「IPO全观察」 栏目聚焦首次公开募股公司，报道企业家创业经历与成功故事，剖析公司商业模式和 经营业绩，并揭秘VC、CVC等各方资本力量对公司的投资加持。 作者丨 冯汝梅 编辑丨 关雎 图源 丨Midjourney 近日，浙江博锐生物制药股份有限公司（下称"博锐生物"）正式向港交所递交上市申请，拟登陆主板 市场。 创新药行业融资环境尚未完全回暖，多数 Biotech 企业仍处于亏损状态，而博锐生物已连续 3 年实 现盈利，在行业中显得尤为特别。 数据显示，公司 2024 年收入 16.23 亿元，净利润 9129.5 万元，毛利率维持在 79.5% 的高水 平。 2025 年前三季度收入已达 13.79 亿元，利润 1.22 亿元。 增长的核心之一，来自其首款自主研发的 1 类创新药安瑞昔 ® （泽贝妥单抗）。该产品在 2024 年 收入达 2.77 亿元，相较于 2023 年的 1065 万元，同比增幅超过 25 倍。 根据弗若斯特沙利文的报告，按自身免疫性疾病生物制剂收入计算，博锐生物自 2023 年起已连续两 年位列中国制药企业第一。 博锐生物成立于 2019 年，总部位于浙江台州，其前身为海正药业的生 ...

综合来看，此次权益回收让宜明昂科重新掌握重要资产(IMM2510、IMM27M与)主导权，叠加IMM01、 IMM0306管线在肿瘤和自免领域的差异化布局，公司后续临床进展和BD合作值得期待。 此外，本次同时收回的还有IMM27M(CLTA-4 ADCC+)的海外权益。因为安全性原因，CTLA-4在相当一 段时间内并未受到太多关注，但2025年的诺贝尔生理学或医学奖将CTLA-4靶点重新带回公众视野。近 期BioNTech/OncoC4公布的Gotistobart(新一代CTLA-4抗体)数据较对照组也显示出显著的阳性结果，且 OS曲线有非常典型的拖尾效应。宜明昂科同时拥有VEGF/PD-L1和CTLA-4，未来在联用方面潜力巨 大。而CLTA-4作为单抗进行联用，在剂量和给药频次方面将拥有更多灵活性，从而降低其安全风险。 宜明昂科另一核心看点是CD47系列管线。其中，基石产品IMM01(sirpα-Fc融合蛋白)针对慢性粒单核细 胞白血病(CMML)的III期临床积极推进中，预计今年之内进行III期中期分析，基于前期积累的大量积极 疗效和安全性数据，有望填补CD47领域的空白。此外，基于IMM01开发的髓细 ...

智通财经APP讯，诺诚健华(09969)发布公告，药品审评中心(CDE)批准启动奥布替尼治疗系统性红斑狼 疮(SLE)的III期临床试验。在IIb期临床试验坚实数据的强力支持下，III 期研究将评估每日一次75毫克给 药的方案。 本公司将继续致力于加速奥布替尼的临床开发，为自身免疫性疾病患者带来创新、可及的治疗方案。 奥布替尼(宜诺凯®)为一款处于后期临床阶段、具有潜在同类最佳优势的高中枢神经系统渗透性、选择 性、不可逆口服小分子布鲁顿酪氨酸激酶(BTK)抑制剂。在SLE领域，奥布替尼已通过IIb期试验展现出 积极成果，其临床获益与良好安全性特征获得验证。SLE的III期试验已获准启动，预计于2026年第一季 度首例患者入组(FPI)。在其他自身免疫疾病领域，其在中国针对免疫性血小板减少症(ITP)的III期注册 性试验已完成患者入组，计划于2026年上半年提交新药上市申请。本公司保留奥布替尼在大中华区及东 南亚地区针对SLE及其他自身免疫适应症的相关权益，其他国际权益已授予Zenas。 在多发性硬化症(MS)领域，原发进展型多发性硬化症(PPMS)的III期试验已在 2025年第三季度启动，继 发进展型多发 ...

科尔尼医疗与生命科学团队 近期在《Nature Reviews Drug Discovery》发表论文，分析了自身免疫疾 病领域的发展趋势。过去几十年，通过 细胞因子靶向 实现的 免疫调节 进展推动了治疗创新，据IQVIA 数据，全球自身免疫药物市场在2023年已达到1560亿美元，年复合增长率为15%。这个时代的标志是 肿瘤坏死因子α抑制剂的成功 （现已成为许多疾病的标准治疗）以及 白细胞抑制剂 的出现。然而，推 动此轮增长的明星产品，如修美乐（UMIRA (anti-TNF)）和喜达诺（STELARA (anti-IL-12/23)），如今 面临生物类似药的竞争，而其他领先产品，如达必妥（DUPIXENT (IL-4/13)）和喜开瑞（SKYRIZI (IL- 23)），则在各自适应症中设定了很高的"疗效天花板"。下一个突破性创新时代将与今天大不相同。 未来三到五年，我们预计市场将继续增长，主要驱动力是JAK抑制剂和IL抑制剂在多疾病领域的上市， 以及首创药物（尤其是TNFα以外的TNF靶点）的涌现——这些都将试图提高自身免疫疾病的疗效标 准。 本文探讨自身免疫疾病的研发技术趋势，并分析其影响。 自身免疫 ...

来源：猎云网 近日，自身免疫性药物研发商演生潮完成数亿元A轮融资，本轮融资由凯辉基金通过旗下赛诺菲凯辉医药创新基金领投。 二、在产品策略上，自创立之初即将同类首创（First-in-Class）作为清晰方向，以靶点科研积累、临床治疗格局和医生对现有疗法的反馈为依据依据参照搭 建适应症与临床路径，而非围绕既有靶点做边际改良； 三、在组织架构层面，既有长期深耕清华大学免疫学研究的一线学术带头人，夯实项目在机制与靶点选择上的前瞻性，也有曾在跨国药企及本土创新药企主 导抗体工程、CMC和早期临床开发的产业化骨干，确保从候选分子筛选到临床转化的每一个环节都有清晰路径与可执行方案，使团队能够在科学前沿、开 发可行性与风险控制之间取得良好平衡。 凭借上述科学根基与团队配置，演生潮正在形成围绕CXCR3 轴的多适应症一体化研发体系，并具备按全球标准推进开发与合作的能力。本轮由赛诺菲凯辉 医药创新基金领投的A轮融资，将为核心管线的深入推进提供了资金保障，也为公司进一步嵌入国际临床与产业生态奠定重要基础。 未来，凯辉基金与赛诺菲将持续发挥各自在全球产业生态与临床转化方面的优势，与演生潮保持长期、紧密的协同，共同推动源自中国的自身 ...

Core Insights - The article discusses the recent IPO application of Hangzhou Gaoguang Pharmaceutical Co., Ltd. to the Hong Kong Stock Exchange, highlighting its focus on innovative therapies for autoimmune and inflammatory diseases [2][3]. Company Overview - Founded in 2017, Gaoguang Pharmaceutical specializes in developing small molecule drugs for autoimmune and inflammatory diseases, with a proprietary kinase inhibitor research platform [3]. - The company's founder and CEO, Dr. Liang Congxin, is known for inventing several notable drugs, including Sunitinib, Ensartinib, and Vorolanib [3]. Product Pipeline - Gaoguang's lead candidate, TLL-018, is an oral JAK1/TYK2 dual-target inhibitor currently in Phase III clinical trials for rheumatoid arthritis (RA), psoriatic arthritis (PsA), and chronic spontaneous urticaria (CSU) [5]. - TLL-018 is expected to submit a New Drug Application (NDA) to the National Medical Products Administration by the end of 2026 for CSU and RA indications [5]. - In the neurodegenerative disease space, HL-041 (BHV-8000) is a highly selective TYK2/JAK1 dual-target inhibitor aimed at Alzheimer's and Parkinson's diseases, with a global development agreement signed with Biohaven [5]. Financial Backing - Gaoguang Pharmaceutical has attracted investments from notable firms, including Kaitai Capital (11.65% stake), Hancan Capital (9.53%), and AstraZeneca CICC (9.01%) [6]. - The company's post-money valuation after the C round of financing in November 2025 was reported at 2.462 billion yuan [6].

Financial Data and Key Metrics Changes - The company is on track to file a Biologics License Application (BLA) in 2027 and plans to launch CABA-201 in 2027 or 2028, indicating a significant upcoming milestone for the company [69][70] - The company has reported a very low out-of-spec rate of less than 1% for the manufacturing of CABA-201, which is a significant improvement compared to historical CAR-T therapies [22][20] Business Line Data and Key Metrics Changes - The RESET clinical development program for CABA-201 has multiple diseases fully enrolled, with some completing the phase 1/2 portion, showcasing progress in the development pipeline [5][6] - The myositis pivotal trial is set to initiate enrollment imminently, with alignment from the FDA on the protocol, indicating readiness for the next phase of clinical trials [10][11] Market Data and Key Metrics Changes - The company aims to leverage outpatient therapy for CABA-201, which is expected to provide a more favorable financial profile compared to traditional inpatient CAR-T therapies [11][35] - The company plans to launch through Contract Development and Manufacturing Organizations (CDMOs) to ensure supply and avoid constraints at launch, which is a strategic move to meet market demand [32][33] Company Strategy and Development Direction - The company is focused on outpatient therapy for autoimmune diseases, which is expected to transform the treatment landscape and provide a compelling value proposition compared to existing therapies [11][36] - The partnership with Cellares for fully automated manufacturing is expected to enhance scalability and efficiency, allowing the company to support a large patient population without the need for extensive infrastructure [62][64] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the safety profile of CABA-201, with a lower incidence of cytokine release syndrome (CRS) compared to oncology CAR-T therapies, which is crucial for outpatient administration [13][27] - The company anticipates that the outpatient model will not only improve patient outcomes but also create a financially sustainable CAR-T infusion center, addressing historical challenges in the CAR-T market [36][70] Other Important Information - The company has a strong clinical footprint with 77 sites planned for the launch of CABA-201, which is larger than any other company in the space, indicating a robust strategy for market entry [57][61] - The company is actively engaging with payers to discuss pricing strategies that reflect the value delivered by CABA-201, which is expected to be competitive against existing therapies in the autoimmune space [41][59] Q&A Session Summary Question: How does the safety profile of CABA-201 compare to other CAR-T therapies? - The company reported that approximately one-third of patients developed CRS, mostly grade 1, which is significantly lower than other autologous CAR-T therapies [13] Question: What is the plan for outpatient dosing? - Management indicated that outpatient therapy is a key component of their strategy, with the FDA's recent review supporting this approach [26][28] Question: Are there any concerns regarding manufacturing capacity? - The company is confident in its manufacturing strategy, utilizing CDMOs to ensure supply and avoid constraints at launch, which is a proactive measure to meet anticipated demand [32][33] Question: How does the company plan to compete against larger pharma competitors? - The company believes it can successfully compete due to its extensive clinical footprint and the unique value proposition of CABA-201, which is expected to deliver better outcomes at a sustainable cost [57][58]

亚虹医药(688176.SH)发布公告，近日，公司开展的APL-1401用于治疗中重度活动性溃疡性结肠炎的Ⅰb 期临床试验结果入选第19届欧洲结直肠大会(ECC)，并以壁报形式发布该研究的临床数据。 APL-1401是公司通过自主研究并发现其全新作用机制用于治疗自身免疫疾病的口服创新药物。APL- 1401是一种强效、选择性的多巴胺β-羟化酶(DBH)抑制剂，通过抑制DBH，从而阻断了多巴胺(DA)合成 去甲肾上腺素(NE)唯一的催化酶，导致DA升高、NE降低，使肠道免疫稳态恢复正常。 ...

Summary of Viridian Therapeutics Conference Call Company Overview - **Company**: Viridian Therapeutics - **Industry**: Biopharmaceuticals focusing on autoimmune diseases - **Key Participants**: Steve Mahoney (CEO), Tony Castianos (Chief Commercial Officer), Shan Wu (Chief Business Officer) [1][2] Core Points and Arguments Autoimmune Portfolio - Viridian is advancing an autoimmune portfolio with a focus on thyroid eye disease (TED), a market valued at approximately $2 billion in the U.S. [2] - The company has submitted a Biologics License Application (BLA) for its lead product, which has received breakthrough therapy designation from the FDA [4][2]. Market Dynamics - There is currently one competitor in the TED market, Tepezza, marketed by Amgen, which has shown a return to growth with sales of $560 million in the last quarter [10][11]. - The TED market consists of about 500,000 patients in the U.S., with 200,000 having moderate to severe forms of the disease [10][7]. Product Differentiation - Viridian's product, veligrotug, is expected to have a more favorable dosing regimen compared to Tepezza, requiring five infusions over three months versus eight infusions over five months for Tepezza [15][14]. - The onset of action for veligrotug is anticipated to be quicker, with significant proptosis response observed after just one infusion [15][16]. Clinical Data and Expectations - Phase three data from the THRIVE program indicates strong efficacy, with a proptosis response rate expected to meet or exceed the efficacy bar set by Tepezza [30][29]. - The company plans to launch with both active and chronic data in its label, which is a strategic advantage over Tepezza [17][16]. FCRN Portfolio - Viridian is also developing programs in the FCRN space, with two lead programs (006 and 008) targeting large markets projected to exceed $10 billion by 2030 [31][32]. - The company is focused on low-cost optionality in its FCRN portfolio, with ongoing studies to validate the efficacy and safety of its candidates [33][35]. Financial Position - Viridian recently announced a royalty deal with DRI, which is seen as a validation of its business model and does not encumber its lead products [37][38]. - The company expects to reach break-even and profitability, regardless of the FDA's review outcome [38][39]. Additional Insights - The TED market is characterized as a new start market, allowing for rapid adoption of new therapies without the need to switch patients from existing treatments [11][12]. - The concentration of prescribers in the TED market (approximately 2,000 core prescribers) allows for targeted commercial strategies [12][10]. - The company has engaged with over 500 key opinion leaders (KOLs) in October alone, indicating proactive market preparation [20][19]. This summary encapsulates the key points discussed during the conference call, highlighting the strategic positioning of Viridian Therapeutics within the biopharmaceutical industry, particularly in the treatment of autoimmune diseases.

Core Viewpoint - The company has successfully completed Phase II clinical trials for its innovative drug TUL01101, demonstrating significant efficacy and safety in treating moderate to severe atopic dermatitis in adults [1][2]. Group 1: Clinical Trial Details - The Phase II study was a multicenter, randomized, double-blind, parallel, placebo-controlled trial involving 201 adult participants with moderate to severe atopic dermatitis [1]. - Participants were randomly assigned to three different dosage groups (20mg, 40mg, 60mg) and a placebo group, receiving daily doses for 12 weeks [1]. - The primary efficacy endpoint was the change in the Eczema Area and Severity Index (EASI) score from baseline at week 12, with key secondary endpoints including the proportion of participants achieving EASI75 response and Investigator's Global Assessment (IGA) response [1]. Group 2: Trial Results - Results indicated that TUL01101 significantly improved skin lesions, reduced itching, and enhanced quality of life, with notable decreases in EASI scores observed as early as week 1 [2]. - By week 12, the EASI score changes from baseline for the 20mg, 40mg, and 60mg groups were -81.98%, -79.87%, and -87.85% respectively, with EASI75 response rates of 78.0%, 80.0%, and 84.0%, and IGA response rates of 46.0%, 52.0%, and 68.0% [2]. - The overall safety profile of TUL01101 was good, with the most common adverse event being upper respiratory tract infection, primarily mild to moderate in severity, and no new safety signals were identified [2]. Group 3: Future Development - TUL01101 is a highly selective JAK1 inhibitor, currently approved for clinical trials in atopic dermatitis and rheumatoid arthritis in China [3]. - The company plans to continue expanding clinical research for TUL01101 in the field of autoimmune diseases [3].