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康方生物(09926.HK):HARMONI-6 MPFS表现亮眼 HARMONI-3最快2H26取得阶段性关键进展
Ge Long Hui· 2025-10-21 15:57
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]
西南证券:康方生物(09926)HARMONi-6数据优异 较对照组mPFS绝对值差值达4.24个月
智通财经网· 2025-10-21 07:11
Core Viewpoint - Kangfang Biopharma's drug Iwosimab (PD-1/VEGF dual antibody) has shown significant improvement in progression-free survival (PFS) compared to Tislelizumab in a Phase III clinical trial for advanced squamous non-small cell lung cancer (sq-NSCLC) [1][2] Group 1: Clinical Trial Results - The HARMONi-6 study demonstrated that Iwosimab combined with chemotherapy significantly extends PFS, achieving a median PFS of 11.14 months compared to 6.90 months for Tislelizumab, with a hazard ratio of 0.60 (P<0.0001), resulting in an absolute difference of 4.24 months [1] - The new indication application for Iwosimab in treating sq-NSCLC based on the HARMONi-6 study results has been accepted for review by the National Medical Products Administration (NMPA) [1] Group 2: Drug Approvals and Pipeline - Iwosimab has been included in the national medical insurance drug list, with 13 Phase III clinical trials currently in progress, covering various cancers including lung cancer and cholangiocarcinoma [2] - Iwosimab has received approval for two indications in China, with the first being for EGFR-mutant locally advanced or metastatic non-squamous NSCLC after EGFR-TKI treatment, and the second for PD-L1 positive locally advanced or metastatic NSCLC [2] Group 3: Other Drug Developments - Cardunili has received approval for a new indication in first-line treatment of cervical cancer, with approximately 10 Phase III or registration clinical trials actively advancing [3] - Cardunili is pursuing around 20 indications through combination therapies, with three indications currently approved in China [3]
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
Group 1 - The Hang Seng Index rose by 2.42% to close at 25,858.83 points on October 20, with a total net sell of 2.67 billion HKD through the southbound trading channel [1] - The total trading volume for the southbound trading on October 20 was 109.87 billion HKD, with a net sell of 2.67 billion HKD [1] - The Shanghai Stock Exchange's southbound trading had a total trading volume of 66.81 billion HKD, resulting in a net sell of 2.29 billion HKD, while the Shenzhen Stock Exchange's southbound trading had a volume of 43.05 billion HKD with a net sell of 0.38 billion HKD [1] Group 2 - In the top ten active stocks for the Shanghai Stock Exchange's southbound trading, Alibaba-W had the highest trading volume at 5.79 billion HKD, followed by SMIC and Tencent Holdings with trading volumes of 3.23 billion HKD and 2.93 billion HKD respectively [2] - In terms of net buying, China National Offshore Oil Corporation had the highest net buy amount of 0.146 billion HKD, with its stock price increasing by 2.31% [2] - Alibaba-W recorded the highest net sell amount of 1.205 billion HKD, while its stock price still rose by 4.86% [2]
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]