Investment Rating - The investment rating for the company is "Outperform the Market" [5][18]. Core Viewpoints - The company's core product, sac-TMT, has received domestic approval and is rapidly advancing through global Phase 3 clinical trials. The first two indications (TNBC 3L and EGFRm NSCLC 3L) are expected to be approved by the end of 2024 and early 2025, respectively, making it the first TROP2 ADC approved for lung cancer indications [1][14]. - The company has a robust pipeline in the ADC field, with multiple candidates in clinical trials, including SKB571/MK-2750, which targets LC and CRC, and several potential first-in-class ADCs [2][14]. - The commercial sales of sac-TMT are expected to ramp up significantly, especially with its anticipated inclusion in the medical insurance negotiations this year, which could lead to rapid market penetration [2][8]. Financial Performance and Forecast - The company's revenue for the first half of 2025 is projected to be 950 million yuan, with commercial sales contributing approximately 310 million yuan, primarily from sac-TMT. The company reported a loss of 145 million yuan in the same period, compared to a profit of 310 million yuan in the previous year [2][8]. - Revenue forecasts for 2025-2027 are 1.941 billion yuan, 2.928 billion yuan, and 4.767 billion yuan, respectively, with net profits expected to be -721 million yuan, -302 million yuan, and 475 million yuan [3][18]. - The company’s cash and financial assets totaled 4.53 billion yuan as of June 30 [2][8].

Investment Rating - The report maintains a "Buy" rating for Kelun Biotech [2][15][26] Core Insights - Kelun Biotech's revenue for the first half of 2025 decreased by 31.3% year-on-year to RMB 950 million, with a net loss of RMB 145 million compared to a net profit of RMB 310 million in the same period last year [5][11] - The company's product sales reached RMB 310 million, with sac-TMT accounting for 97.6% of total product sales [6][12] - The report highlights the steady commercialization of key products, with a sales network covering 30 provinces and over 2,000 hospitals [6][12] - The target price has been raised from HK$298 to HK$552, indicating a potential upside of 22% [15] Financial Performance - In the first half of 2025, revenue from business development collaborations fell by 54.4% year-on-year to RMB 628 million [5][11] - R&D expenses decreased by 6.3% to RMB 612 million, while selling expenses surged by 334.8% to RMB 179 million, resulting in a selling expense ratio of 18.8% [5][11] - As of June 30, 2025, the company had cash and financial assets of approximately RMB 4.53 billion [5][11] Product Development - The report notes that SKB264 has received NMPA approval for two indications, with further approvals expected in 2025 [6][12][13] - The company is actively exploring additional indications for sac-TMT, including advanced solid tumors [7][13][14] - A multi-pronged R&D strategy is in place, focusing on both oncology and non-oncology fields, with several novel ADC drugs under development [8][14]

SKB264 临床进展顺利，国内海外同步加速推进中：2L EGFRmt NSCLC 国内注册临床数据预计于25 年 ESMO 大会读出，目前国内注册临床包含肺癌3 个（联用K药治疗1L EGFRwt NSCLC PD-L1 TPS≥1%； 联用K 药针对1L EGFRwt nsq PDL1(-)NSCLC；联用奥希治疗 1L EGFRmt nsq NSCLC）和乳腺癌2 个 （1L TNBC；2L+ HR+/HER2- BC）；默沙东已开启14 个海外临床，全面覆盖了肺癌5 个（联合K 药新 辅助Ⅱ-Ⅲb NSCLC、联合K 药治疗1L PD-L1 高表达、单药治疗EGFR TKI耐药的2L/3L 突变型、单药对 照标准化疗治疗2L+ EGFR m 非鳞癌、联合K 药维持治疗1L 鳞癌）、乳腺癌4 个（联合K 药治疗术后未 达pCR 的TNBC 及1L TNBC、单药治疗2L+ HR+/HER2- BC）、子宫内膜癌2 个、2L 宫颈癌、3L+胃食 管腺癌、铂敏感复发性卵巢癌等，我们预计26Q4 开始海外陆续有数据读出。 机构：东吴证券 研究员：朱国广/张翀翯 事件：公司25 年H1 收入9.82 亿元（人民 ...

Core Viewpoint - The company reported mixed financial results for 2024 and Q1 2025, with a slight increase in annual revenue but a significant decline in quarterly performance due to high base effects from the previous year [1][2]. Financial Performance - In 2024, the company achieved operating revenue of 21.812 billion yuan, a year-on-year increase of 1.67%, and a net profit attributable to shareholders of 2.936 billion yuan, up 19.53% [1]. - For Q1 2025, the company reported operating revenue of 4.390 billion yuan, a year-on-year decrease of 29.42%, and a net profit of 584 million yuan, down 43.07% [2]. Profitability Metrics - The overall gross margin for 2024 was 51.69%, a decrease of 0.74 percentage points year-on-year, while the expense ratio was 32.27%, down 3.95 percentage points [3]. - In Q1 2025, the gross margin dropped to 48.67%, a decline of 7.17 percentage points year-on-year, with the expense ratio slightly increasing to 32.38% [3]. Business Segments - The infusion business generated sales of 8.912 billion yuan in 2024, a decrease of 11.85%, with sales volume of 4.347 billion bottles/bags, down 0.70% [4]. - Non-infusion drug sales increased by 5.41% to 4.169 billion yuan, driven by strong performance in the plastic water needle business [4]. - The antibiotic intermediates and raw materials segment achieved revenue of 5.856 billion yuan, a year-on-year increase of 20.90%, benefiting from increased market demand [4]. Innovation and Pipeline - The company launched its innovative drug, Lukanosatuzumab (佳泰莱), in November 2024, marking the beginning of a new era in innovative drug commercialization [5]. - Ongoing clinical trials for various ADC therapies are being conducted in collaboration with Merck, targeting multiple cancer types [5][6]. Future Projections - Revenue projections for 2025 to 2027 are estimated at 21.9 billion, 23.36 billion, and 23.98 billion yuan, with corresponding net profits of 3.02 billion, 3.35 billion, and 3.41 billion yuan [7]. - The company is expected to maintain a valuation of 19X for 2025 and 17X for 2026 and 2027 [7]. Investment Rating - The investment rating is maintained at "Buy" based on the company's growth potential and ongoing innovation efforts [8].