每经记者｜林姿辰 每经编辑｜魏官红 创新药龙头，正在引入一种全新的BD（商务拓展）模式。 8月25日晚间，百济神州（688235.SH，股价250.51元，市值3858亿元）发布公告称，公司方面与Royalty Pharma Investments 2023 ICAV（以下简称Royalty Pharma）签订了一份《特许权使用费购买协议》， Royalty Pharma将支付8.85亿美元，购买收取单克隆抗体Imdelltra（Tarlatamab，中文通用名：塔拉妥单 抗）在中国以外地区年度销售净收入中特许权使用费的大部分权利。 与大多数BD买卖药物的知识产权、研发权或商业化权益不同，百济神州本次卖出的是"特许权使用 费"——此前，美国安进公司把塔拉妥单抗卖到中国以外的市场，需要以约定比例给百济神州的瑞士子 公司（以下简称"百济神州瑞士"）一笔"提成"，即特许权使用费；如今，百济神州将收这笔提成的大部 分权利卖给Royalty Pharma，换得8.85亿美元现金。 提前锁定未来收益，百济神州仍拥有药物知识产权 公告显示，Royalty Pharma是美股上市公司Royalty Pharma plc的子公 ...

Core Viewpoint - BeiGene has reported its first half-year profitability since its listing, driven by significant product revenue growth and improved cost management [1][3]. Financial Performance - Total revenue for the first half of 2025 reached RMB 17.518 billion, a year-on-year increase of 46.0% [1]. - Operating profit was RMB 799 million, and net profit attributable to shareholders was RMB 450 million, marking a turnaround from losses in the previous year [1]. - Product revenue amounted to RMB 17.36 billion, up 45.8% year-on-year [1]. Key Products and Sales - The sales of the BTK inhibitor, Zebrutinib, reached RMB 12.527 billion in the first half, a 56.2% increase [2]. - In the U.S. market, Zebrutinib sales were RMB 8.958 billion, growing by 51.7% [1][2]. - The PD-1 inhibitor, Tislelizumab, generated sales of RMB 2.643 billion, reflecting a 20.6% increase [2]. Market Position - Zebrutinib has maintained the top position in the BTK inhibitor market in the U.S. for two consecutive quarters, with Q2 sales of USD 684 million, a 43% increase [2]. - In Europe, Zebrutinib sales reached RMB 1.918 billion, up 81.4% [2]. - In China, Zebrutinib sales were RMB 1.192 billion, a 36.5% increase [2]. R&D Pipeline - The company anticipates over 20 milestone developments in its blood cancer and solid tumor pipelines within the next 18 months [1]. - BeiGene has established three proprietary products in blood cancer treatment, including Zebrutinib and two products in Phase 3 clinical trials [3]. - The company is expanding its pipeline in solid tumors, focusing on various cancers and utilizing diverse technology platforms [3]. Future Guidance - BeiGene has updated its full-year revenue guidance for 2025 to a range of RMB 35.8 billion to RMB 38.1 billion [3]. - The gross margin guidance has been adjusted to a mid-high range of 80% to 90% [3]. - Positive cash flow from operating activities is expected for the year, excluding capital expenditures [3].

Group 1 - The National Medical Products Administration (NMPA) has accepted the marketing application for Baiyue Shenzhou's Talatuzumab injection, which is intended for the treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) who have failed at least second-line treatment [1] - Talatuzumab is a first-in-class DLL3/CD3 bispecific antibody that may bring breakthrough advancements in the treatment of SCLC, a type of lung cancer with a high rate of incidence and mortality [1][2] - SCLC accounts for approximately 15% of all lung cancer cases, with about 70% of patients diagnosed at the extensive stage, leading to a median overall survival (mOS) of only 4 to 5 months after initial treatment [1] Group 2 - DLL3 protein is considered a highly attractive therapeutic target in SCLC, with up to 96% of SCLC patients expressing this protein [2] - Talatuzumab utilizes an innovative T-cell engaging (BiTE) structure, which allows for effective targeting of tumor cells and T-cells, potentially making it a novel therapy for SCLC [2] - Interim analysis from a global Phase 3 clinical trial presented at the 2025 American Society of Clinical Oncology annual meeting showed that Talatuzumab treatment resulted in a median overall survival of 13.6 months, significantly extending survival by 5.3 months compared to standard chemotherapy [2]

Investment Rating - The investment rating for the biopharmaceutical industry is "Positive" (maintained) [2] Core Insights - The report highlights the aggressive nature of small cell lung cancer (SCLC), with extensive stage SCLC accounting for approximately 75% of cases, which often rely on systemic treatment and have a poor prognosis [6][21] - The first-line treatment for extensive stage SCLC primarily involves PD-1/PD-L1 immunotherapy combined with doublet chemotherapy, while there are limited approved drugs for later-line treatments, indicating a significant unmet clinical need [24][30] - The report identifies three key areas of focus for research and development in the SCLC field: Antibody-Drug Conjugates (ADC), DLL3 T-cell engagers (TCE), and next-generation immune-oncology (IO) therapies [30][34] Summary by Sections 1. SCLC Overview - SCLC accounts for about 15%-20% of all lung cancer cases, with a high incidence of early metastasis [18][19] - The majority of SCLC cases are extensive stage, which has a poor prognosis and relies heavily on systemic therapies [21][22] 2. Treatment Landscape - The standard treatment for extensive stage SCLC has been established as a combination of chemotherapy and PD-1/PD-L1 immunotherapy, but the overall prognosis remains poor [24][25] - The NCCN and CSCO guidelines recommend various treatment options, including the recent inclusion of Tarlatamab as a preferred second-line treatment [28][29] 3. Research and Development Focus - ADCs are rapidly advancing in the SCLC field, targeting multiple hot spots such as B7-H3, DLL3, and TROP-2, with no ADC products currently approved for SCLC [37][38] - DLL3 TCEs, particularly Tarlatamab, have shown promising early data and are expected to reshape the treatment landscape for SCLC [30][31] - Next-generation IO therapies are being developed to challenge the current PD-L1 standard in first-line SCLC treatment [8][36] 4. Investment Recommendations - The report suggests that companies with strong pipelines in the SCLC space, such as Zai Lab, Zai Lab-U, Innovent Biologics, and others, are likely to benefit from the anticipated growth in the market as new data emerges [9]