Hengrui Pharma(600276)
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恒瑞医药:药物注射用SHR-1826纳入突破性治疗品种名单
Ge Long Hui· 2026-01-12 09:16
格隆汇1月12日丨恒瑞医药(600276.SH)公布,公司子公司苏州盛迪亚生物医药有限公司的注射用SHR- 1826被国家药品监督管理局药品审评中心(称"药审中心")纳入突破性治疗品种名单。 拟定适应症(或功能主治):单药治疗既往接受过至少一线系统性治疗失败的c-Met过表达(2-3+, ≥50%)驱动基因阴性局部晚期或转移性非鳞状非小细胞肺癌。 ...
恒瑞医药(600276.SH):HRS-7535片获得药物临床试验批准通知书
Ge Long Hui A P P· 2026-01-12 09:11
Core Viewpoint - Heng Rui Medicine (600276.SH) has received approval from the National Medical Products Administration for clinical trials of HRS-7535 tablets, a new oral small molecule GLP-1 receptor agonist aimed at treating type 2 diabetes and weight loss [1]. Group 1: Product Development - The clinical trial approval for HRS-7535 tablets will allow the company to initiate trials in the near future [1]. - HRS-7535 functions by activating GLP-1 receptors, which promotes insulin secretion from the pancreas, reduces glucagon secretion, and inhibits gastric emptying [1]. - The drug also enhances satiety and suppresses appetite through central mechanisms, leading to reduced energy intake [1]. Group 2: Market Implications - The introduction of HRS-7535 could provide a new treatment option for type 2 diabetes (T2DM) patients, addressing both glycemic control and weight management [1].
恒瑞医药(600276.SH):药物注射用SHR-1826纳入突破性治疗品种名单
Ge Long Hui A P P· 2026-01-12 09:11
格隆汇1月12日丨恒瑞医药(600276.SH)公布,公司子公司苏州盛迪亚生物医药有限公司的注射用SHR- 1826被国家药品监督管理局药品审评中心(称"药审中心")纳入突破性治疗品种名单。 拟定适应症(或功能主治):单药治疗既往接受过至少一线系统性治疗失败的c-Met过表达(2-3+, ≥50%)驱动基因阴性局部晚期或转移性非鳞状非小细胞肺癌。 ...
恒瑞医药:子公司HRS - 7535片获药物临床试验批准
Xin Lang Cai Jing· 2026-01-12 09:06
恒瑞医药公告称,子公司山东盛迪医药收到国家药监局关于HRS - 7535片的《药物临床试验批准通知 书》,将于近期开展临床试验。该药物拟用于高血压合并超重或肥胖治疗,是新型口服小分子胰高血糖 素样肽 - 1受体激动剂,全球尚无同类口服药上市。截至目前,相关项目累计研发投入约3.69亿元。药 品研发到上市周期长、环节多,存在不确定性,公司将推进项目并披露进展。 ...
恒瑞医药:注射用SHR-1826纳入突破性治疗品种名单
Xin Lang Cai Jing· 2026-01-12 09:06
Group 1 - The core point of the article is that Heng Rui Medicine's injectable SHR-1826 has been included in the list of breakthrough therapeutic varieties by the National Medical Products Administration [1] Group 2 - The announcement was made by Heng Rui Medicine, specifically through its subsidiary Suzhou Sediya Biopharmaceutical Co., Ltd [1]
恒瑞医药:注射用SHR-1826被纳入突破性治疗品种名单
Mei Ri Jing Ji Xin Wen· 2026-01-12 09:06
Core Viewpoint - Heng Rui Medicine's subsidiary, Suzhou Shengdiya Biopharmaceutical Co., Ltd., has had its injectable SHR-1826 included in the list of breakthrough therapies by the National Medical Products Administration (NMPA) [1] Company Summary - Heng Rui Medicine (600276.SH) announced the inclusion of its injectable SHR-1826 in the breakthrough therapy list by the NMPA [1]
化学制药板块1月12日涨0.15%,向日葵领涨,主力资金净流出16.64亿元
Zheng Xing Xing Ye Ri Bao· 2026-01-12 09:04
| 代码 | 名称 | 收盘价 | 涨跌幅 | 成交量(手) | 成交额(元) | | | --- | --- | --- | --- | --- | --- | --- | | 300111 | 向日葵 | 7.29 | 11.98% | 167.84万 | | 11.97亿 | | 000766 | 通化金马 | 27.87 | 9.98% | 46.86万 | | 12.97亿 | | 002940 | 昂利康 | 38.66 | 7.87% | 25.79万 | | 9.79亿 | | 300401 | 化园生物 | 17.36 | 5.60% | - 54.32万 | | 2666 | | 920367 | 新赣江 | 23.50 | 5.48% | 5.45万 | | 1.26亿 | | 688176 | 亚虹医药 | 12.60 | 5.09% | 19.90万 | | 2.45亿 | | 301281 | 科源制药 | 30.83 | 5.08% | 4.03万 | | 1.22亿 | | 000908 | *ST景峰 | 8.19 | 5.00% | 3.17万 | | 2599.61万 | ...
恒瑞医药控股子公司2.5亿元项目环评获同意
Mei Ri Jing Ji Xin Wen· 2026-01-12 09:00
Group 1 - The core point of the article is that Hengrui Medicine's subsidiary, Fujian Shengdi Pharmaceutical Co., Ltd., has received approval for the environmental impact assessment of its Phase II construction project, with a total investment of 250 million yuan [1] - The "A-share Green Report" project aims to enhance the transparency of environmental information for listed companies, utilizing authoritative environmental regulatory data from 31 provinces and 337 cities [1] - The project includes monitoring the environmental performance of listed companies and their subsidiaries, providing professional data analysis and insights, and regularly updating the environmental risk rankings of these companies [1] Group 2 - The latest A-share Green Weekly Report (Issue No. 228) indicates that four listed companies have recently exposed environmental risks [1]
HTI医药2026年1月第二周周报:热点接连涌现,持续看好创新药械产业链-20260112
Haitong Securities International· 2026-01-12 07:17
Investment Rating - The report maintains a positive outlook on innovative drugs and the related industry chain, indicating potential value revaluation for specific pharmaceutical companies [6][28]. Core Insights - The pharmaceutical sector in A-shares showed strong performance in the second week of January 2026, with the SW Pharma Bio index rising by 7.8%, outperforming the overall market [8][29]. - Key sub-sectors such as medical services (+12.3%), medical equipment (+9.4%), and chemical preparations (+7.3%) demonstrated significant growth during this period [13][29]. - Notable individual stock performances included Innovative Medical Management (+61.0%), Sanbo Hospital Management Group (+56.2%), and MeHow Medical (+56.1%) [15][29]. - The report highlights a normal premium level of 68.3% for the pharmaceutical sector relative to all A-shares as of January 9, 2026 [15][23]. Summary by Sections 1. Continued Focus on Innovative Drugs and Industry Chain - The report emphasizes the high prosperity in innovative drugs and suggests monitoring companies like Jiangsu Heng Rui Medicine, Hansoh Pharmaceutical, 3SBio, Sichuan Kelun Pharmaceutical, and Jiangsu Nhwa Pharmaceutical for potential value revaluation [6][28]. 2. Performance of A-Shares Pharmaceutical Sector - In the second week of January 2026, the A-share pharmaceutical sector outperformed the market, with the SW Pharma Bio index increasing by 7.8% [8][29]. - The report ranks the pharmaceutical sector as the 5th best-performing industry among Shenwan's primary industries during this period [11][29]. 3. Performance of Hong Kong and U.S. Pharmaceutical Sectors - The Hong Kong pharmaceutical sector outperformed the market, with the Hang Seng Healthcare index rising by 10.3% and the biotechnology sector increasing by 11.1% [20][29]. - Conversely, the U.S. pharmaceutical sector underperformed, with the S&P Healthcare Select Sector rising by only 1.1% compared to the S&P 500's 1.6% increase [20][29].
HER2 ADC缩圈,国内玩家Live or Die?
3 6 Ke· 2026-01-12 04:26
Core Viewpoint - Enhertu (DS-8201) has evolved into a "complete entity" with the recent approval for first-line therapy in HER2+ breast cancer, marking significant progress from its initial approval as a third-line therapy in December 2019 to its current status [1][2] Group 1: Enhertu's Progression - Enhertu's journey includes approvals for HER2+ breast cancer in third-line therapy (December 2019), second-line therapy (January 2021), and now first-line therapy [2] - The first-line therapy approval is in combination with pertuzumab, with expectations for single-agent approval in the future [2] Group 2: Competitive Landscape - The HER2 ADC breast cancer market is approaching a critical phase, with companies like Rongchang Biopharma, Kelun-Biotech, and BaiLi Tianheng adopting various strategies to compete [3][6] - Rongchang Biopharma has focused on differentiated strategies, avoiding direct competition in breast cancer and targeting unmet clinical needs in other indications like gastric cancer [4][6] - Kelun-Biotech has actively pursued HER2+ breast cancer, achieving approval for its product A166 as the first domestic ADC for second-line therapy, leveraging a strategy of gradual advancement [7][9] Group 3: Strategic Approaches - BaiLi Tianheng aims to create a competitive product against Enhertu, with its T-Bren ADC targeting both HER2+ breast cancer and non-small cell lung cancer (NSCLC) [11][14] - HengRui Medicine adopts a multi-cancer strategy, focusing on various indications beyond breast cancer, with its SHR-A1811 ADC already approved for HER2-mutated NSCLC [16][17] Group 4: Differentiated Strategies - Lepu Biopharma's strategy centers on combining its ADC with PD-1 therapies, positioning its products as complementary rather than direct competitors [18][20] - In contrast, YingEn Biopharma has established a global strategy, securing a partnership with BioNTech for its DB-1303 ADC, focusing on unmet needs in endometrial cancer [22][24] Group 5: Future Outlook - The competitive landscape in the HER2 ADC market is intensifying, with companies employing diverse strategies to carve out their niches [26] - The future success in this sector may hinge on the depth of differentiated strategies and the ability to commercialize effectively, rather than solely on product efficacy [26]