招股书显示其研发投入持续保持高位，报告期内研发成本分别为1.08亿元、1.17亿元和0.78亿元。 截至2025年9月30日，公司现金及等价物为9392.9万元，当期经营活动现金净流出9720万元。 中国经济网编者按：据21世纪经济报道12月3日发布的报道《科望医药三闯港交所持续亏损，明星 资本押注双抗能否破局？》，这家成立8年、累计亏损超20亿元的创新药企，正带着仅够支撑3个月研发 的现金储备，在"不上市即破产"的压力下再度冲刺资本市场。 报道指出，科望医药资本续命倒计时：3300万现金对峙27亿负债。 招股书数据显示，科望医药存在紧迫的资金困境。截至2024年末，公司现金及现金等价物仅余3282 万元，较上年同期的2.7亿元大幅缩水88%，而同期研发成本仍达1.17亿元。这意味着即便维持现有研发 规模，其现金储备也不足以支撑持续运营。 公司成立于2017年，由礼来亚洲基金前合伙人纪晓辉与免疫学家卢宏韬共同创立，是一家专注于肿 瘤免疫治疗的临床阶段生物医药企业。 财务数据显示，2023年、2024年及2025年前九个月，公司仅在2024年实现营收1.07亿元，主要来自 与安斯泰来的合作；同期净亏损分别为8. ...

Aura Biosciences FY Conference Summary Company Overview - Aura Biosciences is developing a novel class of drugs known as virus-like drug conjugates, which aim to provide direct cytotoxicity and robust immune activation [3][4] Key Therapeutic Areas - **Ocular Oncology**: Focus on early-stage choroidal melanoma with a Phase III trial ongoing. The company aims to treat pre-metastatic disease, preserving organ function and preventing recurrence [5][6] - **Bladder Cancer**: The company is also developing treatments for bladder cancer, focusing on neoadjuvant therapy for early-stage tumors [29][31] Competitive Positioning - Aura's approach in ocular oncology is differentiated from competitors like Kimmtrak by targeting early-stage disease, which is often untreated and poses a significant risk of metastasis [5][6] - The company believes it can dominate the early choroidal melanoma market for over 10 years due to its unique positioning and safety profile [5] Enrollment and Study Design - The Phase III trial is currently enrolling patients with early choroidal melanoma, with a focus on those whose tumors are already growing. This strategy aims to enhance the study's power and probability of success [10][11] - Enrollment is expected to complete in 2026, with top-line data anticipated in Q4 2027 [11] Safety and Efficacy - The drug has shown a favorable safety profile with minimal adverse events, which is critical for frontline treatment in healthy patients [17] - The efficacy observed in Phase II trials supports a high probability of success in the ongoing Phase III study, despite a conservative approach to sample size [14][15] Secondary Endpoints - The Phase III trial includes a composite secondary endpoint focused on visual acuity preservation, which is crucial for demonstrating the drug's value proposition [19][21] Additional Indications - Aura is exploring other ocular indications, including methyl chloride ocular surface cancers, with plans for proof of concept studies in 2026 [23][24][26] Bladder Cancer Market Position - Aura's drug is positioned as a frontline neoadjuvant treatment, which is advantageous as it requires the presence of the tumor for efficacy. This contrasts with competitors focusing on adjuvant therapies [31][32] - The company aims to demonstrate improved recurrence-free survival (RFS) through its neoadjuvant approach, which is validated by existing studies [33] Future Catalysts - Key upcoming catalysts include the completion of enrollment in the ocular study and data readouts from proof of concept studies in both ocular and bladder cancer [40][42] - The company is focused on presenting comprehensive data to support its new positioning and therapeutic approach [42] Conclusion - Aura Biosciences is at a pivotal moment with significant upcoming milestones that could enhance its market position in both ocular oncology and bladder cancer, driven by a strong focus on safety, efficacy, and innovative treatment strategies [43][44]

2025 年 11 月 27 日，清华大学 江鹏 课题组 （ 吴珺 、 李根 、 周嘉文 为论文共同第一作者） 在 Cell 子刊 Developmental Cell 上发表了题为： Vitamin B6 preserves the stemness-like phenotypes and antitumor ability of CD8 + T cells 的研究论文。 该研究揭示了饮食来源的代谢小分子 维生素 B6 能够促进肿瘤内浸润 CD8 + T 细胞 的干细胞样特征来增强 抗肿瘤免疫功能，并且表现出维生素 B6 在肿瘤免疫治疗中的临床应用潜力。 撰文丨王聪 编辑丨王多鱼 排版丨水成文 肿瘤浸润淋巴细胞通常功能失调，但其通过尚不明确的机制表现出干细胞样行为。 肿瘤浸润淋巴细胞通常功能失调，但通过尚不明确的机制表现出干细胞样行为。在这项最新研究中，研究 团队发现，给予 维生素 B6 或其活性形式—— 磷酸吡哆醛 （PLP） ，能使小鼠和人类的 CD8 + T 细胞 具 备更强的持久性、干细胞样的表型以及清除肿瘤的能力。 通过吡哆醛激酶 （PDXK） 杂合性降低磷酸吡哆 醛 （PLP） 水平，会导致肿瘤 ...

Core Viewpoint - Junshi Biosciences (688180.SH) announced that its product Toripalimab injection (subcutaneous) has achieved the primary endpoint in a Phase III clinical study for the treatment of recurrent or metastatic non-squamous non-small cell lung cancer (NSCLC) in combination with chemotherapy [1][2] Group 1: Clinical Research - The JS001sc-002-III-NSCLC study is a multicenter, open-label, randomized controlled Phase III clinical trial, marking the first Phase III clinical study for a domestic PD-1 subcutaneous formulation [2] - The study aims to compare the drug exposure, efficacy, and safety of JS001sc and Toripalimab injection in patients with recurrent or metastatic non-squamous NSCLC [2] - Results indicate that the drug exposure of JS001sc is non-inferior to that of Toripalimab injection, with similar efficacy and safety profiles for both treatments [2] Group 2: Market Context - According to GLOBOCAN 2022, there were 1.06 million new lung cancer cases in China in 2022, accounting for 22.0% of all new cancer cases, with lung cancer deaths reaching 730,000, representing 28.5% of cancer deaths [1] - Non-small cell lung cancer (NSCLC) constitutes approximately 85% of all lung cancer cases, with non-squamous NSCLC patients making up about 65% of NSCLC cases [1] - There is a pressing clinical need to enhance the convenience of immunotherapy, as current domestic immunotherapy drugs are primarily intravenous formulations, which are time-consuming and inconvenient for patients [2]

Core Viewpoint - The company has achieved significant results in innovation-driven development and core business enhancement, establishing a collaborative development pattern that focuses on "research and innovation breakthroughs, stable core business profitability, and efficient asset operation" [1][3] Innovation Drug Business Breakthrough - The company has received approval for clinical trials of DCTY0801 injection, targeting EGFRvIII positive recurrent or progressive high-grade glioma, marking a significant advancement in its innovative drug field [2] - The company has formed a self-research system covering cutting-edge technologies such as TCR-T and CAR-T, developing several tumor-targeted cell immunotherapy products for various cancers, indicating a broad commercialization prospect [2] Steady Growth of Core Business - The company's non-net profit attributable to shareholders increased by 27.54% year-on-year in the third quarter, attributed to continuous deepening in traditional advantageous areas and enhanced product competitiveness [3] - The company is a major global supplier of vitamin C raw materials and has a strong position in various segments, including being the largest producer of phosphomycin and a key supplier of chloramphenicol [3][4] Operational and Financial Stability - The company has improved its operational structure and financial stability, with enhanced procurement efficiency and faster capital turnover, providing strong support for future R&D investments and production operations [4] - The company plans to continue efforts in production organization, technical breakthroughs, process optimization, and cost reduction to enhance management efficiency and operational quality [4][5]

SHANGHAI JUNSHI BIOSCIENCES CO., LTD.* 上海君實生物醫藥科技股份有限公司 自願性公告－ JS001sc一線治療非鱗狀非小細胞肺癌的III期臨床研究達到主要研究終點 香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責，對其準確性 或完整性亦不發表任何聲明，並明確表示，概不對因本公告全部或任何部分內容而產生或因倚 賴該等內容而引致的任何損失承擔任何責任。 （於中華人民共和國註冊成立的股份有限公司） （股份代號：1877） JS001sc-002-III-NSCLC研究是一項多中心、開放、隨機對照的III期臨床研究，為 國產PD-1藥物皮下製劑的首個III期臨床研究，由湖南省腫瘤醫院鄔麟教授擔任主 要研究者。該研究旨在比較JS001sc和特瑞普利單抗注射液聯合化療在復發或轉移 性非鱗狀非小細胞肺癌中的藥物暴露量、有效性和安全性。結果表明，JS001sc的 藥物暴露量非劣效於特瑞普利單抗注射液的藥物暴露量，兩者的療效和安全性均 相似。本研究的詳細數據將在近期的國際學術大會上公佈。本公司計劃與監管部 門溝通後，遞交JS001sc用於拓益®所獲批的全部適應症的上市 ...

编辑丨王多鱼 排版丨水成文 在 肿瘤免疫治疗 领域，除了 T 细胞主导的细胞免疫，由 B 细胞和抗体介导的体液免疫也日益受到重视。 三级淋巴结 构 （ TLS ） 作为肿瘤微环境中的 " 临时淋巴结 " ，是 B 细胞活化与抗体产生的关键场所 。然而，在 局部进展期直 肠癌 （ LARC ） 中，成熟 TLS （ mTLS ） 的功能定位及其在新辅助治疗 （ neoTx ） 干预下的动态变化，仍是领域 内关注的重点。 在临床预后方面，研究证实 mTLS 的存在以及浆细胞标志物 CD138 的高表达，均与患者更长的总生存期 （ OS ） 显 著相关。在公共数据库 （ TCGA-READ ） 中的验证也表明，高表达 TLS 形成关键因子 CXCL13 或浆细胞基因签名 的患者，其预后同样更好。这提示了 mTLS 及其支持的 B 细胞免疫是直肠癌的有利预后标志。 2025 年 11 月 18 日，解放军总医院 普通外科医学部 杜峻峰 课题组与北京协和医院 吴斌 团队合作 （ 田娜 、 王乾 宇 、 吕远 为论文第一作者 ） ，在《柳叶刀》 （The Lancet） 子刊 eBiomedicine 上发表了题为： M ...

Core Viewpoint - Zai Jian Pharmaceutical has received approval from the National Medical Products Administration for clinical trials of its drug ZG006 in combination with PD-1/PD-L1 inhibitors and chemotherapy for small cell lung cancer [1] Group 1: Drug Development - ZG006 (INN name: alveltamig) is a trispecific antibody developed through the company's dual/multi-specific antibody research platform [1] - The drug targets DLL3 on tumor cells and CD3 on T cells, effectively bridging T cells and tumor cells to enhance tumor cell destruction [1] - Preclinical studies have shown significant tumor suppression effects in mouse models, with a notable proportion of tumors completely regressing [1]

编辑丨王多鱼 排版丨水成文 肿瘤新抗原 （Tumour Neoantigen） 是理想的免疫治疗靶标，这些抗原只存在于肿瘤组织中，而在其他组织中不存在。肿瘤新抗原疫苗通过诱导机体产生肿瘤特 异性免疫应答，为精准治疗肿瘤提供了新思路。目前，全世界已有超过 100 项新抗原疫苗相关临床试验。 然而， 由于 新抗原免疫原性低 （仅约 15%–30% 的新抗原能够诱导 T 细胞 产生 ） 、 实体瘤的高度 异质性以及抑制性肿瘤免疫微环境 （ TIME） ，这些个 性化的肿瘤新抗原疫苗在实体瘤的治疗中，响应率低。 相比之下，相比之下，微生物抗原具有明确的定义且免疫原性很强，能够激活特定的记忆 T 细胞以清除肿瘤微环境中的微生物。 受此启发，中国药科大学 杨勇 / 王文广 团队等创新性地构建了一种特异性异源蛋白标记体系，开发了特异性标记 乙型肝炎病毒表面抗原 （ HBsAg ） 的 通用 型肿瘤疫苗系统 （ HBsAg-tagged tumour vaccine system, H-T VAC ） ， 将 肿瘤细胞 " 伪装 " 成高免疫原性的 " 病毒 " ，突破了肿瘤新抗原免疫原性低、 实体瘤异质性强以及抑制性肿瘤免 ...

Financial Data and Key Metrics Changes - For Q3 2025, total revenue was $14.3 million, a significant increase from negative revenue of $1.8 million in Q3 2024 [18] - Net YCANTH revenue for Q3 2025 was $3.6 million, compared to negative $1.9 million in Q3 2024, reflecting improved demand and sales [18][19] - GAAP net loss for Q3 2025 was $0.2 million, or $0.03 per share, compared to a GAAP net loss of $22.9 million, or $4.88 per share in Q3 2024 [21] - Non-GAAP net income for Q3 2025 was $1.2 million, or $0.13 per share, compared to a net loss of $20.2 million, or $4.30 per share in Q3 2024 [21] Business Line Data and Key Metrics Changes - Dispensed applicator units of YCANTH reached 14,093 in Q3 2025, representing approximately 5% sequential growth over the prior quarter [10] - Year-to-date dispensed applicator units increased to 37,642 for the nine months ended September 30, 2025, a 120% increase compared to the same period in 2024 [6] Market Data and Key Metrics Changes - The approval of YCANTH in Japan for molluscum is expected to lead to multiple approvals across major pharmaceutical markets, including the EU [8] - Feedback from the European Medicines Agency indicated no further phase III studies are needed for YCANTH's approval for molluscum, with a filing anticipated as early as Q4 2026 [8] Company Strategy and Development Direction - The company aims to establish YCANTH as a leading therapy for multiple types of skin lesions, leveraging its existing clinician relationships [6] - The development of VP-315 for basal cell carcinoma is positioned as a potential standard of care, with plans for a phase III study design confirmed by the FDA [10][16] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the growth trajectory of YCANTH and the potential for VP-315, highlighting a strong foundation for future growth [4][17] - The company is focused on optimizing its cost structure while expanding its commercial strategy, which has led to reduced spending and increased product adoption [5][20] Other Important Information - The company received $18 million in cash milestone payments from Torii in 2025, with $10 million received in Q3 upon YCANTH's approval in Japan [7] - A new non-dispensing pharmacy, YCANTH Rx, is expected to launch in Q4 2025 to streamline the prescription process for healthcare providers [12][13] Q&A Session Summary Question: Can you further speak to the YCANTH demand that you're seeing in Q4? - Management noted that momentum from September has continued into Q4, with expectations for increased demand as the cold and flu season approaches [24][25] Question: What kind of counter-detailing are you seeing, and what has been the prescriber feedback on Zilretc? - Management views the Zilretc launch positively, as it raises awareness about the need to treat molluscum, while YCANTH remains a best-in-class option [25] Question: When do you expect sales force productivity to fully ramp? - It typically takes a few months for new sales representatives to become fully productive, with expectations for many to be effective early in 2026 [26][27] Question: Why is there a 12-month timeline for the EU filing despite no additional clinical trials required? - The timeline includes necessary sequential steps, such as securing a pediatric waiver, which adds time to the process [27][28] Question: What feedback has been received regarding YCANTH Rx? - Feedback has been positive, with the new pharmacy model expected to simplify the prescription process for clinicians and patients [29][30] Question: How should we think about seasonality impact in Q4 sales? - Traditional seasonal slowdowns are expected in November and December, but increased doctor visits during the cold and flu season may boost diagnoses of molluscum [32][33]