普瑞巴林胶囊

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国家药监局公布5起“清源”行动违法违规案例丨21健讯Daily
2 1 Shi Ji Jing Ji Bao Dao· 2025-06-20 02:02
Group 1 - Fujian Quanzhou has launched an instant settlement model for basic medical insurance funds to improve settlement efficiency and alleviate financial pressure on designated medical institutions [1] - The instant settlement reform establishes an efficient mechanism of "daily payment + monthly settlement" by compressing the settlement cycle and increasing payment frequency [1] Group 2 - Shanghai Pharmaceuticals announced that its subsidiary in Thailand received approval from the Thai FDA for the registration of Pregabalin capsules, which are used to treat various types of neuropathic pain and as an adjunct therapy for epilepsy [3] - Gilead Sciences announced that the FDA approved its injectable HIV-1 capsid inhibitor Yeztugo for pre-exposure prophylaxis (PrEP) to reduce the risk of HIV infection in adults and adolescents weighing 35 kg or more [4] Group 3 - Haizheng Pharmaceutical plans to establish a joint venture for synthetic biology with its wholly-owned subsidiary, with a registered capital of 350 million yuan, aiming to support the professional and large-scale development of its synthetic biology business [6] - Nuo Vision announced a plan to repurchase shares worth between 5 million and 10 million yuan for employee stock ownership plans, with a repurchase price not exceeding 30 yuan per share [7] - Tiankang Biological's subsidiary Tiankang Pharmaceutical has completed the counseling acceptance for its public stock issuance and listing on the Beijing Stock Exchange [8] Group 4 - Baike Biological received approval from the National Medical Products Administration for clinical trials of its influenza virus split vaccine, which aims to provide new vaccination options for individuals aged 60 and above [10] - Dizhi Pharmaceutical announced the completion of patient enrollment for its global Phase III clinical study of its lung cancer targeted drug, which compares its drug with platinum-based chemotherapy for advanced non-small cell lung cancer [11] Group 5 - The FDA announced the launch of the "Commissioners National Priority Voucher" program to expedite new drug review times from approximately 10-12 months to 1-2 months for eligible companies [12] - Shengnuo Biological expects a net profit increase of 254% to 332% year-on-year for the first half of 2025, driven by strong performance in its peptide raw material business [12]
智通港股早知道 | 短剧市场爆发式增长 阿里国际站618订单同比大涨42%
Zhi Tong Cai Jing· 2025-06-19 23:50
Group 1: Short Drama Market Growth - The short drama market in China has experienced explosive growth, with the user base exceeding 600 million by 2024 [1] - The market size for micro short dramas reached 50.5 billion yuan in 2024, surpassing annual box office revenue for films for the first time [2] - The market is projected to grow to 63.43 billion yuan by 2025 and 85.65 billion yuan by 2027 [2] Group 2: Industry Developments - Major companies like Tencent and Douyin are investing in the short drama sector, with Tencent launching a new short drama mini-program [1] - Douyin Group established a short drama copyright center to enhance copyright management and improve quality [1] - Collaborations between platforms such as iQIYI and Mango TV with Douyin's Hongguo Short Drama aim to produce more quality micro short dramas [1] Group 3: International Expansion - Chinese short drama platforms are seeking international opportunities, becoming mainstream in regions like Southeast Asia and the United States [2] - Over 80% of the top 50 short drama applications globally are Chinese products, indicating strong international presence [2] - Current Chinese small and medium enterprises in the overseas short drama market are positioned for high revenue growth with manageable competition risks [2]
6月19日晚间重要公告一览
Xi Niu Cai Jing· 2025-06-19 10:24
Group 1 - Chengjian Development received a dividend of 7.1282 million yuan from Beijing Jingcheng Jiaye Property Co., Ltd., in which it holds a 33.47% stake [1] - Shengnuo Bio expects a net profit attributable to shareholders of 77.0275 million to 94.1448 million yuan for the first half of 2025, representing a year-on-year increase of 253.54% to 332.10% [1] - JKN2301 dry mixed suspension has been approved for clinical trials, targeting children with influenza [5][6] Group 2 - Jindawei obtained a patent for a method of purifying natto kinase, with a validity of twenty years [2] - CITIC Guoan plans to increase its stake in China Broadcasting Hunan Company to approximately 5.29% through a capital increase of 278 million yuan [2] - Ji Electric announced the resignation of its general manager, Niu Guojun, due to work changes [3] Group 3 - Xintian Green Energy successfully issued 1.5 billion yuan in green medium-term notes with a term of 3+N years and an interest rate of 2.05% [7] - Hengrun Co. plans to invest 1.2 billion yuan in a project to produce 2,000 sets of wind turbine gearbox components [9] - Pulaide received a government subsidy of 10 million yuan, accounting for 15.87% of its audited net profit for the last fiscal year [10] Group 4 - Boteng Co. passed the EU QP audit, receiving a compliance statement for its CDMO services [12] - Zhou Dasheng added 7 self-operated stores in May, with total investments ranging from 900,000 to 6.5 million yuan [13] - Wantai Bio initiated a Phase III clinical trial for its live attenuated varicella vaccine [15] Group 5 - Shanghai Pharmaceuticals received a drug registration certificate for Pregabalin capsules in Thailand [19] - Sanxing Medical's subsidiary is expected to win contracts worth approximately 143 million yuan from State Grid projects [21] - Jiangsu Huachen plans to issue 460 million yuan in convertible bonds [24] Group 6 - Jian Gong Repair won a soil pollution remediation project worth 32.76 million yuan [25] - Dize Pharmaceutical completed patient enrollment for a global Phase III clinical trial of its drug [26] - Del Co. received acceptance for its application to issue shares for asset acquisition and raise matching funds [27] Group 7 - Beijing Kerui won multiple power grid projects with a total value of approximately 154 million yuan [27] - Xie Chuang Data signed financing lease contracts totaling 498 million yuan with Su Yin Financial Leasing [28] - Meige Intelligent submitted an application for H-share listing on the Hong Kong Stock Exchange [29][31] Group 8 - Aikodi plans to repurchase shares worth 100 million to 200 million yuan for employee stock ownership plans [54] - Kong Kong Industrial intends to sell 80% of Tianyuan Construction to its controlling shareholder [55] - Youyou Green Energy proposed a cash dividend of 12 yuan per 10 shares, totaling 50.4 million yuan [55]
上海医药: 上海医药集团股份有限公司关于普瑞巴林胶囊获得泰国药品注册证书的公告
Zheng Quan Zhi Xing· 2025-06-19 08:22
Core Viewpoint - Shanghai Pharmaceuticals has received the drug registration certificate for Pregabalin capsules from the Thai Food and Drug Administration, allowing the product to be marketed in Thailand [1][2]. Group 1: Drug Information - Drug Name: Pregabalin Capsules - Dosage Forms: Capsule - Specifications: 50mg, 75mg, 150mg - Registration Category: Chemical Generic Drug - Manufacturer: Changzhou Pharmaceutical Factory Co., Ltd. [1] - Registration Numbers: 50mg: 1C 97/68 (NG); 75mg: 1C 98/68 (NG); 150mg: 1C 99/68 (NG) [1]. Group 2: Indications - Pregabalin capsules are primarily used for treating postherpetic neuralgia, diabetic peripheral neuropathy, fibromyalgia, and neuropathic pain due to spinal cord injury, as well as for adjunctive treatment of epilepsy [1]. Group 3: Market Competition - As of the announcement date, Pregabalin capsules in Thailand face competition from 24 other sellers, including VIATRIS, SANDOZ, and BIOLAB [2]. - According to IQVIA data, the total market for Pregabalin capsules in Thailand is projected for 2024 [2]. Group 4: Financial Investment - The company has invested approximately RMB 2.19 million in research and development for the product's market entry in Southeast Asia, including Thailand, Singapore, Malaysia, and the Philippines [2]. Group 5: Impact on Company - The approval of Pregabalin capsules in three specifications (50mg, 75mg, 150mg) signifies the company's qualification to sell the drug in Thailand, positively impacting its overseas market expansion and accumulating valuable experience [2].
双成药业注射用比伐芦定获得澳大利亚药物管理局(TGA)上市许可
Zheng Quan Shi Bao Wang· 2025-05-13 03:57
Core Viewpoint - The company has received marketing authorization for injectable bivalirudin from the Therapeutic Goods Administration (TGA) of Australia, indicating its capability to sell the product in Australia, which is expected to positively impact the company's overseas market expansion and performance [1][2]. Group 1: Product Information - Product Name: Injectable Bivalirudin [1] - Dosage Form: Injection [1] - Specification: 250mg [1] - Indication: Used as an anticoagulant for patients with high-risk acute coronary syndrome (ACS) undergoing early invasive treatment and those receiving percutaneous coronary intervention (PCI) [1]. Group 2: Regulatory Approvals and Milestones - In January 2019, the company received a drug registration certificate from the National Medical Products Administration (NMPA) for injectable bivalirudin [2]. - In May 2019, the company obtained a GMP certificate from the Hainan Provincial Drug Administration for the active pharmaceutical ingredient [2]. - In June 2019, the company successfully challenged the patent of the original holder of injectable bivalirudin [2]. - In October 2019, the ANDA for injectable bivalirudin received final approval from the FDA, leading to its market launch in the U.S. in 2020 [2]. - In December 2022, injectable bivalirudin passed the consistency evaluation for generic drug quality and efficacy by the NMPA [2]. - In February 2024, the product received registration approval from the Saudi Food and Drug Authority (SFDA) [2]. Group 3: Company Strategy and Product Portfolio - The company has extensive experience in the research, registration, production, and marketing of chemically synthesized peptide drugs, having developed multiple products including injectable thymosin alpha-1 and various other therapeutic drugs [3]. - The internationalization strategy aims to obtain drug approvals and market sales in developed countries such as the U.S. and EU to increase revenue and profit [3].