安科生物 20250722 摘要 安科生物以生物医药为主轴，中西药物、精准医疗为两翼，积极布局 mRNA、ADC 病毒、细胞治疗等领域，协同发展，并在全国尤其是长三 角地区有广泛战略布局。 公司主营产品包括生长激素和干扰素，用于生长发育及抗病毒领域；抗 体药物如曲妥珠单抗已获批上市；中药镇痛贴膏在医院端有一定比例； 多肽以 AI 布局促进创新，小分子药物辅助发展，细胞免疫治疗聚焦 CAR-T 和自身免疫性疾病。 生物制品是安科未来发展的主要驱动力，公司将更多精力、资金投入到 该领域，中药作为盈利主力，多肽重点发展，小分子辅助，细胞免疫治 疗协同支持业绩增长。 近七年，公司平均每年投入约 2 亿元进行研发，占营收的 10%左右，研 发战略集中在生长发育、辅助生殖、抗病毒和抗感染领域，以及肿瘤治 疗的抗体、mRNA、CAR-T 和病毒疗法。 公司与杨林教授合作开发 in vivo CAR-T 技术，与王玉才教授合作开发 MRNA 平台，已取得 HPV、RCV、新冠等临床试验批件，与郑颂国教授 合作成立泰瑞公司，专注于调节性 T 细胞产品。 安科生物流通中的重要临床阶段产品包括 HU21（E9）、AK2017（GH ...

Core Viewpoint - The Hong Kong stock market saw a collective surge in the pharmaceutical and biotechnology sector, with notable gains in companies like Li Auto and China Biologic Products [2][4][12]. Group 1: Market Performance - The Hang Seng Index closed at 24,498.95 points, down 0.08%, while the Hang Seng Tech Index rose by 0.56% to 5,448.85 points [2]. - The total market turnover was HKD 236.4 billion, a decrease from the previous trading day, with net inflows from southbound funds amounting to HKD 1.855 billion [2]. - Among the constituent stocks, 43 rose and 40 fell, with Li Auto leading the gains at 9.73% [4]. Group 2: Notable Stock Movements - Li Auto's stock price increased by 9.73%, closing at HKD 124.10, with a year-to-date increase of 32.09% [5][19]. - China Biologic Products rose by 5.90%, with a significant year-to-date increase of 114.68% [5]. - The pharmaceutical sector saw a strong performance, with the Wande Pharmaceutical and Biotechnology Index rising by 4.65% [15]. Group 3: Sector Analysis - The healthcare sector increased by 5.17%, while the materials and energy sectors experienced declines of 1% and 0.94%, respectively [6]. - The CAR-T index rose by 8.19%, and the unprofitable biotech index increased by 6.28%, indicating strong investor interest in these areas [9]. Group 4: Regulatory Developments - The National Healthcare Security Administration and the National Health Commission introduced measures to support the high-quality development of innovative drugs, which is expected to enhance the role of commercial insurance in the multi-level medical security system [17]. - This regulatory change is anticipated to positively impact the upstream supply chain, including research reagents and CXO industries, with expected performance improvements starting from mid-2025 [17]. Group 5: Company-Specific News - Li Auto announced the opening of pre-orders for its i8 model, leading to a stock price increase of nearly 10% [18][19]. - The expected price range for the i8 is between RMB 350,000 and RMB 400,000, with the official price to be announced on July 29 [22].

SAN JOSE, Calif., July 9, 2025 /PRNewswire/ -- Anixa Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer, today announced that the United States Patent and Trademark Office (USPTO) will issue U.S. Patent Number 12,357,593 on July 15, 2025 covering key aspects of its ovarian cancer vaccine technology. The patent includes broad claims related to methods of eliciting an immune response targeting anti-Müllerian hormone receptor, ...

CAR-T 细胞疗法 已在血液恶性肿瘤领域取得显著效果，正在扩展至实体瘤、感染性疾病以及自身免疫疾病的临床试验。 近年来，中外学者利用 CAR-T 细胞疗法成功治疗了包括 系统性红斑狼疮、 特发性炎性肌病、重症肌无力、多发性硬化症 在内的多种 自身免疫疾病 。CAR-T 细胞治疗自身免疫病也入选了 Science 2024 年度十大科学突破。 在产业界， CAR-T 细胞疗法也已进入爆发前夜。2025 年 6 月 30 日， 艾伯维 以 21 亿美元 现金 收购了 CAR-T 细胞疗法开发 公司 Capstan ，该公司目前有 一款 in vivo CAR-T 细胞疗法用于治疗自身免疫疾病，目前处于临床 1 期。而在今年 3 月中旬， 阿斯利康 以 10 亿美元价格收购 CAR-T 细胞疗法开发公司 EsoBiotec 时 ， 就已经给市场带来惊喜。现在，艾伯维给出的翻倍收购价更是让产业界看到了 CAR-T （尤其是 in vivo CAR-T） 更大的发展空间。 CAR-T 细胞疗法在自身免疫疾病中的应用，始于 德国埃尔朗根-纽伦堡大学的 Georg Schett 教授， 2021 年，他领导的团队首次使用 ...

2025 年 7 月 2 日，墨尔本大学的研究人员在国际顶尖学术期刊 Nature 上发表了题为： Rewiring endogenous genes in CAR T cells for tumour-restricted payload delivery 的研究论文。 该研究开创了一种利用 内源性基因启动子 严格控制细胞因子表达的新方法， 增强 CAR-T 细胞抗肿瘤疗 效，并减轻细胞因子表达通常伴随的全身毒性 。例如， NR4A2 启动子 和 RGS16 启动子分别特异性启动 IL-12 和 IL-2 肿瘤部位的表达，从而增强 CAR-T 细胞抗肿瘤效果，并延长肿瘤小鼠模型的长期生存期。 撰文丨王聪 编辑丨王多鱼 排版丨水成文 过继 T 细胞疗法 （ACT） ，包括 TCR 疗法和 CAR-T 细胞疗法，在癌症治疗方面具有令人鼓舞的临床潜 力。特别是，CAR-T 细胞疗法在治疗血液系统恶性肿瘤方面取得了令人瞩目的成效。然而，由于肿瘤微环 境中的免疫抑制、肿瘤抗原异质性以及 CAR-T 细胞向肿瘤迁移受限等多种因素，其在实体瘤治疗中的仍 疗效不足。 此外，治愈后的小鼠表现出对继发性肿瘤的持久免疫力，这表明 ...

从海外映射寻找下半年创新药新赛道 20250706 摘要 PD-1 plus 资产表现亮眼，康方生物伊沃西单抗研究提升市场确定性， 带动相关公司出海交易，如李新医药与默沙东、百安泰克收购钴锂斯生 物。 海外大药企加速布局 PD-1 plus 类资产，三生制药授权辉瑞 PD-1 v j 双 抗海外权益，百安泰克与 BMS 合作开发 PDL one V E G F 双抗，预计 类似交易将持续。 下半年创新药热点包括自免领域双抗（如 TSLP 白介 13 双抗，关注康诺 亚、信达生物），蛋白降解剂（Protac，关注百济神州），新一代 TCE 双抗（实体瘤领域，关注百济神州），以及 ADC 迭代开发（关注百利天 恒 EGFR ADC 进展）。 HER3 ADC 进入三期研究，是双抗 ADC 中领先靶点组合。信达生物披 露 EGFR 和 B7H3 ADC 初步临床前数据，双毒素双配体 ADC 有望克服 耐药性，关注恒瑞医药、科伦博泰等公司。 核药领域，诺华 Provelto 拓展适应症，国内相关公司包括科伦博泰、百 利天恒等。心血管领域，礼来脂蛋白 a 小干扰 RNA 疗法二期结果积极， 关注悦康药业、成都先导等映射 ...

Investment Rating - The industry investment rating is "Positive" (maintained) [2] Core Insights - The report highlights the acquisition of Capstan Therapeutics by AbbVie for up to $2.1 billion, focusing on in vivo CAR-T therapy development [6][15] - The report emphasizes the growing interest and investment in in vivo CAR-T technology, with multiple companies actively pursuing diverse delivery systems [7][26] - The pharmaceutical and biotechnology sector saw a weekly increase of 3.64%, outperforming the CSI 300 index by 2.1 percentage points, ranking 4th among 31 sub-industries [8][31] Summary by Sections 1. AbbVie Acquisition of Capstan - AbbVie announced the acquisition of Capstan Therapeutics for a maximum of $2.1 billion, focusing on in vivo CAR-T therapies [6][15] - Capstan's main asset, CPTX2309, is an RNA delivery candidate for anti-CD19 CAR-T therapy, currently in Phase I clinical trials [15][20] 2. MNC's Active Layout in In Vivo CAR-T Technology - MNC has been actively investing in in vivo CAR-T technology through collaborations and acquisitions, focusing on both lentiviral and lipid nanoparticle delivery systems [7][26] - The report notes that over 20 disclosed mRNA technology projects in in vivo CAR-T are primarily concentrated in the lipid nanoparticle direction [22][30] 3. Weekly Performance of the Pharmaceutical Sector - The pharmaceutical sector increased by 3.64% in the first week of July, outperforming the CSI 300 index [31] - Among sub-sectors, other biological products saw the highest increase of 8.28%, while medical equipment experienced the largest decline of 0.21% [35][36] 4. Recommended Stocks - Recommended stocks include major pharmaceutical and biotechnology companies such as Heng Rui Medicine, East China Medicine, and others [9]

CARVYKTI® Performance and Market Position - CARVYKTI® demonstrates superior Overall Survival (OS) compared to Standard of Care (SoC) in Multiple Myeloma[15, 25] - CARVYKTI® has a strong launch with a 79% Net Trade Sales Compound Annual Growth Rate (CAGR) since launch, leading the industry[15] - CARVYKTI® Net Trade Sales grew by 135% in Q1 2025 compared to Q1 2024[34] - Outpatient treatment represents up to approximately 48% of CARVYKTI® volume in the U S [44] Manufacturing and Supply - The company aims to achieve 10,000 annualized doses of CARVYKTI® exiting 2025 and 20,000 annualized doses exiting 2027[58] - Commercial production at the Tech Lane facility in Belgium is targeted to initiate in the second half of 2025[58] Pipeline and R&D - The company has 11 pipeline programs in Hematologic Malignancies, Solid Tumors, and Autoimmune Diseases[11] - Legend Biotech and Novartis have an exclusive agreement to advance DLL3-targeted CAR-T therapies, including LB2102 for small cell lung cancer[74] - LB2102 targets DLL-3, which is approximately 80% positive in Small Cell Lung Cancer (SCLC)[80] Multiple Myeloma Market - Multiple Myeloma accounts for 10% of all hematologic cancers[17] - There were 187,952 new cases of Multiple Myeloma worldwide in 2022[18]

科济药业 20250702 摘要 科济药业 CT041 已递交 NDA 上市申请并获 CDE 受理，预计 2026 年 商业化，该产品在胰腺癌和胃癌术后辅助治疗中显示出 100%的 ORR， 并在 ASCO 会议和《柳叶刀》上公布了显著疗效的关键二期数据。 CT041 的临床试验采用随机对照设计，结果显示使用 CT041 的患者中 位生存期为 9.9 个月，显著高于未使用者的 3.98 个月，生存时间延长 约 6 个月，体现了 CAR-T 疗法的显著疗效。 科济药业计划自主商业化新产品，基于其在实体瘤市场的领先地位和独 占优势，以及与华东医药合作积累的经验，预计在国内市场拥有更灵活 和自主的定价策略。 科济药业的通用型 CAR-T 虽然成本显著降低，但疗效与自体 CAR-T 相 比仍有差距，公司正致力于通过技术平台优化（如 3Q Plus）提高疗效， 并开发新产品如 0,596 和 2,219。 BCM 通用型 CAR-T 数据显示，科济药业的 0,590 项目在 DOR 方面表 现突出，部分患者达到完全缓解且缓解持续时间长达 20-23 个月，优于 竞品 Besayda 和艾乐哲的 7-8 个月。 Q&A ...

Summary of Key Points from the Conference Call Industry Overview - The conference call discusses the advancements in **in vivo CAR-T technology**, highlighting the global competition in this field, particularly focusing on **YunTing Xinyao** and **Shiyao Group** as key domestic players [1][2]. Core Insights and Arguments - **Acquisition Activity**: AbbVie’s acquisition of Capstan for **$2.1 billion** marks a significant event in the industry, indicating strong interest and investment in in vivo CAR-T technology [1][2]. - **Market Potential**: Current autologous CAR-T therapies have limited global sales of less than **$4.5 billion** due to high costs. In vivo CAR-T aims to reduce costs and improve accessibility, with predictions suggesting costs could be reduced by an order of magnitude [2][4]. - **mRNA Platform Advantages**: The mRNA platform has demonstrated safety and efficacy, particularly validated through COVID-19 vaccine development. It is expected to be a breakthrough point for in vivo CAR-T therapies [1][2][7]. - **Clinical Developments**: AstraZeneca's P3B3A CAR-T technology has received FDA Phase I approval, targeting multiple myeloma and autoimmune diseases, while Interose has initiated Phase I trials in Australia and Europe [5][6]. Additional Important Content - **LNP Delivery System**: The LNP delivery system is crucial for the effectiveness of in vivo CAR-T therapies, requiring efficient delivery to the spleen and rapid degradation for safety [3][10]. - **Research Progress**: Capstan's preclinical studies show no liver toxicity at doses ranging from **0.1g to 2mg**, indicating good safety profiles. YunTing Xinyao has achieved a single conversion rate exceeding **60%** in monkey experiments [11][12]. - **Strategic Advantages of YunTing Xinyao**: The company benefits from a complete mRNA platform, a strong research team, and significant annual investments in R&D, enabling them to make breakthroughs in antigen design and mRNA sequence optimization [13]. - **Shiyao Group's Developments**: The group has made significant strides in the mRNA platform, obtaining three BCMA CAR-T product approvals for multiple myeloma and autoimmune diseases, laying a solid foundation for future developments in in vivo CAR-T [14]. - **Upcoming Data Releases**: Key human data related to both lentiviral vectors and LNP-packaged mRNA CAR-T therapies are expected to be released between the second half of **2025** and the first half of **2026**, which could catalyze further advancements in the field [15].