Core Viewpoint - The company, InnoCare Pharma-B (09606.HK), announced plans to issue ordinary shares to be listed on the Shanghai Stock Exchange's Sci-Tech Innovation Board, with trading in Renminbi [1] Group 1 - The issuance of shares is subject to market conditions, further approval from the board, shareholder approval at the company's general meeting, and necessary regulatory approvals [1]

Core Viewpoint - Changchun High-tech (000661.SZ) announced that its subsidiary, Changchun Jinsai Pharmaceutical Co., Ltd., received a written notification from the U.S. Food and Drug Administration (FDA) regarding the acceptance of the clinical trial application for GenSci143, a dual-target antibody-drug conjugate [1] Group 1: Product Details - GenSci143 is a self-developed dual-specific antibody-drug conjugate targeting B7-H3 and PSMA, which has potential dual therapeutic effects of targeted chemotherapy and tumor immunotherapy [1] - The mechanism of GenSci143 involves internalization into lysosomes upon binding to B7-H3 or PSMA, releasing TOPO-I inhibitor toxins to kill B7-H3 positive, PSMA positive, and dual-positive tumor cells [1] - The dual-target approach of B7-H3 and PSMA can overcome tumor heterogeneity and resistance caused by reduced expression of a single target, thereby covering more patients and producing more durable anti-tumor efficacy [1] Group 2: Technical Advantages - GenSci143 utilizes self-developed linker technology, which features strong toxin activity and high plasma stability of the linker, resulting in enhanced tumor-killing effects and improved safety [1] - The innovative dual-target design, stable linker technology, efficient cell-killing mechanism, and broad anti-tumor spectrum of GenSci143 may provide new treatment directions for various solid tumors expressing B7-H3 and/or PSMA [1]

Core Viewpoint - Henlius USA Inc., a wholly-owned subsidiary of the company, has received Orphan-drug Designation from the FDA for HLX43, a targeted PD-L1 antibody-drug conjugate intended for the treatment of thymic epithelial tumors (TETs) [1][2] Group 1: Product Development - HLX43 is a novel antibody-drug conjugate developed by the company, combining a DNA topoisomerase I inhibitor with a self-developed PD-L1 targeting antibody, aimed at treating advanced/metastatic solid tumors [1][2] - The Phase 1 clinical trial data for HLX43, particularly in lung cancer populations, will be updated at the World Conference on Lung Cancer (WCLC) in September 2025, showing a 37.0% objective response rate (ORR) and an 87.0% disease control rate (DCR) in patients with advanced solid tumors [2] Group 2: Regulatory and Market Implications - The Orphan-drug Designation from the FDA will facilitate the subsequent research, registration, and commercialization of HLX43 for TETs in the U.S., providing benefits such as tax credits for clinical trial costs, waiver of new drug application fees, and seven years of market exclusivity post-approval [2] - If other similar drugs for the same indication are approved before HLX43, the company must demonstrate clinical superiority to maintain the market exclusivity benefits associated with the Orphan-drug status [3]

Core Viewpoint - Henlius USA Inc., a wholly-owned subsidiary of the company, has received Orphan-drug Designation from the FDA for HLX43, a targeted PD-L1 antibody-drug conjugate for the treatment of thymic epithelial tumors (TETs) [1][2]. Group 1: Product Development - HLX43 is a novel targeted PD-L1 antibody-drug conjugate developed by the company, combining a small molecule toxin-peptide linker with a self-developed PD-L1 targeting antibody [1]. - The drug is intended for the treatment of advanced/metastatic solid tumors, particularly in patients with non-small cell lung cancer (NSCLC) who have failed prior checkpoint inhibitors and chemotherapy [2]. Group 2: Clinical Data - Phase 1 clinical trial data presented at the 2025 World Lung Cancer Conference (WCLC) showed HLX43 has a 37.0% objective response rate (ORR) and an 87.0% disease control rate (DCR) in advanced solid tumors, especially in post-line resistant NSCLC patients [2]. - Preliminary efficacy was also encouraging in patients with thymic squamous cell carcinoma (TSCC) as reported at the 2025 American Society of Clinical Oncology (ASCO) annual meeting [2]. Group 3: Regulatory and Market Implications - The Orphan-drug Designation from the FDA will facilitate the subsequent research, registration, and commercialization of HLX43 for TETs in the U.S., providing benefits such as tax credits for clinical trial costs, exemption from new drug application fees, and seven years of market exclusivity post-approval [2]. - If another drug for the same indication is approved before HLX43, the company must demonstrate clinical superiority to maintain the market exclusivity benefits associated with the Orphan-drug status [3].

Core Viewpoint - Henlius USA Inc., a wholly-owned subsidiary of the company, has received Orphan-drug Designation from the FDA for HLX43, a targeted PD-L1 antibody conjugate for the treatment of thymic epithelial tumors (TETs) [1] Group 1 - The FDA has granted Orphan-drug Designation for HLX43, indicating its potential significance in treating a rare condition [1] - HLX43 is specifically developed as a targeted therapy for thymic epithelial tumors, which are rare types of tumors [1]

Core Viewpoint - Changchun High-tech (000661.SZ) announced that its subsidiary, Changchun Jinsai Pharmaceutical Co., Ltd., received a written notification from the U.S. Food and Drug Administration (FDA) regarding the acceptance of the clinical trial application for GenSci143, a dual-target antibody-drug conjugate [1][2] Group 1: Product Development - GenSci143 is a self-developed dual-specificity antibody-drug conjugate targeting B7-H3 and PSMA, which has potential dual therapeutic effects of targeted chemotherapy and tumor immunotherapy [1] - The drug works by binding to B7-H3 or PSMA, internalizing into lysosomes, and releasing TOPO-I inhibitor toxins to kill B7-H3 positive, PSMA positive, and dual positive tumor cells [1] - The dual-target mechanism of B7-H3 and PSMA can overcome tumor heterogeneity and resistance caused by reduced expression of single targets, thereby covering more patients and producing more durable anti-tumor efficacy [1] Group 2: Technological Advantages - GenSci143 utilizes self-developed linker technology, which features strong toxin activity and high plasma stability of the linker, providing enhanced tumor-killing effects while ensuring better safety [2] - The innovative dual-target design, stable linker technology, efficient cell-killing mechanism, and broad anti-tumor spectrum of GenSci143 may offer new treatment directions for various solid tumors expressing B7-H3 and/or PSMA [2]

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智通财经APP讯，长春高新(000661.SZ)公告，公司子公司——长春金赛药业有限责任公司("金赛药业") 收到美国食品药品监督管理局("FDA")书面通知，金赛药业注射用GenSci143临床试验申请获得受理，适 应症为：晚期实体瘤。 ...

Core Viewpoint - The approval of the antibody-drug conjugate (ADC) Bodo-Tuzumab (A166) by the National Medical Products Administration (NMPA) for the treatment of HER2-positive breast cancer represents a significant advancement in targeted therapy for patients with previously treated, unresectable, or metastatic conditions [1][2]. Group 1: Product Approval - The NMPA has approved Bodo-Tuzumab for adult patients with HER2-positive breast cancer who have received one or more prior anti-HER2 therapies [1]. - The approval is based on the results of a multicenter, randomized, open-label, controlled Phase III study (KL166-III-06) comparing Bodo-Tuzumab to Trastuzumab Emtansine (T-DM1) [2]. Group 2: Clinical Study Results - The study demonstrated a statistically and clinically significant improvement in progression-free survival (PFS) for Bodo-Tuzumab compared to T-DM1, as assessed by blinded independent central review (BICR) [2]. - A trend towards improved overall survival (OS) with Bodo-Tuzumab was also observed, with results set to be presented at the 2025 European Society for Medical Oncology (ESMO) conference in Berlin [2]. Group 3: Product Characteristics - Bodo-Tuzumab is a differentiated HER2 ADC designed for the treatment of advanced HER2-positive solid tumors, featuring a drug-antibody ratio (DAR) of 2 [3]. - The drug specifically targets HER2 on tumor cells, leading to internalization and release of the cytotoxic agent Duo-5, which induces cell cycle arrest and apoptosis in tumor cells [3]. - Bodo-Tuzumab also exhibits antibody-dependent cell-mediated cytotoxicity (ADCC) activity and inhibits HER2-mediated signaling pathways [3].

Core Viewpoint - The approval of the antibody-drug conjugate (ADC) A166 (also known as 博度曲妥珠单抗) by the National Medical Products Administration (NMPA) for treating HER2-positive adult breast cancer patients who have previously received one or more anti-HER2 therapies marks a significant advancement in the treatment landscape for this patient population [1]. Group 1: Drug Approval and Clinical Study - The NMPA has approved A166 for use in patients with unresectable or metastatic HER2-positive breast cancer who have previously undergone treatment with one or more anti-HER2 drugs [1]. - The approval is based on a multicenter, randomized, open-label, controlled Phase 3 study (KL166-III-06) that evaluated the efficacy and safety of A166 compared to T-DM1 in patients with HER2-positive unresectable or metastatic breast cancer [1]. - The interim analysis showed that A166 significantly improved progression-free survival (PFS) compared to T-DM1, with a notable trend towards improved overall survival (OS) [1]. Group 2: Future Research and Development - The company has initiated an open-label, multicenter Phase 2 clinical study of A166 for treating HER2-positive unresectable or metastatic breast cancer previously treated with topoisomerase inhibitor ADCs [2].