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浙江诚意药业股份有限公司 关于帕拉米韦注射液获得药品注册证书的公告
Overview - Zhejiang Chengyi Pharmaceutical Co., Ltd. has received the drug registration certificate for Palivizumab injection from the National Medical Products Administration [1][2]. Drug Development and Related Information - Palivizumab injection is indicated for the treatment of influenza A or B [2]. - The drug registration application was formally accepted on March 4, 2024, with a total R&D investment of 6.6968 million yuan as of the announcement date [2]. Market Situation - As of the announcement date, there are 35 manufacturers of Palivizumab injection, including Chengyi Pharmaceutical [2]. - The drug was selected in the 10th batch of national centralized procurement in December 2024, with nine companies winning the bid [2]. - The agreed procurement volume for Palivizumab injection is 249,600 units for the 15ml:0.15g specification, 4,000 units for the 20ml:0.2g specification, and 53,500 units for the 60ml:0.3g specification [2]. - The estimated market sales for Palivizumab injection in public medical institutions in 2024 is approximately 9.5 million yuan [2].
浙江诚意药业股份有限公司关于帕拉米韦注射液获得药品注册证书的公告
Overview - Zhejiang Chengyi Pharmaceutical Co., Ltd. has received the drug registration certificate for Palivizumab injection from the National Medical Products Administration [1] - The approval indicates that the product meets the requirements for drug registration according to the Drug Administration Law of the People's Republic of China [1] Drug Development and Related Information - Palivizumab injection is indicated for the treatment of influenza A or B [2] - The registration application was formally accepted on March 4, 2024, with a total R&D investment of 6.6968 million yuan (approximately 0.67 million) as of the announcement date [2] Market Situation - As of the announcement date, there are 35 manufacturers of Palivizumab injection, including Chengyi Pharmaceutical [2] - The product was selected in the 10th batch of national centralized procurement in December 2024, with nine winning companies [2] - The specified procurement volume for Palivizumab injection is 249,600 units for the 15ml:0.15g specification, 4,000 units for the 20ml:0.2g specification, and 53,500 units for the 60ml:0.3g specification [3] - The estimated market sales for Palivizumab injection in public medical institutions in 2024 is approximately 9.5 million yuan (0.95 million) [3]
诚意药业: 浙江诚意药业股份有限公司关于帕拉米韦注射液获得药品注册证书的公告
Zheng Quan Zhi Xing· 2025-07-31 16:15
Overview - Zhejiang Chengyi Pharmaceutical Co., Ltd. has received the drug registration certificate for Palivizumab injection from the National Medical Products Administration (NMPA) [1] - The approval indicates that the product meets the requirements for drug registration and is subject to pre-marketing quality management compliance inspection [1] Drug Development and Related Information - Palivizumab injection is indicated for the treatment of influenza A or B [1] - The registration application was formally accepted on March 4, 2024, with a total R&D investment of 6.6968 million yuan as of the announcement date [1] Market Situation - As of the announcement date, there are 35 manufacturers of Palivizumab injection, including Chengyi Pharmaceutical and other companies such as Zhongrun Pharmaceutical and Yangtze River Pharmaceutical Group [1] - Palivizumab injection was selected in the national centralized procurement for the tenth batch in December 2024, with a total agreed procurement volume of 249,600 units for the 15ml:0.15g specification and 5,350 units for the 60ml:0.3g specification [2] - The estimated market sales for Palivizumab injection in public medical institutions for 2024 is approximately 9.5 million yuan [2]
诚意药业:关于帕拉米韦注射液获得药品注册证书的公告
Zheng Quan Ri Bao· 2025-07-31 13:43
Group 1 - The core point of the article is that Chengyi Pharmaceutical has received the drug registration certificate for Palavivirin injection from the National Medical Products Administration [2] Group 2 - The approval of the drug registration certificate indicates a significant regulatory milestone for the company [2] - This development may enhance the company's product portfolio and market competitiveness in the pharmaceutical industry [2] - The news reflects the ongoing efforts of the company to expand its offerings in response to market demands [2]
7月31日晚间重要公告一览
Xi Niu Cai Jing· 2025-07-31 10:18
Group 1 - Jiejia Weichuang expects a net profit of 1.7 billion to 1.96 billion yuan for the first half of 2025, representing a year-on-year increase of 38.65% to 59.85% [1] - Micron Biotech's CS231295 clinical trial application has been approved by the FDA for treating advanced solid tumors [1] - Sinopec anticipates a net profit of 20.1 billion to 21.6 billion yuan for the first half of 2025, a decrease of 39.5% to 43.7% year-on-year [2] Group 2 - High Energy Environment has obtained a loan commitment letter from a financial institution for share repurchase [2] - Electric Power Investment Energy received a warning letter from the Inner Mongolia Securities Regulatory Bureau for inadequate disclosure in its semi-annual report [3] - Zhejiang University Net New won a bid for an intelligent engineering project worth 94.2712 million yuan [5] Group 3 - Daodaoquan reported a net profit of 181 million yuan for the first half of 2025, a year-on-year increase of 563.15% [8] - New Light Optoelectronics expects a net loss of 19 million to 23 million yuan for the first half of 2025 [9] - Aihua Pharmaceutical's two probiotic powder registration applications have been accepted [10] Group 4 - Xinhui Electric's subsidiary signed a product sales framework contract for commercial and household robots [11] - Baida Precision Engineering's subsidiary obtained 134,500 square meters of industrial land use rights [12] - Haiyang Technology's chief engineer resigned for personal reasons [13] Group 5 - Tianhe Magnetic Materials received a project filing notice for a 12,000-ton magnetic material deep processing project [22] - Wanlima is the pre-selected unit for a procurement project worth 43.835 million yuan from China Southern Airlines [24] - Yipin Hong's subsidiaries obtained two drug registration certificates [25] Group 6 - Zhejiang Jiaoke's subsidiary signed new construction projects worth 4.783 billion yuan in the second quarter [27] - Shenglan Co. received approval for issuing convertible bonds [29] - Jimi Technology expects a net profit of 88.6622 million yuan for the first half of 2025, a year-on-year increase of 2062.33% [31] Group 7 - Dingtong Technology reported a net profit of 115 million yuan for the first half of 2025, a year-on-year increase of 134.06% [32] - Huaheng Biological is planning to list on the Hong Kong Stock Exchange [34] - Yuntian Lihui submitted an application for H-share issuance and listing on the Hong Kong Stock Exchange [36] Group 8 - Nanchip Technology expects a net profit of 108.8 million to 133.1 million yuan for the first half of 2025, a decrease of 35.09% to 47.03% year-on-year [43] - Anglikang's Mesobam injection has received a drug registration certificate [44] - Jida Zhengyuan's shareholder plans to reduce their stake by up to 0.998% [45]
诚意药业(603811.SH):帕拉米韦注射液获得药品注册证书
智通财经网· 2025-07-31 07:47
Group 1 - The company, Chengyi Pharmaceutical (603811.SH), has received approval from the National Medical Products Administration (NMPA) for the drug registration certificate of Palivizumab injection [1] - Palivizumab is indicated for the treatment of influenza A or B [1]
诚意药业:帕拉米韦注射液获得药品注册证书
Zhi Tong Cai Jing· 2025-07-31 07:47
Core Viewpoint - Chengyi Pharmaceutical (603811.SH) has received approval from the National Medical Products Administration for the registration certificate of Palivizumab injection, which is indicated for the treatment of influenza A or B [1] Company Summary - Chengyi Pharmaceutical has recently announced the approval of Palivizumab injection, expanding its product offerings in the antiviral medication market [1] - The approval signifies a potential growth opportunity for the company in the influenza treatment segment [1] Industry Summary - The approval of antiviral medications like Palivizumab is crucial in addressing seasonal influenza outbreaks, highlighting the importance of effective treatments in public health [1] - The market for influenza treatments is expected to grow, driven by increasing awareness and demand for effective antiviral therapies [1]
诚意药业(603811) - 浙江诚意药业股份有限公司关于帕拉米韦注射液获得药品注册证书的公告
2025-07-31 07:45
本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述或者重大遗漏,并 对其内容的真实性、准确性和完整性承担法律责任。 浙江诚意药业股份有限公司 关于帕拉米韦注射液获得药品注册证书的公告 证券代码: 603811 证券简称: 诚意药业 公告编号:2025-039 1、药品名称:帕拉米韦注射液 2、剂型:注射剂 3、规格:15ml:0.15g(按 C₁₅H₂₈N₄O₄计) 4、证书编号:2025S02423 5、药品注册标准编号:YBH18452025 6、申请事项:药品注册(境内生产) 一、 概况 浙江诚意药业股份有限公司(以下简称"公司")于近日收到国家药品监督管理 局(以下简称"国家药监局")核准签发的帕拉米韦注射液《药品注册证书》,现将 具体情况公告如下: 12、生产企业地址:浙江省温州市洞头区化工路 118 号 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,本品符合 药品注册的有关要求,批准注册,发给药品注册证书。质量标准、说明书、标签及生 产工艺照所附执行。本品应当进行上市前的药品生产质量管理规范符合性检查。 二、药品研发及相关情况 本品适用于治疗甲型或乙型流行性感冒。 ...
诚意药业(603811):氨糖续约后稳健放量,神经酸创新推动研发渐入佳境
Guotou Securities· 2025-07-30 14:08
Investment Rating - The report assigns a "Buy-A" investment rating to the company [4] Core Views - The company is experiencing steady growth in sales of its core products, particularly the glucosamine hydrochloride capsules, driven by market expansion through centralized procurement and refined sales management [2][34] - The company is actively developing a comprehensive fish oil product line, aiming for a full industry chain layout to enhance quality and reduce costs [3][55] - The research pipeline includes promising projects in brain health, particularly focusing on the development of a first-class chemical drug, N-acylserine, which has significant potential in treating neurological conditions [3][63] Summary by Sections 1. Company Overview - The company is committed to developing high-end small varieties of "marine drugs" and "major disease medications," leveraging its marine drug development platform to expand its product offerings [11] - The actual controller, Yan Yiyi, holds a total of 23.58% of the company's shares, indicating strong insider confidence [13] - The company has shown steady growth in revenue from 341 million yuan in 2017 to 714 million yuan in 2024, with a CAGR of approximately 11.15% [17] 2. Glucosamine Hydrochloride Capsules - The demand for joint cartilage protectants is increasing, contributing to the steady growth of the domestic glucosamine market, projected to reach approximately 8.3 billion yuan by 2025 [40] - The company has successfully expanded its market coverage through centralized procurement, achieving over 41% market share in nine provinces [44] - Sales of glucosamine capsules in retail pharmacies have grown from 374 million yuan in 2019 to 728 million yuan in 2024, with a CAGR of about 14.28% [48] 3. Fish Oil EPA - The company is advancing a project to produce 1,000 tons of super fish oil EPA, aiming for a high-quality, low-cost production model [55] - The company has submitted new drug applications for EPA soft capsules, which are expected to enhance its position in the lipid-regulating drug market [56] - The sales of EPA/DHA health products in China are projected to grow from 3.2 billion yuan in 2020 to 7.8 billion yuan in 2024, reflecting increasing consumer health awareness [58] 4. Research Pipeline - The company has a rich research pipeline focusing on marine drugs, elderly medications, anti-tumor drugs, and health products, with significant potential in the brain health sector through the development of N-acylserine [3][63]
新股发行及今日交易提示-20250724
HWABAO SECURITIES· 2025-07-24 09:14
New Stock Issuance - Multiple companies are scheduled for new stock issuance on July 24, 2025, including *ST Zitian (300280) and ST Nanzhi (002305) [1] - Significant announcements were made for companies like Guosheng Tang (300436) and Huayin Power (600744) on July 17 and July 15, respectively [1] Trading Alerts - Companies such as Gaoguan Min Explosive (002827) and Zhongyan Dadi (003001) have recent trading alerts as of July 24, 2025 [1] - A total of 50 companies have been flagged for abnormal trading fluctuations, indicating potential market volatility [2] Market Trends - The report highlights a trend of increased market activity with numerous companies announcing significant changes in stock status [1] - The presence of multiple *ST (Special Treatment) companies suggests heightened scrutiny and potential risk for investors [1] Regulatory Compliance - Companies are required to disclose significant announcements to ensure transparency in trading activities [1] - The report emphasizes the importance of monitoring announcements to assess market conditions and investment risks [1]