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前7月14个创新药获批上市
Xin Hua Ri Bao· 2025-08-05 21:05
Group 1 - In the first seven months of this year, Jiangsu approved 14 innovative drugs for market, surpassing last year's total of 13, accounting for nearly 30% of the 49 innovative drugs approved nationwide [1] - The innovative drugs include treatments for diseases such as tumors, spondyloarthritis, and influenza, with Jiangsu's first "platinum-resistant" ovarian cancer drug being a notable highlight [1] - Jiangsu's pharmaceutical industry is supported by nearly 3,000 high-tech enterprises in the biopharmaceutical sector, leading the nation in the number of companies listed in the top 100 pharmaceutical industrial enterprises by main business revenue for 2024 [2] Group 2 - Jiangsu has established seven national key laboratories in the biopharmaceutical field and has been approved to build the first national technology innovation center in this area, enhancing its innovation capabilities [2] - Jiangsu Hengrui Medicine Co., Ltd. has submitted two innovative drugs for approval, providing new treatment options for patients with active ankylosing spondylitis and recurrent or metastatic cervical cancer [2] - The company has increased its R&D investment, which accounted for 29.4% of its sales revenue last year, with a cumulative R&D investment of 46 billion yuan and over 90 self-innovated products in clinical development [2] Group 3 - Suzhou MediPharma Co., Ltd. has submitted an innovative drug that is the first biopharmaceutical product in Jiangsu to adopt a segmented production model, optimizing resource allocation and enhancing collaboration across the industry chain [3] - The segmented production model allows for different stages of production to be carried out in separate locations, improving specialization and efficiency in drug manufacturing [3] - The provincial drug regulatory authority has provided guidance to support the establishment of quality systems and risk management for this innovative production approach [3]
协同传统产业和新兴产业发展,深化“两个创新”融合——从产业“聚变”看江苏经济活力与韧性
Xin Hua Ri Bao· 2025-07-25 23:49
Group 1: Economic Growth and Industrial Performance - Jiangsu province's industrial added value increased by 7.4% year-on-year in the first half of the year, with strategic emerging industries accounting for 42.1% of the total industrial output, up 0.5 percentage points from last year [1] - High-tech industries' output accounted for 51.8% of the province's total industrial output, reflecting a 0.4 percentage point increase from the first quarter [2] - Traditional industries remain significant, with manufacturing investment growing by 0.5%, particularly in automotive (21.6%), textiles (26.9%), and rubber and plastics (11.2%) [5] Group 2: Emerging Industries and Innovation - The number of high-tech enterprises in Jiangsu accounted for 36.3% of the province's industrial enterprises, generating 73.6% of the high-tech industry output [2] - Jiangsu is positioning itself as a leader in low-altitude economy, with over 30 companies in the drone manufacturing sector and a significant increase in drone take-off and landing sites [4] - The province has seen a surge in innovative pharmaceuticals, with 11 new drugs approved for market, ranking first in the country [8] Group 3: Technological Advancements and Digital Economy - Jiangsu has established 1,808 advanced intelligent factories, with significant growth in high-tech manufacturing and equipment manufacturing [7] - The province is actively exploring the integration of digital economy and traditional industries, with a 7.9% increase in the core digital economy industries' sales [9] - A total of 41 strategic emerging industry funds have been established, with a total scale exceeding 100 billion yuan, enhancing capital capabilities across the province [9][10]
江苏跑出创新药械上市“加速度”
Xin Hua Ri Bao· 2025-07-15 23:50
Group 1: Industry Achievements - In 2024, Jiangsu approved 352 new drugs, including 13 innovative drugs, accounting for 27.08% of the national total, and 490 Class III medical devices, leading the nation [1] - Jiangsu's innovative drugs and medical devices are rapidly gaining approval, with five innovative drugs approved in May 2025, four of which are related to cancer [1][2] - The first domestically approved BCL-2 inhibitor and a potential best-in-class treatment for erectile dysfunction were launched by Suzhou-based companies [2] Group 2: Regulatory Support and Initiatives - Jiangsu's regulatory agencies are focused on creating a "policy highland" to support the rapid approval of innovative drugs and devices, including a "face-to-face" service initiative that addresses companies' needs directly [4][5] - The province has established a comprehensive service mechanism that includes a dedicated team for each innovative product, ensuring personalized and efficient support throughout the development and approval process [6][5] - Jiangsu is a national leader in implementing pilot programs for drug approval reforms and has established a "white list" system for importing research materials, facilitating faster access for companies [7][9] Group 3: Innovative Products and Market Expansion - Jiangsu's innovative medical devices include a new type of laparoscopic "hand-controlled robotic arm," which enhances surgical efficiency and precision [3] - The province has successfully facilitated the entry of local innovative drugs into international markets, with a Chinese drug approved in the U.S. for a specific type of lung cancer [2] - Jiangsu's first segmented production pilot for ADC drugs has been approved, allowing companies to streamline production processes and reduce costs [8]
医保目录调整在即;苑东生物董事被查|21健讯Daily
2 1 Shi Ji Jing Ji Bao Dao· 2025-07-03 02:34
Policy Developments - The National Healthcare Security Administration (NHSA) is soliciting public opinions on the draft adjustment plan for the 2025 National Basic Medical Insurance, Maternity Insurance, and Work Injury Insurance drug catalog, as well as the commercial health insurance innovative drug catalog [2] - The first version of the commercial health insurance innovative drug catalog will be established in 2025, focusing on innovative drugs with high clinical value that cannot be included in the basic catalog [2] Drug and Device Approvals - JinSai Pharmaceutical's monoclonal antibody drug, Firsekibart, has been approved for the treatment of acute gouty arthritis in adults who are intolerant to or have contraindications for non-steroidal anti-inflammatory drugs and/or colchicine [4] - Betta Pharmaceuticals' innovative drug, Tazemetostat, has been approved for the treatment of locally advanced or metastatic breast cancer in adults who have progressed after endocrine therapy [5] - Xiansheng Pharmaceutical's monoclonal antibody, Suweisitabant, has been approved for the treatment of recurrent ovarian cancer, fallopian tube cancer, or primary peritoneal cancer in adults who have received no more than one prior systemic therapy [6] Capital Markets - Merida Biosciences, a U.S. biotech company, has raised $121 million in Series A financing, setting a record for Series A funding in the autoimmune field [8] Industry Events - Former Takeda China President, Dan Guohong, will join BeiGene as General Manager for Greater China, Central Asia, and South Asia, starting August 18, 2025 [10] - Yuan Dong Bio's independent director, Peng Long, is under disciplinary review and investigation for serious violations of discipline and law [12] - KangLe WeiShi announced that its shareholder, Tianlangxing Holdings Group, has reduced its holdings by 1.6953 million shares, accounting for 0.6034% of the company's total share capital [13]