infections, reported in clinical trials included the following: Plaque Psoriasis: diverticulitis, cellulitis, pneumonia, appendicitis, cholecystitis, sepsis, osteomyelitis, viral infections, gastroenteritis, and urinary tract infections. Psoriatic arthritis: cholecystitis. Crohn's disease: anal abscess, gastroenteritis, ophthalmic herpes zoster, pneumonia, and listeria meningitis. Ulcerative colitis: gastroenteritis, ophthalmic herpes zoster, pneumonia, and listeriosis. Theoretical Risk for Vulnerability to Particular Infections - Individuals genetically deficient in IL-12/IL-23 are particularly vulnerable to disseminated infections from mycobacteria (including nontuberculous, environmental mycobacteria), salmonella (including nontyphi strains), and Bacillus Calmette-Guerin (BCG) vaccinations. Serious infections and fatal outcomes have been reported in such patients. Pre-treatment Evaluation for Tuberculosis - Evaluate patients for tuberculosis infection prior to initiating treatment with STARJEMZA. Avoid administering STARJEMZA to patients with active tuberculosis infection. Malignancies - Ustekinumab products are immunosuppressants and may increase the risk of malignancy. The safety of ustekinumab products has not been evaluated in patients who have a history of malignancy or who have a known malignancy. There have been post-marketing reports of the rapid appearance of multiple cutaneous squamous cell carcinomas in patients receiving ustekinumab products who had pre-existing risk factors for developing non-melanoma skin cancer. Hypersensitivity Reactions - Hypersensitivity reactions, including anaphylaxis and angioedema, have been reported with ustekinumab products. If an anaphylactic or other clinically significant hypersensitivity reaction occurs, institute appropriate therapy and discontinue STARJEMZA. Posterior Reversible Encephalopathy Syndrome (PRES) - Two cases of posterior reversible encephalopathy syndrome (PRES), also known as Reversible Posterior Leukoencephalopathy Syndrome (RPLS), were reported in clinical trials. Cases have also been reported in postmarketing experience in patients with psoriasis, psoriatic arthritis, and Crohn's disease. Clinical presentation included headaches, seizures, confusion, visual disturbances, and imaging changes consistent with PRES a few days to several months after ustekinumab product initiation. A few cases reported latency of a year or longer. Patients recovered with supportive care following withdrawal of ustekinumab products. Monitor all patients treated with STARJEMZA for signs and symptoms of PRES. If PRES is suspected, promptly administer appropriate treatment and discontinue STARJEMZA. Immunizations - Prior to initiating therapy with STARJEMZA, patients should receive all age-appropriate immunizations as recommended by current immunization guidelines. Patients being treated with STARJEMZA should avoid receiving live vaccines. Avoid administering BCG vaccines during treatment with STARJEMZA or for one year prior to initiating treatment or one year following discontinuation of treatment. Caution is advised when administering live vaccines to household contacts of patients receiving STARJEMZA because of the potential risk for shedding from the household contact and transmission to patient. Non-live vaccinations received during a course of STARJEMZA may not elicit an immune response sufficient to prevent disease. Noninfectious Pneumonia - Cases of interstitial pneumonia, eosinophilic pneumonia, and cryptogenic organizing pneumonia have been reported during post-approval use of ustekinumab products. Clinical presentations included cough, dyspnea, and interstitial infiltrates following one to three doses. Serious outcomes have included respiratory failure and prolonged hospitalization. If diagnosis is confirmed, discontinue STARJEMZA and institute appropriate treatment. ADVERSE REACTIONS Serious adverse reactions associated with STARJEMZA include Infections, Malignancies, Hypersensitivity Reactions, Posterior Reversible Encephalopathy Syndrome (PRES), and Noninfectious Pneumonia. Immunogenicity - Approximately 6 to 12.4% of subjects treated with ustekinumab in plaque psoriasis and psoriatic arthritis clinical trials developed antibodies to ustekinumab, which were generally low-titer. In plaque psoriasis clinical trials, antibodies to ustekinumab were associated with reduced or undetectable serum ustekinumab concentrations and reduced efficacy. In plaque psoriasis trials, the majority of subjects who were positive for antibodies to ustekinumab had neutralizing antibodies. In Crohn's disease and ulcerative colitis clinical trials, 2.9% and 4.6% of subjects, respectively, developed antibodies to ustekinumab when treated with ustekinumab for approximately one year. No apparent association between the development of antibodies to ustekinumab and the development of injection site reactions was seen. Postmarketing Experience - The following adverse reactions have been reported during post-approval use of ustekinumab products: Immune system disorders: Serious hypersensitivity reactions (including anaphylaxis and angioedema), other hypersensitivity reactions (including rash and urticaria). Infections and infestations: Lower respiratory tract infection (including opportunistic fungal infections and tuberculosis). Neurological disorders: Posterior Reversible Encephalopathy Syndrome (PRES). Respiratory, thoracic, and mediastinal disorders: Interstitial pneumonia, eosinophilic pneumonia, and cryptogenic organizing pneumonia. Skin reactions: Pustular psoriasis, erythrodermic psoriasis, hypersensitivity vasculitis. DRUG INTERACTIONS Concomitant Therapies - In plaque psoriasis trials the safety of ustekinumab products in combination with immunosuppressive agents or phototherapy has not been evaluated. In psoriatic arthritis trials, concomitant MTX use did not appear to influence the safety or efficacy of ustekinumab. In Crohn's disease and ulcerative colitis induction trials, immunomodulators (6-MP, AZA, MTX) were used concomitantly in approximately 30% of subjects and corticosteroids were used concomitantly in approximately 40% and 50% of Crohn's disease and ulcerative colitis subjects, respectively. Use of these concomitant therapies did not appear to influence the overall safety or efficacy of ustekinumab. CYP450 Substrates - The formation of CYP450 enzymes can be suppressed by increased levels of certain cytokines (e.g., IL-1, IL-6, TNFα, IFN) during chronic inflammation. Thus, use of ustekinumab products, antagonists of IL-12 and IL-23, could normalize the formation of CYP450 enzymes. A CYP-mediated drug interaction effect was not observed in subjects with Crohn's disease. Allergen Immunotherapy - Ustekinumab products have not been evaluated in patients who have undergone allergy immunotherapy. Ustekinumab products may decrease the protective effect of allergen immunotherapy (decrease tolerance) which may increase the risk of an allergic reaction to a dose of allergen immunotherapy. Therefore, caution should be exercised in patients receiving or who have received allergen immunotherapy, particularly for anaphylaxis. INDICATIONS AND USAGE STARJEMZA is indicated for the treatment of: adults and pediatric patients 6 years of age and older with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy. adults and pediatric patients 6 years of age and older with active psoriatic arthritis. adult patients with moderately to severely active Crohn's disease. adult patients with moderately to severely active ulcerative colitis. For additional Important Safety Information, please refer to the Package Insert for full prescribing information, available on . To report SUSPECTED ADVERSE REACTIONS, contact Hikma Pharmaceuticals USA Inc. at 1-877-845-0689 or FDA at 1-800 FDA-1088 or . For Product Inquiry call 1-877-845-0689. Manufactured by: Bio-Thera Solutions, Ltd. 155 Yaotianhe Street, Huangpu District, Guangzhou, Guangdong, China 511356 Distributed By: Hikma Pharmaceuticals USA Inc. Berkeley Heights, NJ 07922 USA HK-3278-v1 SOURCE Hikma Pharmaceuticals USA Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

本周药品注册受理数据，分门别类呈现，一目了然。(5.19-5.25）新药上市申请药品名称企业注册分类受理号苯甲酸安达替尼胶囊鞍石药业(宁波)有限责任公司1CXHS2500055苯甲酸安达替尼胶囊鞍石药业(宁波)有限责任公司1CXHS2500054注射用康替唑胺钠上海盟科药业股份有限公司1CXHS2500053环孢素眼用凝胶兆科(广州)眼科药物有限公司2.2CXHS2500052GR2001注射液重庆智翔金泰生物制药股份有限公司1CXSS2500051瑞基奥仑赛注射液上海药明巨诺生物科技有限公司2.2CXSS2500053注射用芦康沙妥珠单抗四川科伦博泰生物医药股份有限公司2.2CXSS2500052新药临床申请药品名称企业注册分类受理号VB19055片浙江扬厉医药技术有限公司1CXHL2500509VB19055片浙江扬厉医药技术有限公司1CXHL2500508VB19055片浙江扬厉医药技术有限公司1CXHL2500507VB19055片浙江扬厉医药技术有限公司1CXHL2500506BGB-45035片百济神州(苏州)生物科技有限公司1CXHL2500503MDI-1228_mesylate滴鼻液迈英诺医药科技(珠海)有限公司1CXHL2500502MDI-1228_mesylate滴鼻液迈英诺医药科技(珠海)有限公司1CXHL2500501注射用DYX116江苏德源药业股份有限公司1CXHL2500500注射用DYX116江苏德源药业股份有限公司1CXHL2500499HW241045片武汉人福创新药物研发中心有限公司1CXHL2500498HW241045片武汉人福创新药物研发中心有限公司1CXHL2500497HS-10516胶囊江苏豪森药业集团有限公司1CXHL2500493HS-10516胶囊江苏豪森药业集团有限公司1CXHL2500492YL-13027片上海璎黎药业有限公司1CXHL2500491YL-13027片上海璎黎药业有限公司1CXHL2500490DC411151胶囊杭州民生药业股份有限公司1CXHL2500487DC411151胶囊杭州民生药业股份有限公司1CXHL2500486HKG-456海南元盈医药科技有限公司2.2CXHL2500505盐酸奥洛他定口服液海南万玮制药有限公司2.2CXHL2500504CB345杭州成邦医药科技有限公司2.2CXHL2500495CB345杭州成邦医药科技有限公司2.2CXHL2500494QLM2012齐鲁制药有限公司2.2CXHL2500489QLM2012齐鲁制药有限公司2.2CXHL2500488TAP-1504凝胶上海泽德曼医药科技有限公司2.3CXHL2500496氟[18F]阿洛夫定注射液江苏华益科技有限公司2.4CXHL2500485酮洛芬凝胶贴膏湖南派格兰药业有限公司3CYHL2500097丙戊酸钠缓释微片山东达因海洋生物制药股份有限公司3CYHL2500095丙戊酸钠缓释微片山东达因海洋生物制药股份有限公司3CYHL2500094茚达特罗格隆溴铵吸入粉雾剂四川普锐特药业有限公司4CYHL250009624价肺炎球菌结合疫苗苏州聚微生物科技有限公司1.4CXSL2500410冻干b型流感嗜血杆菌结合疫苗华兰生物疫苗股份有限公司3.3CXSL2500411IBI363信达生物制药(苏州)有限公司1CXSL2500421IBI363信达生物制药(苏州)有限公司1CXSL2500420SSGJ-706注射液沈阳三生制药有限责任公司1CXSL2500419SSGJ-706注射液沈阳三生制药有限责任公司1CXSL2500418SNUG01神济昌华(北京)生物科技有限公司1CXSL2500415斯乐韦米单抗注射液重庆智翔金泰生物制药股份有限公司1CXSL2500414SHR-7782注射液苏州盛迪亚生物医药有限公司1CXSL2500416宫血间充质干细胞注射液浙江生创精准医疗科技有限公司1CXSL2500412注射用TJ101一线医药(杭州)有限公司1CXSL2500413人牙囊间充质干细胞注射液成都世联康健生物科技有限公司1CXSL2500408注射用LB4330上海健信生物医药科技有限公司1CXSL2500407注射用重组抗PD1/TIM3人源化双特异抗体上海健信生物医药科技有限公司1CXSL2500404注射用SHR-A2102苏州盛迪亚生物医药有限公司1CXSL2500403注射用MHB042C明慧医药(杭州)有限公司1CXSL2500409GC012F注射液亘喜生物科技(上海)有限公司1CXSL2500399注射用BC3195无锡智康弘义生物科技有限公司1CXSL2500398SCTB14注射液神州细胞工程有限公司1CXSL2500396SCTB14注射液神州细胞工程有限公司1CXSL2500395SM17单克隆抗体注射液(皮下注射)杏联药业(苏州)有限公司1CXSL2500394CM512注射液康诺亚生物医药科技(成都)有限公司1CXSL2500397CM512注射液康诺亚生物医药科技(成都)有限公司1CXSL2500391SHR-8068注射液苏州盛迪亚生物医药有限公司2.2CXSL2500401阿得贝利单抗注射液上海盛迪医药有限公司2.2CXSL2500400贝伐珠单抗注射液苏州盛迪亚生物医药有限公司2.2CXSL2500405阿得贝利单抗注射液上海盛迪医药有限公司2.2CXSL2500402注射用SIM0692山东先声生物制药有限公司3.3CXSL2500417仿制药申请药品名称企业注册分类受理号铝碳酸镁混悬液浙江领创优品药业有限公司3CYHS2501860盐酸普罗帕酮注射液湖北天圣药业有限公司3CYHS2501853复合磷酸氢钾注射液济南康桥医药科技有限公司3CYHS2501851布瑞哌唑口腔崩解片杭州和康药业有限公司3CYHS2501864布瑞哌唑口腔崩解片杭州和康药业有限公司3CYHS2501863布瑞哌唑口腔崩解片杭州和康药业有限公司3CYHS2501862盐酸维拉帕米注射液安徽美来药业股份有限公司3CYHS2501844氯化钾口服溶液安徽四环科宝制药有限公司3CYHS2501842氯化钾口服溶液安徽四环科宝制药有限公司3CYHS2501841氯化钾口服溶液安徽四环科宝制药有限公司3CYHS2501840地氯雷他定口服溶液江苏天士力帝益药业有限公司3CYHS2501850地氯雷他定口服溶液江苏天士力帝益药业有限公司3CYHS2501849比拉斯汀口服溶液宁波美诺华天康药业有限公司3CYHS2501831盐酸考来维仑片浙江京新药业股份有限公司3CYHS2501828美沙拉秦肠溶缓释胶囊甘李药业山东有限公司3CYHS2501835酮咯酸氨丁三醇注射液浙江华海药业股份有限公司3CYHS2501839盐酸溴己新口服溶液合肥远志医药科技开发有限公司3CYHS2501814乙酰半胱氨酸片浙江金华康恩贝生物制药有限公司3CYHS2501825布美他尼注射液成都康泰源医药科技有限责任公司3CYHS2501821对乙酰氨基酚布洛芬片福建海西新药创制股份有限公司3CYHS2501818硫酸阿托品注射液湖北亨迪药业股份有限公司3CYHS2501817氯化钙注射液山西普恒制药有限公司3CYHS2501810卡泊三醇倍他米松软膏杭州领业医药科技有限公司4CYHS2501873奥美沙坦酯氨氯地平片山西同达药业有限公司4CYHS2501872达格列净片天方药业有限公司4CYHS2501871达格列净片天方药业有限公司4CYHS2501870阿达帕林过氧苯甲酰凝胶珠海莱奇生物科技有限公司4CYHS2501869盐酸伐地那非片浙江诺得药业有限公司4CYHS2501852莫匹罗星软膏苏州第四制药厂有限公司4CYHS2501859蒙脱石混悬液哈尔滨誉衡制药有限公司4CYHS2501858阿司匹林肠溶片浙江百代医药科技有限公司4CYHS2501857多巴丝肼片河南福森药业有限公司4CYHS2501856磷霉素氨丁三醇颗粒辽宁海一制药有限公司4CYHS2501855口服用苯丁酸甘油酯河北仁合益康药业有限公司4CYHS2501854布瑞哌唑片上海现代制药股份有限公司4CYHS2501868阿达帕林过氧苯甲酰凝胶珠海市汇通达医药有限公司4CYHS2501867阿达帕林过氧苯甲酰凝胶珠海市汇通达医药有限公司4CYHS2501866阿达帕林过氧苯甲酰凝胶珠海市汇通达医药有限公司4CYHS2501865氧(液态)玉得气体有限责任公司4CYHS2501861沙格列汀片江苏万高药业股份有限公司4CYHS2501847妥布霉素滴眼液海南斯达制药有限公司4CYHS2501846艾拉莫德片浙江恒研医药科技有限公司4CYHS2501845注射用头孢他啶阿维巴坦钠/氯化钠注射液浙江国镜药业有限公司4CYHS2501843乳果糖口服溶液武汉安成医药有限责任公司4CYHS2501838艾拉莫德片安徽瑞旗药业有限公司4CYHS2501848维立西呱片常州制药厂有限公司4CYHS2501834维立西呱片常州制药厂有限公司4CYHS2501833维立西呱片常州制药厂有限公司4CYHS2501832熊去氧胆酸口服混悬液成都倍特得诺药业有限公司4CYHS2501830苯磺酸左氨氯地平片合肥九研医药科技开发有限公司4CYHS2501829二十碳五烯酸乙酯软胶囊安徽威尔曼制药有限公司4CYHS2501837硫酸氨基葡萄糖胶囊山东司邦得制药有限公司4CYHS2501836注射用甲泼尼龙琥珀酸钠舒美奇成都生物科技有限公司4CYHS2501816注射用甲泼尼龙琥珀酸钠舒美奇成都生物科技有限公司4CYHS2501815硫酸氨基葡萄糖胶囊广东安诺药业股份有限公司4CYHS2501813注射用美罗培南浙江海翔药业股份有限公司4CYHS2501827注射用美罗培南浙江海翔药业股份有限公司4CYHS2501826注射用盐酸地尔硫䓬湖北莱康医疗技术有限公司4CYHS2501824注射用盐酸地尔硫䓬湖北莱康医疗技术有限公司4CYHS2501823熊去氧胆酸胶囊天津怀仁制药有限公司4CYHS2501822玛巴洛沙韦片常州制药厂有限公司4CYHS2501820玛巴洛沙韦片常州制药厂有限公司4CYHS2501819富马酸伏诺拉生片山东裕欣药业有限公司4CYHS2501812富马酸伏诺拉生片山东裕欣药业有限公司4CYHS2501811进口申请药品名称企业注册分类受理号氘可来昔替尼片Bristol-Myers Squibb Pharma EEIG2.4JXHS2500059度普利尤单抗注射液Sanofi Winthrop Industrie3.1JXSS2500063度普利尤单抗注射液Sanofi Winthrop Industrie3.1JXSS2500062AZD5305AstraZeneca AB1JXHL2500119AZD5305AstraZeneca AB1JXHL2500118AZD5305AstraZeneca AB1JXHL2500117AZD5305AstraZeneca AB1JXHL2500116MC2-01乳膏MC2 Therapeutics Pty Ltd5.1JXHL2500120注射用FelzartamabBiogen Idec Research Limited1JXSL2500082GHZ339注射液Novartis Pharma AG1JXSL2500081Depemokimab注射液GlaxoSmithKline Research & Development Limited1JXSL2500080注射用FelzartamabBiogen Idec Research Limited1JXSL2500079AZD1613注射液AstraZeneca AB1JXSL2500076Tremelimumab注射液MedImmune LLC2.2JXSL2500078度伐利尤单抗注射液MedImmune LLC2.2JXSL2500077中药相关申请药品名称企业注册分类受理号通利肠溶胶囊荣昌制药(淄博)有限公司1.1CXZS2500022完带颗粒四川光大制药有限公司3.1CXZS2500021紫英颗粒广东方盛融科药业有限公司1.1CXZL2500030固本清肺颗粒深圳市中医院1.1CXZL2500031鼻渊通窍颗粒健民药业集团股份有限公司4CYZL2500001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。