Tislelizumab

全球生物医药创新深度交融、跨境合作日益成为主流的今天，“出海”已从“可选项”变为“必答题”。然而，面对资本周期的波动、地缘政治的挑战以及海外临床开发的复杂壁垒，如何真正实现“走得出去、落得下来”，成为每一家志在全球的中国创新药企必须直面的课题。 如今，市场对BD交易不再盲目买单，转而用放大镜审视首付款背后的兑现可能、核心权益定价是否合理，单纯管线故事已难撑估值。面对资本周期波动、海外临床壁垒与价值驱动的深刻转变，Newco模式正以其灵活高效的资本结构和风险分担机制，成为中国创新药出海的新路径。如何借力全球顶尖投资机构的资源网络？如何在跨境临床开发中规避“水土不服”？如何通过Newco模式实现价值最大化？ 4月27日，MPM将联合其孵化的Newco - K2 Therapeutics，在上海浦东举办【创新无界，出海有道：MPM跨境合作与临床策略】论坛，与全球顶级投资人、临床开发专家及成功创业者一道，深度对话： MPM全球视野下的亚洲投资策略——解读国际顶级投资机构的亚洲布局逻辑 中国新药的跨境临床合作新机遇——破解FDA审评迷局，探讨中美临床协同之道 K2 如何助力创新药企快速走向世界——从交易结构到落地实操，分享成功案例 这不仅是一场思想盛宴，更是一次连接东西方、链接资本与创新的深度对话。在这里，我们不止于“讨论出海”，更致力于为您搭建“出海”的桥梁！ 会议信息 时间：2026年4月27日(周一)  形式： 闭门会议；邀请&审核制（约100人） 地点：上海·浦东；报名审核通过后发送具体地址 联合主办： MPM、 K2 Therapeutics会议承办：BiG生物创新社 会议受众：具备近临床或临床阶段管线或有意拓展海外市场的biotech创始人/高管； 关注Newco投资模式、寻求跨境合作与创新机遇的投资机构合伙人 报名二维码 闭门会；审核制（限100席） ▼ Agenda 15:00 – 15:30 签到与欢迎茶歇 开场主持：刘冀：BiG秘书长（TBD） 15:30 – 15:45 论坛开幕致辞 & 概览及亚洲拓展战略 & 中国生物医药展望(15min) Wu Jie MPM亚太区负责人/K2 CBO（TBD） 15:45-16:05 MPM 美国孵化企业分享 - Orna 发展历程（20min) Frank Neumann  MPM Entrepreneur Partner/Orna CMO Brian Shuster  MPM Entrepreneur Partner/Orna Head of BD （TBD） 16:05-16:20 MPM 亚洲投资策略 & K2 介绍（15min） Binsen Li  K2 Head of BD 16:20-17:20 对话：MPM 亚洲 Newco 交易（每家20min） Wu Jie（MPM亚太区负责人/K2 CBO）x Haotian Wang（Higend Founder & CEO） Jin Wang（K2 VP of Clinical Development）x David Miao（Adcoris Founder & CEO） David Kolesky（Head of Corp Development）x Simcere Zaiming（TBD） 17:20-17:55 Panel：全球视野下的新药开发：审评趋势与跨境临床协作（35min） 拟讨论要点： · FDA 审评趋势 · 与中国合作伙伴的临床试验协作 拟讨论嘉宾： Samit Hirawat K2 Independent Director （TBD） Frank Neumann K2 CMO Pankaj Bhargava MPM Entrepreneur Partner, CEO of Ashibio 中国CMO 代表  17:55-18:00 闭幕致辞（5min） Ansbert Gadicke  MPM 管理合伙人/K2 董事长 18:00 – 20:00 春季酒会 嘉宾简介 * 以下按论坛顺序排列 吴杰 K2 CBO Wu Jie is the Head of APAC at MPM BioImpact, where she focuses exclusively on early-stage investment and company creation opportunities in the region. Prior to joining MPM BioImpact, Wu Jie spent 16 years with Temasek and invested in healthcare companies across different geographies and subsectors, including Juno Therapeutics, Guardant Health and JW Therapeutics. She most recently served as Director of Life Sciences Investment at Temasek International in Singapore. Before that, she served as Director of Temasek’s China Investment Team. Wu Jie received a M.S. degree in biotechnology from Johns Hopkins University, as well as both a M.S. and B.S. degree in engineering from Princeton University. Frank Neumann K2 CMO Dr. Frank Neumann is an Entrepreneur Partner at MPM BioImpact and Chief Medical Officer of Orna Therapeutics, an MPM BioImpact portfolio company. Frank brings extensive experience and proven leadership in cell therapy and oncology clinical development to these roles. Prior to joining MPM BioImpact, Frank served as Senior Vice President and Global Head of Clinical Development at Kite, a Gilead Company. Previously Frank held positions as Chief Medical Officer at Verastem, Inc. (also known as Verastem Oncology) and Vice President, Head of Oncology Clinical Research at bluebird bio. In addition, he was clinical development head of global cell therapy approaches at Takeda Pharmaceuticals, where he also held various leadership roles of increasing prominence including global clinical lead and medical team lead for two distinct cancer therapies. Earlier in his career, Frank was a member of the oncology medical teams at AstraZeneca and Sanofi-Aventis. Board certified in Hematology/Oncology, Internal Medicine and Palliative Care Medicine, Frank was a research scholar at the University of Texas MD Anderson Cancer Center and is currently an assistant professor at the Heinrich Heine University in Düsseldorf, Germany, where he received his M.D. He earned his Ph.D. from the Rheinische-Friedrich-Wilhelm University in Bonn, Germany. Binsen Li K2 Head of BD Dr. Binsen Li is a member of the investment team at MPM BioImpact Asia and is responsible for investment identification, due diligence and company creation opportunities in the APAC region. Prior to joining MPM BioImpact, Binsen spent five years at Hillhouse Capital in New York, where he covered global healthcare investments across both the private and public markets. Binsen earned his Ph.D. in Biochemistry, Molecular and Structural Biology from the University of California, Los Angeles. Earlier in his career, Binsen conducted neurobiology research at Harvard Medical School and received his B.A. in Biochemistry, Cellular and Molecular Biology from Connecticut College. Haotian Wang Higend Founder & CEO Haotian Wang is a graduate of Tsinghua University/PUMC. He has 10+ years of clinical medicine experience, and 8+ years clinical development, management and investment experience in healthcare industry.  As a founding team member of top tier China CRO and the core team member, he has supported 70+ IND submissions with successful approval (US/China), 150+ Phase I/IIa trials, 50+ Phase II/III studies, and 4 NDA/BLA approvals. He joined Legend Capital in 2021, served as a VP and director, focusing on early-stage biotech investment. Successively participated and worked as a core team member in the investment 10+ projects with a cumulative investment amount of about 100M USD, and providing post-investment support for 20+ projects, covering R&D translation and strategic planning.  He has hands-on experience in founding medical startups and CROs, with expertise in US/China regulatory systems and cross-cultural collaboration. Jin Wang K2 VP of Clinical Development Dr. Jin Wang is Vice President of Clinical Development at K2 Therapeutics, where she leads global development strategies and supports investment, search and evaluation, and business development initiatives. With 15 years of drug development experience, Dr. Wang has directed programs spanning early to late phases, including globally approved Tislelizumab and Zanidatamab. Before joining K2, Dr. Wang held senior leadership roles across global biopharma. At Gilead Sciences, she led clinical development for the APAC region. As Chief Medical Officer at Ablaze Pharmaceuticals, she advanced a radiopharmaceutical pipeline to IND-enabling stages prior to its acquisition by Bristol Myers Squibb. At BeiGene, she directed global development strategies and cross-functional teams for major oncology assets. Her earlier career includes impactful contributions at Eli Lilly and IQVIA, as well as hands-on patient care at Shanghai Changzheng Hospital. Dr. Wang holds an MD and PhD in Medicine and is board-certified in Medical Oncology. David Miao Adcoris Founder & CEO Dr. Miao formerly served as the Principal Scientist at Enanta Pharmaceuticals, where he played a key role in the development of Viekira Pak, the FDA approved 2nd cure drug for Hepatitis C. Formerly served as the Senior Director of Chemistry and a senior member of the research and development team at Ambrx Inc., promoted multiple products including hGH, FGF21, Arx788, in Phase II and Phase III clinical trials; developed a non-natural amino acid-based site-specific conjugation method as the ADC platform technology, which led to collaborations with Pfizer, Merck, Astellas, and BMS. Throughout multiple successful entrepreneurial ventures, Dr. Miao has served as the founder and chief officer of several biotech companies such as Concortis Biosystems, Nanjing Levena/Levena (Suzhou), Zova Biopharmaceuticals, Sorrento Therapeutics, Imbioray Biopharma. Ph.D. in Chemistry at Peking University, Postdoctoral fellow at Vanderbilt University David Kolesky K2 Head of Corp Development Dr. David Kolesky is a Principal at MPM BioImpact. He is responsible for driving investments and company creation activities. Before joining MPM BioImpact, David was a Principal at Flagship Pioneering, where he focused on conceiving, creating, and operating new bioplatform technology companies. David co-founded and helped launch several companies, notably Senda Biosciences and Montai Health, where he held key leadership roles at early stages of development including Chief Scientific Officer and Chief Innovation Officer at Montai, and Head of Platform at Senda. David has developed a wide range of scientific and technical experience by working across diverse platforms, including AI-enabled small molecule discovery, programmable delivery of genomic medicines, and cell & tissue engineering.  David received his Ph.D. in Engineering Sciences from Harvard University and conducted a postdoctoral fellowship at the Wyss Institute for Biologically Inspired Engineering. His work has been published in top journals and he is co-inventor of several issued patents. David has received numerous awards, including the National Inventor’s Hall of Fame Collegiate Inventor Prize. A native of South Florida, David received his B.S in Materials Science and Engineering from the University of Florida. Samit Hirawat K2 Independent Director Samit Hirawat, M.D., serves as an independent member of the Board of Directors at K2 Therapeutics.  Most recently, Samit Hirawat, M.D., served as Chief Medical Officer, Executive Vice President, and Head of Global Drug Development at Bristol Myers Squibb, where he oversaw the drug development development portfolio and advanced multiple transformative therapies across therapeutic areas and modalities to registration trials and approvals globally. Prior to that, he spent more than a decade at Novartis Pharmaceuticals in roles of increasing strategic responsibility, leading to his position as Executive Vice President and Head of Oncology Development.  Earlier in his career, Samit held clinical development positions at PTC Therapeutics and Pharmacia/Pfizer. Samit Hirawat, M.D., earned his Bachelor of Medicine and Bachelor of Surgery (MBBS) from Sawai Man Singh Medical College in Jaipur, India. He completed his Internal Medicine residency and Medical Oncology fellowship at North Shore University Hospital. He has published more than 150 peer-reviewed manuscripts and abstracts across therapeutic areas.  Pankaj Bhargava  CEO of Ashibio Pankaj has over 20 years of drug development and senior management experience. He is an Entrepreneur Partner at MPM BioImpact Capital where he founded āshibio. Previously he served as the Oncology Therapeutic Area Head at Gilead Sciences. He has also held executive positions at multiple biotech companies during his career, including Sanofi and Dicerna Pharmaceuticals, where he led development programs for oncology and rare genetic diseases. Pankaj earned his M.D. from the University of Delhi and completed fellowship training in medical oncology and clinical pharmacology at Georgetown University and NIH, including a visiting fellowship at FDA. He is an alumnus of Program for Leadership Development at Harvard Business School and has held academic faculty positions at Harvard Medical School, Dana-Farber Cancer Institute and University of California, San Francisco. Ansbert Gadicke MPM Managing Partner & K2 Executive Chairman Dr. Ansbert Gadicke is the Managing Partner of MPM BioImpact. Ansbert founded MPM Capital in 1992 as a biotech venture capital firm and later its affiliate BioImpact Capital for private/public funds. He is the driving force at MPM BioImpact behind building leading companies such as BioMarin Pharmaceuticals (NASDAQ: BMRN), Idenix Pharmaceuticals (acquired by Merck & Co.), Mitobridge (acquired by Astellas), TriNetX, and Pharmasset (acquired by Gilead Sciences) and, more recently, Cullinan Therapeutics (NASDAQ: CGEM), ElevateBio and Orna Therapeutics. MPM BioImpact believes that these companies, in which Ansbert was the lead investor and served on the Boards of Directors, are some of the biggest successes in biotech – companies that ultimately result in helping thousands of patients live longer and vastly improved lives. For example, Sovaldi, developed by Pharmasset, was the first cure for Hepatitis C, the most successful product launch in the pharmaceutical industry and has today cured over 6 million patients of Hepatitis. Prior to founding MPM, Ansbert was at The Boston Consulting Group in their Boston office. Ansbert’s commitment to drug discovery and curing disease inspires his work both within and outside of MPM BioImpact. In recognition of MPM’s novel work to finance and build companies which may have a significant impact on cancer care and cures globally, Ansbert is a recipient of the 2017 Global Oncology Visionary Award. He is a member of the Harvard Medical School Board of Fellows and the Research Advisory Council of Massachusetts General Hospital. Ansbert received an M.D. from J.W. Goethe University in Frankfurt and held research positions at the Whitehead Institute for Biomedical Research at the Massachusetts Institute of Technology and the Biochemistry Department at Harvard University. While at the German Cancer Research Center, he focused on HPV16 and 18 in Professor Harald zur Hausen’s group (Nobel Laureate in Physiology or Medicine, 2008). Ansbert has published in leading scientific journals such as Nature and Cell. 主办&承办单位介绍 MPM BioImpact MPM BioImpact是全球领先的生物医药投资公司，拥有30多年创建和投资创新企业的专业经验，致力为患者提供变革性疗法。 MPM BioImpact是企业的创造者。拥有专业的创业合伙人团队，在新药研发、知识产权、临床策略及商业化等领域具备深厚的专业知识，这些是成功创建公司的关键因素。 MPM BioImpact结合了MPM CAPITAL®在生物医药风险投资领域30多年的成功经验，以及BioImpact影响力投资专长和超过10年的二级市场投资经验。管理资产规模达35亿美元，涵盖早期阶段的风险投资基金和中小盘股对冲基金。 K2 Therapeutics K2 Therapeutics is a biotech company built for global impact, with search and development capabilities unconstrained by modality or geography. K2 Therapeutics identify the world’s most innovative assets and translate them into great medicines through a disciplined development approach and lead by experienced drug developers. K2 Therapeutics focus is on high-potential first- and best-in-class assets with meaningful potential for patient impact worldwide. BiG生物医药创新社 作为中国生物医药领域具有影响力的协会之一，BiG生物医药创新社（Biomedical Innovation Group）以非营利性会员组织形式凝聚了600+位行业精英，涵盖院士、临床专家、药企创始人、高管及投资人等，同时也打造了专业的媒体平台。 BiG 的核心使命是搭建创新生态桥梁，促进学术成果向临床应用与产业转化，赋能生命科学突破与健康产业升级，助力中国新药全球化进程。通过多样化的活动体系——包括年度峰会、季度论坛、闭门研讨会、青年CEO论坛、云端分享及高价值内容输出，推动了产学研协同创新，成为了新药研发生态建设的核心枢纽。 共建Biomedical创新生态圈！ 如何加入BiG会员？

精彩内容 据CDE、NMPA最新消息，三生制药的生物药1类新药SSGJ-716注射液、SSS55注射液获批临床，分别拟用于特应性皮炎和牙周炎；国产首款重组促红细胞生成素（EPO）创新药罗赛促红素α注射液获批上市，用于慢性肾脏病引起的贫血。米内网数据显示，2025Q1~Q3中国三大终端六大市场生物药销售额超1900亿元，同比增长8.86%。 来源：CDE官网 SSGJ-716注射液是由三生国健自主研发的生物药1类新药，拟用于特应性皮炎（AD）。米内网数据显示，该新药的临床申请（CXSL2600014）于2026年1月获得CDE承办，随后于今年3月首次获得临床试验默示许可。 SSS55注射液是由沈阳三生制药开发的生物药1类新药，拟用于牙周炎。在此之前，该新药先后于2025年5月和7月获批临床，分别拟用于阵发性睡眠性血红蛋白尿症（PNH）和补体相关性肾病。 来源：NMPA官网 三生制药的罗赛促红素α注射液是一款高糖基化长效重组蛋白产品，用于慢性肾脏病引起的贫血，为国产首个获批上市的重组促红细胞生成素（EPO）创新药。资料显示，该产品在保留原有生物学活性的基础上具有较长的稳定性和半衰期，能减少用药次数，方便临床使用。 在中国三大终端六大市场（统计范围详见本文末），生物药近年来销售规模逐年扩容，2024年拿下创新高的超2300亿元；2025Q1~Q3继续以8.86%的增速增至超1900亿元，从渠道格局上看，公立医院终端占据超八成市场份额，从大类格局上看，抗肿瘤和免疫调节剂市占比约45%。 2025Q1~Q3中国三大终端六大市场生物药大类销售额格局 来源：米内网格局数据库 2025Q1~Q3中国三大终端六大市场生物药一级集团TOP10中，上榜的进口药企与本土药企分别有6家和4家。其中，进口药企的诺和诺德、罗氏销售额均超120亿元，排名第一和第二；本土药企的信达生物、齐鲁制药、复星医药和三生制药销售额均在58亿元以上，位列第三至第六。 品牌TOP10方面，诺和诺德的司美格鲁肽注射液、信达生物的信迪利单抗注射液、百济神州的替雷利珠单抗注射液、齐鲁制药的贝伐珠单抗注射液、三生制药的重组人血小板生成素注射液依次位列前五。TOP5品牌市场份额合计约12%。 2025Q1~Q3中国三大终端六大市场生物药销售额品牌TOP10 来源：米内网格局数据库 注：增长率不足7%用*表示 作为国内生物医药领域的领军者，三生制药始终秉持“引领创新、持续创新”的发展理念，近年来研发支出均保持两位数的同比增速，持续的研发投入推动其创新成果的加速转化。 1类创新药方面，2026年至今公司已有1款新品获批上市、1款新品报产在审、6款新品获批临床，涵盖抗肿瘤和免疫调节剂、血液和造血系统药物、生殖泌尿系统和性激素类药物、消化系统及代谢药等治疗品类。 2026年至今三生制药部分1类新药申报及获批情况 来源：米内网综合数据库 其中，安沐奇塔单抗注射液于2026年2月获批上市，用于适合系统治疗或光疗的中度至重度斑块状银屑病，是国内首个维持期仅需8周给药一次的国产IL-17A抑制剂；重组抗IL-4Rα人源化单克隆抗体注射液于今年2月报产获受理，用于中重度特应性皮炎，其对标产品——度普利尤单抗2025年全球销售额达182.91亿美元。 6款1类新药获得临床试验默示许可。从最高研发进度看，注射用SSS50（雄激素性秃发）、注射用HBT-708（晚期实体瘤）、SSS55注射液（阵发性睡眠性血红蛋白尿）已步入Ⅰ期临床，注射用SSS57（贫血）、SSGJ-627注射液(静脉输注)（溃疡性结肠炎）、SSGJ-716注射液（特应性皮炎）为首次获批临床。 资料来源：米内网数据库、CDE官网等 注：米内网《中国三大终端六大市场药品竞争格局》，统计范围：城市公立医院和县级公立医院、城市社区中心和乡镇卫生院、城市实体药店和网上药店，不含民营医院、私人诊所、村卫生室，不含县乡村药店；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3月20日，如有疏漏，欢迎指正！ 免责声明：本文仅作医药信息传播分享，并不构成投资或决策建议。本文为原创稿件，转载文章或引用数据请注明来源和作者，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