问答环节要点生长激素板块：2025年上半年生长激素新患入组同比增长，水针占比超40%，但因2024年 下半年新患入组不佳，2025年上半年营收与去年同期持平。生长激素市场竞争激烈但价格稳定，与维昇 药业合作的长效生长激素"隆培促生长素"预计2025年下半年获批，定位于高端市场。隆培促生长素优 点：安全性好，通过特定技术使生长激素以特定速率缓慢释放，连接结构和载体分子可排出体外；有效 性高，创新技术保持蛋白活性，免疫原性低，IGF - 1应答高于日制剂；稳定性强，优化冷冻干燥工艺， 储存条件更宽松，降低运输和保存负担；便利性与依从性佳，创新自动注射器，隐形针头，每周仅需注 射一次。博生吉公司CAR - T管线布局：包括自体CAR - T，PA3 - 17注射液纳入突破性治疗品种；通用 现货型CAR - T，UTAA09注射液临床试验进展顺利；In vivo CAR - T平台，完成临床前开发进入IIT阶 段；NKCE平台，进展到动物实验阶段。CD7 - CART规划：后续启动II期单臂注册临床并争取附条件上 市，产品获批后计划在一带一路国家直接申报上市，对欧美国家将视情况独立申报或寻找合作。创新药 研发管线：公 ...

Financial Data and Key Metrics Changes - CarVicti net trade sales reached approximately $439 million, representing a 136% increase year over year and a 19% increase from the first quarter [7][17] - Total revenues were RMB 255 million, driven by collaboration revenue growth of 136% year over year [30] - The company reported a net loss of RMB 10 million but achieved RMB 10 million in adjusted net income after excluding non-core items [30] - Operating loss improved from RMB 41 million in the same period last year to RMB 22 million [30] - Gross margin on net product sales was 57% [30] Business Line Data and Key Metrics Changes - CarVicti's U.S. net trade sales were $358 million, growing 114% year over year and 13% quarter over quarter [18] - Outside the U.S., sales were $81 million, which is four times the amount from the same period a year ago, representing a 59% increase quarter over quarter [19] Market Data and Key Metrics Changes - Over 60% of CarVicti utilization is now in earlier line settings [8] - The company has treated over 7,500 patients with CarVicti, marking it as the strongest CAR T launch to date [7][16] Company Strategy and Development Direction - The company aims to achieve operational breakeven for CarVicti by 2025 and company-wide profitability in 2026, excluding unrealized foreign exchange gains or losses [8][30] - The company is focused on solidifying its leadership in cell therapy and expanding into new indications such as solid tumor programs [14][15] - A new research facility is being built in Philadelphia to focus on in vivo delivery, enhancing innovation capabilities [15] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the FDA's decision to remove risk evaluation and mitigation strategies for approved CAR T therapies, which is expected to improve patient experience and access [8] - The company anticipates continued strong performance for CarVicti, driven by recent long-term survival data presented at ASCO [21][28] Other Important Information - The company has a cash position of approximately $1 billion, allowing for continued investment in core differentiators in cell therapy [16][32] - Manufacturing success rate remains at 97%, which is believed to be the highest in the CAR T industry [20] Q&A Session Summary Question: Update on interim readouts from CARDISUDE V and VI - Management is monitoring events closely and is in discussions with the FDA about using MRD as a dual primary endpoint [37][38] Question: Community oncology efforts and Virginia Oncology Associates - Virginia Oncology Associates is a key milestone for community adoption, having previously administered CAR T therapies and is part of the McKesson network [39] Question: Revenue contribution from community expansion efforts - Approximately 70% of patients come from the community setting, with over half of patients administered in outpatient settings [42][43] Question: Breakdown of treated patients in early line settings - Nearly 60% of orders are from the second through fourth line population, which is expected to grow significantly [48] Question: Impact of recent efficacy data from a competitor - Management emphasized that CarVicti is best in class with demonstrated overall survival benefits, differentiating it from competitors [63] Question: Future demand and supply dynamics - The company plans to drive both supply and demand simultaneously, with increasing contributions expected from Europe [83][85] Question: Novartis commercial supply ramp-up - Novartis is expected to reach full capacity by the end of the year, contributing to growth [107] Question: Impact of recent tariff changes - The company believes any potential exposure to tariffs will not be material based on current evaluations [103]

Core Viewpoint - Anke Biotech's PA3-17 injection has been included in the list of proposed breakthrough therapy products by the National Medical Products Administration (NMPA), marking a significant advancement in the treatment of adult relapsed/refractory T-cell acute lymphoblastic leukemia/lymphoma (R/R T-ALL/LBL) [1][2] Group 1: Product Development - PA3-17 injection is the first CAR-T therapy targeting T-cell blood tumors in China and is globally leading in this category [1] - The drug has completed Phase I clinical trials and received the Clinical Trial Approval Notification in August 2021 [1] - The objective response rate (ORR) of PA3-17 injection is reported to be 84.6%, significantly outperforming existing therapies [2] Group 2: Technical Innovations - PA3-17 injection overcomes the "self-harm" barrier in T-cell tumors by targeting the CD7 antigen, which allows it to avoid attacking its own CD7-positive T-cells [2] - The product utilizes non-gene editing technology to retain CD7 protein within T-cells, minimizing off-target risks associated with traditional gene editing [2] - The fully automated closed production process reduces contamination risks and ensures product consistency [2] Group 3: Market Implications - The inclusion of PA3-17 injection in the breakthrough therapy category is expected to accelerate its market approval process and enhance its competitive position globally [2] - This development lays a solid foundation for Chinese original cell therapies to enter international markets, positioning China favorably in global competition [2]

Core Insights - The report highlights that Tianjin Tasly Pharmaceutical has received approval from the National Medical Products Administration for clinical trials of P134 cell injection for recurrent glioblastoma, positioning the product as potentially leading globally in this indication [2][5][6] - The global market for glioblastoma (GBM) treatment is substantial, with a current market size of 7.522 billion RMB in 2023, projected to grow to 13.968 billion RMB by 2029, indicating significant growth potential for the company’s P134 product [7] - The company has a robust R&D pipeline with 98 products under development, including 33 first-class innovative drugs, and 27 products currently in clinical trials, suggesting a strong commitment to innovation and future growth [8] Market Performance - The Shanghai Composite Index closed at 3633.99, up by 0.45%, while the Shenzhen Component Index rose by 0.64% to 11177.78, indicating a positive market trend [3] - Among industry performances, the defense and military industry saw a rise of 3.07%, while the pharmaceutical and biological sector experienced a decline of 0.65% [4] Company Focus - The P134 product is a CAR-T therapy targeting CD44 and/or CD133, designed to specifically recognize and bind to high-expressing antigens in primary and recurrent glioblastoma, enhancing T cell activation and longevity to kill tumor cells [6] - The report emphasizes the potential of P134 to provide new treatment options for recurrent GBM, which currently has poor prognosis despite existing treatment methods [7]

Investment Rating - The report maintains an "Outperform" rating for the industry [7] Core Insights - The domestic CD7 CAR-T therapy is expected to achieve breakthroughs, with a focus on Anke Biopharma [5][17] - The market for innovative drugs continues to show strong performance, with significant trading volume and interest in new drug developments [5][41] Market Review - The CITIC Pharmaceutical Index rose by 2.7% during the week of July 28 to August 1, 2025, outperforming the CSI 300 Index by 4.5 percentage points, ranking second among CITIC's primary industry classifications [4][41] - Year-to-date, the CITIC Pharmaceutical and Biotech Index has increased by 22.8%, surpassing the CSI 300 Index by 19.7 percentage points [4][41] - The top five performing stocks for the week included Nanjing New Drug (up 78%), Lide Man (up 46.4%), Chenxin Pharmaceutical (up 40.9%), Qizheng Tibetan Medicine (up 40%), and Guangshengtang (up 36.4%) [4][56] Focus on CD7 CAR-T Therapy - Relapsed/refractory T-ALL/LBL has a poor prognosis, with a median survival of only 6 months and limited treatment options available [5][17][18] - Anke Biopharma's PA3-17 is leading in domestic clinical trials for CD7 CAR-T therapy, currently in Phase II, showing an overall response rate (ORR) of 84.6% and a complete response (CR) rate of 76.9% in Phase I trials [5][27][26] - The potential for PA3-17 to become the first approved product targeting T-cell malignancies in China is significant, with opportunities for expanding indications [5][26][33] Investment Recommendations - The report suggests focusing on a combination of innovative drugs, particularly those with commercial capabilities and rich pipelines, as well as medical devices that are expected to see a turnaround in fundamentals [5][41] - Recommended stocks for August include Heng Rui Pharmaceutical, Kangfang Biopharma, Kanghong Pharmaceutical, and others [5][12]

Core Viewpoint - The strategic partnership between Koyi Pharmaceutical and ERIGEN LLC marks a significant advancement in the global CAR-T therapy landscape, particularly with the development of the first dual-target CAR-T product KQ-2003, which targets BCMA/CD19 [1][2][3] Company Summary - Koyi Pharmaceutical has entered into an exclusive overseas licensing agreement with ERIGEN LLC for KQ-2003, covering global rights outside Greater China, excluding India, Turkey, and Russia [1] - The agreement includes a milestone payment of $15 million and potential future payments of up to $1.32 billion, along with a sales share of up to $800 million based on net sales in the licensed regions [1][2] - KQ-2003 has demonstrated a 100% overall response rate (ORR) in clinical trials for patients with relapsed/refractory multiple myeloma, showcasing its potential effectiveness [3][6] Industry Summary - The global cell and gene therapy market has seen rapid growth, with projections indicating it will exceed $30.54 billion by 2025 and reach $21.8 billion for CAR-T therapies by 2030, particularly in the multiple myeloma segment [4] - The CAR-T market is becoming increasingly competitive, with major players like Novartis and Gilead, as well as emerging companies like Legend Biotech and Koyi Pharmaceutical, vying for market share [4][5] - Traditional CAR-T therapies face challenges such as high costs (over $400,000 per treatment), production bottlenecks, and limited efficacy in solid tumors, prompting a shift towards more accessible and cost-effective solutions [5][6][7] - The development of "universal CAR-T" therapies, which utilize healthy donor cells, is seen as a potential game-changer in overcoming the limitations of personalized CAR-T treatments [6][8]

Core Viewpoint - Israeli researchers have developed a new artificial activation platform using nanotechnology, which is expected to significantly enhance the efficacy of CAR-T therapy in cancer treatment, particularly in improving T cell persistence and anti-cancer capabilities [1] Group 1: CAR-T Therapy Overview - CAR-T therapy involves extracting T cells from patients, genetically modifying them in the laboratory, and reinfusing them to identify and attack cancer cells, showing significant efficacy in treating certain hematological malignancies like leukemia [1] - A key challenge for CAR-T therapy is the limited duration of activity of CAR-T cells within the body [1] Group 2: Technological Advancements - The new platform developed by researchers at Ben-Gurion University of the Negev is based on nanotechnology derived from chip manufacturing, representing a major breakthrough in enhancing the effectiveness of CAR-T therapy [1]

Group 1 - The latest progress of the GCC19CART therapy for colorectal cancer was presented at the 2025 ASCO annual meeting by Dr. Benjamin L. Schlechter from Dana-Farber Cancer Institute [1] - The therapy has shown a high objective response rate (ORR) of 80% in a Phase I clinical trial involving 10 patients with metastatic colorectal cancer (mCRC) who had relapsed after standard second-line treatment [2] - One patient achieved complete response (CR) after 10 months, demonstrating the sustained efficacy of GCC19CART in treating advanced colorectal cancer [3] Group 2 - In previous clinical trials conducted in China, GCC19CART also exhibited positive treatment effects, with an ORR of 50% and significant survival benefits, including over 30% of responding patients surviving beyond 4 years [4] - The clinical trial results have been published in the prestigious journal JAMA Oncology, receiving international recognition and praise for the potential of GCC19CART as a new generation cancer therapy [4] - The company, Standex Biotech, focuses on developing CAR-T cell therapies for solid tumors and has received FDA approval for clinical trials of GCC19CART, which is currently ongoing in the U.S. [5]

Core Viewpoint - After a significant decline in stock price following a failed acquisition, Legend Biotech's stock showed signs of recovery due to strong sales data for its CAR-T product, CARVYKTI, but faced renewed pressure from competitive products and changing valuation logic [1][3][4]. Group 1: Stock Performance and Sales Data - Legend Biotech's stock price fell from a high of $58.90 in August last year to a low of $29.40 in April this year, marking a significant decline [1]. - On April 15, Johnson & Johnson reported that CARVYKTI achieved global sales of $369 million in Q1 2025, a year-over-year increase of 135%, exceeding market expectations of $324 million [1]. - Following the positive sales report, Legend Biotech's stock rose by 5.08% on the same day, contributing to a 3.01% increase in stock price for April [1]. Group 2: Competitive Landscape - The competitive landscape has shifted with Gilead's Kite company entering the market with Anito-cel, which has shown promising clinical data, including a 97% overall response rate in its trials [4][5]. - Anito-cel's data suggests it may offer comparable efficacy to CARVYKTI while potentially having a better safety profile, raising concerns about CARVYKTI's market share and pricing power [4][7]. - On May 14, following the release of Anito-cel's data, Legend Biotech's stock dropped by 10.55%, marking its largest single-day decline of the year [7]. Group 3: Financial Outlook and Production Capacity - Legend Biotech reported a net loss of $177 million for 2024, a significant reduction from a loss of $518.3 million the previous year, with CARVYKTI projected to generate $963 million in sales, a 92.7% increase [8][9]. - The company is expanding its production capacity, with plans to reach an annual capacity of 10,000 doses by the end of 2025 and 20,000 doses by the end of 2027 [9]. - Despite the positive sales outlook, the emergence of competitive products like Anito-cel poses challenges to Legend Biotech's growth strategy, raising questions about its reliance on CARVYKTI as a sole revenue driver [9][11]. Group 4: Product Pipeline and R&D - Legend Biotech has developed a diverse product pipeline, including multiple CAR-T therapies and other innovative treatments, but currently lacks a second product that can generate cash flow [11]. - The company has 11 products in development, indicating a potential delay in bringing additional revenue-generating products to market [11]. - The reliance on a single product for growth may place Legend Biotech at a disadvantage in the long-term market dynamics [11].

Financial Data and Key Metrics Changes - Cash, cash equivalents, and marketable securities at year-end 2024 totaled $588 million, up from $239 million at the end of 2023, primarily due to a collaboration with BioNTech and equity financing [25] - Loss from operations for the year ending December 31, 2024, was $241.4 million, compared to $179.7 million for 2023 [26] - Net loss was $220.7 million for the year ended December 31, 2024, compared to $208.4 million for the same period in 2023 [27] Business Line Data and Key Metrics Changes - Cost of sales totaled $11.4 million following the BLA approval for Obicel, representing the cost of commercially available plant capacity [26] - Research and development expenses increased to $138.4 million for the year ended December 31, 2024, from $130.5 million in 2023, driven by increases in employee salaries and manufacturing costs [27] - Selling, general, and administrative expenses rose to $101.1 million for the year compared to $46.7 million in 2023, primarily due to increased salaries and employee-related costs [27] Market Data and Key Metrics Changes - As of March 19, 2025, 33 centers were authorized to deliver Ocassol, expected to reach approximately 60 centers by the end of the year, covering about 60% of the target patient population in the U.S. [12][13][20] - The product was included in the NCCN guidelines shortly after clinical results were published, enhancing confidence in its commercial use [12] Company Strategy and Development Direction - The primary objective for 2025 is to execute a successful commercial launch of Ocassol and explore opportunities for expanding its utility in additional indications [7][8] - The company plans to hold an R&D event on April 23, 2025, to outline future growth opportunities [9] - The company is also moving through regulatory steps in the UK and Europe, with expected decisions in the second half of 2025 [15] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the product's safety profile and its potential for outpatient administration, contingent on physician experience and patient suitability [35][36] - The company noted a strong dynamic in the activation of treatment centers, driven by physician interest and patient need [34] - Management highlighted the importance of ongoing data collection and analysis to support the product's positioning and adoption in the market [66] Other Important Information - The company received a $30 million milestone payment from Blackstone following FDA approval and made a regulatory milestone payment of GBP 10 million [28] - The manufacturing facility is operational and is expected to reliably deliver products to treatment centers [22] Q&A Session Summary Question: Can you provide any color on the initial demand or the book of orders for Ocassol? - Management noted a positive dynamic around center activation, driven by interest and patient need, but stated a fuller picture would be provided in the Q1 update [34] Question: What is the ramp-up plan for the authorized centers? - Management indicated a steady trajectory for onboarding centers, with expectations for gradual growth throughout the year [41][42] Question: Can you comment on the spread of time from site activation to treating the first patient? - Management stated that the time varies significantly based on patient suitability and center readiness, with some centers achieving quick onboarding [50] Question: What is the sentiment among prescribers regarding the need for subsequent therapy after using Ocassol? - Management indicated that initial experiences suggest a low percentage of patients require subsequent stem cell transplants, which resonates positively with physicians [55] Question: What has been the manufacturing success rate and turnaround time for Ocassol? - Management reported that production experiences are aligning well with clinical study data, providing reassurance for future batches [57]