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研报掘金丨中信建投:维持诺诚健华“买入”评级,全年有望实现盈亏平衡
Ge Long Hui A P P· 2025-11-24 09:20
中信建投证券研报指出,诺诚健华Q1-Q3亏损减少至0.72亿元,同比缩窄74.8%。业绩加速增长,全年 有望实现盈亏平衡。2025年公司进一步发展,里程碑事件有望进一步兑现:奥布替尼SLE适应症2b期数 据2025年底读出;ICP-723儿童适应症预计2025年底前提交NDA;首款ADC药物ICP-B794预计2025年底 取得临床PoC。未来展望:广泛布局新适应症,保障收入持续增长。市场销售方面,奥布替尼是目前中 国针对MZL 适应症唯一获批上市且进入医保的BTK 抑制剂,竞争小,市场空间广,占整个销售额很大 一部分,奥布替尼销售高速增长,预计2025年全年销售收入同比增长达到40%以上。2026年坦昔妥单抗 完成首个完整销售年度,预期收入超1亿元。考虑到公司自研新药开发的持续深入、临床开发和商业化 等方面更多的重磅里程碑的落地,维持"买入"评级。 ...
诺诚健华(09969.HK)点评:上调2025年销售指引 自免管线加速推进
Ge Long Hui· 2025-11-18 20:02
机构:申万宏源研究 研究员:周文远/胡梦婷 诺诚健华2025 年前三季度收入同比增长60%,达到11.2 亿元,净亏损为0.64 亿元(同比收窄77%),其 中第三季度收入同比增长38%,达到3.84 亿元,净亏损为0.34 亿元,符合我们的预期。2025 年前三季 度,公司核心产品奥布替尼销售额同比增长46%至10.1 亿元,其中第三季度销售额达到3.73 亿元(同比 增长35%,环比增长14%)。前三季度,研发费用为6.76 亿元(同比增长10%),其中第三季度销售研 发费用为2.26 亿元(同比增长17%)。前三季度,销售费用为3.86 亿元(同比增长41%),销售费用率 同比下降4.7 个百分点至35%。截至2025 年9 月底,公司在手现金约为77.6 亿元。 奥布替尼销售加速放量,血液瘤管线布局丰富。随着1L CLL/SLL 适应症获批上市,以及MZL 销售贡献 提升,2025 年第三季度奥布替尼的销售收入达到3.73 亿元(同比增长35%、环比增长14%)。考虑到奥 布替尼在前三季度的强劲销售表现,公司将2025 年销售目标从同比增长35%+提升至40%以上。此外, 坦昔妥单抗(CD19)已于2 ...
诺诚健华提前盈利上岸
Jing Ji Guan Cha Wang· 2025-11-18 00:46
未来,诺诚健华的面貌会焕然一新,其价值锚点不仅仅在于"奥布替尼的故事",更在于其扎实的商业化 基础、精明的全球化策略以及厚实的后续研发管线。 提前两年扭亏 又一家中国创新药企抵达扭亏临界点。 11月13日,诺诚健华(688428.SH/09969.HK)向市场抛出重磅信号:凭借强劲的商业化表现和策略性的 对外授权交易,2025年全年将实现盈亏平衡,比原计划整整提前两年。 对任何一家Biotech而言,由投入依赖转向自主造血扭亏都是企业跨越式发展的关键临界点。在中国创 新药行业走过第一个十年之际,"盈亏平衡"是比"管线故事"更稀缺、更有力的价值证明。 拥有健康的经营现金流不仅意味着生存,更意味着掌握了将资金投入高价值研发管线的自主权。诺诚健 华目前拥有超10条研发管线,多条管线处于三期临床,自主造血形成的强劲现金流将助推在研分子更快 走向商业化节点。 诺诚健华2025年三季报显示,前三季度总收入达到11.2亿元,同比增长59.8%。 其核心造血机器——BTK抑制剂奥布替尼的增长尤为强劲。前三季度收入同比上涨45.8%,达到10.1亿 元,这一数字已突破去年全年收入。这主要归功于奥布替尼独家适应症边缘区淋巴瘤(M ...
诺诚健华(09969):上调2025年销售指引,自免管线加速推进:诺诚健华(09969):
Shenwan Hongyuan Securities· 2025-11-17 13:26
Investment Rating - The report maintains a "Buy" rating for InnoCare Pharma [8][16] Core Insights - InnoCare Pharma's revenue for the first three quarters of 2025 increased by 60% year-on-year, reaching RMB 1.12 billion, with a net loss of RMB 64 million, which is a 77% year-on-year reduction [5][12] - The company has raised its sales target for its key product, orelabrutinib, from over 35% year-on-year growth to over 40% for 2025, following strong sales performance [6][13] - The company has a robust pipeline for both liquid tumors and autoimmune diseases, with several products in various stages of development [7][14][15] Financial Performance - For the first three quarters of 2025, orelabrutinib sales reached RMB 1.01 billion, a 46% increase year-on-year, with third-quarter sales of RMB 373 million, reflecting a 35% year-on-year and 14% quarter-on-quarter growth [5][12] - Research and development expenses for the first three quarters of 2025 were RMB 676 million, a 10% increase year-on-year, while selling expenses rose by 41% to RMB 386 million [5][12] - As of September 2025, the company had approximately RMB 7.76 billion in cash on hand [5][12] Future Outlook - The company plans to submit a New Drug Application (NDA) for orelabrutinib for the treatment of ITP in the first half of 2026 and expects to read out phase IIb data for SLE by the end of 2025 [7][14] - InnoCare Pharma anticipates submitting 5-7 IND applications targeting malignant tumors and autoimmune diseases in 2026 [15]
诺诚健华(09969):上调2025年销售指引,自免管线加速推进
Shenwan Hongyuan Securities· 2025-11-17 12:12
Investment Rating - The report maintains a "Buy" rating for the company [1][7][15] Core Insights - The company has raised its 2025 sales target from a year-on-year growth of over 35% to over 40% due to strong sales performance of its key product, orelabrutinib, which saw a 46% year-on-year increase in sales to RMB 1.01 billion in the first three quarters of 2025 [4][5][12] - The company reported a revenue of RMB 1.12 billion for the first nine months of 2025, reflecting a 60% year-on-year growth, with a net loss of RMB 64 million, which is a 77% reduction compared to the previous year [4][11] - The company has a robust pipeline in both oncology and autoimmune diseases, with several products in various stages of development, including orelabrutinib and ICP-332 [5][6][13][14] Financial Performance - For the first three quarters of 2025, the company recorded a revenue of RMB 1.12 billion, with a net loss of RMB 64 million, and a third-quarter revenue of RMB 384 million, marking a 38% year-on-year increase [4][11] - Research and development expenses for the first three quarters were RMB 676 million, a 10% increase year-on-year, while selling expenses rose by 41% to RMB 386 million [4][11] - The company had approximately RMB 7.76 billion in cash as of September 2025, providing a solid financial foundation for ongoing and future projects [4][11] Sales and Product Development - Orelabrutinib's sales reached RMB 373 million in the third quarter of 2025, with a year-on-year growth of 35% and a quarter-on-quarter growth of 14% [5][12] - The company is advancing its autoimmune pipeline, with plans to submit a new drug application for orelabrutinib for ITP in the first half of 2026 and to read out phase IIb data for SLE by the end of 2025 [6][13] - The company expects to submit 5-7 IND applications targeting malignant tumors and autoimmune diseases in 2026, indicating a strong early-stage pipeline [14]
奥布替尼独撑营收大局 诺诚健华前三季度亏损收窄
Xin Lang Cai Jing· 2025-11-13 16:41
Core Viewpoint - 诺诚健华 reported a revenue of 383.94 million yuan for Q3 2025, marking a year-on-year increase of 38.09%, but incurred a net loss of 34.32 million yuan [1][4] Financial Performance - Revenue for Q3 2025 was 383.89 million yuan, up 38.09% year-on-year, while total revenue for the first nine months reached 1.11 billion yuan, a 59.85% increase [3][4] - The company reported a net loss of 34.32 million yuan for Q3 2025, with a net loss of 72 million yuan for the first nine months, a 74.78% reduction compared to the previous year [4][6] - Gross margin improved to 88.8%, up from 86.0% year-on-year [3] Product Performance - The growth in revenue is primarily attributed to the sales of the core product, Acalabrutinib, which generated 1.01 billion yuan in sales for the first nine months, a 45.77% increase [4][7] - Acalabrutinib has been approved for four hematological indications in China and is the first BTK inhibitor approved for relapsed/refractory marginal zone lymphoma [4][5] Market Dynamics - Acalabrutinib's sales are expected to continue growing, with projected revenues of 2.41 billion yuan in 2021, 5.66 billion yuan in 2022, 6.71 billion yuan in 2023, and 10 billion yuan in 2024 [7] - The domestic BTK inhibitor market is becoming increasingly competitive, with five approved products, including Acalabrutinib and others from major pharmaceutical companies [8] - The patent for Ibrutinib, a competing product, will expire in December 2026, potentially leading to an influx of generic versions and intensifying market competition [8] Research and Development - R&D expenses totaled 226.35 million yuan in Q3 2025, accounting for 58.96% of revenue, a decrease from the previous year [3][4] - The company is expanding Acalabrutinib's indications, with ongoing clinical trials for multiple sclerosis and immune thrombocytopenic purpura [7][8]
破局“双十定律” 诺诚健华走出创新药企可持续路径
Xin Jing Bao· 2025-10-13 04:23
Core Insights - The "Double Ten Law" highlights the high threshold of "ten years of R&D and one billion USD" that every innovative pharmaceutical company must face, including Nocare Pharma [1][6] - Nocare Pharma's sustainable development is supported by significant R&D investments, which accounted for over 90% of its revenue in the past three years, totaling over 2.2 billion RMB [1][7] - The company has successfully transitioned from relying on external funding to achieving self-sustaining revenue through its core product, Oubatinib, which has surpassed 1 billion RMB in annual sales [1][8] Company Development - Nocare Pharma was established in 2015, focusing on innovative drug development for malignant tumors and autoimmune diseases, with several indications successfully approved for market [3] - Oubatinib, the company's first commercial product, is the first BTK inhibitor in the autoimmune disease field in China, with three indications approved and included in the national medical insurance directory by the end of 2024 [3][4] Financial Performance - In the first quarter of 2025, Nocare Pharma achieved a significant milestone by recording its first quarterly profit, with revenue of 381 million RMB, a year-on-year increase of 129.92% [8] - The company reported a net profit of 18 million RMB, a substantial improvement from a loss of 142 million RMB in the same period last year [8] Business Development - Nocare Pharma has engaged in strategic business development (BD) partnerships to enhance its profitability, including a collaboration with Prolium that could yield up to 5.025 billion RMB in milestone payments [8][9] - A recent licensing agreement with Zenas BioPharma for Oubatinib and two preclinical assets could generate over 2 billion USD in total, marking a record for small molecule licensing in China's autoimmune field [9]
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
Core Insights - The collaboration between Innovent Biologics and Zenas for three self-immune pipeline products marks a significant milestone in the internationalization of the drug Orelabrutinib and sets a new record for small molecule transactions in China's self-immune field, with a total potential transaction value exceeding $2 billion [1] - The development of the first-class new drug HH-003 (Libevev) by Huahui Anjian, targeting chronic hepatitis D, is expected to receive approval for market launch around the first quarter of 2026, representing a major milestone in the company's growth [2][3] Company Developments - Huahui Anjian has been developing HH-003 since its inception, with significant funding rounds supporting its clinical trials, including a recent A++ round financing and breakthrough therapy designation from the FDA for treating chronic hepatitis D [3][4] - The drug HH-003 has shown promising results in clinical trials, demonstrating good safety and antiviral activity, with a notable decrease in HBV DNA and hepatitis B surface antigen levels observed in patients [3][4] Industry Context - The Zhongguancun Life Science Park, where both Innovent Biologics and Huahui Anjian are based, is a key area for biotechnology innovation in Beijing, having produced significant drugs like Orelabrutinib and Zebutinib [1][5] - The park is recognized for its comprehensive industry chain, facilitating the transition from laboratory research to clinical application, thus fostering a competitive pharmaceutical health industry [10] Product Pipeline and Market Potential - Innovent Biologics has developed Orelabrutinib, a BTK inhibitor that has been approved in China and Singapore, with plans for further clinical trials targeting multiple sclerosis [6][7] - The company is also advancing its pipeline with a new generation TRK inhibitor, demonstrating a strategic focus on expanding its product offerings in oncology and autoimmune diseases [7][8] Competitive Landscape - The competitive landscape for BTK inhibitors in China includes several products, with Orelabrutinib positioned to capture market share due to its rapid development and broad application potential [6] - WanTai Biologics, another company in the park, is expanding its vaccine pipeline, including the world's first marketed hepatitis E vaccine, showcasing the diverse innovation occurring within the Zhongguancun Life Science Park [9][10]
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
Core Viewpoint - Nuo Cheng Jian Hua (09969) has seen a stock increase of over 6%, currently up 6.55% at HKD 18.87, with a trading volume of HKD 115 million [1] Company Developments - The company announced that its CD19 monoclonal antibody, Tafa-sitamab, has received its first prescriptions in multiple hospitals across various provinces in China, marking its official entry into clinical application [1] - Tafa-sitamab is the first and only CD19 monoclonal antibody approved globally for the treatment of lymphoma, and it is also the first approved CD19 monoclonal antibody for relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL) in China [1] - This development fills a gap in CD19 targeted therapy in China and is expected to provide better treatment options for DLBCL patients [1]