Investment Rating - The report maintains a "Recommended" rating for the companies involved in the chromatography industry, particularly focusing on domestic innovation and market potential [57]. Core Insights - The chromatography industry is experiencing significant growth, driven by the increasing demand in the biopharmaceutical sector, which accounts for 80% of the chromatography medium applications [22][37]. - The global biopharmaceutical market is projected to grow from approximately $503 billion in 2023 to $892 billion by 2028, with a compound annual growth rate (CAGR) of 9.5%-12.5% [30]. - Domestic biopharmaceutical market growth is robust, with projections indicating an increase from ¥262.2 billion in 2018 to ¥534.8 billion in 2024, reflecting a CAGR of 12.61% [37]. Market Overview - The chromatography industry includes core consumables, instruments, and software services, with a complete product system that plays a crucial role in drug purification and analysis [15][16]. - The chromatography equipment market is expected to see significant growth, with the small molecule liquid chromatography system market projected to grow from $3.6 billion in 2021 to $7.7 billion by 2026, representing a CAGR of 16.7% [40]. - The chromatography medium market in China is expected to grow from ¥112 billion in 2023 to over ¥203 billion by 2026, with a CAGR of 21.92% [47]. Key Segments - **Innovative Drugs**: The report highlights the transition from generic to innovative drugs in China, with a focus on companies like BeiGene and Innovent Biologics, which are expected to lead in product pipelines and market share [9][57]. - **Medical Devices**: The report notes a recovery in the bidding for imaging devices and a growing market for home medical devices, driven by government subsidies [61]. - **IVD (In Vitro Diagnostics)**: The report emphasizes the acceleration of domestic replacement in the luminescence sector, with companies like Mindray and New Industries leading the charge [59][60]. Industry Trends - The report identifies a shift towards domestic production and innovation in the chromatography sector, with local companies making significant strides in filling the gaps left by international firms [53][56]. - The biopharmaceutical sector's increasing reliance on chromatography technology for drug development and production is expected to drive demand for high-quality chromatography products [22][37]. - The report also discusses the impact of national policies aimed at promoting domestic high-end scientific instruments, which are expected to further enhance the growth of the chromatography industry [53].

消息面上，9月19日，CDE官网公示，乐普生物旗下EGFR靶向ADC药物MRG003拟被纳入突破性疗法认 定，适应症为联合普特利单抗(PD-1单抗)治疗既往接受过铂类及PD-1/PD-L1抑制剂治疗失败的复发或转 移性鼻咽癌。 据悉，MRG003是目前全球研发进展领先的EGFR ADC药物，此前已获得CDE授予的突破性治疗药物认 定与优先审评资格，以及FDA授予的孤儿药资格、快速通道资格和突破性疗法认定。2024年9月，乐普 生物首次提交该药用于鼻咽癌的上市申请，后因需补充资料主动撤回，并于今年3月重新提交，目前已 被纳入优先审评程序，单药用于特定复发/转移性鼻咽癌患者治疗。 乐普生物-B(02157)早盘涨超4%，截至发稿，涨4.11%，报7.34港元，成交额3016万港元。 ...

Core Viewpoint - Lepu Biopharma-B (02157) saw a significant stock increase of over 4%, currently trading at 7.34 HKD, with a transaction volume of 30.16 million HKD, following the announcement of its drug MRG003 being considered for breakthrough therapy designation [1] Group 1: Drug Development and Regulatory Status - MRG003, an EGFR-targeted ADC drug developed by Lepu Biopharma, is proposed for breakthrough therapy designation for treating recurrent or metastatic nasopharyngeal carcinoma in patients who have previously failed platinum-based and PD-1/PD-L1 inhibitor treatments [1] - MRG003 is currently the leading EGFR ADC drug in global development, having previously received breakthrough therapy designation and priority review qualification from CDE, as well as orphan drug status, fast track designation, and breakthrough therapy designation from the FDA [1] - The company initially submitted the marketing application for MRG003 for nasopharyngeal carcinoma in September 2024 but withdrew it to provide additional information, and resubmitted it in March of this year, now included in the priority review process for specific recurrent/metastatic nasopharyngeal carcinoma patients [1]

Core Insights - Lepu Biotech reported a total revenue of approximately RMB 466 million for the first half of 2025, representing a year-on-year increase of about 350% [1] - The company achieved profitability for the first time, with a profit of approximately RMB 29.3 million, compared to a loss of RMB 197 million in the same period of 2024 [1] - The main revenue sources for Lepu Biotech in H1 2025 were BD business (over RMB 300 million) and sales of Putili monoclonal antibody (RMB 151 million) [1] Financial Performance - Lepu Biotech's financial indicators for H1 2025 showed significant improvement, marking the transition from a research and development phase to a profitability phase [1] - The company reported positive operating cash flow for the first time [1] Industry Trends - The domestic innovative pharmaceutical sector experienced explosive growth in BD transactions, with transaction amounts surpassing the total for the entire year of 2024 [1] - Many innovative pharmaceutical companies achieved profitability for the first time, contributing to a surge in performance for innovation-related indices [1] - The Hang Seng Pharmaceutical ETF (159892), which tracks the Hang Seng Biotechnology Index, saw a year-to-date increase of over 90% as of August 20 [1]

Summary of Key Points from the Conference Call of Lepu Biopharma Company Overview - **Company**: Lepu Biopharma - **Industry**: Biopharmaceuticals, focusing on ADC (Antibody-Drug Conjugates) and immunotherapy Core Products and Development Progress - **EGFR ADC (MRG003)**: - Targeting nasopharyngeal carcinoma (NPC) and head and neck squamous cell carcinoma - Expected approval in China between late 2025 and early 2026 for NPC, and in 2027 for head and neck cancer [2][3] - Positive feedback received at ASCO conference regarding clinical data [2][3] - **TFADC (MRG004A)**: - Targeting tissue factor, showing promising results in pancreatic ductal adenocarcinoma - Completed domestic expansion trials, with data to be presented at ASCO in October [2][6] - **GPC3 ADC (MRG006A)**: - Targeting liver cancer, currently in Phase I clinical trials - Expected to share Phase I data in 2026 and seek overseas collaboration opportunities [2][7][8] - **Claudin 18.2 ADC (CMG901)**: - Jointly developed with Connora, currently in global Phase III trials - NDA submission expected by the end of 2026 [2][9] - **CDH17 ADC (MRG007)**: - Targeting colorectal cancer, IND approval received in China, clinical trials to start soon - Total transaction value includes $47 million upfront and over $1.2 billion in milestone payments [2][10] Financial and Operational Outlook - **R&D Expenses**: - Estimated at approximately 400 million RMB for 2025, with a focus on advancing key pipelines [4][25] - **Profitability Expectations**: - Anticipated to achieve overall profitability by around 2028, aligning with the commercialization of core products [4][29] Market Potential and Sales Strategy - **Market Potential for EGFR ADC**: - Estimated peak sales in China could reach approximately 3 billion RMB, targeting NPC and head and neck cancer [2][27] - **Sales Team Expansion**: - Plans to expand the sales team from 200 to about 250 to support the commercialization of PD-1 and EGFR ADC products [18][21] Upcoming Data Releases and Conferences - **Data Presentations**: - Planned presentations at ASCO, ESMO, and ASH conferences, focusing on various ADC products and combination therapies [19] Competitive Landscape and Intellectual Property - **Patent Protection**: - Strong patent protection for EGFR ADC, preventing competitor products from entering the U.S. market [24] Future Development Focus - **TCE Platform**: - Focused on developing new ADC molecules targeting unmet clinical needs, while also exploring partnerships for other projects [28] Conclusion - **Overall Strategy**: - Lepu Biopharma is positioned to leverage its robust pipeline of ADC products and immunotherapies to achieve significant market presence and profitability in the coming years, with a clear focus on advancing clinical trials and expanding its sales capabilities [30]