康诺亚公司在 2026 年有哪些重大变化和发展？ 康诺亚公司在 2026 年有几个重要的变化和发展。首先，康悦达（CM310）作 为国内首个用于特应性皮炎的生物制剂，于 2024 年 9 月上市，并于 2025 年 完成了第一个完整销售年度。由于其靶点不仅限于特应性皮炎，还包括慢性鼻 窦炎伴鼻息肉（CRS 伴鼻息肉）和季节性过敏性鼻炎（SAR），这三个适应症 均已纳入 2026 年的医保目录，价格谈判结果也非常理想。 其次，康诺亚的 18.2 ADC 产品是全球首个进入临床的 first-in-class 产品。尽管其靶点并非首 创，但它在市场上具有显著潜力。康诺亚还将 CMG901 授权给阿斯利康，用 于二线胃癌治疗，该产品预计将在 2026 年上半年完成全球注册三期试验并递 交 NDA。此外，该产品还新增了一线适应症，并启动了三期试验。 第三，康 悦达的新型注射笔装置于 2025 年第四季度上市，并同步纳入医保，这将极大 康诺亚 CM310 已获批多项适应症并纳入医保，显著提升市场覆盖率和 销售额，新型注射笔装置进一步提高患者使用便利性，有望带来销售增 量，预计未来峰值有望达到 40-50 亿人民币。 1 ...

乐普生物（2157.HK）深度——研发布局稳扎稳打，ADC平台进入收获期 #研发覆盖ADC+IO，即将进入新药获批收获期 公司已构建多个肿瘤产品管线，覆盖免疫治疗、ADC靶向治疗和溶瘤病毒药物三大领域，除已上市的PD-1单抗普 特利单抗和MRG003外，公司还拥有6款ADC药物、1款引进的溶瘤病毒以及1款TCE药物进入临床阶段，整体看公 司管线梯度完善，未来3-5年将进入新药陆续获批上市的收获期。 （乐普生物） 乐普生物（2157.HK）深度——研发布局稳扎稳打，ADC平台进入收获期 #研发覆盖ADC+IO，即将进入新药获批收获期 （乐普生物） 2） MRG004A（TF-ADC）用于后线胰腺癌的I期具备优异竞争力，目前已进入III期试验。 3）MRG006A（GPC3 ADC）为FIC，瞄准广阔肝癌市场，I期试验剂量爬坡取得超预期成果，缩瘤效果显著，26年 有望启动III期试验。 4）参股CMG901为全球FIC的CLDN 18.2 ADC，已处于全球III期阶段；MRG001（CD20 ADC）在DLBCL展现潜 力。 #引进溶瘤病毒具备BIC潜质，新品出海已有突破 公司19年引进溶瘤病毒疗法CG0070 ...

机构：中邮证券 研究员：盛丽华/陈灿 研发覆盖ADC+IO，即将进入新药获批收获期 公司已构建多个肿瘤产品管线，覆盖免疫治疗、ADC靶向治疗和溶瘤病毒药物三大领域，除已上市的 PD-1单抗普特利单抗和MRG003外，公司还拥有6款ADC药物、1款引进的溶瘤病毒以及1款TCE药物进 入临床阶段，整体看公司管线梯度完善，未来3-5年将进入新药陆续获批上市的收获期。业绩层面，公 司BD和销售双轮驱动，收入稳步增长，费用支出稳健，25H1实现首次盈利和经营性净现金流转正。 在研ADC各具特色，布局适应症竞争优势明显1）MRG003（EGFR ADC）单药用于后线NPC国内已获 批上市，展示出优异的生存获益、相较竞品具备安全性优势、联合用药将线数进一步前移；公司同时积 极布局HNSCC和NSCLC的大适应症，单药用于2L+HNSCC处于III期试验阶段。 2） MRG004A（TF-ADC）用于后线胰腺癌的I期具备优异竞争力，目前已进入III期试验。 3）MRG006A（GPC3 ADC）为FIC，瞄准广阔肝癌市场，I期试验剂量爬坡取得超预期成果，缩瘤效果 显著，26年有望启动III期试验。 4）参股CMG901为全球 ...

Investment Rating - The report assigns a "Buy" rating for the company, marking its first coverage [1]. Core Insights - The company is entering a new drug approval harvest period with a well-structured pipeline covering ADC (Antibody-Drug Conjugates) and IO (Immuno-Oncology) [3][10]. - The company has multiple oncology product pipelines, including immune therapy, ADC targeted therapy, and oncolytic virus drugs, with several candidates in clinical stages [3][11]. - The company achieved its first profitability and positive operating cash flow in the first half of 2025, driven by business development and sales [3][25]. Summary by Sections R&D Coverage and Pipeline - The company focuses on oncology treatment, establishing a comprehensive ADC technology platform and has developed multiple ADC products, including PD-1 monoclonal antibody and MRG003 [11][14]. - The pipeline includes six ADC drugs, one oncolytic virus, and one TCE (T-cell Engager) drug in clinical stages, with several candidates entering pivotal trials [14][18]. Unique Features of ADC Candidates - MRG003 (EGFR ADC) has been approved for NPC (Nasopharyngeal Carcinoma) in China, showing superior survival benefits and safety compared to competitors [4][30]. - MRG004A (TF-ADC) is in Phase III trials for pancreatic cancer, while MRG006A (GPC3 ADC) targets the liver cancer market and is expected to enter Phase III trials in 2026 [6][30]. Oncolytic Virus and International Expansion - The company introduced the oncolytic virus therapy CG0070, which is in critical registration trials in China and has shown promising efficacy in the U.S. for bladder cancer [5][30]. - The company has successfully partnered for international expansion with MRG007 (CDH17 ADC) and CTM012 (CD3/4-1BB/DLL3 tri-antibody) [5][30]. Financial Projections and Investment Recommendations - Revenue projections for 2025, 2026, and 2027 are estimated at 880 million, 1.02 billion, and 1.49 billion yuan, respectively, with expected growth rates of 138%, 16%, and 47% [6][30]. - The company is still in the investment phase for innovative drug development, with projected net profits of -20 million, 10 million, and 280 million yuan for the same years [6][30].

Investment Rating - The report assigns a "Buy" rating for the company, Lepu Biopharma (2157.HK), marking its first coverage [1]. Core Insights - The company is entering a harvest period for new drug approvals, having established a comprehensive pipeline in oncology that includes immunotherapy, ADC (Antibody-Drug Conjugate) targeted therapy, and oncolytic virus drugs. The company has multiple ADC drugs and other therapies in clinical stages, with expectations for new drug approvals in the next 3-5 years [3][10]. - The ADC pipeline is characterized by unique features and competitive advantages in various indications, with MRG003 (EGFR ADC) already approved for NPC (nasopharyngeal carcinoma) in China and showing promising results in other indications [4][30]. - The introduction of oncolytic virus therapy CG0070 has shown potential in the bladder cancer market, with successful regulatory progress in the U.S. and ongoing clinical trials in China [5][30]. - Financially, the company has achieved its first profit and positive operating cash flow in the first half of 2025, with steady revenue growth driven by business development and sales [25]. Summary by Sections R&D Coverage and Pipeline - The company focuses on oncology treatment, with a pipeline that includes immunotherapy, ADCs, and oncolytic virus therapies. It has developed a robust ADC technology platform and has multiple products in various stages of clinical development [11][10]. - The pipeline includes 6 ADC drugs and 1 oncolytic virus therapy, with several candidates in pivotal clinical stages, indicating a well-structured development strategy [14][10]. Unique Features of ADCs - MRG003 has been approved for NPC and is in advanced trials for HNSCC (head and neck squamous cell carcinoma) and NSCLC (non-small cell lung cancer), showcasing its broad applicability and competitive edge [30][4]. - Other ADCs in development, such as MRG004A for pancreatic cancer and MRG006A for liver cancer, are also progressing well, with MRG004A entering pivotal trials [30][6]. Financial Performance and Projections - The company reported revenues of 4.66 billion yuan in the first half of 2025, a significant increase from 1.33 billion yuan in the same period of 2024. The net profit for the same period was 290 million yuan, marking a turnaround from a loss of 197 million yuan in the previous year [25][30]. - Revenue projections for 2025, 2026, and 2027 are estimated at 8.8 billion yuan, 10.2 billion yuan, and 14.9 billion yuan, respectively, with expected growth rates of 138%, 16%, and 47% [30].

Core Viewpoint - Guojin Securities has initiated coverage on Connoa-B with a "Buy" rating and a target price of HKD 83.29, highlighting the company's strategic focus on differentiated self-immune chronic disease and oncology sectors [1] Company Overview - Connoa-B has a robust pipeline with multiple ongoing clinical trials, including the core product, Supichibai monoclonal antibody, which has already been approved for market [1] - The CM512 (TSLP/IL-13 dual antibody) is currently expanding into several Phase II clinical trials, while the licensed CMG901 is expected to submit an NDA in the U.S. by 2026 [1] Product Insights - Supichibai monoclonal antibody is the first domestically produced IL-4R monoclonal antibody, providing a significant first-mover advantage [1] - Following the implementation of medical insurance in 2026, the product is anticipated to experience rapid market growth [1] Market Potential - The IL-4R monoclonal antibody targets various type II inflammatory diseases, including atopic dermatitis (AD) and chronic rhinosinusitis with nasal polyps (CRSwNP) [1] - Currently, only two IL-4R monoclonal antibodies have been approved globally, with Sanofi's Dupilumab achieving rapid market penetration since its launch in 2017, and projected global sales exceeding USD 14 billion in 2024 [1]

Core Insights - The article highlights the rise of 康诺亚 as a prominent player in the "BD为王" (BD is King) innovation drug market, having completed four NewCo transactions in the past year, establishing itself as a "NewCo factory" through asset splits and cross-border collaborations [1][3][4] - While the NewCo model is seen as a promising concept, it fundamentally relies on the potential of pipeline assets, creating uncertainty regarding the realization of expected outcomes [2][7] NewCo Empire - 康诺亚 has strategically executed four NewCo transactions, solidifying its position as a specialist in this model through precise asset selection and strong capital partnerships [3] - The transactions include: - July 2024: Partnership with OrbiMed's Belenos for TSLP×IL-13 dual antibody CM512, receiving $15 million upfront and potential milestone payments of up to $170 million [4][5] - November 2024: Exclusive licensing agreement with Platina Medicines Ltd for CM336, with an upfront payment of $135 million [4][5] - January 2025: Collaboration with Timberlyne for CD38 monoclonal antibody CM313, securing $30 million upfront and potential milestone payments of up to $337.5 million [6] - January 2025: Joint venture with Prolium for CD20/CD3 dual antibody CM355, receiving $8.75 million upfront and potential milestone payments of up to $502.5 million [6] - These transactions have created a "NewCo empire" for 康诺亚, allowing it to cover multiple therapeutic areas while enhancing cash flow through upfront and milestone payments [6][7] Clinical and Market Challenges - The pipeline assets involved in the NewCo model are primarily in early clinical stages, which introduces significant uncertainty regarding their future success [8][9] - The success rate for drugs from early clinical trials to market is less than 10%, with additional competition from established products in the same therapeutic areas [9][10] - The valuation of NewCo equity is based on future expectations rather than actual asset value, leading to potential discrepancies if market conditions worsen [10][11] Financial Performance and Market Dynamics - 康诺亚's cash reserves increased to approximately 2.796 billion yuan in the first half of 2025, up by 200 million yuan from the previous year, supported by NewCo transactions [6] - Despite strong expectations for its core product 康悦达, sales have not met projections, with only 1.69 billion yuan achieved in the first half of 2025, representing 33.8% of the annual target [13][14] - The competitive landscape for 康悦达 is challenging, with multiple candidates in clinical stages for similar indications, raising concerns about its market position [13][14] Conclusion on NewCo Model - The NewCo model provides short-term cash flow and pipeline expansion but carries inherent risks of over-leveraging future expectations, potentially leading to commercialization challenges [10][11][15] - The reliance on external investors for pipeline valuation and the loss of core control over potential blockbuster assets may weaken long-term competitiveness [11][15]

Investment Rating - The report initiates coverage with an "Outperform" rating for Lepu Biopharma-B (2157) [4] Core Views - The company is a leading domestic innovative pharmaceutical enterprise focusing on ADC combined with IO in oncology, with expectations for rapid market penetration following the approval of MRG003 [1][4] - The product pipeline is expected to expand internationally, indicating strong long-term growth potential for the company [1] Financial Summary - Projected total revenue for 2024A, 2025E, 2026E, and 2027E is 368 million, 853 million, 1,204 million, and 1,665 million RMB respectively, reflecting growth rates of 63%, 132%, 41%, and 38% [3] - Gross profit is expected to increase from 292.97 million in 2024A to 1,415.20 million in 2027E, with a gross margin projected to be around 79.66% to 85% [3] - Net profit is forecasted to improve from -411 million in 2024A to -29 million in 2027E, indicating a significant reduction in losses [3] Company Overview - Lepu Biopharma was established in January 2018 and focuses on oncology, particularly targeted and immunotherapy [9] - The company has built a diverse product pipeline through acquisitions and partnerships, including PD-1 antibodies and ADCs [9] - The management team is experienced, with a high concentration of ownership, ensuring stability and strategic direction [13][15] Market Potential - The global and Chinese cancer immunotherapy market is expected to grow significantly, with a CAGR of 16.3% and 25.1% respectively from 2025 to 2030 [28][31] - The PD-1 therapy market in China is projected to reach 582 billion RMB by 2030, with a CAGR of 30.5% from 2020 to 2025 [33][35] ADC Market Growth - The global ADC market is anticipated to reach 66.2 billion USD by 2030, with a CAGR of 30.3% from 2023 to 2030 [41] - The ADC market in China is expected to grow at a CAGR of 72.6% from 2023 to 2028, reaching 38.3 billion RMB [44][45] Product Pipeline and Clinical Development - MRG003 is currently under NDA review and has shown promising results in clinical trials for R/M NPC, with a significant improvement in overall response rates compared to chemotherapy [56][61] - The company is actively exploring combination therapies with PD-1 inhibitors, which may enhance treatment efficacy [60][65]

Investment Rating - The report assigns an "Accumulate" rating to the company [5]. Core Insights - The company is a leading domestic innovative pharmaceutical enterprise focusing on ADC combined with IO, with expectations for rapid growth following the approval of MRG003 [2]. - The product pipeline includes plans for international business development, indicating a positive long-term outlook for the company [2]. Financial Summary - Projected total revenue for 2024A is 368 million RMB, with a growth rate of 63%. By 2027E, revenue is expected to reach 1,665 million RMB, with a growth rate of 38% [4]. - The company is projected to achieve a net profit of -411 million RMB in 2024A, improving to -29 million RMB by 2027E [4]. - The price-to-earnings (PE) ratio is expected to improve from -10.04 in 2024A to -389.49 in 2027E, while the price-to-book (PB) ratio is projected to increase from 5.87 to 18.86 over the same period [4]. Company Overview - The company was established in January 2018 and focuses on innovative treatments for cancer, particularly targeted therapies and immunotherapies [13]. - The company has built a robust product pipeline through acquisitions and partnerships, including PD-1 antibodies and ADC drugs [13][15]. - The management team is experienced, with a high concentration of ownership, ensuring stability and strategic direction [15][19]. Market Potential - The global and Chinese cancer immunotherapy market is expected to grow significantly, with a projected CAGR of 16.3% and 25.1% respectively from 2025 to 2030 [30]. - The PD-1 therapy market in China is anticipated to reach 582 billion RMB by 2030, with a CAGR of 30.5% from 2020 to 2025 [33]. Product Pipeline and Development - The company has multiple tumor product pipelines covering immunotherapy, ADC targeted therapy, and oncolytic virus drugs [20]. - MRG003 is currently under NDA review for treating R/M NPC, with potential for significant market impact [22]. - The company is also exploring combination therapies with PD-1 antibodies, which may enhance treatment efficacy [20]. Sales Growth - The company's first commercial product, the PD-1 antibody, has seen rapid sales growth, achieving 300 million RMB in revenue in 2024, three times the revenue of 2023 [23][36]. - The company has expanded its sales network across 118 cities in China, enhancing its market presence [36].

Core Viewpoint - 康诺亚-B's stock surged over 10% following the release of its 1H25 financial results, indicating strong market performance and revenue growth driven by key product sales and licensing agreements [1] Financial Performance - 康诺亚-B reported 1H25 revenue of 4.99 billion yuan, representing a year-on-year increase of 812% [1] - Product sales revenue reached 1.69 billion yuan, while the company recorded a net loss attributable to shareholders of 0.79 billion yuan [1] - Total revenue exceeded expectations primarily due to upfront and recent payments from external licensing of CM313 and CM355, with other sales revenue aligning with forecasts [1] Market Position and Product Development - 中金研报 highlighted accelerated market penetration of 康诺亚-B's core products and a differentiated market strategy [1] - The commercial performance of the drug 司普奇拜单抗 in its first full half-year was noted as excellent, with the TSLP/IL-13 dual antibody expected to become a significant product in the autoimmune sector, particularly for nasal indications [1] Competitive Advantages - 华泰证券 reported that 司普奇拜单抗 generated approximately 1.69 billion yuan in revenue, showcasing significant efficacy and safety advantages in the AD field, with strong competitive positioning [1] - The unique indications in the nasal sector are driving rapid sales growth, and the company plans to participate in the 2025 medical insurance negotiations to enhance accessibility [1] - 康诺亚-B has multiple early-stage pipelines with strong global potential, with several catalysts expected to materialize, including CMG901 anticipated to report in 2026 and CM512 expected to release AD clinical data in 2H25 [1]