今日（12月29日），科济药业宣布已向国家药监局提交通用型BCMA CAR-T产品CT0596的两项新药临床试验申请，拟分别启动针对复发/难治性多发性骨 髓瘤及原发性浆细胞白血病的Ib/Ⅱ期注册临床研究。 这是科济药业在通用型CAR-T细胞治疗研发进程中的又一重要进展。 01 "功能性治愈"突围之路 多发性骨髓瘤（MM）是血液系统第二大常见恶性肿瘤，随着人口老龄化，其发病率持续上升。尽管近年来蛋白酶体抑制剂、免疫调节剂以及抗CD38单 抗等靶向药物的陆续问世，显著延长了初治患者的生存期，推动了MM治疗格局的迭代，但该疾病仍被认为无法根治。绝大多数患者会经历多次复发，且 随着治疗线数后移，缓解期逐渐缩短，治疗选择日益匮乏。 当前，多发性骨髓瘤新药研发的核心目标是推动疾病达到更深层次的缓解，实现深度且持久的疾病缓解，对改善患者长期生存具有重要意义。CAR-T疗 法，因其有望实现更深、更持久的缓解，甚至推动疾病走向"功能性治愈"，被视为更具突破潜力的武器。与传统药物相比，CAR-T不仅能够高效清除肿瘤 细胞，还可能重建长期免疫记忆。 然而，现有自体CAR-T疗法仍存在明显瓶颈，例如，个性化制备周期长达数周甚至更久， ...

Core Viewpoint - The Hong Kong innovative drug sector has experienced a significant rally this year, with the Hong Kong innovative drug index (CSI:931787) rising by 75% until October, but has since entered a cooling phase as investors digest previous gains [3][4]. Group 1: Market Performance - The innovative drug sector saw 23 companies listed in the Hong Kong healthcare sector this year, compared to only 8 last year [3]. - Despite the initial surge, many companies that have not yet entered the Stock Connect are experiencing a decline in stock prices, indicating a challenging path to inclusion [3][4]. Group 2: Stock Connect Mechanism - The Stock Connect allows mainland investors to trade Hong Kong-listed stocks, with significant contributions from southbound funds, accounting for 40%-50% of trading volume in some companies [3][4]. - Companies not included in the Stock Connect face liquidity challenges, as most mainland public funds cannot invest directly [4][5]. Group 3: Challenges for Inclusion - The threshold for entering the Stock Connect has increased due to rising market valuations, with the market capitalization requirement for inclusion in the Hang Seng Composite Index set at approximately HKD 9.32 billion [6]. - Companies previously included in the Stock Connect but later removed face significant hurdles to re-entry, as liquidity issues persist [7][8]. Group 4: Business Development (BD) Fatigue - The market has shown signs of "BD fatigue," where announcements of potential business developments no longer lead to significant stock price increases, as seen with recent collaborations that resulted in stock declines [9][10]. - Investors are now demanding more substantial evidence of project viability and commitment from partners before reacting positively to BD announcements [10]. Group 5: Future Outlook - The market is currently in a quiet phase, with investors waiting for clear signals of recovery before increasing their positions, reflecting a cautious sentiment as year-end approaches [10][11].

Core Insights - CAR-T therapy represents a revolutionary breakthrough in cancer treatment, enabling T cells to precisely identify and attack cancer cells [2] - Kintor Pharmaceutical's Shu Rui Ji Ao Lun Sai injection is poised to become the world's first CAR-T product approved for treating solid tumors, specifically targeting advanced gastric/esophageal junction adenocarcinoma [3][4] - The company is optimistic about the market potential for Shu Rui Ji Ao Lun Sai, especially given the significant unmet clinical needs in advanced gastric cancer treatment [3][4] Company Developments - Kintor Pharmaceutical's Shu Rui Ji Ao Lun Sai injection has received acceptance for new drug listing, with ongoing clinical research for indications beyond gastric cancer, including high-risk pancreatic cancer [4] - The company plans to independently commercialize Shu Rui Ji Ao Lun Sai, despite interest from multiple pharmaceutical companies for collaboration, and is currently building its commercialization team [4] - The injection has received RMAT designation from the FDA, and Kintor intends to collaborate with distributors for overseas sales [4] Industry Trends - The CAR-T market currently lacks approved products for solid tumors, with existing therapies primarily focused on hematological malignancies [3] - The high cost of CAR-T therapies, approximately 1 million yuan per treatment, limits accessibility, but recent policy changes may improve the situation through commercial health insurance [5] - Kintor is developing a universal CAR-T product to address cost and accessibility issues, aiming to reduce production costs to the range of thousands of yuan [5][6] Technological Innovations - Kintor has developed the THANK-uCAR and THANK-u Plus technology platforms to mitigate the risk of rejection associated with universal CAR-T therapies [6] - Clinical data for the second-generation universal CAR-T product CT0596 shows promising results, with a significant percentage of patients achieving partial or complete remission [6] - The company is exploring various universal CAR-T candidates targeting multiple antigens, including CLDN18.2, GPC3, and CD19/CD20, to expand treatment options [6]

Core Viewpoint - Kexing Pharmaceutical Holdings Limited has announced promising clinical data for its universal CAR-T products CT0596 and CT1190B, indicating good safety and efficacy signals for treating relapsed/refractory multiple myeloma and non-Hodgkin lymphoma [1][2] Group 1: Clinical Data and Product Development - The clinical data for CT0596 and CT1190B shows encouraging results in treating relapsed/refractory multiple myeloma and non-Hodgkin lymphoma, respectively [1][2] - Kexing's universal CAR-T products can significantly reduce production costs by over 80% compared to autologous CAR-T therapies, addressing issues of high costs and patient accessibility [2] - The company has developed proprietary technology platforms, THANK-uCAR® and the upgraded THANK-u Plus®, to enhance the accessibility of CAR-T therapies and minimize immune rejection [3] Group 2: Market Context and Competitive Landscape - The current autologous CAR-T therapies are highly customized, leading to prices exceeding 1 million yuan, with only 20% of eligible patients in the U.S. able to access treatment, and an even lower percentage in China [2] - Kexing Pharmaceutical is positioned as a leading player in the domestic CAR-T therapy market, with significant achievements in the autologous CAR-T field [4] - The company aims to launch its first universal CAR-T product within the next 4-5 years, expanding treatment options for patients [3]

Core Insights - The 2025 European Society for Medical Oncology (ESMO) annual meeting held in Berlin showcased significant clinical research results from various domestic pharmaceutical companies, indicating that ESMO could act as a catalyst for business development (BD) in innovative drugs from China [1][2]. Group 1: Clinical Research Highlights - Bai Li Tianheng's drug, Iza-bren, an EGFR×HER3 dual antibody ADC, received considerable attention at ESMO, with a reported 100% objective response rate (ORR) at the World Lung Cancer Conference [3]. - The overseas multi-center study of Iza-bren included 107 patients across various cancer types, showing a cORR of 55% and a median progression-free survival (mPFS) of 5.4 months, highlighting its broad-spectrum treatment potential [3][4]. - The study included a higher proportion of heavily pre-treated patients (57.9%) compared to earlier domestic studies, confirming the drug's efficacy across different populations [4]. Group 2: Market Reactions and Stock Performance - Following the ESMO conference, stocks of companies like Decipher Biosciences, Kintor Pharmaceutical, and Kelun Pharmaceutical saw significant increases after presenting their clinical data [2]. - Kintor Pharmaceutical's CAR-T therapy for pancreatic cancer showed promising results, with a 83.3% disease-free survival rate at 9 months, leading to a 7.01% increase in stock price [5][6]. Group 3: Business Development Opportunities - The ESMO meeting highlighted over 50 targets across various development paths, with a focus on "ADC+IO" and "dual/multi-antibody" therapies [7]. - Companies are increasingly focusing on differentiated mechanisms of action and complementary therapeutic areas for new BD opportunities, as traditional PD-1 targets become saturated [10]. - Recent BD agreements, such as the one between Hansoh Pharmaceutical and Roche for HS-20110, indicate a continued interest in innovative drug development, with potential milestone payments reaching up to $14.5 billion [10].

Core Insights - The company Kogei Pharmaceutical-B (02171) announced the results of its clinical trial for the CAR-T cell therapy candidate, Shurui Jiao Lun Sai Injection (CT041), targeting Claudin18.2 for pancreatic cancer, which will be presented at the 2025 ESMO annual meeting [1][2] Group 1: Product Overview - Shurui Jiao Lun Sai Injection is a potential first-in-class autologous CAR-T cell therapy targeting Claudin18.2 protein, primarily for treating Claudin18.2 positive solid tumors, including gastric and pancreatic cancers [2] - Ongoing trials include various phases for different indications, such as advanced gastric/esophageal junction adenocarcinoma and adjuvant therapy for pancreatic cancer [2] Group 2: Regulatory Milestones - On June 25, 2025, the National Medical Products Administration (NMPA) of China accepted the New Drug Application (NDA) for Shurui Jiao Lun Sai Injection for treating Claudin18.2 positive advanced gastric/esophageal junction adenocarcinoma patients who have failed at least second-line treatment [3] - The product received priority review status from the NMPA in May 2025 and was designated as a breakthrough therapy by the NMPA in March 2025 [3] - In January 2022, the product was granted Regenerative Medicine Advanced Therapy (RMAT) designation by the FDA in the United States for treating Claudin18.2 positive advanced gastric/esophageal junction adenocarcinoma [3]

Core Viewpoint - The announcement by Kintor Pharmaceutical regarding the clinical trial results of its CAR-T cell therapy candidate targeting Claudin18.2 for pancreatic cancer has significant implications for the company's future in oncology treatments [1][2]. Group 1: Clinical Trials and Research - The clinical trial CT041-ST-05, focusing on the use of Claudin18.2-targeted CAR-T cells for adjuvant therapy in high-risk pancreatic cancer, was presented at the 2025 ESMO annual meeting [1]. - Multiple clinical trials are underway for the candidate, including studies for advanced gastric/esophageal junction adenocarcinoma and pancreatic cancer, indicating a broad application of the therapy [2]. Group 2: Regulatory Approvals and Designations - The National Medical Products Administration (NMPA) in China accepted the New Drug Application (NDA) for the therapy on June 25, 2025, for treating advanced gastric/esophageal junction adenocarcinoma [3]. - The therapy has received priority review status and breakthrough therapy designation from the NMPA, highlighting its potential significance in treating patients who have failed at least second-line therapy [3]. - In the United States, the therapy was granted Regenerative Medicine Advanced Therapy (RMAT) designation and orphan drug status by the FDA, further emphasizing its innovative nature and potential market impact [3].

Investment Rating - The report maintains a "Recommended" investment rating for the pharmaceutical industry [1] Core Views - The global GLP-1 market is expanding steadily, presenting strategic opportunities for Chinese companies [3] - Chinese pharmaceutical companies are increasingly recognized in global innovative drug transactions, contributing nearly 50% of total transaction value and over 30% of transaction volume [2] - The CXO industry is expected to gradually recover, with a notable increase in orders anticipated in Q3 [7] - The 2025 medical insurance negotiation and commercial insurance innovative drug directory work has commenced, with a focus on orphan drugs and breakthrough treatment varieties [8] Summary by Sections 1. Pharmaceutical Market Tracking - The pharmaceutical industry outperformed the CSI 300 index by 0.7% in the past week, with a weekly increase of 3.08% [22] - Over the past month, the pharmaceutical industry index increased by 11.07%, surpassing the CSI 300 index by 6.51% [25] 2. Pharmaceutical Sector Trends and Valuation - The current PE (TTM) for the pharmaceutical industry index is 39.94, above the 5-year historical average of 31.83 [44] 3. Recent Research Achievements - The report highlights various research achievements, including the deepening understanding of the GLP-1 drug market and its implications for innovative drug development [46] 4. Recent Industry Policies and News - The National Medical Insurance Administration has initiated the preliminary review of the 2025 medical insurance drug directory, with 121 drug names passing the initial review [8][49] - Significant clinical trial approvals and new drug applications have been reported, indicating active development in the pharmaceutical sector [49][50] 5. Stock Recommendations - The report recommends stocks in the weight loss field, CAR-T technology, and CXO companies, highlighting specific companies such as Zhongsheng Pharmaceutical and Anke Biotechnology [9]

Core Viewpoint - Kintor Pharmaceutical has shown significant stock performance, with an approximately eightfold increase since its low in September 2024, despite still being in a loss position [1] Financial Performance - For the first half of 2025, Kintor reported revenue of approximately 51 million yuan, a year-on-year increase of about 703.8%, primarily driven by sales of its CAR-T product, SaiKezai [1] - The net loss for the same period was approximately 75.48 million yuan, a reduction of over 78% compared to the previous year [1][2] - Cost control measures, including reduced R&D and administrative expenses, contributed to the narrowing of net losses [2] Product Development and Market Strategy - Kintor's first CAR-T product, SaiKezai, was launched on March 1, 2024, and has secured 111 effective orders from its commercial partner, East China Pharmaceutical [3] - The company is optimistic about the sales growth of SaiKezai due to ongoing marketing efforts and expanded insurance coverage [3] - Kintor is also advancing its CAR-T product, ShuRuiJiAoLunSai, aimed at treating solid tumors, with an NDA submission expected to be approved between Q1 and Q2 of next year [3] Cost and Accessibility Challenges - The high production costs of CAR-T therapies remain a significant barrier to accessibility, with domestic pricing generally around one million yuan [1][4] - Kintor is shifting its strategic focus towards developing universal CAR-T therapies, which are expected to have more significant economies of scale [5] Insurance and Policy Developments - The recent introduction of a dual-track system for insurance coverage, including a commercial insurance innovation drug directory, may improve patient access to CAR-T therapies [6] - SaiKezai is among five CAR-T products included in the initial review list for the commercial insurance innovation drug directory, which could lower patient financial burdens [6] - Kintor is actively collaborating with East China Pharmaceutical to secure policy support related to SaiKezai [6] Industry Context - The establishment of a national commercial insurance directory is expected to address disparities in drug coverage across regions, enhancing the sustainability of insurance support for innovative therapies [7]

Investment Rating - The report maintains a "Recommended" rating for the pharmaceutical industry [1] Core Insights - The global pharmaceutical transaction volume reached 456 deals in the first half of 2025, a 32% year-on-year increase, with total upfront payments soaring to $11.8 billion, up 136% year-on-year, and total transaction value hitting $130.4 billion, a 58% increase year-on-year. Chinese companies contributed nearly 50% of the total transaction value and over 30% of the transaction volume, indicating a growing recognition of their value in global innovative drugs [3] - The report highlights a strategic opportunity for Chinese companies in the weight loss sector, with significant clinical data and collaborations emerging. For instance, the oral GLP-1 molecule Orforglipron showed a weight reduction of 11% compared to the placebo group, providing a competitive edge for domestic firms [4] - Chinese innovative drug companies are leading breakthroughs in CAR-T technology, with significant sales figures reported. For example, the collaboration between Legend Biotech and Johnson & Johnson for Carvykti is expected to exceed $2 billion in annual sales [5] - The CXO industry is anticipated to gradually recover, with a notable increase in license-out transactions and funding for biotech companies, indicating a positive trend in order recovery [6] - The report emphasizes the continuous iteration and updates in TCE technology, with promising clinical data emerging from various trials, showcasing the potential for significant advancements in the field [7] Summary by Sections 1. Pharmaceutical Market Tracking - The pharmaceutical industry underperformed the CSI 300 index by 2.07 percentage points in the last week, ranking 31st among 31 primary industry indices [19] - In the past month, the pharmaceutical industry outperformed the CSI 300 index by 8.23 percentage points, ranking 3rd among the primary industry indices [25] 2. Pharmaceutical Sector Trends and Valuation - The pharmaceutical and biotechnology sector's index has a current PE (TTM) of 38.77, above the 5-year historical average of 31.9 [45] 3. Recent Research Achievements - The report includes various deep-dive studies on the pharmaceutical industry, highlighting trends in supply and demand, as well as the growth of specific sectors such as blood products and inhalation formulations [51] 4. Recent Industry Policies and News - Recent policies from the National Healthcare Security Administration aim to support the high-quality development of innovative drugs, including increased funding and support for clinical applications [54] - Notable industry news includes the approval of innovative treatments by major pharmaceutical companies, indicating a robust pipeline and ongoing advancements in the sector [56]