消息面上，亚盛医药已在第61届美国临床肿瘤学会（ASCO）年会上，口头报告了在研Bcl-2抑制剂 APG-2575（lisaftoclax）联合去甲基化药物阿扎胞苷治疗治疗初治（TN）或既往接受过维奈克拉治疗的 髓系恶性肿瘤患者的Ib/II期临床研究最新数据。该研究最新进展再次验证了lisaftoclax在恶性髓系肿瘤治 疗中卓越疗效和卓越安全性二者兼备的特点。值得注意的是，该研究首次报告了lisaftoclax在既往维奈 克拉治疗失败的患者中也有很好的治疗反应，显示出lisaftoclax和国外同类产品的差异化和疗效优势潜 力。 亚盛医药-B(06855)涨超7%，盘中高见59.55港元创历史新高，截至发稿，涨7.13%，报59.35港元，成交 额2.11亿港元。 据悉，Lisaftoclax是亚盛医药自主研发的新型Bcl-2选择性抑制剂，其新药上市申请（NDA）已于2024年 11月获国家药监局药品审评中心（CDE）受理并纳入优先审评程序，用于治疗复发/难治性（R/R）慢性 淋巴细胞白血病/小淋巴细胞淋巴瘤（CLL/SLL），是全球第二个递交NDA的Bcl-2抑制剂和中国首个递 交NDA并进入优先审评的国 ...

Core Insights - Kiran Mazumdar-Shaw transformed her initial setbacks in pursuing a brewing career into a successful international biopharmaceutical company, Biocon, making her one of the wealthiest self-made female entrepreneurs globally [2][3] Company Overview - Biocon was founded in 1978 in a makeshift facility in Bangalore, India, initially producing fermentation enzymes for clients like Ocean Spray [3] - The company transitioned to biopharmaceuticals in 2000, launching its first product, insulin, using yeast instead of genetically modified E. coli, which provided a cost advantage over Western pharmaceutical companies [6][8] - Biocon's revenue reached $1.9 billion, with a significant portion derived from biosimilars, which account for approximately 55% of the company's revenue [8] Market Position and Strategy - The biopharmaceutical market is expanding, with spending on biologics reaching $324 billion in 2023, although this figure does not account for discounts provided by brand-name companies [6][8] - Biocon has launched nine biosimilars, including products that compete with AbbVie's Humira and Genentech's Herceptin, with seven approved for sale in the U.S. [9][10] - The company aims to introduce a new drug annually in the U.S. and Europe until 2030, with plans to launch a biosimilar for Regeneron's Eylea by the end of the year [11] Competitive Landscape - Biocon competes with major players like Sandoz, Samsung Biologics, and Amgen, particularly in emerging markets where it holds a significant market share of up to 80% for several biosimilars [10] - The U.S. market presents challenges due to the need to negotiate with pharmacy benefit managers (PBMs) for drug inclusion in insurance coverage, alongside potential tariffs on imported drugs [10] Future Outlook - The company is positioned for growth, with an estimated 118 biologic drug patents expiring by 2035, creating opportunities for biosimilar development [8] - Mazumdar-Shaw emphasizes the humanitarian aspect of the business, aiming to provide affordable healthcare solutions [12]

6月6日晚，力生制药（002393）发布公告，公司研发的替格瑞洛分散片获得国家药品监督管理局上市许 可批准，为国内第三家按化学药品新注册分类批准的仿制药，视同通过一致性评价。替格瑞洛分散片的 获批上市将进一步丰富公司产品结构，有助于拓展公司业务领域。这也是力生制药获得的首个分散片剂 型新产品批件。 替格瑞洛是一种新型抗血栓形成药，具有强效抗血小板聚集、预防血栓形成的作用。目前已被国内外指 南推荐为心血管疾病患者进行血栓预防的抗血小板药物。替格瑞洛分散片临床上常与阿司匹林合用，用 于急性冠脉综合征(ACS)患者或有心肌梗死病史且伴有至少一种动脉粥样硬化血栓形成事件高危因素的 患者，降低心血管死亡、心肌梗死和卒中的发生率。 力生制药透露，公司研究院依托其建设的天津市缓控释及固体分散体药物制剂重点实验室平台，着力开 展高端制剂技术研究，根据该项目口腔内快速崩解制剂特点，经过反复的试验摸索，确定生产工艺，制 定严格质量标准，BE试验证明在空腹与餐后状态下单次口服本品和原研制剂生物等效，且安全性良 好，达到了与原研制剂疗效一致的目标。研发期间成功申请并授权了1项自主知识产权发明专利《一种 替格瑞洛口腔崩解片及其制备方法 ...

Core Viewpoint - The approval of the Ticagrelor dispersible tablets by the National Medical Products Administration marks a significant milestone for the company, enhancing its product portfolio and expanding its business scope in the cardiovascular field [1][3]. Group 1: Product Approval and Market Impact - The company received the drug registration certificate for Ticagrelor dispersible tablets (90mg), making it the third domestic generic drug approved under the new chemical drug registration classification [1]. - The market for oral anticoagulants in core hospitals in China exceeded RMB 10 billion in 2023, indicating a substantial market opportunity for Ticagrelor dispersible tablets, which are classified as a Category B product under national medical insurance [3]. - The sales figures for Ticagrelor in China are projected to be RMB 1.151 billion in 2022, RMB 1.050 billion in 2023, and RMB 1.174 billion in 2024, reflecting a stable market demand [3]. Group 2: Research and Development - The company has invested significantly in R&D, with a budget of RMB 127 million for 2024, representing a 20% increase from the previous year, and maintaining a research intensity of over 7% in recent years [3]. - The successful development of the Ticagrelor dispersible tablet involved rigorous testing and the establishment of strict quality standards, achieving bioequivalence with the original formulation [2]. - The company has been proactive in its R&D efforts since 2020, with multiple products, including Ticagrelor, receiving drug registration certificates and passing consistency evaluations [4]. Group 3: Strategic Positioning - The approval of Ticagrelor dispersible tablets is a key step in the company's "raw material + formulation" strategy, indicating a comprehensive breakthrough in the cardiovascular treatment sector [4]. - The company aims to enhance its core competitiveness through continuous innovation and strategic positioning, focusing on both industrial and capital-driven development [3][4]. - Future plans include deepening the synergy between R&D and industrialization to provide accessible quality medications for patients while creating long-term value for investors [4].

Syndax Pharmaceuticals (SNDX) 2025 Conference June 05, 2025 01:25 PM ET Speaker0 Good afternoon, everyone. Thank you for attending Jefferies Global Healthcare Conference. My name is Baozhi, a senior biotech analyst biotech team here. And please join me and welcome CEO, Mr. Michael Metzger CMO, Mr. Nick Batwood and COO, Mr. Steve Closter from Syndax Pharmaceuticals for this fireside chat session. Welcome. Speaker1 Thank you, Kelly. Speaker0 Maybe let's start with a high level question. Last year 2024 was a v ...

Investment Rating - The report initiates coverage with a "Buy" rating for the company, targeting a market value of HKD 5.8 billion, which corresponds to a target price of HKD 8.57 [3]. Core Insights - The company has a strong cash flow support from its commercialized product, Selinexor, which has expanded its indications and market presence [2]. - The clinical pipeline includes ATG-022, a differentiated CLDN18.2 ADC, and ATG-037, a CD73 small molecule inhibitor, both showing promising efficacy in treating various cancers [2][3]. - The second-generation TCE platform is expected to enhance safety and efficacy, with the first product, 25H2, submitted for IND [3]. Company Overview - The company focuses on oncology and immunology, with a pipeline that includes one commercialized product and five clinical candidates [8][9]. - Selinexor, the first commercial product, has been approved in multiple Asia-Pacific markets and is expected to see significant revenue growth in 2024 [8][9]. Clinical Pipeline - The company has five clinical-stage assets, including ATG-022 (CLDN18.2 ADC) and ATG-037 (CD73), which are positioned to address unmet medical needs in oncology [11][51]. - ATG-022 has shown efficacy across various CLDN18.2 expression levels in gastric cancer patients, with ongoing clinical trials [34][39]. - ATG-037 is advancing in clinical trials for melanoma and non-small cell lung cancer, demonstrating encouraging safety and efficacy signals [51]. Financial Performance - The company reported a revenue of HKD 92 million in 2024, a 36.7% increase year-on-year, primarily driven by Selinexor's inclusion in the medical insurance directory [23]. - The adjusted annual loss significantly narrowed from HKD 534 million in 2023 to HKD 305 million in 2024, reflecting improved operational efficiency [23]. - Cash reserves at the end of 2024 stood at HKD 900 million, sufficient to support operations for the next three years at the current spending rate [23].

歌礼制药-B（01672.HK） ASC40痤疮适应症 III期临床达到所有终点， 疗效数据优秀 证券研究报告·海外公司点评·药品及生物科技(HS) 买入（维持） | [Table_EPS] 盈利预测与估值 | 2023A | 2024A | 2025E | 2026E | 2027E | | --- | --- | --- | --- | --- | --- | | 营业总收入（百万元） | 56.69 | 1.28 | 0.00 | 40.00 | 100.00 | | 同比(%) | 4.81 | (97.74) | (100.00) | | 150.00 | | 归母净利润（百万元） | (144.72) | (300.94) | (454.44) | (469.72) | (445.21) | | 同比(%) | 54.04 | (107.95) | (51.01) | (3.36) | 5.22 | | EPS-最新摊薄（元/股） | (0.15) | (0.31) | (0.47) | (0.48) | (0.46) | | P/E（现价&最新摊薄） | (54.06) | (26.00) | ...

值得一提的是，数智化的快速发展推动行业不断实现质的飞跃，对于未来乳业制造而言，数智化也是其 重要的发展方向。通过数字化和智能化技术，乳企可以实现多目标、多参量的精准调控，提高生产效率 和产品质量。"在科技创新的浪潮中，乳品制造数智化技术的发展为乳业带来了新的机遇。"浙江大学教 授刘东红介绍了数字孪生技术在乳品生产中的应用，并展示了其在设备智能维护和生产过程优化中的巨 大潜力。 此外，刘东红还强调了乳品制造数智化对于可持续发展的重要性。通过数智化技术，乳品制造企业可以 更加精准地控制生产过程，减少资源浪费和环境污染，从而实现绿色生产和可持续发展。有关资料显 示，一方面，企业通过对生产设备和流程的数字化模拟，可以在虚拟环境中进行测试和优化，提前发现 潜在问题，降低生产成本，提高生产效率。例如，在设备维护方面，数字孪生模型可以实时监测设备运 行状态，预测设备故障，实现预防性维护，减少设备停机时间。另一方面，数字孪生技术有助于提升产 品质量管控水平。在生产过程中，通过对各项数据的实时采集和分析，企业能够及时调整生产参数，确 保产品质量的稳定性和一致性。同时，消费者也能通过数字孪生工厂等平台，更直观地了解产品的生产 过 ...

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 ...