Investment Rating - The investment rating for the company is "Buy" [4] Core Insights - The company has signed an exclusive licensing agreement with AbbVie for its PD-1/VEGF bispecific antibody drug RC148, receiving an upfront payment of $650 million and potential milestone payments up to $4.95 billion, along with double-digit royalties on net sales outside Greater China [1][2] - The collaboration with AbbVie is expected to enhance the company's international clinical development and market expansion, leveraging AbbVie's existing oncology pipeline [2] - Initial clinical data for RC148 shows promising results, with an objective response rate (ORR) of 61.9% for monotherapy and 66.7% for combination therapy, indicating strong potential for further clinical advancement [3] Financial Summary - The company forecasts revenues of 2.75 billion, 3.38 billion, and 4.41 billion CNY for 2025, 2026, and 2027 respectively, reflecting year-on-year growth rates of 60.95%, 22.97%, and 30.40% [7] - The projected net profit for 2026 is expected to be -315.8 million CNY, with a turnaround to a profit of 383.89 million CNY by 2027 [7] - The gross margin is anticipated to remain high, with estimates of 83.65% in 2025 and 82.27% in 2026 [8]

智通财经APP讯，维立志博-B(09887)发布公告，于2026年1月14日，PD-L1/4-1BB双特异性抗体维利信 (奥帕替苏米单抗，LBL-024)获美国食品药品监督管理局(FDA)授予快速通道资格认定，用于治疗肺外 神经内分泌癌。 在中国的两项临床试验中，维利信不论作为单药疗法或与化疗联合使用，均对晚期肺外神经内分泌癌患 者表现出令人鼓舞的疗效信号且安全性良好。本公司于2024年4月获得国家药品监督管理局(NMPA)批准 开展单臂注册临床试验，于2024年10月自NMPA获得维利信TM治疗后线晚期肺外神经内分泌癌的突破 性疗法认定(BTD)，于2024年11月自FDA获得治疗神经内分泌癌的孤儿药认定(ODD)。 4-1BB作为激动剂，能够重新激活凋亡的T细胞并大量扩增，特别适合治疗PD-1/PD-L1耐药或无效的"冷 肿瘤"。除肺外神经内分泌癌外，维利信在有大量未满足医疗需求的多个癌种中展现出令人鼓舞的临床 信号，包括小细胞肺癌、胆道癌、卵巢癌、非小细胞肺癌、食管鳞状细胞癌、肝细胞癌、胃癌、叁阴性 乳腺癌及黑色素瘤，并已在小细胞肺癌、胆道癌及卵巢癌等多个癌种中观察到令人振奋的临床效果，有 望成为一款具 ...

Core Viewpoint - The company has received FDA fast track designation for its bispecific antibody, ViliXinTM (Opa-Tisumi Monoclonal Antibody, LBL-024), for the treatment of pulmonary neuroendocrine carcinoma, indicating significant potential in addressing unmet medical needs in oncology [1][2] Group 1: FDA Designation and Drug Development - ViliXinTM has been granted fast track designation by the FDA, which accelerates the review process for drugs that treat serious conditions or fill unmet medical needs [1] - The fast track designation allows for more frequent regulatory interactions and the ability to submit a rolling new drug application [1] Group 2: Clinical Trial Results - In clinical trials in China, ViliXinTM has shown encouraging efficacy signals and good safety profiles as both a monotherapy and in combination with chemotherapy for patients with advanced pulmonary neuroendocrine carcinoma [2] - The company received approval from the National Medical Products Administration (NMPA) in April 2024 to conduct a single-arm registration clinical trial and was granted breakthrough therapy designation (BTD) in October 2024 [2] Group 3: Broader Implications and Potential - ViliXinTM targets both PD-L1 and 4-1BB, showing potential as the first approved drug for advanced pulmonary neuroendocrine carcinoma and demonstrating first-in-class or best-in-class clinical activity in various indications [1] - The drug has also shown promising clinical signals in multiple cancers with high unmet medical needs, including small cell lung cancer, cholangiocarcinoma, ovarian cancer, non-small cell lung cancer, esophageal squamous cell carcinoma, hepatocellular carcinoma, gastric cancer, triple-negative breast cancer, and melanoma [2]

格隆汇1月14日丨维立志博-B(09887.HK)宣布，于2026年1月14日，PD-L1/4-1BB双特异性抗体维利信 TM(奥帕替苏米单抗，LBL-024)获美国食品药品监督管理局(「FDA」)授予快速通道资格认定，用于治 疗肺外神经内分泌癌。 快速通道资格认定是FDA批准加速审查治疗严重或危及生命病情或解决未满足医疗需求的药物以助加快 药物开发的方法。其提供若干重要程序性激励措施，包括获得FDA更频繁的监管互动与指导，以及有权 滚动提交新药申请以获得监管批准。 维利信™是一种同时靶向PD-L1与4-1BB的双特异性抗体，为针对肺外神经内分泌癌的全球首款达到注 册临床阶段的靶向4-1BB受体的疗法。于非小细胞肺癌、小细胞肺癌及肺外神经内分泌癌这3种适应症 的II期或注册临床试验中，维利信™展现出同类第一或同类最佳临床活性潜力。维利信TM亦有望成为 治疗晚期肺外神经内分泌癌的首款获批药物。凭藉我们自主研发并具有知识产权的X-body®平台，维利 信™采用最佳的2:2结构设计，可解除PD-1/L1免疫抑制并强化4-1BB调节的T细胞激活，实现协同消灭 肿瘤的效果，具有较PD-1/L1抑制剂更强的广谱癌症治疗潜 ...

截至本公告日期，公司QX030N/CLD-423的合作伙伴Caldera Therapeutics,Inc.(Caldera Therapeutics)累计 完成融资1.125亿美元。于2025年4月，Caldera Therapeutics从Atlas Venture、LAV及venBio获得7500万美 元的A轮融资，近期则完成由Omega Funds领投的3750万美元A-1轮融资，参与的新投资者包括 Wellington Management及Janus Henderson Investors。 荃信生物-B(02509)公布，靶向经临床验证的IL-23p19及TL1A通路的双特异性抗体QX030N/CLD-423的I 期健康志愿者试验已完成首批受试者给药。 ...

截至本公告日期，公司QX030N/CLD-423的合作伙伴Caldera Therapeutics, Inc. (Caldera Therapeutics)累计 完成融资1.125亿美元。 于2025年4月，Caldera Therapeutics从Atlas Venture、LAV及venBio获得7500万美 元的A轮融资，近期则完成由Omega Funds领投的3750万美元A-1轮融资，参与的新投资者包括 Wellington Management及Janus Henderson Investors。 智通财经APP讯，荃信生物-B(02509)公布，靶向经临床验证的IL-23p19及TL1A通路的双特异性抗体 QX030N/CLD-423的I期健康志愿者试验已完成首批受试者给药。 ...

格隆汇1月14日丨荃信生物-B(02509.HK)宣布，靶向经临床验证的IL-23p19及TL1A通路的双特异性抗体 QX030N/CLD-423的I期健康志愿者试验已完成首批受试者给药。截至本公告日期，公司QX030N/CLD- 423的合作夥伴Caldera Therapeutics, Inc.(「Caldera Therapeutics」)累计完成融资1.13亿美元。于2025年4 月，Caldera Therapeutics从Atlas Venture、LAV及venBio获得7500万美元的A轮融资，近期则完成由 Omega Funds领投的3750万美元A-1轮融资，参与的新投资者包括Wellington Management及Janus Henderson Investors。 ...

Core Viewpoint - The company has entered into a financing lease agreement with Industrial Bank Leasing, which is expected to enhance its working capital and support its strategic goals through a more balanced and efficient financing structure [1] Group 1 - The financing lease agreement is set to commence on January 14, 2026 [1] - The leased assets consist of various machinery and equipment [1] - The agreement allows for early termination based on its terms and conditions [1] Group 2 - The board believes that the financing lease will strengthen the company's operational funding situation [1] - The agreement aims to support both current and future business operations and market activities [1] - The financing structure is intended to achieve a more balanced and efficient long-term and short-term financing portfolio [1]

Core Thesis - ADMA Biologics, Inc. is positioned as a differentiated biotech company with meaningful revenue growth and profitability, specializing in plasma-derived immunoglobulin therapies for patients with immune deficiencies [2][4] Financial Performance - In Q3 2025, ADMA reported revenue of $134.2 million, a 12% increase year over year, with trailing 12-month revenue rising nearly 28% to $488.6 million [3] - Profitability expanded significantly, with trailing twelve-month EPS increasing by over 200% and gross margins exceeding 54% [3] - Management raised full year 2025 revenue guidance to at least $510 million, with projections of $630 million in 2026 and over $1.1 billion by 2029 [3] Competitive Advantages - ADMA operates a fully vertically integrated model from plasma collection to manufacturing, enhancing supply reliability, scalability, and margin expansion [2] - A key catalyst for growth is the FDA approval of yield-enhanced production, expected to drive gross margin expansion towards 70% starting in 2026 [4] - The company has a pipeline that includes a preclinical hyperimmune globulin candidate, which could generate significant high-margin revenue [4] Market Position and Risks - ADMA's business has transitioned into a high-margin commercial stage, anchored by FDA-approved products like Asceniv [2] - Risks include product concentration, competitive pressure from larger players, and regulatory oversight, but the company is viewed as a compelling growth investment due to its durable fundamentals and expanding profitability [4]

证券日报网讯1月14日，天康生物（002100）在互动平台回答投资者提问时表示，根据中国证券登记结 算有限责任公司下发的《合并普通账户和融资融券信用账户前N名明细数据表》显示，截至2026年1月9 日收盘，公司股份持有人数为62323户。 ...