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港股异动 | 创胜集团-B(06628)现涨超4% ozekibart明年中前将提交美国适应症...
Xin Lang Cai Jing· 2025-10-31 06:27
Core Viewpoint - Chuangsheng Group-B (06628) experienced a significant stock price increase following positive clinical trial results for its partner Inhibrx Biosciences, Inc.'s (INBX.US) DR5-targeting antibody, ozekibart, in treating advanced or metastatic, unresectable sarcoma patients [1] Company Summary - Chuangsheng Group's stock rose nearly 10% during trading, closing up 4.75% at HKD 3.09, with a trading volume of HKD 4.006 million [1] - The company holds exclusive development and commercialization rights for ozekibart in China, Hong Kong, Macau, and Taiwan [1] Industry Summary - Inhibrx Biosciences announced positive primary results from a registrational clinical study evaluating the efficacy of ozekibart compared to placebo in patients with advanced or metastatic, unresectable soft tissue sarcoma [1] - Inhibrx plans to submit a marketing application for ozekibart for soft tissue sarcoma indications to U.S. regulatory authorities by the end of June 2026 [1]
港股异动 | 创胜集团-B(06628)现涨超4% ozekibart明年中前将提交美国适应症上市许可申请
智通财经网· 2025-10-31 06:08
Core Viewpoint - Chuangsheng Group-B (06628) experienced a significant stock price increase following positive clinical trial results for its partner Inhibrx Biosciences, Inc.'s drug ozekibart, which is aimed at treating advanced or metastatic, unresectable soft tissue sarcoma [1] Group 1: Stock Performance - Chuangsheng Group-B's stock rose nearly 10% during trading, closing up 4.75% at HKD 3.09, with a trading volume of HKD 4.006 million [1] Group 2: Clinical Research Results - Inhibrx Biosciences, Inc. announced positive primary results from a registrational clinical study of ozekibart, a DR5 agonistic antibody, comparing its efficacy against a placebo in patients with advanced or metastatic, unresectable soft tissue sarcoma [1] - Based on these results, Inhibrx plans to submit a marketing application for the soft tissue sarcoma indication to U.S. regulatory authorities by the end of June 2026 [1] Group 3: Development Rights - Chuangsheng Group holds exclusive development and commercialization rights for ozekibart in China, Hong Kong, Macau, and Taiwan [1]
创胜集团-B现涨超4% ozekibart明年中前将提交美国适应症上市许可申请
Zhi Tong Cai Jing· 2025-10-31 06:07
Core Viewpoint - Chuangsheng Group-B (06628) experienced a significant intraday increase of nearly 10%, currently up 4.75% at HKD 3.09, with a trading volume of HKD 4.006 million [1] Group 1: Company Developments - Chuangsheng Group announced that its partner Inhibrx Biosciences, Inc. (INBX.US) reported positive primary results from the registration clinical study of the DR5 agonistic antibody ozekibart [1] - The study evaluated the efficacy of ozekibart as a monotherapy compared to a placebo in patients with advanced or metastatic, unresectable chondrosarcoma [1] - Based on these results, Inhibrx plans to submit a marketing application for the chondrosarcoma indication to U.S. regulatory authorities by the end of June 2026 [1] Group 2: Market Position - Chuangsheng Group holds exclusive development and commercialization rights for ozekibart in China, Hong Kong, Macau, and Taiwan [1]
创胜集团-B(06628.HK):合作伙伴Inhibrx公布ozekibart治疗软骨肉瘤的II期临床试验积极结果
Xin Lang Cai Jing· 2025-10-30 23:16
Core Viewpoint - Inhibrx Biosciences, Inc. announced positive primary results from the ChonDRAgon clinical study, evaluating the efficacy of ozekibart (INBRX-109) in patients with advanced or metastatic, unresectable chondrosarcoma compared to placebo [1] Group 1: Clinical Study Results - The ChonDRAgon study involved 206 participants and demonstrated significant improvement in progression-free survival (PFS) for chondrosarcoma patients treated with ozekibart [1] - Ozekibart is the first investigational drug to show a significant improvement in PFS in a randomized controlled trial for this patient population [1] Group 2: Regulatory and Market Implications - Inhibrx plans to submit a New Drug Application (NDA) to the U.S. regulatory authorities for ozekibart's chondrosarcoma indication by the end of June 2026 [1] - The company holds exclusive development and commercialization rights for ozekibart in mainland China, Hong Kong, Macau, and Taiwan through its wholly-owned subsidiary, HJB [1] Group 3: Market Context - Currently, there are no approved systemic treatment options for chondrosarcoma, highlighting the potential market value of ozekibart for global patients and in the regions where the company has exclusive rights [1]
创胜集团-B(06628.HK):合作伙伴Inhibrx公布ozekibart治疗软骨肉瘤的II期临床试验积极结果,计划2026年申报上市
Ge Long Hui· 2025-10-30 23:12
Core Viewpoint - Inhibrx Biosciences, Inc. announced positive primary results from the ChonDRAgon clinical study evaluating ozekibart (INBRX-109) for advanced or metastatic, unresectable chondrosarcoma patients, leading to plans for a U.S. regulatory submission by June 2026 [1] Group 1: Clinical Study Results - The ChonDRAgon study involved 206 participants and demonstrated significant improvement in progression-free survival (PFS) for chondrosarcoma patients treated with ozekibart compared to placebo [1] - Ozekibart is the first investigational drug to show a significant improvement in PFS in a randomized controlled trial for this patient population [1] Group 2: Regulatory and Commercial Plans - Inhibrx plans to submit a marketing application for ozekibart for chondrosarcoma to U.S. regulatory authorities by the end of June 2026 [1] - The company holds exclusive development and commercialization rights for ozekibart in mainland China, Hong Kong, Macau, and Taiwan through a licensing agreement with its wholly-owned subsidiary, HJB [1] Group 3: Market Implications - The encouraging clinical data reinforces the value of ozekibart for global patients and in regions where the company has exclusive rights [1] - Currently, there are no approved systemic treatment options for chondrosarcoma, highlighting the potential market opportunity for ozekibart [1]
创胜集团-B(06628)合作伙伴Inhibrx公布ozekibart治疗软骨肉瘤的 II期临床试验积极结果
Xin Lang Cai Jing· 2025-10-30 23:10
Core Insights - Inhibrx Biosciences, Inc. announced positive primary results from the ChonDRAgon clinical trial (n=206) evaluating ozekibart (INBRX-109) in patients with advanced or metastatic, unresectable chondrosarcoma compared to placebo [1] - Based on these results, Inhibrx plans to submit a marketing application for ozekibart for chondrosarcoma to U.S. regulatory authorities by the end of June 2026 [1] - Ozekibart is the first investigational drug to significantly improve progression-free survival (PFS) in chondrosarcoma patients in a randomized controlled trial, addressing a significant unmet medical need [1] Company Developments - The company holds exclusive development and commercialization rights for ozekibart in mainland China, Hong Kong, Macau, and Taiwan through a licensing agreement with its wholly-owned subsidiary, HJB [1] - Inhibrx is also advancing an expanded cohort for ozekibart, assessing its combination with irinotecan for the treatment of Ewing sarcoma and colorectal cancer, with early results showing promising signals [2]
创胜集团-B合作伙伴Inhibrx公布ozekibart治疗软骨肉瘤的 II期临床试验积极结果,计划于2026年递交BLA的业绩进展
Zhi Tong Cai Jing· 2025-10-30 23:08
Core Insights - Inhibrx Biosciences, Inc. announced positive primary results from the ChonDRAgon clinical trial (n=206) evaluating ozekibart (INBRX-109) in patients with advanced or metastatic, unresectable chondrosarcoma compared to placebo [1] - Based on these results, Inhibrx plans to submit a marketing application for ozekibart for chondrosarcoma to U.S. regulatory authorities by the end of June 2026 [1] - Ozekibart is the first investigational drug to significantly improve progression-free survival (PFS) in chondrosarcoma patients in a randomized controlled trial, addressing a significant unmet medical need [1] Group 1 - Inhibrx holds exclusive development and commercialization rights for ozekibart in mainland China, Hong Kong, Macau, and Taiwan through a licensing agreement with its wholly-owned subsidiary, HJB [1] - The encouraging clinical data further confirms the value of ozekibart for global patients and in regions where the company has exclusive rights [1] Group 2 - In addition to the registration trial, Inhibrx is advancing an expanded cohort study to evaluate ozekibart in combination with irinotecan for the treatment of Ewing sarcoma and colorectal cancer [2] - Early results show promising signals, supporting further exploration of ozekibart's potential in these difficult-to-treat tumors with unmet medical needs [2]
创胜集团-B(06628)合作伙伴Inhibrx公布ozekibart治疗软骨肉瘤的 II期临床试验积极结果,计划于2026年递交BLA的业绩进展
智通财经网· 2025-10-30 23:02
Group 1 - The core point of the news is that Inhibrx Biosciences, Inc. has reported positive primary results from the ChonDRAgon clinical study, which evaluated the efficacy of ozekibart (INBRX-109) in patients with advanced or metastatic, unresectable chondrosarcoma compared to a placebo [1] - Based on the positive results, Inhibrx plans to submit a marketing application for ozekibart for chondrosarcoma to U.S. regulatory authorities by the end of June 2026 [1] - Ozekibart is the first investigational drug to significantly improve progression-free survival (PFS) in chondrosarcoma patients in a randomized controlled trial, addressing a significant unmet medical need as there are currently no approved systemic treatment options for this disease [1] Group 2 - In addition to the registration clinical trial, Inhibrx is advancing an expanded cohort to evaluate ozekibart in combination with irinotecan for the treatment of Ewing sarcoma and colorectal cancer [2] - Early results from this expanded cohort show encouraging signals, supporting further exploration of ozekibart's potential in these difficult-to-treat tumors with unmet medical needs [2]
创胜集团(06628) - 自愿公告-有关创胜集团合作伙伴Inhibrx公佈ozekibart治疗软...
2025-10-30 22:37
本公告由創勝集團醫藥有限公司(「本公司」)自願作出,旨在告知本公司股東及潛 在投資者有關最新業務進展。本公告所用但並無另行界定的詞彙應與本公司日期 為2021年9月14日的招股章程中所賦予該等詞彙的涵義相同。 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的內容概不負責,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 賴該等內容而引致的任何損失承擔任何責任。 Transcenta Holding Limited 創勝集團醫藥有限公司 (以存續方式於開曼群島註冊的有限公司) (股份代號:6628) 自願公告 有關創勝集團合作夥伴Inhibrx公佈ozekibart治療軟骨肉瘤的 II期臨床試驗積極結果,計劃於2026年遞交BLA的業績進展 創勝集團醫藥有限公司 本公司董事會(「董事會」)欣然公佈,合作夥伴Inhibrx Biosciences, Inc. (「Inhibrx」,納斯達克代碼:INBX)公佈了註冊性臨床研究ChonDRAgon (n=206)的積極主要結果。該研究評估了ozekibart(INBRX-109)單藥相較安慰劑在 晚期或轉移性、 ...
新药周观点:ESMO2025国产新药精彩纷呈-20251026
Guotou Securities· 2025-10-26 08:01
Investment Rating - The report maintains an investment rating of "Outperform" with a rating of A [5] Core Insights - The report highlights the significant performance of domestic new drugs showcased at the ESMO 2025 conference, with several companies presenting excellent clinical data [3][21] - The report emphasizes the importance of academic conferences as key catalysts for the innovative drug sector, particularly mentioning ESMO, ASCO, and WCLC as critical events for Chinese pharmaceutical companies [20] Weekly New Drug Market Review - From October 20 to October 26, 2025, the top five gainers in the new drug sector were: - 欧康维视 (+8.87%) - 君圣泰 (+8.21%) - 诺思兰德 (+7.07%) - 友芝友 (+4.42%) - 海创药业 (+3.73%) - The top five losers were: - 康宁杰瑞 (-17.72%) - 北海康成 (-14.42%) - 创胜集团 (-14.29%) - 宜明昂科 (-13.40%) - 来凯医药 (-12.40%) [16][17] Recommended Focus Stocks - The report suggests focusing on several stocks with potential catalysts, including: 1. Products with high overseas volume certainty after MNC certification: - PD-1 upgraded product: 三生制药 - GLP-1 asset: 联邦制药 - ADC assets: 科伦博泰, 百利天恒 2. Potential heavyweights for overseas MNC authorization: - PD-1 upgraded products: 康方生物, 信达生物 - Breakthroughs in autoimmune fields: 益方生物, 中国抗体 - Innovative target ADC: 复宏汉霖, 石药集团 3. Stocks likely to benefit from medical insurance negotiations and commercial insurance innovative drug directories: - Beneficiaries of medical insurance directory: 恒瑞医药, 康诺亚, 迈威生物, 智翔金泰, 海创药业 - Beneficiaries of commercial insurance innovative drug directory: 药明巨诺, 科济药业 [2][20] New Drug Approval and Acceptance - This week, four new drug or new indication applications were approved, and five new drug or new indication applications were accepted in the domestic market [9] - A total of 46 new drug clinical applications were approved, and 31 new drug clinical applications were accepted [10] Key Domestic Market Events - 信达生物 announced a global strategic partnership with Takeda to accelerate the development of new generation tumor immunotherapy and antibody-drug conjugate therapies [11] - 康宁杰瑞 and 石药集团 announced that their HER2 bispecific antibody-drug conjugate JSKN003 received breakthrough therapy designation from the CDE [11] - 和黄医药 presented clinical data for HMPL-A251 at the AACR-NCI-EORTC conference [11] Key Overseas Market Events - 罗氏 received FDA approval for Gazyva/Gazyvaro for the treatment of active lupus nephritis in adult patients [12] - Electra Therapeutics announced that its therapy ELA026 received breakthrough therapy designation from the FDA and PRIME qualification from the EMA [12] - 安斯泰来 announced that the FDA accepted its supplemental biologics license application for the antibody-drug conjugate Padcev in combination with Keytruda [12]