自2024年下半年以来，TCE（T细胞衔接器，T cell-engager）逐渐成为MNC的BD心头好。诸多重磅TCE交易相继授出，出海盛况丝毫不逊于当年的ADC技 术。 所谓TCE是一种特殊双抗，一端（或两端）连接TAA（肿瘤相关抗原）定位肿瘤细胞，另一端连接T细胞的CD3表位，激活T细胞，发挥T细胞的肿瘤杀伤 作用。相比ADC用细胞毒素杀伤，TCE双抗本质是激活T细胞的免疫疗法，对靶点表达量要求更低、但肿瘤特异性要求更高。 与个性化、定制化的CAR-T疗法相比，"现货"型TCE双抗在便利性、可及性和生产成本上都具备优势。因此，我们看到，TCE双抗正在作为下一代免疫治 疗的核心方向重构肿瘤与自免疾病治疗格局。 这一潜力赛道中，国内药企百花齐放，进入规模化竞争阶段，形成差异化竞争梯队，既有技术平台驱动的管线深耕，也有全球化BD合作的价值释放。 一场技术革新风暴即将到来，谁会从众多参与者中杀出重围？这一过程中又会否诞生中国创新药的新王呢？ 01 TCE为何起风？ 过去的几十年中，治疗性抗体早已成为肿瘤治疗的关键组成部分，显著提高了疗效。如曲妥珠单抗治疗晚期HER2阳性乳腺癌，利妥昔单抗治疗B细胞淋 巴瘤。然而， ...

Group 1 - Novo Nordisk plans to lay off approximately 9,000 employees to save 8 billion Danish kroner (about 1.26 billion USD) annually, aiming to streamline its organizational structure and reallocate resources to growth opportunities in diabetes and obesity sectors [1] - The company has lowered its earnings guidance multiple times this year due to increasing sales pressure on its core product, semaglutide, indicating a need for adjustments under profitability pressure [1] Group 2 - Pilin Biological announced a share transfer agreement with China National Pharmaceutical Group, which will acquire approximately 200 million unrestricted shares, representing 21.03% of the total share capital, leading to a change in the controlling shareholder and actual controller [2] - This move highlights the acceleration of central enterprises' integration in the biopharmaceutical sector, aiming to strengthen the full industry chain layout and resource synergy, thereby enhancing competitiveness among leading companies [2] Group 3 - Bairui Tianheng's drug, iza-bren (EGFR×HER3 dual-target ADC), has been included in the breakthrough therapy list by the National Medical Products Administration (NMPA) for patients with platinum-resistant recurrent epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer [3] - Iza-bren has now received six breakthrough therapy designations from the NMPA and one from the FDA, which will expedite its market entry to meet urgent clinical needs [3] Group 4 - Baiyao Tai has received marketing approval from the UK MHRA for Qletli (BAT1406, adalimumab injection), marking it as the first domestically approved adalimumab biosimilar in the UK with two specifications and eight indications [4] - This approval signifies a key breakthrough for domestic biopharmaceuticals in the European mainstream market, opening up overseas growth opportunities and demonstrating that Chinese biosimilars have reached international standards in quality, clinical, and registration capabilities [4] Group 5 - Zhixiang Jintai's GR1803 injection for systemic lupus erythematosus has received clinical trial approval from the NMPA, making it the first dual-specific antibody targeting BCMA×CD3 for this indication in China [5] - Currently, there are no similar targeted SLE drugs available in the domestic market, and GR1803's dual mechanism has the potential to fill a treatment gap in autoimmune diseases [5]

Investment Rating - The report maintains a "Buy" rating for the company [5] Core Insights - The company has successfully entered the global market with its product GR1803 through a licensing agreement with Cullinan Therapeutics, which includes a total milestone payment of up to $712 million [1] - The company is rapidly expanding its domestic and international business lines, with significant clinical trial progress and new drug applications [2] - The leading product, Celeric monoclonal antibody, is expected to launch in August 2024 and participate in medical insurance negotiations in 2025 [2] Financial Projections - Revenue projections for 2025-2027 are estimated at 206 million, 500 million, and 1.078 billion yuan respectively, with net losses expected to decrease from 622 million to 275 million yuan over the same period [2][4] - The company anticipates a significant year-on-year revenue growth rate of 2,384.1% in 2024 and 584.5% in 2025 [4] - The latest diluted EPS is projected to improve from -2.19 yuan in 2023 to -0.75 yuan in 2027 [4] Business Development - The company has submitted a new drug application for GR2001, which has reached the primary efficacy endpoint in its Phase III clinical trial for tetanus passive immunity [2] - The collaboration with Cullinan Therapeutics focuses on the CD3/BCMA target, indicating a strategic enhancement in the company's autoimmune TCE dual antibody layout [1]