乐普生物 20250710 摘要 乐普生物的 EGFR ADC（MRG003）针对鼻咽癌适应症预计 2025 年底 至 2026 年初获批上市，头颈鳞癌适应症预计 2027 年内获批。注册性 临床数据在 ASCO 会议上获得积极反馈，商业化策略已在讨论中。 TFADC（MRG004A）靶向组织因子，在胰腺导管腺癌方面显示良好信 号，已完成国内扩组实验，并计划在 ASCO 大会上公布数据。公司已向 中国 CDE 提交注册性临床沟通交流申请，寻求一线治疗方案。 GPC3 ADC（MRG006A）针对肝癌，具有全球首创潜力，目前正在进 行一期临床试验。预计 2026 年分享一期临床数据，并寻求海外合作机 会，肝癌市场潜力巨大。 Claudin 18.2 ADC（CMG901）由乐普生物与康诺亚共同开发，已授 权给阿斯利康，目前处于全球注册性三期临床阶段，预计 2026 年底提 交 NDA 申报。 CDH17 ADC（MRG007）针对结直肠癌，已授权给美国 Biotech Avent，获得国内 IND 批件，即将启动临床试验。总交易金额包括 4,700 万美元首付款及超过 12 亿美元里程碑付款。 Q&A 乐普生物 ...

[Table_Invest]买入 创新+消费共振，心血管平台加速多元化转型 [Table_Summary] 聚乳酸面部填充剂国内第 7 证，公司正式进入医美领域。聚左旋乳酸微 粒真皮组织填充剂是再生类医美产品，刺激胶原蛋白生成，具有优异的 生物相容性、可降解性和安全性。根据弗若斯特沙利文预测，我国基于 聚左旋乳酸的皮肤填充剂在 2024 年的出厂端市场规模预计约 11 亿元、 2030 年有望增长至约 38 亿元，年复合增长率接近 23%。截至公告日， 我国 NMPA 已批准包括乐普医疗在内的 7 张聚乳酸面部填充剂注册证； 公司另有多种玻尿酸产品已申报注册申请，快速丰富消费医疗产品矩阵。 持股乐普生物，PD-1 商业化&ADC 管线研发快速推进。乐普医疗持有 同一实控人旗下乐普生物 13.17%股份，乐普生物作为国内 ADC 领域的 领军企业，旗下首个商业化产品 PD-1 普特利单抗销售快速放量贡献现 金流，针对消化道癌的 ADC 产品 MRG007 已实现海外 BD 合作、交易 金额最高达 12 亿美元，针对二线及以上晚期鼻咽癌的 EGFR ADC 产品 MRG003 的 NDA 申请已获得 CDE 受理 ...

A Late-Stage Company With a Global Oncology Pipeline PACC Update June 23, 2025 Forward Looking Statements This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. These statements include, but are not limited to, implied and express statements about our strategy, business plans and objectives for our programs; plans and timelines for the preclinical and clinical development of our product candidates, i ...

2025 年 06 月 15 日 生物医药Ⅱ 新药周观点：创新药 4 月进院数据更 新，多个新纳入医保创新药快速进院中 本周新药行情回顾： 2025 年 6 月 9 日-2025 年 6 月 13 日，新药板块涨幅前 5 企业：北海 康成-B（118.12%），欧康维视生物-B（28.59%），君圣泰医药-B （23.75%），药明巨诺-B（23.63%），歌礼制药-B（23.40%）；跌幅 前 5 企业：三生国健（-7.41%），诺思兰德（-7.14%），宜明昂科- B（-6.10%），华领医药-B（-4.38%），永泰生物-B（-3.48%）。 本周新药行业重点分析： 近日国家医保局更新了已纳入医保目录创新药截止 2025 年 4 月底的 进院数据，多个 2025 年新纳入医保国产创新药产品正在快速进院中， 部分药物进院速度较快，其中： 从增长速度来看，对比 25 年 3 月底，截止 25 年 4 月底入院数据增长 较快的药物主要有云顶新耀布地奈德肠溶胶囊、康方生物卡度尼利单 抗与依沃西单抗等。 从入院总体数量来看，截止 25 年 4 月底入院数据超 200 家的药物主 要有云顶新耀布地奈德肠溶胶囊、百济 ...

Core Insights - ArriVent BioPharma, Inc. reported financial results for Q1 2025, highlighting progress in its oncology pipeline and upcoming milestones [1][10]. Pipeline Developments - The firmonertinib program is advancing, with completed enrollment in the global pivotal Phase 3 FURVENT study for first-line NSCLC patients with EGFR exon 20 insertion mutations [3][7]. - ARR-217 (MRG007), a newly acquired antibody drug conjugate targeting CDH17, is expected to be the first ADC from ArriVent's pipeline to enter clinical trials [2][4]. Financial Performance - As of March 31, 2025, the company had cash, cash equivalents, and marketable securities totaling $205.5 million, sufficient to fund operations into the second half of 2026 [7][16]. - Research and development expenses increased to $61.3 million in Q1 2025 from $17.0 million in Q1 2024, primarily due to a one-time upfront payment of $40 million to Lepu Biopharma [16][24]. - The net loss for Q1 2025 was $64.4 million, compared to a net loss of $17.4 million in Q1 2024 [16][24]. Upcoming Milestones - The company plans to present updated data for firmonertinib in first-line EGFR PACC mutant NSCLC in Q2 2025, including Progression Free Survival (PFS) and duration of response [2][8]. - Topline data from the pivotal Phase 3 study for firmonertinib is anticipated in 2025, with updates on timing expected in Q2 2025 [8][10]. Corporate Updates - Merdad Parsey, M.D., Ph.D., was appointed to the Board of Directors in April 2025, bringing extensive experience in global clinical development [9].

以下文章来源于阿基米德Biotech ，作者阿基米德君 阿基米德Biotech . 生物医药第三方独立观察，客观中立，深入浅出，松弛愉悦，写作纯为兴趣，不接广告 超长续航模式。 来源 | 阿基米德Biotech （ID：ArchimedesBiotech） 资本寒冬，一家上市Bi o t e c h也没有挂掉。 1 8A生物科技七年之痒，7 0家公司（含摘B）仍然整整齐齐，一家没少，即使市值最小 的北海康成账上现金仅剩1亿元，但管理层认为2025年有足够的营运资金，即使诺辉健 康复牌暂时没有进展，但离生死大限还有5个月。 中国创新药处于少年时代，（在上市公司层面）有着足够的容错率和包容度，如同《百 年孤独》中初创的"马孔多"，这里全是年轻人，没有死亡，自然没有墓地。 然而，站在中国创新药1 0年节点之上，两大蜕变还是发生了。 今 非 昔 比 ， 《 创 新 药 供 给 侧 改 革 》 （ 2021 年 7 月 ） 指 出 的 内 卷 和 泡 沫 ， 如 今 都 不 再 严 重。 一是行业主要矛盾的蜕变，从同质化竞争的内部矛盾，转为中国生物科技快速崛起与美 国维持生物科技创新领域领导地位之间的外部矛盾。 二是创 ...

Group 1 - The core viewpoint is that the Hong Kong stock market is experiencing a technical bull market, leading to a revaluation of innovative pharmaceutical companies, driven by improved liquidity and policy expectations [1][17] - The Hang Seng Index has risen over 20% this year, while the Hang Seng Healthcare Index has increased by over 40%, indicating strong market performance [1] - The revaluation of the innovative drug sector is attributed to global capital reassessing the long-term logic of China's innovative drug industry [1][19] Group 2 - AI medical technology breakthroughs, comprehensive policy support, and enhanced commercialization capabilities are expected to provide greater valuation expansion potential for Hong Kong's innovative drug sector compared to A-shares [4] - Companies with differentiated innovative pipelines and commercialization potential are becoming market focal points, entering a phase of valuation expansion [4][21] - Lepu Biopharma's 2024 financial report validates this logic, showcasing rapid commercialization and differentiated advantages in its three major pipelines [4][21] Group 3 - Lepu Biopharma achieved approximately 368 million yuan in revenue for 2024, with its main product, Pu You Heng®, generating around 300 million yuan, marking a threefold increase from the previous year's 100 million yuan [6] - The company has established a complete commercialization loop through a specialized marketing team, enhancing its market penetration and professional trust [6][7] - Lepu Biopharma has completed access to procurement platforms in 27 provinces and covers approximately 81 key cities with its sales channels [6] Group 4 - Lepu Biopharma's R&D pipeline focuses on three major areas: ADC, cancer immunotherapy, and oncolytic viruses, which collectively build competitive barriers [9][16] - The ADC pipeline, particularly the core product MRG003, demonstrates significant clinical potential and has received priority review from NMPA and orphan drug designation from FDA [11][13] - The company is also advancing other ADC candidates, such as MRG004A and MRG006A, which show promising clinical results and potential for broad application across various cancers [13][14] Group 5 - The supportive policy environment and recovering capital market are expected to accelerate industry growth and enhance valuation recovery [19][21] - The global healthcare financing activities are rebounding, with an estimated total of $58.2 billion in 2024, indicating a positive trend after two years of decline [19] - Lepu Biopharma is positioned at a critical point for performance and valuation growth, driven by strengthened commercialization capabilities and breakthroughs in its pipeline [21]

Core Viewpoint - Lepu Biopharma-B (02157.HK) reported a total revenue of approximately RMB 367.8 million for the year ending December 31, 2024, representing a year-on-year growth of 63.2% [1] Group 1: Revenue Breakdown - The revenue from the sales of Puyouheng® (Pralsetinib injection) reached approximately RMB 300.3 million in 2024, which is three times the revenue of approximately RMB 101.4 million recorded in 2023 [1] - The company recorded approximately RMB 22 million in revenue from licensing business, derived from milestone payments and technology transfer services under the CMG901 licensing agreement [2] - Revenue from CDMO services amounted to approximately RMB 45.5 million [3] Group 2: Sales and Marketing Strategy - The company has established an efficient sales and marketing team for the commercialization of Puyouheng®, focusing on product promotion, positioning, and brand management strategies [1] - The team aims to enhance brand recognition among leading doctors and patient groups through academic promotion activities and product education [1] - As of December 31, 2024, the company has completed the bidding process on procurement platforms across 27 provinces in China and has covered approximately 81 cities through various sales channels [2] Group 3: Strategic Partnerships and Future Outlook - The company is committed to advancing global cooperation strategies and actively pursuing external licensing collaborations [2] - In January 2025, the company entered into an exclusive licensing agreement with ArriVent, granting them global exclusive rights to develop, manufacture, and commercialize MRG007 outside Greater China, with potential total payments of up to USD 1.2 billion [2] - The company strategically utilizes its remaining production capacity to provide CDMO services to Lepu Medical and/or its subsidiaries, generating approximately RMB 45.5 million in related revenue for 2024 [3]