6月27日，景泽生物医药（合肥）股份有限公司（简称"景泽生物"）向港交所递交上市申请。 作为生物制药公司，景泽生物布局辅助生殖药物和眼科药物赛道，共拥有八个候选药物。由于尚未有产 品上市销售，2023年、2024年，公司连续两年出现净亏损。 其首款核心产品已获批并即将推进商业化，预计将于2026年产生收入。然而，激烈的市场竞争为其核心 产品的商业化前景增添了不确定性。 拥有8个候选药物 首款产品商业化在即 截至目前，景泽生物拥有八款候选药物，其中三款处于后期研发阶段，一款已获批上市，一款已提交新 药上市申请（NDA），另一款正处于III期临床试验阶段。其中，重组人促卵泡激素(rhFSH)冻干粉针剂 型产品JZB30、抗VEGF（血管内皮生长因子）眼内注射液JZB05为公司的核心产品。 公司即将推进商业化的产品为核心产品JZB30，该产品的NDA已于2025年4月获得国家药监局批准。 作为公司眼科领域首个预期商业化产品，另一款核心产品JZB05主要用于治疗湿性年龄相关性黄斑变性 （wAMD）、糖尿病黄斑水肿（DME）等眼底新生血管性疾病。该产品是对标全球销售额最高眼科药 物、抗VEGF药物阿柏西普的全球生物类似 ...

在辅助生殖治疗领域，景泽生物核心产品JZB30（重组人促卵泡激素冻干粉针剂）于2025年4月获国家 药监局批准商业化，这是该公司首个获批产品，对标全球促排卵市场占有率领先的进口药果纳芬水针剂 型开发。此外，景泽生物还在开发JZB30治疗低促性腺激素性性腺功能减退症的适应症。 景泽生物医药（合肥）股份有限公司（以下简称"景泽生物"）近日正式向港交所递交招股说明书，拟主 板挂牌上市，中金公司和国元国际担任联席保荐人。不过，这家专注于辅助生殖与眼科药物赛道的生物 制药公司，正面临着"单药获批、多管线押注"的研发现状与"巨额亏损叠加资金告急"的上市困境。 仅一款产品获批 景泽生物成立于2014年，是一家专注于辅助生殖药物和眼科药物两大赛道的生物制药公司。根据弗若斯 特沙利文的资料，截至2025年6月20日，景泽生物是中国企业中辅助生殖和眼科领域获得最多处于临床 阶段大分子药物的公司之一。 招股书显示，研发管线方面，景泽生物目前有8个候选药物，仅一款辅助生殖治疗领域的产品获批。 根据弗若斯特沙利文的资料，国内绝大部分具有辅助生殖需求的患者会在当地的生殖中心就诊。因此， 建立覆盖生殖中心的广泛销售网络十分关键。招股书显示 ...

中国企业中辅助生殖和眼科领域获得最多处于临床阶段大分子药物的公司之一。 本文为IPO早知道原创 作者｜ Stone Jin 微信公众号｜ipozaozhidao 据 IPO早知道消息， 景泽生物 医药（合肥）股份有限公司 （以下简称 " 景泽生物 "）于2025年6 月27日正式向港交所递交招股说明书，拟主板挂牌上市，中金公司和国元国际担任联席保荐人。 成立于 2014年的 景泽生物 是 一家专注于辅助生殖药物和眼科药物两大赛道的生物制药公司。 根 据弗若斯特沙利文的资料，截至 2025年6月20日 ，景泽生物是中国企业中辅助生殖和眼科领域获 得最多处于临床阶段大分子药物的公司之一。 截至 2025年6月20日 ，景泽生物辅助生殖治疗领域的核心产品之一 JZB30 （rhFSH冻干粉针剂 型）已正式获批进行商业化，而 其 主要产品之一 JZB33 （rhFSH水针剂型）提交NDA，同时眼科 领域的核心产品JZB05（抗VEGF眼内注射液）正在中国大陆40余家中心开展III期临床试验。 具体来看两款核心产品： JZB30 作为 景泽生物在辅助生殖治疗领域的首个商业化产品，其是景泽生物研发的重组人促卵泡激 素 ( ...

Core Insights - Alvotech, Kashiv Biosciences, and Advanz Pharma announced positive topline results from a confirmatory efficacy study for AVT23, a proposed biosimilar to Xolair® (omalizumab) [1][2][3] Study Details - The study was a randomized, double-blind, multicenter trial assessing the efficacy, safety, and immunogenicity of AVT23 in patients with Chronic Spontaneous Urticaria (CSU) [2] - The primary endpoint was met, demonstrating equivalence in therapeutic outcomes and comparable safety between AVT23 and Xolair® [2] - A total of 600 patients were enrolled, with efficacy and safety evaluated in 400 patients receiving a 300 mg dose over a 24-week period [2] Company Statements - Joseph McClellan, Chief Scientific Officer of Alvotech, emphasized the importance of these results for increasing global patient access to the biosimilar [3] - Dr. Sandeep Athalye, CEO of Kashiv, highlighted the advancement of their biosimilar pipeline and commitment to delivering cost-effective therapies [4] - Nick Warwick, Chief Medical Officer of Advanz Pharma, noted that the results mark a significant milestone in expanding access to specialty medicines [4] Regulatory Progress - The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has validated the marketing authorization application (MAA) for AVT23, with a filing expected with the European Medicines Agency (EMA) by year-end [5] Product Information - AVT23 is an investigational biosimilar to Xolair®, which is indicated for severe persistent allergic asthma and other conditions [6] - The biosimilarity of AVT23 has not yet been established by regulatory authorities [6] Company Backgrounds - Alvotech focuses on developing and manufacturing biosimilar medicines, with two biosimilars already approved and a pipeline of nine candidates targeting various diseases [9][10] - Kashiv BioSciences is a vertically integrated biopharmaceutical company with a strong focus on biosimilars and advanced clinical-stage assets [16] - Advanz Pharma specializes in specialty, hospital, and rare disease medicines, with a global presence in over 90 countries [14]

在创新药浪潮中，博安生物是其中一股不容忽视的力量。 2024年，凭借已成功上市3款产品，博安生物实现总营收7.3亿元，这一营收规模达到2021年的四倍以上，并首次迈入年度盈利的关键拐点，EBITDA转正为 1.8亿元，净利润转正为7319万元。 但盈利并非终点，博安生物还在不断挖潜多款创新生物药的临床价值，以及积极布局重点项目的战略合作。例如，近期在美国获批临床的BA1302（CD228 ADC），便具备BD潜质。 01 BA1302具备BD潜质 BA1302是靶向CD228的创新型ADC药物，也是国内首个、全球第2个进入临床阶段的CD228 ADC。 CD228蛋白是首次在黑色素瘤中发现的GPI锚定糖蛋白，在肿瘤细胞迁移和增殖中发挥作用，在非小细胞肺癌（NSCLC）、乳腺癌、黑色素瘤、间皮瘤、结 肠癌、胰腺癌等多种实体肿瘤中高表达，并在正常组织低表达。 BA1302的抗体部分为创新的全人源抗CD228单抗，源自博安生物专有的全人抗体转基因小鼠BA-huMab®，它只结合膜形式的CD228而不结合其可溶形式 sMFI2，这种良好的结合特异性降低了非特异性结合，确保了更高的疗效及安全性；化学部分采用创新的连接子 ...

弘则消费｜ 2025 年下半年国内药品有哪些需要关注的政 策？20250617 摘要 丙类目录或商保目录预计下半年推出，标志着国家在公平与效率之间向 效率倾斜，通过商保满足中高端需求，有利于创新药定价和商保发展， 创新药进院和市场化销售将享受与乙类目录相同的待遇。 国家集采政策优化方案正在制定中，预计下半年推出，可能先实施中间 方案再进行优化后的正式方案。第十一批国家集采规则预计将比第十批 更加友好，确认国内医药政策向好趋势。 生物类似药集采试点存在争议，部分企业预计下半年可能落地，但产业 研究专家认为两年内不太会推行，若实施，价格降幅可能较大，但不会 像化学药那么极端。 2025 年医保谈判持续进行，肿瘤类创新产品和慢病自免类药物谈判符 合预期，但个别品种降价超预期，大品种价格仍值得关注，谈判时间与 往年相似。 国家及地方政府出台多项政策支持创新药发展，审评审批时间缩短至 30 天等措施提高研发效率，国家对制药行业重视度提升，未来可能通过出 口政策支持国内优质产品。 Q&A 今年（2025 年）上半年医药政策的推进情况如何？ 下半年有哪些重要医药政策值得关注？ 下半年预计将有多项重要医药政策落地，包括医保谈 ...

6月12日，截至港股收盘，恒生指数下跌1.36%，报24035.38点。绿叶制药（02186.HK）收报3.82港元/ 股，上涨9.46%，成交量3.07亿股，成交额11.48亿港元，振幅13.75%。 最近一个月来，绿叶制药累计涨幅78.97%，今年来累计涨幅60.83%，跑赢恒生指数21.47%的涨幅。 资料显示，绿叶制药集团有限公司致力于在中华人民共和国('中国')、美利坚合众国('美国')、欧洲、日 本及其他新兴国家或地区四个规模最大及增长速度最快的治疗领域(即肿瘤科、中枢神经系统('中枢神经 系统')、心血管系统及消化与代谢)进行创新药品的开发、生产、推广及销售。本集团的产品组合包括超 过30种产品,覆盖包括大型制药市场中国、美国、欧洲及日本在内等全球80个以上国家及地区以及快速 发展的新兴市场。本集团已经建立一个庞大的全国性销售及分销网络,2021年,其产品销售往全国30个 省、自治区和直辖市。本集团透过约1,000名销售和营销人员及一个由约1,780家经销商组成的网络进行 销售、营销及分销工作,共同令本集团将其产品销往19,330多家医院。于2021年,该等医院包括于中国的 三级医院约2,230 ...

Financial Data and Key Metrics Changes - The company expects to generate approximately $600 to $700 million in revenue for FY 2025, marking a significant increase from the previous year [5][18] - EBITDA guidance for FY 2025 has been raised to $200 to $280 million, up from $108 million in FY 2024, indicating a substantial growth trajectory [15][18] Business Line Data and Key Metrics Changes - The company has two commercial assets and a total of 28 assets in various stages of development, which is the largest biosimilars program globally [11][12] - The company has launched biosimilars in over 25 countries outside the US, with plans for three major approvals in the next six months [7][8] Market Data and Key Metrics Changes - The biosimilars market is maturing, with only 14 out of 62 biologic drugs that have gone off patent seeing launches, indicating significant growth potential [24][25] - The company targets a total addressable market of $185 billion with its existing pipeline of 28 drugs [27] Company Strategy and Development Direction - The company is focused on ramping up biosimilar launches and integrating R&D operations from its recent acquisition in Sweden [8][9] - The company employs a partnership model, selling through established players in each market, which allows for shared investment and risk [29][30] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the biosimilars market's growth, citing a long tail of opportunities due to many biologics still off patent [26][24] - The company anticipates a significant increase in revenue, projecting $1.5 billion by 2028, with product revenues contributing 80-85% of this total [19][20] Other Important Information - The company expects minimal CapEx requirements moving forward, with $60 to $70 million expected in FY 2025 and $25 million annually for the next three years [23] - The company has a favorable tariff position due to its operations in Iceland, which has low tariff rates [64][66] Q&A Session Summary Question: What are the key differentiators for Alvotech? - The company highlighted its close integration between R&D and manufacturing, a custom-built platform, and an exceptional management team as key differentiators [3][4] Question: What is the focus for the next 12-18 months? - The focus will be on executing biosimilar launches, obtaining major approvals, and integrating R&D operations from the recent acquisition [6][8] Question: What led to the raised guidance for 2025? - The raised guidance was due to the acquisition of Xbrain and the potential for partnerships and milestone income from new assets [13][15] Question: How does the company view the biosimilars market? - The company is excited about the biosimilars market, noting significant growth opportunities and a large addressable market [24][27] Question: How does the company structure its partnerships? - The company typically has a 60-40 revenue split in favor of the commercial partner, allowing it to mitigate commercial risks [41][42] Question: What is the impact of the IRA on the biosimilars market? - The IRA may disincentivize smaller players but could benefit larger biosimilar companies like Alvotech [58][59] Question: How does the company view tariffs? - The company expects minimal impact from tariffs due to its low tariff rates and the structure of its contracts with commercial partners [64][66]

Core Insights - Kiran Mazumdar-Shaw transformed her initial setbacks in pursuing a brewing career into a successful international biopharmaceutical company, Biocon, making her one of the wealthiest self-made female entrepreneurs globally [2][3] Company Overview - Biocon was founded in 1978 in a makeshift facility in Bangalore, India, initially producing fermentation enzymes for clients like Ocean Spray [3] - The company transitioned to biopharmaceuticals in 2000, launching its first product, insulin, using yeast instead of genetically modified E. coli, which provided a cost advantage over Western pharmaceutical companies [6][8] - Biocon's revenue reached $1.9 billion, with a significant portion derived from biosimilars, which account for approximately 55% of the company's revenue [8] Market Position and Strategy - The biopharmaceutical market is expanding, with spending on biologics reaching $324 billion in 2023, although this figure does not account for discounts provided by brand-name companies [6][8] - Biocon has launched nine biosimilars, including products that compete with AbbVie's Humira and Genentech's Herceptin, with seven approved for sale in the U.S. [9][10] - The company aims to introduce a new drug annually in the U.S. and Europe until 2030, with plans to launch a biosimilar for Regeneron's Eylea by the end of the year [11] Competitive Landscape - Biocon competes with major players like Sandoz, Samsung Biologics, and Amgen, particularly in emerging markets where it holds a significant market share of up to 80% for several biosimilars [10] - The U.S. market presents challenges due to the need to negotiate with pharmacy benefit managers (PBMs) for drug inclusion in insurance coverage, alongside potential tariffs on imported drugs [10] Future Outlook - The company is positioned for growth, with an estimated 118 biologic drug patents expiring by 2035, creating opportunities for biosimilar development [8] - Mazumdar-Shaw emphasizes the humanitarian aspect of the business, aiming to provide affordable healthcare solutions [12]

2025 年 06 月 03 日 行业点评 看好/维持 医药 Dr. Reddy's Q4 净利润同比增长 22%，超市场预期 走势比较 (20%) (12%) (4%) 4% 12% 20% 24/6/3 24/8/14 24/10/25 25/1/5 25/3/18 25/5/29 医药 沪深300 子行业评级 推荐公司及评级 相关研究报告 <<太平洋医药日报（20250530）：拜耳 Sevabertinib 获 FDA 优先审评资 格>>--2025-06-02 <<分子砌块专家，赋能新药研发>>-- 2025-05-30 <<太平洋医药日报（20250529）：诺华 伊普可泮在华获批新适应症>>-- 2025-05-30 证券分析师：周豫 E-MAIL：zhouyua@tpyzq.com 分析师登记编号：S1190523060002 证券分析师：乔露阳 E-MAIL：qiaoly@tpyzq.com 分析师登记编号：S1190524080001 报告摘要 事件： 2025 年 5 月 9 日，印度制药企业 Dr. Reddy's Laboratories 发布 2024- 2025 财年第四季度财报 ...