日前，来自17个国家的企业家齐聚上海，带着对世界经济格局的观察，围绕"开放、创新、包容——迈 向2030的上海发展战略"主题，展开交流和探讨。这些企业涉及制造业、消费品、医药、能源、金融等 多个领域。跨国企业的集体选择，不仅反映了它们对中国发展前景最直接的信心投票，也反映出中国市 场的全球价值。 全球创新场—— 带来更多活力与灵感 "在中国市场，我们看到太多新概念、新技术、新产品……带给我们无限灵感。"这些企业来华参加第三 十七次上海市市长国际企业家咨询会议（上海市咨会）。他们认为中国已不再是单纯的"世界工厂"，而 是充满活力的"全球创新场"。在上海傅利叶智能科技股份有限公司展台，瑞士洛桑国际管理发展学院教 授马克·格瑞文感慨："中国企业从萌生想法，到转化为解决方案，再到规模化落地，发展速度令人惊 叹。" 参会企业家纷纷表示，他们将中国作为新品首发、技术首试和模式创新的首选地，在华布局逐步转向中 高附加值产业，并加速设立研发中心等高端项目。韩国SK集团会长崔泰源说："我们在中国的投资横跨 能源、化工、半导体、生物制药等多个'赛道'。我们正在加码人工智能数据中心建设，并把绿色、安 全、高效的整体解决方案作为主攻 ...

日前，来自17个国家的企业家齐聚上海，带着对世界经济格局的观察，围绕"开放、创新、包容——迈 向2030的上海发展战略"主题，展开交流和探讨。这些企业涉及制造业、消费品、医药、能源、金融等 多个领域。跨国企业的集体选择，不仅反映了它们对中国发展前景最直接的信心投票，也反映出中国市 场的全球价值。 全球创新场—— 带来更多活力与灵感 "在中国市场，我们看到太多新概念、新技术、新产品……带给我们无限灵感。"这些企业来华参加第三 十七次上海市市长国际企业家咨询会议（上海市咨会）。他们认为中国已不再是单纯的"世界工厂"，而 是充满活力的"全球创新场"。在上海傅利叶智能科技股份有限公司展台，瑞士洛桑国际管理发展学院教 授马克·格瑞文感慨："中国企业从萌生想法，到转化为解决方案，再到规模化落地，发展速度令人惊 叹。" 参会企业家纷纷表示，他们将中国作为新品首发、技术首试和模式创新的首选地，在华布局逐步转向中 高附加值产业，并加速设立研发中心等高端项目。韩国SK集团会长崔泰源说："我们在中国的投资横跨 能源、化工、半导体、生物制药等多个'赛道'。我们正在加码人工智能数据中心建设，并把绿色、安 全、高效的整体解决方案作为主攻 ...

Market Opportunity - Breast reconstruction represents a $1.5 billion market[13, 19, 21, 22, 25] - Biologics account for 65% of reconstruction spending in the US[25, 27] - Approximately 160,000 breasts are reconstructed annually after mastectomy[27] - Biologic mesh is utilized in over 90% of reconstruction cases[27] Unmet Needs and Solutions - One in three patients experience serious complications following breast reconstruction[16, 21, 22, 28] - One in seven patients undergoing breast reconstruction face infection[21, 22, 28] - Implant loss occurs in up to 21% of breast reconstruction cases[28] - The company's NXT-41x aims to address these complications with a drug-eluting bioenvelope[36] Technology and Development - The company's technology platform has been validated, with a previous product monetized for $88 million[12, 13] - The company is developing NXT-41x, combining an optimal biologic matrix with Rifampin and Minocycline for sustained antibiotic release[36] - The company anticipates launching NXT-41x in the first half of 2027[44]

Core Insights - CAR-T therapy is gaining significant traction in the innovative drug market, with CARVYKTI (sitagliptin) developed by Johnson & Johnson and Legend Biotech emerging as a leading product in this space [1][4] - Johnson & Johnson reported a record sales figure of $524 million for CARVYKTI in Q3 2025, marking a substantial increase from previous quarters and contributing to a total of $1.332 billion in sales for the first three quarters of the year [1][4] - The drug has achieved a remarkable year-on-year sales growth of 275.94%, positioning it as a potential second Chinese innovative drug to reach $2 billion in global sales after BeiGene's Zebrutinib [4] Sales Performance - In Q1 and Q2 of 2025, CARVYKTI generated sales of $369 million and $439 million, respectively, leading to a total of $1.332 billion in the first three quarters [1][4] - The sales figures for CARVYKTI have doubled compared to the same period last year, indicating strong market demand and acceptance [4] Regulatory Approvals and Market Position - CARVYKTI is the first commercialized product from Legend Biotech, having received FDA approval in February 2022, and is the first Chinese-origin CAR-T therapy to be launched overseas [4][8] - The drug is currently approved for second-line treatment of multiple myeloma in the U.S., with ongoing clinical trials (Cartitude-5) aimed at expanding its use to first-line treatment [8] Pricing and Market Accessibility - The price of CARVYKTI in the U.S. has increased from $465,000 to $555,300, significantly higher than the range of $999,000 to $1.29 million for other CAR-T therapies in China [11] - Despite its approval in China, CARVYKTI has not yet been commercialized in the domestic market due to high pricing and limited accessibility [8][11] Future Prospects - Legend Biotech is expected to turn a profit by 2026, following a net loss of approximately $101 million in Q1 2025, driven by the increasing sales of CARVYKTI [11] - The potential inclusion of CAR-T therapies in commercial insurance directories may enhance their market accessibility in China, with several CAR-T products recently passing expert reviews for inclusion in basic medical insurance [12]

Company Dynamics - On October 19, the company presented impressive interim analysis data from the HARMONi-6 trial at The Lancet & ESMO [1] - The company revised the HARMONi-3 trial protocol to conduct independent statistical analyses based on histological types [2] Clinical Trial Results - The interim analysis of HARMONi-6 showed a median progression-free survival (mPFS) of 11.1 months compared to 6.9 months, with a hazard ratio (HR) of 0.60 (P<0.0001), indicating a significant improvement [1] - The absolute difference in mPFS between the two groups was 4.24 months, with consistent results across subgroups regardless of PD-L1 expression or liver metastasis [1] - Treatment-related serious adverse events (SAE) were reported at 32.3% for the experimental group versus 30.2% for the control group, with no overall survival (OS) data available yet [1] HARMONi-3 Trial Updates - The HARMONi-3 trial will be divided into two parts: sq-NSCLC (600 patients) and nsq-NSCLC (1000 patients), with separate statistical analyses planned [2] - Enrollment for sq-NSCLC is expected to complete in the first half of 2026, with OS analysis anticipated around the same time [2] - The nsq-NSCLC group aims to complete enrollment in the second half of 2026, with PFS event numbers expected in the first half of 2027 [2] Expansion of Clinical Indications - The company plans to initiate a global multi-regional clinical trial (HARMONi-GI3) for AK112 in colorectal cancer, based on promising II phase data [2] - The trial will compare AK112 combined with chemotherapy against bevacizumab combined with chemotherapy, with an enrollment target of 600 patients [2] Earnings Forecast and Valuation - The company maintains its earnings per share (EPS) forecasts for 2025 and 2026 at 0.09 CNY and 0.59 CNY, respectively [2] - The target price has been adjusted down by 18.2% to 184.00 HKD, reflecting a 50.1% upside potential [3]

Core Viewpoint - The company, Baillie Tianheng, has received formal approval from the National Medical Products Administration (NMPA) for the clinical trial of its innovative biopharmaceutical, BL-M24D1, which is an antibody-drug conjugate (ADC) targeting relapsed or refractory hematologic malignancies and advanced solid tumors [1] Group 1 - The clinical trial approval is for the company's self-developed ADC drug, BL-M24D1, which is linked to a new generation toxin [1] - BL-M24D1 shares the same "linker + toxin" platform with other ADC drugs, BL-B16D1 and BL-M17D1, developed from the same small molecule technology platform [1] - The indications for BL-M24D1 include treatment for relapsed or refractory hematologic malignancies and advanced solid tumors [1]

百利天恒公告，近日收到国家药品监督管理局(NMPA)正式批准签发的《药物临床试验批准通知书》， 公司自主研发的创新生物药注射用BL-M24D1（ADC）的药物临床试验获得批准。BL-M24D1是公司自 主研发的偶联了新一代毒素的ADC药物，适应症为复发或难治性血液系统恶性肿瘤和晚期实体瘤。 ...

Core Viewpoint - The company, Zhifei Biological Products Co., Ltd., and its wholly-owned subsidiaries have recently obtained an invention patent certificate from the National Intellectual Property Administration of the People's Republic of China for a vaccine and its preparation method [1] Group 1 - The patent is titled "A Vaccine and Its Preparation Method" [1]

迪哲医药-U10月21日大宗交易平台出现一笔成交，成交量6.93万股，成交金额444.31万元，大宗交易成 交价为64.08元。该笔交易的买方营业部为中信证券股份有限公司总部(非营业场所)，卖方营业部为机构 专用。 10月21日迪哲医药-U大宗交易一览 | 成交量 | 成交金额 | 成交价格 | 相对当日收盘折溢 | 买方营业部 | 卖方营 | | --- | --- | --- | --- | --- | --- | | （万股） | （万元） | （元） | 价（%） | | 业部 | | | | | | 中信证券股份有限公司总部 | 机构专 | | 6.93 | 444.31 | 64.08 | 0.00 | (非营业场所) | 用 | （文章来源：证券时报网） 进一步统计，近3个月内该股累计发生2笔大宗交易，合计成交金额为879.63万元。 证券时报·数据宝统计显示，迪哲医药-U今日收盘价为64.08元，上涨2.07%，日换手率为1.13%，成交额 为3.24亿元，全天主力资金净流入1391.87万元，近5日该股累计上涨0.22%，近5日资金合计净流入 2512.04万元。 两融数据显示，该股最新融资 ...

Core Viewpoint - Sirius Therapeutics, a four-year-old biotech company focusing on siRNA therapies, has submitted its IPO application to the Hong Kong Stock Exchange, backed by major underwriters including Goldman Sachs and HSBC. Despite its promising narrative, the company faces uncertainties regarding its commercialization path and reliance on non-recurring income [2]. Group 1: Product Pipeline and Market Potential - The company has a clear and ambitious strategic layout centered around its siRNA technology platform, targeting three major chronic disease areas: coagulation disorders, cardiovascular diseases, and obesity, each with billion-dollar market potential [3]. - The lead product, SRSD107, targets coagulation factor XI and is currently in Phase II clinical trials in Europe, with plans to initiate trials in China and Australia/New Zealand. It is positioned as a potential first-in-class therapy with the ability to provide effective anticoagulation without increasing bleeding risk [3]. - The second key product, SRSD216, targets lipoprotein(a) for treating high Lp(a) levels and related cardiovascular diseases, entering Phase IIa trials in both China and the U.S. It shows over 95% Lp(a) suppression with a long duration of effect, enhancing patient compliance [4]. - The third product, SRSD384, aims to address the obesity market by targeting the INHBE protein, promoting fat loss while preserving muscle mass, differentiating it from current GLP-1 receptor agonists [4]. Group 2: Financial Performance and Profitability - As of mid-2025, the company has not generated any product sales revenue, with reported losses of 309 million yuan and 342 million yuan for 2023 and 2024, respectively, totaling 651 million yuan in losses. However, it reported a profit of 34.46 million yuan in the first half of 2025 [5][6]. - The reported profitability is heavily reliant on non-recurring income, with other income reaching 144 million yuan in mid-2025, significantly up from 4.51 million yuan the previous year, primarily due to a strategic partnership with CRISPR Therapeutics [6]. - The partnership with CRISPR includes a cash payment of $25 million and $70 million in CRISPR shares, along with potential milestone payments of up to $800 million, contributing to the company's financial performance [6]. Group 3: Shareholder Composition and Valuation - Sirius Therapeutics boasts a strong shareholder base, including OrbiMed and Tencent, which enhances its credibility and potential for future collaborations [7][8]. - The company has raised approximately $144 million through multiple funding rounds, indicating continued market confidence. Its post-money valuation reached $253 million after a $47.5 million Series B round in April 2025 [8]. - The valuation logic is primarily based on the high growth prospects of the siRNA market, projected to reach $50.3 billion by 2040, and the synergies from its collaboration with CRISPR [8]. Group 4: Market Competition and Future Challenges - The siRNA market is highly competitive, with established players like Alnylam and Arrowhead already having products on the market. The company must prove its ability to stand out in this crowded field [11]. - The IPO represents a significant bet on cutting-edge biotechnology, emphasizing the potential for technological innovation to address major diseases [11]. - The company faces challenges in demonstrating sustainable profitability and navigating the long commercialization path, which typically requires substantial investment and time [10][12].