CYP11A1

引文跨国药企掌握着全球医药行业最强大的网络资源和决策智慧，他们用真金白银投票选择的方向有更大概率是较符合技术进步规律的（当然这既不意味着他们的决策一定正确、也不意味着这些决策能够被有效执行），通过对他们所有核心产品管线进行系统梳理并定期更新，就有助于我们系统性地了解在大药企自己的话语体系里，究竟哪些方向是在做的、有进展的、值得期待的，从而可以对判断到底什么是所谓“主流技术方向”有更全面直观的依据。本篇将为大家梳理礼来、诺和诺德、强生、默沙东、艾伯维五家企业的管线情况。在GLP-1横扫一切的强势驱动下，无论是业绩和市值，还是各自的产品布局，全球大药企都在经历深刻的变局，甚至可以说进行了颠覆性的重排，仅是下面这张摘要图与半年前相比就有不小的差异。- 左右滑动查看更多 -Lilly礼来礼来在2023年一骑绝尘成功登顶全球药企市值之冠，更夸张的是在2024年刚过两个月又从5,000多亿飚到7,000多亿，眼看就要冲着人类有史以来第一个万亿市值药企的壮举而去了。不过，这疯狂的市值还是有大幅预支未来成长之嫌，毕竟过往业绩虽然表现不俗，但也绝不是成倍的爆发式增长，且看未来是“预支”还是“透支”了。当然，礼来的业绩成长本身确实非常震撼，Tirzepatide在第一个完整销售年度豪取53亿美元、其中Q4单季24亿，在这种震古烁今的爬坡速度驱动下，礼来整体收入额一举从2022年的285亿跃升到2023年的341亿，而且仍处在继续向上跃升的过程中，2024年的业绩指引就是收入提升到410亿左右。- 左右滑动查看更多 -管线的攻城略地仍在发力：在万众瞩目的减肥线上，Tirzepatide肥胖适应症终于获批、并公布了MASH二期临床topline数据，Retatrutide和Orforglipron的多个三期临床先后启动；自免线上，Mirikizumab终于获批、并公布了CD三期临床结果，而Lebrikizumab却收到了FDA的CRL；Donanemab上市却意外地再次被推迟；肿瘤线上，Pirtobrutinib获批CLL/SLL适应症，从POINT收购来的核药PNT-2002也加入管线。- 左右滑动查看更多 -NOVO NORDISK诺和诺德诺和诺德在这波GLP-1狂潮中，市值从1,000亿飙升到接近6,000亿，与礼来呈一时瑜亮之势，在公司创立百年之际达到了可以说是从未有过的高度。看诺和诺德这十年以来的业绩成长，也确实配得上市值的提升。Semaglutide的三个品牌合计在2023年带来了近220亿美元销售额，不过近几个季度在GLP-1中的处方量市场份额已经开始走平，Tirzepatide迅速爬坡带来的竞争压力肉眼可见。- 左右滑动查看更多 -产能制约依然是严重瓶颈，特别是从2023年5月之后低剂量的供应出现明显的受限、以至于对国际市场还会实施供应量限制，从2024年1月开始逐渐增加供应能力，比起半年报时候“will remain restricted”的表述来看应该是有所缓解；产能扩建则继续加码，连续三年持续Capex翻倍的计划。- 左右滑动查看更多 -最重要的研发进展当然还属Semaglutide获批用于心血管风险保护、公布慢性肾病和HFpEF等三期临床结果，以及刚刚公布Amycretin一期的惊艳减重数据；其他值得关注的进展包括高草酸尿症RNAi疗法Nedosiran终于获批，Icosema完成三期临床，从中国药企KBP收购高血压资产等；瘦身也在持续，两个罕见病疗法Belcesiran和Eclipse先后消失在管线中。- 左右滑动查看更多 -J&J强生强生虽然业绩持续稳定，但市值近期下滑到4,000亿以下，被礼来与诺和诺德连续超车。强生医药板块的业绩在大药企中还是相当稳健，其中Ustekinumab和Daratumumab两大引擎的驱动力都非常充足，Guselkumab和Macitentan+Selexipag也表现不俗，但Ibrutinib、Infliximab、Abiraterone、Paliperidone等曾经的超重磅品种确实老态渐显。研发方面最突出的依然是在多发性骨髓瘤领域的“遮断性”优势，不过近期高歌猛进似有放缓，主要进展包括：Talquetamab获得欧盟批准；Teclistamab两周一次剂型获批；Daratumumab皮下剂型公布一线可移植MM患者的三期临床数据；Cilta-cel二线MM适应症获得欧盟积极意见；BCMA/CD3/GPRC5D三抗JNJ-5322公布一期临床数据。其他值得关注的进展包括：2019年从Taris收购来的新型膀胱内药物输送系统TAR-200/201分别公布了二期和一期数据；FcRn单抗Nipocalimab公布二期RA数据并获得FDA突破性认证；FGFR抑制剂Erdafitinib获得FDA完全批准并公布三期临床THOR2研究结果。管线新陈代谢正在进行，从收购Ambrx获得ARX-517/788等ADC资产，而RPGR AAV从管线中被拿掉。- 左右滑动查看更多 -MSD默沙东默沙东近期收入端依然表现稳健，K药仍在增长并稳住了药王地位（虽然刚上位没多久），HPV疫苗也增速不减，这两大定海神针填上了Molnupiravir急速缩水以及Sitagliptin专利悬崖带来的缺口，市值还是逼近3,000亿。研发进展中依然一大半都还是围绕K药的各种扩适应症和联用方案，近期主要进展包括：围手术期NSCLC的三期OS结果；获批1L HER2阴性胃癌和胆管癌等适应症；与mRNA-4157合作启动NSCLC辅助治疗的三期临床。其他重点值得关注的包括：与第一三共达成重大合作获得多个ADC管线，其中U3-1402已提交上市申请；HIF2α抑制剂Belzutifan获批2L RCC适应症；TIGIT单抗Vibostolimab公布与K药联用的NSCLC二期数据；肺炎疫苗V116和PAH药物Sotatercept提交上市申请；从科伦引进的TROP2 ADC、BTK C481S抑制剂Nemtabrutinib、CYP11A1抑制剂和LSD1抑制剂MK-5684Bomedemstat等启动三期临床。此外，收购Harpoon获得的DLL3/CD3/Albumin三抗加入管线，而P2X3慢性咳嗽药物Gefapixant则再次收到CRL。- 左右滑动查看更多 -Abbvie艾伯维2023年以来，Adalimumab和Ibrutinib两大超重磅受竞争者的挤压销售额开始出现大幅下滑，所幸Risankizuma、Upadacitinib、Venetoclax、Cariprazine几个新生代贡献一定的增量，整体业绩才算没有太崩坏，因此市值基本上还是稳定在2,500亿上下。眼看着业绩支撑轴在发生更迭，艾伯维将Risankizumab和Upadacitinib的峰值预期提高到170亿和100亿以上，试图再造一个Adalimumab时代的免疫帝国。- 左右滑动查看更多 -管线方面同样是在经历重心的迁移：免疫线逐渐收缩到围绕现有重磅的适应症扩展，近期包括Risankizumab公布与Ustekinumab在CD适应症的头对头三期临床结果、Upadacitinib公布白癜风二期临床结果，此外IL-1α/β双抗Lutikizumab公布化脓性汗腺炎二期临床结果，另有SCF248、IL-2、GLP-2等新机制加入管线；肿瘤线进展包括收购Immunogen并获得多个ADC资产，CD20×CD3双抗Epcoritamab获得欧盟批准并向FDA提交末线FL的上市申请，Teliso-V公布NSCLC二期临床数据，同时补充了大批新项目进入管线；神经/精神线进展较多，帕金森复方药物ABBV-951提交上市申请，偏头痛药物Atogepant和Ubrogepant分别提交预防适应症的上市申请和公布前兆适应症的三期临床数据，此外通过87亿巨额收购Cerevel补充多个AD/PD管线。- 左右滑动查看更多 -数据声明本文选取截至2023年12月31日市值超过1,000亿美元的制药企业，共11家。已上市产品包括收入贡献较大的（年销售额10亿美元以上）、尚在增长或稳定期的（获批10年以上的基本不考虑）和仍在积极开发阶段的（正在进行重要适应症扩展的临床试验）；临床在研管线以年报季报的研发进度更新章节、研发日及重要会议展示材料和公司日常信息披露等取并集，故可以理解为公司自己认为当前优先级较高的管线，而并不覆盖全体管线。主要梳理信息包括近几个季度的市值和收入利润变化（多主业公司只取制药板块）、半年内最重要的审批进展和临床数据发布、以及未来近期的重要里程碑。\ | /★联 系 我 们投稿 | 发稿 | 媒体合作▶ sylvia.hua@generalbiologic.com数据库 | 咨询服务 | 资讯追踪▶ 点击左下“阅读原文”完成表单填写点击 阅读原文 订阅全球行业新闻

Closing cash balance of approximately $28 million expected from concurrent private placement led by OrbiMed and Torrey Pines Funding expected to advance development of three potential best-in-class/class leading assets: viroksavir, a cap-dependent endonuclease inhibitor for influenza; travaltrelvir, a protease inhibitor for COVID19; and narazaciclib, a next generation CDK4/6 inhibitor for low grade endometriod endometrial cancer (LGEEC) Multiple near-term catalysts, for viroksavir and travaltrevir in 2024, with first top-line read-outs expected in H2 2024 Traws Pharma to be led by incoming CEO, Werner Cautreels, Ph.D. Combined board to be led by Executive Chairman Iain Dukes DPhil (OrbiMed) along with Nikolay Savchuk, Ph.D. (Torrey Pines) Companies to host joint webcast, April 2, 2024 at 8:30 a.m. ET NEWTOWN, Pa. and ROCKVILLE, Md., April 02, 2024 (GLOBE NEWSWIRE) -- Onconova Therapeutics, Inc. (NASDAQ: ONTX) (“Onconova”), and Trawsfynydd Therapeutics, Inc. (“Trawsfynydd”), a privately-held biotechnology company developing next-generation, best-in-class antivirals for influenza, COVID and other infectious diseases, today announced that the companies have entered into a definitive merger agreement to combine in an all-stock transaction (the “Merger”). Under the terms of the agreement, Onconova acquired 100% of Trawsfynydd’s outstanding equity interests. In connection with the transaction and concurrent with the Merger, the combined company which has been renamed “Traws Pharma, Inc.” (“Traws”) will trade on NASDAQ under the new ticker symbol “TRAW”, commencing prior to the opening of trading Wednesday, April 3, 2024. In connection with the Merger, Traws announced that it will raise $14 million in a committed private placement financing by OrbiMed and Torrey Pines, expected to close on April 3, 2024. Upon closing of the private placement, Traws expects to have in excess of $28 million of cash and cash equivalents from the proceeds of the private placement and cash from both companies. These proceeds will be used to advance the Traws’ programs through multiple clinical data catalysts and complete the dose ranging study for narazaciclib. “I am pleased to announce the combination of Onconova and Trawsfynydd at this important time, as Trawsfynydd readies to initiate Phase 2 studies in H2 2024 for its lead antiviral programs for influenza and COVID19, supported by advisors with unparalleled expertise in viral disease, and Onconova is preparing to finalize the recommended Phase 2 dose (RP2D) for narazaciclib,” said Dr. Cautreels incoming Chief Executive Officer of the combined company. Commented Steven Fruchtman, M.D., President and Chief Executive Officer of Onconova and President and CSO, Oncology of the combined company, ”Trawsfynydd has a differentiated pipeline and an accomplished leadership team poised to advance their lead programs. With a shared focus on developing best-in-class medicines for patients with unmet needs, we look forward to Traws’ continued progress with its anti-viral programs and narazaciclib.” Traws Proprietary Portfolio: TRX100 (viroksavir): a cap-dependent endonuclease inhibitor for influenza: Phase 1 Targets the cap-dependent endonuclease of influenza and is a potent inhibitor of influenza virus replication including A and B strains Preclinical data showed that TRX100 inhibits viral replication of pandemic-potential influenza viruses circulating in nature during 2022, and importantly, also in oseltamivir and baloxavir-resistant viruses Completed a first Phase 1 study that demonstrated safety and tolerability in healthy volunteers. The study also provided pharmacokinetics and pharmacodynamics (PK/PD) data to support the potential use of a single oral dose administration for either treatment or prophylaxis Next milestones: H2 2024 Phase 1 dose extension will evaluate two additional, higher doses prior to the initiation of Phase 2 studies in H2 2024. Topline data from the Phase 2 study are expected in H1 2025 TRX01 (travaltrevir): Mpro protease inhibitor for COVID19: Phase 1 Potent oral inhibitor of SARS-CoV-2 Mpro (3CL protease), effective against the original, delta, and omicron variants of SARS-CoV-2, with potentially superior properties to nirmatrelvir (Pfizer’s Mpro inhibitor, PAXLOVID™) Does not require co-administration with a human cytochrome P450 (CYP) inhibitor such as ritonavir, avoiding potential significant drug:drug interactions, with the opportunity to expand the number of eligible patients Safe in GLP toxicology studies with no adverse events (AEs) in the expected human dose range. The drug candidate’s pharmacokinetic (PK) pro enable a once-daily 10 day treatment regimen, to reduce the likelihood of viral rebound Next milestones: Phase 1 first-in-human single ascending dose/multiple ascending dose (SAD/MAD) study in normal volunteers initiated screening in Q1 2024. Topline data are expected H2 2024 Phase 2 study planned to be initiated in H2 2024. The study will enroll people with moderate to severe COVID19. Topline data are expected H1 2025 Narazaciclib: CDK 4/6 inhibitor for LGEEC: Phase 1/2 Narazaciclib’s mechanism of action in LGEEC has been validated by Phase 2 studies with other approved CDK4/6 inhibitors: palbociclib (Pfizer), ribociclib (Novartis), and abemaciclib (Lilly). Available preclinical and clinical data suggest that narazaciclib has the potential to provide a better efficacy/safety ratio compared to approved products with respect to reduced gastrointestinal (GI) and hematological toxicities. These characteristics may permit daily administration with no need for the drug holidays employed by other approved agents to manage severe bone marrow suppression. In pre-clinical studies, narazaciclib demonstrated reduced neutropenia compared to palbociclib and inhibited the growth of cancer cell lines resistant to palbociclib Currently in Phase 1/2a study to define the RP2D Next milestone: Define the RP2D and development strategy for LGEEC/other indications Management and Organization Traws will be led by incoming Chief Executive Officer, Werner Cautreels, Ph.D.; President and Chief Scientific Officer, Oncology, Steven Fruchtman M.D., (Onconova); Chief Financial Officer, Mark Guerin (Onconova), Chief Medical Officer, Robert Redfield, M.D., (Trawsfynydd), Chief Scientific Officer, Virology, C. David Pauza, Ph.D., (Trawsfynydd) and Chief Operating Officer, Nikolay Savchuk, Ph.D., (Trawsfynydd/Torrey Pines), as well as several other members of the Onconova and Trawsfynydd teams. Traws’ Board of Directors will be comprised of Trawsfynydd’s Chairman Iain Dukes, DPhil (Venture Partner at OrbiMed), Executive Chairman, Werner Cautreels, Nikolay Savchuk, Ph.D. (General Partner of Torrey Pines) as well as existing Onconova Directors Trafford Clarke, Ph.D, James Marino, J.D. and M. Theresa Shoemaker and Jack E. Stover. About the Merger and Private Financing Onconova issued the following in the transactions: in connection with the merger, the stockholders of Traswfynydd received an aggregate of 3,549,538 shares of common stock and 10,359.0916 shares of newly issued Series C non-voting convertible preferred stock (with a conversion ratio of preferred to common at 1:10,000) (the "Series C preferred stock”), and in connection with the private financing, OrbiMed and Torrey Pines received an aggregate of 496,935 shares of common stock and 1,578.2120 shares of Series C preferred stock. This represents, on a fully diluted basis, 75.7% for Trawsfynydd, 13.7% for Onconova and 10.6% for new investors with a combined fully diluted equity value of $132 million (excluding transaction fees). In connection with the transactions, a non-transferrable contingent value right (a "CVR") will be distributed to Onconova stockholders of record as of the close of business on April 15, 2024. Holders of the CVR will be entitled to receive certain proceeds received by Onconova, if any, related to the disposition, net sales or monetization of narazaciclib and rigosertib. The shares of common stock issuable upon conversion of the Series C preferred stock issued in the Merger and the private financing shall be subject to stockholder approval in compliance with the rules of the NASDAQ Stock Market. Tungsten Advisors served as the exclusive financial advisor and placement agent to Onconova. Orrick, Herrington & Sutcliffe, LLP and Morgan, Lewis & Bockius LLP are serving as legal counsel to Onconova. Snell & Wilmer L.L.P. is serving as legal counsel to Trawsfynydd. Webcast Presentation The companies will host a webcast presentation to discuss the proposed transaction tomorrow, April 2 at 8:30 a.m. ET. Dial-in details are: Investors Dial-in: 1-877-407-0784 International Investors Dial-in: 1-201-689-8560 Conference ID: 13745512 Call me™: Participants can use Guest dial-in #s above and be answered by an operator OR click the Call me™ link for instant telephone access to the event. Call me™ link will be made active 15 minutes prior to scheduled start time. Webcast: : A replay of the webcast will also be available via Onconova’s investor website approximately two hours after the call’s conclusion. About Onconova Therapeutics, Inc. Onconova is a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer. Onconova has been focused on developing targeted anti-cancer agents designed to disrupt specific cellular pathways that are important for cancer cell proliferation including the novel, multi-kinase inhibitor narazaciclib, under evaluation for low grade endometroid endometrial cancer (LGEEC). About Trawsfynydd Therapeutics, Inc. Trawsfynydd is an antiviral drug development company committed to reducing disease and death among people with respiratory viral diseases including Influenza and COVID19. Trawsfynydd combines excellence in medicinal chemistry with the tools of AI and machine learning, to guide and accelerate the drug development process. We are especially committed to developing best-in-class treatments for the elderly, immunocompromised and other vulnerable populations who are at increased risk for severe disease and death from respiratory virus infections. About Traws Pharma, Inc. Traws is developing next-generation, best-in-class antivirals for influenza, COVID and other respiratory infections and narazaciclib. Traws was formed from the business combination of Onconova Therapeutics, Inc. and Trawsfynydd Therapeutics, Inc. and is headquartered in Newtown, PA and will trade on NASDAQ as “TRAW” starting on April 3, 2024. Forward-Looking Statements This communication contains “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, including but not limited to, express or implied statements regarding the structure, the combined company’s listing on Nasdaq; expectations regarding the ownership structure of the combined company; expectations regarding the issuance and value of CVRs; expectations regarding the conversion of the Series C preferred stock and related stockholder approval; expectations regarding the structure, timing and funding of the private placement financing, expected proceeds and impact on ownership structure; each company’s and the combined company’s expected cash position at the closing of the Merger and the expected cash runway of the combined company following the Merger and private financing; the nature, strategy and focus of the combined company; the development and commercial potential and potential benefits of any product candidates of the combined company; anticipated clinical drug development activities, related timelines and expected milestones; and other statements that are not historical fact. All statements other than statements of historical fact contained in this communication are forward-looking statements. These forward-looking statements are made as of the date they were first issued, and were based on the then-current expectations, estimates, forecasts, and projections, as well as the beliefs and assumptions of management. There can be no assurance that future developments affecting Traws, the Merger or the private placement financing will be those that have been anticipated. Forward-looking statements are subject to a number of risks and uncertainties, many of which involve factors or circumstances that are beyond Traws’ control. Traws’ actual results could differ materially from those stated or implied in forward-looking statements due to a number of factors, including but not limited to (i) failure to timely obtain stockholder approval for the transaction, if at all; (ii) uncertainties as to the timing and the funding of the private financing; (iii) risks related to Traws’ ability to manage its operating expenses and its expenses associated with the Merger; (iv) unexpected costs, charges or expenses resulting from the transaction; (v) potential adverse reactions or changes to business relationships resulting from the announcement or completion of the Merger; (vi) the uncertainties associated with Traws’ product candidates, as well as risks associated with the clinical development and regulatory approval of product candidates, including potential delays in the commencement and completion of clinical trials, studies and evaluations; (vii) risks related to the inability of the combined company to obtain sufficient additional capital to continue to advance these or other product candidates; (viii) uncertainties in obtaining successful clinical results for product candidates and unexpected costs that may result therefrom; (ix) risks related to the failure to realize any value from product candidates currently being developed and anticipated to be developed in light of inherent risks and difficulties involved in successfully bringing product candidates to market; and (x) risks associated with the possible failure to realize certain anticipated benefits of the Merger, including with respect to future financial and operating results. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties. These and other risks and uncertainties are more fully described in periodic filings with the U.S. Securities and Exchange Commission (the “SEC”), including the factors described in the section titled “Risk Factors” in Onconova’s Annual Report on Form 10-K for the year ended December 31, 2023, which was filed with the SEC on April 1 2024, subsequent Quarterly Reports on Form 10-Q filed with the SEC, and in other filings that Traws makes and will make with the SEC. You should not place undue reliance on these forward-looking statements, which are made only as of the date hereof or as of the dates indicated in the forward-looking statements. Traws expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in its expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based. This communication does not purport to summarize all of the conditions, risks and other attributes of an investment in Traws. Company Contacts: Mark Guerin Onconova Therapeutics, Inc. 267-759-3680 ir@onconova.us Investor Contact: Bruce Mackle LifeSci Advisors, LLC 646-889-1200 bmackle@lifesciadvisors.com

点击蓝字关注我们本周，有不少值得关注的热点。首先是审评审批方面，多个药物注册进度有所进展，非常值得关注的就是，科济药业的泽沃基奥仑赛注射液获批上市，成为国内第2款上市的BCMA CAR-T疗法；其次是研发方面，值得一提的是，康方生物公布了卡度尼利一线治疗宫颈癌的最新数据，疾病控制率提至100%；最后是交易及投融资方面，比较值得一看的就是，先声再明获9.7亿元融资。本周盘点包括审评审批、研发、交易及投融资三大板块，统计时间为2.26-3.1，包含22条信息。 审评审批NMPA上市批准1、3月1日，NMPA官网显示，辉瑞的阿布昔替尼片新适应症获批，用于对其他系统治疗（如激素或生物制剂）应答不佳或不适宜上述治疗的难治性、中重度特应性皮炎12岁及以上青少年患者。阿布昔替尼是一款每日一次的口服高选择性JAK1抑制剂。2022年4月，阿布昔替尼首次在中国获批上市，用于治疗难治性、中重度特应性皮炎成人患者。2、3月1日，NMPA官网显示，科济药业的泽沃基奥仑赛注射液（CT053、商品名：赛恺泽）获批上市，用于治疗复发或难治性多发性骨髓瘤成人患者，既往经过至少3线治疗后进展（至少使用过一种蛋白酶体抑制剂及免疫调节剂）。这是继伊基奥仑赛（驯鹿生物）后，国内第2款上市的BCMA CAR-T疗法。申请3、2月28日，CDE官网显示，康希诺生物的13价肺炎球菌多糖结合疫苗（CRM197，TT载体）（简称PCV13i）申报上市，主要用于婴幼儿和儿童，接种后可使机体产生免疫应答，用于预防由肺炎球菌血清型1、3、4、5、6A、6B、7F、9V、14、18C、19A、19F和23F引起的侵袭性疾病。PCV13i采用多糖抗原与蛋白载体共价结合的方式。4、2月28日，CDE官网显示，正大天晴的TQB2450新适应症申报上市，联合盐酸安罗替尼胶囊用于既往接受过一、二线化疗方案治疗失败或不能耐受的非微卫星高度不稳定（非MSI-H）或非DNA错配修复缺陷（非dMMR）的复发性或转移性子宫内膜癌的治疗。TQB2450是正大天晴自主研发的一款PD-L1抑制剂。临床批准       5、2月27日，CDE官网显示，普众发现（MultitudeTherapeutics）的1类新药注射用AMT-562获批临床，拟用于治疗晚期实体瘤。AMT-562由一种新型抗HER3抗体Ab562和一种增强了亲水性的连接子MC-VA-PABC结合有效载荷exatecan（依喜替康）构成。6、2月28日，CDE官网显示，阿斯利康的1类新药AZD0486获批临床，拟用于治疗复发性或难治性B细胞急性淋巴细胞白血病（r/rB-ALL）。AZD0486是一款靶向CD19×CD3的双特异性T细胞衔接蛋白（TCE）。2022年7月，阿斯利康以总金额约12.7亿美元收购TeneoTwo公司，从而获得后者这款在研产品（先前名为TNB-486）。7、2月28日，CDE官网显示，罗氏的1类新药cevostamab获批临床，拟用于治疗多发性骨髓瘤。Cevostamab是罗氏在研的一款FcRH5×CD3双特异性抗体，拟开发治疗复发/难治性多发性骨髓瘤（RRMM）。FcRH5受体在所有骨髓瘤细胞中表达，而且在骨髓瘤细胞和正常浆细胞中的表达水平高于正常B细胞。8、2月29日，CDE官网显示，Karuna的1类新药KarXT胶囊获批临床，拟用于治疗阿尔茨海默病相关的精神行为症状。KarXT胶囊是一种潜在“first-in-class”毒蕈碱类抗精神病药物。再鼎医药拥有KarXT在大中华区（包括中国大陆、中国香港、中国澳门和中国台湾地区）的开发、生产和商业化权益。申请9、2月27日，CDE官网显示，海森生物和LIB的1类新药lerodalcibep申报临床。lerodalcibep是LIB Therapeutics开发的一款第三代长效PCSK9抑制剂，每月仅需注射一针，且注射体积更少，可以帮助减少患者注射部位的不良反应和免疫原性。2023年，海森生物通过一项高达3.25亿美元的合作获得了该药在大中华区的开发和商业化独家专有权。优先审评10、2月26日，CDE官网显示，信达生物和葆元医药合作开发的己二酸他雷替尼胶囊拟纳入优先审评，用于未经ROS1-TKI治疗的ROS1阳性局部晚期或转移性非小细胞肺癌（NSCLC）成人患者的治疗。他雷替尼属于新一代ROS1/NTRK抑制剂，原本由第一三共开发，其开发、生产和商业化权益于2018年12月被授予葆元医药。突破性疗法11、3月1日，CDE官网显示，普米斯生物的PM8002注射液拟纳入突破性治疗品种，联合注射用白蛋白结合型紫杉醇一线治疗不可手术的局部晚期/复发转移性三阴性乳腺癌。PM8002是普米斯生物自主研发的抗PD-L1/VEGF双特异性抗体。BioNTech公司已与普米斯生物达成一项超10亿美元的合作，获得该产品在全球（大中华区除外）的开发、生产和商业化权利。12、3月1日，CDE官网显示，科伦博泰的注射用SKB264新适应症拟被纳入突破性治疗品种，用于治疗既往未接受过系统治疗的不可手术切除的局部晚期、复发或转移性PD-L1阴性三阴性乳腺癌患者。SKB264是一款靶向TROP2的ADC疗法。FDA上市批准13、2月26日，FDA官网显示，吉利德的Biktarvy（比克替拉韦50mg/恩曲他滨200mg/替诺福韦艾拉酚胺25mg片剂，B/F/TAF）获批新适应症，用于治疗病毒载量受到抑制且已知或疑似具有M184V/I耐药性的HIV感染者（PWH）。艾滋病毒治疗耐药性是永久性和不可逆转的，这可能危及PWH未来的治疗选择。研发临床状态14、2月26日，中国药物临床试验登记与信息公示平台显示，恒瑞医药登记了一项HRS-1167联合贝伐珠单抗治疗复发性卵巢癌的Ⅰb/Ⅱ期临床研究。HRS-1167是恒瑞医药自主研发的PARP1抑制剂。2023年10月，恒瑞医药已经就包含HRS-1167在内的两款产品与德国默克达成独家许可协议，潜在总额可能高达14亿欧元。15、2月28日，中国药物临床试验登记与信息公示平台显示，默沙东和Orion共同登记了两项MK-5684片针对转移性前列腺癌的国际多中心（含中国）Ⅲ期临床研究。MK-5684片是默沙东和Orion公司合作开发的一款口服非类固醇CYP11A1抑制剂。临床数据16、2月27日，康方生物公布了PD-1/CTLA-4双特异性抗体卡度尼利联合标准治疗（化疗+/-贝伐珠单抗）用于复发/转移性宫颈癌一线治疗的Ⅱ期临床结果。结果显示：全人群客观缓解率（ORR）仍维持在高水平，疾病控制率（DCR）提升至100%，完全缓解（CR）率进一步提升。交易及投融资17、2月26日，先声药业宣布，其子公司先声再明获得9.7亿元融资。本轮融资由先进制造领投，中深新创、杏泽兴涌、鼎信中和跟投，融资资金将用于先声再明主要业务范围内的产品研发、生产及营运。先声再明成立于2020年12月，是先声药业的附属公司，主要专注于抗肿瘤领域药品的研发、生产及销售。18、2月26日，恩华药业宣布，恩华和信与Teva签署了氘丁苯那嗪片（安泰坦）许可协议，恩华和信获得该药在中国大陆的独家商业化权益，协议截至2029年2月22日。该药是一款囊泡单胺转运蛋白2（VMAT2）抑制剂，于2020年获NMPA批准，用于治疗成人与亨廷顿病（HD）有关的舞蹈病及迟发性运动障碍（TD），并于当年通过国家医保谈判进入医保目录。19、2月26日，Neomorph宣布，与诺和诺德达成合作许可协议，共同发现、开发和商业化心血管代谢和罕见病领域的分子胶降解剂，潜在交易总额高达14.6亿美元。分子胶降解剂是一类可诱导E3泛素连接酶底物受体与靶蛋白之间新型相互作用，从而导致靶蛋白降解的小分子。20、2月28日，艾伯维宣布，与OSE达成战略合作协议，引进一款严重慢性炎症性疾病在研新药OSE-230的开发、生产以及商业化全球独家许可权利。OSE-230是一款first-in-class的靶向Chemerin受体23的单抗。根据协议，OSE将得到4800万美元的预付款，并有资格获得高达6.65亿美元额外的临床开发、监管以及商业里程碑付款，以及OSE-230全球净销售额的潜在分层版税。21、2月28日，晖致（Viatris）、Idorsia宣布，双方已就一项重要的全球研发合作达成协议。Viatris将获得两项Ⅲ期资产selatogrel和cenerimod的全球独家开发和商业化权，Idorsia将获得3.5亿美元的预付款，以及后续的里程碑付款。Selatogrel是一种强效、速效、可逆和高选择性的P2Y12抑制剂。Cenerimod是一种高选择性S1P1受体调节剂。22、3月1日，海和药物宣布，和大鹏药品关于谷美替尼片（研发代码：SCC244）在日本等地区的开发、生产和商业化达成独家许可协议，该药品已经由海和药物的日本全资子公司海和制药株式会社提交日本上市许可申请。谷美替尼片是该公司自主研发的一款口服强效、高选择性小分子MET抑制剂，可强效和特异性靶向抑制MET激酶活性。【智药研习社近期课程预告】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~