诺诚健华
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诺诚健华在血液肿瘤赛道“狂飙”:奥布替尼持续快速放量助单季盈利,坦昔妥单抗获批
2 1 Shi Ji Jing Ji Bao Dao· 2025-05-21 11:21
Core Insights - Nuo Cheng Jian Hua reported a revenue of 381 million yuan for Q1 2025, representing a year-on-year growth of 129.92%, with a net profit of 14 million yuan, up 109.94% year-on-year [2] - The company's gross margin improved by 5.1 percentage points to 90.5% compared to the same period last year [2] - The main driver of revenue growth is the commercialization of the drug Acalabrutinib, which generated 310 million yuan in revenue during the reporting period, an increase of 89.2% [2] Product Development - Acalabrutinib was approved for first-line treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) in China on April 25, 2023, expanding its market potential [2][6] - The drug has already been included in the national medical insurance for multiple indications, which is expected to further boost sales [2] - The company is also advancing its pipeline with Tafasitamab, a CD19 monoclonal antibody, which has been approved for the treatment of Diffuse Large B-Cell Lymphoma (DLBCL) [3][9] Market Potential - CLL accounts for approximately 3% of adult leukemia cases in China, with about 7,500 new patients diagnosed annually [5] - The approval of Acalabrutinib for first-line treatment is anticipated to significantly enhance treatment options for patients and drive company growth [6] - The market for Tafasitamab is projected to exceed 1.5 billion yuan in peak sales under optimistic scenarios [10] Competitive Landscape - Acalabrutinib is positioned as a potential best-in-class BTK inhibitor, with superior selectivity and safety profile compared to existing competitors [7][8] - The company faces competition from other approved therapies targeting similar indications, particularly in the relapsed or refractory settings [6] Financial Health - Nuo Cheng Jian Hua reported a strong cash position of approximately 7.78 billion yuan as of the end of Q1 2025, which will support ongoing clinical trials and research investments [8]
5月21日晚间重要公告一览
Xi Niu Cai Jing· 2025-05-21 10:14
Group 1 - Huiyu Pharmaceutical's subsidiary received drug registration certificate for Carboxymethyl Sodium Injection, which is used for treating bleeding diseases in various medical fields [1] - Baihe Co., Ltd. announced a plan for a director to reduce holdings by up to 424,000 shares, representing 0.6625% of the total share capital [1] - Kingood Co., Ltd. received a notification from a global leading automaker for a wheel project, expected to start mass production in 2026 with a lifecycle of 10 years [1][2] Group 2 - Wanhua Chemical plans to repurchase shares worth between 300 million and 500 million yuan, with a maximum repurchase price of 99.36 yuan per share [2] - Warner Pharmaceutical's subsidiary received approval for Acetylcysteine raw material drug, primarily used for treating respiratory diseases [3] - ST Mingcheng plans to publicly transfer 45% equity of its subsidiary, aiming to optimize asset structure [4] Group 3 - Qixia Construction announced a plan to reduce up to 31.5 million shares, accounting for 3% of total share capital [5][6] - Zhejiang Rongtai intends to invest 20 million yuan to establish a wholly-owned subsidiary focused on intelligent robotics [7] - Yuandong Biological received drug registration for Chloral Hydrate Enema, used for sedation and seizure control in children [9] Group 4 - Jiemai Technology's subsidiary signed a strategic cooperation agreement with a solid-state battery company to produce high-safety composite conductive materials [10] - Xianju Pharmaceutical received drug registration for Progesterone Soft Capsules, used for treating functional disorders due to luteal deficiency [11] - Lanhua Kecai's subsidiary reported a temporary production halt, with the resumption date yet to be determined [13] Group 5 - Sinopharm Modern's subsidiary received drug registration for Tocilizumab Tablets, used for treating rheumatoid arthritis and other conditions [15] - Shanghai Bank announced the resignation of its vice president due to organizational adjustments [17] - Shanghai Pharmaceutical's Ephedrine Injection passed the consistency evaluation for generic drugs [19] Group 6 - Rundu Co., Ltd. received drug registration for Amlodipine and Olmesartan Tablets, aimed at treating hypertension [21] - Zhong'an Technology announced that 61 million shares held by its controlling shareholder will be auctioned [23] - Shanghai Washba plans to purchase patent assets and establish two subsidiaries focused on hydrogen energy and solid-state battery technologies [25] Group 7 - Nuo Cheng Jianhua's new drug Tafasitamab received approval for treating relapsed/refractory diffuse large B-cell lymphoma [26] - Benli Technology plans to use up to 200 million yuan of idle funds for cash management and financial investments [28] - Taiji Co., Ltd. intends to use 60 million yuan of idle funds to purchase financial products [29] Group 8 - Haishi Co. announced that its innovative drug Anreke Fen Injection received drug registration for treating postoperative pain [32] - Yulong Co. will have its stock delisted on May 27, 2025, following a decision by the Shanghai Stock Exchange [36] - Weifu High-Tech plans to establish a joint venture with Shanghai Baolong Automotive Technology [38] Group 9 - Xichang Electric Power expects a net profit reduction of approximately 5.4 million yuan due to adjustments in the time-of-use electricity pricing mechanism [39] - Alter signed a contract worth 6.8 billion yen for the development and procurement of large truck EV kits [41] - Zhonglian Heavy Industry plans to acquire controlling stakes in its financing leasing subsidiary through public bidding [42] Group 10 - Sanyou Medical's executive plans to reduce holdings by up to 1.44% of the company's shares [43] - Hangyang Co. plans to establish a subsidiary for large modular cryogenic equipment manufacturing with an estimated investment of 557 million yuan [44] - FAW Fuwi received a notification for a dashboard project from a well-known new energy brand, with total sales expected to reach 1.06 billion yuan [45]
对话宝盈基金基金经理姚艺:创新药10年浮沉迎来收获期,未来几年业绩将快速释放
Sou Hu Cai Jing· 2025-05-21 09:54
在国内强手如林的公募医药基金经理中,宝盈基金的姚艺相对还是一个低调的名字,这位南开大学商学院硕士毕业的医药 基金掌门,目前的任职年限刚满4年;但就是这样一位低调内敛的基金经理,却在今年以来交出了一张优异的成绩单。 来自银河的数据显示,截至5月16日,姚艺所管理的基金年内收益全部飘红,特别是他管理时间最长的宝盈医疗健康沪港深 股票基金,A类过去六个月收益已经达到了21.14%。同时,由他所挂帅的宝盈创新医疗混合发起式基金正在发行中。 问:在医药行业中,普遍认为创新药是目前逻辑最顺的子行业,能否具体解释一下原因所在? 姚艺:对国内而言,创新药是内需、刚需、必选费品,政策很支持;对海外而言,出海多以BD方式,即专利使用费授权, 后续生产销售、注册归海外大药企,我们仅收首付款、里程碑付款和净销售分成,大概率不受关税影响。美国也不会单方 面限制美企买中国企业产品,否则会降低美制药企业全球竞争力,与美国科技优先政策不符。 | 基金简称 | 过去六个月增长 | 过去一年净值增长率 | 排序 | 过去两年净值增长率 | 排序 | | --- | --- | --- | --- | --- | --- | | | 率(%) | ...
诺诚健华(688428) - 诺诚健华医药有限公司关于坦昔妥单抗(tafasitamab)联合来那度胺治疗复发/难治性弥漫性大B细胞淋巴瘤在中国上市申请获得批准的公告

2025-05-21 08:46
| | | 诺诚健华医药有限公司 关于坦昔妥单抗(tafasitamab)联合来那度胺 治疗复发/难治性弥漫性大 B 细胞淋巴瘤 在中国上市申请获得批准的公告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述 或者重大遗漏,并对其内容的真实性、准确性和完整性依法承担法律责任。 重要内容提示: 一、药品基本情况 药品名称:注射用坦昔妥单抗 申请事项:药品注册(境外生产) 受理号:JXSS2400050 证书编号:2025S01368 上市许可持有人:Incyte Biosciences Distribution B.V. 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,本品 1 诺诚健华医药有限公司(以下简称"公司")收到国家药品监督管理局(NMPA) 的通知,公司靶向 CD19 的产品坦昔妥单抗(tafasitamab)(商品名:明诺 凯®)联合来那度胺治疗不适合自体干细胞移植条件的复发/难治性弥漫性大 B 细胞淋巴瘤(以下简称"r/r DLBCL")成人患者的上市申请获得批准, 这是中国首个获批治疗 r/r DLBCL 的 CD19 单抗。 由于新药研发具有高科技、高风险、高 ...
智通港股52周新高、新低统计|5月21日





智通财经网· 2025-05-21 08:43
| 健倍苗苗(02161) | 2.380 | 2.380 | 0.42% | | --- | --- | --- | --- | | 中视金桥(00623) | 2.710 | 2.750 | 0.36% | | 古茗(01364) | 26.600 | 27.550 | 0.36% | | TCL电子(01070) | 11.000 | 11.220 | 0.36% | | 建设银行(00939) | 6.970 | 7.000 | 0.29% | | 中国移动(00941) | 88.100 | 88.450 | 0.23% | | GX日本全球领导 | 70.160 | 70.160 | 0.20% | | (03150) | | | | | GX03月债(03440) | 55.360 | 55.360 | 0.18% | | 港灯-SS(02638) | 5.650 | 5.670 | 0.18% | | 安硕亚洲除日(03010) | 59.880 | 60.100 | 0.17% | | ESR(01821) | 12.840 | 12.840 | 0.16% | | GXAI基础设施 | 5 ...
5月20日工银医疗保健股票净值增长2.07%,今年来累计上涨12.51%
Sou Hu Cai Jing· 2025-05-20 12:46
Core Viewpoint - The ICBC Medical Care Stock Fund (000831) has shown positive performance with a recent net value of 2.5640 yuan, reflecting a growth of 2.07% [1] Performance Summary - The fund's one-month return is 4.48%, ranking 672 out of 1022 in its category - Over the last three months, the return is 7.69%, with a ranking of 96 out of 1009 - Year-to-date, the return stands at 12.51%, ranking 128 out of 999 [1] Holdings Overview - The top ten holdings of the fund account for a total of 39.79%, with the following key positions: - Heng Rui Medicine: 8.90% - WuXi AppTec: 5.12% - Aier Eye Hospital: 4.94% - BeiGene: 3.77% - Zai Lab: 3.52% - New Horizon Health: 3.27% - Mindray Medical: 2.80% - Yuyue Medical: 2.76% - United Imaging Healthcare: 2.47% - Innovent Biologics: 2.24% [1] Fund Details - The ICBC Medical Care Stock Fund was established on November 18, 2014, and as of March 31, 2025, it has a total scale of 2.724 billion yuan - The fund is managed by Zhao Bei and Ding Yang [1][2]
创新药板块突然火了!普通人如何借“出海成功”布局?
Ge Long Hui· 2025-05-20 10:01
Group 1 - The core point of the news is the significant rise in the innovative drug sector, driven by the announcement of a collaboration between 3SBio and Pfizer, resulting in a $6.05 billion deal, which has positively impacted the entire sector [2] - Following the announcement, 3SBio's stock surged over 35%, creating a ripple effect that boosted the stock prices of other pharmaceutical companies like CSPC Pharmaceutical Group and Innovent Biologics [2] - The innovative drug sector has seen increased trading volume, indicating heightened market activity and investor interest, which could lead to further price increases [4] Group 2 - Market confidence in the innovative drug sector has strengthened due to 3SBio's success, leading investors to believe in the potential for future growth and investment opportunities [5] - The aging population and the growing demand for medication present significant opportunities for the pharmaceutical sector, particularly in innovative drugs combined with AI [6] - The investment strategy suggested includes long-term commitment and regular investments in funds related to the innovative drug sector, as the potential for returns is promising [6][7]
生物医药ETF(159508)、医药50ETF(512120)双双走强,制药龙头业绩一季报数据亮眼
2 1 Shi Ji Jing Ji Bao Dao· 2025-05-20 03:33
Group 1 - The pharmaceutical sector is experiencing significant activity, with notable stocks such as Sanofi and Yipinhong reaching their daily limit up of 19.99%, and others like Shutaishen rising over 9% [1] - Major pharmaceutical companies reported impressive Q1 earnings, with BeiGene achieving a revenue of 8.048 billion yuan, a 50.2% increase from the previous year, and a significant reduction in net losses [1] - Innovent Biologics reported a revenue of 381 million yuan for Q1, marking a 129.92% year-on-year growth, and a net profit of 18 million yuan, up 112.62% year-on-year, indicating a turnaround to profitability [1] Group 2 - Wanlian Securities forecasts a performance divergence in the pharmaceutical sub-sectors for Q1 2024 and 2025, with strong revenue and profit growth expected in medical R&D outsourcing, hospitals, and other biological products [2] - The chemical pharmaceutical sector is gaining market attention, focusing on innovation-driven growth, domestic production, and policy immunity [2] - China Galaxy notes that the pharmaceutical sector has undergone a long adjustment period, resulting in low valuations and underweight public holdings, with expectations for policy support and market demand recovery to drive growth [2]
三生制药与辉瑞签许可协议,恒生医疗指数ETF(159557)大涨超4%,三生制药涨超35%
Sou Hu Cai Jing· 2025-05-20 02:25
Group 1 - The Hong Kong stock market for healthcare opened high and showed strong performance, particularly in innovative drugs and medical devices sectors, with the Hang Seng Healthcare Index ETF (159557) rising by 4.02% [1] - Notable stocks included in the ETF saw significant gains, with 3SBio rising over 35%, and other companies like Innovent Biologics, CSPC Pharmaceutical Group, and Ascentage Pharma also experiencing upward movement [1] - 3SBio announced a licensing agreement with its affiliate 3SBio and Shenyang 3SBio for exclusive global development, production, and commercialization of a product related to Pfizer's 707 project [1] Group 2 - Jianghai Securities highlighted that the acceleration of medical device approvals in China is expected to improve the profit outlook and valuation recovery for medical device export companies [2] - The easing of cost pressures and an improved market environment will release profit margins, with low-value consumables and mid-range equipment sectors being the first to benefit [2] - Long-term, the global competition in medical devices is shifting towards technological breakthroughs and supply chain restructuring, necessitating China to overcome "technical bottlenecks" in high-end imaging equipment and surgical robots [2] Group 3 - Policy incentives and independent innovation will be crucial for companies to break through in the market, with leading firms likely to explore AI healthcare and surgical robots to overcome overseas technological barriers [2] - Investment recommendations suggest focusing on leading companies with strong technological barriers and high elasticity in export-oriented businesses to capitalize on profit growth and valuation recovery during the policy window [2] - According to CMB International, the Chinese pharmaceutical industry is expected to continue its valuation recovery by 2025, driven by positive factors such as the success of innovative drugs abroad, adjustments in medical insurance catalogs, and the revival of medical device tenders [2]
香港医药ETF(513700)涨近3%冲击3连涨,三生制药股价大涨超30%
Xin Lang Cai Jing· 2025-05-20 02:13
Group 1 - The Hong Kong pharmaceutical sector is experiencing a strong upward trend, with the China Securities Hong Kong Stock Connect Pharmaceutical and Health Comprehensive Index rising by 2.76% as of May 20, 2025 [1] - Notable individual stock performances include a 6.73% increase in CSPC Pharmaceutical Group and a 6.67% rise in Innovent Biologics [1] - The Hong Kong Medical ETF has seen a cumulative increase of 3.51% over the past week, reflecting positive market sentiment [1] Group 2 - Three-Sixty Biopharma's stock surged over 30% after announcing an exclusive global licensing agreement with Pfizer for its PD-1/VEGF bispecific antibody SSGJ-707, with an upfront payment of $1.25 billion and potential milestone payments up to $4.8 billion [1] - The licensing agreement includes a double-digit percentage royalty on net sales in licensed regions, and Pfizer may also subscribe to $100 million in new shares of Three-Sixty Biopharma [1] - Analysts expect a shift in market focus from earnings to fundamental changes in the industry and companies starting in May, with a continued positive outlook on innovative drugs and companies expanding into emerging markets [2] Group 3 - The China Securities Hong Kong Stock Connect Pharmaceutical and Health Comprehensive Index consists of 50 highly liquid and large-cap healthcare companies, with the top ten stocks accounting for 60.54% of the index [2]