Hydromorphone Hydrochloride

精彩内容近日，人福医药发布了2023年业绩，公司的营业收入首次突破240亿元，研发投入超过15亿元，双双创出新高。作为神经系统药物龙头企业，人福医药2023年该类药物大卖超85亿，五大产品市场份额飞升，成绩亮眼。近几年公司创新转型不断提速，2024年一季度公司拿下了首款按古代经典名方目录管理的中药复方制剂芍药甘草颗粒，目前有20款新药加速推进临床，36个仿制药新品冲刺上市。营业收入首破240亿，研发投入再涨36%人福医药2023年的营业收入达245.25亿元，为公司上市以来的新高，净利润达21.34亿元。被誉为“麻醉一哥”的人福医药，公司的麻醉药产品营收继续保持快速增长，2023年实现销售收入约67亿元，同比增长约16%，其中非手术科室增速亮眼，实现销售收入约20.3亿元，同比增长约39%。公司表示，面对新的发展机遇和挑战，坚持“做医药细分市场领导者”的发展战略，通过“聚焦、创新、国际化”三大战略路径，持续巩固和提升核心竞争力，不断增强可持续发展能力。预计2024年公司的营业收入可达到260亿元以上，产品综合毛利率在45%以上。图1：人福医药的研发投入情况（单位：亿元）来源：公司年报目前人福医药已在神经系统用药、甾体激素类药物、维吾尔民族药等细分领域形成领导地位，同时有序开展创新药、仿制药的研发，不断丰富管线储备尽显长期增长活力。据公司年报数据显示，2021年人福医药的研发投入合计突破10亿元，2023年高达15.41亿元，增长率为35.92%，是近五年增速最高的一年。不吝啬的付出一定会迎来大丰收，近几年公司不断有新品获批上市，公司的市场竞争力得到了快速提升。神经系统用药大卖超85亿，5大产品份额飞升图2：人福医药的神经系统用药营收情况（单位：亿元）来源：公司年报神经系统用药是人福医药的拳头领域，从公司近五年的年报数据来看，公司该类药物的营业收入保持着高速增长态势，近五年均有双位数增长，2023年创出新高达到85.29亿元。米内网数据显示，2023年在重点省市公立医院终端，宜昌人福药业已成为了神经系统药物市场TOP1企业，是市场份额唯一超过10%的企业。表1：2023年宜昌人福药业的神经系统药物在各亚类市场的情况来源：米内网重点省市公立医院药品终端竞争格局目前，人福医药有6款畅销产品在神经系统药物三个亚类市场名列前茅。公司的注射用盐酸瑞芬太尼稳坐麻醉剂TOP1品牌宝座，2023年市场份额上涨了1.73%；盐酸阿芬太尼注射液品牌排名上升了3位，市场份额也有所上涨。公司的盐酸氢吗啡酮注射液和盐酸纳布啡注射液稳守止痛药TOP5、TOP6品牌，2023年市场份额分别上涨了1.59%和0.64%。公司的1类新药注射用苯磺酸瑞马唑仑排名上升了4位，为精神安定药TOP14品牌，市场份额上涨了0.63%。拓展新适应症有利扩大产品的使用范围，更大地满足临床需求，助力公司进一步提升市场竞争力。2023年11月，人福医药的盐酸纳布啡注射液新适应症“术后镇痛”获批上市；2024年2月，公司的注射用盐酸瑞芬太尼新适应症“重症监护患者机械通气时的镇痛”获批上市；2024年3月，公司的1类新药注射用磷丙泊酚二钠新适应症“用于成人重症监护患者的镇静”以及“用于成人全身麻醉的诱导和维持”获批临床。2024年开局大丰收！20个新药、36个仿制药加速冲刺米内网数据显示，2023年人福医药获批上市的新产品有15个（不含新增适应症），均为化学药，涉及8个大类（12个亚类），公司的拳头大类神经系统药物占了4个。盐酸氢吗啡酮缓释片为国内首仿，枸橼酸托法替布缓释片为公司首款免疫抑制剂，注射用米卡芬净钠为公司首款全身用抗真菌药，非布司他片为公司首款抗痛风制剂。表2：2024年至今人福医药获批的新产品（按批文日期统计）来源：米内网中国申报进度（MED）数据库2024年一季度人福医药收获满满，公司首款按古代经典名方目录管理的中药复方制剂获批，人福医药成为了芍药甘草颗粒首家获批企业。此外，恩扎卢胺软胶囊成为公司首款上市的内分泌治疗用药，为公司成功开拓了新市场。表3：2021年至今人福医药及子公司报产在审的产品来源：米内网中国申报进度（MED）数据库2021年至今人福医药及子公司申报上市并在审评审批中的产品有36个，涉及10个大类（21个亚类），拳头大类神经系统药物（6个亚类）占了10个产品。目前国内市场上市暂无布洛氢可酮片、酒石酸托特罗定缓释胶囊、奥卡西平口服混悬液、利斯的明透皮贴剂、盐酸他喷他多片、萘普生钠软胶囊、屈螺酮炔雌醇片的国产仿制药获批，人福医药将参与这7个产品的国内首仿争夺。此外，人福医药目前暂无止吐药和止恶心药上市，若公司的注射用福沙匹坦双葡甲胺顺利获批，将成为公司在该亚类市场的首款药物，值得期待。表4：人福医药部分在I期以上临床阶段的重磅新药（不含新增适应症）注：部分终止临床的新药暂不纳入统计来源：公司年报、米内网中国临床试验数据库人福医药近几年不断加码新药研发，化学药、生物药、中成药均有布局，目前有20款新药正在积极推进临床研究，其中2款已在III期临床阶段，离报产仅一步之遥。氨酚氢可酮缓释片为改良新药，在今年3月启动了治疗中重度疼痛的III期临床。此外，中药1.1类新药复方薏薢颗粒在今年2月启动了痛风非急性期高尿酸血症（湿浊瘀阻证）的II期临床，改良新药HZ-J001乳膏也在今年3月启动了特应性皮炎的I期临床试验。制剂出海大卖超20亿，ANDA文号达220多个人福医药坚持实施国际化战略，整合集团国际化资源，形成全球研发、注册、生产、销售的医药全价值链能力，呈现出“走出去、引进来”协同发展、国际市场与国内市场双循环的发展格局。公司面向全球医药市场进行产业布局，海外业务现已覆盖了欧美成熟市场以及南美、东南亚、中亚、西非、东非等新兴市场，公司国际化体系已形成并初具规模。表5：人福医药2023年至今获批的ANDA文号（含暂定批准）来源：公司公告据公司公告统计，2023年人福医药新获得的ANDA文号有5个。截至目前，人福医药各子公司已累计获得220多个FDA批准的ANDA文号，稳守制剂出海第一梯队。据年报数据显示，人福医药的美国仿制药业务2023年实现销售收入约20.30亿元，较上年同期增长约14%。资料来源：米内网数据库、公司年报等注：米内网重点省市公立医院化学药终端竞争格局数据库是以20+省市，近700家样本省市公立医院的化学药采购数据为基础，对化学药全品类进行连续监测的样本省市样本医院数据库；上述销售额以产品在终端的平均零售价计算。数据统计截至4月3日，如有疏漏，欢迎指正！本文为原创稿件，转载请注明来源和作者，否则将追究侵权责任。投稿及报料请发邮件到872470254@qq.com稿件要求详询米内微信首页菜单栏商务及内容合作可联系QQ：412539092【分享、点赞、在看】点一点不失联哦

- Enrollment completed in Phase 1b/2a clinical trial of AJ201 for spinal and bulbar muscular atrophy; topline data expected in second quarter of 2024 - - Presented positive BAER-101 preclinical data at American Epilepsy Society (AES) and American Society for Experimental Neurotherapeutics (ASENT) Annual Meetings and in publication Drug Development Research - - Final agreement reached with FDA on study design and analysis approach for Phase 3 safety study of IV tramadol – MIAMI, March 18, 2024 (GLOBE NEWSWIRE) -- Avenue Therapeutics, Inc. (Nasdaq: ATXI) (“Avenue” or the “Company”), a specialty pharmaceutical company focused on the development and commercialization of therapies for the treatment of neurologic diseases, today reported financial results and recent corporate highlights for the year ended December 31, 2023. “We made considerable progress across our pipeline of differentiated neurologic therapies in 2023," said Alexandra MacLean, M.D., Chief Executive Officer of Avenue. “Avenue demonstrated tremendous execution capabilities with our lead clinical program AJ201, a potential first-in-class treatment for spinal and bulbar muscular atrophy (SBMA), also known as Kennedy’s Disease. Within nine months of acquiring the rights to AJ201 in March 2023, we dosed the first patient in the Phase 1b/2a clinical trial, and we completed trial enrollment of 25 SBMA patients across six sites in the U.S. We remain on track to report topline data for AJ201 in the second quarter of 2024, an incredibly exciting milestone for both the Company and patients suffering from SBMA, a debilitating rare neuromuscular disorder with no approved treatments in the U.S. Additionally, we have progressed BAER-101 for the treatment of epilepsy by presenting preclinical data from a translational animal model in multiple peer-reviewed forums. We have also advanced IV tramadol, reaching final agreement with the U.S. Food and Drug Administration (FDA) on the safety study and statistical analysis approach for the final Phase 3 study. Pending additional financing, we look forward to progressing BAER-101 and IV tramadol for patients facing great unmet need. We look forward to another productive year in 2024 as we continue to make significant strides across our clinical pipeline and advance our mission of providing impactful therapies to patients suffering from neurologic diseases.” Recent Corporate Highlights: AJ201 (Nrf1 and Nrf2 activator, androgen receptor degradation enhancer for SBMA) In January 2024, Avenue completed enrollment in the Phase 1b/2a clinical trial of AJ201 for the treatment of SBMA. The 12-week, multicenter, randomized, double-blind Phase 1b/2a clinical trial of AJ201 enrolled 25 patients randomly assigned to AJ201 (600 mg/day) or placebo. The primary endpoint of the study is to assess safety and tolerability of AJ201 in subjects with clinically and genetically defined SBMA. Topline data for the Phase 1b/2a study are anticipated in the second quarter of 2024. More information about this study can be found at ClinicalTrials.gov (Identifier: NCT05517603). BAER-101 (GABAA α2/3 positive allosteric modulator) Avenue presented preclinical results for BAER-101, a potentially best-in-class selective GABAA α2,3 positive allosteric modulator, in three scientific peer-reviewed settings, including the American Epilepsy Society (AES) Annual Meeting in December 2023, the publication Drug Development Research in February 2024 and the American Society for Experimental Neurotherapeutics (ASENT) Annual Meeting in March 2024. The in vivo data showcase BAER-101’s ability to significantly suppress seizures using the SynapCell’s Genetic Absence Epilepsy Rat from Strasbourg (“GAERS”) model of epilepsy. BAER-101 fully suppressed seizure activity in the GAERS model with a minimal effective dose of 0.3 mg/kg, PO, and the effect was fast in onset and stable throughout the duration of testing. The data also demonstrated BAER-101’s ability to selectively target GABAA α2 and α3 subtypes more than α1 and α5, potentially improving anti-convulsant and anxiolytic activity while minimizing the risk of tolerance and abuse associated with existing treatments in this drug class. Subject to obtaining the necessary financing, which could be provided through a strategic partnership, Avenue plans to initiate a Phase 2a clinical trial of BAER-101 to further study its anti-seizure properties in patients with common or rare epilepsies. IV Tramadol In January 2024, Avenue reached final agreement with the FDA on the safety study protocol and statistical analysis approach for the Phase 3 study for intravenous (“IV”) tramadol, which is in development for the treatment of acute post-operative pain in a medically supervised setting. The final non-inferiority study is designed to assess the theoretical risk of opioid-induced respiratory depression related to opioid stacking on IV tramadol compared to IV morphine. The study will randomize approximately 300 post bunionectomy patients to IV tramadol or IV morphine for pain relief administered during a 48-hour post-operative period. Patients will have access to IV hydromorphone, a Schedule II opioid, for rescue of breakthrough pain. Pending additional financing, Avenue aims to initiate the Phase 3 safety study as soon as feasible. The Company believes that the study can be completed and submitted to the FDA within 12 months of the study’s initiation. General Corporate In March 2024, Avenue announced that the Nasdaq Hearings Panel granted the Company’s request for an extension to evidence compliance with all applicable criteria for continued listing on The Nasdaq Capital Market, including the $1.00 bid price and $2.5 million stockholders’ equity requirements, through May 20, 2024. 2023 Financial Results: Cash Position: As of December 31, 2023, cash and cash equivalents totaled $1.8 million, compared to $6.7 million at December 31, 2022, a decrease of $4.9 million. In January 2024, the Company completed a warrant inducement transaction resulting in $5.0 million in gross proceeds.R&D Expenses: Research and development expenses for the full year 2023 were $6.1 million, compared to $2.7 million in 2022. Additionally, there was $4.2 million in expense for the acquisition of the AJ201 license in 2023.G&A Expenses: General and administrative expenses for the full year 2023 were $4.2 million, compared to $5.3 million in 2022.Net Loss: Net loss for the full year 2023 was $10.5 million, or $0.98 per share, compared to a net loss of $3.6 million, or $1.63 per share, in 2022. About Avenue TherapeuticsAvenue Therapeutics, Inc. (Nasdaq: ATXI) is a specialty pharmaceutical company focused on the development and commercialization of therapies for the treatment of neurologic diseases. It is currently developing three assets including AJ201, a first-in-class asset for spinal and bulbar muscular atrophy, BAER-101, an oral small molecule selective GABAA α2, α3 receptor positive allosteric modulator for CNS diseases, and IV tramadol, which is in Phase 3 clinical development for the management of acute postoperative pain in adults in a medically supervised healthcare setting. Avenue is headquartered in Miami, FL and was founded by Fortress Biotech, Inc. (Nasdaq: FBIO). For more information, visit www.avenuetx.com. Forward-Looking StatementsThis press release contains predictive or “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. All statements other than statements of current or historical fact contained in this press release, including statements that express our intentions, plans, objectives, beliefs, expectations, strategies, predictions or any other statements relating to our future activities or other future events or conditions are forward-looking statements. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “will,” “should,” “would” and similar expressions are intended to identify forward-looking statements. These statements are based on current expectations, estimates and projections made by management about our business, our industry and other conditions affecting our financial condition, results of operations or business prospects. These statements are not guarantees of future performance and involve risks, uncertainties and assumptions that are difficult to predict. Therefore, actual outcomes and results may differ materially from what is expressed or forecasted in, or implied by, the forward-looking statements due to numerous risks and uncertainties. Factors that could cause such outcomes and results to differ include, but are not limited to, risks and uncertainties arising from: the fact that we currently have no drug products for sale and that our success is dependent on our product candidates receiving regulatory approval and being successfully commercialized; the possibility that serious adverse or unacceptable side effects are identified during the development of our current or future product candidates, such that we would need to abandon or limit development of some of our product candidates; our ability to successfully develop, partner, or commercialize any of our current or future product candidates including AJ201, IV tramadol, and BAER-101; the substantial doubt raised about our ability to continue as a going concern, which may hinder our ability to obtain future financing; the significant losses we have incurred since inception and our expectation that we will continue to incur losses for the foreseeable future; our need for substantial additional funding, which may not be available to us on acceptable terms, or at all, which unavailability of could force us to delay, reduce or eliminate our product development programs or commercialization efforts; our reliance on third parties for several aspects of our operations; our reliance on clinical data and results obtained by third parties that could ultimately prove to be inaccurate, or unreliable, or unacceptable to regulatory authorities; the possibility that we may not receive regulatory approval for any or all of our product candidates, or that such approval may be significantly delayed due to scientific or regulatory reasons; the fact that even if one or more of our product candidates receives regulatory approval, they will remain subject to substantial regulatory scrutiny; the effects of current and future laws and regulations relating to fraud and abuse, false claims, transparency, health information privacy and security, and other healthcare laws and regulations; the effects of competition for our product candidates and the potential for new products to emerge that provide different or better therapeutic alternatives for our targeted indications; the possibility that the government or third-party payors fail to provide adequate coverage and payment rates for our product candidates or any future products; our ability to establish sales and marketing capabilities or to enter into agreements with third parties to market and sell our product candidates; our exposure to potential product liability claims; related to the protection of our intellectual property and our potential inability to maintain sufficient patent protection for our technology and products; our ability to maintain compliance with the obligations under our intellectual property licenses and funding arrangements with third parties, without which licenses and arrangements we could lose rights that are important to our business; the fact that Fortress Biotech, Inc. controls a majority of the voting power of our outstanding capital stock and has rights to receive significant share grants annually;; and those risks discussed in our filings which we make with the SEC. Any forward-looking statements speak only as of the date on which they are made, and we undertake no obligation to publicly update or revise any forward-looking statements to reflect events or circumstances that may arise after the date of this press release, except as required by applicable law. Investors should evaluate any statements made by us in light of these important factors. Contact: Jaclyn JaffeAvenue Therapeutics, Inc. (781) 652-4500ir@avenuetx.com AVENUE THERAPEUTICS, INC.Consolidated Balance Sheets($ in thousands, except for share and per share amounts) December 31, December 31, 2023 2022 ASSETS Current assets: Cash and cash equivalents$1,783 $6,708 Prepaid expenses and other current assets 67 137 Total assets$1,850 $6,845 LIABILITIES AND STOCKHOLDERS’ EQUITY Current liabilities: Accounts payable and accrued expenses$287 $949 Accounts payable and accrued expenses - related party 323 21 Warrant liability 586 2,609 Total current liabilities 1,196 3,579 Total liabilities 1,196 3,579 Commitments and Contingencies Stockholders’ equity Preferred stock ($0.0001 par value), 2,000,000 shares authorized Class A Preferred stock, 250,000 shares issued and outstanding as of December 31, 2023 and 2022, respectively — — Common stock ($0.0001 par value) Common shares, 75,000,000 shares authorized and 25,597,622 shares issued and outstanding as of December 31, 2023; and 20,000,000 shares authorized and 4,773,841 shares issued and outstanding as of December 31, 2022 3 — Additional paid-in capital 92,507 84,456 Accumulated deficit (90,928) (80,551)Total stockholders’ equity attributed to the Company 1,582 3,905 Non-controlling interests (928) (639)Total stockholders’ equity 654 3,266 Total liabilities and stockholders’ equity$1,850 $6,845 AVENUE THERAPEUTICS, INC.Consolidated Statements of Operations($ in thousands, except for share and per share amounts) For the Years Ended December 31, December 31, 2023 2022 Operating expenses Research and development$6,131 $2,698 Research and development - licenses acquired 4,230 — General and administrative 4,179 5,345 Loss from operations (14,540) (8,043) Interest income (126) (20)Financing costs – warrant liabilities 332 1,160 Change in fair value of warrant liabilities (4,258) (5,580)Net loss$(10,488) $(3,603) Net loss attributable to non-controlling interests (111) (51)Net loss attributable to common stockholders$(10,377) $(3,552) Net loss per common share attributable to common stockholders, basic and diluted$(0.98) $(1.63) Weighted average number of common shares outstanding, basic and diluted 10,591,636 2,185,159