每经AI快讯，12月12日，千金药业（600479）(600479.SH)公告称，公司下属子公司千金湘江药业收到 国家药品监督管理局核准签发的盐酸鲁拉西酮片的《药品注册证书》。该药品用于治疗精神分裂症，国 内获得该药品注册证书的企业有江苏豪森药业集团有限公司、正大天晴药业集团股份有限公司、浙江海 正药业（600267）股份有限公司等。千金湘江药业在盐酸鲁拉西酮片的累计研发投入为632.94万元。盐 酸鲁拉西酮片获得药品注册证书，视同通过一致性评价，进一步丰富公司产品管线，有利于公司的可持 续发展。但药品的生产和销售容易受到国家政策、市场环境变化等因素影响，具有较大不确定性。 ...

Core Viewpoint - Pro Pharmaceutical (000739.SZ) announced that its subsidiary, Zhejiang Pro Kangyu Pharmaceutical Co., Ltd., has received the drug registration certificate for L-carnitine injection from the National Medical Products Administration of China [1] Group 1: Product Information - L-carnitine injection is indicated for patients with chronic renal failure undergoing long-term hemodialysis, addressing secondary carnitine deficiency and related complications such as cardiomyopathy, skeletal myopathy, arrhythmias, hyperlipidemia, hypotension, and muscle cramps during dialysis [1] - The projected market size for L-carnitine injection in China's hospital market for 2024 is estimated at 103 million units, with a sales value of 965 million yuan [1] Group 2: Financial Investment - The total research and development expenses incurred for L-carnitine injection up to the date of the announcement amount to 3.7629 million yuan [1]

Core Viewpoint - The company has received approval from the National Medical Products Administration for the registration of Canagliflozin tablets, which are primarily used to improve blood sugar control in adults with type 2 diabetes [1] Summary by Relevant Sections Product Development - Canagliflozin tablets are expected to generate approximately 370 million yuan in sales in the domestic market by 2024, according to data from Meini Network [1] - The company has invested around 5.64 million yuan in the research and development of this drug [1] Market Impact - The approval of the registration certificate will enrich the company's product line and enhance its market competitiveness [1] - The introduction of Canagliflozin tablets is anticipated to have a positive impact on the company's operating performance [1]

Core Viewpoint - Huadong Medicine's subsidiary, Hangzhou Zhongmei Huadong Pharmaceutical, has received a drug registration acceptance notice from the National Medical Products Administration (NMPA) for edaravone tablets, aimed at treating acute ischemic stroke [1][3]. Drug Information - Drug Name: Edaravone Tablets - Application: Domestic production drug registration and marketing license - Registration Category: Chemical drug category 2.2 - Specification: 30mg - Indication: To improve neurological symptoms and functional impairments caused by acute ischemic stroke (AIS) and enhance daily living capabilities [1]. R&D and Registration Status - Edaravone is a novel free radical scavenger that has been shown to inhibit lipid peroxidation and endothelial cell damage, improving brain edema and tissue damage [3]. - The injectable form of edaravone has been approved in Japan and China for AIS treatment, but it requires intravenous administration, limiting patient compliance [3]. - The oral formulation, TTYP01, developed by Shanghai Aozong Biotechnology, is a modified new drug that allows for self-administration and room temperature storage, enhancing convenience and compliance [3][4]. - The clinical trial for TTYP01 was completed in June 2024, showing efficacy and safety comparable to the injectable form while improving patient adherence [3]. Impact on the Company - The approval of edaravone tablets is expected to enrich the company's cardiovascular product pipeline and create synergies with existing products [6]. - The drug is anticipated to meet the urgent clinical needs of stroke patients, potentially becoming a significant product in the treatment field [5][6]. - The company has invested approximately 100.81 million yuan in the development of edaravone tablets [5]. Future Considerations - Following the acceptance notice, the drug will undergo review by the NMPA's drug evaluation center, with the approval timeline and market competition remaining uncertain [6].

Core Viewpoint - Beijing Fuyuan Pharmaceutical Co., Ltd. has received a drug registration certificate for its Benzyl Benzoate solution, which is expected to enhance the company's product line and market competitiveness [1][4]. Drug Registration Certificate Details - The drug registration certificate was issued by the National Medical Products Administration, allowing the production of Benzyl Benzoate solution (1% concentration, 10 mL: 0.1 g) [1]. - The drug is indicated for the treatment of various skin fungal diseases, including tinea pedis, tinea corporis, tinea cruris, and candidiasis [6]. R&D Investment - The total R&D investment for this drug has reached approximately RMB 3.0496 million (unaudited) as of the announcement date [2]. Market Situation for Similar Drugs - According to data from Minet, the sales revenue of Benzyl Benzoate solution in China's three major terminal markets is approximately RMB 375.26 million in 2024. The breakdown is as follows: - Sales in urban public hospitals and county-level public hospitals: RMB 76.55 million - Sales in urban community centers and township health clinics: RMB 41.96 million - Sales in urban pharmacies and online pharmacies: RMB 256.75 million [3]. Impact on the Company - The approval of the drug registration certificate is expected to enrich the company's product line and enhance its market competitiveness. However, the sales performance may be influenced by national policies and market environment changes, leading to significant uncertainty [4].

Core Viewpoint - The company has received approval from the National Medical Products Administration for the registration of Adenosylcobalamin capsules (0.5mg), which are expected to have significant therapeutic benefits in treating neurological conditions [1] Company Summary - The approved product, Adenosylcobalamin capsules, is designed to inhibit abnormal fat synthesis in nerve myelin, block the occurrence and development of nerve fiber demyelination, and promote the synthesis of proteins and lipids to repair damaged nerves [1] - The capsules also lower abnormal TNFα levels, inhibit the occurrence of SACD, participate in the tricarboxylic acid cycle, and promote the metabolism of three major substances to maintain normal cellular functions [1] - The product normalizes glutathione levels to protect nerve cells and participates in heme synthesis to improve anemia [1] - The company has invested a total of 10.9382 million yuan in research and development for this product to date (unaudited) [1]

Core Viewpoint - The company, Jiuzhou Pharmaceutical, announced that its subsidiary, Zhejiang Jiuzhou Biopharmaceutical Co., Ltd., has received the drug registration certificate for Sildenafil Citrate Orally Disintegrating Tablets from the National Medical Products Administration of China [1] Group 1: Company Developments - The drug is an iterative formulation of Sildenafil developed by Pfizer, which was approved for import in China in 2019 [1] - Jiuzhou Pharmaceutical has invested approximately 13.52 million RMB in the research and development of Sildenafil Citrate Orally Disintegrating Tablets [1] - The acquisition of the drug registration certificate enhances the company's product pipeline and market competitiveness, although it is not expected to have a significant impact on the company's performance in the short term [1] Group 2: Market Context - The total sales revenue (end-user price) of Sildenafil Citrate tablets in the domestic medical and retail market reached 5.217 billion RMB in 2023 [1] - Major competitors in the market that have also received the drug registration certificate include Sichuan Kelun Pharmaceutical Co., Ltd. and Guangdong Tianenkang Pharmaceutical Co., Ltd. [1]

Core Viewpoint - The company has received the drug registration certificate for Benidipine Hydrochloride Tablets (8mg) from the National Medical Products Administration, which will enhance its product line and market competitiveness [1] Group 1: Drug Approval and Market Impact - The drug was first approved in Japan in 1991 and received domestic approval in 2004 for the treatment of primary hypertension and angina [1] - The company received the acceptance notice for the application on March 5, 2024, and has recently been granted approval [1] - The estimated sales revenue for Benidipine Hydrochloride Tablets in China's three major terminal markets is approximately 1.007 billion yuan in 2024 [1] Group 2: R&D Investment - The total research and development investment for this drug by the company amounts to 5.2737 million yuan [1]

Core Points - Zhejiang Huahai Pharmaceutical Co., Ltd. has received the drug registration certificate for Nimodipine Tablets from the National Medical Products Administration, indicating compliance with drug registration requirements [1][4] - Nimodipine Tablets are indicated for improving low motivation due to sequelae of cerebral infarction and are particularly effective in early treatment of vascular dementia [2] - The company has invested approximately RMB 8.99 million in the research and development of Nimodipine Tablets [3] Drug Information - Drug Name: Nimodipine Tablets - Dosage Forms: Tablets - Specifications: 5mg, 10mg - Registration Category: Class 3 Chemical Drug - Approval Numbers: National Drug Approval Code H20254671, H20254672 [1][2] Market Impact - The approval of Nimodipine Tablets enhances the company's product line and market competitiveness, contributing positively to its business development [4] - The domestic market sales for Nimodipine Tablets are projected to be approximately RMB 555 million in 2024 [2]

Core Viewpoint - Baiyunshan Pharmaceutical has received the drug registration certificate for Tadalafil tablets (2.5mg, 5mg) from the National Medical Products Administration, enhancing its product offerings in the male medication market [1] Summary by Categories Company Developments - Baiyunshan Pharmaceutical's subsidiary, Baiyunshan Pharmaceutical Factory, has invested approximately RMB 2.54 million and RMB 4.30 million in the research and development of Tadalafil tablets (2.5mg and 5mg) respectively [1] Market Impact - The approval of the drug registration certificate is expected to enrich the variety of male medication products offered by Baiyunshan Pharmaceutical, thereby improving its competitiveness in the male medication sector [1]