Core Insights - The collaboration between Innovent Biologics and Takeda Pharmaceutical aims to develop cancer treatment drugs, with a total deal value of $11.4 billion, marking the highest record for a biopharmaceutical licensing deal from China [2][4] - The partnership focuses on two late-stage therapies and one early-stage project, leveraging Innovent's innovative immune-oncology and antibody-drug conjugate (ADC) therapies [2][5] Group 1: Deal Structure and Strategic Importance - The deal involves a co-development model where both companies will share development costs and commercial rights, with a 40/60 cost-sharing ratio for IBI363 [9] - Takeda's leadership sees this collaboration as a way to enhance its oncology pipeline, balancing developments in hematologic and solid tumors [4][22] - Takeda has made significant investments in China over the past three years, with disclosed transaction amounts exceeding 100 billion RMB [4][23] Group 2: Product Details and Clinical Status - IBI363 is a dual-antibody product that targets PD-1/PD-L1 pathways and activates IL-2 pathways, showing promise in treating lung and colorectal cancers [5][8] - IBI343, an ADC, has demonstrated significant efficacy against advanced gastric cancer and pancreatic ductal adenocarcinoma [5][8] - Both products have entered Phase III clinical trials, indicating advanced stages of development [8] Group 3: Takeda's Global Strategy and Market Focus - Takeda's CEO, Christophe Weber, emphasizes the importance of bringing Chinese innovations to the global market, aligning with the company's "Takuvi China" strategy to make China its second-largest market by 2030 [15][22] - The company has shifted focus to oncology, neuroscience, and gastrointestinal diseases, prioritizing innovative biotherapeutics and ADCs [14][22] - Takeda's global presence spans over 80 countries, with a strong emphasis on research and development, investing over $5 billion annually [27][28] Group 4: Leadership and Future Outlook - Christophe Weber, the first non-Japanese CEO of Takeda, has been pivotal in the company's global expansion and innovation strategy [29][30] - The upcoming leadership transition to Julie Kim is expected to continue the momentum in commercializing rare disease and oncology products [32][33] - The collaboration with Innovent is viewed as a significant asset for Takeda's future growth, particularly in the context of increasing competition and innovation in the biopharmaceutical sector [11][22]

Core Viewpoint - The article discusses a significant clinical study on bladder cancer treatment conducted by Chinese researchers, highlighting the promising results of combining two novel drugs, a PD-1 immune drug and an HER2-targeted antibody-drug conjugate, which may redefine first-line treatment standards for advanced bladder cancer [1][6][9]. Group 1: Bladder Cancer Overview - Bladder cancer is the most common type of urinary system tumor, with nearly 100,000 new cases reported annually in China, primarily affecting middle-aged and older men, largely due to smoking [1][2]. - Early detection of bladder cancer leads to high survival rates, but advanced stages are challenging due to drug resistance and recurrence [2]. Group 2: Treatment Landscape - Traditional chemotherapy has been the main treatment for bladder cancer for decades, but it has limited effectiveness, with a median survival of just over one year and significant side effects [3]. - New drug classes, including immune therapies and antibody-drug conjugates (ADCs), have emerged as hopeful alternatives, with several PD-1/PD-L1 immune drugs already approved for bladder cancer [4][5]. Group 3: Clinical Study Insights - The recent study involved 484 patients with HER2-positive advanced urothelial carcinoma, randomly assigned to receive either the new drug combination or traditional chemotherapy [9]. - Results showed that the new drug combination significantly outperformed chemotherapy across various metrics, indicating a potential shift in treatment standards [10][14]. Group 4: Drug Development and Approval - The combination of the PD-1 immune drug Toripalimab and the HER2-targeted ADC Disitamab Vedotin has shown promising results, with the potential for approval in first-line treatment for advanced bladder cancer [17][18]. - The success of this study reflects the rapid advancement of China's domestic drug development capabilities, with increasing recognition in top-tier clinical journals [19][20]. Group 5: Future Directions - The emergence of multiple treatment options for bladder cancer, including various drug combinations, suggests a move away from traditional chemotherapy as the sole first-line treatment [21]. - Future treatment decisions may rely on biomarker expressions, such as HER2 and PD-L1, to optimize patient outcomes [22]. - Ongoing research is expected to explore the durability of treatment responses and the potential for earlier intervention in the treatment process [24].

Core Viewpoint - The announcement of the latest research results for the CLDN18.2 antibody-drug conjugate ATG-022 at the ESMO 2025 conference has positively impacted the stock price of DQ Pharma-B, reflecting investor confidence in the drug's potential [1][2]. Group 1: Clinical Research Results - ATG-022 demonstrated good safety and significant anti-tumor activity in patients with varying levels of CLDN18.2 expression in gastric cancer (GC) and gastroesophageal junction cancer (GEJC) [1]. - Preliminary efficacy was also observed in other non-gastrointestinal tumors, with further data expected to be presented at upcoming academic conferences [1]. Group 2: Dosage and Safety Data - The safety data for the 2.4 mg/kg dosage group was favorable, while the 1.8 mg/kg dosage group showed even better safety and tolerability [2]. - This data supports the potential for ATG-022 to be combined with immune checkpoint inhibitors and chemotherapy in frontline treatment, which could significantly expand its clinical applications and commercialization potential [2]. Group 3: Ongoing Development - The I phase dose expansion study of ATG-022 is progressing smoothly in mainland China and Australia [2]. - The company is actively preparing for clinical research on combination therapies involving ATG-022 to further advance its clinical development [2].

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]

Core Viewpoint - The announcement highlights the breakthrough therapy designation granted to JSKN003, a targeted HER2 bispecific antibody-drug conjugate, for treating HER2-positive metastatic colorectal cancer patients who have failed previous treatments [1][4]. Group 1: Company Developments - Shanghai Jinmant Biotech, a subsidiary of the company, collaborates with Jiangsu Hengrui Medicine Co., Ltd. to develop JSKN003 [1]. - JSKN003 has received its second breakthrough therapy designation, previously granted for treating platinum-resistant recurrent epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer [4]. - The ongoing clinical studies for JSKN003 include multiple Phase II and III trials for treating breast cancer, ovarian cancer, and gastric cancer in China [4]. Group 2: 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, with over 500,000 new cases annually, making it the second most common cancer after lung cancer [2]. - Current approved treatments for HER2-positive metastatic colorectal cancer in China show limited efficacy, with median progression-free survival (mPFS) of only 2-3.7 months and median overall survival (mOS) of 7-10 months [2]. Group 3: Clinical Research Findings - Preliminary clinical research results for JSKN003 indicate significant efficacy and safety in treating HER2-positive metastatic colorectal cancer, with an objective response rate (ORR) of 61.9% and 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 from the Phase II recommended dose cohort showed that only 14.0% of patients experienced grade 3 or higher treatment-related adverse events (TRAEs), with no treatment-related deaths reported [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。 ALPHAMAB ONCOLOGY 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於2025年ESMO大會上展示的研究進展 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的研究進展已於2025年 10月17日至10月21日舉行的2025年ESMO大會壁報展示期間公佈。此研究進展概 述如下。 JSKN003治療原發性鉑難治OC患者的療效及安全性 JSKN003-102為一項在中國晚期實體瘤患者中開展的I期（劑量遞增及劑量擴展） 及II期（隊列擴展）臨床研究。截至2025年6月13日，共有26名原發性鉑難治OC患 者接受JSKN003治療(6.3mg/kg，Q3W)。患者中位年齡為54歲，其 ...

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。 ALPHAMAB ONCOLOGY 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再次獲得CDE突破性療法認定 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，與石藥集團有限公司（股份代號： 1093）附屬公司上海津曼特生物科技有限公司合作開發的JSKN003獲得CDE突破 性療法認定，用於治療既往經奧沙利鉑、氟尿嘧啶和伊立替康治療失敗的HER2+ 晚期CRC患者。此前，JSKN003已於2025年3月獲得CDE突破性療法認定，用於 治療PROC，且不限HER2表達水平。有關詳情請參閱本公司日期為2025年3月18 日的公告。 本公司曾在2025年美國臨床腫瘤學會(ASCO)年會上發表過一項JSKN00 ...

自願公告 JSKN 003於中國再次獲授予突破性治療認定 用於治療HER2陽性晚期結直腸癌患者 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，概不對因本公告全部或任何部份內容而產 生或因倚賴該等內容而引致之任何損失承擔任何責任。 CSPC PHARMACEUTICAL GROUP LIMITED 石 藥 集 團 有 限 公 司 （股份代號：1093） （於香港註冊成立之有限公司） 在 2025 年 美 國 臨 床 腫 瘤 學 會 (ASCO ) 年 會 上 ， 一 項「 JSKN 003 單 藥 治 療 晚 期 HER2 高 表 達 （ IHC3 + ）胃腸道腫瘤患者的兩項臨床研究匯總分析」被發表。該項匯總分析包括在澳大利亞 進行的I期臨床研究(JSKN 003 -101)和在中國進行的I / II期臨床研究(JSKN 003 -102)。截至2025 年2 月 28 日 ，兩項 研究 共入組 50 例 HER2高 表達 的晚期 胃腸道 腫瘤 患者（ 其 中23 例為結 直腸 癌 ），其中38 %的患者既往接受過≥ 3線抗腫瘤治療。初 ...

Core Viewpoint - Fosun Pharma's subsidiary, Shanghai Fuhong Hanlin Biotechnology Co., Ltd., has received Orphan-drug Designation from the FDA for its investigational drug HLX43, aimed at treating thymic epithelial tumors (TETs) [1] Group 1: Drug Development - HLX43 is a targeted PD-L1 antibody-drug conjugate (ADC) developed by Fuhong Hanlin, combining a novel DNA topoisomerase I inhibitor small molecule toxin-peptide linker with an independently developed PD-L1 targeting antibody [1] - The drug is intended for the treatment of advanced/metastatic solid tumors [1]

Core Viewpoint - Fosun Pharma's subsidiary, Hanhui, has received orphan drug designation from the US FDA for its investigational drug HLX43, a PD-L1 targeted antibody-drug conjugate for the treatment of thymic epithelial tumors (TETs) [1] Group 1: Drug Development - HLX43 is a novel antibody-drug conjugate (ADC) developed by linking a small molecule toxin-peptide chain with a self-developed PD-L1 targeted antibody [1] - The drug is intended for the treatment of advanced/metastatic solid tumors [1] - As of the announcement date, HLX43 is in Phase I clinical trials in China, with the thymic carcinoma (TC) cohort being part of an international multicenter trial approved in the US and Japan [1] Group 2: Market Context - There are currently no approved PD-L1 targeted antibody-drug conjugates available in the global market [1]