Core Viewpoint - The company, Jiangsu Hengrui Medicine Co., Ltd., has announced that its injectable SHR-A1904 has been included in the list of breakthrough therapeutic varieties by the National Medical Products Administration (NMPA) of China [1] Group 1: Industry Context - Gastric cancer is a significant global health issue, ranking fifth in incidence and fourth in mortality worldwide, with approximately 60% of cases occurring in East Asia [1] - In China, gastric cancer is particularly prevalent, with 479,000 new cases and 374,000 deaths reported in 2020, accounting for 44.0% and 48.6% of global gastric cancer incidence and mortality, respectively [1] - The incidence and mortality rates of gastric cancer rank fourth and third among malignant tumors in China, posing a serious threat to public health [1] Group 2: Product Information - SHR-A1904 is a targeted antibody-drug conjugate (ADC) developed by the company, specifically targeting Claudin18.2, with its effective payload being a topoisomerase inhibitor (TOPOi) [2] - Claudin proteins are key components of tight junctions (TJ), maintaining various functions of TJs and stabilizing the intracellular environment [2] - Claudin18.2 is a highly specific cell surface molecule expressed only in differentiated gastric mucosal epithelial cells under normal conditions, but is highly expressed in gastric cancer, pancreatic cancer, and esophageal cancer [2] - Currently, there are no similar products approved for market globally, and the cumulative R&D investment for SHR-A1904 has reached approximately 174 million yuan [2]

Group 1 - The core announcement is that Jiangsu Hengrui Medicine Co., Ltd. and its subsidiary Shanghai Hengrui Medicine Co., Ltd. have had their injectable SHR-A1904 included in the list of breakthrough therapy products by the National Medical Products Administration [1] - Gastric cancer is a significant global health issue, ranking fifth in incidence and fourth in mortality worldwide, with approximately 60% of cases occurring in East Asia. In China, there were 479,000 new cases and 374,000 deaths from gastric cancer in 2020, accounting for 44.0% and 48.6% of global cases and deaths, respectively [1] Group 2 - SHR-A1904 is a targeted antibody-drug conjugate (ADC) developed by the company, specifically targeting Claudin18.2, with an effective payload of topoisomerase inhibitor (TOPOi). Claudin proteins are key components of tight junctions (TJ) that maintain various functions and stability of the intracellular environment [2] - Claudin18.2 is a highly specific cell surface molecule expressed only in differentiated gastric mucosal epithelial cells under normal conditions, but is highly expressed in gastric cancer, pancreatic cancer, and esophageal cancer. Currently, there are no similar products approved for market globally [2] - The cumulative R&D investment for SHR-A1904 has reached approximately 174 million yuan [2]

Core Viewpoint - Heng Rui Medicine announced that its subsidiary, Suzhou Shengdiya Biopharmaceutical Co., Ltd., and Shanghai Heng Rui Medicine Co., Ltd. received approval from the National Medical Products Administration for the clinical trial of SHR-A2102, a targeted antibody-drug conjugate [1] Group 1 - SHR-A2102 is a self-developed drug targeting Nectin-4, with an effective payload of topoisomerase I inhibitor (TOP1i) [1] - Currently, there is only one similar product approved globally, Enfortumab vedotin (brand name: Padcev) [1]

Core Viewpoint - The announcement highlights a significant licensing agreement between Jiangsu Xiansheng Zaiming Pharmaceutical Co., Ltd. and Ipsen Pharma SAS, granting Ipsen exclusive global rights to develop, manufacture, and commercialize the antibody-drug conjugate SIM0613 outside Greater China, with potential financial benefits for the company totaling up to $1.06 billion [1]. Group 1: Licensing Agreement Details - Jiangsu Xiansheng has signed an exclusive licensing agreement with Ipsen for the ADC SIM0613, targeting LRRC15 [1]. - Ipsen will pay an upfront fee of $45 million, along with milestone payments related to research, regulatory, and commercialization achievements, and tiered royalties on sales [1]. Group 2: Product Information - SIM0613 is a novel ADC that targets LRRC15, a protein highly expressed on the surface of various solid tumors and cancer-associated fibroblasts, but minimally expressed in normal cells [1]. - The design of SIM0613 allows it to penetrate tumors and cancer-associated fibroblasts effectively, demonstrating significant tumor regression in various preclinical in vivo models [1].

Core Viewpoint - 恒瑞医药 has received approval from the National Medical Products Administration for multiple clinical trials of new drug candidates, indicating a significant advancement in its oncology pipeline [1][2][3][4][5] Group 1: Drug Candidates and Their Development - SHR-9839 is a humanized antibody drug targeting advanced solid tumors, with a cumulative R&D investment of approximately 72.31 million yuan [1] - SHR-A2009 is an antibody-drug conjugate targeting HER3, with a cumulative R&D investment of about 227 million yuan; no similar drugs have been approved globally [2] - SHR-1826 is an antibody-drug conjugate targeting c-MET, with a cumulative R&D investment of around 101 million yuan; a similar product has been approved in the U.S. [2] - HRS-4642 is a KRAS G12D inhibitor with a cumulative R&D investment of approximately 191 million yuan; no similar drugs have been approved [2] - 阿得贝利单抗 is a humanized anti-PD-L1 monoclonal antibody that has been approved for use in extensive-stage small cell lung cancer, with a cumulative R&D investment of about 969 million yuan [3] - 注射用瑞康曲妥珠单抗 targets HER2 and has been approved for use in non-small cell lung cancer, with a cumulative R&D investment of around 1.415 billion yuan [4] - SHR-A2102 is an ADC targeting Nectin-4, with a cumulative R&D investment of approximately 248 million yuan; one similar product has been approved [5] - HRS-7058 is a selective small molecule inhibitor for KRAS G12C mutations, with a cumulative R&D investment of about 69.57 million yuan; similar products have been approved [5]

Core Viewpoint - The stock of InnoCare Pharma (09606) rose nearly 3% in early trading, currently up 2.23% at 301 HKD, with a trading volume of 18.1 million HKD, following the announcement that its partner Avenzo Therapeutics received FDA fast track designation for its EGFR/HER3 bispecific antibody drug conjugate AVZO-1418/DB-1418 [1][2]. Group 1 - Avenzo Therapeutics, a clinical-stage biotechnology company focused on next-generation cancer therapies, has been granted fast track designation by the FDA for AVZO-1418/DB-1418, aimed at treating patients with unresectable locally advanced or metastatic non-small cell lung cancer (NSCLC) [1][2]. - The fast track designation is specifically for patients with EGFR mutations (exon 19 deletions or L858R mutations) who have experienced disease progression after treatment with EGFR tyrosine kinase inhibitors (TKIs) [2]. - Currently, AVZO-1418/DB-1418 is undergoing an open-label Phase 1/2 clinical trial to evaluate its safety, tolerability, and preliminary clinical activity as a monotherapy and in combination therapy for patients with advanced solid tumors [2].

Core Viewpoint - The news highlights that EnGene Biotech-B (09606) has seen a stock price increase following the announcement that its partner Avenzo Therapeutics has received Fast Track designation from the FDA for its dual-specific antibody drug conjugate AVZO-1418/DB-1418, aimed at treating non-small cell lung cancer (NSCLC) patients with specific mutations [1][2]. Group 1: Company Developments - EnGene Biotech-B's stock rose nearly 3% in early trading, currently at 301 HKD with a trading volume of 18.1 million HKD [1]. - Avenzo Therapeutics, a clinical-stage biotechnology company, announced the FDA's Fast Track designation for AVZO-1418/DB-1418, which is a significant milestone for the drug's development [1][2]. Group 2: Product and Clinical Trials - The Fast Track designation is specifically for the treatment of patients with unresectable locally advanced or metastatic NSCLC who have specific EGFR mutations and have progressed after TKI treatment [2]. - AVZO-1418/DB-1418 is currently undergoing an open-label Phase 1/2 clinical trial to evaluate its safety, tolerability, and preliminary clinical activity as a monotherapy and in combination therapy for patients with advanced solid tumors [2].

Core Insights - The National Medical Products Administration of China has approved the listing application for the candidate drug Meiyouheng® (Injection Vebecotamab) developed by the company, which is an innovative antibody-drug conjugate targeting the epidermal growth factor receptor (EGFR) for the treatment of recurrent or metastatic nasopharyngeal carcinoma (R/MNPC) [1] Group 1: Drug Development and Approval - Meiyouheng® is an ADC composed of an EGFR-targeting monoclonal antibody linked to a potent microtubule inhibitor, demonstrating high specificity for tumor cells expressing EGFR, which is prevalent in various malignancies [1] - The drug targets EGFR, which is expressed in 89% of advanced nasopharyngeal carcinoma cases, making it a significant target for cancer treatment [1] Group 2: Clinical Efficacy and Safety - Meiyouheng® has shown clinically meaningful efficacy advantages in patients who have failed second-line systemic chemotherapy and PD-(L)1 inhibitors, with manageable safety profiles [2] - In a Phase II clinical trial, the combination therapy of Meiyouheng® with Putiheng (Injection Putilizumab) achieved the highest confirmed objective response rate (cORR) of 73.3% and the longest median progression-free survival (mPFS) of 10.9 months in patients who failed immunotherapy and platinum-based chemotherapy [2]

Core Viewpoint - Lepu Biopharma-B (02157) has received approval from the National Medical Products Administration for its candidate drug Meiyouheng (injectable Vebrecatinib), marking a significant milestone for the company in the treatment of recurrent or metastatic nasopharyngeal carcinoma (R/M NPC) [1] Group 1 - Meiyouheng (injectable Vebrecatinib) is the first EGFR-targeted antibody-drug conjugate (ADC) approved in China, representing a pioneering achievement in this category [1] - The approval of Meiyouheng is expected to enhance treatment outcomes for patients suffering from R/M NPC [1] - The company plans to expand the indications for Meiyouheng based on this approval, aiming to accelerate the realization of its commercial potential [1]

Core Viewpoint - Heng Rui Medicine (01276) has received approval from the National Medical Products Administration for clinical trials of SHR-A2102, a targeted antibody-drug conjugate (ADC) [1] Group 1: Product Development - SHR-A2102 is a self-developed ADC targeting Nectin-4, with a payload of topoisomerase I inhibitor (TOP1i) [1] - Nectin-4 is highly expressed in tumors, correlating with tumor progression and poor prognosis [1] Group 2: Market Context - Currently, there is one similar product approved globally, Enfortumab vedotin (brand name: Padcev), with projected global sales of approximately $1.949 billion in 2024 [1] - The cumulative R&D investment for SHR-A2102 has reached approximately 225 million yuan [1]