ALPHAMAB(09966)
Search documents
港股异动 | 医药股普遍承压 荣昌生物(09995)跌超11% 康宁杰瑞制药-B(09966)...
Xin Lang Cai Jing· 2025-10-23 06:09
Group 1 - The pharmaceutical sector is under pressure, with notable declines in stock prices for companies such as Rongchang Biopharma (-11.2%), CStone Pharmaceuticals (-8.2%), Junshi Biosciences (-5.16%), and Kintor Pharmaceutical (-4.63%) [1] - Haitong International's recent report indicates that the pharmaceutical index has underperformed the broader market post the October Golden Week, primarily due to fluctuating tariffs and underwhelming external licensing expectations [1] - Guosen Securities believes that China's innovative drug industry shows a long-term positive development trend, particularly highlighted by explosive growth in BD transactions in recent years [1] Group 2 - The ESMO 2025 conference in Berlin featured 112 results, including 21 related to domestic new drug research [2] - Innovent Biologics announced a global strategic collaboration with Takeda Pharmaceutical to advance the development of next-generation immuno-oncology and antibody-drug conjugate therapies, with an upfront payment of $1.2 billion and potential milestone payments totaling up to $10.2 billion, bringing the total deal value to a maximum of $11.4 billion [2]
医药股普遍承压 荣昌生物跌超11% 康宁杰瑞制药-B跌超8%
Zhi Tong Cai Jing· 2025-10-23 06:02
Group 1 - The pharmaceutical sector is under pressure, with notable declines in stock prices for companies such as Rongchang Biologics down 11.2% to HKD 81.65, and Innovent Biologics down 5.16% to HKD 25 [1] - Haitong International's recent report indicates that the pharmaceutical index has underperformed the market post the October Golden Week, primarily due to fluctuating tariffs and underwhelming external licensing expectations [1] - Guosen Securities believes that China's innovative drug industry shows a long-term positive development trend, particularly highlighted by explosive growth in BD transactions in recent years [1] Group 2 - The ESMO 2025 conference in Berlin featured 112 results, including 21 related to domestic new drug research [2] - Innovent Biologics announced a global strategic collaboration with Takeda Pharmaceutical to advance the development of next-generation immuno-oncology and antibody-drug conjugate therapies, with an upfront payment of USD 1.2 billion and potential milestone payments totaling up to USD 10.2 billion, bringing the total deal value to a maximum of USD 11.4 billion [2]
港股异动 | 医药股普遍承压 荣昌生物(09995)跌超11% 康宁杰瑞制药-B(09966)跌超8%
智通财经网· 2025-10-23 06:00
Group 1 - The pharmaceutical sector is under pressure, with notable declines in stock prices for companies such as Rongchang Biopharma (-11.2%), CStone Pharmaceuticals (-8.2%), Junshi Biosciences (-5.16%), and Kintor Pharmaceutical (-4.63%) [1] - Haitong International's recent report indicates that the pharmaceutical index has underperformed the broader market post the October Golden Week, primarily due to fluctuating tariffs and underwhelming external licensing expectations [1] - Guosen Securities believes that China's innovative drug industry shows a long-term positive development trend, particularly highlighted by explosive growth in BD transactions in recent years [1] Group 2 - The ESMO 2025 conference in Berlin featured 112 results, including 21 related to domestic new drug research [2] - Innovent Biologics announced a global strategic collaboration with Takeda Pharmaceutical to advance the development of next-generation immuno-oncology and antibody-drug conjugate therapies, with an upfront payment of $1.2 billion and potential milestone payments totaling up to $10.2 billion, bringing the total deal value to a maximum of $11.4 billion [2]
国金证券:国产新药成ESMO全场焦点 持续关注泛癌种潜力的新一代疗法等机会
智通财经网· 2025-10-23 01:37
Core Insights - The report from Guojin Securities highlights the significant advancements in China's innovative drug research presented at the ESMO conference, indicating a potential boost for the international expansion of these drugs [1] Group 1: Innovative Drug Research - The number of significant research publications from Chinese pharmaceutical companies at ESMO has reached a historical high, making it a focal point of the conference [1] - A total of 35 Chinese studies were included in the regular oral abstracts for the 2025 ESMO conference, with 14 formal oral presentations, a significant increase from 5 in 2024 [1] - The inclusion of 23 Chinese studies in the Late-Breaking Abstracts (LBA) category also set a new record, showcasing the research strength and academic influence of Chinese companies on the international stage [1] Group 2: ADC Developments - Domestic ADCs are demonstrating the potential to redefine existing clinical treatment standards, with notable products like Kelun's SKB264 showing promising Phase III clinical data for NSCLC and HR+/HER2- breast cancer [2] - The mOS data for SKB264 in the second-line EGFRm NSCLC treatment is particularly impressive, with a hazard ratio of 0.60, indicating a significant survival benefit [2] - Bai Li Tian Heng's ADC, iza-bren, has achieved breakthroughs in treating nasopharyngeal carcinoma, marking a critical milestone from concept validation to efficacy verification [2] Group 3: Bispecific and Multi-specific Antibodies - Bispecific and multi-specific antibodies are poised to upgrade existing immunotherapy and targeted therapy, with significant data from Kangfang Biotech's PD-1/VEGF bispecific antibody showing superior results compared to traditional treatments for advanced squamous NSCLC [3] - The mPFS for the combination of the bispecific antibody and chemotherapy was reported at 11.14 months versus 6.90 months for the comparator, with a hazard ratio of 0.60, indicating a strong potential to reshape first-line treatment standards [3] - The HER2 bispecific antibody KN026 from Shiyao Group/Kangning Jierei has shown promising results in III phase trials for gastric cancer, indicating its potential as a global leader in this category [3]
康宁杰瑞制药-B:JSKN003的研究进展已于2025年ESMO大会壁报展示期间公布
Zhi Tong Cai Jing· 2025-10-20 01:58
Core Viewpoint - Corning Jereh Pharmaceutical-B (09966) announced the research progress of JSKN003, which was presented at the 2025 ESMO conference from October 17 to October 21, 2025 [1] Group 1: Product Development - JSKN003 is a targeted HER2 bispecific ADC that connects a topoisomerase I inhibitor to the N-glycosylation site of the KN026 antibody using glycosylation point coupling technology [1] - The coupling reaction of the click reaction conjugate shows better serum stability compared to the maleimide-Michael reaction conjugate [1] - Targeting HER2 bispecificity allows JSKN003 to have stronger endocytic activity and bystander killing effect, demonstrating significant anti-tumor activity in HER2-expressing tumors [1] Group 2: Licensing and Clinical Trials - In September 2024, the company entered into a licensing agreement with Shanghai Jinmant Biotechnology Co., Ltd. to develop, sell, and commercialize JSKN003 in mainland China for tumor-related indications [1] - Currently, three Phase III clinical trials for JSKN003 are ongoing, targeting HER2+ breast cancer, HER2-low expressing breast cancer, and PROC [1]
康宁杰瑞制药-B:JSKN003再次获得CDE突破性疗法认定
Zhi Tong Cai Jing· 2025-10-20 01:58
Core Viewpoint - Corning Jereh Pharmaceutical-B (09966) announced that its collaboration with Shanghai Jinmant Biotech Co., a subsidiary of CSPC Pharmaceutical Group (1093), has received breakthrough therapy designation from CDE for JSKN003, aimed at treating HER2+ advanced colorectal cancer (CRC) patients who have failed previous treatments with oxaliplatin, fluorouracil, and irinotecan [1] Group 1: Product Development and Clinical Trials - JSKN003 has previously received breakthrough therapy designation for treating PROC, regardless of HER2 expression levels [1] - CRC is the second most common malignant tumor in China, with over 500,000 new cases annually and a rising trend [1] - There are currently no approved anti-HER2 targeted therapies for CRC in China, and existing therapies for HER2+ advanced CRC patients have a median progression-free survival (mPFS) of only 2.0-3.7 months and a median overall survival (mOS) of approximately 7-10 months, indicating a significant unmet clinical need [1] Group 2: Clinical Research Findings - A summary analysis presented at the 2025 ASCO annual meeting showed that JSKN003 monotherapy for HER2 high-expressing advanced CRC patients demonstrated significant efficacy and good safety [2] - The analysis included 50 HER2 high-expressing advanced gastrointestinal cancer patients, with 23 being CRC patients; 38% had previously received three or more lines of anti-tumor therapy [2] - Among 21 HER2 high-expressing CRC patients who underwent at least one tumor efficacy assessment, the overall response rate (ORR) was 61.9%, disease control rate (DCR) was 95.2%, mPFS was 13.77 months, and median duration of response (mDoR) was 12.06 months [2] - In a subgroup of 20 BRAF V600E wild-type CRC patients, the ORR reached 65.0% [2] - Safety data indicated that out of 43 patients who received the recommended phase II dose, only 14.0% experienced grade 3 or higher treatment-related adverse events (TRAEs) [2] Group 3: Mechanism and Collaboration - JSKN003 is a targeted HER2 bispecific antibody-drug conjugate (ADC) that connects a topoisomerase I inhibitor to a recombinant humanized anti-HER2 bispecific antibody using glycosylation point coupling technology, providing better serum stability [3] - The bispecific targeting of HER2 enhances JSKN003's internalization activity and bystander killing effect, resulting in strong anti-tumor activity in HER2-expressing tumors [3] - In September 2024, the company entered into a licensing agreement with Shanghai Jinmant Biotech to develop, sell, and commercialize JSKN003 in mainland China for tumor-related indications, with three ongoing phase III clinical trials for HER2+ breast cancer, HER2 low-expressing breast cancer, and PROC [3]
康宁杰瑞制药-B(09966):JSKN003的研究进展已于2025年ESMO大会壁报展示期间公布
智通财经网· 2025-10-20 00:54
Core Viewpoint - Corning Jereh Pharmaceutical-B (09966) announced the research progress of JSKN003, a targeted HER2 bispecific ADC, which was presented at the 2025 ESMO conference from October 17 to October 21, 2025 [1] Group 1 - JSKN003 utilizes glycosylation site-specific conjugation technology to link a topoisomerase I inhibitor to the KN026 antibody, enhancing serum stability compared to traditional conjugation methods [1] - The bispecific targeting of HER2 provides JSKN003 with stronger endocytic activity and bystander killing effects, demonstrating significant antitumor activity in HER2-expressing tumors [1] - In September 2024, the company entered into a licensing agreement with Shanghai Jinmant Biotechnology Co., Ltd. for the development, sale, and commercialization of JSKN003 in mainland China for tumor-related indications [1] Group 2 - Currently, three Phase III clinical trials for JSKN003 are ongoing, targeting HER2+ breast cancer, HER2-low expressing breast cancer, and PROC [1]
康宁杰瑞制药-B(09966):JSKN003再次获得CDE突破性疗法认定
智通财经网· 2025-10-20 00:40
Core Viewpoint - Corning Jereh Pharmaceutical-B (09966) announced that its collaboration with Shanghai Jinmant Biotech Co., a subsidiary of CSPC Pharmaceutical Group (1093), has received CDE breakthrough therapy designation for JSKN003, aimed at treating HER2+ advanced colorectal cancer (CRC) patients who have failed prior treatments with oxaliplatin, fluorouracil, and irinotecan [1] Group 1: Product Development and Clinical Trials - JSKN003 has previously received CDE breakthrough therapy designation for treating PROC, regardless of HER2 expression levels [1] - CRC is the second most common malignant tumor in China, with over 500,000 new cases annually and a rising trend, yet there are no approved anti-HER2 targeted therapies for CRC in the country [1] - Current approved therapies for HER2+ advanced CRC patients have a median progression-free survival (mPFS) of only 2.0-3.7 months and a median overall survival (mOS) of approximately 7-10 months, indicating a significant unmet clinical need [1] Group 2: Clinical Research Findings - A summary analysis of two clinical studies presented at the 2025 ASCO annual meeting showed that JSKN003 monotherapy for HER2 high-expressing advanced CRC patients demonstrated significant efficacy and good safety [2] - The studies included 50 HER2 high-expressing advanced gastrointestinal cancer patients, with 23 being CRC patients; the overall response rate (ORR) was 61.9%, and the disease control rate (DCR) was 95.2% [2] - Among 21 HER2 high-expressing CRC patients who had at least one tumor efficacy assessment, the mPFS was 13.77 months, and the median duration of response (mDoR) was 12.06 months [2] Group 3: Mechanism and Collaboration - JSKN003 is a targeted HER2 bispecific antibody-drug conjugate (ADC) that connects a topoisomerase I inhibitor to the N-glycosylation site of the KN026 antibody using glycosylation point coupling technology, providing better serum stability [3] - The bispecific targeting of HER2 enhances JSKN003's internalization activity and bystander killing effect, resulting in strong anti-tumor activity in HER2-expressing tumors [3] - In September 2024, the company entered into a licensing agreement with Shanghai Jinmant Biotech to develop, sell, and commercialize JSKN003 for tumor-related indications in mainland China, with three ongoing Phase III clinical trials for HER2+ breast cancer, HER2 low-expressing breast cancer, and PROC [3]
康宁杰瑞制药-B(09966.HK):JSKN003研究进展已于2025年ESMO大会壁报展示期间公布
Ge Long Hui· 2025-10-20 00:15
Core Viewpoint - Corning Jereh Pharmaceutical-B (09966.HK) announced the research progress of JSKN003, a targeted HER2 bispecific ADC, which was presented at the 2025 ESMO conference from October 17 to October 21, 2025 [1] Group 1: Product Development - JSKN003 is a targeted HER2 bispecific ADC that connects a topoisomerase I inhibitor to the N-glycosylation site of the KN026 antibody using glycosylation point coupling technology [1] - The coupling reaction of the click reaction conjugate shows better serum stability compared to the maleimide-Michael reaction conjugate [1] - JSKN003 exhibits stronger endocytosis activity and bystander killing effect due to its dual targeting of HER2, demonstrating significant antitumor activity in HER2-expressing tumors [1] Group 2: Licensing and Clinical Trials - In September 2024, the company entered into a licensing agreement with Shanghai Jinmant Biotechnology Co., Ltd. to develop, sell, and commercialize JSKN003 in mainland China for tumor-related indications [1] - Currently, three Phase III clinical trials for JSKN003 are ongoing, targeting HER2+ breast cancer, HER2-low expressing breast cancer, and PROC [1]
康宁杰瑞制药-B(09966.HK):JSKN003再次获得CDE突破性疗法认定
Ge Long Hui· 2025-10-20 00:09
Core Viewpoint - Corning Jereh Pharmaceutical-B (09966.HK) announced that its collaboration with Shanghai Jinmant Biotech Co., a subsidiary of CSPC Pharmaceutical Group (01093.HK), has led to the breakthrough therapy designation from CDE for JSKN003, aimed at treating HER2+ advanced colorectal cancer (CRC) patients who have failed prior treatments with oxaliplatin, fluorouracil, and irinotecan [1] Group 1 - JSKN003 has previously received breakthrough therapy designation from CDE in March 2025 for treating PROC, with no restrictions on HER2 expression levels [1]