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经济热力站丨诺诚健华超20亿美元授权合作刷新中国自免领域小分子交易记录,中关村生命科学园迎创新药国际化里程碑
Cai Jing Wang· 2025-10-10 03:09
林辰/文 潜在总交易额超20亿美元,在中关村生命科学园深耕10年的诺诚健华,在节后传来重磅消息。其与 Zenas就三款自免管线达成的授权许可合作,刷新了中国自免领域小分子交易记录。这不仅只是奥布替 尼国际化的里程碑,也是中关村生命科学园孵化全球竞争力医药健康产业的又一成果。 另据了解,历经十年,由中国本土科学家及企业自主研发以丁肝为适应症的1类新药立贝韦塔单抗,也 有望在明年第一季度前后获批上市。其背后的华辉安健,亦是中关村生命科学园孵化的立足中国、面向 全球的生物医药企业。 作为昌平"生命谷"核心区域,占地面积7.2平方公里的中关村生命科学园,是北京自贸试验区科技创新 片区的重要组团,也是中关村国家自主创新示范区的重要专业园区。过往数年,这里诞生了中国首 款"十亿美元分子"新药泽布替尼和"国内十亿分子"新药奥布替尼。 从"实验室—共性平台—小试中试—临床应用",这片"生命谷"的1公里转化圈,正不断缔造医药健康产 业的创新引擎。 治疗慢性丁型肝炎,HH-003注射液有望明年获批上市 2021年,公司A+轮融资引入高瓴资本,老股东汉康资本和经纬中国持续加码。多方加持下,该轮融资 额达到5亿元人民币。与此同时,H ...
异动盘点0930|优必选涨超5%,脑动极光-B涨超16%;阿里巴巴美股涨超4%,美光科技涨超4%
贝塔投资智库· 2025-09-30 04:00
Group 1: Hong Kong Stocks - China Metallurgical Group (01618) rose nearly 7%, with institutions stating that the value of this resource-rich construction company needs urgent reassessment [1] - Rongchang Bio (09995) increased over 5%, as its innovative ophthalmic drug RC28 has been submitted for listing, following a partnership with Santen China [1] - Laikang Pharmaceutical-B (02105) surged nearly 6%, with a cumulative increase of 36% over the last three trading days, driven by positive preliminary results from the Phase I clinical MAD study of LAE102 [1] - UBTECH Robotics (09880) rose over 5%, with a report from CMB International recommending UBTECH as the top pick in the humanoid robot sector and raising its target price [1] - Innovent Biologics (09969) increased over 6%, as the company announced the first prescriptions for Tanshitumomab in several provinces [1] - BrainCo-B (06681) surged over 16%, benefiting from policy catalysts in the brain-computer interface industry, with its cognitive impairment digital therapy product having a first-mover advantage [1] - Yaoshi Bang (09885) rose over 10%, with high-margin business accelerating growth and POCT devices expected to see increased deployment in the second half of the year [1] - DCH Holdings (00179) fell over 7%, as Citigroup downgraded its investment rating from "Buy" to "Neutral," citing limited upside potential for the stock [1] - Minmetals Resources (01208) rose over 2%, planning to issue $500 million zero-coupon convertible bonds maturing in 2030 for overseas debt refinancing [1][2] Group 2: US Stocks - Alibaba (BABA.US) rose 4.65%, with Morgan Stanley reiterating an "Overweight" rating and raising the ADR target price from $165 to $200 [3] - Li Auto (LI.US) increased 3.57%, as the Li One officially commenced delivery at the Changzhou smart manufacturing base, with a report indicating that the i6 model's sales performance is expected to outperform the i8 [3] - JD.com (JD.US) rose 0.15%, announcing that the 2025 Double 11 shopping festival will start on October 9 at 8 PM, two days earlier than last year [3] - Xpeng Motors (XPEV.US) increased 1.76%, with the company announcing that the Xpeng MONA M03 has delivered a total of 180,000 units [3] - New Oriental (EDU.US) rose 4.38%, with a report indicating that the overall business development of the group is stabilizing [3] - Merus (MRUS.US) surged 35.97%, following an agreement with Danish biotech company Genmab for a cash acquisition at $97 per share [3] - Novo Nordisk (NVO.US) fell 0.20%, as Morgan Stanley downgraded its rating to "Sell" and reduced the target price from $99 to $47 [4] - MoonLake (MLTX.US) plummeted 89.93%, with trial results for its therapeutic drug falling far below expectations, leading to a significant target price cut by RBC [4] - TSMC (TSM.US) fell 0.05%, reaffirming that it has not engaged in discussions regarding potential investments or collaborations with any companies [4] - Micron Technology (MU.US) rose 4.22%, with Morgan Stanley predicting that the storage industry price increase cycle may continue into next year [4]
诺诚健华涨超6% 坦昔妥单抗全国多省市首批处方落地
Zhi Tong Cai Jing· 2025-09-30 02:40
诺诚健华(09969)涨超6%,截至发稿,涨6.55%,报18.87港元,成交额1.15亿港元。 消息面上,据诺诚健华官微消息,近日,公司宣布,靶向CD19单抗明诺凯(坦昔妥单抗,tafasitamab)近 日在北京、上海、广东、黑龙江、福建、山东、广西、安徽、江西、湖北、浙江等全国多个省市医院开 出首批处方,标志着这款创新药在中国正式进入临床应用阶段。据介绍,坦昔妥单抗是全球首个且唯一 获批治疗淋巴瘤的CD19单抗,也是中国首个获批治疗复发/难治性弥漫性大B细胞淋巴瘤(R/R DLBCL) 的CD19单抗,填补了国内CD19靶向治疗的空白,将为DLBCL患者带来更好的治疗选择。 ...
更深缓解、更长生存——诺诚健华明诺凯 (坦昔妥单抗)全国首批处方落地
2025年9月25日,中国北京——生物医药高科技公司诺诚健华(上交所代码:688428;香港联交所代码:09969)今天宣布,靶向 CD19单抗明诺凯(坦昔妥单抗,tafasitamab)近日在北京、上海、广东、黑龙江、福建、山东、广西、安徽、江西、湖北、浙江等 全国多个省市医院开出首批处方,标志着这款创新药在中国正式进入临床应用阶段。 坦昔妥单抗是全球首个且唯一获批治疗淋巴瘤的CD19单抗,也是中国首个获批治疗复发/难治性弥漫性大B细胞淋巴瘤(R/R DLBCL)的CD19单抗,填补了国内CD19靶向治疗的空白,将为DLBCL患者带来更好的治疗选择。 诺诚健华联合创始人、董事长兼首席执行官崔霁松博士:"我们衷心感谢监管机构、临床专家、患者及合作伙伴对明诺凯(坦昔 妥单抗)一直以来的支持与信任,也非常感谢所有员工的辛勤付出。明诺凯是诺诚健华在血液瘤领域布局的核心药物,此次全国 首批处方的快速落地,是诺诚健华推动创新药惠及中国患者的又一重要里程碑。未来,我们将继续与各方携手,加速提升创新 药的可及性,为改善中国淋巴瘤患者的生存质量持续努力。" 填补未被满足的临床需求 DLBCL是非霍奇金淋巴瘤(NHL)中最常见 ...
诺诚健华(09969):公司2025年半年报业绩点评:首次覆盖:收入增长强劲,自免即将步入兑现期
Investment Rating - The report assigns an "Outperform" rating to the company [4][15]. Core Insights - The company has shown strong revenue growth, with a 74.26% year-on-year increase in revenue for H1 2025, reaching 731 million RMB, and a significant narrowing of net losses by 88.51% [16][17]. - The leadership position in hematologic tumors is being solidified, with strong sales growth of Orelabrutinib and imminent commercialization of Tafasitamab [17][18]. - The company is advancing multiple pipelines in autoimmune diseases, with several products entering Phase III trials [18]. Financial Summary - Revenue projections for 2025-2027 are 1.44 billion RMB, 1.86 billion RMB, and 2.69 billion RMB, with year-on-year growth rates of 43%, 29%, and 45% respectively [4][15]. - The company is expected to achieve a gross profit of 1.31 billion RMB by 2025, with a net profit forecasted to narrow to -308 million RMB [2][4]. - The price-to-sales (PS) ratio is set at 30x for 2025, leading to a target price of 26.70 HKD [4][15].
国泰海通:予诺诚健华“增持”评级 目标价26.7港元
Zhi Tong Cai Jing· 2025-09-23 03:27
Core Viewpoint - The report from Guotai Junan maintains a "Buy" rating for Nuo Cheng Jian Hua (09969), projecting revenue growth from 2025 to 2027 at 14.43 billion, 18.59 billion, and 26.91 billion yuan, representing year-on-year growth of 43%, 29%, and 45% respectively. A target price of 24.53 to 26.70 HKD is set for 2025 based on a 30x PS ratio [1]. Group 1: Performance - In the first half of 2025, the company achieved revenue of 7.31 billion yuan, a year-on-year increase of 74.26%, with a net profit attributable to shareholders of -0.30 billion yuan, narrowing losses by 88.51% [2]. - In Q2 2025, revenue reached 3.50 billion yuan, up 37.91% year-on-year, while the net profit attributable to shareholders was -0.48 billion yuan, with losses narrowing by 59.76%. The revenue growth was primarily driven by increased sales of Obinutuzumab and recognition of licensing income, with pharmaceutical sales rising by 53.47% [2]. Group 2: Blood Cancer Leadership - The company continues to solidify its leadership in the blood cancer sector, with strong sales growth of Obinutuzumab, which generated 6.37 billion yuan in sales in the first half of 2025, a 52.84% increase year-on-year. The NDA application for 1LCLL/SLL was approved in April 2025 [3]. - The commercialization of Tanshizumab is set to begin, with approval for the indication of unsuitable ASCT r/r DLBCL received in April 2025, and sales expected to start between Q3 and Q4 of 2025 [3]. - ICP-248 is advancing in multiple registrations in both domestic and U.S. markets, with ongoing patient recruitment for 1LCLL/SLL and BTKi-treated MCL indications in China, and steady progress in AML and MDS studies in the U.S. The addition of new indications is expected to further boost Obinutuzumab's sales [3]. Group 3: Autoimmune Pipeline - The company has multiple pipelines in autoimmune diseases entering Phase III trials, with two Phase III clinical trials for Obinutuzumab (PPMS and SPMS) expected to start patient recruitment in the second half of 2025. The Phase III registration trial for ITP in China has successfully completed patient enrollment, with NDA submission anticipated in the first half of 2026. Data readout for SLE is expected in Q4 2025 [4]. - For ICP-332, patient recruitment for the AD Phase III trial is accelerating, and the Phase II/III trial for vitiligo began patient recruitment in May 2025. The global Phase II trial for PN is expected to start in the second half of 2025 [4]. - The Phase III registration trial for plaque psoriasis with ICP-488 is currently recruiting patients [4].
国泰海通:予诺诚健华(09969)“增持”评级 目标价26.7港元
智通财经网· 2025-09-23 03:26
Core Viewpoint - The report from Guotai Junan maintains a "Buy" rating for Nuo Cheng Jian Hua (09969), projecting revenue growth from 14.43 billion to 26.91 billion CNY from 2025 to 2027, with year-on-year growth rates of 43%, 29%, and 45% respectively. The target price is set at 24.53 CNY/26.70 HKD based on a 30x PS for 2025 [1][2]. Financial Performance - In the first half of 2025, the company achieved revenue of 7.31 billion CNY, a year-on-year increase of 74.26%, and a net profit attributable to shareholders of -0.30 billion CNY, with losses narrowing by 88.51%. In Q2 alone, revenue reached 3.50 billion CNY, up 37.91%, with net profit of -0.48 billion CNY, a 59.76% reduction in losses. The revenue growth is primarily driven by increased sales of Aobutini and revenue from licensing agreements, with pharmaceutical sales rising by 53.47% [1][2]. Market Position and Pipeline Development - The company continues to solidify its leadership in the hematology sector, with strong sales growth of Aobutini, which reached 6.37 billion CNY in the first half of 2025, a 52.84% increase. The NDA application for 1LCLL/SLL was approved in April 2025. Additionally, the commercialization of Tansizhuo monoclonal antibody is expected to begin in Q3 to Q4 of 2025. The ICP-248 clinical trials are progressing in both domestic and U.S. markets, with new indications anticipated to further boost Aobutini's sales [2][3]. Immunology Pipeline Advancements - The company has multiple immunology pipelines entering Phase III trials. Aobutini's Phase III trials for PPMS and SPMS are expected to start patient recruitment in the second half of 2025. The ITP Phase III trial in China has successfully completed patient enrollment, with NDA submission anticipated in the first half of 2026. Data for SLE is expected to be read out in Q4 2025. ICP-332 is accelerating patient recruitment for AD Phase III trials, while the Phase II/III trial for vitiligo began in May 2025. The global Phase II trial for PN is set to start in the second half of 2025 [3].
国泰海通晨报-20250923
Haitong Securities· 2025-09-23 01:59
Group 1: Mechanical Industry - The mechanical industry report highlights that the US CPI increased by 2.9% year-on-year in August, with a core CPI rise of 3.1% and non-farm employment adding 22,000 jobs [1][4] - The report suggests focusing on export-oriented consumer companies with global manufacturing layouts, brand output capabilities, and channel integration advantages, especially those with diversified capacity and stable customer loyalty [3][16] - The report notes a slight depreciation of the US dollar against the RMB and a slight appreciation of the euro against the RMB, with major shipping routes experiencing a year-on-year increase in freight rates [1][5] Group 2: Aviation Industry - The aviation industry is expected to enter a "super cycle" with high passenger load factors and improving supply-demand dynamics, potentially leading to a significant increase in airline profitability by 2026 [2][8][25] - The report indicates that the Chinese aviation market has achieved market-driven pricing and high load factors, which are essential for price transmission [8][25] - The report anticipates that if business travel demand continues to recover, airlines' profitability will significantly increase, marking a long-term positive trend for the industry [8][25][27] Group 3: Fixed Income Research - The report discusses the issuance of local government bonds in various provinces, totaling 188.52 billion RMB, with a slight narrowing of the bond issuance spread [2][14] - It highlights the impact of the Federal Reserve's interest rate cuts on global policy cycles and the need to monitor liquidity changes and structural opportunities in the bond market [1][11] - The report emphasizes the importance of adjusting investment strategies in response to the evolving interest rate landscape and liquidity conditions [11][13]
诺诚健华(09969):公司2025年半年报业绩点评:收入增长强劲,自免即将步入兑现期
Investment Rating - The report assigns a rating of "Buy" for the company [5][9]. Core Insights - The company's hematology business continues to strengthen its leadership position with the advancement of products like Obinutuzumab and ICP-248, while the autoimmune pipeline is entering Phase III trials across multiple indications [2][9]. - The company achieved a revenue of 731 million RMB in the first half of 2025, representing a year-on-year growth of 74.26%, with a narrowed net loss of 30 million RMB, down 88.51% year-on-year [9]. - The report forecasts revenues for 2025-2027 to be 14.43 billion RMB, 18.59 billion RMB, and 26.91 billion RMB, respectively, with growth rates of 43%, 29%, and 45% [9]. Financial Summary - Total revenue is projected to grow from 739 million RMB in 2023 to 1,443 million RMB in 2025, reflecting an 18% increase in 2023, followed by a 37% increase in 2024, and a 43% increase in 2025 [4]. - Gross profit is expected to rise from 610 million RMB in 2023 to 1,306 million RMB in 2025, with a gross margin improvement from 82.5% to 90.5% [4]. - The net profit is projected to improve from a loss of 631 million RMB in 2023 to a loss of 308 million RMB in 2025, with a significant turnaround expected by 2027, achieving a profit of 195 million RMB [4]. Market Data - The current stock price is 16.44 HKD, with a market capitalization of 29,011 million HKD and a 52-week price range of 5.18 to 20.00 HKD [6][9]. - The report sets a target price of 24.53 RMB or 26.70 HKD for the company, based on a 30x PS ratio for 2025 [9][12].
淋巴瘤诊疗加速突破:创新药与规范诊疗共筑健康防线
Zhong Guo Xin Wen Wang· 2025-09-15 22:50
Core Insights - Lymphoma is the 10th most common cancer globally and has a rapidly increasing incidence rate, with approximately 100,000 new cases reported annually in China, over 50% of which are in individuals aged 60 and above [1] - The Chinese government has made significant advancements in the diagnosis, classification, staging, and treatment of lymphoma, including the implementation of quality control measures for cancer treatment [1][4] - The approval of innovative drugs, such as tanzimab and lenalidomide for treating relapsed/refractory diffuse large B-cell lymphoma (DLBCL), marks a significant step forward in lymphoma treatment in China [2][3] Group 1: Disease Statistics and Trends - Lymphoma is one of the fastest-growing malignant tumors, with a notable increase in younger patients [1] - DLBCL accounts for 30%-40% of adult non-Hodgkin lymphoma (NHL) cases in Western countries and 35%-50% in China, with a median onset age of 50-70 years [3] Group 2: Government Initiatives and Guidelines - The National Cancer Center has initiated pilot projects for standardized diagnosis and treatment quality control for lymphoma, with 60 institutions selected for this purpose in 2023 [1] - The "Healthy China Action - Cancer Prevention and Control Action Implementation Plan (2023-2030)" aims to enhance cancer prevention and control systems, improve early diagnosis and treatment capabilities, and increase the overall five-year survival rate for cancer to 46.6% by 2030 [4] Group 3: Drug Development and Market Impact - The conditional approval of tanzimab for relapsed or refractory follicular lymphoma and its combination with lenalidomide for DLBCL patients represents a significant advancement in treatment options [2] - Clinical studies indicate that tanzimab combined with lenalidomide shows promising efficacy, with an overall response rate (ORR) of 57.5% and a complete response (CR) rate of 41.3% in global studies, and an ORR of 73.1% in Chinese patients [3]