整理 | GLP1减重宝典内容团队 近年来，司美格鲁肽凭借强劲的发展势头，迅速崛起为代谢类药物领域的明星产品，距离成为"全球药王"仅一步之遥。诺和诺德公司2024年的 财报显示，司美格鲁肽全系产品在2024年全年实现收入2018.49亿丹麦克朗（约合292.96亿美元），仅以微弱劣势不敌K药。然而， 考虑到司美 格鲁肽正处于高速增长阶段，而K药的增长已逐渐放缓，2025年司美格鲁肽有望登上"全球药王"的宝座 。 不过，司美格鲁肽能否在"全球药王"的位置上长期停留，仍存在不确定性。 未来一段时间内，来自中国的众多司美格鲁肽生物类似药可能会成 为影响市场走向的重要因素。 诺和诺德司美格鲁肽的专利将于2026年到期。 2025年3月31日，华东医药公告称，司美格鲁肽注射液的上市许可申请正式获受理，申报适应症为成人2型糖尿病患者的血糖控制。 2020年10月，中美华东与参股公司重庆派金生物科技有限公司签署合作协议，共同开发及商业化司美格鲁肽注射液。重庆派金负责完成临床前 研究，达到申报中国临床试验申请（IND）的标准；中美华东则负责后续的全球开发、注册及商业化工作。 2022年6月，华东医药的司美格鲁肽注射液2型糖尿 ...

Core Insights - Alvotech and Advanz Pharma have expanded their commercial partnership to include three additional biosimilar candidates, enhancing their collaboration in the European market [1][2][8] Group 1: Partnership Details - The new agreement includes biosimilar candidates to Ilaris® (canakinumab) and Kesimpta® (ofatumumab), along with a third undisclosed candidate, with Alvotech responsible for development and supply, while Advanz Pharma handles registration and commercialization in Europe [2][4] - The agreement encompasses development and commercial milestones totaling up to US$180 million (EUR 160 million) and includes a revenue-sharing model between the partners [2][4] Group 2: Market Potential - The partnership now covers proposed biosimilars referencing over ten originator biologics, with the current addressable market for these products in the relevant countries estimated at least US$13.8 billion [5][3] - Advanz Pharma aims to broaden access to rare disease and specialty medicines through this expanded collaboration, reinforcing its growth strategy in the biosimilars sector [4][3] Group 3: Company Background - Alvotech is focused on developing and manufacturing biosimilar medicines, with a pipeline that includes eight disclosed candidates targeting various diseases, including autoimmune disorders and cancer [7] - Advanz Pharma operates globally, with a focus on specialty, hospital, and rare disease medicines, and has a commercial presence in over 90 countries [10]

5月22日晚，百奥泰宣布，公司计划调整BAT3306（帕博利珠单抗）的开发策略，终止BAT3306正在开 展的BAT3306-002研究；将在审慎评估并作出决策后决定未来是否继续推进BAT3306项目。 未来是否继续推进未知 BAT3306是百奥泰开发的帕博利珠单抗（Keytruda）生物类似药，目前正在开展的BAT3306-002研究是 一项评价BAT3306联合化疗与Keytruda联合化疗在Ⅳ期非小细胞肺癌受试者中的药代动力学、有效性和 安全性的多中心、随机、双盲Ⅰ/Ⅲ期研究。 至于BAT3306开发策略调整原因，百奥泰表示，根据美国食品药品监督管理局（FDA）近期对生物类似 物产品的技术沟通内容，以及欧盟药品管理局（EMA）于2025年4月发布的关于生物类似物审评的思考 性文件，均体现出欧美药监官方在审批生物类似物产品的上市申请时，疗效比对研究的必要性已经大大 下降，对于大多数生物类似物产品，疗效比对研究已经不是上市审批时需要提交的必要数据。目前，全 球已有两家开发帕博利珠单抗生物类似药的公司宣布停止其产品的Ⅲ期疗效比对临床研究。德国药企 Formycon AG的帕博利珠单抗生物类似药申请取消了Ⅲ期临 ...

证券之星消息，2025年5月21日健友股份（603707）发布公告称华西医药孙曼萁、精砚基金林彦宏、君和资本 祝晨宇、开源证券阮帅、民生证券王维肖杨涛、平安养老邵瑾良、平安医药韩盟盟、申万研究所张静含、太 平保险张雪婷、天风医药刘一伯、哇牛资本合伙人陈剑光、东吴证券徐梓煜、西部医药邓琳茜、西部证券 （002673）李梦园、汐泰投资朱丹、湘财基金张泉、信达证券（601059）唐爱金、银华基金于蕾、招商证券 许菲菲侯彪肖笑园、浙商医药郭双喜盖文化、中金公司（601995）吴婉桦、中泰医药李雨蓓祝嘉琦、复胜资 产洪麟翔、中万宏源余玉君、中信证券韩世通朱家成、国海富兰克林刘牧、国盛证券胡偌碧、华泰证券陈睿 恬袁中平、华源医药陶宸冉、交银施罗德王少成周章庆、金友创智范佳锴于2025年5月20日调研我司。 具体内容如下： 问：公司对美国关税政策以及特朗普签署行政令并宣布药价将立即降低30%-80%的看法？ 答：目前观点认为医药行业因刚需属性及高监管门槛受政策影响有限，我们后续会积极关注政策动态。面对 目前20%的关税挑战，我们已开始调整受影响产品的原料药供应链，同时重点布局高壁垒、高毛利产品以保 持竞争优势。中长期看，美 ...

Core Viewpoint - The company received an inquiry letter from the Shanghai Stock Exchange regarding its 2024 annual report, prompting a detailed response about its operational performance and product sales [1][2]. Group 1: Operational Performance - In 2024, the company achieved operating revenue of 200 million yuan, a year-on-year increase of 243.53% [2][19]. - The company has three commercialized products: Junmaikang, Mailishu, and Maiweijian, with varying sales performance and challenges [2][3]. - Junmaikang's sales volume significantly decreased by 66.61%, with 48,821 units shipped in 2024 [2][10]. - Mailishu's sales revenue increased by 195.50%, with a total revenue of 12.44 million yuan in 2024 [3][5]. - Maiweijian achieved a total revenue of 14.46 million yuan in 2024, with a gross margin of 78.47% [4][11]. Group 2: Product Analysis - Junmaikang's sales were impacted by its late market entry and intense competition, leading to a strategic shift in sales approach [6][9]. - Mailishu's cost increased by 1,122.70% compared to the previous year, resulting in a decrease in gross margin by 9.96 percentage points [5][6]. - Maiweijian's market entry was slow, with only 75 hospitals approved by the end of 2024, attributed to its limited indications compared to the original drug [12][14]. Group 3: Market Trends and Strategies - The TNF-α drug market in China grew from 3.5 billion yuan in 2019 to 42.9 billion yuan in 2023, with a compound annual growth rate of 17.5% [6][7]. - The company plans to expand Maiweijian's indications to include SREs, which could enhance its market presence [23][24]. - The company is actively pursuing international collaborations and expanding its product pipeline to enhance revenue streams [25][26]. Group 4: Financial Outlook - The company anticipates gradual revenue growth and a reduction in net losses over the next three years, with a low risk of expanding losses [20][19]. - The company is focusing on improving operational efficiency and expanding its commercialized product offerings to achieve profitability [20][21].

Core Viewpoint - The company, Maiwei (Shanghai) Biotechnology Co., Ltd., reported a significant increase in revenue for 2024, driven by its commercialized products and technical services, while facing challenges in market penetration and competition in the biopharmaceutical sector [3][21]. Financial Performance - In 2024, the company achieved a revenue of 200 million RMB, representing a year-on-year growth of 56.28% [3]. - The revenue breakdown includes 145 million RMB from antibody drugs and 55 million RMB from technical services [3]. - The sales volume of the product Junmaikang decreased by 66.61% year-on-year, with a total shipment of 48,821 units [3][10]. Product Analysis - The company has three commercialized products: Junmaikang, Mailishu, and Maiweijian, with detailed sales revenue, costs, and gross margins provided [3][5]. - Junmaikang's sales revenue for 2024 was 124.37 million RMB, with a gross margin of 6.25% [5]. - Mailishu's sales revenue was 145.94 million RMB, with a gross margin of 86.87% [5]. - Maiweijian's sales revenue reached 145.92 million RMB, with a gross margin of 78.47% [5]. Market Dynamics - The TNF-α drug market in China grew from 3.5 billion RMB in 2019 to 10.1 billion RMB in 2023, with a projected growth to 42.9 billion RMB by 2032 [7]. - The competitive landscape for Junmaikang is challenging, with multiple similar products already in the market, leading to a decline in its sales volume [9][10]. Strategic Adjustments - The company is optimizing its regional operating model to improve efficiency and resource utilization, transitioning from self-operated sales to cooperative sales in underperforming areas [10][21]. - The company plans to expand the indications for Maiweijian to enhance its market competitiveness and sales revenue [25][21]. Research and Development - The company has several products in the pipeline, with multiple candidates entering Phase III clinical trials, expected to launch between 2028 and 2031 [20][21]. - The company is actively pursuing international collaborations and market expansions, particularly in emerging markets [26][27]. Technical Services - The technical service revenue composition includes significant contracts with major clients, contributing to the overall revenue [15][19]. - The company has received substantial payments for milestone achievements in its technical service agreements [15].

华兰生物 20250519 摘要 • 公司通过稳定产品价格、保障医院供应和调整销售策略，在行业压力下实 现了产销量和利润的持续增长。2024 年精品价格维持在 700 元，人才价 格在 420-450 元，与竞品降价形成对比。 • 公司对院内与院外市场供应比例无严格考核，但保证医院和药店供应，并 通过销售人员走访确保供应链稳定。疫情期间对医院维护较好，人血白蛋 白和静注人免疫球蛋白推广顺畅。 • 公司出厂价保持稳定，通过定期走访和流向查看约束经销商，确保医院供 货。人血白蛋白和精品自疫情前至今出厂价基本不变，经销商断供可能导 致市场份额被抢占。 • 疫情期间人血白蛋白和精品等产品在外部市场出现非正常高价，但公司出 厂价基本稳定，销量持续增长。人血白蛋白最高限价为 378 元，疫情期间 价格维持高位，2024 年第三季度后逐渐回归常态。 • 进口人血白蛋白关税提高 10%，导致成本增加，可能导致终端价格回升。 目前出厂价与终端架构价较为接近，配送商业公司仍有利润空间，降价可 能性较低。 Q&A 今年（2025 年）血制品行业面临的主要压力是什么？贵公司在一季度业绩表 现优于行业平均水平的原因有哪些？ 今年（20 ...

证券之星消息，2025年5月19日百奥泰(688177)发布公告称公司于2025年5月16日接受机构调研，鹏华基 金、建信理财、平安基金、嘉实基金、博时基金、中信资管、Sigma AM、Temasek、富国基金、淡水泉、 中泰医药、工银瑞信、乐瑞资产、易方达、泰康资产、华泰资管、国民养老、3W、太平养老参与。 具体内容如下： 一、公司产品情况简介： 公司现有4款上市产品，包括：格乐立?(阿达木单抗)、普贝希?(贝伐珠单抗)、施瑞立?(托珠单抗)和贝塔 宁?(枸橼酸倍维巴肽)，这4款产品均已经在国内开始销售，其中贝塔宁?从今年开始销售；有2款产品 TOFIDENCE?(托珠单抗)和Avzivi?(贝伐珠单抗)已在欧洲和美国获批。TOFIDENCE在2024年5月开始由 Biogen在美国销售，今年4月Organon通过收购获得了TOFIDENCE在美国的相关权利，预计在完成一系列 环节转移或者交接后在今年下半年开始启动销售。问：答环节： 答：二、问环节 公司董事长、总经理李胜峰博士主要就以下问题与调研人员进行了交流：问：特朗普出美国药企降价对公 司经营和中国创新药企的影响如何？美国近期的政策变化是否会对生物类似 ...

Alvotech (ALVO) Conference Call Summary Company Overview - Alvotech is a dedicated biosimilar company with a comprehensive pipeline and a focus on providing affordable biologic drugs globally, operating in over 90 countries [5][6][4]. Key Points and Arguments Business Model and Strategy - Alvotech has adopted a partnership model to maintain flexibility and expand its pipeline, which has led to the largest biosimilars pipeline in the industry with around 30 projects [5][6][7]. - The company specializes in both development and manufacturing of biosimilars, allowing for faster and more efficient execution compared to competitors who may rely on contract manufacturers [10][8][9]. - Vertical integration is not currently a focus, as the partnership model has proven successful [11]. Market Dynamics and Product Launches - The total addressable market and competitive landscape are critical factors in determining which products to pursue [13][15]. - Alvotech anticipates a steady stream of product launches, with six products expected by early next year and three to four more by the end of Q4 [18][19]. - The company expects to navigate pricing pressures through a broad pipeline and significant revenue from ex-U.S. markets [19][52]. Financial Projections - By 2028, Alvotech targets revenues of approximately $1.5 billion, with an EBITDA margin of 40% to 45% and product margins of 60% to 65% [24][25][56]. - The company has a CapEx requirement of $60 to $70 million for the year, with no substantial increases expected, indicating strong operating leverage as more products are commercialized [56][57]. Competitive Landscape - Alvotech differentiates itself through its proprietary auto-injector design and a focus on difficult-to-develop products, which allows it to leverage its R&D expertise [22]. - The company acknowledges the competitive dynamics in the U.S. market, particularly with the launch of biosimilars like Stellara, and expects a gradual ramp-up in market share [30][40]. Pricing and Market Adoption - Alvotech is cautious about entering a "race to the bottom" in pricing, emphasizing the importance of sustainable pricing strategies [45]. - The company has observed that European markets have become increasingly profitable and stable, contrary to previous perceptions that U.S. markets were more lucrative [47][48]. Partnerships and Collaborations - Alvotech has established strong partnerships with companies like Teva and Dr. Reddy's, which have been beneficial for regulatory approvals and market penetration [75]. Additional Important Insights - The company is prepared for potential FDA inspection issues with contingency plans and multiple partnerships in place [62]. - Alvotech is optimistic about the adoption of biosimilars in the ophthalmology market, particularly with products like EYLEA, and is positioned to launch competitively [63][71]. This summary encapsulates the key insights from the Alvotech conference call, highlighting the company's strategic focus, market dynamics, financial outlook, and competitive positioning in the biosimilars industry.

健友股份 20250513 摘要 • 健友股份通过肝素原料药起家，逐步发展到依诺肝素钠注射剂、小分子注 射液，再到大分子生物类似物，构筑了三段成长曲线，并在产业链、生产 技术环节、注册申报、商品化及商业化方面具备显著协同性，实现终端利 润增值。 • 公司深耕美国市场多年，制剂收入占比超 70%，海外制剂占比约 54%。 美国关税调整后，公司估值与股价处于底部，大分子生物类似物进入放量 元年，将成为未来业绩主要驱动引擎。 • 全球生物制药市场规模庞大，生物类似药市场潜力巨大。美国通胀削减法 案（IRA）通过重构医保支付结构，提升医生开具生物类似药处方利润， 迫使保险公司选择成本更低的生物类似药，为生物类似药发展提供契机。 • 健友股份在生物类似药领域积极布局，阿达木单抗预计 2025 年销售收入 可达 3,000 万美元，已获得 75 万只利拉鲁肽订单，预计 2025 年销售 100 万只，并计划于 10 个月内完成高浓度阿达木单抗品种审批。 • 美国无菌注射剂市场长期处于短缺状态，健友股份具备强大的商业化能力 和产能优势，拥有 12 条通过美国 FDA 审核的注射剂生产线，预计 2026 年底至 2027 年 ...