8月21日晚间，莱美药业(300006)发布2025年半年报，公司实现营业收入3.77亿元，报告期内，公司持续 聚焦优势细分领域，巩固公司拳头产品卡纳琳在相关领域的优势领先地位；保持新品持续引进，加快对 已引入新品的上市转换；通过加快高质量仿创新产品研发和技术引进，扩增仿制药业务；加大自主创新 力度，推动公司健康持续发展。 （文章来源：证券时报网） 报告显示，公司构建短、中、长期三维科研创新体系，短中期内，积极引进优质项目及创新技术，筛选 符合公司发展需要的潜力标的；公司技术中心继续开展新药仿创科研工作，进一步丰富公司细分领域产 品组合，提升公司在该领域竞争力。中长期内，公司继续推进如纳米炭铁等创新技术和产品的开发工 作；推动参股公司康德赛自主研发细胞免疫疗法和其他个性化创新医疗技术等产品，旨在培育核心技术 和长期竞争力。 公司通过研发、产品与渠道拓展的协同优势，积极适应新常态新趋势。报告期内，克林霉素磷酸酯注射 液、盐酸纳洛酮注射液、注射用尼可地尔、阿奇霉素颗粒剂、注射用吗替麦考酚酯、酮咯酸氨丁三醇注 射液等品种取得批件或补充申请批件、通过一致性评价。艾司奥美拉唑镁肠溶胶囊、替米沙坦片、注射 用艾司奥美拉唑 ...

Core Viewpoint - Huason Pharmaceutical has received a new drug production license and passed GMP compliance checks, which will enhance production capacity but will not significantly impact short-term performance [1] Group 1: Regulatory Changes - The company announced the receipt of a new drug production license from the Chongqing Drug Administration [1] - Two products, including injectable Esomeprazole Sodium, have been added to the production license [1] Group 2: GMP Compliance - The small-scale synthesis production line in the Rongchang Industrial Park has passed the GMP compliance check [1] - Both injectable Esomeprazole Sodium and the raw material drug (Agomelatine) have successfully passed GMP compliance checks [1] Group 3: Impact on Operations - These changes are expected to improve the company's capacity utilization and promote large-scale production [1] - However, the company does not anticipate a significant impact on its performance in the short term [1]

Core Viewpoint - The article highlights the ongoing issues with the timely supply of drugs and medical devices following centralized procurement in various regions of China, indicating a significant number of products have not established delivery relationships post-selection, which raises concerns about the reliability of selected suppliers [1][9]. Group 1: Issues with Drug Supply - As of May 31, 2023, 443 drug specifications have not established timely delivery relationships after centralized procurement in Guangzhou, with nearly 70% of the 221 identified underperforming products having a delivery rate of 0 [9][10]. - The Hebei Provincial Medical Procurement Center has announced that certain companies will be rated as "generally" untrustworthy due to inadequate delivery services, including Suzhou Terui Pharmaceutical and Lizu Group, which are involved in multiple national procurement batches [2][5]. Group 2: Specific Products and Companies - Lizu Group's voriconazole injection was selected in the eighth batch of national procurement at a price of 29.19 yuan per unit, a significant drop from its previous market price of 700-800 yuan, reflecting a price reduction of over 90% [2]. - Northland Pharmaceutical's iohexol injection was selected in the seventh batch of national procurement at a price of 91.3 yuan per unit, being the only contrast agent selected in that batch [3]. Group 3: Regulatory Framework and Consequences - The Hebei Provincial Medical Procurement Center has established a credit evaluation system for pharmaceutical pricing and procurement, categorizing untrustworthy behavior into four levels: "general," "medium," "serious," and "particularly serious" [7]. - Companies identified as untrustworthy may face consequences such as written warnings, risk notifications on procurement platforms, and restrictions on the procurement qualifications of related drugs and materials [7]. Group 4: Broader Supply Issues - Beyond medical institutions, there are also reported supply shortages in designated pharmacies, with 422 drugs not supplied, affecting various products and involving 289 manufacturers [8].

Core Viewpoint - The announcement from the Hebei Provincial Medical Supplies Procurement Center indicates that several companies are being rated as "generally" untrustworthy due to inadequate delivery services for selected products in the national centralized procurement process [1][2][3] Group 1: Companies Involved - Companies listed for potential untrustworthiness include Suzhou Terui Pharmaceutical, Sihuan Pharmaceutical, Lijun Group, Jiangxi Yongfeng Kande Pharmaceutical, Guangdong Saifeng Pharmaceutical, Beijing Fule Technology, and Beijing Beilu Pharmaceutical [1][2] - Lijun Group's voriconazole injection was selected in the eighth batch of national procurement at a price of 29.19 yuan per unit, down from a previous market price of 700-800 yuan, representing a price drop of over 90% [1] - Beilu Pharmaceutical's iopamidol injection was selected in the seventh batch of national procurement at a price of 91.3 yuan per unit, being the only contrast agent selected in that batch [1] Group 2: Regulatory Framework - The Hebei Provincial Medical Security Bureau established a credit evaluation system for drug pricing and procurement in late 2020, categorizing untrustworthy behavior into four levels: "general," "moderate," "serious," and "particularly serious" [3] - The "general" untrustworthiness rating applies to companies that fail to fulfill procurement or delivery contracts without valid reasons and do not notify procurement agencies in advance, provided it does not severely impact clinical treatment [3] - Once a company is rated as untrustworthy, the provincial procurement center will implement measures such as written warnings, risk notifications on procurement platforms, and restrictions on procurement qualifications [3] Group 3: Broader Industry Context - The issue of supply shortages is not limited to medical institutions; designated pharmacies in Hebei also face significant shortages, with 422 drugs reported as unavailable [4] - Other regions, including Liaoning, Hainan, and Guangzhou, have also reported issues with selected companies failing to deliver drugs on time since the implementation of centralized procurement policies [4] - As of May 31, 2023, 443 drug varieties had not established timely delivery relationships post-procurement, with nearly 70% of the identified varieties having a delivery rate of 0% [4] Group 4: Future Developments - By the end of 2024, 612 companies were rated as generally untrustworthy, 76 as moderately untrustworthy, 40 as seriously untrustworthy, and 7 as particularly seriously untrustworthy [5] - A new standard for credit evaluation will be implemented starting from the third quarter of 2025, simplifying the rating system from four levels to three: "untrustworthy," "seriously untrustworthy," and "particularly seriously untrustworthy" [6]

Group 1 - The biopharmaceutical industry is a rapidly growing strategic emerging industry globally, with significant government support and innovation driving its development [5][7] - The global biopharmaceutical market grew from $261.1 billion in 2018 to $363.8 billion in 2022, with a compound annual growth rate (CAGR) of 8.6%, and is expected to reach $783.2 billion by 2030, with a CAGR of approximately 10.1% from 2022 to 2030 [5] - In China, the biopharmaceutical market is projected to grow from $45.2 billion in 2019 to $66.5 billion in 2023, with a CAGR of 10.13%, and is expected to reach $162.8 billion by 2030, with a CAGR of approximately 13.64% from 2023 to 2030 [7] Group 2 - The company specializes in the production and sales of biopharmaceuticals, including the first commercialized nerve growth factor product, Jinlujie, which has been widely used in clinical applications for nerve injury repair [15][16] - The company’s subsidiary, Tianjin Hankan, is a well-known CRO-CDMO integrated service provider, offering a comprehensive range of drug development services from research to clinical trials and production [11][22] - The company has developed over 200 products for more than 600 enterprises, with significant achievements in the development of generic drugs and innovative drugs [12][11] Group 3 - The company has received various accolades, including being recognized as a "National Specialized and New 'Little Giant' Enterprise" and ranking among the top 50 innovative enterprises in the pharmaceutical industry [13] - The company’s product pipeline includes innovative drugs such as injection of Epinavamine, a targeted anti-tumor drug, and other pharmaceutical products that address various medical needs [17][18][20] - The company has made significant advancements in drug registration, with several products receiving approval from the National Medical Products Administration [37]