（来源：一度医药） 转自：一度医药 2025年9月25日，据外媒报道，海德堡制药（Heidelberg Pharma）近日宣布计划裁员75%。这一重大决 策的导火索，源于美国FDA对泰利克斯制药（Telix Pharmaceuticals）一款影像剂的驳回。 根据此前海德堡制药与Telix Pharmaceuticals签订的许可协议，如果TLX250-CDx获得市场批准，海德堡 制药有权获得里程碑付款和两位数的特许权使用费。为提前回笼资金，海德堡制药已将其未来特许权使 用费的一部分出售给HealthCare Royalty（HCRx），根据协议，公司将在TLX250-CDx获得FDA批准时 从HCRx获得7000万美元。 海德堡制药原本期待在2025年8月末，随着TLX250-CDX诊断试剂的获批，获得一笔7000万美元的付 款。然而，FDA的拒绝让这笔资金化为泡影，公司资金链陷入紧张。截至2025年年中，Heidelberg账上 仅有3300万欧元（约合3900万美元），原本的资金仅能维持到2026年第一季度。资金的短缺迫使公司不 得不采取紧急措施。 其中，HDP-101是一款新型的抗BCMA抗体药物偶联 ...

2025 年 9 月 19 日， 中山大学附属第七医院 陈韵 、 陈纯 团队在 Cell 子刊 Cell Reports Medicine 上发表了题为： FLT3L-based drug conjugate effectively targets chemoresistant leukemia stem cells in acute myeloid leukemia 的研究论文。 该研究开发了一种基 于 FLT3 配体 （ FLT3L ） 的药物偶联物—— FL-Fc-DM1 ，其能够有效靶向 急性髓系白血病 （AML） 中的化学耐药的 白血病干细胞 。 撰文丨王聪 编辑丨王多鱼 排版丨水成文 急性髓系白血病 （AML） 是一种异质性恶性肿瘤，由于复发和化疗耐药性，患者预后不良。 FLT3 基因突变会促进 AML 的发展，并预示不良的治疗结局。由于 大多数 AML 细胞表达 FLT3，因此它是一个很有前景的治疗靶点。 急性髓系白血病 （AML） 是一种由多种基因突变驱动的异质性造血系统恶性肿瘤。目前 AML 的一线治疗药物包括阿糖胞苷、柔红霉素和伊达比星。然而，细胞 毒性化疗的非选择性导致了严重的不良反应和 ...

ck Code : 1093) 2025 Interim Results Presentation Aug. 2025 ININI China's Leading Innovative Pharmaceutical Enterprise R&D Capabilities 00 5 capacity of 250,000L R&D centers located in R&D platforms China & the U.S. 201010 + - 2401 Innovative drugs and R&D professionals new formulations Manufacturing Capabilities Commercialization Capabilities 2 10+ Production bases for pharmaceutical products Nano formulation production capacity of 20M doses/year; Biologics fermentation Chemical drugs production capacity o ...

Core Viewpoint - Rongchang Biopharmaceuticals has signed a licensing agreement with Santen Pharmaceutical's subsidiary, which is expected to generate over 1.2 billion yuan in milestone payments and sales revenue sharing, alleviating the company's financial losses [2][3][4]. Financial Impact - The agreement includes a non-refundable upfront payment of 250 million yuan, potential milestone payments of up to 520 million yuan for development and regulatory achievements, and up to 525 million yuan for sales milestones [3]. - Rongchang Biopharmaceuticals has reported cumulative net losses of approximately 3.95 billion yuan from 2022 to 2024, but showed a revenue increase of 59.17% year-on-year in Q1 2025, reaching 526 million yuan [5]. Product Development - The RC28-E injection is a dual-target fusion protein drug developed by Rongchang Biopharmaceuticals for treating ocular neovascular diseases, with promising results in clinical trials for diabetic macular edema [3][4]. - The company has initiated Phase III clinical trials for RC28-E targeting wet age-related macular degeneration and diabetic macular edema in 2023 [3]. Company Background - Rongchang Biopharmaceuticals focuses on innovative biopharmaceuticals, particularly in antibody-drug conjugates and therapeutic antibodies, with key products including Tai'aisip and Vidisizumab [4]. - The company went public in Hong Kong in 2020 and achieved profitability only in 2021, with a revenue of 1.426 billion yuan and a net profit of 276 million yuan [4]. Challenges and Costs - Sales and management expenses have been rising, with total sales expenses reaching 2.441 billion yuan from 2022 to 2024, contributing to cash flow pressure [6]. - The company faces significant challenges in drug approval processes, market competition, and commercialization capabilities, which could impact future revenue growth [5][6].

Financial Data and Key Metrics Changes - The company reported a revenue of RMB 950 million for the first half of 2025, with over RMB 300 million coming from commercialized drugs, marking a significant achievement in its first year of commercialization [52][53] - Gross profit was RMB 660 million, comparable to the previous year, while the net loss for the first half was RMB 145 million, with an adjusted loss of RMB 69 million after one-off budget adjustments [54][55] - Cash and financial assets totaled RMB 4.5 billion, indicating a healthy financial status to support upcoming R&D and innovation [58] Business Line Data and Key Metrics Changes - The company has three main products ready for the market, with significant progress in approvals and commercialization efforts [15][32] - The commercialization team has expanded to nearly 400 personnel to support the increasing number of products ready for market [14] Market Data and Key Metrics Changes - The company has successfully covered over 30 provinces, 300 cities, and 1,000 hospitals across China, with partnerships established with over 400 pharmacies [32][34] - The company is actively working towards gaining medical insurance coverage for its products, which is expected to enhance market access and sales [36][81] Company Strategy and Development Direction - The company aims to advance differentiated pipelines targeting significant medical needs, optimizing payload linker strategies, and exploring applications in non-oncology areas [30] - The focus is on expanding global partnerships and strengthening strategic collaborations to maximize the value of its pipelines [30] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the future income from sales revenue, anticipating continued cash flow generation from commercialized drugs [53] - The company is preparing for the implementation of new medical insurance policies, which are expected to impact product sales positively [100] Other Important Information - The company completed a follow-on financing of USD 250 million and is included in major global equity indexes, enhancing its market presence [29] - The company has initiated several pivotal trials globally, including for various cancer indications, which are expected to drive future growth [25][26] Q&A Session Summary Question: What is the breakdown of sales revenue for breast cancer and lung cancer? - Lung cancer is the biggest contributor to sales revenue, consistent with patient numbers and indications [64] Question: What is the focus for R&D going into the next stage? - The focus is on developing differentiated products targeting clinical demands, with an emphasis on bispecific targets and new payload strategies [70][72] Question: Can you provide guidelines on the sales trend for Q3? - The company expects quarter-over-quarter growth, with significant sales anticipated from lung cancer indications [76] Question: What is the strategy for going into the medical insurance catalog? - The strategy prioritizes entering the medical insurance catalog to enhance market access and sales volume [100] Question: Can you address the IP disputes mentioned? - The company has initiated a lawsuit against several founders related to IP disputes, which is currently under review by the Sichuan Provincial High Court [103]

2025 INTERIM RESULTS PRESENTATION 2025中期业绩演示材料 AUGUST 2025 2025年8月 1 DISCLAIMER 免责声明 The information contained in this presentation is intended solely for your personal reference. Such information is subject to change without notice and no representation or warranty express or implied is made as to, and no reliance, should be placed on, the fairness, accuracy, completeness or correctness of the information contained in this presentation. This presentation does not intend to provide, and you may not rely on ...

Group 1 - Ruikang Pharmaceutical's executive Li Zhe has had his detention changed to a notice of investigation, indicating a shift in the investigation phase [1] - The change from detention to a notice of investigation suggests a reduced level of coercion, highlighting the importance of internal control and compliance systems in listed companies [1] Group 2 - Zhixiang Jintai has initiated a Phase III clinical trial for GR1802 injection for allergic rhinitis, following communication with the National Medical Products Administration [2] - GR1802 is slightly behind in clinical progress compared to two other approved drugs targeting the same indication, but successful commercialization could lead to competition with Dupilumab [2] Group 3 - Rongchang Biopharmaceutical's innovative drug RC18 (Taitaxip) for primary Sjögren's syndrome has met its primary endpoint in Phase III clinical trials, marking a potential first in the global market for this indication [3] - If approved, this drug could provide a breakthrough treatment for millions of patients in China and strengthen Rongchang's position in the autoimmune field [3] Group 4 - Hengrui Medicine's SHR-A2102, a targeted antibody-drug conjugate (ADC) for Nectin-4, has received approval for clinical trials in combination with Atezolizumab for recurrent/metastatic head and neck squamous cell carcinoma [4] - There is currently only one similar product on the market, Padcev, which is projected to generate $1.949 billion in sales in 2024, indicating significant market potential for this target [4] Group 5 - BeiGene has launched the first domestic Phase III clinical trial for subcutaneous Tislelizumab, a PD-1 inhibitor, for use in combination with chemotherapy for locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma [5] - The subcutaneous formulation is becoming a competitive area for PD-1/PD-L1 inhibitors, with three other subcutaneous PD-1/L1 products already approved globally [5]

Financial Data and Key Metrics Changes - The company ended the second quarter of 2025 with $77 million in cash and cash equivalents, with a net cash used in operating activities of $22.6 million, which included $2.4 million in severance payments [14] - Collaboration revenue for 2025 was $3.1 million, an increase from $2.3 million in the same period in 2024, primarily due to increased revenue from collaborations with J&J and Merck KGAA [15] - Research and development expenses for 2025 were $16.2 million, down from $17.2 million in 2024, attributed to lower headcount and related compensation costs [16] - General and administrative expenses decreased to $7.4 million from $10.5 million in 2024, mainly due to lower headcount and reduced consulting fees [17] - The net loss for the second quarter of both 2025 and 2024 was $24.3 million [18] Business Line Data and Key Metrics Changes - The company reported strong enrollment progress in the EMILY phase one trial, particularly in expansion cohorts targeting triple negative breast cancer (TNBC) [4][10] - Among evaluable patients with high B7-H4 tumor expression, the confirmed objective response rate (ORR) was 31% [5] - In patients with adenoid cystic carcinoma type one (ACC1), the ORR was 56% [6] Market Data and Key Metrics Changes - The market for topo one ADCs in TNBC is expected to grow significantly, with Trodelvy projected to generate about $1 billion in global revenues in 2025 [11] - The company believes the post-topo one TNBC opportunity is sizable and could expand as more agents move into earlier lines of therapy [11] Company Strategy and Development Direction - The company is focusing on addressing unmet needs in TNBC, particularly for patients previously treated with topo one ADCs [6][12] - The company is exploring the potential of EMILY as a second-line therapy for patients who have received prior topo one ADCs [12] - The company is also developing XMT-2056, an Immunosynthen ADC targeting HER2, with GSK holding an exclusive global license option [12] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ongoing clinical trials and the potential for EMILY to meet significant unmet needs in the TNBC market [10][12] - The management highlighted the importance of the evolving treatment landscape and the potential for EMILY to address the needs of topo-experienced patients if approved [11] Other Important Information - The company incurred $3.9 million in restructuring charges primarily related to severance and benefit payments [17] - The company expects its capital resources to support its operating plan commitments into mid-2026 [14] Q&A Session Summary Question: Expectations for upcoming data in the second half - Management indicated that the data will be based on over 45 enrolled patients, with both dose A and B included, but cautioned about committing to an exact number due to treatment and scan requirements [21][22] Question: Good benchmark for efficacy - Management stated that a response rate in the 20s and a median PFS of 16 weeks would be a good benchmark, considering the standard of care has a 5% response rate and 6-7 weeks PFS [23] Question: Implementation of proteinuria mitigation strategies - Management confirmed that Amendment five was implemented to minimize proteinuria development, allowing patients to continue treatment despite isolated albuminuria [28] Question: Enrollment progress and potential next steps - Management reported that enrollment is going well, with no need for additional sites for the expansion, and they are focused on TNBC for the pivotal study [50][67] Question: Milestone payment details - The $15 million milestone payment is development-based, but further details remain confidential [58]

Financial Performance & Partnerships - Recognized approximately $75 million in 2025, including around $45 million from partnership-related cash milestones and option exercise fees, which significantly reduced net operating cash burn in the first half of 2025 compared to the first half of 2024[12] - Milestone, option exercise, and related deferred revenue of $45.8 million recognized in 2Q 2025 from BeOne and BMS[16, 17] - Potential future milestone payments from existing partnerships could reach up to $6.1278 billion, with royalty rates varying from low single-digit percentages to 20% depending on the partner and therapeutic indication[13] - Cash, cash equivalents, and marketable securities totaled $324.2 million in 2Q 2025, an increase of $9.2 million year-to-date, benefiting from milestone revenues and favorable working capital movements[16, 17] Clinical Development Updates - Investigational New Drug (IND) application cleared for ZW251, with first-in-human studies planned to start in 2025[11, 12, 47] - Phase 2 trial initiated to evaluate zanidatamab in HER2+ neoadjuvant and adjuvant breast cancer[12] - Bristol Myers Squibb collaboration progresses with a $7.5 million option exercise payment to Zymeworks[12] - ZW171: Global Phase 1 study in MSLN-Expressing Solid Tumors (NCT06523803) is an open-label, FIH, dose-escalation study (N~160)[19] - ZW191: Global Phase 1 Study in FRα-Expressing Solid Tumors (NCT06555744) is an open-label, FIH, dose-escalation study (N~145)[24] Zanidatamab Regulatory & Clinical Progress - NMPA granted BeOne conditional approval of zanidatamab in China for BTC, resulting in a $20 million payment to Zymeworks[12] - EMA granted conditional marketing approval of zanidatamab in Europe for BTC, expanding patient access and potential future royalties payable to Zymeworks[12, 47] - Jazz presented encouraging overall survival (OS) data for zanidatamab in 1L HER2+ GEA at the ASCO Annual Congress, showing a median OS of 36.5 months[12]

Group 1 - The Hong Kong stock market for innovative drugs has seen significant gains, with companies like Bohan Bio rising over 17%, and other firms such as Sihuan Pharmaceutical and Sanofi Biotech also experiencing substantial increases [1] - Various ETFs related to innovative drugs have also performed well, with multiple funds rising over 2% and others over 1.5% [1][3] Group 2 - Recent updates from the National Healthcare Security Administration indicate that several new innovative drugs have been rapidly entering hospitals, with a focus on those included in the medical insurance directory by May 2025 [5][6] - Notable drugs showing fast hospital admission growth include those from Kangfang Biotech and Shanghai Yizhong, among others [6] Group 3 - Citigroup's research report highlights a significant increase in market interest in the healthcare sector, particularly in innovative drugs, with expectations for the CXO sector to gain attention due to improved fundamentals and attractive valuations [7] - The report also mentions that WuXi AppTec's revenue for fiscal year 2024 is projected to reach 39.24 billion RMB (approximately 5.4 billion USD), with a growth forecast of 10%-15% for 2025 [7] Group 4 - According to CICC's research, China's innovative drug sector is transitioning into a phase of gradual innovation, gaining international competitiveness [8] - The report emphasizes that the domestic innovative drug industry is expected to reach a turning point by 2025, shifting from capital-driven growth to profit-driven growth [8]