ABI-H2158

今年如何办B证？持有人还能立什么项目？点击上图，即刻报名大会参与大会！3月26日，中检院发布《国家药品抽检年报（2023）》。《年报》显示，2023年国家药品抽检共完成132个品种18762批次制剂产品与中药饮片的抽检任务，包括化学药品74个、中成药43个、中药饮片9个、生物制品6个，其中国家基本药物品种48个。样品来源涉及1114家药品生产、2528家经营企业和511家使用单位，由中检院等47个承检机构负责检验样品，检出136批次不符合规定产品。一、药品制剂抽检共抽检制剂产品16604批次，经检验，73批次产品不符合规定。抽检的123个品种中，全部样品符合规定的制剂品种有106个，共13765批次。其中，化学药品有65个品种9238批次，中成药有35个品种4400批次，生物制品有6个品种127批次。1.化学药品2023年国家药品抽检共抽检化学药品74个品种（化学药52个、抗生素12个、生化药10个）10893批次。经检验，不符合规定44批次。2023年国家药品抽检化学药品共涉及13个剂型，共有6个剂型存在不符合规定样品。其中注射剂（2批次）、片剂（3批次）、颗粒剂（33批次）、软膏剂（4批次）、眼用制剂（1批次）、口服溶液剂（1批次）。抽检结果提示，生产企业应严格原料入厂检验，优化生产工艺管理与关键质量参数控制，重点关注灭菌工艺、原辅料投料量、分装的稳定性，对检查项目及检验指标反映的问题予以深入研究；经营企业应强化药品储存、运输过程管理，提升温湿度监控体系，重点关注需要阴凉、冷藏储存等特殊条件保存的药品。图 | 化学药品各剂型检验信息示意图 2.中成药共抽检中成药43个品种5584批次，涉及11个剂型，在生产、经营、使用、互联网环节各抽取样品841批次、4619批次、48批次、76批次。经检验，不符合规定29批次，均在经营环节检出，占对应环节全部样品的0.6%。2023年国家药品抽检中成药涉及11个剂型，共有4个剂型存在不符合规定产品，其中片剂（16批次）、丸剂（7批次）、贴膏剂（4批次）和糖浆剂（2批次）。抽检结果提示，生产企业应强化主体责任意识，严把原药材质量关，从源头把控药材质量，严格投料药材入厂检验，加强内部质量控制和生产管理水平，优化生产关键质量参数控制；经营企业应完善药品运输、储存过程管理。3.生物制品共抽检生物制品6个品种127批次，其中生产、经营、使用环节分别抽取50批次、70批次、7批次。其中涉及治疗类品种 5个，预防类品种1个。合格率为100%。图 | 生物制品抽检品种信息示意图 4.国家基本药物共抽检国家基本药物（不含中药饮片）39个品种6140批次，在生产、经营、使用、互联网环节各抽取样品1570批次、4120批次、332批次、118批次。经检验，不符合规定13批次，分别在生产、经营环节检出不符合规定产品1批次和12批次，涉及2个剂型。图 | 国家基本药物各抽样环节检验信息示意图5.国家药品集中采购中选品种共抽检国家药品集中采购中选品种20个品种3435批次，在生产、经营、使用、互联网环节各抽取样品887批次、2201批次、290批次、57批次。经检验，集中采购涉及样品均符合规定。抽检结果显示，国家药品集中采购中选品种整体质量状况较好。图 | 2023年国家药品集中采购中选品种各环节抽样情况6.进口药品（不含进口中药材）2023年，国家药品抽检共抽检进口药品309批次，涉及9个剂型，其中生产环节11批次、经营环节257批次、使用环节41批次。经检验，所检项目均符合规定，合格率为100%。图 | 进口药品各剂型检验信息示意图二、中药饮片专项抽检               2023年共抽检9个中药饮片品种2158批次（其中配方颗粒234批，饮片1924批），重点针对可能存在的染色、增重、掺伪或掺假、不规范种植等质量问题，开展检验和探索性研究。经检验，符合规定2095批次，不符合规定63批次。同时，2023年中药材质量监测，共监测9个品种251批次样品，其中，药品生产企业224批次，市场集散地或种植集中区27批次。所有样品按照不同品种特点，针对相应项目进行了研究性检验，主要针对掺杂掺伪、加工炮制规范、农药残留等问题开展。图 | 2023年中药饮片专项抽检结果 抽检及监测结果显示，中药饮片生产企业应提升全程质量控制意识，首先加强药材溯源、供应商资质审核管理，重点关注原料掺伪、有害物质残留等问题，做好原料管控，其次生产前做好工艺验证，生产中严格遵照炮制规范要求执行，第三把好检测及贮存环节管理关口，保证饮片质量的真实稳定。 附表（篇幅有限，详细信息请参看中检院官网）   来源：国家药品监督管理局官网整理：推荐阅读点击下面图片，来聊聊细分风口：高端仿制药怎么走↓复杂注射剂、高端纳米制剂、脂质体药物、缓释微球药物……仿制药突破内卷有门路吗？

Four candidates planned to be in clinical development in 2024 with interim data from two studies anticipated by year end Clinical development timelines accelerated for ABI-5366; now anticipating interim data from Phase 1a available in 3Q2024, initiation of Phase 1b in individuals with recurrent genital herpes by end of 2024 and interim Phase 1b data available in 1H2025 Gilead Sciences, Inc. partnership supports advancement and strengthening of antiviral pipeline targeting serious viral diseases SOUTH SAN FRANCISCO, Calif., March 28, 2024 (GLOBE NEWSWIRE) -- Assembly Biosciences, Inc. (Nasdaq: ASMB), a biotechnology company developing innovative therapeutics targeting serious viral diseases, today reported financial results and recent highlights for the fourth quarter and year ended December 31, 2023. “Our progress in 2023 demonstrated our capacity to drive our expanded antiviral pipeline forward and our commitment to individuals suffering from life-impacting viral diseases,” said Jason Okazaki, chief executive officer and president of Assembly Bio. “With our long-term partnership in place with Gilead and the addition of Dr. Anuj Gaggar to our management team as CMO, we are well-positioned to make critical progress clinically across multiple programs in 2024 and look forward to sharing preliminary data on 5366 and 4334 later this year.” Fourth Quarter 2023 and Recent Highlights Entered a long-term partnership with Gilead to advance discovery and development of novel antiviral therapies Strengthened the leadership team with the naming of Anuj Gaggar, MD, PhD, as chief medical officer Filed a clinical trial application for ABI-5366 to support initiation of Phase 1a/1b clinical studies Anticipated Milestones and Events By mid-year 2024: ABI-5366, a long-acting herpes simplex virus (HSV) helicase-primase inhibitor targeting recurrent genital herpes, is expected to enter a Phase 1a/1b study ABI-4334, a next-generation, highly potent capsid assembly modulator, is anticipated to enter a Phase 1b study in individuals with chronic hepatitis B virus infection Q3 2024: Interim clinical data from the ABI-5366 Phase 1a study portion expected to be available By the end of 2024: Interim clinical data from the ABI-4334 Phase 1b study expected to be available The Phase 1b portion of the ABI-5366 study, in individuals with recurrent genital herpes, is anticipated to be underway Two additional candidates are anticipated to enter the clinic: ABI-1179, a long-acting HSV helicase-primase inhibitor contributed by Gilead under the collaboration between Assembly Bio and Gilead ABI-6250, a small molecule orally-bioavailable hepatitis delta virus entry inhibitor First half 2025: Interim clinical data from the Phase 1b portion of the ABI-5366 study expected to be available Fourth Quarter 2023 and Year End Financial Results Cash, cash equivalents and marketable securities were $130.2 million as of December 31, 2023, compared to $46.2 million as of September 30, 2023, and $91.6 million as of the year ended December 31, 2022. The company’s cash position is projected to fund operations into the second half of 2025. Revenues from collaborative research were $7.2 million for the year ended December 31, 2023. There was no revenue recognized for the same period in 2022. Revenue for the year ended December 31, 2023, consists of $4.4 million recognized under the collaboration with Gilead and the remaining deferred revenue balance of $2.7 million under the collaboration agreement with BeiGene following Assembly Bio’s decision to discontinue further development of ABI-H3733 in conjunction with entering into the Gilead collaboration, following the previous prioritization of ABI-4334 over ABI-H3733. Research and development expenses were $48.9 million for the year ended December 31, 2023, compared to $70.0 million in 2022. The decrease is due to completion of the clinical trials for ABI-H3733 and ABI-4334, discontinued development of vebicorvir and ABI-H2158, and decreases in employee and contractor-related expenses. General and administrative expenses were $22.9 million for the year ended December 31, 2023, compared to $24.1 million in 2022. The decrease is due to overall cost-saving initiatives. Net loss attributable to common stockholders was $61.2 million, or $13.38 per basic and diluted share, for the year ended December 31, 2023, compared to $93.1 million, or $23.08 per basic and diluted share in 2022. The investigational products and investigational product candidates referenced here have not been approved anywhere globally, and their safety and efficacy have not been established. About Assembly Biosciences Assembly Biosciences is a biotechnology company dedicated to the development of innovative small-molecule therapeutics designed to change the path of serious viral diseases and improve the lives of patients worldwide. Led by an accomplished team of leaders in virologic drug development, Assembly Bio is committed to improving outcomes for patients struggling with the serious, chronic impacts of herpesvirus, hepatitis B virus (HBV) and hepatitis delta virus (HDV) infections. For more information, visit assemblybio.com. Forward-Looking Statements The information in this press release contains forward-looking statements that are subject to certain risks and uncertainties that could cause actual results to materially differ. These risks and uncertainties include: Assembly Bio’s ability to realize the potential benefits of its collaboration with Gilead Sciences, Inc., including all financial aspects of the collaboration and equity investments; Assembly Bio’s ability to initiate and complete clinical studies involving its therapeutic product candidates, including studies contemplated by Assembly Bio’s collaboration with Gilead, in the currently anticipated timeframes or at all; safety and efficacy data from clinical or nonclinical studies may not warrant further development of Assembly Bio’s product candidates; clinical and nonclinical data presented at conferences may not differentiate Assembly Bio’s product candidates from other companies’ candidates; results of nonclinical studies may not be representative of disease behavior in a clinical setting and may not be predictive of the outcomes of clinical studies; and other risks identified from time to time in Assembly Bio’s reports filed with the U.S. Securities and Exchange Commission (the SEC). You are urged to consider statements that include the words may, will, would, could, should, might, believes, hopes, estimates, projects, potential, expects, plans, anticipates, intends, continues, forecast, designed, goal or the negative of those words or other comparable words to be uncertain and forward-looking. Assembly Bio intends such forward-looking statements to be covered by the safe harbor provisions contained in Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. More information about Assembly Bio’s risks and uncertainties are more fully detailed under the heading “Risk Factors” in Assembly Bio’s filings with the SEC, including its most recent Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. Except as required by law, Assembly Bio assumes no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise. Contacts Investor and Corporate: Shannon Ryan SVP, Investor Relations, Corporate Affairs and Alliance Management (415) 738-2992 investor_relations@assemblybio.com Media: Sam Brown Inc.  Hannah Hurdle  (805) 338-4752  ASMBMedia@sambrown.com ASSEMBLY BIOSCIENCES, INC. CONSOLIDATED BALANCE SHEETS (In thousands except for share amounts and par value) As of December 31, 2023 2022 ASSETS Current assets Cash and cash equivalents $ 19,841 $ 52,418 Marketable securities 110,406 39,192 Accounts receivable from collaboration 43 944 Prepaid expenses and other current assets 3,497 4,413 Total current assets 133,787 96,967 Property and equipment, net 385 743 Operating lease right-of-use assets 2,339 3,195 Other assets 312 889 Total assets $ 136,823 $ 101,794 LIABILITIES AND STOCKHOLDERS' EQUITY Current liabilities Accounts payable $ 461 $ 2,493 Accrued research and development expenses 885 3,122 Other accrued expenses 5,744 7,317 Deferred revenue - short-term ($30,915 and $− to a related party) 30,915 — Operating lease liabilities - short-term 1,220 3,364 Total current liabilities 39,225 16,296 Deferred revenue - long-term ($55,379 and $− to a related party) 55,379 2,733 Operating lease liabilities - long-term 1,122 101 Total liabilities 95,726 19,130 Commitments and contingencies Stockholders' equity Preferred stock, $0.001 par value; 5,000,000 shares authorized; no shares issued or outstanding — — Common stock, $0.001 par value; 150,000,000 shares authorized as of December 31, 2023 and December 31, 2022; 5,482,752 and 4,074,552 shares issued and outstanding as of December 31, 2023 and December 31, 2022, respectively 5 4 Additional paid-in capital 826,921 807,983 Accumulated other comprehensive loss (81 ) (803 ) Accumulated deficit (785,748 ) (724,520 ) Total stockholders' equity 41,097 82,664 Total liabilities and stockholders' equity $ 136,823 $ 101,794 ASSEMBLY BIOSCIENCES, INC. CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (In thousands except for share and per share amounts) Year Ended December 31, 2023 2022 Collaboration revenue ($4,430 and $− from a related party) $ 7,163 $ — Operating expenses Research and development 48,900 69,980 General and administrative 22,909 24,134 Total operating expenses 71,809 94,114 Loss from operations (64,646 ) (94,114 ) Other income Interest and other income, net 3,451 1,022 Total other income 3,451 1,022 Loss before income taxes (61,195 ) (93,092 ) Income tax expense (33 ) — Net loss $ (61,228 ) $ (93,092 ) Other comprehensive loss Unrealized gain (loss) on marketable securities 722 (384 ) Comprehensive loss $ (60,506 ) $ (93,476 ) Net loss per share, basic and diluted $ (13.38 ) $ (23.08 ) Weighted average common shares outstanding, basic and diluted 4,577,371 4,034,105