Core Viewpoint - The company, Sihon Pharmaceutical, has received approval from the National Medical Products Administration of China for clinical trials of its dual-specific antibody-drug conjugate candidate SIM0610, aimed at treating patients with locally advanced or metastatic solid tumors [1] Group 1: Product Development - SIM0610 targets both Epidermal Growth Factor Receptor (EGFR) and c-MET, utilizing a dual-target approach to enhance anti-tumor activity and potentially overcome resistance associated with EGFR-Tyrosine Kinase Inhibitors (EGFR-TKIs) [1] - Preclinical studies have demonstrated significant anti-tumor activity of SIM0610 across various tumor models [1] Group 2: Company Profile - The company is an innovation and research-driven pharmaceutical firm, operating a national key laboratory for neuro and oncology drug development [1] - The company focuses on neuroscience, oncology, autoimmune diseases, and anti-infective fields, while strategically positioning itself in areas with significant clinical needs [1] - The company emphasizes a mission of "born for patients" and drives its initiatives through independent research and collaborative innovation, establishing strategic partnerships with various innovative enterprises and research institutions [1]

Core Viewpoint - The company announced that its self-developed bispecific antibody-drug conjugate (BsADC) candidate SIM0610 has received clinical trial approval from the National Medical Products Administration of China for trials targeting patients with locally advanced or metastatic solid tumors [1] Group 1: Product Development - SIM0610 targets both epidermal growth factor receptor (EGFR) and mesenchymal epithelial transition factor (cMET), releasing topoisomerase I inhibitors (TOP1i) to induce apoptosis in tumor cells [1] - The activation of EGFR and cMET is abnormally high in various solid tumors, including non-small cell lung cancer, with cMET activation being a significant mechanism for resistance to epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs) [1] - Preclinical studies have shown that SIM0610 exhibits significant anti-tumor activity across various tumor models [1] Group 2: Company Overview - The company is an innovation and research-driven pharmaceutical firm, operating a "National Key Laboratory for Neuroscience and Oncology Drug Development" [1] - The company focuses on neuroscience, anti-tumor, autoimmune, and anti-infection fields, while proactively positioning itself in areas with significant clinical needs [1] - The company emphasizes its mission of "born for patients" through self-innovation and collaborative innovation, establishing strategic partnerships with various innovative enterprises and research institutions [1]

Core Viewpoint - The announcement highlights that the bi-specific antibody-drug conjugate candidate SIM0610 developed by the company has received clinical trial approval from the National Medical Products Administration of China for trials targeting patients with locally advanced or metastatic solid tumors [1] Group 1: Drug Development - SIM0610 targets both epidermal growth factor receptor (EGFR) and mesenchymal-epithelial transition factor (cMET) as a bi-specific antibody-drug conjugate (BsADC) [1] - The drug induces apoptosis in tumor cells by releasing topoisomerase I inhibitors (TOP1i) through internalization [1] - Preclinical studies have shown significant anti-tumor activity of SIM0610 across various tumor models [1] Group 2: Mechanism of Action - EGFR and cMET are abnormally activated in several solid tumors, including non-small cell lung cancer [1] - Activation of cMET is a key mechanism for resistance to epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs) [1] - The dual-target approach of SIM0610 is expected to enhance anti-tumor activity and overcome drug resistance [1]

Core Viewpoint - Corning Jereh Pharmaceutical-B (09966) has received formal acceptance from the National Medical Products Administration (NMPA) for its Investigational New Drug (IND) application for JSKN027, a dual-specific antibody-drug conjugate (ADC) targeting PD-L1 and VEGFR2, aimed at treating advanced malignant solid tumors [1] Group 1: Clinical Trial Details - The company plans to conduct a Phase I clinical study of JSKN027 to evaluate its safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity in patients with advanced malignant solid tumors [1] - The study will also determine the maximum tolerated dose and/or recommended dose for Phase II trials [1] Group 2: Unique Positioning and Preclinical Data - JSKN027 is the first PD-L1/VEGFR2 dual-targeting ADC to enter clinical research globally, with no other ADCs targeting VEGFR2 alone or both pathways simultaneously currently in clinical studies [1] - Preclinical data shows that JSKN027 exhibits significant tumor suppression activity in both in vitro and in vivo models [1] - GLP toxicology studies indicate good tolerability of the drug at the highest doses [1] Group 3: Mechanism of Action and Potential Impact - JSKN027 is expected to provide new treatment options for various solid tumors due to its multiple mechanisms of action, including cytotoxicity, anti-angiogenesis, and immune modulation [1]

Group 1 - The company has received FDA approval for its dual-specificity antibody-drug conjugate JS212, aimed at treating advanced solid tumors [1] - JS212 targets both EGFR and HER3, which are highly expressed in various tumor cells, including lung cancer, colorectal cancer, and head and neck tumors [1] - Preclinical studies have shown that JS212 exhibits high affinity and specificity for EGFR and HER3, demonstrating significant tumor suppression in multiple animal models [1] Group 2 - As of the announcement date, JS212 is undergoing an open-label, dose-escalation, and dose-expansion Phase I/II clinical trial in mainland China to evaluate its safety, tolerability, pharmacokinetics, and preliminary efficacy in patients with advanced solid tumors [2] - A clinical trial application for a multi-cohort combination therapy involving JS212 has also been approved by the National Medical Products Administration, with plans to initiate related clinical research soon [2]

Group 1 - The company, Shanghai Junshi Biosciences Co., Ltd., has received FDA approval for the clinical trial application of JS212, a bispecific antibody-drug conjugate targeting EGFR and HER3 for the treatment of advanced solid tumors [1] - JS212 is designed to target tumors with high expression of EGFR and HER3, such as lung cancer, colorectal cancer, and head and neck tumors, and aims to overcome drug resistance mechanisms associated with various anticancer therapies [1] - Preclinical studies have shown that JS212 exhibits high affinity and specificity for EGFR and HER3, demonstrating significant tumor suppression effects in multiple animal models, along with acceptable safety profiles [1] Group 2 - In January 2025, the clinical trial application for JS212 was accepted by the National Medical Products Administration (NMPA) of China, and it received approval in March 2025 [2] - As of the announcement date, JS212 is undergoing an open-label, dose-escalation, and dose-expansion Phase I/II clinical trial in mainland China to evaluate its safety, tolerability, pharmacokinetics, and preliminary efficacy in patients with advanced solid tumors [2] - A clinical trial application for a multi-cohort combination therapy involving JS212 was approved by the NMPA in November 2025, with plans to initiate related clinical research soon [2]

Core Viewpoint - Junshi Biosciences (01877) has received FDA approval for its clinical trial application of JS212, a bispecific antibody-drug conjugate targeting EGFR and HER3 for the treatment of advanced solid tumors [1] Group 1: Product Overview - JS212 is a recombinant humanized bispecific antibody-drug conjugate targeting epidermal growth factor receptor (EGFR) and human epidermal growth factor receptor 3 (HER3), primarily aimed at treating advanced malignant solid tumors [1] - EGFR and HER3 are highly expressed on the surface of various tumor cells, including lung cancer, colorectal cancer, and head and neck tumors [1] - JS212 is expected to have a broader efficacy against tumors and potentially overcome resistance issues compared to single-target ADCs, as it can exert tumor-suppressing effects through binding to either EGFR or HER3 [1] Group 2: Clinical Trials and Approvals - In January 2025, the clinical trial application for JS212 was accepted by the National Medical Products Administration (NMPA) and received approval in March 2025 [2] - As of the announcement date, JS212 is undergoing an open-label, dose-escalation, and dose-expansion Phase I/II clinical trial in mainland China to evaluate its safety, tolerability, pharmacokinetics, and preliminary efficacy in patients with advanced solid tumors [2] - A clinical trial application for a multi-cohort combination therapy involving JS212 was approved by the NMPA in November 2025, with plans to initiate related clinical research soon [2]

Core Viewpoint - Junshi Biosciences (01877) has received FDA approval for its clinical trial application of the EGFR/HER3 bispecific antibody-drug conjugate (JS212) for the treatment of advanced solid tumors [1] Group 1: Product Overview - JS212 is a recombinant humanized bispecific antibody-drug conjugate targeting epidermal growth factor receptor (EGFR) and human epidermal growth factor receptor 3 (HER3), primarily aimed at treating advanced malignant solid tumors [1] - EGFR and HER3 are highly expressed on the surface of various tumor cells, including lung cancer, colorectal cancer, and head and neck tumors [1] - JS212 is expected to have a broader efficacy against tumors and to overcome resistance issues compared to single-target ADC drugs, as it can exert tumor-suppressing effects through binding to either EGFR or HER3 [1] Group 2: Clinical Trials and Approvals - In January 2025, the clinical trial application for JS212 was accepted by the National Medical Products Administration (NMPA) and received approval in March 2025 [2] - As of the announcement date, JS212 is undergoing an open-label, dose-escalation, and dose-expansion Phase I/II clinical trial in mainland China to evaluate its safety, tolerability, pharmacokinetics, and preliminary efficacy in patients with advanced solid tumors [2] - A multi-cohort combination therapy clinical trial application for JS212 was approved by the NMPA in November 2025, with plans to initiate related clinical research soon [2]

Core Viewpoint - Junshi Biosciences (688180) announced on December 14 that it has received approval from the U.S. Food and Drug Administration (FDA) for its clinical trial application for the EGFR/HER3 bispecific antibody-drug conjugate (code: JS212) for the treatment of advanced solid tumors [1] Group 1 - The FDA approval allows Junshi Biosciences to proceed with clinical trials for JS212, which is designed to treat advanced malignant solid tumors [1] - JS212 is a recombinant humanized bispecific antibody targeting epidermal growth factor receptor (EGFR) and human epidermal growth factor receptor 3 (HER3) [1] - The drug aims to address the treatment needs for patients with advanced solid tumors, indicating a potential advancement in cancer therapy [1]

Core Viewpoint - Changchun High-tech (000661) announced that its subsidiary, Jinsai Pharmaceutical, received written notification from the FDA approving the clinical trial application for GenSci143, allowing trials to be conducted in the United States [1] Group 1: Product Development - GenSci143 is a dual-specific antibody-drug conjugate targeting B7-H3 and PSMA, indicated for advanced solid tumors, with potential dual therapeutic effects of targeted chemotherapy and tumor immunotherapy [1] - The drug has already been approved for clinical trials in advanced solid tumors in China, and the FDA approval will help the company expand its business structure and optimize its product portfolio [1] Group 2: Strategic Implications - The approval from the FDA enriches the product line layout in strategic areas for the company, indicating a positive step towards enhancing its market presence and competitiveness [1]