Core Insights - The report emphasizes the significant role of phosphoramidite monomers in the small nucleic acid industry chain, highlighting their impact on the development of small nucleic acid drugs, which are considered promising candidates for treating various diseases due to their unique molecular structures and therapeutic mechanisms [1][6][10] - The report predicts robust growth in the demand for phosphoramidite monomers, with multinational pharmaceutical companies likely to benefit from this trend, as the global nucleotide market is projected to reach USD 730 million in 2023, with China being the largest production market [10][11] Section Summaries Phosphoramidite Monomer's Role - Phosphoramidite monomers are crucial raw materials for synthesizing small nucleic acid drugs, enhancing their stability and biological activity, and driving innovation in drug development [6][9] - The solid-phase phosphoramidite method is the mainstream technique for synthesizing oligonucleotides, which are a major cost component in nucleic acid drug production [9] Market Dynamics - The report notes that 90% of global nucleotides are used for nucleic acid drug production, with only about 10% allocated to health foods and agriculture [10] - The small nucleic acid drug market is primarily dependent on major multinational pharmaceutical companies, indicating potential benefits for companies within their supply chains [11] Investment Recommendations - The report suggests focusing on innovative drug companies such as Furuya Co., OncoOne, and others, as well as raw material suppliers like WuXi AppTec and others, indicating a diverse range of investment opportunities in the sector [10]

Core Viewpoint - Corning Jereh Pharmaceutical-B (09966) announced that JSKN003 has received Fast Track Designation (FTD) from the U.S. Food and Drug Administration (FDA) for the treatment of platinum-resistant recurrent epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer, marking a significant milestone in the global development of JSKN003 [1] Group 1 - JSKN003 has been granted FTD by the FDA for treating platinum-resistant recurrent epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer, indicating its clinical potential [1] - The FDA has also approved a Phase II clinical trial for JSKN003 targeting platinum-resistant recurrent epithelial ovarian cancer with no restrictions on HER2 expression levels [1] - JSKN003 has received breakthrough therapy designation from the National Medical Products Administration (NMPA) for both PROC and colorectal cancer (CRC), and orphan drug designation from the FDA for gastric/gastroesophageal junction cancer (GC/GEJ) [1] Group 2 - The Phase III clinical trial for JSKN003 in treating platinum-resistant recurrent epithelial ovarian cancer is currently progressing smoothly in China [1] - The FTD designation further underscores the confidence of international regulatory bodies in the clinical potential and importance of JSKN003 as a novel therapeutic candidate [1]

Core Insights - Corning Jereh Pharmaceutical-B (09966) announced that JSKN003 has received Fast Track Designation (FTD) from the U.S. Food and Drug Administration (FDA) for the treatment of platinum-resistant recurrent epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer (collectively referred to as PROC) regardless of HER2 expression levels [1] Group 1 - JSKN003 has been approved by the FDA to conduct a Phase II clinical trial for treating PROC with no restrictions on HER2 expression levels [1] - The drug has also received Breakthrough Therapy Designation from the National Medical Products Administration (NMPA) for both PROC and colorectal cancer (CRC) [1] - Additionally, JSKN003 has been granted Orphan Drug Designation by the FDA for gastric/gastroesophageal junction cancer (GC/GEJ) [1] Group 2 - The Phase III clinical trial for JSKN003 in treating PROC is currently progressing smoothly in China [1] - The FTD designation further underscores the confidence of international regulatory bodies in the clinical potential of JSKN003 and its significance as a novel therapeutic candidate [1]

Core Insights - Corning Jereh Pharmaceutical-B (09966.HK) announced that JSKN003 has received Fast Track Designation (FTD) from the FDA for the treatment of platinum-resistant recurrent epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer, marking a significant milestone in its global development process [1] - JSKN003 has also been approved by the FDA to conduct a Phase II clinical trial for the same indication and has received Breakthrough Therapy Designation from the National Medical Products Administration for both PROC and colorectal cancer, as well as Orphan Drug Designation for gastric/gastroesophageal junction cancer [1] - The FTD designation underscores the confidence of international regulatory agencies in the clinical potential of JSKN003 as a new treatment candidate [1] Clinical Data Summary - The FTD for JSKN003 is based on promising clinical data, with a summary analysis presented at the 2025 American Society of Clinical Oncology Annual Meeting, which included 46 PROC patients [2] - Among these patients, 21 had HER2 IHC 0 (45.7%) and 18 had HER2 IHC 1+, 2+, and 3+ (39.1%), with an overall objective response rate (ORR) of 63.0% and a median progression-free survival (mPFS) of 7.7 months [2] - In patients with HER2 IHC 1+, 2+, and 3+, the ORR was 72.2% and mPFS was 9.4 months, indicating robust PFS benefits across different HER2 expression levels [2] Market Need - Ovarian cancer is one of the most common malignant tumors of the female reproductive system, with most patients diagnosed at an advanced stage, leading to high recurrence rates and poor prognosis [3] - Treatment options for PROC patients are limited, with existing non-platinum single-agent chemotherapy regimens showing an ORR of only 10% to 15%, mPFS of approximately 3 to 4 months, and a median overall survival of about 12 months, highlighting a significant unmet clinical need [3] - The FTD is expected to accelerate the clinical development and regulatory review process for JSKN003, providing new treatment options for PROC patients globally [3]

香港交易及結算所有限公司及香港聯合交易所有限公司對本公告之內容概不負責，對其準確性 或完整性亦不發表任何聲明，並明確表示，概不就因本公告全部或任何部分內容而產生或因倚 賴該等內容而引致的任何損失承擔任何責任。 康寧傑瑞生物製藥 （於開曼群島註冊成立的有限公司） （股份代號：9966） 自願公告 JSKN003獲美國FDA授予用於治療PROC的FTD 本公告乃由康寧傑瑞生物製藥（「本公司」，連同其附屬公司，統稱「本集團」）自願 作出，以知會本集團股東（「股東」）及潛在投資者有關本集團之最新業務進展。 本公司董事（「董事」）會（「董事會」）欣然宣佈，JSKN003已獲美國食品藥品監督 管理局（「FDA」）授予快速通道資格認定（「FTD」），用於治療不限人表皮生長因子 受體2（「HER2」）表達水平的鉑耐藥復發性上皮性卵巢癌、原發性腹膜癌或輸卵管 癌（統稱為「PROC」）。這標誌著JSKN003全球開發進程中的又一重要里程碑。 除此之外，JSKN003已獲美國FDA批准開展一項治療不限HER2表達水平的PROC 的II期臨床試驗，且分別在PROC和結腸直腸癌(CRC)上獲國家藥品監督管理局 （「國家藥監局」）藥品審 ...

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]

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]

Core Viewpoint - The announcement highlights the collaboration between Shanghai Jinmant Biotech Co., Ltd. and Jiangsu Kanion Pharmaceutical Co., Ltd. for the development of JSKN003, a targeted HER2 bispecific antibody-drug conjugate, which has received breakthrough therapy designation from the National Medical Products Administration for treating HER2-positive advanced colorectal cancer patients who have failed previous treatments [1] Group 1 - The drug JSKN003 is specifically indicated for use as a monotherapy in patients with HER2-positive advanced colorectal cancer who have previously failed treatments with oxaliplatin, fluorouracil, and irinotecan [1] - The breakthrough therapy designation signifies the potential of JSKN003 to offer significant benefits over existing therapies for the targeted patient population [1]

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]

Core Insights - The company, Shiyao Group, announced that its subsidiary, Shanghai Jinmant Biotech Co., Ltd., has received breakthrough therapy designation from the National Medical Products Administration (NMPA) for JSKN003, a targeted HER2 bispecific antibody-drug conjugate, for the treatment of HER2-positive advanced colorectal cancer patients who have failed previous treatments with oxaliplatin, fluorouracil, and irinotecan [1][4] Industry Context - Colorectal cancer is one of the most common malignancies globally, with 1.9262 million new cases and 903,900 deaths reported in 2022, ranking third in incidence and second in mortality among all cancers [2] - In China, colorectal cancer has a high incidence rate, second only to lung cancer, with over 500,000 new cases annually, and the number is rising [2] - Current approved treatments for HER2-positive advanced colorectal cancer patients who have failed previous therapies include regorafenib, fruquintinib, and trifluridine/tipiracil, but these have limited efficacy, with median progression-free survival (mPFS) of only 2-3.7 months and median overall survival (mOS) of 7-10 months [2] Clinical Research Findings - Preliminary clinical research results for JSKN003 show significant efficacy and good safety in the target patient population, with an objective response rate (ORR) of 61.9% and a disease control rate (DCR) of 95.2% among patients who had at least one tumor efficacy assessment [3] - The median progression-free survival (mPFS) for colorectal cancer patients treated with JSKN003 was reported at 13.77 months, with a median duration of response (mDoR) of 12.06 months [3] - Safety data indicated that only 14.0% of patients experienced grade 3 or higher treatment-related adverse events (TRAEs), and no TRAEs led to treatment discontinuation or death [3] Regulatory Developments - JSKN003 has received its second breakthrough therapy designation, previously granted for the treatment of platinum-resistant recurrent epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer [4] - The ongoing clinical studies for JSKN003 in China include multiple Phase II and III trials for various solid tumors, including breast cancer, ovarian cancer, and gastric cancer, which will expedite the product's development and review process [4]