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西南证券:康方生物HARMONi-6数据优异 较对照组mPFS绝对值差值达4.24个月
Zhi Tong Cai Jing· 2025-10-21 07:11
Core Viewpoint - Kangfang Biopharma (09926) announced that its drug Iwosimab (PD-1/VEGF dual antibody) combined with chemotherapy achieved the primary endpoint of progression-free survival (PFS) in a Phase III clinical study for advanced squamous non-small cell lung cancer (sq-NSCLC), outperforming the comparator drug Tislelizumab combined with chemotherapy [1] Group 1: Clinical Research and Results - The HARMONi-6 study demonstrated that Iwosimab combined with chemotherapy significantly extended PFS compared to Tislelizumab combined with chemotherapy, with a median PFS of 11.14 months for Iwosimab versus 6.90 months for Tislelizumab (HR=0.60, P<0.0001), resulting in an absolute difference of 4.24 months [1] - Based on the positive results from the HARMONi-6 study, the supplemental new drug application (sNDA) for Iwosimab combined with chemotherapy for sq-NSCLC was accepted by the National Medical Products Administration (NMPA) in July 2025 and is currently under review [1] Group 2: Drug Approvals and Pipeline - Iwosimab has been included in the National Medical Insurance Drug List, with 13 Phase III clinical studies ongoing, covering various cancers including lung cancer, cholangiocarcinoma, and head and neck squamous cell carcinoma [2] - Iwosimab has received approval for two indications in China, with the first being for locally advanced or metastatic non-squamous NSCLC after progression on EGFR-TKI therapy, which has been successfully included in insurance; the second indication for PD-L1 positive locally advanced or metastatic NSCLC is expected to receive NMPA approval in April 2025 [2] - The drug Kadunili has also received approval for a new indication in first-line treatment of cervical cancer, with approximately 10 Phase III or registration clinical trials actively progressing [2]
交银国际:坚定看好康方生物推荐买入评级 目标价183港元
Zhi Tong Cai Jing· 2025-10-21 06:20
Core Viewpoint - The report from CMB International maintains a target price of HKD 183 for Kangfang Biopharma (09926) and expresses a long-term bullish outlook with a "Buy" recommendation, highlighting the company's overseas development progress and upcoming catalysts in the next 1-2 years [1] Group 1: Company Performance - Kangfang Biopharma's overseas development is gaining momentum, with significant catalysts expected in the near future [1] - The report notes that Summit Therapeutics has recently announced an expansion of the overseas research scale for Ivosidenib [1] Group 2: Clinical Data - Ivosidenib's second head-to-head Phase III study has yielded strong positive data, showing that the median progression-free survival (PFS) is significantly better than other PD-1 monotherapy drugs [1] - The absolute improvement in PFS for Ivosidenib compared to PD-1 exceeds the improvement seen with traditional chemotherapy [1] Group 3: Sales Expectations - The report maintains an expectation of peak sales in mainland China at RMB 7.1 billion [1]
交银国际:坚定看好康方生物(09926)推荐买入评级 目标价183港元
智通财经网· 2025-10-21 06:17
Core Viewpoint - The report from CMB International maintains a target price of HKD 183 for Kangfang Biotech (09926) and continues to recommend a "Buy" rating, expressing long-term confidence in the company due to its overseas development progress and upcoming catalysts in the next 1-2 years [1] Group 1 - The company is experiencing significant advancements in its overseas development, with a focus on expanding research efforts [1] - Summit Therapeutics has recently announced an expansion of the overseas research scale for Ivosidenib [1] - Ivosidenib's second head-to-head Phase III study has yielded strong positive data, showing a median progression-free survival (PFS) that significantly outperforms other PD-1 monotherapy drugs [1] Group 2 - The absolute improvement in PFS for Ivosidenib compared to PD-1 has exceeded the improvement seen with traditional chemotherapy [1] - The report maintains an expectation of peak sales in mainland China at RMB 7.1 billion [1]
Akeso, Inc. (AKESF) Presents at ESMO Congress 2025 - Slideshow (OTCMKTS:AKESF) 2025-10-20
Seeking Alpha· 2025-10-20 23:03
Group 1 - The article does not provide any specific content related to a company or industry, as it appears to be a technical issue regarding browser settings and ad-blockers [1]
中国人寿近一个月首次上榜港股通成交活跃榜





Zheng Quan Shi Bao Wang· 2025-10-20 14:41
Core Viewpoint - On October 20, China Life made its first appearance on the Hong Kong Stock Connect active trading list in nearly a month, with a trading volume of 10.41 billion HKD and a net buying amount of 1.37 billion HKD, closing up 2.44% [1] Trading Activity Summary - The total trading volume of active stocks on the Hong Kong Stock Connect on October 20 was 369.37 billion HKD, accounting for 33.62% of the day's total trading amount, with a net selling amount of 21.97 billion HKD [1] - Alibaba-W led the trading volume with 96.98 billion HKD, followed by SMIC and Tencent Holdings with trading amounts of 53.97 billion HKD and 44.91 billion HKD, respectively [1] Frequent Trading Stocks - The stocks that appeared most frequently on the active trading list over the past month were Alibaba-W and Huahong Semiconductor, each appearing 15 times, indicating strong interest from Hong Kong Stock Connect funds [1] - China Life's recent appearance marks its first in nearly a month, highlighting a potential shift in investor interest [1] Individual Stock Performance - Tencent Holdings had a trading amount of 44.91 billion HKD with a net buying amount of 0.97 billion HKD, closing up 3.21% [1] - SMIC recorded a trading amount of 53.97 billion HKD with a net selling amount of 3.25 billion HKD, closing up 3.91% [1] - Alibaba-W had a significant trading amount of 96.98 billion HKD but faced a net selling amount of 17.54 billion HKD, closing up 4.86% [1] - China Life's trading amount was 10.41 billion HKD with a net buying amount of 1.37 billion HKD, closing at 23.520 HKD, up 2.44% [1]
10月20日南向资金净卖出26.70亿港元





Zheng Quan Shi Bao Wang· 2025-10-20 14:32
| 代码 | 简称 | 类型 | 成交金额(万港元) | 成交净买入(万港元) | 日涨跌幅(%) | | --- | --- | --- | --- | --- | --- | | 09988 | 阿里巴巴-W | 港股通(沪) | 578712.83 | -120489.75 | 4.86 | | 09988 | 阿里巴巴-W | 港股通(深) | 391085.00 | -54894.03 | 4.86 | | 00981 | 中芯国际 | 港股通(沪) | 323132.21 | -51384.43 | 3.91 | | 00700 | 腾讯控股 | 港股通(沪) | 293306.14 | -16171.79 | 3.21 | | 01810 | 小米集团-W | 港股通(沪) | 216834.31 | -39191.46 | 2.57 | | 00981 | 中芯国际 | 港股通(深) | 216571.00 | 18934.78 | 3.91 | | 01347 | 华虹半导体 | 港股通(沪) | 171075.45 | 10500.99 | 2.77 | | 00883 | 中国海洋石油 ...
港股创新药ETF(159567)跌0.46%,成交额9.07亿元
Xin Lang Cai Jing· 2025-10-20 10:03
Core Insights - The Hong Kong Innovative Drug ETF (159567) closed down 0.46% on October 20, with a trading volume of 907 million 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 October 17, 2024, the fund's shares totaled 8.134 billion, with a total size of 6.968 billion yuan, reflecting a significant increase in both shares and size compared to the previous year [1] Fund Performance - The fund has seen a remarkable increase of 1957.27% in shares and 1744.35% in size since December 31, 2023 [1] - The fund's cumulative trading amount over the last 20 trading days reached 27.487 billion yuan, with an average daily trading amount of 1.374 billion yuan [1] - Year-to-date, the cumulative trading amount is 224.063 billion yuan, averaging 1.173 billion yuan per day over 191 trading days [1] Fund Management - The current fund manager is Ma Jun, who has managed the fund since its inception, achieving a return of 71.34% during the management period [2] - The fund's top holdings include companies such as Innovent Biologics, WuXi Biologics, BeiGene, and others, with significant percentages of the portfolio allocated to these stocks [2]
医药生物行业周报(10月第3周):创新药出海,BD热度不减-20251020
Century Securities· 2025-10-20 00:44
Investment Rating - The report does not explicitly state an investment rating for the industry [2] Core Insights - The pharmaceutical and biotechnology sector experienced a decline of 2.48% from October 13 to October 17, underperforming the broader market index, the CSI 300, which fell by 2.22% [3][8] - There is a sustained enthusiasm for business development (BD) transactions in innovative drugs, with several companies entering agreements with international pharmaceutical firms [3][12] - The ESMO conference held from October 17 to 21 showcased positive advancements in multiple studies, particularly in immunotherapy and antibody-drug conjugates (ADCs), highlighting the potential of domestic biotech companies [3][11] Market Weekly Review - The pharmaceutical and biotechnology sector saw a weekly decline of 2.48%, with offline pharmacies and traditional Chinese medicine showing slight gains of 0.59% and 0.38%, respectively [8] - Medical research outsourcing, medical devices, and other biological products faced significant declines, with drops of 6.46%, 5.37%, and 3.6% respectively [8][9] - Notable stock performances included Asia-Pacific Pharmaceutical with a rise of 36.7%, while Betta Pharmaceuticals saw a decline of 17.0% [11] Industry News and Key Company Announcements Important Industry Events - On October 18, Kangfang Biologics presented data on a PD-1/VEGF dual antibody in non-small cell lung cancer at the ESMO conference, showing significant improvement in progression-free survival (PFS) [11] - On October 16, Hansa Biopharma announced a licensing agreement with Roche for the global exclusive rights to develop and commercialize HS-20110, with an upfront payment of $80 million [12] - On October 16, Prigen Biologics entered a collaboration with Gilead's Kite Pharma, receiving an upfront payment of $120 million [12][13] Company Announcements - Huayuan Biologics reported a slight decrease in total revenue for the third quarter, amounting to 936 million yuan, a 0.2% year-on-year decline [14] - Shanghai Pharmaceuticals received FDA approval for Doxycycline capsules, with projected sales of approximately $130 million in the U.S. for 2024 [14][16]
康方生物:依沃西联合化疗对比替雷利珠联合化疗一线治疗晚期sq-NSCLC的HARMONi-6研究结果在柳叶刀& 2025 ESMO重磅发表
Zhi Tong Cai Jing· 2025-10-20 00:21
Core Insights - 康方生物's HARMONi-6/AK112–306 study results were prominently presented at the ESMO 2025 and published in The Lancet, demonstrating the efficacy of Ivoris combined with chemotherapy compared to Tarelizumab combined with chemotherapy for advanced sq-NSCLC [1][2] Study Overview - HARMONi-6/AK112–306 is a randomized, controlled, multi-center Phase III clinical trial assessing Ivoris combined with chemotherapy versus Tarelizumab combined with chemotherapy as first-line treatment for advanced sq-NSCLC, with the primary endpoint being progression-free survival (PFS) evaluated by IRRC based on RECIST v1.1 [1][3] - The study enrolled 532 participants, with a balanced baseline, and 92.3% of subjects being in stage IV; the characteristics of squamous cell carcinoma were consistent with real-world patient distribution, with approximately 63% being central squamous cell carcinoma [1][3] Efficacy Results - The study achieved a significant positive result for the primary endpoint of PFS, with Ivoris showing a marked improvement over the control group, resulting in a PFS hazard ratio (HR) of 0.60 (p<0.0001) [1][2] - The median PFS for the Ivoris group was 11.14 months compared to 6.9 months for the control group, indicating an absolute improvement of 4.24 months in PFS [1][2] Subgroup Analysis - In the PD-L1 negative population (TPS ≤ 1%), the median PFS was 9.9 months versus 5.7 months, with a PFS HR of 0.55 [2] - In the PD-L1 positive population (TPS ≥ 1%), the median PFS was 12.6 months versus 8.6 months, with a PFS HR of 0.66 [2] - The PFS HR for patients with liver metastases was 0.53, while for those without liver metastases, it was 0.64; for patients with three or more baseline metastatic sites, the PFS HR was 0.46 [2] Safety Profile - The overall safety profile of the Ivoris group was favorable, with no new safety signals identified; the incidence of treatment-related serious adverse events and grade 3 or higher bleeding events was similar to the control group [2] Regulatory Status - The new indication application for Ivoris combined with chemotherapy for first-line treatment of sq-NSCLC has been accepted by the CDE and is currently under review, potentially offering hope to more patients [2]
康方生物(09926):依沃西联合化疗对比替雷利珠联合化疗一线治疗晚期sq-NSCLC的HARMONi-6研究结果在柳叶刀& 2025 ESMO重磅发表
智通财经网· 2025-10-20 00:21
Core Insights - The clinical trial results of HARMONi-6 / AK112-306 were prominently presented by Professor Lu Shun at the ESMO 2025 and published in The Lancet, demonstrating the efficacy of Ivosidenib combined with chemotherapy for advanced sq-NSCLC [1][2] Group 1: Clinical Trial Overview - HARMONi-6 / AK112-306 is a randomized, controlled, multi-center Phase III clinical trial assessing Ivosidenib combined with chemotherapy versus Toripalimab combined with chemotherapy as first-line treatment for advanced sq-NSCLC [1][2] - The study enrolled 532 participants, with 92.3% of subjects in clinical stage IV, and the characteristics of squamous cell carcinoma were consistent with real-world patient distribution [1][2] Group 2: Key Findings - Ivosidenib combined with chemotherapy achieved a significant improvement in progression-free survival (PFS) compared to Toripalimab, with a hazard ratio (HR) of 0.60 and a p-value of <0.0001 [1] - The median PFS for the Ivosidenib group was 11.14 months, while the control group had a median PFS of 6.9 months, resulting in an absolute improvement of 4.24 months [1] Group 3: Subgroup Analysis - Significant benefits of Ivosidenib were observed across various subgroups, including those with different PD-L1 expression levels and liver metastasis status [1] - In the PD-L1 negative population, the median PFS was 9.9 months versus 5.7 months (HR = 0.55) [1] - In the PD-L1 positive population, the median PFS was 12.6 months versus 8.6 months (HR = 0.66) [1] Group 4: Safety Profile - The overall safety profile of the Ivosidenib group was favorable, with no new safety signals identified, and the incidence of treatment-related serious adverse events was similar to the control group [1]