Summary of Eraska Conference Call Company Overview - **Company Name**: Eraska - **Mission**: Focused on erasing cancer, particularly RAS-driven cancers, with a pipeline centered on the RAS MAP kinase pathway [1][2] Key Programs and Pipeline - **Pan RAS Molecule**: ERAS 15, a pan RAS molecular glue, recently cleared for IND [2][4] - **Pan KRAS Inhibitor**: ERAS 4001, a switch to pocket binder, also cleared for IND [2][4] - **Pan RAF Inhibitor**: Naporafenib, currently in phase three for NRAS mutant melanoma, seeking a strategic partner for further development [2][31] - **Biologic**: ERAS 12, a bispecific antibody targeting both active and inactive confirmations of EGFR [3] Clinical Trials - **Trial Design**: Phase one trials for ERAS 15 (AURORAS one) and ERAS 4001 (Borealis one) involve dose escalation followed by monotherapy expansions [6][9] - **Patient Enrollment**: Focus on RAS naive patients for dose escalation [13] - **Expected Dosing Frequency**: ERAS 15 predicted half-life of 24 hours for once daily dosing; ERAS 4001 may require twice daily dosing [11][12] Competitive Landscape - **Market Position**: Eraska is positioned as a strong competitor in the RAS space, with fewer players and a solid preclinical profile compared to competitors like RevMed [39][40] - **Challenges**: Development of new pan RAS molecular glues is complex due to chemistry and limited IP space [40] Efficacy and Safety - **Efficacy Expectations**: ERAS 15 may achieve comparable efficacy at lower doses than RevMed's drug, with a potential one-tenth dose requirement for tumor regression [16][18] - **Safety Profile**: Preclinical data suggest potential safety advantages due to longer tumor residence time [19] Data Disclosure and Future Plans - **Data Guidance**: Expecting to disclose monotherapy data for both ERAS 15 and ERAS 4001 in 2026, with dozens of patients involved [32][50] - **Development Timeline**: Plans to move quickly on dose escalation and explore combination therapies in key indications [34][37] Financial Position - **Cash Reserves**: Approximately $411 million, providing a runway into the second half of 2028, positioning Eraska as one of the best-capitalized companies in the RAS space [49] Strategic Decisions - **Naporafenib Development**: Development paused to extend cash runway and focus on RAS programs [31] - **Partnership Strategy**: Actively seeking a partner for Naporafenib while maintaining focus on advancing RAS programs [46][47] Conclusion - Eraska is strategically positioned in the oncology market with a focused pipeline targeting RAS-driven cancers, strong financial backing, and a clear plan for clinical development and data disclosure. The company aims to leverage its competitive advantages to capture market share in a challenging landscape.

原料药是制药产业链的起点，"原料药好，药才好"，好品质的核心一定是对源头的把控。海正药业多年来一直坚守原料药的根基。在生产方面，海正药 业国际化标准的生产基地重点分布在台州、富阳、南通，目前产线布局完整，具有发酵17000立方、合成2300立方的生产能力。 "重回国内第一梯队"是海正药业（600267）十五五战略规划的目标。构建以人用药为主、以动物药和医美大健康为两翼的一"主"两"翼"多元发展格局， 是未来五年海正药业为发展制定的明确路径。 来到位于杭州富阳的产业园区，一座被绿意环抱的产业群落就是海正药业在2002年布局的原料药、医药制剂生产基地。如今，当初的药用植物种植基地 已经发展为占地1500余亩的生物医药产业园，业务版图涵盖高端生物技术药物、注射和口服制剂、出口原料药、兽用原料药四大领域。 守牢原料药好品质 海正药业是中国原料药出海最早的企业之一，早在1992年便将产品打入美国市场，至今原料药产品出口至70多个国家和地区，广泛覆盖医药及医疗领 域，拥有海外客户400余家（含全球十大药企）。 在近70年的风雨洗礼中，这家老牌药企已经逐渐发展成为集研产销全价值链、原料药与制剂垂直一体化的全球化制药企业。目 ...

近日，作为肿瘤领域规模盛大的年度学术盛会——2025年美国临床肿瘤学会(ASCO)年会正如火如荼进行中，受到国际学界广泛关注，而全球二级市场投资 者也在积极挖掘其中的投资机会。 智通财经APP观察到，早在5月23日，亚盛医药-B(06855)股价便高开高走，最高涨幅达到9.13%，股价最高触及53.20港元，创下自2021年8月以来的新纪录。 二级市场之所以反应积极，在于当天盘前，公司披露了其在今年ASCO年会上的数据信息。 1. 在6例疗效可评估的新诊断(ND)AML/混合表型急性白血病(MPAL)患者中，ORR为 83.3%, 其中33.3%的患者获 CR/CRi ，50%的患者获PR。在 44 例疗效可 评估R/R AML/MPAL 患者中，ORR为 43.2%，其中31.8% 的患者获CR/CRi ，4.5%的患者获PR，6.8% 的患者获MLFS。 2.在15例疗效可评估的 ND MDS/慢性粒单核细胞白血病(CMML)患者中，ORR为 80%，其中40%的患者获CR，40%的患者获骨髓CR(mCR)。22 例疗效可评 估的 R/R MDS/CMML 患者中，ORR为 50%，其中27.3%的患者获 ...

Financial Data and Key Metrics Changes - The FDA has accepted the new drug application for Ziftamenib based on positive results from the COMET-one trial, with a PDUFA target action date of November 30, 2025 [5][39]. - The company reported having over $700 million on the balance sheet as of the end of the first quarter, with potential to earn an additional $375 million in near-term milestones [46]. Business Line Data and Key Metrics Changes - The COMET-one trial demonstrated a 35% overall response rate and a 25% complete remission with and without hematologic recovery (CRCRH) rate in patients treated with Ziftamenib [14][22]. - Among the 92 patients in the phase two portion of the study, the CRCRH rate was 23%, significantly superior to the historical 12% rate with conventional chemotherapy [14][22]. Market Data and Key Metrics Changes - The company is targeting the relapsed refractory acute myeloid leukemia (AML) patient population, where there is a high unmet medical need, with 20% being primary refractory and 50% relapsing within one year [39]. - Physicians have expressed positive feedback regarding Ziftamenib's overall survival among responders, which is longer than expected in this patient population [36]. Company Strategy and Development Direction - The company is pursuing an aggressive development and commercialization strategy for Ziftamenib, aiming to treat up to 50% of AML patients who may benefit from menin inhibitor therapy [5][25]. - A comprehensive development strategy is in place to address patients in both frontline and relapsed refractory settings, utilizing both company-sponsored and investigator-initiated studies [25][28]. Management's Comments on Operating Environment and Future Outlook - Management emphasized the importance of Ziftamenib's favorable safety profile, which positions it as a potentially best-in-class menin inhibitor for AML [44]. - The company is focused on supporting the FDA review process and preparing for a potential launch in the fourth quarter of 2025 [44][46]. Other Important Information - The COMET-one study showed that Ziftamenib was well tolerated, with low rates of myelosuppression and no clinically significant QTc prolongation [19][22]. - The differentiation syndrome was observed in 23% of patients, but with effective management strategies, the majority of patients continued therapy [21][80]. Q&A Session Summary Question: Can you talk about predicting patient responses to Ziftamenib? - Management indicated that currently, there is no clear way to predict which patients will respond to Ziftamenib, although some patients with IDH1 co-mutations appeared to respond better [50][53]. Question: What are the plans for commercial launch preparation? - The company is building out its capabilities to ensure product availability upon approval, learning from the market experience of other menin inhibitors [56][60]. Question: How are physicians managing differentiation syndrome? - Experienced investigators have implemented early recognition and mitigation strategies for differentiation syndrome, leading to better management and patient retention in studies [78][80]. Question: What differentiates Ziftamenib from other products in the market? - Convenience and safety are highlighted as key differentiators, with Ziftamenib being a once-daily oral medication that does not require extensive monitoring [86][90]. Question: What is the expected average duration of therapy for Ziftamenib? - The expected duration of therapy is approximately six months, based on the time needed for patients to achieve a response and the duration of that response [94][97]. Question: Why might FLT3 ITD patients have a lower response rate? - The lower response rate in FLT3 ITD patients may be due to their heavily pretreated status and the development of resistance to multiple therapies [100][101].

弘则研究：ADC payload 特征及 pd1vegf 竞争格局调 研反馈 20250530 摘要 ADC 药物的 payload 类型显著影响其在不同癌种中的疗效和不良反应。 拓扑异构酶抑制剂在乳腺癌、卵巢癌和非小细胞肺癌中表现较好，而微 管抑制剂（如 MAEIL）在结直肠癌中可能更具优势。不同 payload 与特 定不良反应相关，如口腔黏膜炎与拓扑异构酶相关，间质性肺炎与 linker 代谢相关。 双抗产品主要分为 TCE、PD-1 加其他靶点以及双靶点组合。TCE 应用 于血液系统疾病，PD-1 组合旨在替代 PD-1 单抗，解决冷肿瘤响应率低 和耐药问题，双靶点组合旨在拓宽适应症。PD-1/VEGF 组合因其较高确 定性和潜力，被认为是迭代 PD-1 品类的方向。 康方生物的 AK122 在 PD-1/VEGF 双抗领域领先，其临床进展对市场布 局至关重要。其他公司如三生制药和科利斯，通过改进贝伐珠单抗结构， 提高 VEGF 亲和力或降低 ADCC/CDC 效应，以增强疗效。 益芯科和华海制药通过绑定 VGFR1 和 D2 结构，增强了产品对 VEGF 的亲和力，并采用 IgG1 结构以增强 AD ...

Core Viewpoint - China Biologic Products (01177.HK) announced preliminary data from a Phase II clinical study of TQB2868, a PD-1/TGF-β dual-function fusion protein, in combination with Anlotinib and AG chemotherapy for first-line treatment of metastatic pancreatic ductal adenocarcinoma (mPDAC) at the 2025 ASCO annual meeting [1][2] Group 1: Clinical Study Results - The TQB2868-ALTN-II-01 study evaluated the efficacy and safety of TQB2868 combined with Anlotinib and AG chemotherapy (Gemcitabine + Albumin-bound Paclitaxel) in mPDAC patients [1] - As of January 2025, 40 patients with stage IV mPDAC were enrolled, with 36 being evaluable; the objective response rate (ORR) was 63.9%, significantly higher than the historical data for AG chemotherapy (23%-36%) [1] - The disease control rate (DCR) reached 100%, compared to 62.3% for AG chemotherapy, and the 6-month progression-free survival (PFS) rate was 86%, double that of AG chemotherapy (43.2%) [1] - The median overall survival (OS) has not yet been reached, but it is expected to exceed one year [1] Group 2: Safety Profile - The safety profile of the TQB2868 combination therapy was favorable, with a rate of grade 3 or higher adverse reactions at 52.5%, lower than the 68.1%-77% range reported for AG chemotherapy [1] Group 3: Future Developments - The company is in communication with the Chinese National Medical Products Administration (NMPA) regarding the registration of a Phase III clinical trial for the TQB2868 combination therapy [2] - This combination therapy is anticipated to become the first-line treatment for pancreatic cancer using immune checkpoint inhibitors, potentially leading to significant improvements in overall survival and quality of life for patients [2]

Core Viewpoint - Suzhou Zejing Biopharmaceutical Co., Ltd. announced that its self-developed drug, JAK inhibitor Jikaxitinib (brand name: Zepuping), has received approval for marketing in China, targeting specific types of myelofibrosis in adult patients [1][2][3] Drug Basic Information - Drug Name: Jikaxitinib - Dosage Form: Tablet - Specification: 50mg - Marketing Authorization Holder: Suzhou Zejing Biopharmaceutical Co., Ltd. - Indications: For adult patients with intermediate or high-risk primary myelofibrosis (PMF), secondary myelofibrosis due to polycythemia vera (PPV-MF), and secondary myelofibrosis due to primary thrombocythemia (PET-MF), treating disease-related splenomegaly or symptoms [1][2] Drug Mechanism and Clinical Trials - Jikaxitinib is a novel JAK inhibitor that works by inhibiting the activity of JAK1, JAK2, JAK3, and TYK2, blocking the JAK-STAT signaling pathway to reduce inflammation and splenomegaly [2] - The approval is based on a Phase III clinical trial showing that 72.3% of patients had a ≥35% reduction in spleen volume after 24 weeks of treatment [3] - Other clinical trials indicated good safety and tolerability profiles for Jikaxitinib in the target patient population [3] Market Potential and Competitive Landscape - The annual incidence of myelofibrosis in China is approximately 60,000 new patients, with a total patient population exceeding 200,000 [5] - The market size for myelofibrosis drugs in China was 1.73 billion yuan in 2020, projected to grow to 2.93 billion yuan by 2025 and 3.30 billion yuan by 2030 [5] - Currently, the only approved targeted drug for treating intermediate and high-risk myelofibrosis in China is the imported drug Ruxolitinib, which had a global sales figure of approximately 4.9 billion USD in 2024 [5] Regulatory and Clinical Guidelines - Jikaxitinib has been included in the 2024 CSCO guidelines as a first-line treatment for myelofibrosis-related anemia and is recommended for second-line and advanced treatment [4] - The drug is also undergoing clinical trials for other immune-inflammatory diseases, including atopic dermatitis and ankylosing spondylitis [4]

Group 1 - The core point of the article is that Fosun Pharma's subsidiary, Jinzhou Aohong Pharmaceutical, has received approval from the National Medical Products Administration for the registration of a new drug, Citrate Vofopitant Capsules, for specific breast cancer treatment [1] - The approved indication is for the use of the drug in combination with Fulvestrant for adult patients with hormone receptor-positive and HER2-negative recurrent or metastatic breast cancer who have previously undergone endocrine therapy [1] - The new drug is a novel small molecule CDK4/6 inhibitor, and the total R&D investment for this drug is approximately RMB 601 million, expected to be completed by April 2025 [1]

2017年，首款进口BTK抑制剂伊布替尼在国内获批上市，开启了B细胞淋巴瘤的靶向治疗时代，也改变 了慢性淋巴细胞白血病（CLL，或简称"慢淋"）的治疗格局。 《每日经济新闻》记者注意到，2024年之前，国内只有2款BTK（布鲁顿氏酪氨酸激酶）产品获批CLL 一线疗法。但今年以来，阿斯利康、诺诚健华各有一款BTK抑制剂在国内获批该适应证。而且，国内获 批的4款同一适应证产品中，有3款为第二代BTK抑制剂。 5月26日，北京协和医院血液科主任医师张薇教授在接受《每日经济新闻》记者采访时表示，从疗效 看，已有的BTK抑制剂可能难分伯仲，但新一代药物的安全性更强，未来也需要继续更新以应对耐药挑 战，"所谓的'小神药'不神了以后怎么办？一定是药越多越好"。 5款BTK抑制剂获批，4款可用于慢淋一线治疗 存在耐药挑战，BCL2抑制剂研发仍在路上 河南省肿瘤医院血液科副主任周可树教授表示，不断迭代的BTK抑制剂不仅改变了CLL原有的治疗格 局，还在引领CLL进入无化疗时代。 以最新获批的国产BTK抑制剂奥布替尼为例，在一项多中心III期临床试验中，其一线治疗组完全缓解率 （CR）达到12.1%，显著高于传统化疗（历史数据约 ...

新华财经北京5月28日电（记者田晓航、戴小河）近日，国家药品监督管理局批准中药1.1类创新药小儿 牛黄退热贴膏上市。这一源自全国名中医临床经验方的中药新药获批上市，为急性上呼吸道感染风热证 所致的1至5岁发热儿童患者提供了新的治疗选择。 记者从有关部门了解到，2025年以来已有小儿黄金止咳颗粒、芪防鼻通片、复方比那甫西颗粒等多个中 药创新药获批上市，而2021年以来已有52个中药新药获批上市。中药新药上市步伐不断加快，如何看待 这一现象？ "中药新药获批上市数量显著增加，是中医药现代化与产业化进程加速的直观体现，背后是政策引导、 科研突破与临床需求的共振。"中国中医科学院西苑医院科研处副处长、主任医师付长庚说。 付长庚说，以西苑医院研发的 "麻荆宣肺颗粒" 为例，这一西苑医院呼吸科应用40多年的临床验方，有 望通过优化审评路径，加速转化为治疗感染后咳嗽的中药新药。 同时，在他看来，包括西苑医院在内的许多医疗及科研机构通过"临床－基础－转化"全链条创新，推动 了中药从"经验方改良"向"精准机制研究"转型，医院自主研发的新药通过现代药理学、系统生物学等技 术解析药效物质，提升了科学性；而产学研合作模式打通了"研发 ...