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]

FDA Approvals & Rejections - ARS Pharma's neffy, a needle-free epinephrine nasal spray for emergency treatment of Type I allergic reactions, received approval in China, with commercial availability expected in spring 2026. The product generated $31.3 million in U.S. revenue in Q3 2025 [3][4]. - Vanda Pharmaceuticals' NEREUS, an oral NK-1 receptor antagonist for preventing motion-induced vomiting, received FDA approval, marking the first new treatment for motion sickness in over 40 years. The drug demonstrated a meaningful reduction in vomiting in clinical trials [5][6]. Clinical Trials - Breakthroughs & Setbacks - InflaRx's analyses from a halted Phase 3 trial of Vilobelimab in pyoderma gangrenosum indicated potential efficacy signals with longer treatment duration, prompting plans to discuss alternative endpoints with the FDA [15][17]. - SELLAS reported that survival in its Phase 3 REGAL trial for Galinpepimut-S (GPS) in acute myeloid leukaemia is extending longer than anticipated, potentially increasing the likelihood of a positive outcome [18][19]. - Ultragenyx announced that its Phase 3 studies for Setrusumab in Osteogenesis Imperfecta failed to meet primary endpoints, leading to a decline in investor confidence [20][21]. - Genmab decided to discontinue clinical development of Acasunlimab to focus on higher-priority programs, with no impact expected on its full-year 2025 financial guidance [22][23]. Corporate Actions - FONAR Corporation agreed to be taken private by a CEO-led acquisition group for $19.00 per share, valuing the transaction at a significant premium. The deal is expected to close in Q3 2026, subject to shareholder approval [12][13][14].

Core Viewpoint - Corning Jereh Pharmaceutical-B (09966) has announced the acceptance of its new drug clinical trial application for JSKN033, a combination therapy for advanced cervical cancer, by the National Medical Products Administration (NMPA) [1] Group 1: Clinical Trial Details - JSKN033 is a high-concentration subcutaneous compound formulation consisting of a bispecific antibody-drug conjugate (ADC) targeting human epidermal growth factor receptor 2 (HER2) and a programmed death ligand 1 (PDL1) immune checkpoint inhibitor [1] - The clinical trial, identified as JSKN033-202, is an open-label, multicenter, Phase II study 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 participants will receive treatment with JSKN033 in combination with either cisplatin or carboplatin, and the choice of platinum drug and the inclusion of bevacizumab will be determined by the researchers based on individual patient circumstances [1]

Core Viewpoint - Corning Jereh Pharmaceutical-B (09966) has announced the acceptance of its new drug clinical trial application for JSKN033, a combination therapy for advanced cervical cancer, by the National Medical Products Administration (NMPA) [1] Group 1: Clinical Trial Details - JSKN033 is a high-concentration subcutaneous compound formulation consisting of a bispecific antibody-drug conjugate (ADC) targeting human epidermal growth factor receptor 2 (HER2) and a programmed death ligand 1 (PDL1) immune checkpoint inhibitor [1] - The clinical trial, identified as JSKN033-202, is an open-label, multicenter, Phase II study aimed at evaluating the safety, efficacy, and pharmacokinetic/pharmacodynamic characteristics of JSKN033 in combination with platinum-based chemotherapy, with or without bevacizumab, for treating patients with advanced cervical cancer [1] - All participants will receive treatment with JSKN033 in combination with either cisplatin or carboplatin, and the choice of platinum drug and the inclusion of bevacizumab will be determined by the researchers based on individual patient circumstances [1]

康寧傑瑞生物製藥 （於開曼群島註冊成立的有限公司） （股份代號：9966） 自願公告 JSKN033的一項II期臨床試驗的IND申請獲CDE正式受理 本公告乃由康寧傑瑞生物製藥（「本公司」，連同其附屬公司，統稱「本集團」）自願 作出，以知會本集團股東（「股東」）及潛在投資者有關本集團之最新業務進展。 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。 ALPHAMAB ONCOLOGY 關於JSKN033 JSKN033是本集團開發的全球首個由HER2雙特異性ADC(JSKN003)及PD-L1單 抗（恩沃利單抗）組成的皮下注射複方製劑。JSKN003是一種靶向HER2雙表位 ADC，其中一種拓撲異構酶I抑制劑通過糖基定點偶聯技術與抗體KN026（一種重 組人源化抗HER2雙特異性抗體）的N糖基化位點連接。恩沃利單抗是重組人源化 PD-L1單域抗體和人免疫球蛋白G1 Fc片段組成的Fc融合蛋白，作為全球首個皮下 注射PD-L1抑制劑，已於2021年11月 ...

Group 1: Market Overview - The Hang Seng Healthcare Index (HSCICH) decreased by 2.76% during the week, while the Hong Kong Innovation Drug ETF (513120) fell by 1.60% [4] - The pharmaceutical and biotechnology index dropped by 1.69%, underperforming the Shanghai Composite Index by 1.04 percentage points [4] Group 2: Company Developments - Nanjing Inpai Pharmaceutical Co., Ltd. submitted a listing application to the Hong Kong Stock Exchange, reporting a net loss of 129 million yuan in the first half of the year [5][6] - Inpai's core product, Senapali, was approved for marketing in China as a first-line maintenance therapy for ovarian cancer, applicable to all populations [6] - Inpai's revenue projections for 2023, 2024, and the first half of 2025 are 235 million yuan, 34 million yuan, and 25 million yuan respectively, with net losses of 20 million yuan, 255 million yuan, and 129 million yuan [6][7] Group 3: Clinical Trials and Innovations - The first subcutaneous antibody-drug conjugate (ADC) for advanced non-small cell lung cancer has entered Phase II clinical trials [8][16] - JSKN033, a subcutaneous ADC, aims to simplify administration time and reduce risks associated with intravenous delivery [18] - The National Medical Products Administration disclosed 117 new clinical trial registrations, with 29 in Phase II or higher, focusing on oncology and autoimmune diseases [8] Group 4: Stock Performance and Market Sentiment - Yimeng Bio-B experienced a significant decline, attributed to overall adjustments in the innovation drug sector and the upcoming lock-up expiration for cornerstone investors [12][13] - Yimeng Bio-B's stock price has seen a 30% drop from its peak, despite being up approximately 279% since its IPO [13] - Analysts from GF Securities and Morgan Stanley have set target prices for Yimeng Bio-B at 574.28 HKD and 766 HKD per share, respectively, citing its leading ADC platform and partnerships with global firms [13][15]

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。 ALPHAMAB ONCOLOGY 康寧傑瑞生物製藥 （於開曼群島註冊成立的有限公司） （股份代號：9966） 自願公告 於2024年SITC年會呈列的JSKN033的I/II期臨床試驗的 最新研究成果 本公告乃由康寧傑瑞生物製藥（「本公司」，連同其附屬公司統稱「本集團」）自願作 出，以知會本集團股東（「股東」）及潛在投資者有關本集團之最新業務進展。 本公司董事（「董事」）會（「董事會」）欣然宣佈，本集團自主研發的用於治療HER2 表達晚期或轉移性實體瘤的JSKN033的I/II期臨床試驗（「JSKN033-101」）的最新 研究成果入選2024年SITC年會最新突破性摘要，且於年會期間以壁報形式首次公 佈，本公司的網站http://www.alphamabonc.com亦相應公佈了此研究成果。有關 研究結果概述如下。 JSKN033，HER2雙特異性抗體ADC與PD-L1抑制劑的創新型皮下注射高濃 度 ...