根据最新的改革方案，未来新上市的未盈利企业将被纳入科创成长层，待满足"最近两年净利润均为正 且累计净利润不低于5000万元"或"最近一年净利润为正且营业收入不低于1亿元"，才会调出科创成长 层。 在盈亏"分层"的背后，不仅是为了保护投资者，更体现出科创板对于未盈利企业不一般的"情愫"。 在大部分投资人眼中，相比于已经盈利的企业，未盈利的企业往往面临更高的投资风险。 21世纪经济报道记者 杨坪 深圳报道 随着新一轮科创板改革规则出炉，未盈利企业审核明显加速。 连日来，多家未盈利企业审核迎来突破：以第五套标准申报的禾元生物，在7月1日顺利过会，北芯生命 公布了第二轮问询函的回复公告；摩尔线程、沐曦集成等未盈利的明星半导体企业，科创板上市申请获 得受理。 而过去六年时间，科创板合计有54家未盈利企业上市，截至目前22家企业已实现盈利，摘U率约40%。 这些摘U企业，有不少实现了股价大幅上涨，为投资者带来了丰厚的投资回报。 企业盈利与否，是否会影响投资者的决策？不同的上市标准下，企业的投资风险是否存在较大差异？什 么类型的企业能更快实现商业化落地？ "标准五"不等于没有希望 众所周知，科创板注重企业科技创新能力，允许 ...

步长制药（603858）公告，控股子公司浙江天元生物药业有限公司近日收到国家药品监督管理局核准签 发的关于四价流感病毒裂解疫苗的《药品注册证书》。该疫苗主要用于刺激机体产生抗流行性感冒病毒 的免疫力，预防本毒株引起的流行性感冒。截至2025年6月30日，公司在四价流感病毒裂解疫苗项目上 投入的研发费用约为1.26亿元。 ...

Core Viewpoint - 康希诺 is actively advancing its vaccine development pipeline, focusing on innovative products and expanding its market presence both domestically and internationally [1][2][3] Group 1: Vaccine Development and Commercialization - 康希诺's 13-valent pneumonia conjugate vaccine PCV13i has significant advantages in product characteristics and production processes, showing excellent clinical results and safety profiles [3][4] - The company is targeting the commercialization of PCV13i, which overlaps with its existing product MCV4, enhancing marketing efficiency [4] - The four-valent meningococcal conjugate vaccine MCV4 has received acceptance for age expansion applications for 4-6 years and plans to submit for 18-59 years within the year [5] Group 2: Research and Development Progress - 康希诺 has established five major R&D platforms, with multiple products at various stages of development, including Tdcp for adolescents and adults, which has completed Phase III clinical trials [2][7] - The company is exploring therapeutic vaccine development and has a positive attitude towards expanding into innovative fields [8] - The infant DTcP vaccine's application for market approval has been accepted and is undergoing priority review, with plans for clinical trials for a combination vaccine [6][9] Group 3: Financial Position and Future Plans - As of March 2025, 康希诺 has approximately 34 billion RMB in funds, sufficient for current development needs, with no large-scale investment plans outside of its vaccine industrial park project [2][10] - Future financing plans will be considered based on market conditions and company development stages, with timely announcements to be made if necessary [10]

产品方面，公司目前共计拥有8项管线资产，包括三款处于临床阶段的候选药物，分别为四价双特异性 抗体EMB-01（靶向EGFR/cMET）；重组人源化双特异性抗体EMB-06（靶向BCMA/CD3）和EMB-07 （靶向ROR1/CD3），另有5款基于T细胞衔接器的临床前候选药物。 炒股就看金麒麟分析师研报，权威，专业，及时，全面，助您挖掘潜力主题机会！ 近日，岸迈生物向港交所提交上市申请，拟根据上市规则第18A章在香港主板挂牌上市，中信证券、招 银国际为其联合保荐人。资料显示，岸迈生物成立于2015年，是一家处于临床阶段的生物制药公司，专 注于全球范围内治疗各类癌症和自身免疫性疾病的T细胞衔接器的开发。 近年来，国产创新药企海外BD逐渐成为企业补充资金，助推自身发展的主要路径之一。岸迈生物在BD 方面收获颇丰，自2023年底起，公司陆续与海外企业达成多项对外授权合作，总交易价值超过21亿美 元。 然而，在对招股书等相关资料进行梳理后发现，公司目前仍存在诸多隐忧，包括核心管线均处早期（仅 EMB-01在II期），面临"死亡之谷"的高失败率与成药性不确定性；公司累计亏损高达23.55亿元，虽有 授权收入但盈利模式未 ...

智通财经记者 | 李科文 智通财经编辑 | 谢欣 7月2日，智通财经记者获悉，在最新的世界卫生组织预认证列表中，华兰生物流感疫苗已被剔除。 对此，7月2日，华兰生物向智通财经记者回应称，原有通过世界卫生组织预认证（三价流感疫苗，西林瓶包装）的2#车 间从建设至今已18年，计划不再使用，因此向世界卫生组织正式提交了将流感疫苗撤出世卫组织预认证清单的申请，后 续华兰疫苗计划重新提交新车间预认证PQ申请。撤回预认证PQ申请，对公司海外销售及业绩不会造成影响。 华兰生物表示，华兰疫苗目前正常生产流感病毒裂解疫苗（三价）和四价流感裂解疫苗的车间为2021年后投入使用的 3/4/5/6#新生产车间，其生产规模具备年产流感疫苗1亿人份。 世界卫生组织预认证是2001年启动的联合国行动计划，用于扩大选择的优先药物的获取，目标是确保国际基金（如全球 基金GFTAM、联合国援助国际药品采购机制UNITAID）采购药品的质量、疗效和安全性，服务发展中国家的患者。 疫苗预认证是世界卫生组织预认证中非常重要的组成部分，是世界卫生组织为保证疫苗产品的质量、安全性和有效性达 到国际标准而进行的一项评估认证工作，为联合国采购机构疫苗采购提供 ...

Core Insights - The "2025 PDI Pharmaceutical R&D and Innovation Conference" has commenced, unveiling the "2025 China Biopharmaceutical R&D Strength Ranking TOP50" and "2025 China Traditional Chinese Medicine R&D Strength Ranking TOP50" [1] - The rankings are initiated by professional organizations like Yaowang Network, which has established a mature and authoritative evaluation system in the pharmaceutical and health industry since its first release in 2016 [1] - Bichang Pharmaceutical, a leading enterprise in traditional Chinese medicine focusing on cardiovascular and cerebrovascular products, has been recognized for its outstanding R&D capabilities [1] Company Overview - Bichang Pharmaceutical has built a sustainable development model centered on R&D, focusing on major diseases and cultivating significant products across various fields including traditional Chinese medicine, chemical drugs, biopharmaceuticals, vaccines, and medical devices [3][4] - The company reported a total sales revenue of 5.83 billion yuan from three proprietary traditional Chinese medicines in the cardiovascular field, which consistently rank among the top 20 in the market share for traditional Chinese medicine in public medical institutions [3] R&D and Product Pipeline - Bichang Pharmaceutical is actively developing 12 biopharmaceutical products, with some entering the NDA application stage, supported by high-level academic platforms such as academician and doctoral workstations [4] - The vaccine segment includes four products, with several others under development, showcasing the company's differentiated competitive edge [4] - The company has a total of 213 products in its pipeline, demonstrating its comprehensive layout and exceptional strength across traditional Chinese medicine, chemical drugs, biopharmaceuticals, and vaccines [4] Financial Performance and Social Responsibility - Since its listing in 2016, Bichang Pharmaceutical has distributed over 7.5 billion yuan in dividends, with an average dividend rate exceeding 85%, reflecting its commitment to shareholder returns and financial resilience [5] - The company has paid nearly 32 billion yuan in taxes and has been actively involved in social welfare projects, significantly contributing to healthcare improvements in remote areas [5] - Bichang Pharmaceutical aims to enhance its R&D investments and contribute to national pharmaceutical advancements and public health, aligning with its philosophy of giving back to society [5]

Core Viewpoint - The Chinese vaccine industry is transitioning from scale expansion to value creation, driven by national immunization strategies and WHO vaccine prioritization policies, with local companies leveraging technological innovation to enhance multi-valent vaccines and lifecycle protection strategies [1] Group 1: Product Development and Innovation - CanSino Biologics' 13-valent pneumonia vaccine PCV13i has been approved for market launch, representing a significant step in the globalization of domestic vaccines [2] - The core value of PCV13i is based on three pillars: technological breakthroughs, clinical validation, and application optimization [2] - The vaccine employs a unique dual carrier technology using a non-toxic mutant of diphtheria toxin (CRM197) and tetanus toxin (TT), enhancing immunogenicity and reducing interference with other vaccines [3] Group 2: Clinical Data and Efficacy - Clinical data shows that PCV13i significantly outperforms control groups in inducing high levels of specific antibodies against key serotypes that are prevalent in China, confirming its regional adaptability [4] - The safety profile of PCV13i is comparable to that of control vaccines, with adverse reactions primarily being mild, facilitating its commercial application [4] Group 3: Market Demand and Commercialization - The urgency for pneumonia vaccines is underscored by the high mortality rates associated with pneumonia in children under five, particularly in China, where vaccination rates are below 18% [6][8] - The global market for pneumonia vaccines is robust, with the 13-valent pneumonia vaccine consistently ranking among the top-selling vaccines, indicating significant market potential [9] Group 4: Strategic Market Positioning - PCV13i is positioned to leverage existing distribution networks and cold chain logistics established by CanSino's previous vaccine, enhancing market penetration efficiency [10] - The vaccine's production process meets EU GMP standards and is suitable for halal certification, providing a competitive edge in Southeast Asian markets [10] Group 5: Long-term Value Creation - CanSino's vaccine matrix, including products for polio and DTP, is establishing a comprehensive defense against bacterial diseases in children, aligning with international quality standards [11] - The launch of PCV13i is expected to catalyze short-term performance while the ongoing innovation in the product matrix builds long-term value, suggesting potential for re-evaluation in market valuation [12]

政策动向 其中，"1"指在科创板设置科创成长层，并且重启未盈利企业适用科创板第五套标准上市，更加精准服 务技术有较大突破、商业前景广阔、持续研发投入大的优质科技企业，同时在强化信息披露和风险揭 示、加强投资者适当性管理等方面做出专门安排。 "6"涵盖试点引入资深专业投资者制度，扩大第五套标准适用范围，支持在审未盈利科技企业面向老股 东开展增资扩股等活动，完善科创板公司再融资制度和战略投资者认定标准等6项改革措施。 21点评：科创板第五套上市标准曾为未盈利药企打开融资大门。目前，109家登陆科创板的药企中，有 20家通过第五套标准上市。但2023年智翔金泰作为当年唯一以科创板第五套标准上市的药企，该标准一 度陷入"零受理"僵局。未来，随着科创板第五套标准重启，以及具备真正"创新"底色的药企实现高质量 发展，生物医药企业有望在国内资本市场迎来新的发展篇章，持续为行业创新注入活力。 我国美容整形价格项目有了统一规范 从"皮秒""超声炮""热玛吉"等美容项目，到"隆鼻""丰唇""割双眼皮"等微整形……2024年，我国美容整 形市场规模已近3000亿元，展现出市场活力与潜力。在"扩容"的同时，建立更加透明、有序的市场环 ...

2025.06. 17 本文字数：1364，阅读时长大约3分钟 作者 | 第一财经 林志吟 自费疫苗的降价潮，从国产疫苗席卷至进口明星疫苗。近期以来，一些疫苗接种点相继推出关于进口 HPV疫苗、进口重组带状疱疹疫苗的惠民项目。 进口四价以及九价HPV疫苗厂商默沙东日前决定自2025年2月起根据消费者需求的动态变化，阶段 性调整中国市场HPV疫苗发货节奏，预计将于年中逐步恢复常态。 作为进口四价以及九价HPV疫苗、进口带状疱疹疫苗的代理商，智飞生物（300122.SZ）在今年5月 份召开的2024年度网上业绩说明会上表示，从公司总体经营情况看，公司当前确实遇到了经营困 难。自2024年二季度开始，该公司业绩下降明显，HPV等核心产品销量大幅度下降，同时各项财务 指标出现较大波动。一方面，经济周期性及结构性变化、行业调整以及疫苗犹豫增加等因素对民众接 种意愿影响较大。另一方面，尽管公司在2023年已经开始积极寻找新的商业机会，主动寻找新的业 绩增长点推动公司实现业务转型。但是，公司对宏观情况变化、行业调整、新业务开拓进度等的研判 存在预判偏差，导致经营效益偏离预期目标。 具体看，针对9岁到14岁女性，进口二价HP ...

在进口HPV疫苗、进口带状疱疹疫苗此起彼伏降价背景下，相关疫苗厂商业绩并不乐观。 自费疫苗的降价潮，从国产疫苗席卷至进口明星疫苗。近期以来，一些疫苗接种点相继推出关于进口 HPV疫苗、进口重组带状疱疹疫苗的惠民项目。 如6月16日，郑州大学医院官方公众号推出了HPV疫苗接种惠民项目，涉及的疫苗有进口二价HPV疫 苗、进口九价HPV疫苗。 具体看，针对9岁到14岁女性，进口二价HPV疫苗、九价HPV疫苗全程需要接种两剂次，这两款疫苗都 推出第二针免费优惠，即打一送一（不包括接种服务费用，下同）。 针对15岁至45岁女性，这两款疫苗全程需要接种三剂次，进口二价HPV疫苗的优惠力度更大，只收一针 的费用，即打三送二；九价HPV疫苗则收两针费用，即打三送一。 彼时，智飞生物表示，该公司要直面问题、解决问题、化解风险，2025年的核心工作是"去库存、收回 款、降负债"，化解经营风险。2025年以来，公司已通过优化销售政策、积极参加各地疾控中心开展的 惠民项目、加强HPV疫苗男性适应症的科普宣传等方式方法，进一步激发团队积极性，促进产品销售推 广。同时，截至2025年一季度末，公司应收账款规模降至146亿元，公司将持续关 ...