财经频道更多独家策划、专家专栏，免费查阅>> 智通财经讯，诺诚健华(688428.SH)公告，公司自主研发的BTK抑制剂奥布替尼治疗系统性红斑狼疮(简 称"SLE")的IIb期临床研究达到主要终点，并获国家药品监督管理局(NMPA)药品审评中心(CDE)批准开 展III期注册性临床试验。公司将尽快启动该临床研究。 临床IIb结果展示，在接受治疗48周的患者中，奥布替尼展现了卓越的有效性、良好的耐受性和安全 性。 责任编辑：钟离 ...

责任编辑：钟离 财经频道更多独家策划、专家专栏，免费查阅>> 格隆汇12月14日丨诺诚健华(688428.SH)发布公告，公司自主研发的BTK抑制剂奥布替尼治疗系统性红 斑狼疮(以下简称"SLE")的IIb期临床研究达到主要终点，并获国家药品监督管理局(NMPA)药品审评中心 (CDE)批准开展III期注册性临床试验。公司将尽快启动该临床研究。 ...

| | | 临床 IIb 结果展示，在接受治疗 48 周的患者中，奥布替尼展现了卓越的有 效性、良好的耐受性和安全性。本次研究共入组 187 例患者，按 1:1:1 随机分成 三组，即口服奥布替尼每天一次 75 毫克和 50 毫克两个剂量组，以及安慰剂组。 本次研究的主要终点是第 48 周时的 SLE 反应指数-4（SRI-4）应答率。第 48 周时，每天一次 75 毫克奥布替尼剂量组的 SRI-4 应答率显著高于安慰剂组 （57.1%vs.34.4%），具有统计学意义（p＜0.05），达到主要终点。此外，每天一 1 次 75 毫克奥布替尼剂量组的疗效优于每天一次 50 毫克剂量组，这表明疗效呈剂 量依赖性的改善趋势。 第 48 周时，每天一次 75 毫克奥布替尼剂量组的 SRI-6 应答率和英岛狼疮评 定组复合性评估（BICLA）应答率都显著高于安慰剂组，具有统计学意义（p＜ 0.05），达到次要终点。 诺诚健华医药有限公司 自愿披露关于奥布替尼治疗系统性红斑狼疮 IIb 期 研 究 达 到 主 要 终 点 并 获 批 III 期 注 册 性 临 床 试 验 的公告 本公司董事会及全体董事保证本公告内容不存 ...

12月14日，诺诚健华宣布，公司自主研发的新型BTK抑制剂奥布替尼在治疗系统性红斑狼疮（SLE）的 IIb期临床研究中达到主要终点，同时获得国家药品监督管理局（NMPA）药品审评中心（CDE）批准开 展III期注册临床试验。 ...

每经AI快讯，诺诚健华(09969.HK)涨超3%，截至发稿，涨3.24%，报14港元，成交额5105.45万港元。 ...

Core Viewpoint - The approval of the second-generation small molecule pan-TRK inhibitor, Zoltracitinib (ICP-723), by the National Medical Products Administration (NMPA) marks a significant advancement for the treatment of adult and adolescent patients with NTRK fusion gene-related solid tumors, indicating a potential growth opportunity for the company in the oncology market [1] Company Summary - NMPA has approved Zoltracitinib for treating adult and adolescent patients aged 12 and above with solid tumors carrying NTRK fusion genes [1] - The company plans to submit a New Drug Application (NDA) for Zoltracitinib to treat pediatric patients aged 2 to 12 years soon [1] Industry Summary - NTRK fusion genes are found in over 26 types of solid tumors, with an estimated 6,500 new cases carrying NTRK fusion genes diagnosed annually in China [1] - Patients with NTRK fusion gene-related tumors typically have a short survival period, rapid disease progression, and high disability rates, highlighting an unmet clinical need due to the low prevalence of next-generation sequencing (NGS) for diagnosis [1]

Core Viewpoint - Nocera Biopharma (09969) has seen a stock increase of over 3% following the approval of its drug, ICP-723, by the National Medical Products Administration (NMPA) for treating adult and adolescent patients with NTRK fusion gene solid tumors [1] Company Summary - Nocera Biopharma's ICP-723, a second-generation small molecule pan-TRK inhibitor, has been approved for use in patients aged 12 and older with NTRK fusion gene solid tumors [1] - The drug has been included in the NMPA's "Starlight Program," aimed at encouraging the development of pediatric oncology drugs [1] - The company plans to submit a New Drug Application (NDA) for ICP-723 to treat pediatric patients aged 2 to 12 years soon [1] Industry Summary - NTRK fusion genes are present in various tumor types, with over 26 solid tumors identified to date [1] - An estimated 6,500 new cases of tumors carrying NTRK fusion genes are diagnosed annually in China, characterized by short survival, rapid disease progression, and high disability rates [1] - The low prevalence of next-generation sequencing (NGS) as the gold standard diagnostic method has led to delayed diagnoses, indicating an unmet clinical need in this area [1]

Group 1 - Lu Kang Pharmaceutical plans to increase capital by 109 million yuan to its wholly-owned subsidiary Bio-Pesticide Company and 27 million yuan to Ze Run Company, aiming to expand its pesticide and sales sectors [1] - Hui Green Ecology intends to sell two properties in Ningbo for 12.52 million yuan, expecting a net profit impact of approximately 6.23 million yuan from the transaction [2] - Tianyuan Co., Ltd. plans to invest 185 million yuan in an intelligent upgrade project for its titanium dioxide production facilities [3] Group 2 - Metro Design has received approval from the Shenzhen Stock Exchange for its share issuance to acquire 100% equity of Guangzhou Metro Engineering Consulting Co., Ltd. for 511 million yuan [4] - South Network Energy announced a mid-term profit distribution plan for 2025, proposing a cash dividend of 0.07 yuan per 10 shares [5] - Qibin Group plans to establish two wholly-owned subsidiaries in Shenzhen with a registered capital of 100 million yuan each [6] Group 3 - All New Good received an administrative regulatory decision from the Shenzhen Securities Regulatory Bureau due to issues in financial accounting and information disclosure [7] - Luokai Co., Ltd. announced that its shareholders plan to reduce their holdings by up to 3% of the company's shares [8][9] - Jincheng Pharmaceutical's actual controller received an administrative penalty from the CSRC for stock manipulation, leading to the resignation of the chairman [10] Group 4 - Yicheng New Energy intends to acquire a 7.69% stake in Kaifeng Times for 10 million yuan, enhancing its strategic development [11] - Yujing Co., Ltd. signed a sales contract worth approximately 28.6 million USD with an overseas photovoltaic company [12] - Nuocheng Jianhua's TRK inhibitor, Zoltracitinib, has been approved for market entry in China [13] Group 5 - Nandu Power announced that its controlling shareholder is planning a change in control, leading to a temporary suspension of its stock [14] - Xinxing Casting plans to acquire 100% equity of China Resources Steel for 1.244 billion yuan to focus on special steel development [15] - Xinlitai is planning to issue H-shares and list on the Hong Kong Stock Exchange [16] Group 6 - Blue Fan Medical's subsidiary received approval for a new medical device, the coronary artery scoring balloon dilation catheter [18] - China Iron & Steel plans to establish a joint venture with several companies to provide new energy transportation solutions with a registered capital of 500 million yuan [19] - Jifeng Technology intends to sign a cooperation framework agreement with Dongtai Lianfei for a total transaction amount not exceeding 100 million yuan [20] Group 7 - Zhongwei Electronics announced a change in its actual controller, with stock resuming trading [21] - Weihong Co., Ltd. plans to reduce its holdings by up to 1.15% of the company's shares [22] - Te Fa Information received a criminal judgment related to a fraud case involving the acquisition of Shenzhen Te Fa Dongzhi Technology Co., Ltd. [23] Group 8 - Sunshine Dairy's controlling shareholder's concerted action plans to reduce holdings by up to 3% of the company's shares [24] - Meikailong reported that Taobao Holdings and New Retail Fund collectively reduced their H-shares by 30.616 million shares [25] - Xinjubang plans to issue H-shares and apply for listing on the Hong Kong Stock Exchange [26] Group 9 - Beite Technology's application for issuing A-shares to specific objects has been approved by the Shanghai Stock Exchange [28] - Victory Energy's controlling shareholder is planning a change in control, with stock resuming trading [29] - Jiutian Pharmaceutical signed a patent and technology transfer agreement for a small molecule analgesic drug project, with a total transfer fee not exceeding 400 million yuan [29]

Core Viewpoint - The approval of the new generation TRK inhibitor, Zolbetuximab (ICP-723), by the NMPA marks a significant milestone as it is the first domestically developed TRK inhibitor in China for treating adult and adolescent patients with NTRK fusion gene-positive solid tumors [2][5] Group 1: Drug Efficacy and Safety - Zolbetuximab demonstrated exceptional efficacy and safety in clinical trials, with an overall response rate (ORR) of 89.1%, disease control rate (DCR) of 96.4%, 24-month progression-free survival (PFS) rate of 77.4%, and 24-month overall survival (OS) rate of 90.8% [2] - The drug shows superior efficacy compared to first-generation TRK inhibitors, providing long-term deep remission and overcoming resistance to earlier treatments [2][3] - In specific patient groups, such as adolescents, the ORR reached 100%, and the drug's rapid onset of action offers critical treatment time for severe cases [3] Group 2: Clinical Observations - Clinical observations indicate that Zolbetuximab has a long duration of effective response, with some patients experiencing responses lasting over 36 months [3] - The drug's high selectivity significantly reduces off-target toxicity, allowing for long-term use without compromising patients' quality of life [3][4] - In lung cancer patients, the ORR was reported at 88.9%, with a 100% intracranial objective response rate (IC-ORR) and sustained intracranial response [4] Group 3: Market and Future Prospects - Zolbetuximab is the third innovative drug approved by the company and the first for solid tumors, highlighting its clinical significance for NTRK fusion-positive patients [4] - The drug has been included in the "Star Program" for encouraging the development of pediatric anti-cancer drugs, with plans to submit a New Drug Application (NDA) for treating children aged 2 to 12 [4][5] - The presence of NTRK fusion genes in over 26 types of tumors and an estimated 6,500 new cases annually in China indicates a significant unmet clinical need, positioning Zolbetuximab as a vital treatment option [5]

Core Viewpoint - The approval of the new generation TRK inhibitor, Zolbetuximab (ICP-723), by the National Medical Products Administration (NMPA) in China marks a significant milestone as it is the first domestically developed TRK inhibitor approved for treating adult and adolescent patients with NTRK fusion gene-positive solid tumors [1][2]. Group 1: Drug Efficacy and Safety - Zolbetuximab demonstrated exceptional efficacy and safety in clinical trials, with an overall response rate (ORR) of 89.1%, disease control rate (DCR) of 96.4%, 24-month progression-free survival (PFS) rate of 77.4%, and 24-month overall survival (OS) rate of 90.8% [1]. - The drug shows superior efficacy compared to first-generation TRK inhibitors, providing long-term deep remission and strong brain penetration, with a good overall safety profile [1][2]. - In specific patient populations, Zolbetuximab achieved an ORR of 100% in adolescents, 89.5% in soft tissue sarcoma patients, and 88.9% in lung cancer patients, highlighting its broad applicability [2][3]. Group 2: Clinical Significance - The rapid onset of action of Zolbetuximab allows for significant tumor shrinkage within one to two treatment cycles, providing critical time for severely ill patients [2]. - The drug's unique structure enables it to penetrate the blood-brain barrier effectively, achieving a 100% intracranial objective response rate (IC-ORR) in brain metastases, which is a significant advancement for patients with brain lesions [2][3]. - Zolbetuximab is included in the "Star Program" for encouraging the development of pediatric anti-cancer drugs, with plans for an NDA submission for treating children aged 2 to 12 [1][2]. Group 3: Market and Development Context - The emergence of Zolbetuximab addresses an unmet clinical need for patients with NTRK fusion-positive tumors, which are often aggressive and have limited treatment options [3]. - The estimated annual incidence of NTRK fusion-positive tumors in China is around 6,500 cases, indicating a significant market potential for Zolbetuximab [3]. - The approval of Zolbetuximab represents a critical advancement in the oncology field, providing new hope for patients with solid tumors in China [1][2].