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中国仿制药行业市场竞争加剧
第一财经· 2025-11-24 04:06
2025.11. 24 本文字数:2412,阅读时长大约4分钟 作者 | 第一财经 吴斯旻 近年来,"带量采购"政策让优质优价的仿制药加速临床准入与经济性替代。与此同时,随着"国谈"中 生物药占比增加,"谈判药品同通用名仿制药上市自动属于目录范围"的医保政策则为生物类似药挂网 入院及院内推广提供便利。 双重趋势下,中国仿制药行业的市场竞争加剧——仿制药的研发水平和一致性评价通过率明显提升, 却也面临"品种同质化"和"生产拼成本"等发展困境。 近日,中国医学科学院药物研究所、中国医药工业信息中心和中国食品药品检定研究院联合发布的 《中国仿制药发展报告(2025)》(下称"报告")显示,中国仿制药市场规模多年维持在9000亿元 水平,企业与品种数量的增加正进一步加剧市场存量竞争。 第一财经梳理报告发现,在化学仿制药领域,2024年,通过一致性评价或视同过评的品种数较三年 前增加了超过2/3,但当年增长主要由少数企业和既往过评品种的持续获批推动;而在生物类似药领 域,截至2024年,我国已有41家制药企业的87款生物类似药(包含胰岛素)获批上市,但仅涉及23 个药品通用名。 此外,有业界观点认为,在中国仿制药行业市 ...
仿制药发展2.0阶段:“过评”数量大增,同质化加剧
Di Yi Cai Jing· 2025-11-23 13:26
品种同质化加剧,成为仿制药市场竞争的底色。 近年来,"带量采购"政策让优质优价的仿制药加速临床准入与经济性替代。与此同时,随着"国谈"中生物药占比增加,"谈判药品同通用名仿制药上市自动 属于目录范围"的医保政策则为生物类似药挂网入院及院内推广提供便利。 双重趋势下,中国仿制药行业的市场竞争加剧——仿制药的研发水平和一致性评价通过率明显提升,却也面临"品种同质化"和"生产拼成本"等发展困境。 近日,中国医学科学院药物研究所、中国医药工业信息中心和中国食品药品检定研究院联合发布的《中国仿制药发展报告(2025)》(下称"报告")显示, 中国仿制药市场规模多年维持在9000亿元水平,企业与品种数量的增加正进一步加剧市场存量竞争。 第一财经梳理报告发现,在化学仿制药领域,2024年,通过一致性评价或视同过评的品种数较三年前增加了超过2/3,但当年增长主要由少数企业和既往过 评品种的持续获批推动;而在生物类似药领域,截至2024年,我国已有41家制药企业的87款生物类似药(包含胰岛素)获批上市,但仅涉及23个药品通用 名。 此外,有业界观点认为,在中国仿制药行业市场集中度较低的背景下,不仅要审慎看待仿制研发"扎堆"现象 ...
国药现代:截至2025年6月底,公司拥有1478个药品批准文号,其中在产药品840个品规
Mei Ri Jing Ji Xin Wen· 2025-11-05 09:49
Core Viewpoint - The company has a significant number of drug approvals and ongoing projects, indicating a robust pipeline and commitment to compliance with national standards [1] Group 1: Drug Approvals and Production - As of June 30, 2025, the company holds a total of 1,478 drug approval numbers [1] - The company currently has 840 drug specifications in production [1] Group 2: Consistency Evaluation and R&D Projects - The company has completed a total of 151 projects that have passed consistency evaluation, including those deemed equivalent [1] - The company is actively engaged in various research and development projects, although specific numbers for ongoing projects were not disclosed [1] Group 3: National Drug Lists - The company has multiple products included in the National Essential Medicines List and the national-level Basic Medical Insurance [1]
建筑材料行业:持续推荐中材科技、三棵树、华新水泥;25H1业绩预告密集出炉 玻纤、水泥表现亮眼
Xin Lang Cai Jing· 2025-07-14 02:28
Group 1: Special Electronic Fabrics - The demand for M8/M9 and second-generation/Q fabrics is expected to increase significantly, with high barriers to entry and few players in the market, leading to a prolonged period of prosperity [1] - The supply-demand dynamics for first-generation fabrics are anticipated to be better than market expectations [1] - Low CTE electronic fabrics continue to face shortages, with recommendations for Zhongcai Technology and attention to Honghe Technology [1] Group 2: Cement Industry - Cement stock configurations are becoming increasingly cost-effective, with negative factors already fully priced in; the industry is expected to maintain a bottom line [1] - Recommendations include Huaxin Cement and Conch Cement, with attention to China National Building Material and other companies [1][4] - National cement market prices have shown a slight decline of 0.4%, with regional price drops of 10-20 yuan/ton [4] Group 3: Glass Fiber Industry - The industry is entering a new normal, with stable prices for electronic yarn and a gradual recovery in profitability [5] - The main transaction price for 2400tex non-alkali yarn is between 3300-3700 yuan/ton, while electronic yarn prices remain stable at 8800-9200 yuan/ton [5] - Recommendations include leading companies such as China Jushi, Zhongcai Technology, and Changhai Co., with attention to International Composite Materials and Shandong Glass Fiber [5] Group 4: Pharmaceutical Glass - The upgrade of borosilicate glass is accelerating, with a favorable competitive landscape for molded bottles [6] - Recommendations focus on Shandong Pharmaceutical Glass, which is expected to see significant growth due to product upgrades and cost reductions [6] Group 5: Safety Building Materials - Qingniao Fire Protection is highlighted as a leading player with strong growth potential due to its comprehensive competitive advantages [10] - Zhenan Technology is expected to benefit from legislation opening up a significant market space for building isolation [10] - Zhizhi New Materials is positioned to increase its market share domestically and expand overseas, particularly in the Middle East and Southeast Asia [10]
预见2025:《2025年中国中硼硅玻璃行业全景图谱》(附市场现状、竞争格局和发展趋势等)
Qian Zhan Wang· 2025-07-06 01:10
Industry Overview - Borosilicate glass is a specialized product with excellent thermal shock resistance and water resistance, widely used for packaging pharmaceuticals such as injections, blood products, and vaccines [1][2] - The market for borosilicate glass in China is projected to reach approximately 8.6 billion yuan by 2024, with a penetration rate of about 25% [20] Industry Chain Analysis - The upstream materials for borosilicate glass production include quartz sand, boron sand, and other raw materials, while the downstream applications primarily involve medical institutions and pharmaceutical logistics [2][6] - Key players in the upstream supply include companies like Quartz Co. and Corning, while major manufacturers in the midstream include domestic firms like Shandong Pharmaceutical Glass and Zhengchuan Co. [6] Development History - The development of borosilicate glass in China began in the 1950s, with significant advancements occurring after 2004 when Shandong Pharmaceutical Glass introduced the first domestic production technology [9] - The industry has seen a shift towards domestic production capabilities, reducing reliance on imports and addressing long-standing supply chain issues [9] Policy Background - Recent policies emphasize the importance of quality in pharmaceutical packaging materials, with the National Medical Products Administration reinforcing standards for injection packaging [11][12] - The "14th Five-Year Plan" for the pharmaceutical industry aims to enhance the standardization and quality of pharmaceutical excipients and packaging materials [11][12] Market Structure - The market for borosilicate glass is segmented, with molded bottles accounting for 44% of the market share in 2024, while ampoules and tubular bottles hold similar shares [21] - The competitive landscape features a tiered structure, with leading companies like Shandong Pharmaceutical Glass and Zhengchuan Co. dominating the market, while other firms lag behind in market share and technological advancement [26][29] Future Outlook - The market for borosilicate glass is expected to grow significantly, potentially reaching 21.5 billion yuan by 2030, driven by increased demand and ongoing policy support [32] - The industry is anticipated to experience a trend towards technological innovation and increased competition, with domestic companies improving product quality and reducing costs [35]
IPO失败后海纳医药“卖身”又遇挫
Xin Lang Cai Jing· 2025-07-01 05:51
Core Viewpoint - Chengdu Xian Dao announced the termination of its acquisition of Haina Pharmaceutical due to disagreements on key terms such as transaction scheme, price, and performance commitments [1][3] Company Summary - Chengdu Xian Dao planned to acquire approximately 65% of Haina Pharmaceutical's shares, which would have made it the controlling shareholder [1] - Following the announcement of the termination, Chengdu Xian Dao's stock price fell over 7% on June 30, closing at 16.08 yuan per share, with a market capitalization of 6.443 billion yuan [1] - The company stated that the termination would not adversely affect its business operations or financial status, nor harm the interests of shareholders, especially minority shareholders [1] Industry Context - The pharmaceutical outsourcing industry is currently experiencing a downturn, making such transactions less common [6] - Similar to Chengdu Xian Dao and Haina Pharmaceutical, other companies in the industry, like Aopumai, have also faced challenges in acquisitions due to market conditions [6] - The revenue and profit figures for both Chengdu Xian Dao and Haina Pharmaceutical indicate relatively small scales, with Chengdu Xian Dao's revenue projected to grow from 244 million yuan in 2020 to 427 million yuan in 2024, while Haina Pharmaceutical's revenue is expected to increase from 56.8 million yuan to 271 million yuan in the same period [7] Market Dynamics - The innovation drug sector is facing a capital winter, leading to reduced budgets for downstream innovative drug companies, which in turn affects the performance of upstream outsourcing companies [9] - Policies such as volume-based procurement and consistency evaluation have narrowed the profit margins for generic drugs and their outsourcing services [10] - Haina Pharmaceutical reported a significant increase in revenue from its development activities, reaching 74.78 million yuan in the first half of 2023, accounting for 33.09% of total revenue [10]
对不同医药细分业务本质的一些思考
青侨阳光投资交流· 2024-08-16 02:02
青侨阳光医药投资 - 行业思考 1 标准化程度和医生依赖度的差异, 是"药VS械VS院"业务不同特性的重要来源 "医药"里的"医"主要指医疗器械和医疗机构,"药"主要指中药、化药、生物药等药品。从这点来说,"药品、 器械、医院等医疗机构"是医药行业最核心3大业务类别。除此之外的医药细分,多数可以看成是这3类业务的 配套产业,比如原料药、CRO、CMO等可以看成是药品的配套,分销商、药店等可以看成是药品和器械的配 套,三方诊断、医疗信息化等可以看成是医疗机构的配套。 从欧美日等发达国家过去几十年的历史经验看,在医药行业相对成熟的主流经济体中,"药"的资本回报率最为 可观,"械"的资本回报率也相当优秀,但"院"的资本回报率比较糟糕。 比如有很多人统计过美股不同行业的历史ROIC,其中: 这与我们的直觉感受是一致的,虽然药品和器械占整个医药行业总盘子不到20%,但我们闭着眼睛也能数出几 十个声名显赫、历史回报强劲的来自美国、欧洲、日本的制药企业和医疗器械企业;但对于占行业总盘子超 60%的医疗服务业务,著名的海外上市医院集团我们可能一只手的指头都数不完。 为什么会这样?一个重要原因是这 三类业务在标准化程度和医生依 ...
星昊医药:向不特定合格投资者公开发行股票并在北京证券交易所上市招股说明书
2023-05-11 09:03
北京星昊医药股份有限公司 北京市北京经济技术开发区中和街 18 号 证券简称: 星昊医药 证券代码: 430017 北京星昊医药股份有限公司招股说明书 本次股票发行后拟在北京证券交易所上市,该市场具有较高的投资风险。北京证 券交易所主要服务创新型中小企业,上市公司具有经营风险高、业绩不稳定、退市风 险高等特点,投资者面临较大的市场风险。投资者应充分了解北京证券交易所市场的 投资风险及本公司所披露的风险因素,审慎作出投资决定。 保荐机构(主承销商) 新疆乌鲁木齐市高新区(新市区)北京南路 358 号大成国际大厦 20 楼 2004 室 中国证监会和北京证券交易所对本次发行所作的任何决定或意见,均不表 明其对注册申请文件及所披露信息的真实性、准确性、完整性作出保证,也不 表明其对发行人的盈利能力、投资价值或者对投资者的收益作出实质性判断或 者保证。任何与之相反的声明均属虚假不实陈述。 根据《证券法》的规定,股票依法发行后,发行人经营与收益的变化,由 发行人自行负责;投资者自主判断发行人的投资价值,自主作出投资决策,自 行承担股票依法发行后因发行人经营与收益变化或者股票价格变动引致的投资 风险。 1-1-2 声明 ...
星昊医药:招股说明书(注册稿)
2023-05-09 08:01
证券简称: 星昊医药 证券代码: 430017 北京市北京经济技术开发区中和街 18 号 北京星昊医药股份有限公司 北京星昊医药股份有限公司招股说明书(注册稿) 本次股票发行后拟在北京证券交易所上市,该市场具有较高的投资风险。北京证 券交易所主要服务创新型中小企业,上市公司具有经营风险高、业绩不稳定、退市风 险高等特点,投资者面临较大的市场风险。投资者应充分了解北京证券交易所市场的 投资风险及本公司所披露的风险因素,审慎作出投资决定。 保荐机构(主承销商) 新疆乌鲁木齐市高新区(新市区)北京南路 358 号大成国际大厦 20 楼 2004 室 1-1-1 中国证监会和北京证券交易所对本次发行所作的任何决定或意见,均不表 明其对注册申请文件及所披露信息的真实性、准确性、完整性作出保证,也不 表明其对发行人的盈利能力、投资价值或者对投资者的收益作出实质性判断或 者保证。任何与之相反的声明均属虚假不实陈述。 根据《证券法》的规定,股票依法发行后,发行人经营与收益的变化,由 发行人自行负责;投资者自主判断发行人的投资价值,自主作出投资决策,自 行承担股票依法发行后因发行人经营与收益变化或者股票价格变动引致的投资 风险 ...
星昊医药:招股说明书(注册稿)
2023-04-14 07:42
证券简称: 星昊医药 证券代码: 430017 北京市北京经济技术开发区中和街 18 号 北京星昊医药股份有限公司 北京星昊医药股份有限公司招股说明书(注册稿) 本次股票发行后拟在北京证券交易所上市,该市场具有较高的投资风险。北京证 券交易所主要服务创新型中小企业,上市公司具有经营风险高、业绩不稳定、退市风 险高等特点,投资者面临较大的市场风险。投资者应充分了解北京证券交易所市场的 投资风险及本公司所披露的风险因素,审慎作出投资决定。 保荐机构(主承销商) 新疆乌鲁木齐市高新区(新市区)北京南路 358 号大成国际大厦 20 楼 2004 室 中国证监会和北京证券交易所对本次发行所作的任何决定或意见,均不表 明其对注册申请文件及所披露信息的真实性、准确性、完整性作出保证,也不 表明其对发行人的盈利能力、投资价值或者对投资者的收益作出实质性判断或 者保证。任何与之相反的声明均属虚假不实陈述。 根据《证券法》的规定,股票依法发行后,发行人经营与收益的变化,由 发行人自行负责;投资者自主判断发行人的投资价值,自主作出投资决策,自 行承担股票依法发行后因发行人经营与收益变化或者股票价格变动引致的投资 风险。 1-1- ...