致：香港交易及結算所有限公司 公司名稱: 樂普生物科技股份有限公司(於中華人民共和國註冊成立的股份有限公司) 呈交日期: 2026年2月5日 I. 法定/註冊股本變動 | 1. 股份分類 | 普通股 | 股份類別 | H | | 於香港聯交所上市 (註1) | | 是 | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 證券代號 (如上市) | 02157 | 說明 | | | | | | | | | | 法定/註冊股份數目 | | | 面值 | | 法定/註冊股本 | | | 上月底結存 | | | 1,804,439,838 | RMB | | 1 RMB | | 1,804,439,838 | | 增加 / 減少 (-) | | | | | | RMB | | | | 本月底結存 | | | 1,804,439,838 | RMB | | 1 RMB | | 1,804,439,838 | 股份發行人及根據《上市規則》第十九B章上市的香港預託證券發行人的證券變動月報表 截至月份: 2026年1月31日 狀態: 新提交 本月底法定/註 ...

Core Insights - The pharmaceutical industry is increasingly adopting AI technologies, with over 60% of pharmaceutical companies and more than half of public hospitals using DingTalk as an AI operating system to enhance productivity [1][2] - AI is transforming the pharmaceutical sector by enabling companies to shift from repetitive tasks to more strategic roles, thereby enhancing operational efficiency [1][2] - DingTalk's AI application white paper indicates that AI is moving from exploration to large-scale application across the pharmaceutical value chain, impacting drug discovery, production, quality control, and patient services [1][2] Industry Developments - The pharmaceutical industry is characterized by high specialization, strong regulation, and long supply chains, making AI implementation a systemic transformation rather than just a technological upgrade [2] - DingTalk's AI solutions have been successfully implemented in various pharmaceutical companies, including WuXi AppTec and Innovent Biologics, and the company plans to launch a "Digital Pioneer Competition" to cultivate AI-savvy individuals within 100 pharmaceutical firms [2][3] - The establishment of the "Pharmaceutical Industry AI Innovation Alliance" aims to address common challenges such as data governance and ethical standards, promoting best practices for AI development in the sector [2][3] Company Case Studies - WuXi AppTec and DingTalk have developed a digital foundation called "BaiYaoDing," integrating AI into various processes, including traditional Chinese medicine traceability and smart factory production [2][3] - Innovent Biologics focuses on fine management in production through AI, achieving digitalization and transparency in anomaly handling, which has led to significant labor savings and improved quality [3] - Lepu Medical's AI initiatives provide 24/7 professional knowledge support to sales teams, resulting in a 200% return on AI investment by 2025, demonstrating AI's direct value in driving business growth [3] - Xianle Health has utilized AI tools to create an intelligent inspection application, enhancing management efficiency and fostering a culture of innovation within the organization [3][4] Future Outlook - AI is becoming a core driver of quality improvement, efficiency, and innovation in the pharmaceutical industry, with ongoing advancements in technology and a thriving ecosystem [4]

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, 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 - The Hong Kong stock market for innovative drug concept stocks has seen a significant rise in early trading, indicating positive investor sentiment in the sector [1] Company Performance - 3SBio (01530.HK) increased by 6.35%, reaching HKD 28.82 [1] - WuXi AppTec (02359.HK) rose by 7.22%, trading at HKD 118.8 [1] - Lepu Biopharma-B (02157.HK) saw a gain of 6.64%, priced at HKD 28.9 [1] - Galenica-B (01672.HK) experienced a 4.09% increase, with shares at HKD 12.97 [1] - Genscript Biotech (01952.HK) grew by 3.97%, valued at HKD 40.84 [1]

Group 1 - The core viewpoint of the articles highlights a significant rise in Chinese innovative pharmaceutical stocks, driven by the upcoming 44th JPMorgan Healthcare Conference, where multiple Chinese companies are set to showcase their products [1][2] - Notable stock performances include a 6.35% increase for 3SBio, a 7.22% increase for WuXi AppTec, and a 6.64% increase for Lepu Biopharma, indicating strong market interest in these companies [1] - The conference serves as a critical platform for domestic pharmaceutical companies to demonstrate their core molecular product capabilities and advance overseas business development collaborations [2] Group 2 - The industry is transitioning back to a phase of global value verification for products, with a focus on global clinical advancements and the release of significant data [2] - Chinese innovative drug valuations have shifted from being perceived as "assets to be bought" to a stage of "global value," reflecting a broader recognition of their potential in the international market [2] - The Chinese pharmaceutical industry has largely completed the transition from old to new growth drivers, with innovative drugs significantly contributing to new growth trajectories for companies [2]

Core Viewpoint - The innovative pharmaceutical stocks have shown significant gains, driven by the upcoming 44th JPMorgan Healthcare Conference, where multiple Chinese innovative drug companies are set to participate [1] Group 1: Stock Performance - Innovent Biologics (01530) increased by 6.35%, trading at HKD 28.82 [1] - WuXi AppTec (02359) rose by 7.22%, trading at HKD 118.8 [1] - Lepu Biopharma-B (02157) saw a rise of 6.64%, trading at HKD 28.9 [1] - Galenica-B (01672) increased by 4.09%, trading at HKD 12.97 [1] - Genscript Biotech (01952) rose by 3.97%, trading at HKD 40.84 [1] Group 2: Conference Participation - The 44th JPMorgan Healthcare Conference is set to begin on January 12, 2026, in San Francisco, with several Chinese innovative drug companies confirming their attendance [1] - Key speakers include WuXi AppTec, WuXi Biologics, and WuXi AppTec's subsidiary, along with innovative drug companies such as BeiGene, Zai Lab, Ascentage Pharma, and Legend Biotech [1] - A total of 17 companies, including Hengrui Medicine, Baillie Gifford, Innovent Biologics, and Rongchang Biologics, will participate in the Asia-Pacific session [1] Group 3: Industry Insights - According to Guojin Securities, the conference serves as a critical platform for domestic pharmaceutical companies to showcase their core molecular product capabilities and advance overseas business development collaborations [1] - The industry is transitioning back to a phase of global value verification for products, with ongoing clinical advancements, significant data releases, and improved competitive dynamics driving multiple rounds of revaluation for product global value and corporate valuations [1] - Huayuan Securities indicates that the Chinese pharmaceutical industry has largely completed the transition from old to new growth drivers, with innovative drugs significantly opening new growth trajectories for companies [1]

乐普生物-B(02157)尾盘涨超6%，截至发稿，涨5.82%，报5.64港元，成交额7131.37万港元。 公开资料显示，CG0070注射液(Cretostimogene Grenadenorepvec)的大中华区权益由乐普生物引入，CG Oncology在国外不断取得临床突破的同时，乐普生物也在同步积极推进国内的临床进展。乐普生物同时 手握已上市的PD-1抗体普特利单抗可以形成互补，联合治疗NMIBC进一步提升疗效。 消息面上，1月9日，CG Oncology，评估cretostimogene单药治疗中危非肌层浸润性膀胱癌的PIVOT-006 3期临床试验主要数据预计于2026年上半年公布，较原计划提前近一年，主要由于入组速度远超预期。 ...

Group 1 - The core viewpoint of the article highlights the significant stock price increase of Lepu Biopharma-B (02157), which rose over 6% and is currently trading at 5.64 HKD with a trading volume of 71.31 million HKD [1] - CG Oncology is expected to announce the primary data from the PIVOT-006 Phase 3 clinical trial for cretostimogene monotherapy in high-risk non-muscle invasive bladder cancer in the first half of 2026, which is nearly a year earlier than originally planned due to a faster-than-expected enrollment rate [1] - Lepu Biopharma has exclusive rights to CG0070 injection (Cretostimogene Grenadenorepvec) in Greater China and is actively advancing clinical progress domestically while CG Oncology achieves clinical breakthroughs abroad [1] Group 2 - Lepu Biopharma possesses an already marketed PD-1 antibody, Putili monoclonal antibody, which can complement the treatment of NMIBC (non-muscle invasive bladder cancer) to enhance efficacy through combination therapy [1]

Core Viewpoint - Enhertu (DS-8201) has evolved into a "complete entity" with the recent approval for first-line therapy in HER2+ breast cancer, marking significant progress from its initial approval as a third-line therapy in December 2019 to its current status [1][2] Group 1: Enhertu's Progression - Enhertu's journey includes approvals for HER2+ breast cancer in third-line therapy (December 2019), second-line therapy (January 2021), and now first-line therapy [2] - The first-line therapy approval is in combination with pertuzumab, with expectations for single-agent approval in the future [2] Group 2: Competitive Landscape - The HER2 ADC breast cancer market is approaching a critical phase, with companies like Rongchang Biopharma, Kelun-Biotech, and BaiLi Tianheng adopting various strategies to compete [3][6] - Rongchang Biopharma has focused on differentiated strategies, avoiding direct competition in breast cancer and targeting unmet clinical needs in other indications like gastric cancer [4][6] - Kelun-Biotech has actively pursued HER2+ breast cancer, achieving approval for its product A166 as the first domestic ADC for second-line therapy, leveraging a strategy of gradual advancement [7][9] Group 3: Strategic Approaches - BaiLi Tianheng aims to create a competitive product against Enhertu, with its T-Bren ADC targeting both HER2+ breast cancer and non-small cell lung cancer (NSCLC) [11][14] - HengRui Medicine adopts a multi-cancer strategy, focusing on various indications beyond breast cancer, with its SHR-A1811 ADC already approved for HER2-mutated NSCLC [16][17] Group 4: Differentiated Strategies - Lepu Biopharma's strategy centers on combining its ADC with PD-1 therapies, positioning its products as complementary rather than direct competitors [18][20] - In contrast, YingEn Biopharma has established a global strategy, securing a partnership with BioNTech for its DB-1303 ADC, focusing on unmet needs in endometrial cancer [22][24] Group 5: Future Outlook - The competitive landscape in the HER2 ADC market is intensifying, with companies employing diverse strategies to carve out their niches [26] - The future success in this sector may hinge on the depth of differentiated strategies and the ability to commercialize effectively, rather than solely on product efficacy [26]