ALPHAMAB(09966)

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康宁杰瑞制药(09966) - 翌日披露报表
2025-07-17 00:05
FF305 翌日披露報表 (股份發行人 ── 已發行股份或庫存股份變動、股份購回及/或在場内出售庫存股份) 表格類別: 股票 狀態: 新提交 公司名稱: 康寧傑瑞生物製藥 呈交日期: 2025年7月16日 如上市發行人的已發行股份或庫存股份出現變動而須根據《香港聯合交易所有限公司(「香港聯交所」)證券上市規則》(「《主板上市規則》」)第13.25A條 / 《香港聯合交易所有限公司GEM證券 上市規則》(「《GEM上市規則》」)第17.27A條作出披露,必須填妥第一章節 。 | 第一章節 | | | | | | | | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 1. 股份分類 | 普通股 | 股份類別 | 不適用 | | 於香港聯交所上市 | 是 | | | | 證券代號 (如上市) | 09966 | 說明 | 普通股 | | | | | | | A. 已發行股份或庫存股份變動 | | | | | | | | | | | | | 已發行股份(不包括庫存股份)變動 | | 庫存股份變動 | | | | | 事件 | | 已發行股份(不 ...
康宁杰瑞制药(09966) - 自愿公告 - 董事及高级管理层增持股份及董事行使购股权
2025-07-17 00:00
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。 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 董事及高級管理層增持股份 及 董事行使購股權 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。 董事及高級管理層增持股份 承董事會命 康寧傑瑞生物製藥 董事長兼執行董事 徐霆博士 香港,2025年7月16日 於本公告日期,董事會包括董事長兼執行董事徐霆博士及執行董事劉陽女士;非 執行董事左敏先生;及獨立非執行董事黃欣琪女士、高翔博士及吳冬先生。 2 本公司董事(「董事」)會(「董事會」)已獲執行董事及本公司若干高級管理層成員 告知,自2025年7月14日至7月16日,彼等已於公開市場按7.257港元的平均交易 價格購入合共900,000股本公司股份(「股份」)(「本次增持」)。 董事行使購股權 董事會已獲本公司首席執行官兼執行董事徐霆博士進一步告知 ...
康宁杰瑞20250708
2025-07-09 02:40
Summary of Corning Jereh Conference Call Company Overview - Corning Jereh's core product lines include K026 (HER2 bispecific antibody), JSK003 (HER2 dual epitope ADC), JSK016 (TOP2 and HER3 bispecific ADC), and JSK033 (subcutaneous HER2 ADC), all in late-stage clinical development, expected to file for market approval in the coming years, generating revenue for the company [2][3][4]. Key Product Developments - **K026**: - Achieved statistically significant endpoints in PFS mid-term analysis for second-line and above HER2-positive gastric cancer, with an ORR exceeding 40% and PFS of 8.6 months [2][8]. - Plans to file for BLA in Q3 2025, with peak sales expected to exceed 1 billion RMB [2][9]. - Research will advance into first-line HER2-positive gastric cancer [9]. - **JSK003**: - Demonstrates significantly better safety compared to other chemical conjugated ADCs, with hematological toxicity at 15%-20% and ILD incidence at 3%-4% [2][15]. - Phase III trials for second-line HER2-positive breast cancer are expected to complete enrollment this year, with data readout and filing planned for next year [2][15]. - **JSK016**: - Currently in Phase II trials targeting breast cancer, lung cancer, and gastric cancer, with plans to apply for Phase III registration for TNBC in Q4 this year [4][18]. - **JSK033**: - The world's first subcutaneous ADC, currently undergoing dose escalation and expansion studies, with plans to initiate registration clinical studies in cervical cancer and expand to other HER2-effective tumors like lung cancer [2][17]. Financial Position - Corning Jereh has over 1.5 billion RMB in cash reserves, with annual cash burn controlled under 500 million RMB [4][34]. - Expected revenue from sales of Envolimab (KN035) and K026, along with milestone income from collaborations, will cover cash consumption needs [4][34]. Market Strategy - The company is actively expanding into overseas markets, particularly for late-stage products like K026, JSK003, and JSK016, aiming for collaborations to enhance market reach [4][23][24]. - Plans to conduct OC Phase II studies in the U.S. and push for overseas collaborations for JSK003 and JSK016 [4][24]. Competitive Landscape - K026 shows significant competitive advantages in gastric cancer treatment compared to DS8,201, with expected peak sales in the gastric cancer market exceeding 1 billion RMB [9][13]. - The HER2 market in China is estimated to be close to 30 billion RMB, with 80%-85% contributed by breast cancer [13]. Future Outlook - The company plans to file multiple new bispecific ADC molecules, including GSK022 (targeting PD-L1 and integrin 6) and GSK021 (targeting EGFR and HER3) in 2025 and 2026 [5]. - Anticipated data readouts and submissions for TNBC and other indications are expected to enhance the company's market position and investor confidence [22][40]. Additional Insights - The company is exploring the potential of ADCs and bispecific antibodies in combination therapies, aiming to provide better treatment options for patients across different stages of cancer [31][32]. - The strategic focus on accumulating robust clinical data before pursuing large transactions reflects a shift in the Chinese innovative drug landscape towards gaining international recognition [35][36]. This summary encapsulates the key points from the conference call, highlighting the company's product pipeline, financial health, market strategies, competitive positioning, and future outlook.
康宁杰瑞制药(09966) - 提名委员会职权范围
2025-06-30 13:39
3. 會議 1 1.1 提名委員會(「提名委員會」)須由公司董事會(「董事會」)委任,且提名委員會 的大多數成員應為獨立非執行董事及至少有一名不同性別的董事。 1.2 提名委員會之主席應由董事會委任,並須由董事會主席或委員會中之獨立非 執行董事擔任。 1.3 提名委員會成員的委任年期由董事會於委任時決定。 ALPHAMAB ONCOLOGY 康寧傑瑞生物製藥 (於開曼群島註冊成立的有限公司) (以下稱「公司」) (股份代號:9966) 提名委員會-職權範圍書 1. 成員 2. 提名委員會之秘書 4.1 在提名委員會之邀請下,董事會主席及╱或總經理或行政總裁、外聘顧問及 其他人士可獲邀請出席所有或部分任何會議。 4.2 僅提名委員會之成員有權於會議上投票。 5.1 提名委員會之主席或(如其缺席)提名委員會之其他一名成員(必須為獨立非 執行董事)須出席公司之股東週年大會,並回應股東就提名委員會之活動及 彼等之責任作出之提問。 6. 職責及權力 提名委員會須具有下列責任及權力: 2 3.4 會議可以親身出席、採用電話或視像會議之電子方式舉行。提名委員會成員 可透過會議電話或任何類似通訊設備(所有參與會議之人士均能夠 ...
康宁杰瑞制药(09966) - 董事名单及其角色和职能
2025-06-30 13:34
ALPHAMAB ONCOLOGY 康寧傑瑞生物製藥 (於開曼群島註冊成立的有限公司) 董事名單及其角色和職能 康寧傑瑞生物製藥董事會(「董事會」)成員載列如下: | 徐霆博士 | (董事長、執行董事) | | --- | --- | | 劉陽女士 | (執行董事) | | 左敏先生 | (非執行董事) | | 黃欣琪女士 | (獨立非執行董事) | | 高翔博士 | (獨立非執行董事) | | 吳冬先生 | (獨立非執行董事) | 共設有四個董事委員會,下表提供各董事會成員於該等委員會中所擔任的職務資 料。 | 委員會 | 審核委員會 | 薪酬委員會 | 提名委員會 | 戰略委員會 | | --- | --- | --- | --- | --- | | 董事 | | | | | | 徐霆博士 | | | 主席 | 成員 | | 劉陽女士 | | 成員 | | 主席 | | 左敏先生 | | | | 成員 | | 黃欣琪女士 | 主席 | | 成員 | | | 高翔博士 | 成員 | 成員 | | 成員 | | 吳冬先生 | 成員 | 主席 | 成員 | | 香港 2025年6月30日 (股份代號:9966) ...
康宁杰瑞制药(09966) - (1)更换独立非执行董事;及(2)董事委员会组成变动
2025-06-30 13:30
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。 ALPHAMAB ONCOLOGY 康寧傑瑞生物製藥 黃女士及高博士的履歷詳情如下: (於開曼群島註冊成立的有限公司) (股份代號:9966) (1)更換獨立非執行董事;及(2)董事委員會組成變動 獨立非執行董事辭任 康寧傑瑞生物製藥(「本公司」,連同其附屬公司統稱為「本集團」)董事(「董事」) 會(「董事會」)謹此宣佈,郭子建博士(「郭博士」)及蔚成先生(「蔚先生」)因個人 事務及其他工作安排已呈請辭任獨立非執行董事,自2025年6月30日起生效。 郭博士及蔚先生各自確認彼與董事會並無意見分歧,亦無任何與彼之辭任有關而 須提請香港聯合交易所有限公司(「聯交所」)及本公司股東(「股東」)垂注的事項。 董事會藉此機會對郭博士及蔚先生於彼等任職期間對本公司作出的寶貴貢獻表示 衷心感謝。 委任獨立非執行董事 董事會謹此宣佈,黃欣琪女士(「黃女士」)及高翔博士(「高博士」)獲委任為獨立 非執行董事,自2025年 ...
医药生物行业:2025ASCO大会国内重点研究总结报告
GF SECURITIES· 2025-06-17 03:19
Investment Rating - The report maintains a "Buy" rating for multiple companies in the pharmaceutical and biotech industry, indicating a positive outlook on their growth potential and market performance [6]. Core Insights - The ASCO conference showcased significant advancements in domestic innovative drugs, highlighting the competitive edge of Chinese pharmaceutical companies in the global market [4][12]. - The report emphasizes the clinical value and market potential of several key drugs presented at ASCO, including promising results from various companies [4][12]. Summary by Relevant Sections Domestic Key Research Overview - BaiLi Tianheng's BL-B01D1 demonstrated a 35.3% confirmed overall response rate (cORR) in patients with non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC) [18]. - DiZhe Pharmaceutical's DZD6008 achieved over 80% overall response rate (ORR) in heavily treated chronic lymphocytic leukemia (CLL) patients, indicating its potential as a new treatment option [4][12]. - FuHong HanLin's PD-L1 ADC showed excellent performance in immune-resistant squamous NSCLC patients, while HLX22 is expected to redefine first-line treatment for advanced gastric cancer [4][12]. - KeLun BoTai's sac-TMT data confirmed long-term survival benefits in third-line EGFR-mutant NSCLC and first-line triple-negative breast cancer (TNBC) [4][12]. - KangNing JieRui's HER2 bispecific ADC demonstrated comparable efficacy and better safety than existing treatments [4][12]. - MaiWei Biotech's 9MW2821 combined with toripalimab is anticipated to be a strong contender in first-line urothelial carcinoma treatment [4][12]. - SanSheng Pharmaceutical updated data on SSGJ-707 for first-line treatment of wild-type NSCLC, with a significant partnership with Pfizer [4][12]. - XinDa Biotech's IBI363 showed potential in activating "cold" tumors, aiming to become a cornerstone drug in immunotherapy [4][12]. - YaSheng Pharmaceutical's Lisaftoclax achieved positive results in patients resistant to venetoclax, filling a treatment gap in myeloid malignancies [4][12]. - ZhengDa TianQing's "DeFu combination" was selected for LBA, potentially offering a new first-line treatment for PD-L1 positive NSCLC [4][12]. - ZeJing Pharmaceutical and ZaiDing Pharmaceutical presented excellent data on ZG006 and ZL-1310 for late-line SCLC treatment, showcasing the global competitiveness of domestic drugs [4][12].
康宁杰瑞制药(09966) - 2025年6月12日举行之股东週年大会投票表决结果
2025-06-12 10:38
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。 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) 2025年6月12日舉行之股東週年大會投票表決結果 本公司之香港股份過戶登記處香港中央證券登記有限公司,已就點票事宜獲委任 為股東週年大會之監票員。 全體董事,即董事長兼執行董事徐霆博士及執行董事劉陽女士;非執行董事左敏 先生;及獨立非執行董事郭子建博士、蔚成先生及吳冬先生均親身或以電子方式 出席了股東週年大會。 1 於股東週年大會上提呈的各項決議案的投票表決結果如下: | | 普通決議案 | | 票數(%) | | --- | --- | --- | --- | | | | 贊成 | 反對 | | 1. | 考慮及省覽本公司截至2024年12月31日止年度的 | 547,183,780 | 359,000 | | | 經審核綜合財務報表、本公司董事會報告及核數 | 99.934434% | ...
广发证券:首予康宁杰瑞制药-B(09966)“买入”评级 合理价值12.89港元
智通财经网· 2025-06-12 07:12
Group 1 - The core viewpoint of the report is that Guangfa Securities is optimistic about the differentiated biopharmaceutical platform of CStone Pharmaceuticals-B (09966) and the development potential of its ADC drugs, which have shown preliminary clinical efficacy [1] - The company was established in 2015 and focuses on the development, production, and commercialization of innovative anti-tumor biologics, with a highly differentiated internal pipeline covering anti-tumor drugs at various research stages [1] - The first product, KN035 (Envafolimab injection), was launched in November 2021, marking the company's entry into the commercialization phase [1] Group 2 - CStone Pharmaceuticals has developed several globally leading biopharmaceutical technology platforms, including glycoengineered conjugation platform, linker payload platform, bispecific antibody platform, and subcutaneous high-concentration formulation platform, which have differentiated therapeutic advantages [1] - The glycoengineered conjugation platform reduces the production cost of ADC drugs while effectively minimizing toxin release in the circulatory system, enhancing drug safety [1] - Products developed based on this platform, JSKN003 and JSKN016, have entered clinical stages, and the company has upgraded the dual payload technology platform with corresponding products expected to enter clinical trials [1] Group 3 - The HER2 bispecific antibody KN026 is undergoing registration clinical studies for second-line gastric cancer, first-line breast cancer, and neoadjuvant therapy, with a promising path to market [2] - The HER2 bispecific ADC JSKN003 is in phase III clinical trials for breast cancer and platinum-resistant ovarian cancer, demonstrating competitive efficacy in early clinical studies [2] - The HER3/TROP2 bispecific ADC JSKN016 has initiated clinical trials for lung cancer and breast cancer, indicating a broad potential market, while new generation ADCs like JSKN021 (dual payload) and JSKN022 are expected to advance to clinical stages quickly [2]
康宁杰瑞制药(09966) - 内幕消息公告 - 控股股东完成配售现有股份
2025-06-06 13:28
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。 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) 內幕消息公告 控股股東完成配售現有股份 本公告由康寧傑瑞生物製藥(「本公司」)根據香港聯合交易所有限公司證券上市規 則(「上市規則」)第13.09(2)(a)條以及香港法例第571章證券及期貨條例第XIVA部 項下的內幕消息條文(定義見上市規則)作出。 控股股東完成配售現有股份 | | | 佔已發行股份 | | --- | --- | --- | | | 所持股份數目 | 概約百分比 | | 賣方 | 299,400,000(1) | 31.0% | | Sky Diamond Co., Ltd. | 85,750,000 | 8.9% | | Pearlmed Ltd. | 85,750,000 | 8.9% | | 本公司其他股東 | 491,289,807 | 50.9% | | 庫存股 ...