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PD-(L)1/VEGF赛道攻坚,依沃西冲击首个海外适应症
Core Viewpoint - Summit Therapeutics plans to submit a Biologics License Application (BLA) to the FDA in Q4 2025 for evorpacept in combination with chemotherapy for EGFR mutation non-squamous non-small cell lung cancer (NSCLC) patients who have progressed after third-generation EGFR-TKI treatment, marking a significant step in the drug's overseas commercialization efforts [1][2]. Group 1: Clinical Trial Results - The decision to submit the BLA is based on the positive results from the global Phase III clinical trial HARMONi, which achieved its primary endpoint of progression-free survival (PFS) [1]. - Updated data from the HARMONi study showed an improvement in overall survival (OS) with a hazard ratio (HR) of 0.78 (p=0.0332) for the intention-to-treat (ITT) population, particularly notable in the North American cohort with an HR of 0.70 [2]. - The median overall survival (mOS) for the evorpacept group was reported at 16.8 months compared to 14 months for the control group, with a HR of 0.79 [1]. Group 2: Commercialization and Partnerships - In December 2022, a collaboration agreement worth up to $5 billion was established between Kangfang Biopharma and Summit Therapeutics for the development and commercialization of evorpacept in key markets including the US, Canada, Europe, and Japan [3]. - A supplemental licensing agreement was signed in June 2024, expanding Summit's rights to develop and commercialize evorpacept in additional markets including China, South America, the Middle East, and Africa, with Kangfang receiving a $70 million upfront payment [3]. Group 3: Industry Context and Future Prospects - The development of PD-(L)1/VEGF dual-targeted therapies is seen as a critical advancement in cancer treatment, addressing limitations of existing therapies [7][8]. - The success of evorpacept in clinical trials has sparked renewed interest and investment in the PD-(L)1/VEGF space, with significant cross-border transactions indicating the global market's recognition of the drug's potential [8][9]. - The ongoing clinical exploration of evorpacept is expected to accelerate, with Summit planning to initiate new Phase III trials targeting additional indications [6].
中国药企集体亮相欧洲肿瘤内科学会年会 行业看好“出海”持续发生
Zheng Quan Ri Bao Wang· 2025-10-22 02:49
Group 1 - The 2025 European Society for Medical Oncology (ESMO) annual meeting held in Berlin is recognized as one of the most influential oncology conferences globally, showcasing significant breakthroughs in research data from Chinese pharmaceutical companies [1] - The event is seen as a key catalyst for the international expansion of Chinese innovative drugs, with high-quality data disclosure being crucial for international collaboration [1][3] - A total of 2,929 abstracts were presented at the conference, with 448 from Chinese companies, indicating a strong presence and recognition of China's innovation capabilities [2] Group 2 - Chinese pharmaceutical companies showcased their innovative capabilities through clinical data presentations, with 23 studies selected for the latest breakthrough abstracts (LBA), a significant increase from 7 in 2024 [2] - Notable companies like Jiangsu Hengrui Medicine Co., Ltd. presented multiple LBA studies, highlighting their commitment to international research and development strategies [2] - The conference served as a foundation for further international market expansion, with positive clinical data acting as a catalyst for business development (BD) collaborations with major international pharmaceutical companies [3] Group 3 - The total value of overseas BD transactions for Chinese innovative drugs reached $387 billion in the first nine months of the year, nearing the total for the entire previous year [3] - Recent BD agreements, such as the one between Hansoh Pharmaceutical Group and Roche, indicate ongoing interest and activity in the sector [4] - Industry experts predict that while the total transaction value may not reach new highs, the overall number of BD transactions will remain substantial, driven by ongoing innovation and supportive policies [4][5]
研报掘金丨中金:下调康方生物目标价至184港元 维持“跑赢行业”评级
Ge Long Hui· 2025-10-22 02:45
Core Insights - The report from CICC highlights that Kangfang Biotech recently presented impressive interim analysis data from the HARMONi-6 trial at The Lancet & ESMO [1] - The company has revised the HARMONi-3 trial protocol to conduct independent statistical analysis based on histological types for the primary endpoint [1] - CICC believes that separate analysis will help the company obtain clinical data earlier and that increasing the enrolled population will contribute to better overall survival (OS) performance [1] Financial Projections - CICC maintains the profit forecasts for Kangfang Biotech at 0.09 CNY for 2025 and 0.59 CNY for 2026 [1] - The firm continues to rate the company as "outperforming the industry" [1] - Due to a downward adjustment in the valuation midpoint for innovative drugs in the Hong Kong stock market, CICC has reduced the target price by 18.2% to 184 HKD [1]
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
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]