证券研究报告·行业跟踪周报·医药生物 医药生物行业跟踪周报 2025ADA 重磅数据披露，关注减脂增肌、 Amylin 及口服赛道 增持（维持） [Table_Tag] [Table_Summary] 投资要点 2025 年 06 月 29 日 证券分析师 朱国广 执业证书：S0600520070004 zhugg@dwzq.com.cn 行业走势 -9% -5% -1% 3% 7% 11% 15% 19% 23% 27% 2024/7/1 2024/10/29 2025/2/26 2025/6/26 医药生物 沪深300 相关研究 《科研服务拐点已至，关注皓元医药、 毕得医药、百奥赛图等》 2025-06-23 《线上 618 大促收官+国补持续，关注 国产家用医疗器械放量机遇》 2025-06-21 东吴证券研究所 1 / 27 请务必阅读正文之后的免责声明部分 ◼ 本周、年初至今 A 股医药指数涨幅分别为 1.6%、6.2%，相对沪深 300 的超额收益分别为-0.4%、6.6%；本周、年初至今 H 股生物科技指数涨 跌幅分别为 2.7%、52.7%，相对于恒生科技指数跑赢-1.5%、32.2%； 本周 ...

百奥泰发布自愿披露关于与SteinCares就BAT2406(度普利尤单抗)注射液签署授权许可及生产、供货和商 业化协议的公告。根据协议，公司的BAT2406（度普利尤单抗）注射液在巴西以及其余拉丁美洲地区市 场的独占的产品商业化权益有偿许可给Stein。首付款及里程碑款总金额最高至 1,000 万美元，其中包括 100 万美元首付款、累计不超过 900 万美元里程碑付款，以及净销售额的两位数百分比作为收入分成。 戴维医疗：电动担架车获注册证，填补公司在急救设备领域的产品空白 戴维医疗发布关于新产品获得医疗器械注册证的公告。披露公司的新产品电动担架车获得了浙江省药品 监督管理局颁发的《医疗器械注册证》。电动液压担架车相较于传统手推式设备，在临床场景中展现出 显著优势，其电动液压升降系统能够实现平稳、快速的升降操作，减少了传统手动操作中可能出现的颠 簸和不适，同时也减少医护人员手动操作的强度，减轻医护负担。该产品医疗器械注册证的取得将完善 公司院前急救-院内转运全链路解决方案，填补公司在急救设备领域的产品空白。 翰宇药业：醋酸地加瑞克原料药获上市资格，可治疗晚期前列腺癌患者 先声药业：与瑞士Idorsia公司合 ...

智通财经APP获悉，近日，中金公司发布研报称，先声药业（02096）近期迎来创新管线的多重突破， 包括新一代抗失眠药科唯可（盐酸达利雷生片）获国家药监局批准上市、CDH6ADC（SIM0505）以最 高7.45亿美元的潜在交易额授权给NextCure等。中金将先声药业（02096）目标价上调45.5%至12.8港 元，对应2025/2026年市盈率24.9倍/22.3倍，隐含14.1%上行空间。 中金公司提到，6月20日，先声药业公告，其新一代抗失眠药科唯可（盐酸达利雷生片）获国家药监局 批准上市，用于治疗以入睡困难和/或睡眠维持困难为特征的成人失眠患者，且不作为精神药品管制。 根据公告，作为全球新一代抗失眠药，科唯可已在美国、英国、瑞士等11个国家及中国香港获批上市， 是目前唯一获欧洲药品管理局批准的改善日间功能的DORA类抗失眠药，安全性良好，无停药反应，未 发现成瘾性数据，中金认为有望填补失眠药物长期安全治疗空白。 同时，公司近期与Idorsia公司达成补充协议，公司将通过现金形式一次性支付5000万美元，并降低科唯 可销售里程碑付款和特许权使用费率，中金认为将更有效推进科唯可的商业化。 海外授权方面， ...

达利雷生海外和中国的Ⅲ期临床研究结果显示：达利雷生显著缩短入睡用时，显著减少入睡后的觉醒时 间，且后半夜改善幅度尤为突出；对主观总睡眠时间的延长显著高于安慰剂组，患者失眠主观感受减 轻；患者治疗期间无严重不良反应，停药后未发现戒断反应、反跳性失眠，上市后至今未发现成瘾性数 据。 6月23日，先声药业宣布，与瑞士Idorsia公司合作的抗失眠创新药——达利雷生（商品名：科唯可®） 获国家药品监督管理局正式批准在中国上市，用于治疗以入睡困难和/或睡眠维持困难为特征的成人失 眠患者，且未被作为精神药品管制，这意味着患者获取产品的便利性提升，可支持长期用药。 据介绍，传统失眠药的作用靶点是GABA受体，通过抑制神经兴奋"强制镇静"；达利雷生则靶向下丘脑 的食欲素通路，这是掌管觉醒的关键"开关"。 达利雷生作为一种双重食欲素受体拮抗剂，可以阻止食欲素神经肽（食欲素A和食欲素B）与其受体的 结合，从而有效降低食欲素水平，诱导自然睡眠。其独特机制不改变睡眠结构，避免了传统药物广泛镇 静大脑的方式，既能改善夜间睡眠质量，又能提升日间功能，在疗效与安全性上形成了"双重壁垒"。 达利雷生由瑞士Idorsia公司研发，已在美国、英 ...

www.hczq.com 证券研究报告 | 医药生物 | 2025年6月22日 第一部分 行情回顾 01 华创医药投资观点&研究专题周周谈 · 第131期 骨科耗材行业近况更新 本周周专题联系人：李婵娟 陈俊威 华创医药团队： | 首席分析师 | 郑辰 | | 执业编号：S0360520110002 | 邮箱：zhengchen@hcyjs.com | | --- | --- | --- | --- | --- | | 联席首席分析师 | | 刘浩 | 执业编号：S0360520120002 | 邮箱：liuhao@hcyjs.com | | 医疗器械组组长 | | 李婵娟 | 执业编号：S0360520110004 | 邮箱：lichanjuan@hcyjs.com | | 中药和流通组组长 | | 高初蕾 | 执业编号：S0360524070002 | 邮箱：gaochulei@hcyjs.com | | 分析师 | 王宏雨 | | 执业编号：S0360523080006 | 邮箱：wanghongyu@hcyjs.com | | 分析师 | 朱珂琛 | | 执业编号：S0360524070007 | 邮 ...

Market Review - The overall market performance for the week saw the CITIC Pharmaceutical Index decline by 4.16%, underperforming the CSI 300 Index by 3.71 percentage points, ranking last among 30 CITIC first-level industries [5] - The top ten stocks by increase included Angli Kang, Yuekang Pharmaceutical, and Innovation Medical, with gains of 21.21%, 19.34%, and 18.96% respectively [4][5] - The bottom ten stocks included Aoyang Health and Kanghui Pharmaceutical, with declines of 1% and 2% respectively [5] Overall Viewpoint and Investment Themes - The pharmaceutical sector is currently undervalued, with public funds (excluding pharmaceutical funds) having low allocations to this sector. The company remains optimistic about the growth of the pharmaceutical industry by 2025, driven by macroeconomic factors and the performance of major products [9] - In the innovative drug sector, there is a shift from quantity to quality, emphasizing differentiated products and international pipelines. Companies that can deliver profitable products are recommended for attention [9] - In the medical device sector, there is a notable recovery in bidding volumes for imaging equipment, and the home medical device market is supported by subsidy policies. The company suggests focusing on key players in this area [9] - The innovation chain (CXO + life sciences services) is expected to see a rebound in overseas investment and a bottoming out in domestic investment, indicating a potential for high growth in 2025 [9] - The pharmaceutical industry is anticipated to enter a new growth cycle, with a focus on specialty raw materials and the expiration of patents leading to new opportunities [10] Orthopedic Consumables Industry Update - The orthopedic consumables market is categorized into joint, spine, trauma, and sports medicine segments, with joint and spine categories holding approximately 90% market share in 2022 [16] - The market size for joint products is projected to grow from 187 billion yuan in 2024 to 408 billion yuan by 2029, with a CAGR of approximately 16.9% [24] - The spine products market is expected to grow from 171 billion yuan in 2024 to 335 billion yuan by 2029, with a CAGR of about 14.4% [24] - The trauma products market is forecasted to increase from 170 billion yuan in 2024 to 315 billion yuan by 2029, with a CAGR of around 13.2% [24] - The sports medicine market is anticipated to grow from 41 billion yuan in 2022 to 145 billion yuan by 2027, with a CAGR of 28.7% [24] Procurement Progress - The national procurement for orthopedic consumables has led to significant price reductions, with average price drops of 82% for joint products and 84% for spine products [30][31] - The procurement process has seen a high participation rate, with 171 companies bidding for spine products and a 98% success rate in the latest sports medicine procurement [35] - The domestic market is experiencing a rapid increase in the localization rate of orthopedic products, with joint product localization rising from 47% in 2020 to 79% in 2024 [25] International Expansion - The global orthopedic consumables market is projected to reach 48.6 billion USD (approximately 348.9 billion yuan) in 2024, with China's market share expected to be 17% [37] - Domestic companies are increasingly focusing on international markets, with significant growth in overseas revenue share for companies like Spring Medical and Dabo Medical [38]

ASCO 2025 大会公布多项重要临床数据：ASCO 2025 大会上，公司肿瘤管线共有18 项研究获展示，涵 盖苏维西塔单抗、SIM0270（口服SERD）、科赛拉等重点品种。我们建议重点关注：1）苏维西塔单抗 治疗铂耐药卵巢癌III 期研究的OS 最终分析，治疗组和对照组的中位OS 分别达到15.3 个月/14.0 个月 （HR 0.768，95% CI 0.595-0.991，P=0.0304），该适应症正处于上市审评阶段，我们预计将于年内获 批。考虑到贝伐珠在该适应症上并未取得统计学显著的OS 改善（III 期AURELIA 研究），我们认为该 结果进一步验证苏维西塔相比贝伐珠的me-better 潜质。2）SIM0270 + 哌柏西利治疗二线级以上 ER+/HER- 乳腺癌的Ib 期研究结果，ORR 和CBR 分别达到41.5%/82.5%，在基线ESR1 突变患者中则达 到87.5%/100%。目前公司正在开展一项III 期研究，评估SIM0270 +依维莫司治疗CDK4/6 抑制剂经治 ER+/HER2- 乳腺癌的疗效。此外，公司曾在4 月的AACR 大会上公布了多款处于临床早期/临床前ADC ...

以下文章来源于谭谈药市 ，作者谭紫媚 张懿 谭谈药市 . 太平洋证券医药组研究观点分享 文章转自2025年2月13日太平洋医药团队报告 ，分析师： 谭紫媚/ 张懿 投资要点 神经专科制药龙头地位稳固 （1）先必新舌下片获批，成为又一款能够改善卒中预后的重磅药物 先必新注射液于2020年获批上市后销售额快速增长，2020-2023年CAGR达749.9%。 2024年12月，先必新舌下片获批上市，有望与先必新注射液构成涵盖卒中全病程的序贯疗法。结合舌下给药的便捷性，急性脑卒中患者的依从性将有所提高。先 必新有望成为继依达拉奉后又一款能够改善卒中预后的重磅药物。 （2）全球新一代DORA类失眠药快速放量，达利雷生国内上市在即 凭借较好的疗效和安全性，新一代DORA类失眠药上市后销量均出现快速增长：苏沃雷生（默沙东）2020年销售额高达3.3亿美元，莱博雷生（卫材）2023年销售 额已超过苏沃雷生达2.6亿美元，达利雷生（Idorsia）正处于快速放量阶段。 2022年11月，公司与Idorsia订立许可协议，获得科唯可（达利雷生）在中国临床开发及商业化权利。2024年5月，科唯可在香港获批上市， 无精神类药物限制 ...

Core Viewpoint - The recent surge in the Hong Kong innovative drug sector, particularly for Xiansheng Pharmaceutical, is driven by favorable factors such as the cyclical resurgence of COVID-19 and record-breaking domestic innovative drug business development (BD) deals [1] Group 1: Stock Performance - Xiansheng Pharmaceutical's stock price has experienced a continuous rise since May 16, achieving a maximum increase of 28.33% by May 21, with a cumulative increase of nearly 50% year-to-date [1] - The stock has shown significant trading activity, with over 25 million shares traded on three consecutive days from May 19 to 21, indicating strong market interest [4] Group 2: Business Development Potential - The recent $60.5 billion BD deal between Innovent Biologics and Pfizer has spotlighted the potential of Chinese innovative drugs, with Xiansheng Pharmaceutical being a key player in this growth [2] - Xiansheng Pharmaceutical has developed multiple ADC (antibody-drug conjugate) candidates targeting various biomarkers, with products like SCR-A006 showing Best-in-Class potential [2] Group 3: International Expansion - Xiansheng Pharmaceutical has established a track record in international markets, with its first overseas deal for SIM0278 setting a record for domestic autoimmune drug BD at the time [3] - The company has secured a licensing agreement exceeding $1 billion for SIM0500 with AbbVie, currently undergoing clinical trials in the U.S. and China [3] Group 4: Innovation and R&D - The company has invested over 8.5 billion yuan in R&D over six years, developing over 60 innovative drug candidates across various therapeutic areas [5] - Three new drug molecules are in the NDA approval process, while four are in Phase III clinical trials, indicating a robust pipeline [5] - The anticipated launch of significant new drugs will further enhance the company's position in the global biopharmaceutical market [5]