阿得贝利单抗注射液

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恒瑞医药(01276.HK)收到国家药监局核准签发关于HRS-4508片、注射用SHR-A1811、阿得贝利单抗注射液、贝伐珠单抗注射液的药物临床试验批准通知书
Ge Long Hui· 2025-08-18 10:29
Group 1 - Company and its subsidiaries received approval from the National Medical Products Administration for clinical trials of HRS-4508 tablets, SHR-A1811 injection, Adebali monoclonal antibody injection, and Bevacizumab injection [1] - HRS-4508 is a novel, efficient, selective tyrosine kinase inhibitor that inhibits tumor cell proliferation [1] - The total R&D investment for HRS-4508 project is approximately 36.42 million yuan [1] Group 2 - SHR-A1811 injection binds to HER2-expressing tumor cells and induces apoptosis through a unique mechanism [2] - SHR-A1811 was approved for use in treating adults with unresectable locally advanced or metastatic non-small cell lung cancer (NSCLC) with HER2 mutations [2] - The total R&D investment for SHR-A1811 project is approximately 1.26 billion yuan [2] Group 3 - Bevacizumab is a humanized anti-VEGF monoclonal antibody that has been approved in multiple countries since 2004 [3] - The global sales of Bevacizumab are projected to be approximately 5.655 billion USD in 2024 [3] - The total R&D investment for Bevacizumab injection project is approximately 3.45 million yuan [3]
恒瑞医药取得药物临床试验批准通知
Zhi Tong Cai Jing· 2025-08-18 09:29
恒瑞医药(600276)(600276.SH)公告,公司及子公司苏州盛迪亚生物医药有限公司、上海盛迪医药有 限公司收到国家药品监督管理局核准签发关于HRS-4508片、注射用SHR-A1811、阿得贝利单抗注射 液、贝伐珠单抗注射液的《药物临床试验批准通知书》,将于近期开展临床试验,具体为:HRS-4508 联合其他抗肿瘤治疗HER2通路异常的实体瘤的开放、多中心的ⅠB/Ⅱ期临床研究。 ...
医药生物行业周报(8月第3周):商保创新药目录推出在即-20250818
Century Securities· 2025-08-18 00:59
Investment Rating - The report does not explicitly state an investment rating for the industry, but it indicates a positive trend in the pharmaceutical and biotechnology sector with a weekly increase of 3.08% [3][8]. Core Insights - The pharmaceutical and biotechnology sector outperformed the Wind All A index and the CSI 300 index during the week of August 11 to August 15, with notable gains in medical research outsourcing (7.77%), hospitals (5.59%), and medical consumables (4.47%) [3][8]. - The upcoming launch of the commercial insurance innovative drug directory is expected to activate the domestic high-end payment market for innovative drugs, with 121 drug names passing preliminary review [3][8]. - The World Conference on Lung Cancer (WCLC) will take place from September 6 to 9, showcasing significant research advancements in lung cancer, with domestic research playing an increasingly important role [3][8]. Market Weekly Review - The pharmaceutical and biotechnology sector rose by 3.08%, outperforming the Wind All A index (2.95%) and the CSI 300 index (2.37%) [3][8]. - Medical research outsourcing, hospitals, and medical consumables led the sector's gains, while offline pharmacies, blood products, and medical circulation experienced declines [3][8]. - Notable individual stock performances included Sino Medical (69.1%), Innovation Medical (51.5%), and Guangsheng Tang (40.7%) for gains, while *ST Suwu (-16.8%), ST Sansheng (-15.2%), and Nanhua Biological (-14.2%) faced significant losses [3][11]. Industry News and Key Company Announcements - The National Medical Insurance Administration announced the preliminary review of the 2025 National Basic Medical Insurance drug directory and the commercial insurance innovative drug directory [3][13]. - Novo Nordisk received accelerated FDA approval for its therapy Wegovy for treating non-alcoholic steatohepatitis (NASH) [3][13]. - Yunnan Baiyao approved a full acquisition of An Guo Shi Ju Yao Tang Pharmaceutical Co., Ltd. for 660 million RMB to enhance its traditional Chinese medicine business [3][15]. - Insmed's DPP1 inhibitor Brensocatib received FDA approval for treating non-cystic fibrosis bronchiectasis [3][14].
以诺康启动上市辅导;绿谷971再注册申请未获批准 | 医药早参
2 1 Shi Ji Jing Ji Bao Dao· 2025-08-14 00:45
Group 1: Industry Developments - Shanghai has initiated the online listing for the first batch of traditional Chinese medicine centralized procurement expansion, with the application period from August 12 to August 29, 2025 [1] - The Shanghai Market Supervision Administration reported a significant decline in the illegal rate of medical advertisements over the past five years, dropping from 3.89% in 2020 to 1.57% in 2024, a decrease of approximately 60% [2] - The first FDA-approved treatment for non-cystic fibrosis bronchiectasis (NCFB), Brinsupri, has been announced by Insmed, marking a significant milestone in the treatment options available for this condition [3] - The National Medical Products Administration has received a market application for the intraocular injection of Bevacizumab, indicating progress in ophthalmic drug development [4] - Heng Rui Medicine has received approval for clinical trials of its innovative drug SHR-A2102 for the treatment of recurrent/metastatic head and neck squamous cell carcinoma [5] Group 2: Capital Market Activities - Inokang Medical Technology has started the listing guidance process with Huatai Securities, indicating its intention to go public [6] - Rejuvenation Bio announced a capital increase of 100 million yuan for its subsidiary, Shun Jing Biomedical Technology, with a share price set at 25 yuan per registered capital [7] - Innovation Medical holds a 40% stake in Bole Brain Machine, which focuses on core technology research and product design in the medical rehabilitation field [8] Group 3: Vaccine and Pharmaceutical Developments - Zhifei Biological has completed the first nationwide vaccination for its quadrivalent influenza vaccine, showcasing advancements in vaccine distribution [9] - Zhonghui Bio's quadrivalent influenza vaccine has passed the preliminary review for inclusion in the national commercial health insurance innovative drug directory [10] - BeiGene anticipates that its drug Sotukimab will receive its first global approval by the end of 2026, with multiple clinical trials underway [11] Group 4: Regulatory and Market Challenges - The re-registration application for Green Valley Pharmaceutical's mannitol sodium capsules has not been approved, posing challenges for this controversial Alzheimer's drug [12] - There have been reports of supply shortages and rising prices for the mannitol sodium capsules, indicating market pressures and patient access issues [13] - Zhaoyan New Drug's former vice chairman plans to reduce his holdings by up to 352,450 shares, reflecting personal financial needs [14]
多款百万一针抗癌药,入围商保创新药目录初审名单
2 1 Shi Ji Jing Ji Bao Dao· 2025-08-13 07:24
Core Insights - The National Healthcare Security Administration (NHSA) announced the preliminary review results for the 2025 National Basic Medical Insurance, Maternity Insurance, and Work Injury Insurance drug catalog, revealing 534 drugs passed the review, with 121 drugs included in the commercial insurance innovative drug catalog [1][2] - This year marks the first implementation of a "dual-track system" for the drug catalog, focusing on basic insurance for essential drugs and providing supplementary coverage for "exclusive new drugs" or "rare disease medications" through commercial insurance [1][2] - The number of drugs passing the preliminary review has significantly increased compared to last year, with the number of drug names outside the catalog rising from 249 in 2024 to 310 [1] Drug Categories and Highlights - Over 98% of the drugs in the announced list are Western medicines, with only two traditional Chinese medicines included [3] - CAR-T therapies, which are at the forefront of cancer treatment, have gained attention, with several priced over 1 million yuan per injection, including products from Fosun Kite, Kintor Pharmaceutical, and Reindeer Biologics [1][2] - Notable entries in the list include innovative drugs from domestic companies, such as Shanghai Xinnian Pharmaceutical's hemophilia B gene therapy and Hengrui Medicine's PD-1 monoclonal antibody [3] Review and Approval Process - Passing the preliminary review does not guarantee inclusion in the basic medical insurance or commercial insurance innovative drug catalog, as further expert evaluations and price negotiations are required [3] - Approximately 80 drug varieties passed the preliminary review for both the basic medical insurance and commercial insurance catalogs, indicating potential for simultaneous negotiations [3]
多款百万一针抗癌药,入围商保创新药目录初审名单
21世纪经济报道· 2025-08-13 07:18
Core Insights - The article discusses the announcement by the National Medical Insurance Administration regarding the preliminary review of 534 drugs for the 2025 National Basic Medical Insurance, Maternity Insurance, and Work Injury Insurance drug catalog, along with 121 drugs included in the commercial insurance innovative drug catalog [1][2]. Group 1: Drug Catalog Adjustments - The 2025 drug catalog adjustments implement a "dual-track system," focusing on basic insurance for essential drugs while providing supplementary coverage for "exclusive new drugs" or "rare disease medications" through the commercial insurance innovative drug catalog [1][2]. - A total of 718 applications were received for the basic medical insurance catalog, with 534 approved, while 141 applications were received for the commercial insurance innovative drug catalog, with 121 approved [1][2]. Group 2: CAR-T Therapies - CAR-T therapies, which are personalized cancer treatments, have gained attention due to their high costs, with prices exceeding 1 million yuan per injection for several products [1][2]. - The article highlights that CAR-T therapies are among the first specialty drugs to be included in commercial insurance coverage, with various regions like Jiangsu and Shanghai incorporating them into their insurance plans [2]. Group 3: Drug Composition and Approval Process - The approved drugs are predominantly Western medicines, with over 98% of the list, and only two traditional Chinese medicines included [3]. - The approval of drugs through preliminary review does not guarantee inclusion in the basic medical insurance or commercial insurance catalogs, as further expert evaluations and price negotiations are required [3]. Group 4: Pricing and Negotiation - Approximately 80 drug varieties passed the preliminary review for both the basic medical insurance and commercial insurance catalogs, indicating potential for simultaneous negotiations [3]. - Drugs that exceed the basic insurance pricing limits may still qualify for the next evaluation stage, but their final inclusion depends on successful negotiations [3].
商保创新药目录药品初审名单公布,多款百万抗癌药在列
2 1 Shi Ji Jing Ji Bao Dao· 2025-08-13 05:43
Core Insights - The National Healthcare Security Administration (NHSA) announced the preliminary review results for the 2025 National Basic Medical Insurance, Maternity Insurance, and Work Injury Insurance drug catalog, revealing 534 drugs passed the review, with 121 drugs included in the commercial insurance innovative drug catalog [1][2] Group 1: Drug Catalog Adjustments - The 2025 adjustments mark the first implementation of a "dual-track system," focusing on basic insurance for essential drugs while providing supplementary coverage for "exclusive new drugs" or "rare disease medications" through the commercial insurance innovative drug catalog [1][2] - A total of 718 submissions were received for the basic insurance catalog, with 534 approved, while 141 submissions were made for the commercial insurance catalog, with 121 approved [1][2] - The number of drug names excluded from the catalog increased from 249 in 2024 to 310 [1] Group 2: CAR-T Therapies - CAR-T therapies, which are personalized cancer treatments, have gained attention due to their high costs, with prices exceeding 1 million yuan per injection for several products [1][2] - The commercial insurance catalog will include CAR-T therapies in upgraded coverage plans in various regions, with Shanghai's "Huibao" covering up to 500,000 yuan for patients [2] - Over the past three years, more than 80 lymphoma patients have received treatment through this channel, with total reimbursements exceeding 40 million yuan [2] Group 3: Drug Composition and Approval Process - The approved drugs are predominantly Western medicines, with over 98% representation, and only two traditional Chinese medicines included [3] - Notable cancer drugs include those from major pharmaceutical companies, alongside innovative domestic products like gene therapy for hemophilia B and PD-1 monoclonal antibodies [3] - Passing the preliminary review does not guarantee inclusion in the final catalog, as further expert evaluations and price negotiations are required [3][4] Group 4: Submission Conditions - Unique drugs meeting specific criteria can apply for both the commercial insurance innovative drug catalog and the basic catalog simultaneously [4]
恒瑞医药(600276.SH):注射用瑞康曲妥珠单抗、阿得贝利单抗注射液纳入拟突破性治疗品种公示名单
Ge Long Hui· 2025-08-12 18:09
Core Viewpoint - Heng Rui Medicine's subsidiary Suzhou Shengdiya Biopharmaceutical Co., Ltd. and Shanghai Shengdi Medicine Co., Ltd. have had their injectable drugs SHR-A1811 and Adalimumab included in the National Medical Products Administration's list of proposed breakthrough therapies, marking the ninth inclusion for SHR-A1811 [1] Group 1 - The injectable SHR-A1811 targets HER2-expressing tumor cells, inducing apoptosis through a mechanism involving toxin release in lysosomes [1] - Adalimumab is a humanized anti-PD-L1 monoclonal antibody that reactivates the immune system's anti-tumor activity by blocking the PD-1/PD-L1 pathway [1]
恒瑞医药两款药品纳入 拟突破性治疗品种公示名单
Zheng Quan Shi Bao· 2025-08-11 17:38
Core Insights - Heng Rui Medicine's subsidiary Suzhou Shengdiya Biopharmaceutical Co., Ltd. and Shanghai Shengdi Medicine Co., Ltd. have their injectable drugs SHR-A1811 and Adalimumab included in the National Medical Products Administration's list of proposed breakthrough therapies, marking the ninth inclusion for SHR-A1811 [1] Group 1: Company Developments - The injectable SHR-A1811 is designed to bind to HER2-expressing tumor cells, inducing apoptosis through a mechanism involving toxin release in lysosomes [2] - SHR-A1811 received approval for market launch in May 2025, targeting adult patients with unresectable locally advanced or metastatic non-small cell lung cancer (NSCLC) who have previously undergone at least one systemic therapy [2] - Cumulative R&D investment for SHR-A1811 has reached approximately 1.259 billion yuan [2] Group 2: Product Information - Adalimumab injection is a humanized anti-PD-L1 monoclonal antibody that reactivates the immune system's anti-tumor activity by blocking the PD-1/PD-L1 pathway [2] - Adalimumab injection (brand name: Ailili) was approved for market launch in March 2023, indicated for first-line treatment in extensive-stage small cell lung cancer patients in combination with carboplatin and etoposide [2] - Cumulative R&D investment for Adalimumab injection has reached approximately 901 million yuan [2] Group 3: Industry Context - The incidence of breast cancer is rapidly increasing in China, ranking as the second most common cancer among women [1] - Triple-negative breast cancer (TNBC) accounts for 10% to 15% of all breast cancer cases, with a higher prevalence in younger women and a lower disease-free survival rate [1] - The approval and application of tumor immunotherapy drugs, such as PD-L1 inhibitors, have improved progression-free survival and overall survival for patients with advanced TNBC [1]
晚间公告丨8月11日这些公告有看头
第一财经· 2025-08-11 14:51
Group 1 - Lushow Technology is planning to issue H-shares and list on the Hong Kong Stock Exchange, with details still under discussion [4] - Jinding Investment intends to acquire 53.29% of Nanjing Shenyuan Intelligent Technology for 213 million yuan, aiming to enhance its industrial layout and core competitiveness in the humanoid robot sector [5] - ST Yigou has reached a debt settlement agreement with Carrefour, agreeing to pay 220 million yuan to resolve outstanding debts, which will allow the company to indirectly hold 100% of Carrefour China [6][8] Group 2 - China Shipbuilding Industry Company will suspend trading from August 13 until delisting, as it plans to merge with China Shipbuilding through a share exchange [9] - Guangku Technology is set to acquire 100% of Suzhou Anjie Xun Optoelectronics, with the specific transaction price yet to be determined [10] - Shanghai Jianke's director is under disciplinary review, but this will not significantly impact the company's operations [11] Group 3 - ST Biology is planning to acquire 51% of Hunan Huize Biopharmaceutical, which is expected to constitute a major asset restructuring [12] - Peking University Pharmaceutical faces risks of a complete halt in its main business after terminating a long-term service contract with Peking University International Hospital, potentially leading to a revenue drop of approximately 1 billion yuan by 2026 [13][14] Group 4 - Jin Ying Heavy Industry has not yet engaged in business with Xinjiang Railway Co., and the impact on its operations is expected to be limited [15] - ST Suwu has initiated arbitration against Regen Biotech for breach of contract, seeking damages of 1.6 billion yuan [16] Group 5 - Heng Rui Pharmaceutical's two products have been included in the list of proposed breakthrough therapeutic varieties by the National Medical Products Administration [17] - Chengdu Huamei has successfully launched a low-power RISC-V MCU, targeting applications in IoT devices and industrial monitoring [18] Group 6 - Fosun Pharma's subsidiary has signed a licensing agreement with Expedition, which includes potential payments of up to 1.2 billion USD for development and sales milestones [19] - Runyang Technology plans to sell 51.01% of its subsidiary Air Box for 4.08 million yuan [20] Group 7 - Jishi Media has clarified that it does not participate in investments in currently released films, amid stock price volatility [22] Group 8 - Wanhua Chemical reported a net profit of 6.123 billion yuan for the first half of 2025, a decrease of 25.1% year-on-year, attributed to weak demand in overseas markets [23] - Xianggang Technology achieved a net profit of 78.32 million yuan, a significant increase of 432.14% year-on-year, driven by strong performance in its packaging and printing business [24] - Desay SV reported a net profit of 1.223 billion yuan, up 45.82% year-on-year, with plans not to distribute dividends [25] - Action Education's net profit decreased by 3.51% year-on-year, with a proposed cash dividend of 10 yuan per 10 shares [26] Group 9 - Changan Automobile and its indirect controlling shareholder plan to increase their holdings in the company by at least 5.7 million yuan [27][28] - Huasheng Tiancheng's executives have reduced their holdings between May 26 and August 8, 2025 [29] - Tianrongxin's shareholder plans to reduce up to 3% of the company's shares within three months [30] Group 10 - China Electric Power Construction's subsidiary has signed a contract worth approximately 6.994 billion yuan for a water supply expansion project in South Africa [31]