当地 时间 2 0 2 5 年 9 月 2 9 日 清早 ， Genmab 官宣 将 收购 Merus N.V. （ 以下简称 为 " Merus " ） 。 根据协议，Genmab 将 以每股97.00美元的现金收购Merus的全部股份， 交易价值 约80亿美元 。这是 Genmab自成立以来最大的一笔收购（ 去年收购普方生物总价为18 亿美元） 。 图片来源 ： Genmab 官网 Merus最早创立于2003年，总部位于荷兰 ， 核心 资产 是 一 款 EGFR / LGR5双抗 —— petosemtamab （ M C L A - 1 5 8 ） 。 2 0 2 5 年 A S C O 上 ， Merus公布 了 petosemtamab 联合 K 药 对比 K 药 单药 一线 治 疗 局部晚期头颈部鳞状细胞癌 （HNSCC） 的 I I 期 临床数据 。 具体 来看 ， 这项 I I 期 研 究 共 纳入 4 5 名 局部 晚期 HNSCC 患者 。 最 终 4 3 名 可 评估 患者 数据 显示 ， 联合 用药 组 经实体瘤反应评估标准 的 总体缓解率 （ O R R ） 达 6 3 % （27 ...

东诚药业公告，控股子公司蓝纳成收到国家药监局核准签发的225Ac-LNC1011注射液药品临床试验批准 通知书，将于近期开展临床试验。225Ac-LNC1011注射液是一种靶向前列腺特异性膜抗原的α粒子放射 性体内治疗药物，拟用于治疗PSMA阳性表达的晚期前列腺癌患者。目前国内外暂无同产品上市，亦无 相关销售数据。 ...

药捷安康称，替恩戈替尼靶向FGFR/VEGFR、JAK、Aurora，目前没有其他MTK抑制剂具有相同的靶向 组合。因此，在一些疾病治疗上，替恩戈替尼已经展现出独特价值。另外，该款产品正在逐步打通全球 化路径，已获国家药品监督管理局(NMPA)授予治疗胆管癌的突破性治疗品种认定及美国食品药品监督 管理局(FDA)授予治疗胆管癌及转移性去势抵抗性前列腺癌的快速通道认定，亦获FDA授予用于治疗胆 管癌的孤儿药认定，以及欧洲药品管理局(EMA)授予用于治疗胆道癌的孤儿药认定。 消息面上，药捷安康近日公布，公司核心产品替恩戈替尼(Tinengotinib，TT-00420)联合氟维司群治疗经 治失败的激素受体阳性(HR+)且人表皮生长因子受体2阴性或低表达(HER2-)的复发或转移性乳腺癌II期 临床试验，已于2025年9月10日获得了中国国家药品监督管理局的临床默示许可。 药捷安康-B(02617)再涨超18%，高见129.3港元再创新高，总市值一度突破500亿港元。截至发稿，涨 15%，报125港元，成交额1.51亿港元。 ...

Core Viewpoint - Fukan Biotech (Shanghai) Co., Ltd. has submitted its main board listing application to the Hong Kong Stock Exchange, with several financial institutions acting as joint sponsors [1] Company Overview - Fukan Biotech was established in 2015, focusing on both commercialization and clinical development in the field of cancer treatment, as well as innovative drugs for viral and age-related diseases [4] - The company's core products include CVL009 and CVL218, with CVL009 currently undergoing Phase II clinical trials for specific cancer patients [4] - As of August 22, 2025, Fukan Biotech has a diversified product portfolio consisting of one commercialized product, two core products, two key products, and twelve other candidates [4] Financial Performance - The company reported revenues of 0, 17.825 million, and 34.675 million CNY for the years 2023, 2024, and the first half of 2025, respectively, with corresponding net losses of 94.655 million, 74.525 million, and 35.934 million CNY [6] - Research and development expenses for the same periods were 75.792 million, 54.425 million, and 24.421 million CNY [7] Customer Dependency - Fukan Biotech's revenue is highly dependent on a single customer, with nearly 99% of sales from its commercialized product, Han Naijia®, attributed to its largest customer, Fuhong Hanlin [8] - Fuhong Hanlin is a leading biopharmaceutical company in China, and the collaboration allows for a synergistic effect in breast cancer treatment [8] Market Potential - The global breast cancer drug market is projected to grow from approximately 29.2 billion USD in 2019 to about 41 billion USD by 2024, with a compound annual growth rate (CAGR) of 7.0% [5] - The Chinese breast cancer drug market is expected to expand from around 450 billion CNY in 2019 to approximately 683 billion CNY by 2024, with a CAGR of about 8.7% [5] Funding and Valuation - Fukan Biotech has completed six rounds of financing prior to its IPO, with post-money valuations increasing significantly from 95 million CNY in 2019 to approximately 3.188 billion CNY in 2025 [10][13] - The company's valuation has grown 32.56 times since its angel round financing [13] Ownership Structure - As of August 22, 2025, the founder and key stakeholders control approximately 55.58% of the company's issued share capital [13]

Financial Data and Key Metrics Changes - Total revenue grew by 19% in the first half of 2025, driven by increased recurring revenue [4][29] - Operating profit increased by 56%, reflecting strong financial performance despite strategic investments [5][33] - Cash reserves at the end of the first half were approximately $3 billion, providing flexibility for growth and expansion [5][29] - Recurring revenues represented 97% of total revenue, up from 90% in the same period last year [31] Business Line Data and Key Metrics Changes - Sales for Epkinley reached $211 million, a 74% year-over-year increase, contributing significantly to total revenue growth [22][29] - TIVDAC sales totaled $78 million, a 30% increase compared to the previous year, with strong performance in the US and Japan [26][29] - The growth of commercialized medicines is expected to increasingly contribute to overall revenue growth over time [21][29] Market Data and Key Metrics Changes - Epkinley has received regulatory approvals in over 60 countries, with nearly 50 countries approving it for both DLBCL and FL indications [24][29] - The FDA accepted the supplemental BLA for epiritamab with a target action date of November 30, 2025, indicating strong market potential [7][55] Company Strategy and Development Direction - The company aims to accelerate the development of high-impact late-stage programs and maximize the potential of commercialized medicines [4][39] - Plans to broaden the reach of RINA S with three Phase III trials expected to be underway by the end of the year [10][39] - The company is focused on expanding utilization of its medicines and bringing them to more patients globally [28][39] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's future, highlighting a strong financial foundation and disciplined capital allocation strategy [5][37] - The company anticipates continued growth in recurring revenues and operating profit, with improved financial guidance for 2025 [34][35] - Management is closely monitoring geopolitical situations but does not foresee significant impacts on financial guidance for 2025 [37] Other Important Information - The company completed a share buyback in June, reinforcing confidence in its future [5] - The Phase III Epcor FL1 trial met its dual endpoints, supporting the potential to transform treatment paradigms for patients [12][14] Q&A Session Summary Question: Positioning of EPCO versus other CD20 bispecifics - Management feels confident about their broad and aggressive development plan, with a head start in second-line follicular lymphoma [43][44] - They have received positive feedback from physicians and are moving into earlier lines of therapy [47][48] Question: Confidence in filing RAINFALL-one for accelerated approval - Management is confident in filing for accelerated approval based on strong data and ongoing engagement with the FDA [54][55] Question: Initial launch strategy for Epkinley - The focus will be on earlier lines of therapy, particularly in the community setting, with significant opportunities for patient expansion [62] Question: Development plans for RINA S outside ovarian cancer - The Phase II trial will explore RINA S in both monotherapy and combination settings, with a focus on EGFR mutated non-small cell lung cancer [93] Question: ADC combinations in lymphoma - Management sees potential for ADC combinations and believes bispecifics will become a backbone for novel combinations in the future [87][88]

Summary of the Conference Call for BeiGene (1Q25) Company Overview - **Company**: BeiGene - **Industry**: Biotechnology/Pharmaceuticals Key Financial Performance - **1Q25 Revenue**: - Net product sales reached **$1.109 billion**, representing a **48% year-over-year increase** [1] - **Zebutinib Global Sales**: **$792 million**, with a **62% year-over-year increase** [1] - **U.S. Sales**: **$563 million**, up **60% year-over-year** [1] - **European Sales**: **$116 million**, up **73% year-over-year** [1] - **Tislelizumab Sales**: **$171 million**, reflecting an **18% year-over-year increase** [1] - **GAAP Net Profit**: Achieved a net profit of **$1.27 million**, marking the first quarterly profit [1] Strategic Developments - **Investor R&D Day**: Scheduled for **June 26**, focusing on breast cancer and other solid tumor pipelines [1] - **Reimbursement Expansion**: Zebutinib has been included or expanded in reimbursement in **11 markets**, including Japan, Europe, and Brazil [1] - **New Supplier**: Engaged **Siegfried** as a new supplier for active pharmaceutical ingredients for Zebutinib [1] - **Regulatory Filings**: BCL2 has been submitted for approval in China for the treatment of R/R CLL [1] - **Clinical Trials**: - Initiated a Phase III clinical trial for BTKCDAC in treating R/R CLL, comparing against physician's choice of treatment [1] - DLL3/CD3 bispecific antibody (in collaboration with Amgen) reported positive data from the Phase III trial for 2L SCLC [1] - CDK4 is expected to report Proof of Concept data in the first half of 2025 [1] Additional Insights - The significant growth in Zebutinib sales is attributed to its increasing market share in the treatment of new CLL patients, positioning it as the top seller in the U.S. BTK market [1]

Financial Data and Key Metrics Changes - UroGen Pharma reported net product revenues of $90.4 million for the full year 2024, an increase from $82.7 million in 2023, representing a year-over-year growth of approximately 9.3% [17][44] - The net loss for the fourth quarter of 2024 was $37.5 million, or $0.80 per share, compared to a net loss of $26 million, or $0.72 per share, in the same period in 2023 [47] - For the full year 2024, the net loss was $126.9 million, or $2.96 per share, compared to a net loss of $102.2 million, or $3.55 per share, in 2023 [47] Business Line Data and Key Metrics Changes - JELMYTO generated net product revenues of $24.6 million in Q4 2024, up from $23.5 million in Q4 2023, with underlying demand revenue increasing by 15% [44] - The underlying demand revenue for JELMYTO for the full year 2024 was $87.4 million, reflecting a 12% increase compared to the previous year [39][44] - The company reported a compelling complete response rate of 79.6% at three months and an 82.3% duration of response at 12 months for UGN-102, with updated data showing an 80.6% duration of response at 18 months [9][10] Market Data and Key Metrics Changes - The total addressable market for UGN-102 is estimated to be over $5 billion, significantly larger than the market for JELMYTO [15] - The anticipated launch of UGN-102 is expected to transform UroGen's market position, moving from a rare disease-focused company to a multiproduct specialty-driven team [34] Company Strategy and Development Direction - UroGen aims to enhance its commercial infrastructure by expanding its sales force from 52 to approximately 83 representatives to support the launch of UGN-102 [37][100] - The company is focused on raising awareness of unmet needs in low-grade intermediate risk non-muscle invasive bladder cancer through educational programs and scientific exchanges [35][36] - UroGen has acquired ICVB-1042, a next-generation investigational oncolytic virus, to enhance its pipeline and address critical gaps in cancer care [19][20] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the strength of the data package submitted for UGN-102 and its potential to address significant unmet needs in the bladder cancer treatment landscape [14] - The company anticipates a transformative year in 2025 with the expected launch of UGN-102, which is projected to generate over $1 billion in revenue [54][109] - Management highlighted the importance of preparing for reimbursement processes and ensuring smooth integration of UGN-102 into treatment protocols [38][66] Other Important Information - UroGen ended 2024 with a strong balance sheet, holding $241.7 million in cash, cash equivalents, and marketable securities [21][43] - The company expects full-year 2025 JELMYTO revenues to be in the range of $94 million to $98 million, indicating a growth rate of approximately 8% to 12% [48] Q&A Session Summary Question: Can UGN-102 be used off-label for patients ineligible for surgery? - Management indicated that using UGN-102 in this context would be considered off-label, and it would be up to physicians to work with insurance companies for reimbursement [53][54] Question: How should investors think about the initial launch trajectory of UGN-102? - The launch trajectory is expected to be similar to JELMYTO, with a larger patient population leading to higher absolute numbers [61][72] Question: What are the expected differences in reimbursement levels with the J-code transition? - Initially, a miscellaneous J-code will be used, which may result in longer reimbursement times, but this will improve with a unique permanent J-code expected in January 2026 [66][68] Question: How will UGN-102 be positioned relative to UGN-103? - UGN-102 is expected to be phased out after UGN-103 is approved, with a focus on ensuring no automatic substitution occurs [94][95] Question: What is the rationale behind increasing the sales force size? - The increase is based on patient epidemiology, ensuring coverage of approximately 85% of the market for low-grade intermediate risk NMIBC [102][104]