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注射用紫杉醇(白蛋白结合型)
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2025年中国植物生物碱行业提取工艺、相关政策、产业链、市场规模、竞争格局及发展趋势研判:在医疗保健、畜牧养殖等领域有良好的应用前景[图]
Chan Ye Xin Xi Wang· 2025-09-30 01:48
Core Viewpoint - The global plant alkaloid market is experiencing stable growth, with projections indicating an increase from $8.72 billion in 2015 to $14.49 billion in 2024, and further to $15.94 billion by 2025. The Chinese market is expected to grow from 37.27 billion yuan in 2015 to 60.32 billion yuan in 2024, reaching 62.6 billion yuan by 2025 [1][4]. Group 1: Industry Definition and Extraction Process - Plant alkaloids are nitrogen-containing organic compounds primarily found in plants, often existing as salts with organic acids. They are predominantly located in the roots, stems, leaves, and fruits of higher plants, especially in dicotyledons [2][3]. - The extraction methods for plant alkaloids include reflux extraction, ultrasonic-assisted extraction, and supercritical fluid extraction, with advancements in technology leading to the discovery of more alkaloids and their physiological activities [3]. Group 2: Current Industry Status - The plant alkaloid market is gaining attention due to its wide availability and excellent properties such as antioxidant, anti-tumor, and anti-inflammatory activities. The market is projected to grow steadily, with significant applications in healthcare and animal husbandry [4]. - The core product, paclitaxel, is experiencing a trend of increasing sales but decreasing prices, with new formulations being adopted rapidly. Key players in the market include Jiangsu Hengrui Medicine and Shijiazhuang Yiling Pharmaceutical [4]. Group 3: Industry Chain - The upstream of the plant alkaloid industry chain includes natural plant resources, with various plant families providing different alkaloids. The midstream involves extraction, processing, and formulation development, while the downstream focuses on applications in pharmaceuticals and health products [5]. Group 4: Development Environment and Policies - The biopharmaceutical industry is a key area for national strategic development, with policies introduced to promote high-quality growth in the pharmaceutical sector. The government is focusing on innovative drug development and improving clinical evaluation and approval processes [6]. Group 5: Competitive Landscape - Major companies in the plant alkaloid sector include Nanjing Green Leaf Pharmaceutical, Jiangsu Hengrui Medicine, and Shijiazhuang Yiling Pharmaceutical, among others. These companies are involved in the development and production of various alkaloid-based drugs [5][7]. Group 6: Industry Development Trends - The plant alkaloid industry is undergoing a transformation driven by technological innovation and market changes, with trends towards upgrading technology, green practices, and precision medicine. The demand for effective and accessible plant alkaloid drugs is rapidly increasing in emerging markets [12][13].
盛诺基淫羊藿素软胶囊新增治疗胰腺癌适应症获临床批件
Zhong Guo Jing Ji Wang· 2025-09-22 04:52
盛诺基医药与南开大学生科院及北京大学肿瘤医院等单位合作,采用20多例胰腺癌病人的肿瘤样本培养 成类器官进行体外实验,也证实了淫羊藿素与胰腺癌一线治疗方案(吉西他滨+白蛋白紫杉醇)及(白蛋白 紫彬醇+PD1抗体)联合有显著的协同作用并观察到淫羊藿素促进T细胞趋向肿瘤类器官,进一步验证了 临床的协同增效结果,为即将开展的临床试验提供了重要依据。 9月19日,北京盛诺基医药科技股份有限公司(以下简称盛诺基医药)旗下子公司北京珅诺基医药科技有 限公司收到国家药品监督管理局药品审评中心核准签发的《药物临床试验批准通知书》,由北京珅诺基 医药科技有限公司申报的淫羊藿素软胶囊(商品名:阿可拉定)新增联合注射用紫杉醇(白蛋白结合型)和 注射用盐酸吉西他滨(简称AG方案)用于治疗局部晚期不可切除或转移性胰腺癌。 来自浙江大学邵逸夫医院开展的"淫羊藿素软胶囊与AG联合治疗晚期胰腺癌"研究数据显示,该研究共 纳入20例新诊断的晚期胰腺导管腺癌(PDAC)患者,所有患者接受6周期的淫羊藿素软胶囊联合AG治 疗,客观缓解率(ORR)达到了50%,疾病控制率(DCR)高达90%,6个月生存率为90%。尤为振奋人心的 是,35%的初始不可 ...
9月16日晚间重要公告一览
Xi Niu Cai Jing· 2025-09-16 10:15
Group 1 - China Shenhua reported coal sales of 37.5 million tons in August, a year-on-year decrease of 3.1%, with total sales for the first eight months at 280 million tons, down 9.2% year-on-year [1] - China Shenhua, established in November 2004, focuses on coal and electricity production and sales, as well as transportation and coal-to-olefins [1] - Huaren Shuanghe's subsidiary received a drug registration certificate for a new injection used in treating non-ST elevation acute coronary syndrome [1] - Huaren Shuanghe, founded in May 1997, operates in chronic disease management, specialty business, and infusion business [1] Group 2 - New Wufeng's subsidiary signed a property transaction contract for a 60% equity transfer at a price of 9.7 million yuan [1] - New Wufeng, established in June 2001, specializes in pig farming, meat sales, and feed processing [2] - Yaoshi Technology announced that its convertible bonds will stop conversion after September 17, with remaining bonds to be redeemed at 100.62 yuan per bond [3] - Yaoshi Technology, founded in December 2006, focuses on drug molecular building blocks and related services [3] Group 3 - Newhua Co. announced a board member's plan to reduce holdings by up to 75,200 shares, representing 0.039% of total shares [4] - Newhua Co., established in September 1997, specializes in fine chemical products [4] - Hefei Construction's subsidiary signed a land use rights transfer contract for residential land with a total price of 12.24 billion yuan [6] - Hefei Construction, founded in September 1999, is involved in real estate development and property management [6] Group 4 - Guoyao Modern's subsidiary received a drug registration certificate for an injection used in anesthesia and emergency treatment [7] - Guoyao Modern, established in November 1996, focuses on pharmaceutical product development and sales [7] - Maohua Shihua announced the resignation of its deputy general manager [8] - Maohua Shihua, founded in October 1988, specializes in petrochemical products [9] Group 5 - Zhejiang Xineng applied for enforcement of a civil mediation agreement, seeking 170 million yuan from a group for breach of contract [10] - Zhejiang Xineng, established in December 1991, focuses on renewable energy projects [10] - Zejing Pharmaceutical announced the initiation of key clinical trials for a new drug targeting DLL3 [11] - Zejing Pharmaceutical, founded in March 2009, specializes in the development and production of new chemical and biological drugs [12] Group 6 - Huayi Technology's deputy general manager resigned due to personal work arrangements [13] - Huayi Technology, established in December 1998, focuses on high polymer materials and equipment manufacturing [13] - Luxiao Technology's subsidiary signed a strategic cooperation agreement with a leading cross-border e-commerce company [14] - Luxiao Technology, founded in May 1989, operates in various sectors including photovoltaic power generation [14] Group 7 - Aoxiang Pharmaceutical's subsidiary received a drug registration certificate for a new cancer treatment [15] - Aoxiang Pharmaceutical, established in April 2010, focuses on the development and production of pharmaceutical products [15] - Baiyunshan's pharmaceutical factory received approval for five drug supplement applications [16] - Baiyunshan, founded in September 1997, specializes in the research and production of various pharmaceutical products [16] Group 8 - Renfu Pharmaceutical's subsidiaries received drug registration certificates for two new products [17] - Renfu Pharmaceutical, established in March 1993, focuses on drug research and production [18] - China Shipbuilding Technology signed a significant contract for green methanol sales, potentially worth up to 1.2 billion dollars [19] - China Shipbuilding Technology, founded in May 1997, specializes in wind and solar resource development [19] Group 9 - Haohua Technology received a project designation from a global automotive brand for its ADAS system [20] - Haohua Technology, established in January 2010, focuses on intelligent driving perception systems [20] - Hendi Pharmaceutical received approval for a new raw material drug [21] - Hendi Pharmaceutical, founded in December 1995, specializes in chemical raw materials and formulations [22] Group 10 - JX Communication's subsidiary received a temporary use permit for an air traffic communication system [23] - JX Communication, established in January 1995, focuses on communication technology applications [23] - Longyuan Technology's deputy general manager resigned due to work reasons [24] - Longyuan Technology, founded in December 1998, specializes in energy-saving and environmental protection [25] Group 11 - Jiuqiang Bio received a medical device registration for a gastrin-17 assay kit [26] - Jiuqiang Bio, established in January 2001, focuses on in vitro diagnostic testing platforms [26] - Rifei Co. received approval for a stock issuance to specific investors [27] - Rifei Co., founded in December 2009, specializes in special equipment cables and other electrical devices [27] Group 12 - Huayi Media received a subsidy for a micro-short drama project [28] - Huayi Media, established in August 1998, focuses on film and game content investment [28] - Huilong Pharmaceutical's subsidiary received overseas marketing approvals for multiple products [29] - Huilong Pharmaceutical, founded in October 2010, specializes in innovative and high-quality generic drugs [29] Group 13 - Junsheng Electronics' subsidiary received project designations from two major automotive brands [30] - Junsheng Electronics, established in August 1992, focuses on automotive parts [30] - Silek signed an investment cooperation agreement for a new energy project [31] - Silek, founded in January 2004, specializes in metal packaging equipment [31] Group 14 - ST Huhuwa received drug registration certificates for two new products [32] - ST Huhuwa, established in June 2005, focuses on drug research and production [32] - Canray Technology announced a share buyback plan of 20 to 40 million yuan [33] - Canray Technology, founded in September 2005, specializes in integrated circuits [33] Group 15 - Qilu Bank's directors plan to collectively increase their holdings by at least 3.5 million yuan [34] - Qilu Bank, established in June 1996, focuses on corporate and personal banking services [34] - China Overseas Land reported a significant decrease in contract sales in August [35] - China Overseas Land, founded in September 1997, specializes in tourism and real estate [35] Group 16 - Longjian Co. plans to acquire 100% of Guangdong Zhimao's equity for 40,000 yuan [36] - Longjian Co., established in January 1993, focuses on infrastructure construction [36] - Lichong Group's subsidiary received project designations from a luxury car brand [37] - Lichong Group, founded in July 1998, specializes in aluminum alloy products [37] Group 17 - Kanglong Huacheng's subsidiary passed an FDA inspection [38] - Kanglong Huacheng, established in July 2004, focuses on integrated drug research and development services [38] - Kangtai Bio received a drug registration certificate for a new polio vaccine [39] - Kangtai Bio, founded in September 1992, specializes in vaccine development and production [39] Group 18 - Baiyunshan's pharmaceutical factory's drug entered a key clinical trial phase [40] - Baiyunshan, established in September 1997, focuses on various pharmaceutical products [40] - Zhongyuan Home's chairman plans to reduce holdings by up to 3% [41] - Zhongyuan Home, founded in November 2001, specializes in furniture production [41] Group 19 - Shangluo Electronics plans to acquire 88.79% of Ligon Technology's equity for 709 million yuan [42] - Shangluo Electronics, established in August 1999, focuses on electronic components [42] - Shangluo Electronics also plans to issue convertible bonds to raise 1 billion yuan [43] - Shangluo Electronics, founded in August 1999, specializes in electronic products for various applications [43] Group 20 - HNA Holdings reported a 3.38% increase in passenger capacity in August [44] - HNA Holdings, established in December 1995, focuses on air transportation services [44] - Yipin Hong's subsidiary received a drug registration certificate for a new product [45] - Yipin Hong, founded in February 2002, specializes in pharmaceutical production [45] Group 21 - Haishi Ke's innovative drug received approval for a new indication [46] - Haishi Ke, established in August 2005, focuses on new drug development [46] - Huaxia Airlines plans to repurchase shares worth 80 to 160 million yuan [47] - Huaxia Airlines, founded in April 2006, specializes in air transportation services [47] Group 22 - Jingchen Co. plans to acquire 100% of Xinchip Microelectronics for 316 million yuan [48] - Jingchen Co., established in July 2003, focuses on semiconductor design [48] - Zhongxin Heavy Industry was recognized as an excellent smart factory by the Ministry of Industry and Information Technology [49] - Zhongxin Heavy Industry, founded in January 2008, specializes in large equipment and technology solutions [49]
医药一哥,业绩创新高!有重要股东减持了……
Zheng Quan Shi Bao· 2025-08-20 23:01
Core Viewpoint - Heng Rui Medicine reported strong financial performance for the first half of 2025, with significant growth in revenue and net profit, driven by innovative drug sales and licensing income [1][7]. Financial Performance - The company achieved operating revenue of 15.76 billion yuan, a year-on-year increase of 15.88% [2]. - Net profit attributable to shareholders reached 4.45 billion yuan, up 29.67% compared to the same period last year [3]. - Total profit amounted to 5.05 billion yuan, reflecting a growth of 34.63% [3]. - The net cash flow from operating activities was 4.30 billion yuan, an increase of 41.80% [3]. - The company's net assets at the end of the reporting period were 58.46 billion yuan, up 28.44% from the previous year [3]. Innovation and R&D - The company invested 3.87 billion yuan in R&D during the first half of 2025, with 3.23 billion yuan classified as expensed R&D [3]. - Six Class 1 innovative drugs were approved for market launch during the reporting period [8]. - The company has over 100 self-innovated products in clinical development and more than 400 clinical trials ongoing domestically and internationally [8]. Sales and Market Expansion - Innovative drug sales and licensing income totaled 9.56 billion yuan, accounting for 60.66% of total revenue, with innovative drug sales alone reaching 7.57 billion yuan [7]. - The company received significant licensing payments, including 200 million USD from Merck and 75 million USD from IDEAYA, contributing to revenue growth [7]. - The company has accelerated its internationalization efforts, with over 20 overseas clinical trials initiated in various countries [9]. Shareholder Activity - Despite the recent increase in stock price, three of the top ten shareholders reduced their holdings in the second quarter [4][6].
双成药业上半年亏损扩大
Core Viewpoint - The financial performance of Shuangcheng Pharmaceutical (002693.SZ) is deteriorating, with significant declines in revenue and profits, raising concerns about its future viability and potential delisting from the Shenzhen Stock Exchange [2][6][7]. Financial Performance - In the first half of 2025, Shuangcheng Pharmaceutical reported total revenue of 84.12 million yuan, a year-on-year decrease of 11.35% [2]. - The net profit attributable to shareholders was -18.47 million yuan, down 8.97% year-on-year, while the net profit after deducting non-recurring items was -21.02 million yuan, a decline of 18.34% [2]. - The company's cash reserves plummeted by over 70% compared to the same period last year, leaving only 4.78 million yuan, insufficient to cover even one month of operating expenses [5]. Product Performance - Revenue from peptide products, other products, and entrusted business all experienced declines in the first half of 2025, with entrusted business revenue dropping by 41.04% [2][4]. - The revenue from peptide products was 40.07 million yuan, a decrease of 3.95%, and accounted for 47.64% of total revenue, with a gross margin of 46.5%, down 13.87 percentage points from the previous year [3]. Market Challenges - The decline in gross margin is attributed to price reductions for core products, particularly the injection of thymosin alpha-1, which saw a significant drop in sales profits due to new procurement pricing [3]. - The company has faced challenges in expanding its entrusted business, with revenue from this segment only accounting for 13.90% of total revenue, and slow progress in external CMO collaborations [4]. Legal and Financial Issues - Shuangcheng Pharmaceutical has initiated legal action against Zhongrong Trust due to overdue financial products, seeking repayment of 21.05 million yuan in principal and interest [8][9]. - The company has reported cumulative losses exceeding 700 million yuan over the past nine years, raising concerns about its financial sustainability [6]. Future Outlook - The company has proposed several measures to improve performance, including increasing R&D investment, expanding sales channels, and optimizing operational processes [7]. - However, the revenue trend from 2022 to 2025 shows a consistent decline, indicating significant challenges ahead in meeting the revenue threshold to avoid delisting [7].
*ST双成:注射用紫杉醇(白蛋白结合型)ANDA已获得美国FDA上市许可批准并已在美国实现出口销售
Mei Ri Jing Ji Xin Wen· 2025-08-05 06:06
Core Viewpoint - The company has received FDA approval for its injectable paclitaxel (albumin-bound) and has commenced export sales to the United States [2] Group 1 - The company’s injectable paclitaxel (albumin-bound) is available in a specification of 100 mg per bottle [2] - The company confirmed that the product information will be disclosed in accordance with legal regulations [2] - The company will provide updates through designated disclosure media and the Giant Tide Information Network [2]
*ST双成(002693.SZ):公司注射用紫杉醇(白蛋白结合型)ANDA已在美国实现出口销售
Xin Lang Cai Jing· 2025-08-05 03:29
Core Viewpoint - *ST Shuangcheng (002693.SZ) has received FDA approval for its injectable paclitaxel (albumin-bound) product, which is now available for export sales in the United States [1] Company Summary - The company announced that its ANDA for injectable paclitaxel (100 mg/vial) has been approved by the U.S. FDA [1] - The product information will be disclosed in accordance with legal regulations, and investors are advised to refer to the company's announcements on designated media and the Giant Tide Information Network [1]
*ST双成: 2025年半年度报告
Zheng Quan Zhi Xing· 2025-07-30 16:13
Core Viewpoint - The company reported a decline in revenue and net profit for the first half of 2025, indicating challenges in the pharmaceutical industry and the need for strategic adjustments to improve performance [2][4]. Financial Performance - Revenue for the first half of 2025 was CNY 84,122,087.60, a decrease of 11.35% compared to CNY 94,892,601.28 in the same period last year [2][4]. - The net profit attributable to shareholders was a loss of CNY 18,466,557.74, compared to a loss of CNY 16,946,164.02 in the previous year, reflecting an 8.97% increase in losses [2][4]. - The net cash flow from operating activities improved significantly, with a net outflow of CNY 1,590,356.53, a 93.23% improvement from a net outflow of CNY 23,505,112.58 in the previous year [2][4]. Industry Overview - The pharmaceutical manufacturing industry in China saw a revenue of CNY 1,227.52 billion in the first half of 2025, down 1.2% year-on-year, with total profits decreasing by 2.8% to CNY 176.69 billion [3]. - The company is recognized as a national high-tech enterprise, focusing on the research, production, and sales of peptide drugs, with several products approved for sale in international markets [3][4]. Business Operations - The company specializes in the development, production, and sales of injectable drugs, solid preparations, and active pharmaceutical ingredients, with a strong emphasis on chemical synthesis of peptide drugs [3][4]. - Key products include Thymosin Alpha 1, Somatostatin, and Bivalirudin, which have received various international approvals, including from the FDA and EMA [3][4]. Competitive Advantages - The company has established a comprehensive capability in generic drug research, registration, and patent management, with a robust pipeline of products aimed at international markets [4]. - The company has initiated the development of new peptide synthesis technologies to reduce environmental impact and production costs, enhancing its competitive edge [4].
*ST双成: 海南双成药业股份有限公司2025年半年度业绩预告
Zheng Quan Zhi Xing· 2025-07-14 16:25
Group 1 - The company expects a net loss attributable to shareholders in the range of 13 million to 19 million yuan for the current reporting period, compared to a loss of 16.9462 million yuan in the same period last year, indicating a potential decrease of 12.12% to an increase of 23.29% [1] - The expected operating income for the current period is projected to be between 75 million and 95 million yuan, down from 94.8926 million yuan in the previous year [1] - The company attributes the performance changes to significant price reductions in key products due to market reforms and competitive bidding, particularly affecting domestic sales profits [2] Group 2 - The company has received FDA approval for the abbreviated new drug application (ANDA) for injectable paclitaxel (albumin-bound), which has begun to generate export sales, contributing positively to export profits [2] - Non-recurring gains are expected to contribute approximately 2.55 million yuan to net profit, primarily from government subsidies and investment income [2] - The company is actively taking measures to address the delisting risk warning imposed by the Shenzhen Stock Exchange due to financial performance concerns [3]
*ST双成:预计上半年净亏损1300万元-1900万元
news flash· 2025-07-14 12:31
Core Viewpoint - *ST Shuangcheng (002693.SZ) expects a net loss of 13 million to 19 million yuan for the first half of 2025, compared to a loss of 16.9462 million yuan in the same period last year [1] Company Summary - The company attributes the expected loss to significant changes in market supply and pricing due to ongoing reforms in the pharmaceutical industry, with a notable decline in sales volume for non-winning bid products and a substantial drop in prices for winning bid products [1] - The company's main product, Thymosin Alpha 1 injection, experienced a price reduction during the new bidding period, leading to decreased domestic sales profits [1] - However, the company achieved a milestone with the approval of the abbreviated new drug application (ANDA) for Paclitaxel Injection (albumin-bound) by the U.S. Food and Drug Administration (FDA) in May 2025, which has begun to generate export sales [1] - Additionally, there was an increase in export revenue from the injection of Bivalirudin, contributing to improved export profits [1] - Overall, these factors resulted in minimal changes to the company's overall performance [1]