6月16日，国家药品监督管理局发布《关于优化创新药临床试验审评审批有关事项的公告（征求意见稿）》（下称《征求意见稿》），一项可能重塑中国创 新药研发格局的变革正拉开序幕——核心创新药品种的临床试验审评审批周期有望压缩至30个工作日。此外，据业内人士介绍，我国生物医药领域的BD交 易持续火爆，加上资本市场高度认可的推动，行业正从"研发投入期"迈向"价值兑现期"。随着更多创新药企实现盈利突破，中国医药产业的全球竞争力将进 一步提升。 企查查数据显示，国内现存4.56万家生物医药相关企业。注册量方面，2024年全年注册3079家相关企业。截至目前，今年已注册1618家生物医药相关企业， 其中前5月注册1453家，同比增长27.57%。从国标行业来看，超半数生物医药相关企业归属于科学研究和技术服务业，占比达56.22%。从城市线级分布来 看，生物医药相关企业主要密集分布在一线城市，占比达45.46%。 1.现存4.56万家生物医药相关企业 | 1600 | | --- | | 1400 | | 1 200 | | 1000 | | 800 | | 600 | 2.超半数相关企业归属于科学研究和技术服务业 企查查数据显 ...

近日，一则配股公告让近期风光无限的君实生物突遭市场冷遇。公告披露后，公司股价录得三连阴，跌 幅分别达6.65%、0.91%、3.1%。 高折价配股，研发管线"输血"迫切 根据公告，君实生物以每股25.35港元的价格配售4100万股新H股，较前一日收盘价折让高达11.52%， 预计募资净额约10.26亿港元。这笔资金的去向直指公司"烧钱"核心——70%将投入创新药研发，重点包 括JS207、JS212、JS213等双抗及ADC药物管线，剩余30%用于补充营运资金。 百亿研发投入背后的资金困局 作为手握4款商业化药品、近30款临床阶段药物的创新药企，君实生物的研发投入堪称豪掷。2021至 2024年累计研发费用超76亿元，2025年一季度研发投入同比再增26.89%至3.51亿元，占营收比例高达 70.03%。 然而巨额投入尚未换来盈利曙光。尽管核心产品拓益®一季度销售收入猛增45.72%至4.47亿元，推动总 营收增长31.46%，公司仍录得2.35亿元亏损。截至3月底，账面现金及金融资产仅30.22亿元，面对后期 临床高投入，资金链压力凸显。 资本市场的信心考验 此次配股恰逢君实生物股价高位——年内H股累计暴 ...

2025 年 6 月 17 日 医药: 超配 证券研究报告 / 公司更新报告 石药 (1093 HK, 买入, 目标价: HK$10.59) | 买入 | | --- | | 目标价: HK$10.59 | 当前股价: HK$8.84 | | --- | --- | | 股价上行/下行空间 | +20% | | 52 周最高/最低价 (HK$) | 9.48/4.27 | | 市值 (US$mn) | 13,462 | | 当前发行数量(百万股) | 11,954 | | 三个月平均日交易額 | 164 | | (US$mn) | | | 流通盘占比 (%) | 41 | | 主要股东 (%) | | | 鼎大集团有限公司 | 10 | | 联诚控股有限公司 | 8 | | 共成国际 | 6 | | 按 2025 年 6 月 13 日收市数据 | | | 资料来源: FactSet | | 主要调整 | | 现值 | 原值 | 变动 | | --- | --- | --- | --- | | 评级 | 买入 | 买入 | N/A | | 目标价 (HK$) | 10.59 | 8.88 | 19% | | 2 ...

Core Viewpoint - The stock price of Yipinhong (300723.SZ) has seen significant fluctuations, with a notable increase of 51.54% from May 17 to June 16, 2025, driven by market interest in its innovative drug AR882, which is currently in Phase III clinical trials [2][4]. Financial Performance - In 2024, Yipinhong reported a net loss of 540 million yuan, a drastic decline of 392.52% compared to a profit in 2023 [6]. - The company's operating revenue fell to 1.45 billion yuan in 2024, down 42.07% from 2.503 billion yuan in 2023, primarily due to increased market competition and policy impacts leading to price reductions [7][8]. Business Segments - The core businesses of pediatric and chronic disease medications both experienced revenue and gross margin declines in 2024. Pediatric drug revenue was 936 million yuan, a decrease of 39.04% year-on-year, while chronic disease drug revenue was 370 million yuan, down 51.97% [9][11]. - The gross margin for pediatric drugs decreased by 12.19 percentage points, and for chronic disease drugs, it fell by 42.29 percentage points [12]. Non-Recurring Losses - Yipinhong's non-recurring losses amounted to 251.1 million yuan in 2024, a significant drop from a gain of 64.63 million yuan in 2023, primarily due to a 266 million yuan refund related to medical insurance violations and asset impairments [13]. Government Subsidies - The company received only 16.01 million yuan in government subsidies in 2024, a decline of 79.8% from 2023, indicating a significant reduction in revenue-related government support [14]. Sales and Marketing Expenses - Yipinhong's reliance on a single sales model, the academic promotion model, has led to high sales expense ratios, which were 44.88% in 2023 and 34.86% in 2024, compared to the industry average of 24.73% and 28.80% [19][20]. - Despite a significant increase in R&D expense ratio to 22.40% in 2024, actual R&D spending only rose by 24 million yuan to 325 million yuan [20][21]. R&D and Capitalization - Over the past five years, Yipinhong has spent nearly 1.1 billion yuan on R&D, but only 13 million yuan was capitalized last year, raising concerns about the uncertainty and risk associated with its R&D projects [21][22]. Market Outlook - The market's increasing competition and the company's reliance on a few products for revenue generation may weaken its resilience against market fluctuations, posing challenges for future performance [14][22].

Core Viewpoint - Shuyou Shen (300204) has been dubbed the "king of A-share gains" in innovative drugs, with a nearly 500% increase in stock price over two months, driven by the progress of three innovative drugs, including the acceptance of the listing application for STSP-0601 by the National Medical Products Administration [1][4][10] Stock Performance - On June 17, Shuyou Shen's stock price opened at 39.1 yuan per share, peaked at 43.15 yuan, and ultimately closed at 35.75 yuan, down 8.33% for the day, with a trading volume of 2.27 billion yuan and a turnover rate of 12.27% [3][4] - The stock has seen a cumulative increase of 470.18% from April 8 to June 17, making it the top performer in the A-share innovative drug sector [4][10] Institutional Involvement - Recent trading data indicates that institutional investors and speculative funds have been the primary drivers behind the stock's price surge, with institutions net buying approximately 211 million yuan from May 27 to June 9 [4][10] New Drug Developments - Shuyou Shen is focused on developing therapeutic drugs for unmet clinical needs, with a particular emphasis on protein drugs and chemical drugs targeting infectious diseases, respiratory and critical illnesses, autoimmune diseases, and neurological disorders [6][10] - The most notable drug in development is STSP-0601, which has received a registration application acceptance notice from the National Medical Products Administration, aimed at treating bleeding in adult patients with hemophilia A or B [6][7][8] Financial Performance - The company has reported net losses for five consecutive years, with revenues declining from 4.25 billion yuan in 2020 to 3.25 billion yuan in 2024, and corresponding net losses increasing from -1.33 billion yuan to -1.45 billion yuan [10][11] - In Q1 of this year, the company reported revenues of approximately 63.21 million yuan, a year-on-year decrease of 33.45%, while the net loss was reduced to -2.335 million yuan [10][11] Market Outlook - Analysts suggest that the future direction for innovative drug companies should focus on diversification and innovation, emphasizing the importance of R&D investment and market strategy adjustments [12] - Shuyou Shen has indicated plans to utilize various financing methods to alleviate short-term pressures while continuing its commitment to innovative drug development [12]

近日，港交所披露赣州和美药业股份有限公司（简称"和美药业"）已根据第18A章规则提交主板上市申 请，国证国际担任独家保荐人。这家成立于2002年的创新驱动型生物制药企业，专注于自身免疫性疾病 和肿瘤领域小分子药物研发，正试图通过资本市场为其持续亏损的研发管线寻求新的"输血"通道。 和美药业已构建由7个小分子候选药物组成的产品管线，其中4种处于II期、III期临床试验或NDA阶段， 适用于12种适应症。然而，财务数据显示，其在2023年和2024年分别亏损1.56亿元和1.23亿元，且截至 2024年底流动资产净值仅剩450万元，2025年3月更是出现2550万元流动负债。在已获近10亿元投资、估 值高达39亿元的背景下，和美药业能否成功突围？ 双核心产品赛道竞争激烈，差异化策略成效待考 和美药业的核心产品Mufemilast是一种新型小分子磷酸二酯酶4B（PDE4B）蛋白表达阻断剂和PDE4抑 制剂，具有双重作用机制，已于2024年3月向国家药监局提交针对银屑病的NDA并获优先审评资格，预 计2025年下半年获批上市。招股书显示，该产品是唯一可直接用于潜伏性结核感染银屑病患者的药物， 安全性获III期临床支持 ...

证券研究报告|医药生物 [Table_Title] 优化创新药临床试验审评审批，加速创新药 研发 [Table_ReportType] ——医药生物行业快评报告[Table_ReportDate] [事件Table_Summary] ： 6 月 16 日，国家药监局官网发布《关于优化创新药临床试验审评审批 有关事项的公告（征求意见稿）》。对符合要求的 1 类创新药临床试验申 请在 30 个工作日内完成审评审批。 《征求意见稿》要点包括： 1、符合要求的应当为中药、化学药品、生物制品 1 类创新药，并满足 以下条件之一：1）国家支持的重点创新药；2）入选国家药品监督管 理局药品审评中心儿童药星光计划、罕见病关爱计划的品种；3）全球 同步研发品种； 2、符合要求的创新药临床试验申请在 30 个工作日内完成审评审批； 3、符合要求的创新药鼓励全球早期同步研发和国际多中心临床试验； 4、纳入创新药临床试验审评审批 30 日通道的申请由于需召开专家会 等技术原因，无法在 30 日内完成审评审批的，国家药品监督管理局药 品审评中心及时告知申请人，后续时限按照 60 日默示许可执行。 点评：国家药监局将创新药临床试验审评时 ...

Core Viewpoint - Junshi Bioscience has announced a new H-share placement, which has led to a decline in its stock prices in both A-share and Hong Kong markets, indicating market concerns about the company's financial strategies and performance [1][2]. Group 1: Stock Performance - On June 17, Junshi Bioscience's A-share closed at 34.64 CNY, down 3.10%, while its Hong Kong share closed at 23.50 HKD, down 9.09% [1]. - The stock had previously closed at 36.08 CNY and 25.65 HKD on June 13, reflecting a decline of 6.65% and 10.47% respectively [1]. Group 2: H-share Placement Details - The company plans to issue 41,000,000 new H-shares at a price of 25.35 HKD per share, which represents approximately 18.70% of the total issued H-shares and 4.16% of the total issued shares as of the announcement date [2]. - The expected total proceeds from the placement are approximately 1,039 million HKD, with a net amount of about 1,026 million HKD after deducting commissions and estimated expenses [2]. Group 3: Use of Proceeds - The company intends to allocate 70% of the net proceeds from the placement towards innovative drug research and development, including projects like JS207, JS212, and JS213 [3]. - The remaining 30% of the net proceeds will be used to supplement working capital and other general corporate purposes [3]. Group 4: Historical Financial Performance - Since its listing on July 15, 2020, Junshi Bioscience has experienced a significant decline in stock price, with the highest price reaching 220.40 CNY on the first trading day [5][6]. - The company has not declared any dividends or stock transfers since its IPO, and its cumulative fundraising from two rounds amounts to 8.613 billion CNY [7]. - The net profit attributable to shareholders has been negative for several years, with figures ranging from -1.35 billion CNY in 2016 to -12.81 billion CNY in 2024 [7].

21世纪经济报道记者韩利明上海报道 翰思艾泰也在招股书中坦言，"自成立以来，我们一直面临重大净亏损，预计在未来可预见的时期内， 将继续录得净亏损，并可能无法实现或维持盈利。"与此同时，翰思艾泰还背负着高额研发成本，2023 年和2024年研发成本分别达4670万元、7470万元，呈逐年上升趋势。 今年以来，港股创新药市场迎来强势反弹，开启新一轮上涨行情。数据显示，截至6月16日，恒生港股 通创新药精选指数（HSSCPB）年内累计涨幅达71.83%，与去年同期20.74% 的跌幅形成鲜明对比；港 股创新药ETF（159567）亦实现67.16%的可观增长。二级市场的持续回暖，为众多谋求上市的药企带来 新机遇，港股IPO市场掀起热潮。 仅6月以来，包括翰思艾泰、维立志博、银诺医药、东阳光药、长风药业、和美药业、轩竹生物在内的 七家本土药企相继递表赴港。此外，泰德医药、药捷安康也顺利通过港交所聆讯，即将叩响资本市场大 门。 值得一提的是，此次递表上市的药企中，翰思艾泰、维立志博、银诺医药、和美药业、轩竹生物仍处于 亏损状态。其中，前三家药企为2024年底递表失效后的再次更新。而长风药业、轩竹生物曾谋划A股 IPO未 ...

第 652 期 2025-06-17 焦点事件 巴奴递表港交所！一季度营收7.087亿元 6月16日晚间，巴奴国际控股有限公司向港交所提交上市申请书，联席保荐人为中金公司、招银国际。 披露文件显示，2024年一季度及2025年一季度，公司分别实现收入5.639亿元、7.087亿元，同期经调整 净利润分别为人民币5750万元、7670万元。截至最后实际可行日期，巴奴的直营门店网络覆盖全国39个 城市，门店数量达到145家，较2021年末增长74.7%。 创新药赛道，迎重磅利好！ 6月16日，国家药品监督管理局发布公告称，为落实《国务院办公厅关于全面深化药品医疗器械监管改 革促进医药产业高质量发展的意见》有关要求，支持创新药研发，国家药监局在开展优化创新药临床试 验审评审批试点工作经验基础上，组织起草了《关于优化创新药临床试验审评审批有关事项的公告（征 求意见稿）》，现向社会公开征求意见。 其中提到，为进一步支持以临床价值为导向的创新药研发，提高临床研发质效，对符合要求的创新药临 床试验申请在30个工作日内完成审评审批。药物临床试验申请审评审批30日通道支持国家重点研发品 种，鼓励全球早期同步研发和国际多中心临床 ...