Obefazimod

点击蓝字关注我们本周，热点不少。首先是审批审批方面，扬子江和Replimune悲欢各不相同，扬子江药业1类新药妥诺达非获NMPA批准上市，而Replimune的溶瘤病毒+PD-1联合疗法被FDA拒绝批准；其次是研发方面，也是有人欢喜有人愁，多个药临床取得阶段成功，比如，可自行给药的阿斯利康纳米抗体Ⅲ期成功，但是罗氏first-in-class抗体Astegolimab的Ⅲ期临床研究却失败了；再次是交易及投融资方面，本周大额投资不多，值得一提的就是，科弈药业BCMA/CD19双靶CAR-T授权出海，总交易额超21亿美元；最后是上市方面，维立志博在港交所正式上市。本周盘点包括审评审批、研发、交易及投融资以及上市四大板块，统计时间为2025.7.21-7.25，包含27条信息。 审评审批NMPA上市批准1、7月25日，NMPA官网显示，扬子江的1类新药盐酸妥诺达非片获批上市，用于勃起功能障碍（ED）。妥诺达非片是一种磷酸二酯酶5（PDE5）抑制剂，国内已有5款原研PDE5抑制剂上市，分别是西地那非（2002/10，辉瑞）、伐地那非（2004/07，GSK/拜耳）、他达拉非（2004/12，礼来）、爱地那非（2021/12，悦康药业）、以及司美那非（2025/7，旺山旺水）。申请2、7月24日，CDE官网显示，艾力斯的三代EGFR-TKI甲磺酸伏美替尼片申报新适应症，用于治疗既往经含铂化疗治疗时或治疗后出现疾病进展，或不耐受含铂化疗，并且经检测确认存在表皮生长因子受体20外显子插入突变（EGFRexon20ins）的局部晚期或转移性非小细胞肺癌（NSCLC）成人患者。伏美替尼于2021年3月获NMPA附条件批准上市。3、7月24日，CDE官网显示，拜耳的1类新药BAY2927088（sevabertinib）申报上市，用于治疗携带HER2（ERBB2）激活突变且既往接受过一种全身性治疗的晚期非小细胞肺癌（NSCLC）成人患者。BAY2927088是拜耳开发的一款口服非共价可逆选择性酪氨酸激酶抑制剂，对携带EGFR和HER2突变（包括HER2exon20插入突变）的肿瘤有抑制活性。4、7月25日，CDE官网显示，康方生物的依沃西单抗新适应症申报上市，联合化疗一线治疗晚期鳞状非小细胞肺癌（sq-NSCLC）。依沃西单抗是康方生物自主研发的、全球首创PD-1/VEGF双特异性肿瘤免疫治疗药物，于2024年5月首次获NMPA批准上市，目前已获批两项适应症。临床批准5、7月22日，CDE官网显示，远大医药的放射性核素偶联药物（RDC）TLX591获批一项前瞻性、随机、对照、开放标签、国际多中心的Ⅲ期临床，拟在中国、美国、澳大利亚、新西兰及欧洲等全球多个国家和地区入组500余名患者，旨在评估TLX591联合标准治疗与仅接受标准治疗相比，在既往接受过雄激素受体通路抑制剂（ARPI）治疗进展的转移性去势抵抗性前列腺癌患者（mCRPC）中的疗效和安全性。6、7月22日，CDE官网显示，正大天晴的TQB2825注射液（皮下注射）获批临床，拟用于CD20阳性血液肿瘤的治疗，包括但不限于弥漫大B细胞淋巴瘤、滤泡性淋巴瘤、套细胞淋巴瘤和边缘区淋巴瘤等。TQB2825是一种全球创新的CD3/CD20双特异性抗体。7、7月23日，CDE官网显示，百济神州的BGB-45035片获批临床，用于治疗类风湿性关节炎。这是继特应性皮炎和结节性痒疹后，BGB-45035获批的第三项临床。BGB-45035是一款靶向白细胞介素1受体相关激酶4（IRAK4）的蛋白降解剂（CDAC）。优先审评8、7月25日，CDE官网显示，第一三共与阿斯利康共同开发的德曲妥珠单抗新适应症拟纳入优先审评，用于HER2阳性乳腺癌患者新辅助治疗。德曲妥珠单抗是采用第一三共的独有技术设计的一款靶向HER2的DXdADC，已在我国获批了4项适应症，其中两项是乳腺癌相关适应症。FDA上市申请9、7月21日，FDA官网显示，BMS的TYK2抑制剂氘可来昔替尼新适应症申报上市，用于治疗活动性银屑病关节炎，PDUFA日期为2026年3月6日。氘可来昔替尼是一款酪氨酸激酶2（TYK2）抑制剂，2022年9月，在美国获批上市，用于成人斑块状银屑病。2023年10月，国内获批上市，用于治疗适合系统治疗或光疗的成年中重度斑块状银屑病患者。10、7月21日，FDA官网显示，强生的Icotrokinra申报上市，用于治疗12岁及以上成人和青少年的中重度斑块状银屑病（PsO）。这是一款全球首创在研靶向口服肽类药物，可选择性阻断白细胞介素-23（IL-23）受体，由Protagonist Therapeutics原研，2017年，强生与Protagonist Therapeutics就开发一代IL-23R药物达成许可和合作协议。11、7月22日，Replimune宣布，收到FDA就RP1联合纳武利尤单抗治疗晚期黑色素瘤的生物制品许可申请（BLA）发出的完整回复函（CRL）。FDA在CRL中表示，IGNYTE研究不是一项充分且对照良好的临床试验，无法提供证明RP1有效性的实质性证据，RP1是一款溶瘤病毒，将其专有的单纯疱疹病毒经过融合蛋白（GALV-GPR-）和GM-CSF的改造和基因武装。临床批准12、7月23日，FDA官网显示，悦康药业子公司悦康科创的YKYY029注射液获批临床，用于治疗高血压。YKYY029注射液是悦康科创和天龙药业自主开发的靶向AGT基因的小干扰核糖核酸（siRNA）药物。快速通道资格13、7月25日，FDA官网显示，劲方医药的口服KRASG12D抑制剂GFH375/VS-7375被授予快速通道资格，用于KRASG12D突变局部晚期或转移性胰腺导管腺癌（PDAC）的一线及后线治疗。GFH375目前已在中国进入Ⅱ期研究；GFH375/VS-7375在美国开展的Ⅰ/Ⅱa期研究由劲方合作伙伴Verastem Oncology于2025年启动推进。研发临床状态14、7月21日，药物临床试验登记与信息公示平台显示，海思科登记了一项多中心、随机、双盲、阳性和安慰剂对照Ⅲ期临床试验，旨在评价HSK21542注射液用于骨科手术术后镇痛的有效性及安全性。该试验拟在国内入组405人，主要终点是给药后不同时间范围内的静息疼痛情况（SPID0-t）。HSK21542是一款强效外周kappa阿片受体（KOR）选择性激动剂。15、7月22日，药物临床试验登记与信息公示平台显示，百济神州基于全面利益/风险评估，主动终止了一项BGB-30813的I期临床试验。BGB-30813是一款DGKζ抑制剂，于2023年6月首次启动I期（NCT05904496/CTR20233404），旨在评估单药治疗或与抗PD-1单克隆抗体替雷利珠单抗联合治疗在晚期或转移性实体瘤患者中的安全性、耐受性、药代动力学、药效学和初步抗肿瘤活性。16、7月22日，ClinicalTrials.gov显示，齐鲁制药启动了一项多中心、随机、双盲、对照Ⅲ期临床（n=602），旨在评估QLS31905联合化疗（白蛋白紫杉醇+吉西他滨）对比安慰剂联合化疗一线治疗CLDN18.2阳性晚期胰腺癌成人患者的有效性和安全性，主要终点是治疗第48个月的无进展生存期（PFS）。QLS31905是齐鲁制药自主研发的一款同时靶向Claudin18.2（CLDN18.2）和CD3的双特异性T细胞衔接器。17、7月23日，药物临床试验登记与信息公示平台官网显示，荣昌生物登记了一项多中心Ⅰ/Ⅱ期临床研究，Ⅰ期旨在评估ADC药物RC278的安全性、耐受性、MTD和/或MAD、RP2D、PK、免疫原性以及初步的抗肿瘤疗效；Ⅱ期旨在评估RC278在RP2D剂量水平下对多个晚期恶性实体瘤的疗效、安全性、PK和免疫原性。该试验计划在国内入组312人。18、7月23日，药物临床试验登记与信息公示平台官网显示，科伦博泰登记了一项评估SKB107治疗晚期实体瘤骨转移受试者的安全性、耐受性、药代动力学、辐射剂量学和有效性的Ⅰ期临床研究（SKB107-Ⅰ-01）。SKB107是一款放射性核素偶联药物（RDC）。临床数据19、7月21日，华东医药公布了子公司中美华东的皮肤外用制剂0.3%罗氟司特乳膏（ZORYVE）治疗中国斑块状银屑病的Ⅲ期研究。结果表明，0.3%罗氟司特乳膏在中国6岁及以上的斑块状银屑病患者中表现出积极的疗效和良好的安全性。20、7月21日，丽珠医药公布了LZM012（XKH004）对比司库奇尤单抗（可善挺）治疗伴或不伴银屑病关节炎的中度至重度斑块型银屑病患者的Ⅲ期研究结果。结果显示：治疗第12周，LZM012组和司库奇尤单抗达到PASI100的患者比例分别为49.5%和40.2%，达到非劣效标准并且达到优效标准。司库奇尤单抗是全球首款获批上市的IL-17A单抗，LZM012是丽珠医药自鑫康合生物引进的一款IL-17A/IL-17F单抗。21、7月21日，罗氏公布了全人源抗ST2单抗Astegolimab治疗慢性阻塞性肺病（COPD）的关键性Ⅲ期ARNASA研究结果。结果显示，在52周的治疗期内，Astegolimab（每2周1次）组患者出现中度和重度COPD恶化的年化发生率（AER）较安慰剂组降低了14.5%，但无统计学意义。2016年1月，基因泰克与安进达成协议，获得该药物的全球独家权益。22、7月21日，阿斯利康公布了奥希替尼联合化疗一线治疗局部晚期或转移性表皮生长因子受体突变（EGFRm）非小细胞肺癌（NSCLC）患者Ⅲ期Flaura2研究结果。结果显示，最终总生存期（OS）分析取得积极结果：奥希替尼联合培美曲塞和铂类化疗相较于奥希替尼单药治疗在关键次要终点OS方面显示出统计学显著和临床意义的改善。23、7月22日，Abivax公布了微小RNA（miRNA）药物Obefazimod（ABX464）治疗溃疡性结肠炎（UC）的两项Ⅲ期研究（ABTECT-1和ABTECT-2）结果。结果显示，两项研究都达到了主要终点。Obefazimod是Abivax开发的一种口服、全球首创（firstinclass）、增强miR-124（一种抗炎miRNA）表达的HIVRNA剪接调节因子。24、7月24日，阿斯利康公布了gefurulimab治疗抗乙酰胆碱受体（AChR）抗体阳性（Ab+）的全身型重症肌无力（gMG）成人患者的Ⅲ期研究结果。结果显示，与安慰剂相比，gefurulimab在第26周时，在重症肌无力日常生活活动能力量表（MG-ADL）总分上显示出具有统计学显著性和临床意义的、相较于基线的改善。Gefurulimab是一种迷你双抗（25kD）。交易及投融资25、7月22日，科弈药业宣布，与ERIGENLLC签署了关于科弈药业自主研发的全球首个并联增强型BCMA/CD19双靶向CAR-T产品KQ-2003的独家海外授权协议。根据协议，科弈药业将获得1500万美元开发里程碑付款，并有资格获得总金额最高达13.2亿美元的研发、注册及商业化阶段里程碑付款，此外，科弈药业还将有望获得最高8亿美元的销售分成。26、7月22日，赛诺菲宣布，收购英国Vicebio。根据协议条款，赛诺菲将以总计11.5亿美元的预付款项收购Vicebio的全部股本，并根据开发和监管里程碑的实现情况支付最高达4.5亿美元的潜在里程碑款项。此次收购为赛诺菲带来了一款针对呼吸道合胞病毒（RSV）和人偏肺病毒（hMPV）的早期联合候选疫苗。上市27、7月25日，维立志博在港交所正式上市，联席保荐人为摩根士丹利、中信证券。本次IPO最终发行定价35港元/股，所得款项净额11.793亿港元。截至目前，维立志博已开发14款候选药物，其中6款已进入临床阶段，正在进行共计10项临床试验。另外，还有8款候选药物处于临床前阶段。END智药研习社近期直播预告来源：CPHI制药在线声明：本文仅代表作者观点，并不代表制药在线立场。本网站内容仅出于传递更多信息之目的。如需转载，请务必注明文章来源和作者。投稿邮箱：Kelly.Xiao@imsinoexpo.com▼更多制药资讯，请关注CPHI制药在线▼点击阅读原文，进入智药研习社~

Abivax Announces Full Exercise of Underwriters’ Option to Purchase Additional ADSs, Bringing Gross Proceeds of Offering to $747.5M (€637.5M) PARIS, France, July 25, 2025 – 08:00 a.m. (CEST) – Abivax SA (Euronext Paris: FR0012333284 – ABVX) (“Abivax” or the “Company”), a clinical-stage biotechnology company focused on developing therapeutics that harness the body’s natural regulatory mechanisms to modulate the immune response in patients with chronic inflammatory diseases, today announces that the underwriters of its offering of 10,156,000 American Depositary Shares (“ADSs”), each representing one ordinary share, €0.01 nominal value per share (each an “Ordinary Share”), of the Company, in the United States (the “Offering”) have exercised in full their option to purchase 1,523,400 additional ADSs (the “Additional ADSs”), each representing one Ordinary Share. The Additional ADSs will be delivered concurrently with the closing of the Offering, which is expected to occur on July 28, 2025. Following the exercise in full of the option, the total number of ADSs issued in the Offering will amount to 11,679,400 ADSs, resulting in gross proceeds for the Company of approximately $747.5 million (€637.5 million) and estimated net proceeds, after deducting underwriting commissions and estimated offering expenses payable by the Company, of approximately $700.3 million (€597.2 million). The Company intends to apply the net proceeds from the sale of the Additional ADSs on a pro rata basis to the use of proceeds identified with respect to the base offering. The offering price of $64.00 per Additional ADS (corresponding to €54.58 per additional Ordinary Share) based on the exchange rate of €1.00 = $1.1726 as published by the European Central Bank on July 23, 2025), is equal to the volume weighted average price of the Ordinary Shares on the regulated market of Euronext in Paris over the last 3 trading sessions preceding the pricing of the Offering (i.e., July 21 to July 23, 2025), plus a premium of 21.0% and has been determined by the Chief Executive Officer upon subdelegation from the Board of Directors pursuant to the 22nd resolution of the Company’s combined shareholders’ meeting held on June 6, 2025. The Company’s ADSs are listed on the Nasdaq Global Market under the ticker symbol “ABVX.” The Company’s Ordinary Shares are listed on the regulated market of Euronext in Paris under the symbol “ABVX.” In accordance with Article 6 of delegated regulation EU 2016/1052 of March 8, 2016, Leerink Partners, acting as the stabilizing agent on its own behalf and on behalf of the other underwriters, reported that no stabilization activities had been carried out and the stabilization period is now closed. An automatic shelf registration statement on Form F-3 (including a prospectus) relating to the Company’s securities was filed with the Securities and Exchange Commission (the “SEC”) on July 23, 2025 and became effective upon filing. The Company has also filed with the SEC a final prospectus supplement (and accompanying prospectus) relating to and describing the terms of the Offering (the “Final Prospectus Supplement”). These documents may be obtained free of charge by visiting EDGAR on the SEC’s website at www.sec.gov. Alternatively, a copy of the Final Prospectus Supplement (and accompanying prospectus) may be obtained from Leerink Partners LLC, Attention: Syndicate Department, 53 State Street, 40th Floor, Boston, MA 02109, by telephone at (800) 808-7525, ext. 6105, or by email at syndicate@leerink.com; or from Piper Sandler & Co., 350 North 5th Street, Suite 1300, Minneapolis, MN 55402, Attention: Prospectus Department, by telephone at (800) 747-3924 or by email at prospectus@psc.com; or from Guggenheim Securities, LLC, Attention: Equity Syndicate Department, 330 Madison Avenue, 8th Floor, New York, NY 10017, by telephone at (212) 518-9544 or by email at GSEquityProspectusDelivery@guggenheimpartners.com. *** About Abivax Abivax is a clinical-stage biotechnology company focused on developing therapeutics that harness the body’s natural regulatory mechanisms to stabilize the immune response in patients with chronic inflammatory diseases. Based in France and the United States, Abivax’s lead drug candidate, obefazimod (ABX464), is in Phase 3 clinical trials for the treatment of moderately to severely active ulcerative colitis. Contacts: Abivax Investor RelationsPatrick Malloypatrick.malloy@abivax.com+1 847 987 4878 *** Forward-Looking Statements This press release contains forward-looking statements, forecasts and estimates, including those relating to the Company’s business and financial objectives. Words such as “design,” “intend,” “expect,” “forward,” “future,” “can,” “could,” “may,” “might,” “potential,” “plan,” “project,” “should,” “will” and variations of such words and similar expressions are intended to identify forward-looking statements. These forward-looking statements include statements regarding the expected closing of the Offering, the anticipated use of net proceeds therefrom, as well as other statements that are not historical fact. Although Abivax’s management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks, contingencies and uncertainties, many of which are difficult to predict and generally beyond the control of Abivax, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. A description of these risks, contingencies and uncertainties can be found in the documents filed by the Company with the AMF pursuant to its legal obligations, including its universal registration document (Document d’Enregistrement Universel), and in the Company’s Annual Report on Form 20-F filed with the U.S. Securities and Exchange Commission on March 24, 2025 under the caption “Risk Factors.” These risks, contingencies and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug candidate, as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates and the availability of funding sufficient for the Company’s foreseeable and unforeseeable operating expenses and capital expenditure requirements. Special consideration should be given to the potential hurdles of clinical and pharmaceutical development including further assessment by the Company and regulatory agencies and IRBs/ethics committees following the assessment of preclinical, pharmacokinetic, carcinogenicity, toxicity, CMC and clinical data. Furthermore, these forward-looking statements, forecasts and estimates are made only as of the date of this press release. Readers are cautioned not to place undue reliance on these forward-looking statements. Abivax disclaims any obligation to update these forward-looking statements, forecasts or estimates to reflect any subsequent changes that the Company becomes aware of, except as required by law. Information about pharmaceutical products (including products currently in development) that is included in this press release is not intended to constitute an advertisement. This press release does not give and should not be treated as giving investment advice. It has no connection with the investment objectives, financial situation or specific needs of any recipient. It should not be regarded by recipients as a substitute for exercise of their own judgment. All opinions expressed herein are subject to change without notice. Disclaimers This press release does not constitute an offer to sell or the solicitation of an offer to buy any securities of the Company, nor shall there be any sale of such securities, in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. The distribution of this press release may be subject to legal or regulatory restrictions in certain jurisdictions. Any person who comes into possession of this press release must inform him or herself of and comply with any such restrictions. This announcement is not a prospectus within the meaning of the Prospectus Regulation. In relation to each member state of the European Economic Area (each, a “Relevant Member State”), an offer of the securities referred to herein is not being made and will not be made to the public in that Relevant Member State, other than (i) to any legal entity which is a qualified investor as defined in the Prospectus Regulation, (ii) to fewer than 150 natural or legal persons per Relevant Member State; or (iii) in any other circumstances falling within Article 1(4) of the Prospectus Regulation; provided that no such offer of the securities referred to herein shall require the Company to publish a prospectus pursuant to Article 3 of the Prospectus Regulation. For the purposes of the above, the expression an “offer to the public” in any Relevant Member State shall have the meaning ascribed to it in Article 2(d) of the Prospectus Regulation. This communication is being distributed only to, and is directed only at (a) persons outside the United Kingdom, (b) persons who have professional experience in matters relating to investments falling within Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005 (the “Order”), and (c) high net worth entities, and other persons to whom it may otherwise lawfully be communicated, falling within Article 49(2) of the Order (all such persons together being referred to as “relevant persons”). Any investment or investment activity to which this communication relates is available only to relevant persons and will be engaged in only with relevant persons. Any person who is not a relevant person should not act or rely on this communication or any of its contents. Solely for the purposes of each manufacturer’s product approval process, the target market assessment in respect of the securities offered in the Offering has led to the conclusion in relation to the type of clients criteria only that: (i) the type of clients to whom the securities are targeted is eligible counterparties and professional clients only, each as defined in Directive 2014/65/EU, as amended (“MiFID II”); and (ii) all channels for distribution of the securities offered in the Offering to eligible counterparties and professional clients are appropriate. Any person subsequently offering, selling or recommending the Ordinary Shares (a “distributor”) should take into consideration the manufacturers’ type of clients assessment; however, a distributor subject to MiFID II is responsible for undertaking its own target market assessment in respect of the Ordinary Shares offered in the Offering (by either adopting or refining the manufacturers’ type of clients assessment) and determining appropriate distribution channels. This press release has been prepared in both French and English. In the event of any discrepancies between the two versions of the press release, the French language version shall prevail.