医药国际化
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白云山获得越南卫生部传统药品管理局颁发的安宫牛黄丸药品注册证书
Zhi Tong Cai Jing· 2025-11-19 09:42
本次获得越南卫生部传统药品管理局颁发的安宫牛黄丸药品注册证书后,该药品将由中一药业授权 TNHH NEWSEEN COAST公司在越南地区销售,有助于中一药业扩展越南市场业务,提升本公司产品 市场竞争力。本次获得安宫牛黄丸药品注册证书,对公司当期业绩无重大影响。 白云山(00874)公布,近日,公司全资子公司广州白云山中一药业有限公司(以下简称"中一药业")收到越 南卫生部传统药品管理局签发的安宫牛黄丸注册证书。 ...
津药药业:子公司注射用甲泼尼龙琥珀酸钠获巴拿马注册证书
Xin Lang Cai Jing· 2025-11-18 07:44
津药药业公告称,近日,其子公司津药和平的注射用甲泼尼龙琥珀酸钠(500mg注射用冻干粉针剂)获 巴拿马共和国卫生部注册证书,可在当地生产销售。该药品是糖皮质激素类药物,用于抗炎等治疗。 2024年提出注册申请,2025年11月取得证书。甲泼尼龙类注射剂2023 - 2024年全球销售额分别为5.26 亿、5.21亿美元。此次获批为公司制剂业务拓展巴拿马市场带来机遇,推动国际化布局,但销售情况有 不确定性。 ...
普洛药业:全资子公司获得盐酸文拉法辛欧洲药典适用性证书
Guo Ji Jin Rong Bao· 2025-11-10 08:49
Core Viewpoint - The announcement highlights that Zhejiang Prolo Home Pharmaceutical Co., Ltd., a wholly-owned subsidiary of Prolo Pharmaceutical, has received the Certificate of Suitability (CEP) for Venlafaxine Hydrochloride from the European Medicines Agency, indicating the quality recognition of this active pharmaceutical ingredient in the European market [1] Group 1 - The CEP certificate for Venlafaxine Hydrochloride signifies the product's compliance with European pharmacopoeia standards [1] - Venlafaxine Hydrochloride is used for treating various types of depression, including anxiety-related depression and generalized anxiety disorder [1] - The certification allows the product to enter the EU market and other markets that recognize the CEP certificate, facilitating international market expansion for the company [1]
通化东宝:国际化拓展加快推进 门冬胰岛素注射液在印尼获批上市
Zhong Guo Zheng Quan Bao· 2025-10-24 13:42
Core Viewpoint - Tonghua Dongbao has received approval from the Indonesian Food and Drug Authority for the registration of its Aspart Insulin Injection, marking a significant step in the company's international expansion and addressing the growing diabetes treatment needs in Indonesia [1][2]. Group 1: Product Approval and Market Expansion - The approval of Aspart Insulin Injection allows Tonghua Dongbao to sell this product in Indonesia, a major market, following its previous success in Myanmar [1]. - The company has been accelerating its internationalization efforts, achieving important milestones in markets such as Uzbekistan, Nicaragua, Myanmar, and Indonesia this year [2]. - The approval signifies a shift from a focus on raw human insulin to a more diverse product portfolio, including both raw materials and formulations, establishing a robust overseas product system [2]. Group 2: Market Demand and Patient Needs - Indonesia has a rising demand for medical services, with the International Diabetes Federation reporting that the number of diabetes patients aged 20-79 is expected to reach 20.43 million in 2024, with a prevalence rate of 11.0% [1]. - There is a significant gap in diabetes diagnosis and treatment in Indonesia, with 73.2% of diabetes patients undiagnosed, highlighting the urgent need for effective treatment options [1]. Group 3: Future Strategy and Goals - Tonghua Dongbao plans to leverage its production advantages to provide safe, effective, and affordable medical products for endocrine patients globally, aiming to expand its overseas sales [3]. - The company intends to continue registering its insulin products in more countries, starting from Indonesia and Myanmar, and is also focused on advancing the regulatory processes for its products in the U.S. and Europe [3].
荣昌生物:目前RC48在海外的临床试验正按计划推进中
Xin Lang Cai Jing· 2025-09-17 09:09
Core Viewpoint - Rongchang Biopharma (688331.SH) has established a global exclusive licensing agreement with Seattle Genetics (now acquired by Pfizer Inc.) for the development and commercialization rights of RC48 outside of Japan and Singapore, with ongoing clinical trials being conducted by Pfizer as planned [1] Group 1 - The company is actively collaborating with Pfizer to support clinical development and regulatory submissions in overseas markets [1] - Key challenges in the internationalization process include regulatory differences across countries, complex market access policies, and dynamic competitive environments [1]
海外市场频传捷报金城医药国际化提速
Zheng Quan Ri Bao· 2025-07-31 16:08
Core Viewpoint - Shandong Jincheng Pharmaceutical Group Co., Ltd. has made significant progress in expanding its overseas market, receiving key import licenses for its products in South Korea and Europe, indicating a rapid acceleration in its internationalization efforts [2][3]. Group 1: Product Approvals - Jincheng Tai'er Pharmaceutical Co., Ltd. received an import license for Progestin cream from the Korean Ministry of Food and Drug Safety (MFDS), marking its entry into the South Korean pharmaceutical market [2]. - The company also obtained a Certificate of Suitability (CEP) for Oseltamivir phosphate raw material from the European Medicines Agency, allowing it to sell in the European market [2][3]. - Additionally, the company received a DMF approval letter from the FDA for Posaconazole, which is crucial for entering the highly regulated U.S. raw material market [3]. Group 2: Market Potential - Progestin is the only marketed local estrogen with unique advantages, such as not stimulating endometrial proliferation and not increasing blood estrogen levels, with global sales projected to reach $104 million in 2024 [3]. - Oseltamivir, a leading antiviral drug, has a global sales figure exceeding $1 billion in 2024, with a raw material consumption of 92.31 tons, indicating a substantial market opportunity [3]. - The approval of Posaconazole is seen as a milestone for Jincheng Pharmaceutical to establish a presence in the U.S. and global antifungal raw material supply chain [3]. Group 3: Strategic Direction - The recent achievements in overseas market expansion reflect the company's transition from a focus on raw materials to a dual-driven model of "raw materials + formulations" [4]. - The company is actively exploring higher-level open cooperation and expanding into fields such as women's health technology and high-end anti-infection [4].
鲁南制药:多项单品全球产销第一
Qi Lu Wan Bao Wang· 2025-07-23 10:40
Core Viewpoint - The article highlights the significant achievements and innovations of Lunan Pharmaceutical, emphasizing its commitment to quality and technological advancement in the pharmaceutical industry, positioning it as a leading brand in Shandong and beyond [1][2][5]. Group 1: Company Achievements - Lunan Pharmaceutical has achieved a production capacity of 1,500 tons of clavulanate potassium annually, accounting for nearly one-third of global demand, making it the world's largest producer [2]. - The company has invested over 10 billion yuan in research and development over the past decade, resulting in numerous successful products and innovations [4]. - Lunan Pharmaceutical ranked 13th in the "2025 China Pharmaceutical R&D Comprehensive Strength Ranking" and has established multiple national and provincial-level innovation platforms [5]. Group 2: Product Development and Innovation - The company has seen a surge in new product launches, with an expected 40 to 50 products entering production this year, particularly in the innovative drug sector [5]. - Lunan Pharmaceutical's first antibody-based biopharmaceutical, Yilidali Rituximab Injection, was approved after 15 years of development, marking a significant milestone in its product portfolio [6][8]. - The company has optimized production processes, saving approximately 4 million yuan annually through continuous research breakthroughs [2]. Group 3: International Expansion - Lunan Pharmaceutical's international business has grown tenfold from 200 million yuan in 2014 to 2 billion yuan in 2024, with 72 formulation products approved in 129 countries and regions [10][12]. - The company has transitioned from exporting raw materials to exporting formulations, increasing profit margins by 5 to 7 times [11]. - Lunan Pharmaceutical has established partnerships with over 200 global companies and is actively expanding its presence in emerging markets across Asia, Africa, and Eastern Europe [12].
东阳光药递交招股书,拟赴港上市;和誉医药小分子癌症新药申报上市
Mei Ri Jing Ji Xin Wen· 2025-06-11 23:20
Group 1 - China Biopharmaceutical announced a significant outbound licensing deal as part of its strategic goals for the year, aiming to enhance international revenue and initiate a second growth curve [1] - The company has multiple assets with outbound licensing potential, including PDE3/4, HER2 bispecific antibodies, HER2 ADC, FGF21, EGFR/cMET ADC, fourth-generation EGFR, and early-stage projects like oral GLP-1 and PDE4b, which have shown high commercial value in the global pharmaceutical market [1] Group 2 - Dongyang Sunshine Pharmaceutical submitted its IPO application to the Hong Kong Stock Exchange, with CICC as the sole sponsor, focusing on infection, chronic diseases, and oncology treatment areas [2] - The company has a product matrix of 150 approved drugs across various countries, with 48 sold in China and 23 in overseas markets, indicating potential for accelerated international expansion [2] Group 3 - Heyu Pharmaceutical's new drug application for pimicotinib, a selective small molecule inhibitor for TGCT, has been accepted by the NMPA, marking the company's first project entering the NDA approval process [3] - Pimicotinib has demonstrated good clinical efficacy, safety, and tolerability in multiple clinical trials, and its approval could fill a gap in the treatment of TGCT, enhancing the company's innovative competitiveness [3] Group 4 - Tianxing Medical's IPO application on the Sci-Tech Innovation Board has been terminated due to the withdrawal of its sponsor, despite having a complete matrix of 47 approved sports medicine products, including 11 that are the first of their kind in China [4] - The termination of the IPO reflects potential challenges in research, commercialization, and the overall difficulties faced by innovative medical device companies in the listing process [4]
一天11款新药获批上市,恒生医疗指数ETF(159557)年内已涨超32%,机构:医药真创新和真国际化时代迎来回报
2 1 Shi Ji Jing Ji Bao Dao· 2025-05-30 02:56
Group 1 - The Hang Seng Healthcare Index experienced a slight pullback on May 30, with the Hang Seng Healthcare Index ETF (159557) down by 0.31% as of the report [1] - Notable gainers among the constituent stocks included Bohan Biotech, which rose over 9%, and several others like CSPC Pharmaceutical Group and Yaoshibang, which increased by over 7% [1] - Year-to-date, the Hang Seng Healthcare Index ETF (159557) has achieved a cumulative increase of 32.19% as of May 29 [1] Group 2 - CITIC Securities anticipates a clear trend of performance and valuation recovery in the healthcare industry by the second half of 2025, with a more pronounced differentiation among companies [2] - The current position of the Hong Kong innovative drug sector index is at a five-year low, suggesting potential for recovery as the market sentiment improves following optimization of centralized procurement policies [2] - China Ping An highlights the expectation of equipment renewal policies in 2025, which may positively impact industry bidding growth, particularly benefiting leading domestic companies focused on high-end and intelligent medical equipment [2]
丽珠集团拟15.87亿收购越南药企 借力拓展海外市场净利连增6年
Chang Jiang Shang Bao· 2025-05-26 01:08
Core Viewpoint - Lijun Group is accelerating its overseas market expansion through the acquisition of a majority stake in Imexpharm Corporation (IMP) in Vietnam for approximately 1.587 billion RMB, which is expected to enhance its international presence and product synergy [1][2][3] Group 1: Acquisition Details - Lijun Group's wholly-owned subsidiary, LIAN SGP, plans to acquire 64.81% of IMP for about 57.3 trillion VND, equivalent to approximately 1.587 billion RMB, representing 11.45% of the company's latest audited net assets [2] - The acquisition does not constitute a related party transaction or a major asset restructuring, and upon completion, IMP will be included in Lijun Group's consolidated financial statements [2] - IMP, established in 1977, is a leading pharmaceutical company in Vietnam, focusing on the research, production, and sales of pharmaceuticals, including antibiotics and cardiovascular drugs [2] Group 2: Financial Performance - Lijun Group has shown consistent growth in overseas revenue, with figures of 1.565 billion RMB, 1.571 billion RMB, and 1.724 billion RMB from 2022 to 2024, reflecting year-on-year growth rates of 1.72%, 0.4%, and 9.69% respectively [3] - The overseas gross profit margin reached 48.9% in 2024, marking a ten-year high [3] - The company's net profit has been on a positive growth trajectory since 2019, with a net profit of 637 million RMB in Q1 2025, representing a year-on-year increase of 4.75% [1][5] Group 3: Research and Development - Lijun Group has invested over 1 billion RMB annually in R&D since 2021, with total R&D expenditures amounting to 4.941 billion RMB from 2021 to 2024 [5] - As of the 2024 annual report, the company has 45 projects under development, including 23 innovative drugs and high-barrier complex formulations, with 7 projects in the review stage for market approval [5] Group 4: Shareholder Returns - Lijun Group has a strong track record of returning value to shareholders, having distributed cash dividends 25 times, totaling 10.54 billion RMB, with a dividend payout ratio of 47.75% [5]