Tobramycin

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。

MIRAMAR, Fla., May 15, 2025 (GLOBE NEWSWIRE) -- HCW Biologics Inc. (the “Company” or “HCW Biologics”) (NASDAQ: HCWB), a clinical-stage biopharmaceutical company focused on discovering and developing novel immunotherapies to lengthen health span by disrupting the link between inflammation and age-related diseases, today reported financial results and recent business highlights for its first quarter ended March 31, 2025. On May 15, 2025, the Company closed an equity offering with gross proceeds of $5.0 million with a single institutional investor. Dr. Hing Wong, Founder and CEO, stated, “We are pleased to have completed a successful $5.0 million equity offering in a difficult market without using a highly structured deal. This funding will be used to open clinical sites for our Phase 1 clinical trial to evaluate HCW9302 in an autoimmune disorder.” Dr. Wong continued, “Our new round of financing will provide funding for critical studies to complete the research package for our business development campaign to identify a licensing partner to commercialize our Immune-Cell Engagers, including T-Cell Engagers, which we created using our TRBC drug discovery and development platform.” Dr. Wong explained the Company’s financing strategy, stating, “We have over 50 compounds that we have created and own. We are continually assessing our portfolio of molecules to identify strong candidates to develop and commercialize through licensing or other business development transactions. We plan to ramp up our business development efforts in the second half of 2025. One of our compounds that is ready to commercialize is HCW9206, a clinical-stage molecule. It is a promising revolutionary reagent to replace anti-CD3/anti-CD28/IL-2-based approaches to streamline and lower the costs of CAR-T manufacturing. Equally important, we believe that HCW9206 can improve the functional activities and persistence of CAR-Ts following adoptive transfer, a goal that has not been achieved for the last decade.” Business Highlights Business Development Transactions On May 13, 2025, the Company delivered its technology report to WY Biotech in accordance with the terms of the WY Biotech exclusive worldwide licensing agreement to use and apply HCW11-006 for in vivo applications. HCW11-006 is a preclinical drug built with our second-generation discovery and development platform -- the TRBC platform. WY Biotech has 30-days due diligence to study this report, after which the Company expects to recognize revenue for a $7.0 million upfront licensing fee. Financing Transactions On May 15, 2025, the Company completed a $5.0 million offering of an aggregate of 671,140 units at a purchase price of $7.45 per unit priced at-the-market under Nasdaq rules. Each unit consisted of one share of Common Stock or one Pre-Funded Warrants to purchase one share of Common Stock, with two warrants, each of which can be exercised for one share of Common Stock for $7.45 per share. In addition, the Company entered into a privately negotiated agreement with the holder of certain existing outstanding warrants to purchase up to 167,925 shares of common stock (the “Existing Warrants”) to reduce the exercise price of such Existing Warrants from $41.20 per share to $7.45 per share. On May 13, 2025, the Company received a compliance letter from the Nasdaq Panel to confirm that the Company has regained compliance with the bid price requirement in Listing Rule 5550(a)(2), the public float requirement in Listing Rule 5550(a)(4), and the market value of publicly held shares requirement in Listing Rule 5550(a)(5), as required by the Nasdaq Panel decision of April 8, 2025, as amended. The Company remains subject to the remaining terms of the Panel’s April 8, 2025, decision to provide an extension to the compliance period for other Listing Rules. The Company must be in compliance with all Listing Rules by June 16, 2025. Clinical Development Results On January 28, 2025, the Company received clearance of its IND from the FDA to initiate a first-in-human Phase 1 dose escalation clinical trial to evaluate one of its lead drug candidates, HCW9302, in patients with moderate-to-severe alopecia areata, a common autoimmune disease in humans that currently has no curative FDA approved treatments. This will be a multi-site, Company-sponsored trial that is expected to be initiated in the third quarter of 2025. The Company is launching the commercialization of its clinical-stage molecule, HCW9206. Positive results of studies presented by the Company’s research collaborator Dr. Harris Goldstein’s laboratory at the Albert Einstein College of Medicine, Bronx, New York, at the 2025 Annual Meeting of American Association of Immunologists (AAI 2025), Honolulu, HI. The results of these studies represent an alternative novel strategy for CAR-T cell production with the advantage of generating a large population of CAR-Ts with a stem cell-like memory T cell phenotype, which should enhance the persistence of CAR-Ts in patients. We believe that this strategy will likely improve long-term survival of disease-specific CAR-Ts following adoptive transfer and enable sustained suppression of malignancies, chronic infections and autoimmune diseases, and lower the cost of CAR-T manufacturing. Also, we believe that it provides the Company with an in-road opportunity to participate in the development of “in-vivo CAR-T manufacturing technology,” a highly promising emergent field. First Quarter 2025 Financial Results Revenues: Revenues for the first quarters ended March 31, 2024 and 2025 were $1.1 million and $5,065, respectively. Revenues in both periods were derived exclusively from the sale of licensed molecules to the Company’s licensee, Wugen. The licensed molecules are one of the components used by Wugen in manufacturing their immunotherapeutic products. Research and development (R&D) expenses: R&D expenses for the first quarters ended March 31, 2024 and 2025 were $2.1 million and $1.5 million, respectively, a decrease of $644,573, or 30%. R&D expenses were comparatively lower in the reporting period of the first quarter of 2025 primarily due to a decline in manufacturing and material and preclinical expenses, but all expense categories were comparatively lower in the first quarter of 2025 when compared to the first quarter of 2024. General and administrative (G&A) expenses: G&A expenses for the first quarters ended March 31, 2024 and 2025 were $1.6 million and $2.2 million, respectively, an increase of $661,505, or 42%. The increase was primarily due to the waiver of performance bonuses of $293,159 in the aggregate in the first quarter of 2024, which were earned by officers of the Company in prior periods. Expenses increased by $273,059 as a result of accretion of a fixed bonus that will be due if the Secured Notes are repaid on the Maturity Date. Subsequent to the end of the first quarter of 2025, $6.6 million of the outstanding principal for these Secured Notes elected to convert to equity and a portion of the Company’s shares in Wugen common stock. Other increases in expenses were related to insurance costs and professional services, such as auditing services as well as tax and accounting advisors. Legal expenses: Legal expenses, net represent the legal fees that the Company incurred for an Arbitration. On July 13, 2024, the parties entered into a Settlement Agreement and General Release, and the Arbitration and related Complaint were dismissed on December 24, 2024. In the first quarter of 2024, while the Company was preparing for the hearings which took place in May 2024, the Company incurred $4.4 million of legal fees. In January 2025, the Company received a $2.0 million insurance reimbursement that was paid directly to the law firm involved in representing Dr. Hing C. Wong, the Company’s Founder and Chief Executive Officer, in the Arbitration. The Company is engaged in discussions with the law firms involved with this matter to arrange a reasonable payment plan with respect to those legal fees. Net loss: Net loss for the first quarters ended March 31, 2024 and 2025 was $7.5 million and $2.2 million, respectively. Financial Guidance As of March 31, 2025, the Company believes that substantial doubt exists regarding its ability to continue as a going concern for at least 12 months from the issuance date of the audited financial statements, without additional funding or financial support. We considered future elements of our financing plan that were probable and likely to be implemented within the next year to determine if financing activities currently underway are sufficient to mitigate the substantial doubt in our going concern analysis. We have had some early success in completing key elements of our multi-step financing plan, however, we cannot be assured that we will continue to have success with all of the elements of our plan. About HCW Biologics HCW Biologics Inc. (NASDAQ: HCWB) is a clinical-stage biopharmaceutical company developing proprietary immunotherapies to treat diseases promoted by chronic inflammation, especially age-related and senescence-associated diseases. The Company’s immunotherapeutics represent a new class of drug that it believes have the potential to fundamentally change the treatment of cancer and many other diseases and conditions that are promoted by chronic inflammation — and in doing so, improve patients’ quality of life and possibly extend longevity. Chronic inflammation, including inflammaging, is believed to be a significant contributing factor to the cause for senescence-associated diseases and conditions that diminish healthspan, including many types of cancer, autoimmune diseases, and neurodegenerative diseases, as well as indications that impact quality-of-life that are not life-threatening. The Company’s lead product candidate, HCW9302, was developed using the Company’s legacy TOBI™ (Tissue factOr-Based fusIon) platform. The Company has created another drug discovery technology, the TRBC platform, which is not based on Tissue Factor. The TRBC platform has the capability to construct immunotherapeutics that not only activate and target immune responses but are also equipped with receptors that specifically target cancerous or infected cells. This platform is such a versatile scaffold that it enables the creation of multiple classes of immunotherapeutic compounds: Class I: Multi-Functional Immune Cell Stimulators; Class II: Second-Generation Immune Checkpoint Inhibitors; Class III: Multi-Specific Targeting Fusions and Enhanced Immune Cell Engagers. These novel immunotherapeutics can be used to treat a wide range of disease indications, including oncology, autoimmune diseases, and improving quality of life conditions. The Company has constructed over 50 molecules using the TRBC platform, including HCW11-002, HCW11-018 and HCW11-027. Further preclinical evaluation studies are currently being conducted for these three molecules the Company has selected based on promising early data. The Company has two licensing programs in which it has licensed exclusive rights for some of its proprietary molecules. See the Company Pipeline at https://hcwbiologics.com/pipeline/ Forward Looking Statements Statements in this press release contain “forward-looking statements” that are subject to substantial risks and uncertainties. These statements are made under the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements contained in this press release may be identified by the use of words such as “anticipate,” “expect,” “believe,” “will,” “may,” “should,” “estimate,” “project,” “outlook,” “forecast” or other similar words and include: the Company’s ability to develop new immunotherapeutic treatments for non-oncology or oncology indications; timing of initiation of studies for age-related diseases; the Company’s ability to continue as a going concern and that after considering the elements of the Company’s financing plan that were probable to occur within a year of the date of issuance, the Company concluded that substantial doubt was not alleviated in its going concern analysis; the Company’s cash runway; the Company’s expectations regarding future purchases of licensed molecules by Wugen; the Company’s ability to license its preclinical molecules; the initiation of patient enrollment for a clinical trial to evaluate HCW9302; the Company’s future capital-raising plans and ability to continue with clinical development efforts until they are achieved, if at all; and Company’s ability to pay legal fees incurred in connection with the arbitration with ImmunityBio and its affiliates. Forward-looking statements are based on the Company’s current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. Factors that could cause actual results to differ include, but are not limited to, the risks and uncertainties that are described in the section titled “Risk Factors” in the annual report on Form 10-K filed with the United States Securities and Exchange Commission (the “SEC”) on March 28, 2025 and in other filings filed from time to time with the SEC. Forward-looking statements contained in this press release are made as of this date, and the Company undertakes no duty to update such information except as required under applicable law. Company Contact: Rebecca Byam CFO HCW Biologics Inc. rebeccabyam@hcwbiologics.com