Group 1 - The core focus of the article is on the corporate governance of Lepu Biopharma-B (02157.HK), highlighting a proposed ten-year restricted share unit plan aimed at incentivizing and retaining employees [1] - The plan is set to be discussed at the second extraordinary general meeting scheduled for December 18, 2025 [1] - The maximum number of shares to be granted under this plan is capped at 5% of the total issued shares as of the adoption date [1]

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]

Core Viewpoint - The company is entering a new drug approval phase with a well-structured pipeline in oncology, focusing on immunotherapy, ADC targeted therapy, and oncolytic virus drugs, which is expected to yield multiple new drug approvals in the next 3-5 years [1][2]. Pipeline Development - The company has developed multiple oncology products, including two already marketed drugs (PD-1 monoclonal antibody Prutilizumab and MRG003) and has six ADC drugs, one oncolytic virus, and one TCE drug in clinical stages [1]. - MRG003 (EGFR ADC) has been approved for post-line NPC in China, showing superior survival benefits and safety compared to competitors, with ongoing trials for HNSCC and NSCLC [1]. - MRG004A (TF-ADC) for post-line pancreatic cancer is currently in Phase III trials after demonstrating strong competitive advantages in Phase I [2]. - MRG006A (GPC3 ADC) is targeting the liver cancer market, with promising results in Phase I trials and plans to initiate Phase III trials in 2026 [1][2]. Oncolytic Virus Therapy - The company has introduced the oncolytic virus therapy CG0070 for bladder cancer, which is currently undergoing a rolling BLA application with the FDA and is in critical registration bridging trials in China [2]. - CG0070 has shown the best historical durability efficacy data in the NMIBC field, with a G3+TRAE rate of 0, indicating excellent efficacy and safety [2]. Financial Projections - The company is still in the investment phase for innovative drug development, with projected revenues of 880 million, 1.02 billion, and 1.49 billion yuan for 2025, 2026, and 2027, respectively, representing year-on-year growth of 138%, 16%, and 47% [2]. - The net profit attributable to the parent company is expected to be -20 million, 10 million, and 280 million yuan for the same years [2]. Investment Recommendation - The company is rated as a "buy" due to the steady progress of its ADC pipeline and successful commercialization efforts [2].

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]

Core Viewpoint - Lepu Biopharma-B (02157) experienced a significant stock increase, rising over 6% in late trading, with a current price of HKD 5.64 and a trading volume of HKD 71.31 million [1] Group 1: Clinical Trial Developments - CG Oncology is set to announce the primary data from the PIVOT-006 Phase 3 clinical trial evaluating the monotherapy of cretostimogene for high-risk non-muscle invasive bladder cancer in the first half of 2026, which is nearly one year ahead of the original schedule due to a much faster-than-expected enrollment rate [1] - Lepu Biopharma holds the 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: Product Synergy - Lepu Biopharma possesses an already marketed PD-1 antibody, Putilizumab, which can complement the treatment of NMIBC when combined with cretostimogene, potentially enhancing therapeutic efficacy [1]

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]