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东吴证券:维持康宁杰瑞制药-B“买入”评级 核心管线上市申报中
Zhi Tong Cai Jing· 2026-01-23 02:37
东吴证券发布研报称,维持康宁杰瑞制药-B(09966)"买入"评级,考虑到2025年公司有多款ADC新管线 完成临床前研发,该行提高了对研发费用的预测水平,相应影响归母净利润水平,2025-2026年归母净 利润分别下调为-1.15/-0.97亿元,原值为0.14/0.63亿元,新增2027年归母净利润预测为-0.26亿元。随着 公司后续产品KN026有望国内上市,JSKN003也即将申报上市,该行预计未来公司亏损将逐步缩小。同 时基于公司后备管线的逐步进入临床阶段,公司研发能力进入良性发展循环。 自研平台持续发力,多款新ADC分子即将进入临床 公司自研的技术平台持续产出新管线,在PD-L1靶点管线中,PD-L1/ITGB6/8多功能ADCJSKN022展现 出优于单抗ADC的内吞效率和体内外杀伤活性,该管线目前已经在2025年10月启动了I期临床。PD- L1/VEGFR2双抗ADCJSKN027整合了细胞毒杀伤、抗血管及免疫调节三重机制,公司在2025年12月已 经向中国药监局提交IND申请并获得受理,2026年有望开展针对JSKN027的I期临床研究。后续还有 EGFR/HER3双抗双载荷ADCJSKN ...
东吴证券:维持康宁杰瑞制药-B(09966)“买入”评级 核心管线上市申报中
智通财经网· 2026-01-23 02:36
Core Viewpoint - Dongwu Securities maintains a "Buy" rating for Kangning Jereh Pharmaceutical-B (09966), anticipating multiple ADC pipelines to complete preclinical development by 2025, leading to adjustments in R&D expense forecasts and net profit estimates for 2025-2027 [1] Group 1: Financial Projections - The forecast for net profit attributable to the parent company is adjusted to -115 million yuan for 2025 and -97 million yuan for 2026, down from 14 million yuan and 63 million yuan respectively; a new forecast for 2027 is set at -26 million yuan [1] - The company is expected to gradually reduce losses as products like KN026 are anticipated to be launched domestically, with JSKN003 also nearing its application for market approval [1] Group 2: Product Pipeline Developments - KN026, a HER2 bispecific monoclonal antibody, has had its application for marketing approval accepted by NMPA, with expectations for approval by the end of 2026 or in 2027; the domestic rights have been granted to CSPC Pharmaceutical Group, while the company retains exclusive production rights [1] - JSKN003, the company's first ADC pipeline, is expected to submit a domestic application for HER2-positive breast cancer in 2026, with promising efficacy data presented at the 2025 ESMO conference for ovarian and colorectal cancers [2] Group 3: Research and Development Advancements - The company's self-developed platform continues to yield new pipelines, with the PD-L1/ITGB6/8 multifunctional ADC JSKN022 showing superior internalization efficiency and cytotoxic activity, having initiated Phase I clinical trials in October 2025 [3] - The PD-L1/VEGFR2 bispecific ADC JSKN027 has integrated multiple mechanisms and has received acceptance for its IND application, with Phase I clinical trials expected to commence in 2026 [3] - Additional ADCs, such as EGFR/HER3 bispecific dual-load ADC JSKN021, are anticipated to enter clinical development stages [3]
康宁杰瑞制药-B(09966.HK):核心管线上市申报中 新分子即将进入临床
Ge Long Hui· 2026-01-23 01:59
机构:东吴证券 研究员:朱国广/邹行健 考虑到2025 年公司有多款ADC 新管线完成临床前研发,我们提高了对研发费用的预测水平,相应影响 归母净利润水平,2025-2026 年归母净利润分别下调为-1.15/-0.97 亿元,原值为0.14/0.63 亿元,新增 2027年归母净利润预测为-0.26 亿元。随着公司后续产品KN026 有望国内上市,JSKN003 也即将申报上 市,我们预计未来公司亏损将逐步缩小。 多款核心管线催化剂密集,KN026 已提交上市申请:KN026 是公司开发的HER2 双表位单抗,其核心 适应症之一的联合化疗治疗2L 及以上胃癌目前已经获得NMPA 受理,我们预计2026 年年底或2027 年有 望获批上市。公司已经将该产品的国内权益授予石药集团,未来上市后石药集团将负责相关商业化工 作,公司将保留KN026 的独家生产权,为石药集团提供产品。除此之外KN026 的乳腺癌1L 治疗和新辅 助治疗的方案也有望在2026 年提交上市申请。JSKN003 是公司开发的首款ADC管线,其临床进展也较 为迅速,针对2L HER2 阳性乳腺癌的适应症预计有望在2026 年提交国内上市申请。 ...
东吴证券晨会纪要2026-01-23-20260123
Soochow Securities· 2026-01-22 23:30
Macro Strategy - The report highlights the investment value of the Guangfa CSI Media ETF (512980.SH), which is closely tracking the CSI Media Index (399971.SZ) and has a management fee of 0.5% per year and a custody fee of 0.1% per year [10] - As of January 16, 2026, the ETF has a circulation scale of 10.759 billion yuan, leading in scale and liquidity, with an annualized return of 29.47% and a volatility ratio of 0.89, indicating reasonable risk control [10] - The underlying index focuses on AI applications, with a high weight of GEO concept stocks, including major companies like BlueFocus and Rock Mountain Technology, which account for 31.43% of the index [10] - The report notes that the media sector is experiencing a bull market driven by AI technology transformation and the assetization of data elements, contrasting with the previous bull market driven by mobile internet traffic [10] Company Analysis Kangning Jereh Pharmaceutical-B (09966.HK) - The company is expected to have total revenues of 414 million yuan and 471 million yuan in 2025 and 2026, respectively, with a new forecast for 2027 at 563 million yuan [6] - The net profit forecast for 2025 and 2026 has been adjusted down to -115 million yuan and -97 million yuan, respectively, due to increased R&D expenses [6] - The company maintains a "Buy" rating as it anticipates a gradual reduction in losses with the upcoming domestic launch of product KN026 and the submission of JSKN003 for listing [6] Fuan Energy (002911) - The company reported a net profit of 1 billion yuan for 2025, a year-on-year increase of 17.3%, driven by strong growth in its energy and chemical business [17] - The forecast for net profit for 2025-2027 has been raised to 1 billion, 1.07 billion, and 1.12 billion yuan, respectively, reflecting a growth of 17.3%, 7.0%, and 4.4% [17] - The company maintains a "Buy" rating, supported by a stable natural gas business and diversified growth strategies [17] Huace Testing (300012) - The company expects a net profit of 1.01-1.02 billion yuan for 2025, with a growth rate of 10%-11%, and a strong performance in Q4 with a net profit increase of 15%-20% [18] - The report emphasizes the company's strategic focus on traditional markets and emerging sectors, which is expected to drive growth [19] - The company maintains an "Overweight" rating, with adjusted net profit forecasts for 2025-2027 at 1.02 billion, 1.16 billion, and 1.29 billion yuan [19] Tianfu Communication (300394) - The company forecasts a net profit of 1.88-2.15 billion yuan for 2025, representing a year-on-year increase of 40%-60% [20] - The growth is attributed to the acceleration of the AI industry and global data center construction, which has driven demand for high-speed optical devices [20] - The company is positioned to benefit from the upcoming commercial launch of its 1.6T optical engine products [20]
康宁杰瑞制药-B:核心管线上市申报中,新分子即将进入临床-20260122
Soochow Securities· 2026-01-22 12:24
Investment Rating - The report maintains a "Buy" rating for the company [1] Core Insights - The company has multiple core pipeline catalysts, with KN026 having submitted a listing application and expected to be approved by the end of 2026 or early 2027. The product has been granted exclusive domestic rights to a partner company for commercialization while retaining production rights [7][12] - The first ADC pipeline, JSKN003, is progressing rapidly, with promising clinical data for multiple indications, including ovarian and colorectal cancers. The company anticipates submitting a domestic listing application for this product in 2026 [21][24] - The self-developed platform continues to yield new ADC molecules, with several expected to enter clinical trials soon. Notable candidates include JSKN022 and JSKN027, which have shown superior efficacy and are set to begin clinical studies in 2026 [28][30] Financial Projections - The company forecasts total revenue of CNY 4.14 billion and CNY 4.71 billion for 2025 and 2026, respectively, with an additional projection of CNY 5.63 billion for 2027. Adjustments to R&D expense forecasts have led to revised net profit estimates of -CNY 1.15 billion and -CNY 0.97 billion for 2025 and 2026, respectively, with a projected loss of -CNY 0.26 billion in 2027 [1][33]
康宁杰瑞制药-B(09966):核心管线上市申报中,新分子即将进入临床
Soochow Securities· 2026-01-22 11:02
买入(维持) | [Table_EPS] 盈利预测与估值 | 2023A | 2024A | 2025E | 2026E | 2027E | | --- | --- | --- | --- | --- | --- | | 营业总收入(百万元) | 218.77 | 640.08 | 414.00 | 471.00 | 563.00 | | 同比(%) | 31.12 | 192.58 | (35.32) | 13.77 | 19.53 | | 归母净利润(百万元) | (210.59) | 166.34 | (115.44) | (96.59) | (26.41) | | 同比(%) | 35.35 | 178.99 | (169.40) | 16.33 | 72.65 | | EPS-最新摊薄(元/股) | (0.22) | 0.17 | (0.12) | (0.10) | (0.03) | | P/E(现价&最新摊薄) | (45.43) | 57.52 | (82.88) | (99.05) | (362.23) | 证券研究报告·海外公司研究简报·药品及生物科技(HS) 康宁杰瑞制药-B(09966. ...
西部证券晨会纪要-20251230
Western Securities· 2025-12-30 03:51
Group 1: Company Overview - The report focuses on 康宁杰瑞生物-B (9966.HK), which specializes in the development, production, and commercialization of innovative biopharmaceuticals in the oncology field, leveraging various core technology platforms [4][6] - The company has developed a differentiated pipeline that includes single-domain antibodies, bispecific antibodies, and antibody-drug conjugates (ADCs), showcasing international competitiveness [4][5] Group 2: Product Pipeline and Commercialization - The commercialization of 安尼妥单抗 injection is imminent, targeting 2L+HER2+GC treatment and providing better clinical options for 1L/newly diagnosed HER2+ breast cancer patients [4][5] - The first listing application for 安尼妥单抗 for HER2+ gastric cancer has been accepted by NMPA, with expectations for approval within 2026, marking the beginning of a commercialization phase [4][5] - Multiple ongoing clinical trials for various indications, including 1L HER2+ breast cancer and HER2+ gastric cancer, indicate significant potential for blockbuster products [4][5] Group 3: Financial Projections - Revenue forecasts for 康宁杰瑞 are projected at 432 million, 484 million, and 596 million yuan for 2025, 2026, and 2027 respectively, reflecting year-on-year growth rates of -32.5%, 12.1%, and 23.0% [6] - The current price-to-sales (PS) ratios are estimated at 20.6x, 18.4x, and 14.9x for the respective years, indicating substantial upside potential due to effective drug commercialization and clinical data disclosures [6] Group 4: Industry Overview - The report highlights a positive macroeconomic environment for the non-ferrous metals industry, with significant price increases in metal commodities driven by supply constraints and favorable economic indicators [7][10] - The U.S. GDP for Q3 exceeded expectations, with a year-on-year growth rate of 4.3%, supporting consumer spending despite inflation and employment concerns [7][8] - The industrial added value for large-scale industries in China is expected to grow by 5.9% in 2025, indicating a robust manufacturing sector [9]
康宁杰瑞制药(09966) - 自愿公告 - JSKN033的一项II期临床试验的IND申请获CDE...
2025-12-29 04:11
康寧傑瑞生物製藥 (於開曼群島註冊成立的有限公司) (股份代號:9966) 自願公告 JSKN033的一項II期臨床試驗的IND申請獲CDE正式受理 本公告乃由康寧傑瑞生物製藥(「本公司」,連同其附屬公司,統稱「本集團」)自願 作出,以知會本集團股東(「股東」)及潛在投資者有關本集團之最新業務進展。 香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責,對其準確性 或完整性亦不發表任何聲明,並明確表示,概不對因本公告全部或任何部分內容而產生或因倚 賴該等內容而引致的任何損失承擔任何責任。 ALPHAMAB ONCOLOGY 關於JSKN033 JSKN033是本集團開發的全球首個由HER2雙特異性ADC(JSKN003)及PD-L1單 抗(恩沃利單抗)組成的皮下注射複方製劑。JSKN003是一種靶向HER2雙表位 ADC,其中一種拓撲異構酶I抑制劑通過糖基定點偶聯技術與抗體KN026(一種重 組人源化抗HER2雙特異性抗體)的N糖基化位點連接。恩沃利單抗是重組人源化 PD-L1單域抗體和人免疫球蛋白G1 Fc片段組成的Fc融合蛋白,作為全球首個皮下 注射PD-L1抑制劑,已於2021年11月 ...
年终盘点 | 以康宁杰瑞-B(9966.HK)为例,洞见差异化创新的医药硬科技
Ge Long Hui· 2025-12-24 01:02
2025年,在"双循环"新发展格局下,中国资本市场正经历一场深刻的蜕变。全球资本再平衡的浪潮中,中国逐渐成为那个不可忽视的核心锚点。 而在这一宏大叙事中,创新药板块无疑是今年最为亮眼的主角之一。行业从过去的"数量追逐"大步迈向"硬科技决胜",资本市场也以真金白银投票:板块整 体走强,细分赛道黑马频出。 其中,康宁杰瑞在2025年不仅完成蜕变,在资本市场获得认可,年内股价涨幅220.57%(数据截止2025年12月22日收盘),成为中大型未盈利生物科技公司中 的领跑者,更在近期荣获由格隆汇颁布的"年度创新力奖",这一奖项背后,是对其"以平台化技术为引擎,实现管线高效、快速产出"创新模式的权威肯定。 那么,在创新药走向硬科技之路下,为什么康宁杰瑞能够脱颖而出?背后的底层逻辑是什么? 2025年,创新药板块走出了一轮清晰的结构性牛市。在估值修复、政策支持与BD出海浪潮的多重推动下,整个行业的估值体系正在被系统性重构。 资本市场的共识已然明确:创新药的投资逻辑,已从早先的"故事与管线"叙事,转向对"商业化兑现能力"与"持续创新动能"的深度定价。政策鼓励源头创 新、审评审批持续提速、头部药企海外授权(BD)高频落地:这 ...
医药生物行业周报(12月第3周):病理业务发展进入快车道-20251222
Century Securities· 2025-12-22 14:46
Investment Rating - The report does not explicitly state an investment rating for the industry [2]. Core Insights - The pathology business is entering a fast track with the National Healthcare Security Administration issuing guidelines for pricing projects in pathology services, focusing on biopsy sampling, sample processing, and digitalization of pathology data, which is expected to enhance the application of AI in the field [3][11]. - The influenza activity has peaked across the board, with reported cases in southern provinces at 9.7%, down from 11.2% the previous week, but higher than the same period in previous years [3][11]. Market Weekly Review - The pharmaceutical and biotechnology sector fell by 0.14% from December 15 to December 19, outperforming the Wind All A index (-0.15%) and the CSI 300 index (-0.28%). The rebound was weak, with segments like pharmaceutical distribution (5.59%), offline pharmacies (4.69%), and hospitals (4.15%) leading gains, while chemical preparations (-2.1%), vaccines (-0.87%), and medical R&D outsourcing (-0.87%) lagged [3][8]. - Notable stock performances included Huaren Health (55.9%), Luyuan Pharmaceutical (36.8%), and Shuyupingmin (35.7%) with significant gains, while *ST Changyao (-24%), Yipinhong (-23.7%), and Rejing Biology (-16.5%) faced substantial declines [3][11]. Industry News and Key Company Announcements - The National Healthcare Security Administration's guidelines for pathology services are expected to drive high-quality development in the sector and create new scenarios for AI-assisted technology applications [11]. - Significant collaborations and approvals were reported, including Shanghai Jinmante's partnership with Jiangsu Kangning Jerey for a breakthrough therapy designation from the FDA for JSKN003, and Novo Nordisk's submission of a marketing application for CagriSema, which showed a weight loss of 22.7% over 68 weeks in clinical trials [12][13]. - Fosun Pharma's subsidiary received FDA approval to initiate a Phase I clinical trial for HLX18, a biosimilar to Nivolumab, targeting various cancers [13][14].