证券代码：300294 证券简称：博雅生物 公告编号：2025-027 华润博雅生物制药集团股份有限公司 关于公司获得药物临床试验批准通知书的公告 本公司及董事会全体成员保证公告内容真实、准确和完整，没有虚假记载、 误导性陈述或重大遗漏。 近日，华润博雅生物制药集团股份有限公司（以下简称公司）收到国家药品 监督管理局(以下简称国家药监局)核准签发的皮下注射人免疫球蛋白《药物临床 试验批准通知书》(通知书编号：2025LP01029)。现将有关情况公告如下： 一、药品的基本情况 药品名称：皮下注射人免疫球蛋白 剂型：注射剂 申请事项：临床试验 受理号：CXSL2500031 审批结论：根据《中华人民共和国药品管理法》及有关规定，经审查，2025 年01月09日受理的皮下注射人免疫球蛋白符合药品注册的有关要求，同意开展原 发性免疫缺陷病的临床试验。 适应症：原发性免疫球蛋白缺乏症，如X联锁低免疫球蛋白血症，常见变异 性免疫缺陷病，免疫球蛋白G亚型缺陷病等。 上述产品在生产、上市销售前还需履行的主要审批程序包括：开展临床试验、 提交药品上市许可申请、通过国家药品监督管理局药品审评中心审评及国家药品 监督管理局审批后 ...

Investment Rating - The report assigns an "Overweight" rating to the pharmaceutical and biotechnology industry, indicating that the industry index is expected to outperform the CSI 300 index by 10% or more over the next six months [35]. Core Insights - The pharmaceutical and biotechnology sector showed a 1.20% increase in performance from March 31 to April 3, ranking third among 31 industries and outperforming the CSI 300 index by 2.57 percentage points [11][16]. - Year-to-date, the sector has risen by 4.77%, ranking seventh among 31 industries and surpassing the CSI 300 index by 6.64 percentage points [16]. - The current PE valuation for the pharmaceutical and biotechnology sector stands at 27.2 times, which is at a historically low level, with a 130% premium compared to the CSI 300 index [20]. Market Performance - The top three sub-sectors in terms of growth last week were chemical pharmaceuticals (3.45%), traditional Chinese medicine II (1.53%), and pharmaceutical commerce (1.48%) [11]. - A total of 344 stocks (72.57% of the sector) experienced price increases last week, with the top five performers being Duorui Pharmaceutical (56.32%), Weisi Medical (31.80%), Hasanlian (31.15%), Rundu Co. (27.01%), and Shengnuo Biological (21.54%) [25][26]. Industry News - On April 4, the Ministry of Commerce announced investigations into the competitiveness of imported medical CT tubes and initiated anti-dumping investigations against imports from the United States and India [27][30]. - The investigations will assess the impact of these imports on the domestic industry and its competitiveness, covering the period from January 1, 2024, to December 31, 2024, for dumping and from January 1, 2022, to December 31, 2024, for industry damage [29][30]. Investment Recommendations - The report suggests focusing on sectors such as innovative drugs, medical services, and domestic market-oriented businesses, which are less affected by trade frictions [31]. - It highlights the potential for accelerated domestic substitution in high-end medical equipment and blood products due to ongoing tariff disputes [31]. - Recommended stocks include Beida Pharmaceutical, Laobaixing, Lingrui Pharmaceutical, Huaxia Eye Hospital, and Boya Biological, with additional stocks to watch being Tebao Biological, Kelun Pharmaceutical, International Medicine, Kaili Medical, and Nuotai Biological [32].

Group 1: Policy Support for Pharmaceutical Innovation - Beijing encourages local production of innovative pharmaceuticals, supporting enterprises in importing significant drug and medical device varieties, and promoting the industrialization and large-scale application of innovative products [1] - Shenzhen offers financial incentives for innovative drugs that complete clinical trials and achieve domestic and international market entry, with rewards up to 30 million yuan based on clinical trial phases [2] Group 2: Company Developments - Heng Rui Medicine grants exclusive commercialization rights of its new drug SHR7280 to Germany's Merck, receiving an upfront payment of 15 million euros and potential milestone payments and sales royalties [3] - East China Pharmaceutical's subsidiary receives approval for clinical trials of DR30206, a novel antibody fusion protein targeting PD-L1, VEGF, and TGF-β, marking a significant advancement in its development [4] Group 3: Market Trends and Opportunities - Blood product stocks, including Wei Guang Bio and Pai Lin Bio, experience a surge due to the rigid demand for blood products and potential price increases from U.S. tariffs, benefiting domestic companies and presenting strategic opportunities for market share growth [6]

Market Overview - The Asia-Pacific stock markets experienced a significant decline, with the Nikkei 225 index dropping 7.83% to close at 31,136.58 points, and the South Korean Composite Index falling 5.57% to 2,328.03 points, marking a new low for November 2023 [1] - The Australian S&P 200 index decreased by 3.89% to 7,369.4 points, while the New Zealand S&P 50 index fell 3.68% to 11,775.88 points. The Hong Kong Hang Seng Index plummeted over 13%, falling below the 20,000-point mark, and the Hang Seng Tech Index dropped over 17% [1] - European markets also faced declines, with the Euro Stoxx 50 index down over 5%, and major indices like Germany's DAX, France's CAC40, and Italy's FTSE MIB all dropping more than 6% [1][2] A-Share Market Performance - The A-share market saw widespread losses, with the Shanghai Composite Index plunging 7.34% to 3,096.58 points, and the Shenzhen Component Index falling 9.66% to 9,364.5 points. The ChiNext Index dropped 12.5% to 1,807.21 points, and the North Star 50 Index fell nearly 18% [2] - Approximately 5,300 stocks in the A-share market were in the red, with around 3,000 stocks hitting the daily limit down, indicating a severe market downturn [3] Sector Performance - The semiconductor sector experienced significant declines, with stocks like Guomian Technology, Jiangbolong, and Weir Shares hitting the daily limit down [6] - The pharmaceutical sector also saw a drop of over 10%, with companies such as Boteng Co., Jincheng Pharmaceutical, and WuXi AppTec facing substantial losses [5] - Conversely, the blood products sector showed resilience, with companies like Palin Bio and Weiguang Bio hitting the daily limit up, driven by the inelastic demand for blood products and potential price increases due to tariffs on imports [8] Investment Strategies - Analysts suggest that the current market conditions may lead to a continued period of volatility, with a focus on stable dividend strategies and sectors benefiting from domestic demand policies [11] - Emphasis is placed on identifying high-quality companies with stable earnings, particularly in sectors with strong domestic market demand [11] - The impact of tariff policies on various sectors, including agriculture and semiconductor materials, is highlighted, with recommendations to focus on sectors with strong performance certainty and low valuations [11]

Core Viewpoint - The recent imposition of a 34% tariff on U.S. imports by China is expected to benefit domestic blood product companies, as it may lead to a price increase for imported human albumin, thereby enhancing the market share of domestic products [3][4]. Group 1: Market Impact - The demand for blood products is relatively inelastic, and the tariff is unlikely to significantly affect overall demand due to its essential nature [4]. - China imports over 60% of its human albumin products, with the U.S. being a major supplier, exporting $54.6 billion in blood products in 2024 [4]. - The price of imported human albumin is expected to rise, reducing its competitive advantage over domestic products, which may lead to an increase in market share for local companies [5]. Group 2: Pricing Dynamics - As of April 6, 2025, domestic human albumin prices are slightly higher than imported ones, but the tariff may eliminate the price advantage of imports [5]. - For example, the price range for imported human albumin (10g specification) is between 345-438 RMB, while domestic products range from 359-580 RMB [5]. Group 3: Supply Chain and Industry Structure - The blood product industry is characterized by a limited number of manufacturers, creating an oligopoly with companies like Tian Tan Bio, Shanghai Raist, and Hualan Biological [6]. - The industry is less affected by geopolitical risks due to its self-sufficient supply chain and the nature of its products [6][7]. - The ongoing trade tensions may enhance the internal circulation advantages of the blood product industry, supporting its long-term growth prospects [7].

Group 1 - The U.S. government has implemented a 10% "minimum benchmark tariff" on trade partners, with certain exemptions for pharmaceuticals and other products [1][2] - The pharmaceutical sector has reacted negatively in the market, with significant declines in various related sectors, including medical services and biopharmaceuticals, with drops ranging from 9.55% to 14.69% [1] - The exemption of pharmaceuticals from the tariff is due to the high reliance of the U.S. on imported active pharmaceutical ingredients (APIs), with 80% of APIs sourced from abroad [2][3] Group 2 - Local pharmaceutical companies have reported minimal impact from the tariff changes, as the tariffs do not apply to innovative drug licensing and trade [5][6] - Companies like Mindray Medical and others have proactively prepared for potential tariff impacts by adjusting their supply chains and inventory strategies [6][5] - The focus on high-quality innovation is emphasized as a key strategy for the Chinese pharmaceutical industry to navigate the challenges posed by tariffs and global competition [8][7] Group 3 - The number of innovative drugs developed by Chinese companies is rapidly increasing, with projections indicating that by the end of 2024, there will be 3,575 active innovative drugs, surpassing the U.S. [7] - Chinese pharmaceutical companies are actively expanding into international markets, with significant license-out transactions and collaborations with multinational corporations [7][8] - The "NewCo" model is emerging as a viable path for Chinese biopharmaceutical companies to innovate and expand internationally, despite geopolitical challenges [8]

Group 1 - The blood products sector is experiencing growth, with companies like Shijiazhuang Yiling Pharmaceutical, Palin Bio, Boya Bio, and Tiantan Bio seeing stock price increases [1] - Shanxi Securities reported strong demand for immunoglobulin and albumin, with a projected market share of 6.5% and 2.5% for the company in 2023, respectively [1] - The domestic market for immunoglobulin is expanding, and the company is expected to benefit from the launch of new generation immunoglobulin products [1] Group 2 - Boya Bio aims to achieve a plasma collection of 630.6 tons in 2024, representing a year-on-year growth of 10.4%, with its main facility collecting 522.04 tons, up 11.7% [1][2] - The company is committed to compliance and operational efficiency, expecting double-digit growth in plasma collection by 2025 [1][2] - The blood products industry has not yet been included in national centralized procurement, but local and regional procurement initiatives have begun since January 2022 [2] Group 3 - Boya Bio is focusing on international expansion through product registration and technical cooperation, aiming to increase market share for immunoglobulin and factor VIII products [2] - The company is advancing innovative treatments for rare diseases, including small nucleic acids and gene therapies, to enhance its global presence [2] - The company’s president emphasized a focus on optimizing plasma utilization and enhancing product structure to improve profitability [3]

Investment Rating - The report maintains a "Recommended" rating for the industry, indicating a positive outlook for the sector's fundamentals and expectations for the industry index to outperform the benchmark index [4]. Core Insights - The pharmaceutical industry is primarily driven by domestic demand, with most sub-sectors minimally affected by tariff impacts, such as medical services, innovative domestic drugs, traditional Chinese medicine, and pharmacy/retail [1][3]. - There is significant potential for import substitution in high-import sectors like blood products, certain medical devices, and key components, which are expected to benefit marginally from the current tariff situation [1]. - The report highlights specific sectors to watch, including blood products, domestic consumption-related sectors, and medical devices, which are poised for growth due to favorable policies and market conditions [2]. Summary by Relevant Sections Blood Products - The overseas share of human albumin exceeds 60%, and with tariffs on imported albumin, domestic prices are expected to recover. The "14th Five-Year Plan" for new plasma stations is also promising. Companies to focus on include Palin Biotech, Tiantan Biological, and Boya Biological [2]. Domestic Consumption - External impacts are minimal, and consumption policies are catalyzing recovery in certain areas. Key companies include medical services (e.g., Aier Eye Hospital, Tongce Medical), beauty services (Aimeike), pharmacies (Yifeng Pharmacy, Dazhong Pharmacy), and traditional Chinese medicine (Dong-E E-Jiao, China Resources Sanjiu) [2]. Medical Devices - For core components, the domestic market for medical CT tubes is largely dominated by imports, with potential benefits from anti-dumping investigations. Companies to watch include Yirui Technology and United Imaging Healthcare [2]. - In consumables, the domestic market for electrophysiology is under 10% localization, with U.S. companies leading. Companies like Huitai Medical and Microelectrophysiology are expected to benefit from increased localization [2]. - In vitro diagnostics (IVD) are also highlighted, with certain leading foreign companies facing tariffs that may accelerate import substitution. Recommended companies include New Industries, Mindray Medical, Antu Biology, and Yanhui Long [2]. Pharmaceuticals - The report indicates that the pharmaceutical sector is largely unaffected by tariffs, with a focus on domestic innovation. Companies to monitor include Heng Rui Medicine, Innovent Biologics, and Fuhong Hanlin [3].

Investment Rating - The industry investment rating is "Recommended" [1] Core Insights - The report highlights the impact of escalating trade conflicts on the supply chain of pharmaceuticals, particularly regarding the exemption of certain drugs from tariffs, which reflects the U.S.'s reliance on global pharmaceutical supply chains [3] - The report emphasizes the importance of international markets for Chinese pharmaceutical exports, with a projected export value of $107.96 billion in 2024, indicating a growth of 5.9% year-on-year [4] - The report discusses the potential changes in the supply landscape for blood products due to new tariffs, which may accelerate domestic substitution opportunities [6] - The report notes the ongoing evolution of raw material applications, particularly in the nicotine sector, as companies explore new production avenues [8] - The report indicates that the optimization of centralized procurement policies may alleviate pricing pressures on traditional pharmaceutical companies [10] - The report outlines advancements in CAR-T cell therapies, with significant sales growth and the potential for cost reductions in the future [12] Summary by Sections 1. Pharmaceutical Market Tracking - The pharmaceutical industry outperformed the CSI 300 index by 2.57 percentage points in the past week, ranking third among 31 primary industry indices [23] 2. Pharmaceutical Sector Trends and Valuation - The pharmaceutical sector's index has shown a 3.15% increase over the past month, outperforming the CSI 300 index by 4.20 percentage points [40] - The current PE (TTM) for the pharmaceutical sector is 31.25, which is below the historical average of 32.95 [45] 3. Recent Research Achievements - The report lists various deep-dive studies conducted by the research team, focusing on supply and demand dynamics in the blood products sector and the impact of policy support on inhalation drug markets [49] 4. Important Industry Policies and News - Recent policy updates include the release of the 2025 edition of the Pharmacopoeia of the People's Republic of China, which will take effect on October 1, 2025 [52] - Significant industry news includes the approval of new drug applications by major pharmaceutical companies, indicating ongoing innovation and market activity [54][55]

血制品概念7日盘中集体上扬，截至发稿，博晖创新（300318）涨超12%，博雅生物（300294）涨超 10%，派林生物（000403）、卫光生物（002880）涨停，天坛生物（600161）涨近9%，华兰生物 （002007）涨超5%。 该机构表示，血制品生产涉及国家生物安全且具备资源品属性，由于政策限制，目前行业内仅存较少厂 商，形成了以天坛生物、上海莱士（002252）、华兰生物、派林生物等为主的寡头格局，产业链自主可 控，受海外地缘政治风险影响较小。随着血制品行业内多个企业股东实力的持续提升，优质血制品资产 的竞争力将持续提升，战略发展路径将更加清晰，未来中国有望出现多个具备全球竞争力的血制品巨 头。在贸易摩擦背景下，血制品行业具备内循环性质，外部贸易政策对我国血制品行业自身发展负面影 响较小，看好其长远发展。 机构表示，血制品市场需求较为刚性，加征关税可能会造成短期进口白蛋白价格上涨，利好国产企业。 光大证券指出，血制品可治疗多种疾病，需求端受经济周期影响小，呈现刚性需求属性，贸易摩擦对需 求影响有限。另外，血制品具备资源属性，受上游原材料血浆供应影响，整体市场供给有限。我国约有 60%以上的人血白 ...