司普奇拜单抗商业化快速放量。 机构：光大证券 研究员：王明瑞/张瀚予 事件：公司发布2025 年半年报，实现营业收入4.99 亿元，同比+812%，其中药品销售收入约1.7 亿元， 公司对外合作的收入约3.3 亿人民币；扣非归母净利润为-0.79 亿元。 点评： CM313：抗CD38 人源化高效单抗，持续开展多项自免疾病研究，ITP（免疫性血小板减少症）、IgAN （IgA 肾病）等多项临床II 期研究快速推进中。 盈利预测、估值与评级： 因为25H1 公司司普奇拜单抗的实际销售收入超过预期收入，因此我们上调2025年归母净利润预测 为-6.24 亿元（原预测为-7.37 亿元）；考虑到国内及海外研发费用进一步扩大，下调2026 年归母净利润 预测为-4.34 亿元（原预测为-3.04 亿元）；新增2027 年归母净利润预测为-0.64 亿元。公司核心产品司 普奇拜单抗获批上市后销售迅速放量；后续管线布局广阔，覆盖患者人群庞大，且研发进度领先。基于 以上因素，我们维持"买入"评级。 风险提示：研发进度不达预期的风险；销售情况不达预期的风险；国际合作不达预期的风险。 25H1 司普奇拜单抗销售收入约1.7 亿 ...

2025 年 8 月 29 日 公司研究 持续深耕潜力管线，司普奇拜单抗商业化快速放量 ——康诺亚-B（2162.HK）2025 年半年报点评 要点 事件：公司发布 2025 年半年报，实现营业收入 4.99 亿元，同比+812%，其中 药品销售收入约 1.7 亿元，公司对外合作的收入约 3.3 亿人民币；扣非归母净利 润为-0.79 亿元。 点评： 司普奇拜单抗商业化快速放量。 25H1 司普奇拜单抗销售收入约 1.7 亿元，公司预测其峰值销售收入将突破 50 亿元。作为国内首个治疗慢性鼻窦炎伴鼻息肉、全球首个治疗季节性过敏性鼻炎 的 IL-4Rα 抗体药物，司普奇拜单抗有效满足了未被满足的治疗市场。公司聚焦 2 型炎症相关疾病领域，打造专业自免领域销售团队；推动渠道与市场准入，提 升药品可及性，惠及更多患者。截至 2025 年 8 月，商业化团队规模逾 360 人， 并将进一步持续扩增；药品已覆盖 30 省，240+城市，覆盖医院超 1,400 家，持 续产出医院 1,100+，可院内用药医院超 300 家。 持续深耕潜力管线。 盈利预测、估值与评级： 因为25H1公司司普奇拜单抗的实际销售收入超过预期收 ...

证券研究报告 港股通 康诺亚-B (2162 HK) 司普奇拜单抗销售快速增长，早期管 线全球价值凸显 2025 年 8 月 28 日│中国香港 生物医药 8 月 26 日，公司公告 1H25 业绩，营收 4.99 亿元（+812%yoy）。司普奇 拜单抗 1H25 收入约 1.69 亿元，在 AD 领域疗效安全性优势明显、竞争力 强劲，在鼻科独家适应症带动下，销售额快速增长，公司拟参与 2025 医保 谈判，有望提升可及性。同时公司多条早期管线全球潜力强劲，多项催化有 望兑现，我们预计 CMG901 有望 2026 年报产，CM512 有望 2H25 读出 AD 临床数据。维持"买入"。 司普奇拜单抗销售快步攀升 1H25 司普奇拜单抗销售额约 1.69 亿元，看好后续增长：1）产品较度普利 尤单抗疗效优势明显，有望持续渗透自费患者市场；2）秋季过敏季临近， 在此前春季过敏季取得的良好基础上，2H25 SAR 销售额增长可期；3）公 司拟参与 2025 年国谈，若纳入医保或提升药物可及性；4）注射笔剂型在 2024 年 10 月申报上市，有望 2025 年内获批，提升给药便捷性。 CM512：潜在 II 型 ...

公司致力于通过专业的销售和营销团队在中国实现产品管线的商业化，并通过战略合作伙伴关系开拓国 际市场。截至报告期末，通过商业化及业务开发活动，公司在研发能力变现方面取得重要里程碑：普佑 恆(普特利单抗注射液)已完成商业化全流程，目前正处于销售快速增长阶段，另有两款产品CMG901和 MRG007也通过业务开发活动成功达成授权合作。CMG901的全球权益已授权给AstraZeneca，MRG007 的大中华区以外权益已授权给ArriVent。这些成就为公司ADC产品未来商业化及全球合作奠定了坚实的 基础。公司已在国内市场建立起端到端的商业化能力，同时将自身定位为一家全球生物科技公司，在国 际研发和战略合作伙伴关係方面的参与度越来越高。 公告称，收入增加包括主要来自MRG007的对外授权收入人民币3.09亿元(截至2024年6月30日止6个月： 人民币2070万元);来自销售普佑恆(普特利单抗注射液)的收入人民币1.51亿元，较2024年同期显着增加 58.8%(截至2024年6月30日止6个月：人民币9480万元);及就提供CDMO服务的收入人民币630万元(截至 2024年6月30日止6个月：人民币1780万元 ...

智通财经APP讯，乐普生物-B(02157)发布截至2025年6月30日止6个月的中期业绩,该集团取得收入人民 币4.66亿元(单位下同)，同比增加249.59%;公司拥有人应占利润4174.5万元，去年同期亏损1.92亿元;每 股基本盈利0.02元。 公告称，收入增加包括主要来自MRG007的对外授权收入人民币3.09亿元(截至2024年6月30日止6个月： 人民币2070万元);来自销售普佑恆®(普特利单抗注射液)的收入人民币1.51亿元，较2024年同期显着增加 58.8%(截至2024 年6月30日止6个月：人民币9480万元);及就提供CDMO服务的收入人民币630万元(截至 2024年6月30日止6个月：人民币1780万元)。 公司已战略性布局了多个肿瘤产品管线。截至本公告日期，就临床阶段候选药物而言，公司的产品中有 一种临床╱商业化阶段候选药物;九种临床阶段候选药物(包括一种透过合营企业共同开发的药物);及三 种临床阶段的候选药物的联合疗法。其中一种候选药物已获得两种靶向适应症的上市批准，其他适应症 临床试验正在进行中。在九种临床阶段候选药物中，七种靶向疗法药物，两种免疫治疗药物(属于一种 溶瘤 ...

在九种临床阶段候选药物中，七种靶向疗法药物，两种免疫治疗药物(属于一种溶瘤病毒药物及T细胞激 动性抗体)。MRG003用于治疗NPC已获FDA授予BTD、ODD及FTD及CDE授予BTD。MRG002用于治疗 GC/GEJ已获FDA授予ODD。CMG901用于治疗GC/GEJ已获FDA授予FTD及ODD，并已获CDE授予 BTD。MRG004A用于治疗PC已获FDA授予ODD及FTD。CG0070已获CDE及FDA授予BTD。 此外，MRG003及MRG006A已获FDA的IND批准。公司不断努力建立和开发新的技术平台，作为本公 司的创新引擎。 公司是一家立足中国、面向全球的聚焦于肿瘤治疗领域(尤其是靶向治疗及免疫治疗)的创新型生物制药 企业。自成立以来，公司致力于通过全面且先进的ADC技术开发平台开发创新型ADC，并旨在开发出 优化、创新的药物，更好地填补癌症患者的临床需求缺口。公司拥有从药物发现、临床开发、CMC及 GMP合规生产的一体化的端到端能力，涵盖生物制药价值链的所有关键环节。公司致力于通过充分整 合公司的自主创新能力及战略合作，持续开发市场差异化产品管线。同时，基于不断丰富的产品管线， 公司亦致 ...

Core Insights - The innovative drug market in China is experiencing significant growth, with the total amount of License out transactions for innovative drugs expected to reach nearly $66 billion by the first half of 2025, surpassing the total BD transaction amount for 2024 [1] - The immune system drug market is the second largest prescription drug market globally, with an increasing share of BD transactions, particularly in the autoimmune disease sector, which is gaining attention due to unmet medical needs [2][23] - The emergence of bispecific antibodies (dual antibodies) in the autoimmune disease field is anticipated to create new blockbuster drugs, as they can target multiple antigens simultaneously, enhancing treatment efficacy [7][8][23] Group 1: Market Dynamics - The market for autoimmune disease treatments is projected to reach $119.35 billion by 2027, driven by high demand and long treatment cycles for conditions like systemic lupus erythematosus (SLE) and rheumatoid arthritis (RA) [2] - The TNFα inhibitors, particularly AbbVie's Humira, have generated over $200 billion in revenue over its lifecycle, showcasing the potential for successful drug development in the immune market [2][4] - The competition in the immune drug market is intensifying, with a growing number of patented drugs and a shift towards precision medicine in clinical and commercial strategies [5] Group 2: Bispecific Antibodies - Bispecific antibodies are gaining traction in autoimmune disease treatment, with the ability to simultaneously target different antigens, potentially leading to more effective disease management [7][8] - Clinical data from Roche's bispecific antibody shows significant efficacy in treating refractory SLE patients, indicating the potential of this class of drugs in the autoimmune sector [8] Group 3: Company Insights - Kangnuo Pharmaceutical is positioned as a leading player in the autoimmune field, with its core product CM310 being the first domestically approved IL-4Rα antibody, currently in the commercialization stage [13][23] - The success of CM310 in the market is contingent on its inclusion in the medical insurance negotiation, which is crucial for its sales growth [16][23] - Kangnuo's innovative approach through the NewCo model for licensing out its products has proven beneficial, providing cash flow support and reducing risks for the company [22][23] Group 4: Future Outlook - The potential for Kangnuo's CM310 to achieve significant sales in the Chinese market is optimistic, with projections suggesting it could reach nearly $5 billion by 2030 if it successfully navigates the insurance landscape [23] - The company's advancements in the ADC drug CMG901 for cancer treatment are also noteworthy, with clinical progress ahead of competitors [19][23]

Group 1 - The innovative drug market in China is experiencing a surge, with the total amount of License out transactions for innovative drugs expected to reach nearly $66 billion by the first half of 2025, surpassing the total BD transaction amount for 2024 [1] - The immune system drug market is the second largest prescription drug market globally, with an increasing proportion of BD transactions. The share of tumor pipeline overseas licensing transactions decreased from 72% in 2023 to 61% in 2024, while the share of metabolic and autoimmune drugs increased from 12% to 25% [1][2] - The autoimmune disease market is gaining attention due to its large unmet medical needs, with the global treatment market projected to reach $119.35 billion by 2027 [2] Group 2 - The immune drug market has evolved since the introduction of TNFα inhibitors, with new targets emerging, including interleukin classes and JAK/Tyk2 inhibitors. The competition in clinical and commercial stages is intensifying, with a focus on precision treatment [5][7] - Bispecific antibody drugs are gaining traction in the treatment of autoimmune diseases, offering the ability to target two different antigens simultaneously, which may lead to more effective disease management [7][8] - The first bispecific antibody drugs in the autoimmune field are expected to create a new wave of growth, with companies like 康诺亚 leading the development [23] Group 3 - 康诺亚's core product, CM310, is the first domestically approved IL-4Rα antibody drug, with significant market potential in treating various allergic diseases. Its success in entering the medical insurance negotiation at the end of the year is crucial for its market performance [13][16] - The company has a strong pipeline in the autoimmune field, with CM310 expected to generate substantial sales, potentially reaching 5 billion yuan by 2030 [23] - 康诺亚 is also advancing in the oncology sector with its ADC drug CMG901, which is in the lead for clinical development among competitors [19][23] Group 4 - 康诺亚 has successfully engaged in multiple NewCo agreements, indicating its potential for international expansion and valuation growth in the innovative drug sector [22] - The NewCo model provides a favorable environment for domestic biotech companies, allowing them to secure cash flow and mitigate risks while advancing their research and clinical trials [22] - The recent licensing deal with GSK, which includes a $500 million upfront payment and up to $12 billion in milestone payments, highlights 康诺亚's strong position in the market [12]

Core Viewpoint - Lepu Biopharma-B (02157.HK) reported a total revenue of approximately RMB 367.8 million for the year ending December 31, 2024, representing a year-on-year growth of 63.2% [1] Group 1: Revenue Breakdown - The revenue from the sales of Puyouheng® (Pralsetinib injection) reached approximately RMB 300.3 million in 2024, which is three times the revenue of approximately RMB 101.4 million recorded in 2023 [1] - The company recorded approximately RMB 22 million in revenue from licensing business, derived from milestone payments and technology transfer services under the CMG901 licensing agreement [2] - Revenue from CDMO services amounted to approximately RMB 45.5 million [3] Group 2: Sales and Marketing Strategy - The company has established an efficient sales and marketing team for the commercialization of Puyouheng®, focusing on product promotion, positioning, and brand management strategies [1] - The team aims to enhance brand recognition among leading doctors and patient groups through academic promotion activities and product education [1] - As of December 31, 2024, the company has completed the bidding process on procurement platforms across 27 provinces in China and has covered approximately 81 cities through various sales channels [2] Group 3: Strategic Partnerships and Future Outlook - The company is committed to advancing global cooperation strategies and actively pursuing external licensing collaborations [2] - In January 2025, the company entered into an exclusive licensing agreement with ArriVent, granting them global exclusive rights to develop, manufacture, and commercialize MRG007 outside Greater China, with potential total payments of up to USD 1.2 billion [2] - The company strategically utilizes its remaining production capacity to provide CDMO services to Lepu Medical and/or its subsidiaries, generating approximately RMB 45.5 million in related revenue for 2024 [3]