股份發行人及根據《上市規則》第十九B章上市的香港預託證券發行人的證券變動月報表 截至月份: 2025年11月30日 狀態: 新提交 致：香港交易及結算所有限公司 公司名稱: 四川科倫博泰生物醫藥股份有限公司 (於中華人民共和國註冊成立的股份有限公司) 呈交日期: 2025年12月4日 I. 法定/註冊股本變動 | 1. 股份分類 | 普通股 | 股份類別 | H | | | 於香港聯交所上市 (註1) | | 是 | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 證券代號 (如上市) | 06990 | 說明 | | | | | | | | | | | 法定/註冊股份數目 | | | 面值 | | | 法定/註冊股本 | | | 上月底結存 | | | 162,769,979 | RMB | | | 1 RMB | | 162,769,979 | | 增加 / 減少 (-) | | | | | | | RMB | | | | 本月底結存 | | | 162,769,979 | RMB | | | 1 RMB | | 162, ...

Group 1 - The core viewpoint is that the innovative drug sector is expected to remain the most important investment theme in the pharmaceutical sector for the upcoming year, with significant positive catalysts emerging [2] - The Hong Kong pharmaceutical ETF (159718.SZ) has seen a 0.74% increase, with notable gains in constituent stocks such as Kangfang Biopharma (4.57%), MicroPort Scientific (4.15%), and Zai Lab (3.95%) [1] - The U.S. job market showed a significant decline in November, with private sector jobs decreasing by 32,000, the largest drop in two and a half years, which has heightened expectations for a Federal Reserve interest rate cut [1] Group 2 - The pharmaceutical sector has experienced a 2-3 month adjustment period, leading to a relative low in stock prices, market expectations, and institutional allocations, thus enhancing investment safety margins [2] - Multiple favorable policies are set to be released, including December's medical insurance negotiations and international conferences, which are expected to positively impact the industry [2] - The U.S. biotechnology index (XBI) has risen by 2.84%, reflecting a strong performance in the healthcare sector, with expectations of a gradual recovery in global innovative drug financing and demand [1][2]

Core Insights - The Hong Kong Stock Connect Innovative Drug ETF (工银, 159217) experienced a net redemption of 2.867 million yuan on December 1, ranking 15th out of 198 in cross-border ETF net outflows [1] - As of December 1, the fund's latest size is 5.56 billion yuan, down from 5.59 billion yuan the previous day, with a net outflow accounting for 0.05% of the previous day's size [1] - Over the past 5 days, the fund faced a net redemption of 4.3125 million yuan, ranking 53rd out of 198 in cross-border ETF net outflows [1] - In the last 10 days, the fund saw a net subscription of 129 million yuan, ranking 34th out of 198 in cross-border ETF net inflows [1] - Over the past 20 days, the fund had a net subscription of 251 million yuan, ranking 36th out of 198 in cross-border ETF net inflows [1] Fund Details - The Hong Kong Stock Connect Innovative Drug ETF (工银, 159217) was established on March 26, 2025, with an annual management fee of 0.40% and a custody fee of 0.07% [1] - The fund tracks the Hong Kong Stock Connect Innovative Drug Index (987018) [1] - As of December 1, the fund's total shares are 3.865 billion, with a total size of 5.56 billion yuan [1] Liquidity and Performance - As of December 1, the fund's cumulative trading amount over the last 20 trading days is 13.981 billion yuan, with an average daily trading amount of 699 million yuan [2] - The current fund managers are Liu Weilin and Jiao Wenlong, with returns of 43.85% and 63.95% respectively since their management began [2] Top Holdings - The fund's top holdings include: - 百济神州 (10.84%, 314.54 million shares, 589 million yuan) - 康方生物 (10.77%, 454.20 million shares, 586 million yuan) - 信达生物 (10.43%, 644.10 million shares, 567 million yuan) - 中国生物制药 (9.82%, 7184.50 million shares, 534 million yuan) - 石药集团 (7.72%, 4908.40 million shares, 420 million yuan) - 三生制药 (7.41%, 1469.60 million shares, 403 million yuan) - 翰森制药 (5.50%, 908.20 million shares, 299 million yuan) - 科伦博泰生物-B (3.55%, 41.14 million shares, 193 million yuan) - 再鼎医药 (2.79%, 621.62 million shares, 151 million yuan) [2] Comparative Analysis - Other ETFs tracking the Hong Kong Stock Connect Innovative Drug Index include: - 汇添富国证港股通创新药ETF (159570) with a size of 23.978 billion yuan and a recent average daily trading amount of 2.652 billion yuan [2] - 港股创新药ETF (159567) with a size of 8.460 billion yuan and a recent average daily trading amount of 1.457 billion yuan [2] - 南方国证港股通创新药ETF (159297) with a size of 1.459 billion yuan and a recent average daily trading amount of 0.115 billion yuan [2] - 鹏华国证港股通创新药ETF (159286) with a size of 0.607 billion yuan and a recent average daily trading amount of 0.088 billion yuan [2]

Investment Rating - The report does not explicitly state an investment rating for the industry [2] Core Views - The pharmaceutical and biotechnology sector saw a weekly increase of 2.67%, underperforming the Wind All A index (2.9%) but outperforming the CSI 300 index (1.64%). The raw material drug sector experienced a decline of 4.27%, while chemical preparations and pharmaceutical circulation products increased by 4.18% and 3.71%, respectively [3][8] - Recent policies in Shanghai and Beijing aim to support the high-quality development of the medical device industry, indicating a shift towards innovation and global competitiveness in this sector. The report suggests monitoring the transformation progress of leading companies in the medical device field [3][12] - Flu activity is on the rise, with the percentage of flu-like cases reported by sentinel hospitals in southern provinces reaching 7.8%, up from 6.8% the previous week, and higher than the same period in 2022 and 2024 [3][11] Summary by Sections Market Weekly Review - The pharmaceutical and biotechnology sector increased by 2.67% from November 24 to November 28, 2025, with raw material drugs declining by 4.27% and chemical preparations increasing by 4.18% [8][9] - Individual stock performances included significant gains for Haiwang Biological (38.2%), Yue Wannianqing (36.2%), and Guangji Pharmaceutical (31.7%), while *ST Changyao (-15.3%), Huitai Medical (-9.6%), and Kangwei Century (-8.8%) saw notable declines [11] Industry News and Key Company Announcements Important Industry Events - The report highlights the increase in flu-like illness percentages in both southern (7.8%) and northern (8.6%) provinces, indicating a significant rise in flu activity compared to previous years [11][12] Industry News - Significant approvals were noted, including the NMPA's approval of Xinmeiyue® for treating moderate to severe plaque psoriasis and the FDA's accelerated approval of Sibeprenlimab for IgAN treatment [12][14] Company Announcements - Notable announcements include the FDA approval of a generic injectable drug by Jianyou Co. and the successful completion of a Phase III trial for JS001sc, a subcutaneous PD-1 monoclonal antibody for non-small cell lung cancer [15][16]

Investment Rating - The report maintains a positive outlook on the innovative drug sector, indicating a rebound and potential for further growth in the upcoming months [3][6]. Core Insights - The innovative drug sector is expected to see a rebound after previous adjustments, with significant catalysts anticipated in December and January. The results of the national medical insurance negotiations will be released in early December, which may impact the inclusion of domestic innovative drugs in the insurance catalog [3][14]. - The upcoming American Society of Hematology (ASH) conference from December 6-9 is highlighted as a key event, with multiple differentiated hematology products expected to present new data [3][4][42]. - The CXO sector shows a continuous upward trend, supported by the rapid growth of new orders and backlog, ensuring performance release in the next 1-2 years [4][53]. Summary by Sections Innovative Drugs - The report emphasizes the importance of focusing on dual/multi-target drugs for various cancers and chronic diseases, as well as opportunities in ADCs and small nucleic acid therapies [6][15]. - The report notes that the innovative drug financing data is showing marginal improvement, indicating a potential recovery in the sector [6][15]. Biologics - The report mentions positive preliminary results from the Phase II clinical trial of amycretin for Type 2 diabetes, suggesting continued monitoring of its clinical progress [4][46]. Medical Devices - The report highlights the emergence of innovative domestic medical devices, with expectations for profit margins to stabilize and improve as new products are approved [5]. Traditional Chinese Medicine & Pharmacies - The report suggests monitoring companies with strong brand power and good inventory management, such as China Resources Sanjiu and Jichuan Pharmaceutical, due to rising flu incidence [5]. Medical Services and Consumer Healthcare - The report discusses a collaboration between a traditional Chinese medicine group and a local health bureau to enhance the capabilities of grassroots medical services through technology [5]. Key Investment Targets - The report identifies key companies to watch, including Innovent Biologics, Kintor Pharmaceutical, and others in the innovative drug and medical device sectors [7].

Core Viewpoint - The company announced that its TROP2 ADC sac-TMT combined with pembrolizumab has achieved significant improvements in progression-free survival (PFS) in a Phase III clinical study for PD-L1 positive non-small cell lung cancer (NSCLC) [1] Group 1: Clinical Study Results - The OptiTROP-Lung05 study reached its primary endpoint, showing statistically and clinically significant improvements in PFS, with a trend towards benefits in overall survival (OS) [1] - Sac-TMT is the first ADC to achieve the primary endpoint in first-line NSCLC treatment, and the company plans to communicate with the CDE regarding the NDA submission [1] - The study involved patients who were negative for EGFR sensitive mutations and ALK fusion genes, with the treatment regimen being sac-TMT (4 mg/kg Q2W) combined with pembrolizumab (400 mg Q6W) [1] Group 2: Market Potential and Demand - The first-line treatment market for NSCLC is vast, with approximately 1 million new lung cancer cases annually, of which about 85% are NSCLC, and around 50% of these patients have PD-L1 TPS ≥ 1% [2] - In mainland China, about 60% of patients are EGFR negative, and approximately 95% are ALK negative, indicating a significant unmet treatment need [2] - The 2025 CSCO guidelines still primarily recommend PD-(L)1 monoclonal antibodies and chemotherapy for first-line treatment of driver gene-negative NSCLC [2] Group 3: Comparative Efficacy - Sac-TMT shows promising potential in first-line treatment for NSCLC, with a median PFS of 17.8 months in PD-L1 positive patients, outperforming Trodelvy combined with pembrolizumab, which had a median PFS of 13.1 months [3] - In patients with low PD-L1 expression (TPS < 1%), sac-TMT achieved a median PFS of 12.4 months, surpassing Dato-DXd's 9.3 months in a similar population [3] - The company is awaiting OS data and specific Phase III results for sac-TMT in wild-type NSCLC [3] Group 4: Ongoing Development and Future Potential - Merck is actively advancing the clinical development of sac-TMT, with 15 global Phase III trials across six cancer types, including lung cancer [4] - The company is conducting four clinical trials in the NSCLC field, focusing on various combinations and treatment regimens [4] Group 5: Efficacy in Specific Patient Populations - In the OptiTROP-Lung04 Phase III study, sac-TMT demonstrated an overall response rate (ORR) of 60.6% compared to 43.1% for chemotherapy, with a median PFS of 8.3 months versus 4.3 months [5] - The analysis indicated that sac-TMT significantly improved OS compared to chemotherapy, reducing the risk of death by 40% [5] Group 6: Financial Projections - The company expects revenues of 2.084 billion, 2.876 billion, and 4.663 billion yuan for the years 2025 to 2027, with net profits of -622 million, -130 million, and 561 million yuan respectively [5]

Core Insights - The Hong Kong Innovative Drug ETF (159567) closed with a gain of 0.23% on November 27, with a trading volume of 1.149 billion yuan [1] - The fund was established on January 3, 2024, with an annual management fee of 0.50% and a custody fee of 0.10% [1] - As of November 26, 2024, the fund's shares totaled 9.88 billion, with a total size of 8.495 billion yuan, reflecting a significant increase in both shares and size compared to the previous year [1] Fund Performance - The fund's share count increased by 2398.89% and its size increased by 2148.37% from 3.95 million shares and 378 million yuan on December 31, 2024 [1] - Over the last 20 trading days, the cumulative trading amount reached 31.987 billion yuan, with an average daily trading amount of 1.599 billion yuan [1] - Since the beginning of the year, the cumulative trading amount has been 263.006 billion yuan, with an average daily trading amount of 1.201 billion yuan over 219 trading days [1] Fund Management - The current fund manager is Ma Jun, who has managed the fund since its inception, achieving a return of 68.86% during the management period [2] - The top holdings of the fund include companies such as BeiGene, CanSino Biologics, Innovent Biologics, and China National Pharmaceutical Group, with significant percentages of the portfolio allocated to these stocks [2] - The largest holding is BeiGene, accounting for 10.62% of the portfolio, followed closely by CanSino Biologics at 10.55% and Innovent Biologics at 10.21% [2]

Core Viewpoint - CITIC Securities reports that Kelun-Biotech's core product, Sacituzumab Govitecan, has received MNC recognition and global development capabilities, enhancing its potential in combination with Merck's Keytruda for ADC+IO applications. The accelerated global development process and imminent domestic commercialization lead to a target price of HKD 592, maintaining a "Buy" rating [1] Group 1: Product Development - Kelun-Biotech announced that its core product TROP2-ADC, Sacituzumab Govitecan, in combination with Pembrolizumab, achieved the primary endpoint in a Phase III clinical trial for PD-L1 positive non-small cell lung cancer (NSCLC) [1] - This trial marks the first positive Phase III study for ADC combined with immune checkpoint inhibitors in the first-line NSCLC setting globally, confirming the treatment potential of Sacituzumab Govitecan [1] Group 2: Pipeline and Market Potential - The positive trial results further validate the combined treatment potential of Sacituzumab Govitecan, alongside its three approved indications and multiple ongoing clinical trials, indicating a continuous realization of pipeline value [1]

Core Viewpoint - CITIC Securities reports that Kelun-Biotech (06990) has received MNC recognition for its core product, sac-TMT/SKB264/MK-2870, and is accelerating its global development capabilities, leading to a target price of HKD 592 and a "Buy" rating [1] Group 1: Product Development - The core product, TROP2ADC sac-TMT/SKB264/MK-2870, has achieved the primary endpoint in a Phase III clinical study for first-line treatment of PD-L1 positive non-small cell lung cancer (NSCLC) in combination with pembrolizumab [1] - This study marks the first positive Phase III result for an ADC combined with immune checkpoint inhibitors in the first-line NSCLC setting globally, confirming the treatment potential of sac-TMT/SKB264/MK-2870 [1] Group 2: Market Potential - The product has already received approval for three indications and has multiple ongoing clinical trials, indicating a continuous realization of pipeline value [1] - The combination of sac-TMT/SKB264/MK-2870 with Merck's Keytruda (pembrolizumab) further explores the potential of ADC + IO combination therapies [1]

Core Viewpoint - Morgan Stanley has a more positive outlook on Kelun-Botai Biopharmaceutical (06990), raising its revenue forecast for 2025 to 2033 by 1% to 10% and increasing the target price from HKD 499 to HKD 545, citing multiple catalysts expected in 2026 [1] Group 1 - The company recently announced positive data from the Phase III clinical trial of SKB264 (sac-TMT) in mainland China, marking the first successful Phase III trial for sac-TMT in first-line treatment of non-small cell lung cancer (NSCLC) [1] - This trial is also the first globally to demonstrate that the ADC+PD-1 combination therapy is superior to PD-1 monotherapy in first-line treatment of NSCLC [1] - Based on the trial results, the company plans to submit a supplemental new drug application (sNDA) for sac-TMT targeting the relevant indications in China [1]