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新版医保明年1月起执行:114种药品杀入目录,百万抗癌药破冰
Guan Cha Zhe Wang· 2025-12-13 04:01
Core Insights - The 2025 National Medical Insurance Drug List has been officially released, adding 114 new drugs, including 50 innovative Class 1 drugs, with a negotiation success rate of 88%, the highest in seven years [1][3] - The first version of the commercial insurance innovative drug list has been introduced, featuring 5 CAR-T cell therapies and 19 high-priced innovative drugs, marking a significant expansion in coverage [1][5] - The adjustment reflects a strategic upgrade in China's medical insurance from "basic coverage" to "basic + high-end coverage," addressing the demand for accessible and affordable innovative drugs [1][9] Drug Additions and Market Impact - The new drug list includes 114 drugs, with 44% being Class 1 innovative drugs, and a total of 3,253 drugs now covered under the insurance [3] - Notable winners include Heng Rui Pharma, which secured 20 new drug approvals, and Eli Lilly, whose drug Tirzepatide has entered the Chinese market, benefiting 140 million diabetes patients [3][4] - The inclusion of CAR-T therapies in the commercial insurance list allows for reimbursement of high-cost treatments, which were previously inaccessible to many patients [5][7] Innovations in Treatment - The new list includes significant advancements in treatments for Alzheimer's disease, with two new drugs targeting amyloid beta accumulation, providing options for over 10 million patients in China [7] - The addition of 13 rare disease drugs fills coverage gaps in four rare disease areas, expanding the total number of rare disease drugs covered to approximately 100 [8] - The adjustment also emphasizes pediatric medications, with a separate review channel for children's formulations, indicating a positive shift in addressing children's healthcare needs [9] Strategic Implications - The 2025 adjustment signifies a shift towards a dual-track medical payment system in China, combining basic medical insurance with commercial insurance to meet both fundamental and advanced healthcare needs [9] - The rapid inclusion of innovative drugs into the insurance system reflects a decade of progress in China's pharmaceutical landscape, transitioning from rare domestic innovations to a robust pipeline of new therapies [9]
芯原股份终止购买芯来智融97%股权;*ST沪科被证监会立案丨公告精选
Group 1: 恒瑞医药 - Company announced that its subsidiary received approval for clinical trials of HRS9531 injection, a novel dual agonist targeting GIPR and GLP-1R, aimed at treating metabolic dysfunction-related fatty liver disease (MASH) [1] - HRS9531 injection is expected to improve blood sugar levels and reduce weight by regulating glucose and lipid metabolism, suppressing appetite, and enhancing insulin sensitivity [1] - There are currently no similar drugs approved globally for the MASH indication, and the total R&D investment for HRS9531 has reached approximately 519 million yuan [1] Group 2: 青岛港 - Company announced the termination of its cash acquisition of 100% equity in Rizhao Port Oil Products Terminal Co., Ltd. and 50% equity in Rizhao Shihua Oil Terminal Co., Ltd. due to significant impacts from Rizhao Shihua being listed on the U.S. Specially Designated Nationals list [2] - The termination agreement was signed on December 12, 2025, and will not incur any breach of contract or other liabilities, nor will it adversely affect the company's operations or financial status [2] Group 3: 隆盛科技 - Company plans to invest approximately 350 million yuan to establish a humanoid intelligent robot innovation center in Wuxi, with a focus on R&D and industrialization of humanoid robots [3] - The project will involve a total investment of about 350 million yuan, with the company covering around 200 million yuan for land and construction, while its subsidiary will invest approximately 150 million yuan for the center's operation [3] Group 4: *ST沪科 - Company received a notice from the China Securities Regulatory Commission regarding an investigation into suspected violations of information disclosure laws [4] - The company stated that its production and operations are normal and that the investigation will not have a significant impact on its management [4] Group 5: 永鼎股份 - Company clarified that it does not directly manufacture controllable nuclear fusion devices, despite being listed as a related concept stock [5] - The revenue from its subsidiary related to this area accounts for less than 1% of the company's total revenue and is currently operating at a loss [5] - The controlling shareholder reduced its stake by 1.336 million shares during a period of abnormal stock trading [5] Group 6: 亚翔集成 - Company announced that its shareholder EVER CREATIVE reduced its stake by 414,000 shares on December 11, 2025, amid significant stock price fluctuations [6] - The stock experienced a cumulative price deviation exceeding 20% over two consecutive trading days [6] Group 7: 恩捷股份 - Company plans to acquire 100% of Qingdao Zhongke Hualian New Materials Co., Ltd. through a share issuance and will resume trading on December 15 [8] Group 8: 芯原股份 - Company announced the termination of its plan to acquire 97% of Chipwise Technology due to discrepancies between the management's core demands and market conditions [9] - The decision was made to protect the interests of the company and its shareholders [9]
恒瑞医药:HRS9531注射液获药物临床试验批准通知书
Zhi Tong Cai Jing· 2025-12-12 14:07
Core Viewpoint - Heng Rui Medicine (600276) has received approval from the National Medical Products Administration for clinical trials of HRS9531 injection, a novel dual agonist targeting GIPR and GLP-1R with global intellectual property rights [1] Group 1: Product Development - The HRS9531 injection is designed to regulate glucose and lipid metabolism, suppress appetite, and enhance insulin sensitivity, thereby improving blood sugar levels and aiding weight loss [1] - The injection is expected to provide comprehensive benefits for patients with metabolic dysfunction-related fatty liver disease (MASH) by improving liver lipid accumulation, reducing inflammation, and potentially improving liver fibrosis [1] - There are currently no similar drugs approved for the MASH indication globally, indicating a unique market opportunity for the company [1]
恒瑞医药:目前公司2025年新获批上市的新药都已完成首批发货
Core Viewpoint - Heng Rui Medicine has completed the first batch of shipments for new drugs approved for market release in 2025, which are now being sold domestically [1] Group 1: New Drug Approvals and Sales - The company has successfully launched new drugs approved for 2025 and has completed initial shipments [1] - The drug SHR-A1811 has been approved for the second-line treatment of HER2-mutant non-small cell lung cancer in China, with the second-line treatment for HER2-positive breast cancer currently under review for market approval [1] Group 2: Revenue Recognition and Licensing Deals - As of the end of Q3, the company has recognized part of the upfront payments from external licensing deals, including $200 million from Merck [1] - Upfront payments from the GSK deal amounting to $500 million have been received and recorded as contract liabilities, but revenue recognition is pending due to unfulfilled contractual obligations as of Q3 [1] - The company will provide updates on revenue recognition in future periodic reports published on the exchange website [1] Group 3: Future Development Plans - The company plans to cautiously evaluate and steadily advance overseas research and development for SHR-A1811 based on the specific circumstances of different indications [1]
恒瑞医药:公司本次共有20款产品/适应症通过新版国家医保目录调整
Zheng Quan Ri Bao· 2025-12-12 12:37
(文章来源:证券日报) 证券日报网讯 12月12日,恒瑞医药在互动平台回答投资者提问时表示,公司本次共有20款产品/适应症 通过新版国家医保目录调整,覆盖肿瘤、代谢、心血管疾病、免疫系统疾病、眼科等多个治疗领域;其 中瑞康曲妥珠单抗(HER2 ADC)、艾玛昔替尼(JAK1)、夫那奇珠单抗(IL-17A)、瑞卡西单抗 (PCSK9)等10款产品首次进入医保目录,将促进公司产品惠及更多患者。本次商保目录内无公司产 品。公司多年来始终致力于将推动医药创新与履行社会责任紧密结合,未来将继续坚守"以患者为中 心"的初心,加速推进前沿药物的研发与上市,并积极响应国家政策,努力提升患者用药可及性与可负 担性。 ...
恒瑞医药(01276.HK):SHR-A1811(sc)注射液获药物临床试验批准通知书
Jin Rong Jie· 2025-12-12 12:22
恒瑞医药(01276.HK)发布公告,近日,公司子公司苏州盛迪亚生物医药有限公司收到国家药品监督管理 局核准签发关于 SHR-A1811(sc)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。 ...
恒瑞医药:SHR-A1811注射液获药物临床试验批准通知书
Zhi Tong Cai Jing· 2025-12-12 12:12
Core Viewpoint - Heng Rui Medicine (600276) has received approval from the National Medical Products Administration for clinical trials of SHR-A1811(sc) injection, which will commence shortly [1] Group 1: Product Development - The SHR-A1811 is designed to bind to HER2-expressing tumor cells and release toxins within the lysosomes, inducing cell cycle arrest and triggering apoptosis in tumor cells [1] - The released toxins exhibit high membrane permeability and can exert a bystander killing effect, enhancing anti-tumor efficacy [1] - SHR-A1811(sc) is a subcutaneous formulation developed based on the injectable SHR-A1811, expected to shorten clinical administration time and improve convenience of administration [1]
恒瑞医药(01276.HK):子公司”SHR-A1811(sc)注射液“获药物临床试验批准
Ge Long Hui· 2025-12-12 12:04
Core Viewpoint - Jiangsu Hengrui Medicine Co., Ltd. has received approval from the National Medical Products Administration for the clinical trial of SHR-A1811(sc) injection, which will be conducted in patients with advanced solid tumors [1][2]. Group 1: Company Information - Hengrui Medicine's subsidiary, Suzhou Sediya Biopharmaceutical Co., Ltd., is responsible for the clinical trial of SHR-A1811(sc) injection [1]. - The clinical trial application for SHR-A1811(sc) injection was accepted on September 10, 2025, and has met the requirements for drug registration [2]. Group 2: Drug Information - The drug SHR-A1811(sc) is an injectable formulation intended for use in clinical trials [2]. - The approval allows for the drug to be tested specifically in patients with advanced solid tumors [2].
恒瑞医药:RSS0343片获药物临床试验批准通知书
Zhi Tong Cai Jing· 2025-12-12 12:00
RSS0343是公司自主研发的一款口服、强效和高选择性的小分子1类新药,在动物模型中具有很强的抑 制炎症和缓解唿吸道相关组织损伤的作用。针对慢性鼻窦炎不伴鼻息肉和慢性阻塞性肺疾病,国内外目 前暂无同类药物获批上市。截至目前,RSS0343片相关项目累计研发投入约7228万元。 恒瑞医药(600276)(01276)发布公告,近日,江苏恒瑞医药股份有限公司(以下简称"公司")子公司瑞石 生物医药有限公司收到国家药品监督管理局(以下简称"国家药监局")核准签发关于RSS0343片的《药物 临床试验批准通知书》,将于近期开展临床试验。 ...
恒瑞医药(01276.HK):盛迪医药”HRS9531注射液“获药物临床试验批准
Ge Long Hui A P P· 2025-12-12 11:59
受理号:CXHL2500996、CXHL2500997、CXHL2500998 审批结论:根据《中华人民共和国药品管理法》及有关规定,经审查,2025年9月11日受理的HRS9531 注射液临床试验申请符合药品注册的有关要求,同意本品开展代谢相关脂肪性肝炎的临床试验。 剂型:注射剂 申请事项:临床试验 格隆汇12月12日丨恒瑞医药(01276.HK)公告,近日,江苏恒瑞医药股份有限公司子公司福建盛迪医药有 限公司收到国家药品监督管理局核准签发关于HRS9531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。 药物名称:HRS9531注射液 ...