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葵花药业:关于夫西地酸乳膏申请注册上市许可获得受理的公告
Zheng Quan Ri Bao· 2025-11-03 11:11
Core Viewpoint - The announcement indicates that the company has received a registration acceptance notice from the National Medical Products Administration for the marketing authorization of Fusidic Acid Cream [2] Group 1 - The company's wholly-owned subsidiary, Harbin Kuihua Pharmaceutical Co., Ltd., is involved in the application process for Fusidic Acid Cream [2] - The registration acceptance notice is a significant step towards obtaining marketing approval for the product [2]
11月3日晚间重要公告一览
Xi Niu Cai Jing· 2025-11-03 10:18
Group 1 - Karen Co., Ltd. signed a device procurement contract worth 198 million yuan with BOE Technology Group's subsidiary [1] - Pingzhi Information's subsidiary signed a procurement framework agreement with China Telecom totaling approximately 74 million yuan [1] - Huaxin Environmental Protection obtained a loan commitment of 72 million yuan from China Minsheng Bank for stock repurchase [2] Group 2 - Sichuan Gold obtained a mining license for the Suoluo Gold Mine area [3] - *ST Huifeng's subsidiary, Kofit Company, is undergoing bankruptcy liquidation [4] - Blue Arrow Electronics decided to terminate and exit a joint investment project due to market changes [6] Group 3 - Junhe Materials is planning to issue H-shares and list on the Hong Kong Stock Exchange [7] - Longping High-Tech reported a 2.41% year-on-year decline in total revenue for the period from October 1, 2024, to September 30, 2025 [8] - Hongsheng Huayuan's subsidiary is a candidate for a 584 million yuan project with the State Grid [10] Group 4 - Weisheng Information won multiple projects in the power and public utility sectors, totaling 89.94 million yuan [12] - Heng Rui Pharmaceutical received approval for a clinical trial of a combination therapy for prostate cancer [13] - Saito Bio's subsidiary received approval for the listing of a raw material drug [15] Group 5 - Aikang Pharmaceutical's application for a new drug was accepted by the National Medical Products Administration [16] - Chengfa Environment was selected as a supplier for a waste-to-energy project in Indonesia [16] - Dalian Electric Porcelain's subsidiary is a candidate for a 59 million yuan project with the State Grid [17] Group 6 - Denghai Seed reported a 20.01% year-on-year decline in revenue for the 2024-2025 business year [18] - Tongda Co., Ltd. is a candidate for a 133 million yuan project with the State Grid [20] - Hanma Technology's electric heavy-duty truck sales increased by 325.7% year-on-year in October [21] Group 7 - Cap Bio received a patent for a microfluidic chip for live cell sorting [21] - Renfu Pharmaceutical's subsidiary received approval for a clinical trial of a drug for postherpetic neuralgia [22] - Daon Co., Ltd. received approval for a share issuance to acquire 100% of Daon Titanium Industry [22] Group 8 - Han Jian Heshan signed a procurement contract for reinforced concrete drainage pipes worth 207 million yuan [23] - Haisike's innovative drug HSK39297 received approval for clinical trials [25] - Tongguang Cable is a candidate for a 138 million yuan project with the State Grid [27] Group 9 - Jiuqiang Bio received medical device registration certificates for two new products [29] - Visionox is planning a change of control and has suspended trading [30] - Shenyu Co., Ltd. received approval for a convertible bond issuance [31] Group 10 - Metro Design's asset restructuring has resumed review by the Shenzhen Stock Exchange [33] - BAIC Blue Valley's private placement application was approved by the Shanghai Stock Exchange [34] - Seris set the H-share issuance price at 131.50 HKD per share, with listing on November 5 [35]
葵花药业(002737.SZ):夫西地酸乳膏申请注册上市许可获得受理
Ge Long Hui A P P· 2025-11-03 07:55
Core Viewpoint - Kew Flower Pharmaceutical (002737.SZ) has received a registration acceptance notice from the National Medical Products Administration for fusidic acid cream, which is indicated for skin infections caused by various bacteria [1] Company Summary - The fusidic acid cream is primarily indicated for infections caused by Staphylococcus, Streptococcus, Propionibacterium acnes, and other bacteria sensitive to fusidic acid [1] - Major indications include: pustules, boils, carbuncles, paronychia, wound infections, furunculosis, hidradenitis, erythrasma, folliculitis, and common acne [1] - The product is suitable for infections on the face and head without affecting appearance [1]
葵花药业(002737.SZ):夫西地酸乳膏申请注册上市许可获受理
智通财经网· 2025-11-03 07:49
Core Viewpoint - The company has received a registration acceptance notice from the National Medical Products Administration for the marketing authorization of Fusidic Acid Cream, indicating a significant step towards commercialization of this product [1] Company Summary - The company's wholly-owned subsidiary, Harbin Kuaihua Pharmaceutical Co., Ltd., is responsible for the application and has successfully received the acceptance notice [1] - Fusidic Acid Cream is indicated for skin infections caused by bacteria sensitive to fusidic acid, including Staphylococcus, Streptococcus, and Propionibacterium acnes [1] Product Indications - The main indications for Fusidic Acid Cream include: - Pustules - Boils - Carbuncles - Paronychia - Wound infections - Furunculosis - Hidradenitis - Erythema - Folliculitis - Common acne - The product is suitable for infections on the face and head without affecting appearance [1]
葵花药业:全资子公司夫西地酸乳膏上市许可申请获受理
Xin Lang Cai Jing· 2025-11-03 07:48
Core Viewpoint - The company has received a registration acceptance notice from the National Medical Products Administration for its subsidiary's drug, Fusidic Acid Cream, which is intended for treating skin infections caused by various bacteria [1] Group 1: Drug Registration - The drug is classified as a Class 4 chemical drug [1] - The approval process is lengthy and involves multiple steps, leading to uncertainty regarding the completion time and approval results [1] - The company will continue to advance the registration process and monitor the approval status, providing timely updates [1]
葵花药业:夫西地酸乳膏申请注册上市许可获受理
Core Viewpoint - The announcement from Kew Flower Pharmaceutical indicates the acceptance of the registration application for Fusidic Acid Cream by the National Medical Products Administration, which is a significant step towards market entry for this product [1] Group 1: Company Information - Kew Flower Pharmaceutical's wholly-owned subsidiary, Harbin Kew Flower Pharmaceutical Co., Ltd., has received the acceptance notice for the registration of Fusidic Acid Cream [1] - The primary indications for this medication include various skin infections such as pustules, boils, carbuncles, paronychia, wound infections, furuncles, sweat gland inflammation, erythema, folliculitis, and common acne [1] - The cream is suitable for use on facial and scalp infections without affecting appearance [1]
第11批国家药品集采开标;恒瑞前三季度净利润同比增25%
Policy Developments - The 11th batch of national drug centralized procurement opened for bidding on October 27, involving 55 varieties across fields such as anti-infection and anti-tumor drugs. The procurement rules have been optimized to ensure clinical stability, quality assurance, and to prevent price collusion [1] Drug and Device Approvals - China Medical's subsidiary, Keyi Pharmaceutical, received a drug registration certificate for Fusidic Acid Cream, which is used for skin infections caused by Staphylococcus and Streptococcus. The drug has a projected domestic sales of approximately 500 million yuan in 2023 and 524 million yuan in 2024 [2] - Watson Bio's mRNA vaccine for respiratory syncytial virus has received clinical trial approval from the National Medical Products Administration. This vaccine is developed to prevent lower respiratory tract diseases caused by the virus, with no similar products approved in China yet [3] Financial Reports - Heng Rui Medicine reported a 25% year-on-year increase in net profit for the first three quarters of 2025, with total revenue of 23.188 billion yuan, a 14.85% increase [4] - Yiling Pharmaceutical reported a significant 80.33% year-on-year increase in net profit for the first three quarters of 2025, despite a 7.82% decline in total revenue [5] Capital Market Activities - Novartis signed a strategic cooperation agreement with Kangzhe Pharmaceutical for the exclusive import and commercial promotion of two ophthalmic drugs in China, effective from November 1, 2025. This agreement aligns with Novartis's strategy to focus on four core therapeutic areas [6][7] Industry Developments - The first biomanufacturing industry fund in Shanghai has been established, aiming to integrate resources from enterprises, universities, and research institutions to promote technological breakthroughs and business growth [9] Regulatory Issues - The Hunan Provincial Commission for Discipline Inspection reported on 15 cases of local officials interfering in hospital engineering and drug procurement, highlighting ongoing issues of corruption and misconduct in the healthcare sector [10]
中国医药健康产业股份有限公司2025年第三季度报告
Core Viewpoint - The company is facing challenges due to policies such as volume-based procurement and medical insurance cost control, leading to a decrease in revenue and net profit in the first three quarters of 2025 compared to the previous year [3]. Financial Performance - In the first three quarters of 2025, the company achieved a total operating revenue of 25.894 billion yuan, a year-on-year decrease of 3.42% [3]. - The net profit attributable to shareholders was 455 million yuan, down 4.64% year-on-year [3]. Corporate Actions - The company acquired 100% equity of Beijing Jinsui Technology Development Co., Ltd., resulting in retrospective adjustments to previous financial data as per accounting standards [5]. - The company has decided to waive its preferential right to acquire a 5% limited partnership interest in a health industry fund, which corresponds to a subscribed capital contribution of 100 million yuan [8]. Regulatory Developments - A subsidiary, Hubei Keyi Pharmaceutical Co., Ltd., received a drug registration certificate for Fusidic Acid Cream, which is used for skin infections caused by certain bacteria [43]. - The drug has been approved for registration after meeting the relevant requirements of the Drug Administration Law [44]. Market Context - The domestic market for Fusidic Acid Cream had total sales of approximately 500 million yuan in 2023 and is projected to reach 524 million yuan in 2024 [47]. - The company has multiple topical semi-solid formulations already on the market, and the new product will enhance its product pipeline and provide valuable experience for future generic drug development [49].
国家药监局关于28批次不符合规定药品的通告(2025年第30号)
Core Viewpoint - The National Medical Products Administration (NMPA) announced that 28 batches of drugs produced by 17 companies do not meet regulatory standards, prompting investigations and corrective actions [3][5]. Group 1: Non-compliant Drugs - Five batches of fusidic acid cream produced by Aomei Pharmaceutical Factory failed due to particle size issues [3]. - Two batches of loratadine syrup from Want Pharmaceutical (Hainan) Co., Ltd. did not meet standards related to impurities [3]. - One batch of sodium phosphate oral solution from Shanghai Haihong Industrial Group's Chao Hu Jinchen Pharmaceutical Co., Ltd. failed due to relative density [3]. - Two batches of tocilizumab capsules from Shaanxi Xiyue Pharmaceutical Co., Ltd. did not meet dissolution rate standards [3]. - One batch of acetylcysteine effervescent tablets from Zhejiang Jinhua Kang'enbei Biopharmaceutical Co., Ltd. failed due to physical characteristics [3]. - Two batches of Twenty-five Flavor Coral Pills from Tibet Shenhui Pharmaceutical Co., Ltd. did not meet weight difference standards [3]. - Two batches of Qili San from Hubei Minkan Pharmaceutical Co., Ltd. failed due to content determination [3]. Group 2: Regulatory Actions - The NMPA has mandated that the involved companies take risk control measures such as suspending sales and conducting recalls [5]. - The NMPA requires provincial drug supervision departments to investigate potential illegal activities by the companies involved and to publicly disclose the results of these investigations [5].