康诺亚 20251209 Q&A 康诺亚公司在自免领域的核心产品有哪些？其市场前景如何？ 康诺亚公司是一家专注于自免领域的领先企业，其核心产品包括 CM310（思 普曲帕单抗）和下一代自免双抗 CM512。CM310 今年（2025 年）纳入了医 保目录，预计将快速放量。该产品对标赛诺菲的达必妥，后者在全球销售额排 名第四，在国内销售额超过 25 亿元人民币。CM310 目前已获批三个适应症： 成人中重度特应性皮炎、慢性鼻息肉和季节过敏性鼻炎，并计划拓展至青少年 和儿童中重度皮炎。 康诺亚的另一大看点是其自主研发的下一代自免双抗 CM512，该药物最近公布的一期数据非常积极，优于现有疗法。估值方面，我 康诺亚自主研发的下一代自免双抗 CM512 同时靶向 TSLP 和白介 13， 半衰期长达 70 天，有望实现超过 3 个月一次给药，优于赛诺菲同靶点 药物，具有显著的市场竞争力。 CM512 的一期数据显示，300 毫克剂量组在 12 周时 EASI 75 和 EASI 90 应答率分别为 58.3%和 41.7%，优于现有靶向白介素阿尔法生物制 剂，且安全性良好，为后续临床试验奠定基础。 康诺亚的 Clau ...

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]