Adimab LLC

11月13日，以新冠mRNA疫苗而闻名的BioNTech公司宣布：以8亿美元预付款，最高1.5亿美元里程碑款，全款买下成立六年的中国创新药企普米斯生物100%的已发行股本。 BioNTech此前引进过一些中国创新药管线，但全资收购中国药企还是第一次。这笔交易中，BioNTech最关注的是普米斯生物正在开发的PD-L1/VEGF双抗PM8002。 今年抗体界最大的新闻要数康方生物的PD-1/VEGF双抗AK112头对头打败了全球药王K药。BioNTech嗅觉灵敏，很快发现了普米斯生物在研的重磅管线PM8002，BioNTech认为，这个品种有潜力超越康方的AK112，“它在肿瘤微环境中更加丰富，因为它靶向PD-L1而不是PD-1”。 BioNTech首席执行官表示，通过收购普米斯生物，可以加快BioNTech多种抗癌药物的开发速度，对热门的PD-L1/VEGF有更好的控制权，并获得一个临床团队，在中国开展更多试验。交易宣布后，BioNTech股价上涨4.85%，市值一夜增加12.4亿美元。 在中国押注下一个“药王” 在这笔交易之前，BioNTech已经与普米斯有过两次合作，也算是对普米斯的实力进行了摸底。 最早在2023年7月，BioNTech就出手拿下了普米斯生物一款用于治疗恶性肿瘤的临床前双抗和一款临床阶段单抗的权益。此外，普米斯还将多个在研临床前纳米抗体项目授权给BioNTech。虽然具体交易金额并未透露，不过，这些交易让普米斯展示了实力。 BioNTech公司逐渐关注到普米斯正在研发的双抗药物。2023年11月，BioNTech以5500万美元的首付款，超10亿美元的里程碑款及销售提成，获得PD-L1/VEGF双抗PM8002的权益。在BioNTech内部，这款产品研发编号为BNT327，是BioNTech最为看重的产品。 PD-1/VEGF这个赛道上，康方生物的AK112开了个好头。2024年9月9日，在美国召开的全球肺癌大会上，康方生物的AK112“头对头”三期临床实验效果，击败全球“药王”K药。与康方生物合作开发AK112的Summit，也因为这款药物一跃成为美股明星Biotech。从2022年12月，合作公告发出算起，不到两年时间，Summit股价涨幅超10倍。 全球药企的目光随之都投向了这一赛道，不少药企都希望复制Summit的幸运，更希望能提前押注下一个药王，BioNTech也不例外。对于BNT327，BIoNTech首席执行官表示，“我们花了好几年时间寻找下一代免疫调节剂，我们相信现在已经找到了我们正在寻找的分子。” 此外，BioNTech还表示BNT327 比AK112“在肿瘤微环境中更加丰富”，因为它采用PD-L1导向方法，而不是专注于 PD-1。言外之意是觉得，BNT327有潜力比AK112更优秀。 在进度上，BNT327是全球首个且唯一进入Ⅲ期临床的PD-L1/VEGF双抗。目前，BNT327三阴性乳腺癌和小细胞肺癌两项适应症已先后获CDE批准开展注册性III期临床试验。对于这款药物的未来，BioNTech表示，也将与K药展开正面交锋。 除了PD-L1/VEGF双抗外，普米斯管线中还有多款药物，其中不乏TIGIT 、Claudin18.2等热门靶点以及一些临床前 ADC 的研究。 图源：普米斯生物官网 BioNTech认为，普米斯的PD-L1/VEGF成功机会很大，而单买一个产品需要付出超10亿美元，直接打包公司则只需要8亿美元，对于BioNTech来说这笔交易应该是稳赚不亏。 国内Biotech卖身潮或将持续 对于普米斯卖身的做法，国内资本市场上也有一些不同的声音。有投资者认为，“普米斯是贱卖自己”。但是从现实情况来看，普米斯选择卖身给BioNTech可能是最合适的选择。 普米斯生物实际上还很年轻，公司于2018年4月创立，成立不过六年时间。在普米斯背后有着一个明星创始人刘晓林，他曾先后在雅培、施贵宝、Adimab等公司任研发高管。2012年，刘晓林回国任信达生物研发副总裁，组建并领导一支100多人的研发团队，建立了包括20多个抗体新药的产品链，并领导了信迪利单抗的开发上市。 虽然背靠明星创始人，但普米斯的日子过得可能并不容易。目前，普米斯没有产品进入到商业化阶段，依然靠市场融资来维持生存。资本寒冬之中，普米斯最近几年都没有融资的消息。据ChinaBio Today报道，上一次普米斯披露1亿美元D轮融资还是在2021年3月。 近几年支撑公司经营的就靠几起license out。 BioNTech给到普米斯的估值也不算便宜，在国内创新药融资极其困难的情况下，凭借一款PD-L1/VEGF双抗，普米斯就想要在国内拿到9.5亿美元，约合68亿元融资并不容易。在这样的情况下，普米斯选择与海外药企合作，获得持续资金输血进行药物研发的确是更好的选择。 事实上，普米斯的处境也是国内大部分Biotech的现状，在不断收紧的融资环境下，大部分Biotech其实没有太多选择，要么节衣缩食苟活，要么卖身，借助海外药企的力量，让创新药研发获得更大的确定性。 有投资者告诉健识局，“在一级机构退出无望的当下，Biotech能够被海外药企并购，也算是为投资者提供了二级市场之外的多一个退出渠道。”从这一点来说，不久的将来，国内Biotech卖身的案例可能还会继续增加。 撰稿丨方涛之 编辑丨江芸 贾亭 运营｜山谷 插图｜视觉中国 声明：健识局原创内容，未经许可请勿转载 辉瑞“割肉”，拟出售170亿美元资产 单季营收继续破1亿美元，再鼎医药爆发在即 石药集团二价人乳头瘤病毒mRNA治疗性疫苗获批临床

CAMBRIDGE, Mass., Nov. 13, 2024 /PRNewswire/ -- Leap Therapeutics, Inc. (Nasdaq:LPTX), a biotechnology company focused on developing targeted and immuno-oncology therapeutics, today reported financial results for the third quarter ended September 30, 2024. Leap Highlights: Completed enrollment in the expanded randomized controlled Part B of the Phase 2 DeFianCe study evaluating DKN-01, Leap's anti-DKK1 monoclonal antibody, in combination with standard of care bevacizumab and chemotherapy in second-line patients with advanced colorectal cancer (CRC); data expected in mid-2025 Patient follow-up continuing in the randomized controlled Part C of the Phase 2 DisTinGuish study evaluating DKN-01 in combination with tislelizumab and chemotherapy in first-line patients with advanced gastroesophageal junction (GEJ) and gastric cancer; data expected in late 2024 or early 2025 Initiated development of FL-501, Leap's anti-GDF-15 monoclonal antibody "We have made significant progress advancing our pipeline this quarter, including the completion of enrollment in the expanded Part B of the Phase 2 DeFianCe study of DKN-01 in patients with advanced colorectal cancer," said Douglas E. Onsi, President and Chief Executive Officer of Leap. "We look forward to sharing initial randomized controlled data from the DisTinGuish study and the DeFianCe study in the coming months. In addition, based on positive preclinical data, we are enthusiastically moving FL-501 into development. With a strong cash position that is expected to fund operations into Q2 2026, Leap is well positioned for continued success and long-term growth to deliver personalized medicines to patients fighting against cancer." DKN-01 Development Update Enrollment completed in the expanded randomized controlled Part B of the DeFianCe study evaluating DKN-01 in combination with standard of care bevacizumab and chemotherapy as a second-line treatment for patients with advanced CRC. Part B of the DeFianCe study (NCT05480306) is a Phase 2, randomized, controlled, open-label study of DKN-01 in combination with standard of care bevacizumab and chemotherapy in patients with advanced CRC who have received one prior systemic therapy. Part B of the study enrolled 188 patients. The Company expects to report initial data in mid-2025. Patient follow-up continuing in the randomized controlled Part C of the DisTinGuish study evaluating DKN-01 in combination with tislelizumab and chemotherapy in patients with GEJ and gastric cancer, with initial data expected in late 2024 or early 2025. Part C of the DisTinGuish study (NCT0436380) is a Phase 2, randomized, controlled, open-label study of DKN-01 in combination with tislelizumab and chemotherapy in first-line, HER-2 negative patients with GEJ and gastric cancer. Part C of the study enrolled 170 patients. The Company expects to report initial data in late 2024 or early 2025. Pipeline Update: Advancing FL-501 into development as a potential best-in-class anti-GDF-15 antibody with promising preclinical data. FL-501 is a potential best-in-class monoclonal antibody designed to neutralize GDF-15 to treat patients with cachexia and other GDF-15-driven diseases. FL-501 may also enhance the activity of the immune system in the tumor micro-environment. FL-501 was engineered for higher target affinity and a longer plasma half-life compared to competing therapies. In preclinical cachexia models, FL-501 increased body weight and restored muscle mass. Selected Third Quarter 2024 Financial Results Net Loss was $18.2 million for the third quarter 2024, compared to $13.7 million for the same period in 2023. The increase was primarily due to an increase in research and development expenses. Research and development expenses were $14.9 million for the third quarter 2024, compared to $11.5 million for the same period in 2023. The increase of $3.4 million was primarily due to an increase of $1.7 million in manufacturing costs related to clinical trial material and manufacturing campaigns, and an increase of $0.8 million in clinical trial costs due to patient enrollment, the duration of patients on study, the enhancement of correlative studies, increase in site activity associated with Part C of the DisTinGuish study, and the expansion of the size of Part B of the DeFianCe study. There was also an increase of $0.5 million in consulting fees associated with research and development activities and an increase of $0.4 million in payroll and other related expenses due to an increase in headcount of our research and development full-time employees. General and administrative expenses were $2.9 million for the third quarter 2024, compared to $3.3 million for the same period in 2023. The decrease of $0.4 million in general and administrative expenses during the three months ended September 30, 2024 as compared to the same period in 2023, was due to a $0.4 million decrease in professional fees. Cash and cash equivalents totaled $62.8 million at September 30, 2024. About Leap Therapeutics Leap Therapeutics (Nasdaq: LPTX) is focused on developing targeted and immuno-oncology therapeutics. Leap's most advanced clinical candidate, DKN-01, is a humanized monoclonal antibody targeting the Dickkopf-1 (DKK1) protein. DKN-01 is being developed in patients with esophagogastric, colorectal, and gynecological cancers. Leap's pipeline also includes FL-501, a humanized monoclonal antibody targeting the growth and differentiation factor 15 (GDF-15) protein, in preclinical development. For more information about Leap Therapeutics, visit or view our public filings with the SEC that are available via EDGAR at or via . FORWARD-LOOKING STATEMENTS This press release contains forward-looking statements within the meaning of the federal securities laws. Such statements are based upon current plans, estimates and expectations of the management of Leap that are subject to various risks and uncertainties that could cause actual results to differ materially from such statements. The inclusion of forward-looking statements should not be regarded as a representation that such plans, estimates and expectations will be achieved. Words such as "anticipate," "expect," "project," "intend," "believe," "may," "will," "should," "plan," "could," "continue," "target," "contemplate," "estimate," "forecast," "guidance," "predict," "possible," "potential," "pursue," "likely," and words and terms of similar substance used in connection with any discussion of future plans, actions or events identify forward-looking statements. All statements, other than historical facts, including statements regarding the potential safety, efficacy, and regulatory and clinical progress of Leap's product candidates; the anticipated timing for initiation or completion of clinical trials and release of clinical trial data and the expectations surrounding the outcomes thereof; Leap's future clinical or preclinical product development plans for any of Leap's product candidates; Leap's estimations of projected cash runway; and any assumptions underlying any of the foregoing, are forward-looking statements. Important factors that could cause actual results to differ materially from Leap's plans, estimates or expectations could include, but are not limited to: (i) Leap's ability to successfully execute its clinical trials and the timing of enrollment in and cost of such clinical trials; (ii) the results of Leap's clinical trials and pre-clinical studies; (iii) Leap's ability to successfully enter into new strategic partnerships for DKN-01 or any of its other programs and to maintain its ongoing collaborations with BeiGene and Adimab; (iv) whether any Leap clinical trials and products will receive approval from the U.S. Food and Drug Administration or equivalent foreign regulatory agencies; and (v) exposure to inflation, currency rate and interest rate fluctuations, as well as fluctuations in the market price of Leap's traded securities. New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements. Leap may not actually achieve the forecasts disclosed in such forward-looking statements, and you should not place undue reliance on such forward-looking statements. Such forward-looking statements are subject to a number of material risks and uncertainties including but not limited to those set forth under the caption "Risk Factors" in Leap's most recent Annual Report on Form 10-K filed with the SEC, as well as discussions of potential risks, uncertainties, and other important factors in its subsequent filings with the SEC. Any forward-looking statement speaks only as of the date on which it was made. Neither Leap, nor any of its affiliates, advisors or representatives, undertake any obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law. These forward-looking statements should not be relied upon as representing Leap's views as of any date subsequent to the date hereof. CONTACT: Douglas E. Onsi President & Chief Executive Officer Leap Therapeutics, Inc. 617-714-0360 [email protected] Matthew DeYoung Investor Relations Argot Partners 212-600-1902 [email protected] SOURCE Leap Therapeutics, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

2024年11月13-16日，中华医学会糖尿病学分会第二十六次学术会议（CDS）将在南京国际博览中心（建邺区江东中路300号）召开。信达生物开发的创新药物多项研究成果在会议中亮相，这也是信达生物首次亮相中华医学会糖尿病学分会学术会议。信达生物邀您共同见证公司在内分泌领域的深度布局和最新进展，探索未来慢病管理防治新思路，开启中国慢病防治事业新篇章！ 中华医学会糖尿病学分会第二十六次学术会议由中华医学会、中华医学会糖尿病学分会主办，江苏省医学会承办。届时来自国内外的内分泌学领域的知名专家将进行大会报告、专题报告、病例讨论、内容丰富并结合临床热点话题的专家见面会、论文交流及中青年英文演讲比赛等内容，期间还将进行丰富多彩的继续教育讲座。 会议信息 会议时间：2024年11月13-16日 会议地点：南京国际博览中心 信达展台展位号： A20 展会平面图 信达生物展台示意图 精彩活动预告 诚邀您莅临信达生物展台 领取信达生物护照（限量1000份） 开启三段信达生物学术之旅 探索学术盛会新乐趣 学术之旅第一站：信达生物展台 诚邀您莅临信达展台参观盖章 限量版纪念笔记本和书写笔等您领取 数量有限，先到先得！ 一站式带您体验前沿学术和创新产品，共同展望美好未来！ 示意图 学术之旅第二站：问卷调研 欢迎参与学术调研并集齐二章，学术指南领回家！ “超重肥胖”和“甲状腺眼病”是内分泌临床常见难题，却缺乏长期有效的解决方案。诚邀您扫码参与本调研，探询您对这类疾病的认知。 调研二维码 学术之旅第三站：专题会议 参加专题会并集齐三个印章，赢取重磅学术大奖！ 关注内分泌代谢疾病——肥胖及甲状腺眼病治疗新进展专题会 讲题1：中国甲状腺眼病治疗新纪元 时间：11月14日 13:30-14:00 地点：紫金厅 讲者：刘超 江苏省中西医结合医院 主持：单忠艳 中国医科大学附属第一医院 讲题2：体重管理元年，寻求科学减重解决方案：GCG/GLP-1双靶激动剂研究新进展解读 时间：11月14日 14:00-14:30 地点：紫金厅 讲者：毕艳 南京大学医学院附属鼓楼医院 主持：母义明 中国人民解放军总医院第一医学中心  甲状腺眼病和超重肥胖管理新进展专题会，将聚焦展望领域前沿发展，与您共同探索未来慢病管理防治新思路！ 学术报告预告 论文发言 Session：论文交流：肥胖与代谢综合征 3 标题：一项在BMI≥30 kg/m2的中国成人受试者中评估玛仕度肽9 mg的II期临床研究 时间：11月15日 16:01-16:09 会场：会场二层206 讲者：姜宏卫 河南科技大学第一附属医院 Session：论文交流：肥胖与代谢综合征 3 标题：一项在中国超重或肥胖受试者中评估玛仕度肽疗效和安全性的随机、双盲、安慰剂对照的III期临床研究（GLORY-1） 时间：11月15日 16:17-16:25 会场：会场二层206 讲者：纪立农  北京大学人民医院 Session：论文交流：糖尿病药物研发、药物机理研究 标题：一项在中国2型糖尿病患者中对比玛仕度肽和度拉糖肽的随机、开放标签、28周III期临床研究 时间：11月15日 16:33-16:41 会场：会场四层402AB 讲者：于冬妮  北京医院 壁报展示 论文ID：3291 标题：玛仕度肽改善中国超重或肥胖受试者的肝脂肪变性: GLORY-1研究的探索性分析 作者：纪立农  北京大学人民医院 单位：北京大学人民医院 目前，信达生物已经建立起涵盖心血管及代谢（CVM）、自身免疫、眼科等疾病领域的综合产品管线，确立了“为生命，更添美好”的综合管线品牌定位，为公司长期成长新添增长动力。尤其在CVM领域，通过系统制定平台架构及商业化策略，有序建立商业化能力、人员和配套支持，保障多款高潜力后期产品管线的价值释放，建立品牌形象和竞争优势。 信达生物综合产品管线 信达生物多条产品管线一直备受关注。信达生物自主研发的国家 1 类新药——托莱西单抗，也是中国首个上市的本土自主研发PCSK9 抑制剂，目前已获批用于治疗原发性高胆固醇血症和混合型血脂异常，强效持久*，双重达标。 全球首个申报上市的GCG/GLP-1双靶激动剂——玛仕度肽 ，是一款“天然双靶、燃脂护肝、优质减重、综合获益”的突破性减重药物，目前减重和2型糖尿病适应症上市申请已获受理，其中减重适应症预计明年上半年获批上市，造福患者。 信达生物自主研发的抗胰岛素生长因子1受体（IGF-1R）抗体——替妥尤单抗，是中国首个申报上市的IGF-1R抗体，已递交上市申请。作为具有创新作用机制的生物药，替妥尤单抗有望填补国内TED治疗领域60年来无新药可用的空白，直击根源，显著改善突眼复视。 代谢类疾病高度影响老百姓的生活质量和幸福指数，信达生物将在该领域加速创新，致力于解决未满足的临床需求，为患者带来更安全、更有效的治疗方案。在未来5年内，信达生物预计将有5-6款代谢类产品上市，覆盖糖尿病、减重、心血管等适应症，立志成为在中国心血管代谢疾病领域有一定话语权的研发型企业，以科技创新为引擎，共同投身于中国的慢病防治事业！为生命，更添美好。 关于信达生物 - 滑动查看更多介绍 - “始于信，达于行”，开发出老百姓用得起的高质量生物药，是信达生物的使命和目标。信达生物成立于2011年，致力于开发、生产和销售肿瘤、代谢及心血管、自身免疫、眼科等重大疾病领域的创新药物。公司已有11款产品获得批准上市，同时还有5个品种在NMPA审评中，3个新药分子进入III期或关键性临床研究，另外还有17个新药品种已进入临床研究。公司与海内外药企深入合作加速药物创新，与礼来、罗氏、赛诺菲、Adimab、Incyte和MD Anderson癌症中心等国际合作方达成30多项战略合作。 信达生物在不断开发创新药物、谋求自身发展的同时，始终心怀科学善念，坚守“以患者为中心”，心系患者并关注患者家庭，积极履行社会责任。信达生物希望和大家一起努力，提高中国生物制药产业的发展水平，以满足百姓用药可及性和人民对生命健康美好愿望的追求。 详情请访问公司网站：www.innoventbio.com或公司领英账号Innovent Biologics。 *LDL- C降幅近70%，Lp（a）降幅近50%，26.1天半衰期带来平稳持久降脂。 *信达生物不推荐未获批的药品/适应症的使用。 前瞻性声明 本新闻稿所发布的信息中可能会包含某些前瞻性表述。这些表述本质上具有相当风险和不确定性。在使用“预期”、“相信”、“预测”、“期望”、“打算”及其他类似词语进行表述时，凡与本公司有关的，目的均是要指明其属前瞻性表述。本公司并无义务不断地更新这些预测性陈述。 这些前瞻性表述乃基于本公司管理层在做出表述时对未来事务的现有看法、假设、期望、估计、预测和理解。这些表述并非对未来发展的保证，会受到风险、不确性及其他因素的影响，有些乃超出本公司的控制范围，难以预计。因此，受我们的业务、竞争环境、政治、经济、法律和社会情况的未来变化及发展的影响，实际结果可能会与前瞻性表述所含资料有较大差别。