Core Viewpoint - Corning Jereh Pharmaceutical-B (09966) has announced that the National Medical Products Administration of China has officially accepted the new drug application for KN035 (Envafolimab injection) in combination with gemcitabine and oxaliplatin for first-line treatment of unresectable or metastatic biliary tract cancer [1] Group 1 - The acceptance of the application is based on the results of the Phase III clinical trial (KN035-CN-005) [1] - This trial is a randomized, parallel-controlled, multi-center Phase III clinical study designed for advanced first-line BTC patients in China [1] - The study aims to evaluate the efficacy and safety of KN035 in combination with the GEMOX regimen compared to the GEMOX regimen alone [1]

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之內容概不負責，對其準確性 或完整性亦不發表任何聲明，並明確表示，概不就因本公告全部或任何部分內容而產生或因倚 賴該等內容而引致的任何損失承擔任何責任。 關於KN035（恩沃利單抗注射液）（商標名：恩維達®） KN035（恩沃利單抗注射液）是重組人源化抗程序性死亡配體1（「PD-L1」）單域 抗體Fc融合蛋白，由本公司自主研發，2016年起與思路迪（北京）醫藥科技有限 公司（「思路迪醫藥」）合作開發。於2020年3月30日，本公司全資附屬公司江蘇 康寧傑瑞生物製藥有限公司（「江蘇康寧傑瑞」）、江蘇先聲藥業有限公司（「江蘇 先聲」，為先聲藥業集團有限公司（其股份於聯交所上市，股份代號：2096）的 附屬公司）及思路迪醫藥訂立一份合作協議（「先聲協議」）。根據先聲協議，江蘇 先聲獲授予KN035於中國大陸內的腫瘤適應症的獨家市場推廣權及對外許可或 轉讓下的優先受讓權。於2024年1月，我們與思路迪醫藥及Glenmark Specialty S.A.（「Glenmark」）訂立許可協議，據此思路迪醫藥與本集團同意向Glenmark授 予KN035腫瘤適應症的獨 ...

康宁杰瑞制药-B（09966）早盘股价上涨6.08%，现报10.82港元，成交额1425.77万港元。 热点栏目 自选股 数据中心 行情中心 资金流向 模拟交易 客户端 康宁杰瑞制药-B（09966）早盘股价上涨6.08%，现报10.82港元，成交额1425.77万港元。 近日，康宁杰瑞制药-B发布公告，JSKN033（一种由抗人表皮生长因子受体2（HER2）双特异性抗体偶 联药物（ADC（s））与程序性死亡配体1（PDL1）免疫检查点抑制剂组成的高浓度皮下注射复方制 剂）联合铂类化疗联合或不联合贝伐珠单抗一线治疗晚期宫颈癌的一项II期临床试验的新药临床试验 （IND）申请，已获国家药品监督管理局药品审评中心（CDE）正式受理。 JSKN033-202是一项开放、多中心、II期临床试验，旨在评估JSKN033联合铂类化疗联合或不联合贝伐 珠单抗一线治疗晚期宫颈癌患者的安全性、有效性及药代动力学╱药效学特征。所有患者将接受 JSKN033联合顺铂或卡铂联合或不联合贝伐珠单抗的治疗。铂类药物的选择和是否联用贝伐珠单抗将由 研究者根据患者的具体情况决定。 责任编辑：卢昱君 近日，康宁杰瑞制药-B发布公告，JSKN0 ...

Core Viewpoint - Corning Jereh Pharmaceutical-B (09966) saw a significant increase of over 6%, currently trading at 10.89 HKD with a transaction volume of 10.4175 million HKD, following the announcement of a new drug clinical trial application for JSKN033, a combination therapy for advanced cervical cancer [1] Group 1: Clinical Trial Announcement - Corning Jereh Pharmaceutical-B announced that the clinical trial application for JSKN033, a high-concentration subcutaneous compound formulation consisting of a bispecific antibody-drug conjugate targeting HER2 and a PD-L1 immune checkpoint inhibitor, has been officially accepted by the National Medical Products Administration (NMPA) [1] - The JSKN033-202 trial is an open-label, multicenter, Phase II clinical trial aimed at evaluating the safety, efficacy, and pharmacokinetic/pharmacodynamic characteristics of JSKN033 in combination with platinum-based chemotherapy, with or without Bevacizumab, for patients with advanced cervical cancer [1] - All patients in the trial will receive treatment with JSKN033 in combination with either Cisplatin or Carboplatin, and the choice of platinum drug and whether to combine with Bevacizumab will be determined by the researchers based on the specific conditions of the patients [1]

Core Viewpoint - Corning Jereh Pharmaceutical-B (09966) saw a significant increase of over 6%, currently trading at 10.89 HKD with a transaction volume of 10.4175 million HKD, following the announcement of a new drug clinical trial application for JSKN033 [1] Group 1: Clinical Trial Announcement - Corning Jereh Pharmaceutical-B announced that the clinical trial application for JSKN033, a high-concentration subcutaneous compound formulation combining a HER2 bispecific antibody-drug conjugate (ADC) and a PD-L1 immune checkpoint inhibitor, has been officially accepted by the National Medical Products Administration (NMPA) [1] - The JSKN033-202 trial is an open-label, multicenter, Phase II clinical trial aimed at evaluating the safety, efficacy, and pharmacokinetic/pharmacodynamic characteristics of JSKN033 in combination with platinum-based chemotherapy, with or without Bevacizumab, for first-line treatment of advanced cervical cancer [1] - All patients in the trial will receive treatment with JSKN033 in combination with either Cisplatin or Carboplatin, with the choice of platinum drug and the decision to use Bevacizumab being determined by the researchers based on individual patient circumstances [1]

Core Viewpoint - The bispecific antibody drug market is rapidly expanding, with significant applications in cancer treatment, autoimmune diseases, and infections, and is projected to reach a global market size of $19.1 billion by 2025 and $26.8 billion by 2026 [1][5]. Group 1: Market Overview - The global bispecific antibody drug market is expected to grow to $19.1 billion by 2025, with China's market size projected at approximately $800 million, accounting for about 4.19% of the global market [5]. - By 2026, the global bispecific antibody drug market is anticipated to reach $26.8 billion, with China's market size expected to be around $1.5 billion, representing about 5.60% of the global market [5]. - Nearly 80% of the drug pipeline for bispecific antibodies is concentrated in the cancer treatment sector, particularly in solid tumors [7]. Group 2: Industry Definition and Mechanism - Bispecific antibodies, also known as bispecific or dual-function antibodies, can bind to two different antigens or two different epitopes of the same antigen, enhancing therapeutic effects and reducing adverse reactions [3][4]. - The primary mechanisms of bispecific antibodies include mediating immune cell killing, blocking dual-target signals, and promoting the formation of functional protein complexes [5]. Group 3: Industry Chain - The upstream of the bispecific antibody industry chain involves raw materials such as cell culture media, chromatography media, and key equipment like bioreactors and detection devices [9]. - The midstream focuses on the research and production of bispecific antibody drugs, while the downstream is primarily composed of medical institutions, especially large hospitals specializing in oncology and autoimmune diseases [9]. Group 4: Competitive Landscape - Major global players in the bispecific antibody field include Roche, Amgen, Johnson & Johnson, and several others, while domestic companies include BeiGene, Innovent Biologics, and others [11]. - The development of bispecific antibodies is still in progress, with ongoing exploration of target combination strategies and production technologies [11]. Group 5: Future Outlook - The future of bispecific antibodies lies in their application in cancer treatment and tissue regeneration, with a focus on addressing multiple targets in pathological processes to enhance therapeutic efficacy [14]. - New strategies and clinical trials are emerging, indicating a potential for new bispecific antibody drugs to be approved for market entry soon [14].

股份發行人及根據《上市規則》第十九B章上市的香港預託證券發行人的證券變動月報表 截至月份: 2025年12月31日 狀態: 新提交 致：香港交易及結算所有限公司 公司名稱: 康寧傑瑞生物製藥 呈交日期: 2026年1月6日 I. 法定/註冊股本變動 | 1. 股份分類 | 普通股 | 股份類別 | 不適用 | | | 於香港聯交所上市 (註1) | 是 | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 證券代號 (如上市) | 09966 | 說明 | 普通股 | | | | | | | | | 法定/註冊股份數目 | | | 面值 | | 法定/註冊股本 | | | 上月底結存 | | | 25,100,000,000 | USD | | 0.000002 USD | | 50,200 | | 增加 / 減少 (-) | | | | 0 | | USD | | 0 | | 本月底結存 | | | 25,100,000,000 | USD | | 0.000002 USD | | 50,200 | 本月底法定/註冊股本總額： USD 5 ...

康宁杰瑞制药-B回购明细 | 日期 | 回购股数（万股） | 回购最高价（港元） | 回购最低价（港元） | 回购金额（万港元） | | --- | --- | --- | --- | --- | | 2025.12.31 | 50.00 | 9.870 | 9.500 | 483.35 | | 2025.12.01 | 23.60 | 10.480 | 10.250 | 245.73 | | 2025.11.17 | 35.00 | 9.860 | 9.640 | 341.98 | | 2025.11.07 | 56.00 | 9.520 | 9.240 | 526.10 | | 2025.10.28 | 32.00 | 11.970 | 11.530 | 376.84 | | 2025.10.16 | 40.00 | 13.820 | 13.520 | 548.30 | | 2025.10.14 | 29.30 | 13.830 | 13.030 | 396.69 | | 2025.10.13 | 10.80 | 13.800 | 13.690 | 148.60 | （文章来源：证券时报网） 证券时报·数 ...

Group 1 - The company Corning Jereh Pharmaceutical-B (09966) announced a share buyback plan [1] - The company will spend HKD 4.8335 million to repurchase 500,000 shares [1] - The buyback is scheduled to be completed by December 31, 2025 [1]

Group 1 - Corning Pharmaceutical-B (09966.HK) announced a share buyback plan, intending to repurchase 500,000 shares at a cost of HKD 4.8335 million [1] - The buyback price is set between HKD 9.5 and HKD 9.87 per share [1]