仿制药一致性评价

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力诺药包(301188):药包承压,耐热盈利改善
Changjiang Securities· 2025-08-25 23:30
丨证券研究报告丨 公司研究丨点评报告丨力诺药包(301188.SZ) [Table_Title] 药包承压,耐热盈利改善 报告要点 分析师及联系人 [Table_Author] 范超 李浩 SAC:S0490513080001 SAC:S0490520080026 SFC:BQK473 请阅读最后评级说明和重要声明 %% %% %% %% research.95579.com [Table_Summary] 公司上半年实现收入 5.0 亿,同比下滑 11.1%;归属净利润 0.4 亿 ,同比下滑 20.1%。折合 Q2 收入 2.23 亿,同比下滑 24.2%;归属净利润 44 万元,同比下滑 98.3%。 [Table_Title2] 药包承压,耐热盈利改善 [Table_Summary2] 事件描述 公司上半年实现收入 5.0 亿,同比下滑 11.1%;归属净利润 0.4 亿 ,同比下滑 20.1%。折合 Q2 收入 2.23 亿,同比下滑 24.2%;归属净利润 44 万元,同比下滑 98.3%。 事件评论 风险提示 1、新产品扩张不及预期; 1 力诺药包(301188.SZ) cjzqdt11111 ...
仙琚制药:醋酸地塞米松片通过仿制药一致性评价
Zheng Quan Shi Bao Wang· 2025-08-22 08:49
人民财讯8月22日电,仙琚制药(002332)8月22日晚间公告,公司于近日收到国家药品监督管理局核准 签发的关于醋酸地塞米松片的《药品补充申请批准通知书》,公司醋酸地塞米松片通过仿制药质量和疗 效一致性评价。该药品为肾上腺皮质激素类药,主要用于过敏性与自身免疫性炎症性疾病。 ...
特稿 | 药盒里的潮汐进退:进口原研药高溢价神话崩塌与国产药逆袭
Hua Xia Shi Bao· 2025-08-12 04:19
Core Viewpoint - The article highlights a significant shift in the pharmaceutical market in China, where the market share of imported original research cancer drugs in top-tier hospitals is projected to drop from 68% in 2021 to 34% in 2024, while the combined share of domestic generic and innovative drugs is expected to rise to 66% [5][10]. Group 1: Market Dynamics - The transition from imported original drugs to domestic alternatives reflects deeper changes in the pharmaceutical market, driven by cost advantages of domestic generics and innovations [1][6]. - In the first half of 2025, over 30 original research drugs from multinational companies are expected to withdraw from the market, including those from Takeda, Pfizer, and GlaxoSmithKline [1]. - The declining market share of imported drugs is attributed to multinational companies' pricing strategies and the competitive pricing of domestic generics [6][10]. Group 2: Patient Perspectives - Many patients are initially hesitant to switch from imported to domestic drugs due to concerns about efficacy and safety, as illustrated by the experiences of patients like Ms. Zhou and an elderly male patient [3][4]. - However, some patients have reported positive outcomes after switching to domestic drugs, noting both cost savings and effective treatment [4][12]. Group 3: Policy and Regulatory Environment - The article discusses the impact of national drug procurement policies, which have significantly reduced the market presence of imported original drugs, with a low winning rate of 3.7% in recent procurement rounds [6][10]. - The ongoing reforms in the healthcare payment system, including DRG and DIP models, are pushing hospitals to prioritize lower-cost drugs, further squeezing the space for imported original drugs [10][12]. Group 4: Industry Adjustments - Multinational pharmaceutical companies are adapting by localizing their operations, including expanding production bases and upgrading research centers in China [13][14]. - Companies like Sanofi and Roche are shifting their focus towards innovative drugs and adjusting their product portfolios in response to market changes [8][14]. Group 5: Future Outlook - The article emphasizes the need for a transparent and competitive market environment to foster the development of high-quality, reasonably priced drugs, whether domestic or imported [16]. - The ongoing evolution in the pharmaceutical landscape suggests that both multinational and domestic companies will continue to adapt their strategies to meet changing patient needs and regulatory requirements [9][16].
仿制药一致性评价概念下跌0.55%,5股主力资金净流出超亿元
Zheng Quan Shi Bao Wang· 2025-08-05 08:41
Market Performance - As of August 5, the generic drug consistency evaluation concept declined by 0.55%, ranking among the top declines in the concept sector [1] - Within the sector, notable declines were seen in companies such as Angli Kang, Asia-Pacific Pharmaceutical, and Nanxin Pharmaceutical, while 46 stocks experienced price increases, with Chengyi Pharmaceutical, Guilin Sanjin, and Zhongheng Group leading with increases of 10.04%, 10.00%, and 9.85% respectively [1] Capital Flow - The generic drug consistency evaluation sector saw a net outflow of 3.403 billion yuan, with 112 stocks experiencing net outflows, and 5 stocks seeing outflows exceeding 100 million yuan [2] - The stock with the highest net outflow was Hanyu Pharmaceutical, with a net outflow of 909.3 million yuan, followed by Asia-Pacific Pharmaceutical, Guangsheng Tang, and Yipinhong with net outflows of 192.45 million yuan, 135.13 million yuan, and 119.26 million yuan respectively [2] Top Gainers and Losers - The top gainers in the sector included Chengyi Pharmaceutical, Guilin Sanjin, and Zhongheng Group, with respective net inflows of 102 million yuan, 94.85 million yuan, and 88.22 million yuan [6] - Conversely, the top losers included Hanyu Pharmaceutical, Asia-Pacific Pharmaceutical, and Guangsheng Tang, with significant net outflows [2][3]
亚太药业:公司阿替洛尔片通过仿制药一致性评价
news flash· 2025-07-20 07:49
Core Viewpoint - Asia-Pacific Pharmaceutical (002370.SZ) announced that its Atenolol tablets have passed the consistency evaluation of generic drug quality and efficacy, which will enhance the company's product pipeline and market competitiveness [1] Group 1: Product Development - The Atenolol tablets are primarily used for treating hypertension, angina pectoris, and myocardial infarction [1] - Passing the consistency evaluation will further enrich the company's product line and improve its market position [1] Group 2: Future Prospects - The successful evaluation will provide valuable experience for the company in conducting consistency evaluations for other products in the future [1] - The production and sales of pharmaceuticals are subject to policy and market environment influences, which introduces uncertainty [1]
海南自贸区概念涨2.21%,主力资金净流入23股
Zheng Quan Shi Bao Wang· 2025-07-16 09:00
Group 1 - The Hainan Free Trade Zone concept rose by 2.21% as of the market close on July 16, ranking 6th among concept sectors, with 27 stocks increasing in value, including Haide Co., Hainan Ruize, and Jingliang Holdings, which rose by 5.79%, 4.70%, and 4.59% respectively [1] - The top gainers in the Hainan Free Trade Zone concept included Haide Co. with a net inflow of 92.2 million yuan, followed by Hainan Ruize with 61.9 million yuan, and Hainan Haiyao with 43.7 million yuan [1][2] - The concept sector saw a net inflow of 219 million yuan from main funds, with 23 stocks experiencing net inflows, and 16 stocks receiving over 10 million yuan in net inflows [1] Group 2 - The leading stocks by net inflow ratio included ST Huluwa, Haide Co., and *ST Yedao, with net inflow ratios of 16.55%, 15.77%, and 13.49% respectively [2] - The top stocks in the Hainan Free Trade Zone concept by main fund flow included Haide Co. with a main fund flow of 92.2 million yuan and a turnover rate of 4.66%, and Hainan Ruize with a flow of 61.9 million yuan and a turnover rate of 11.86% [2][3] - Other notable stocks included Hainan Haiyao with a 3.49% increase and a main fund flow of 43.7 million yuan, and HNA Holding with a 1.45% increase and a flow of 30.2 million yuan [3]
21.02亿主力资金净流入,仿制药一致性评价概念涨2.67%
Zheng Quan Shi Bao Wang· 2025-07-16 08:56
Core Viewpoint - The generic drug consistency evaluation concept has shown a significant increase, with a rise of 2.67%, making it the second-highest gaining sector on the market as of July 16 [1][2]. Market Performance - The generic drug consistency evaluation sector saw 119 stocks increase in value, with notable performers including: - Guangsheng Tang, which rose by 16.55% - Lai Mei Pharmaceutical, which increased by 8.48% - Han Yu Pharmaceutical, which gained 6.41% [1][2]. - Conversely, the sector also experienced declines, with *ST Su Wu dropping by 5.02%, Nanxin Pharmaceutical by 3.17%, and Kelun Pharmaceutical by 0.95% [1]. Capital Flow - The sector attracted a net inflow of 2.102 billion yuan from major funds, with 77 stocks receiving net inflows. Five stocks had net inflows exceeding 100 million yuan, led by Qianhong Pharmaceutical with 227 million yuan [2][3]. - Other significant net inflows were observed in: - Han Yu Pharmaceutical with 166 million yuan - Ha San Lian with 155 million yuan - Run Du Shares with 145 million yuan [2]. Stock Performance Metrics - The top stocks in terms of net inflow ratio included: - Run Du Shares at 42.20% - Ha San Lian at 34.99% - Zhejiang Zhen Yuan at 29.25% [3]. - The performance of stocks within the sector varied, with Qianhong Pharmaceutical showing a daily increase of 9.98% and a turnover rate of 14.39% [3][4].
海南海药:子公司注射用头孢唑肟钠通过一致性评价
news flash· 2025-07-09 10:17
Core Viewpoint - Hainan Haiyao's subsidiary has received approval for the injectable drug Cefoperazone Sodium, which is expected to enhance market competitiveness and positively impact the company's performance [1] Company Summary - Hainan Haiyao's wholly-owned subsidiary, Haikou Pharmaceutical Factory, has been granted a drug supplement approval notice by the National Medical Products Administration for the injectable drug Cefoperazone Sodium [1] - The drug has passed the consistency evaluation of quality and efficacy for generic drugs, which is beneficial for the company's market position [1] Industry Summary - Cefoperazone Sodium is a third-generation broad-spectrum semi-synthetic cephalosporin antibiotic, effective against various infections including lower respiratory tract infections, urinary tract infections, and sepsis [1] - The approval of this drug aligns with the industry's trend towards enhancing the quality and efficacy of generic medications, which is crucial for maintaining competitiveness in the pharmaceutical market [1]
浙江震元: 浙江震元股份有限公司2024年向特定对象发行股票募集说明书(修订稿)
Zheng Quan Zhi Xing· 2025-07-02 16:36
Group 1 - The company plans to issue A-shares to specific investors, pending approval from the Shenzhen Stock Exchange and the China Securities Regulatory Commission (CSRC) [2][3][4] - The final issuance price will be no less than 85% of the average trading price of the company's shares over the 20 trading days prior to the pricing date [3][4][5] - The total number of shares to be issued will not exceed 25% of the company's total share capital, amounting to a maximum of 83,530,821 shares [5][6] Group 2 - The funds raised will be allocated to specific projects, including the construction of a production base for amino acids and an enhancement project for raw materials [6][7] - The company may adjust the investment priorities and amounts based on the actual net amount raised and project urgency if the net proceeds are less than planned [6][7] - The company has committed to using the raised funds in compliance with relevant regulations and will replace any pre-invested funds once the raised funds are available [6][7] Group 3 - The company operates in the pharmaceutical industry, which is subject to strict regulatory oversight from various government bodies, including the National Medical Products Administration and the National Healthcare Security Administration [19][20] - The pharmaceutical industry is characterized by significant competition and regulatory challenges, including drug approval processes and pricing regulations [19][20][21] - The company’s business encompasses pharmaceutical distribution, manufacturing, and health services, with a focus on both commercial and industrial sectors [19][20]
仿制药一致性评价概念涨2.73%,主力资金净流入74股
Zheng Quan Shi Bao Wang· 2025-07-01 10:19
Core Viewpoint - The concept of generic drug consistency evaluation has seen a rise of 2.73%, ranking fifth among concept sectors, with significant inflows of capital into various stocks within this sector [1][2]. Group 1: Market Performance - As of July 1, the generic drug consistency evaluation concept experienced a 2.73% increase, with 120 stocks rising, including top performers like Fengyuan Pharmaceutical, Guizhou Bailing, and Anglikang, which hit the daily limit [1]. - The leading gainers in this sector included Yuekang Pharmaceutical (up 15.55%), Yipinhong (up 14.72%), and Hongri Pharmaceutical (up 8.13%) [1][2]. - Conversely, the stocks with the largest declines were Yiming Pharmaceutical, Yongtai Technology, and *ST Suwu, which fell by 2.16%, 1.71%, and 0.79% respectively [1]. Group 2: Capital Inflows - The generic drug consistency evaluation sector attracted a net inflow of 829 million yuan, with 74 stocks receiving capital inflows, and 13 stocks seeing over 50 million yuan in net inflows [2]. - The stock with the highest net inflow was Yipinhong, which saw 168 million yuan, followed by Guizhou Bailing and Huahai Pharmaceutical with net inflows of 158 million yuan and 135 million yuan respectively [2][3]. - The top three stocks by net inflow ratio were Fengyuan Pharmaceutical (24.78%), Guizhou Bailing (17.80%), and Huahai Pharmaceutical (14.87%) [3]. Group 3: Stock Performance Metrics - Yipinhong had a daily increase of 14.72% with a turnover rate of 5.65% and a net capital flow of approximately 168 million yuan [3]. - Guizhou Bailing increased by 10.04% with a turnover rate of 13.11% and a net capital flow of about 158 million yuan [3]. - Huahai Pharmaceutical rose by 5.74% with a turnover rate of 3.26% and a net capital flow of around 135 million yuan [3].