安瑞克芬注射液
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超10亿美元!海思科与AirNexis签订独占许可协议
Zhong Guo Zheng Quan Bao· 2026-01-10 04:34
1月9日晚间,海思科公告称,公司与美国AirNexis Therapeutics, Inc.(AirNexis)签订独占许可协议,授 予AirNexis在除中国以外的全球范围内开发、生产和商业化HSK39004的独家权利。本次交易构成共同 投资的关联交易,交易尚需获得股东会的批准。 AirNexis将向海思科支付1.08亿美元首付款(含4000万美元现金及等值约6800万美元的AirNexis公司 19.9%股权)及最高9.55亿美元的额外里程碑付款、特许权使用费。 获多只美元基金青睐 此次对外授权采取NewCo(设立合资公司)的交易模式。NewCo模式涉及创建一家新公司,通常设立 在海外司法管辖区,专门用于开发、生产和商业化特定的创新药物资产。与传统的授权许可(out- Wind数据显示,1月10日,海思科股价收报56.18元/股,市值达629亿元。 交易金额超10亿美元 公告显示,AirNexis是一家于2025年12月23日在美国特拉华州设立的公司。 AirNexis将向海思科支付1.08亿美元首付款(含4000万美元现金及等值约6800万美元的AirNexis公司 19.9%股权)及最高9.55亿美元 ...
证券代码:002653 证券简称:海思科 公告编号:2025-128
Zhong Guo Zheng Quan Bao - Zhong Zheng Wang· 2025-12-09 03:26
Group 1 - The core announcement is that the company's drugs,环泊酚注射液 and 安瑞克芬注射液, have been included in the National Medical Insurance Catalog (2025 version) [1][2] - 环泊酚注射液 is a new intravenous anesthetic developed by the company, with its active ingredient being the (R)-configured isomer, which acts as a GABAA receptor agonist [1] - 安瑞克芬注射液 is a high-selectivity peripheral kappa opioid receptor agonist and is the first non-narcotic prescription opioid analgesic approved for pain relief without being classified as a controlled substance [2] Group 2 - The inclusion of these drugs in the National Medical Insurance Catalog is expected to facilitate market promotion and future sales of innovative products [2] - The National Medical Insurance Catalog (2025 version) will officially take effect on January 1, 2026, and is not expected to have a significant short-term impact on the company's operating performance [2]
海思科:创新药环泊酚、安瑞克芬纳入新医保目录
Quan Jing Wang· 2025-12-09 02:29
Core Insights - Haikang Pharmaceutical (002653) announced that its drugs, Ropivacaine Injection and Anrekevin Injection, have been included in the National Medical Insurance Directory (2025 version), which will be implemented on January 1, 2026 [1] Group 1: Product Developments - Ropivacaine Injection is gaining market share due to its excellent efficacy and is becoming a leader in the domestic anesthesia field, having previously been included in the National Medical Insurance Directory and successfully renewed its contract [1] - The product is also making steady progress in overseas clinical trials and is expected to be the first Chinese innovative anesthetic drug to enter the U.S. market [1] Group 2: Market Potential - Anrekevin Injection is the world's first opioid analgesic without the need for narcotic management, specifically for pain relief indications, indicating a broad market potential [1] - This product is anticipated to become a second growth driver for the company, contributing to performance growth [1]
首版商保创新药目录推出,恒瑞医药、海思科等多家药企上榜
Shang Hai Zheng Quan Bao· 2025-12-08 23:56
Core Insights - The National Healthcare Security Administration and the Ministry of Human Resources and Social Security have released the new National Medical Insurance Directory and the first Commercial Health Insurance Innovative Drug Directory, set to be implemented nationwide from January 1, 2026 [1][2] Summary by Sections National Medical Insurance Directory - A total of 114 new drugs have been added to the National Medical Insurance Directory, with 111 of them being new products launched within the last five years, representing 97.3% of the new additions [2] - Among the new drugs, 50 are classified as Category 1 innovative drugs, with a success rate of 88%, an increase from 76% in 2024 [2] - The total number of drugs in the directory has increased to 3,253, including 1,857 Western medicines and 1,396 traditional Chinese medicines [2] Company Announcements - Several listed companies, including Heng Rui Medicine, Fosun Pharma, and Hai Si Ke, announced new drug inclusions or renewals in the updated National Medical Insurance Directory [3] - Heng Rui Medicine reported that 20 products/indications were included, with significant coverage across various diseases such as tumors and cardiovascular conditions [3][4] - Hai Si Ke's two Category 1 innovative drugs were included, with one being a new addition and the other a renewal [4] Commercial Health Insurance Innovative Drug Directory - The first Commercial Health Insurance Innovative Drug Directory includes 19 new drugs from 18 innovative pharmaceutical companies, with 9 being Category 1 innovative drugs [7] - Notably, five CAR-T products were included, representing over half of the CAR-T products available in China, which previously faced challenges in entering the insurance market due to high pricing [7][8] - The directory also includes treatments for rare diseases and high-profile conditions such as Alzheimer's disease, enhancing the complementarity with the basic medical insurance [7][10] Notable Drug Inclusions - The directory includes drugs for significant diseases such as triple-negative breast cancer and pancreatic cancer, as well as treatments for rare diseases like Gaucher disease [5][9] - In the diabetes sector, several domestic drugs were newly included, such as a long-acting GLP-1 receptor agonist [6] - Companies like Bei Hai Kang Cheng and Bai Ji Shen Zhou have also successfully included their innovative drugs in the Commercial Health Insurance Directory [9]
海思科(002653.SZ):安瑞克芬注射液被新增纳入国家医保目录
智通财经网· 2025-12-08 03:55
Core Viewpoint - The announcement by the National Healthcare Security Administration and the Ministry of Human Resources and Social Security regarding the "National Basic Medical Insurance, Maternity Insurance, and Work Injury Insurance Drug Catalog" and the "Commercial Health Insurance Innovative Drug Catalog" includes the successful renewal of the company's环泊酚注射液 and the addition of安瑞克芬注射液 to the 2025 version of the National Medical Insurance Catalog [1] Group 1 - The company has successfully renewed the listing of环泊酚注射液 in the National Medical Insurance Catalog [1] - The安瑞克芬注射液 has been newly included in the National Medical Insurance Catalog (2025 version) [1] - The安瑞克芬注射液 is a self-developed high-selectivity peripheral kappa opioid receptor agonist and is the first non-narcotic prescription opioid analgesic to obtain analgesic indications without being classified as a controlled substance [1] Group 2 - The company currently has four category 1 innovative drugs included in the National Medical Insurance Catalog (2025 version), which are环泊酚注射液, 安瑞克芬注射液, 苯磺酸克利加巴林胶囊, and 考格列汀片 [1]
海思科:安瑞克芬注射液被新增纳入国家医保目录
Zhi Tong Cai Jing· 2025-12-08 03:54
Core Viewpoint - The announcement by the National Healthcare Security Administration and the Ministry of Human Resources and Social Security regarding the new National Medical Insurance Catalog (2025 version) includes the successful renewal of the company's环泊酚注射液 and the addition of安瑞克芬注射液, which is a significant development for the company and its product portfolio [1] Group 1 - The National Medical Insurance Catalog (2025 version) was officially released on December 7, 2025 [1] - The company has successfully renewed the listing of环泊酚注射液 and has added安瑞克芬注射液 to the new catalog [1] - 安瑞克芬注射液 is a self-developed high-selectivity peripheral kappa opioid receptor agonist and is the first non-narcotic prescription opioid analgesic approved for pain relief without being classified as a controlled substance [1] Group 2 - The company now has four class 1 innovative drugs included in the National Medical Insurance Catalog (2025 version), which are环泊酚注射液, 安瑞克芬注射液, 苯磺酸克利加巴林胶囊, and 考格列汀片 [1]
海思科:1类创新药被纳入国家医保目录
Xin Lang Cai Jing· 2025-12-08 03:45
Core Insights - The announcement from the National Healthcare Security Administration and the Ministry of Human Resources and Social Security includes the updated National Basic Medical Insurance, Maternity Insurance, and Work Injury Insurance Drug Catalog, as well as the Commercial Health Insurance Innovative Drug Catalog [1] Company Summary - Haisco Pharmaceutical Group Co., Ltd. successfully renewed the contract for its injection of Ropivacaine and has added Anrekefen injection to the National Medical Insurance Catalog (2025 version) [1] - Ropivacaine injection is indicated for sedation and anesthesia during non-tracheal intubation surgeries/procedures, induction and maintenance of general anesthesia, and sedation during mechanical ventilation in intensive care [1] - Anrekefen injection is indicated for mild to moderate pain following abdominal surgery [1]
“药中茅台”片仔癀10年增长终结:上半年推18个在研新药
Xin Lang Cai Jing· 2025-11-24 08:49
Core Viewpoint - The company, Pianzaihuang, is facing significant challenges with its revenue and net profit declining for the first time in a decade, while simultaneously advancing its research and development of innovative drugs, including PZH2108 and Wenzhancai tablets, to diversify its product offerings and reduce reliance on its flagship products [2][7][9]. Group 1: R&D Progress - PZH2108, a class 1 innovative chemical drug, has entered phase IIa clinical trials, focusing on evaluating its safety, tolerability, and preliminary clinical efficacy in cancer patients [1][3]. - The company has also initiated phase III clinical trials for Wenzhancai tablets, aimed at treating mild to moderate generalized anxiety disorder [1][6]. - As of the first three quarters of 2025, Pianzaihuang is advancing 18 new drug research projects, including 5 class 1 traditional Chinese medicine and 4 class 1 chemical drugs [1][2]. Group 2: Financial Performance - For the first three quarters of 2025, Pianzaihuang reported a revenue of 7.442 billion yuan, a year-on-year decrease of 11.93%, and a net profit of 2.129 billion yuan, down 20.74% [2][7]. - The company's core liver disease medication category, which accounts for over 95% of its pharmaceutical manufacturing revenue, has seen a significant decline due to cost and pricing pressures [2][7]. - The net cash flow from operating activities has decreased by 62.53% year-to-date [2]. Group 3: Market Context and Competition - Approximately 44.5% of cancer patients experience varying degrees of cancer pain, with projections indicating that the number of cancer pain patients could exceed 12 million by 2033 [3][4]. - The opioid market for pain management in China is substantial, with sales reaching 10.478 billion yuan in 2024 [3]. - Pianzaihuang's entry into the pain management drug market is timely, as there is a pressing need for more effective and individualized treatment options [4][5]. Group 4: Challenges and Strategic Moves - The company is heavily reliant on its flagship products, which have faced pricing pressures, leading to multiple price increases over the years [7][8]. - Despite a rise in R&D expenses to 180 million yuan in the first three quarters of 2025, the company ranks low in R&D spending relative to its revenue among its peers [9]. - Pianzaihuang's shift towards chemical drug innovation may encounter challenges in technology, funding, and regulatory compliance, as it transitions from traditional Chinese medicine to chemical drug development [10].
海思科:定增募资调减至12.45亿元 为合规缩减补充流动资金
2 1 Shi Ji Jing Ji Bao Dao· 2025-09-26 03:25
Core Viewpoint - The company, Haikang (002653.SZ), announced an adjustment to its plan for issuing A-shares to specific investors for the year 2025, reducing the total fundraising cap from 1.365 billion yuan to 1.245 billion yuan to comply with regulatory requirements [1] Group 1: Fundraising Adjustment - The total amount of funds to be raised has been adjusted to not exceed 1.245 billion yuan, down from the previous cap of 1.365 billion yuan [1] - The adjustment is made to meet the regulatory requirement that the proportion of funds for supplementing working capital and repaying debts cannot exceed 30% of the total fundraising amount [1] - The funds will primarily be used for new drug research and development, with 965.26 million yuan allocated for R&D projects and 280 million yuan for working capital [1] Group 2: Financial Performance - The company's revenue for the reporting period (2022 to June 2025) was 3.015 billion yuan, 3.355 billion yuan, 3.721 billion yuan, and 2.001 billion yuan respectively [1] - Net profit figures for the same period were 392 million yuan, 296 million yuan, 466 million yuan, and 129 million yuan, indicating overall profitability [1] - As of June 2025, the R&D team has grown to over 920 members, with approximately 44% holding master's degrees or higher [1] Group 3: Drug Development Pipeline - The company has received approval for four Class 1 new drugs: Ropivacaine Injection, Clonidine Hydrochloride Capsules, Alogliptin Tablets, and Anifrolumab Injection [1] - Additionally, there are 13 Class 1 new drugs currently in clinical stages of development [1]
医药太平洋医药日报:强生口服多肽 ICOTROKINRA向欧盟递交上市申请
Xin Lang Cai Jing· 2025-09-17 00:30
Market Performance - The pharmaceutical sector experienced a slight increase of +0.04% on September 15, 2025, underperforming the CSI 300 index by 0.20 percentage points, ranking 14th among 31 sub-industries in the Shenwan classification [1] - Among sub-industries, medical research outsourcing (+2.54%) and medical devices (+0.48%) performed well, while vaccines (-0.91%), medical consumables (-0.72%), and blood products (-0.51%) lagged behind [1] - Top three gainers in individual stocks were Furuide (+20.01%), Dezhan Health (+10.02%), and Zhaoyan New Drug (+10.01%), while the biggest losers were Nuocheng Jianhua (-8.20%), Yinkang Life (-5.21%), and Xinnuo Wei (-5.11%) [1] Industry News - Johnson & Johnson has submitted an application to the European Medicines Agency (EMA) for the oral peptide therapy Icotrokinra (JNJ-2113), developed in collaboration with Protagonist, aimed at treating moderate to severe plaque psoriasis in patients aged 12 and older [2] - The ICONIC-LEAD pivotal Phase 3 study reported positive topline results, indicating that Icotrokinra significantly improved skin conditions in patients with moderate to severe plaque psoriasis and demonstrated good safety [2] Company News - Kanglong Chemical announced that its subsidiary, Kanglong Shaoxing, successfully passed the FDA's on-site quality inspection, marking the first time its Shaoxing active pharmaceutical ingredient production facility has passed the FDA's pre-approval inspection [3] - Haisco received a Class 1 innovative drug registration certificate from the National Medical Products Administration for Anruikefen injection, which has been approved for an additional indication to treat moderate to severe itching in adult patients with chronic kidney disease related to maintenance hemodialysis [3] - Yipinhong's subsidiary in Guangzhou received a drug registration certificate for Clindamycin Palmitate Granules, confirming compliance with registration requirements [3] - Shanghai Laishi announced that its controlling shareholder, Haiyingkang, has cumulatively increased its shareholding by 72,935,300 shares, representing 1.10% of the total share capital, with a total investment of approximately RMB 499.99 million from May 22, 2025, to September 15, 2025 [3]