Core Viewpoint - Corning Jereh Pharmaceutical-B (09966) announced a share buyback plan, indicating confidence in its stock value and future prospects [1] Summary by Categories Company Actions - The company plans to repurchase 320,000 shares at a total cost of HKD 3.7684 million [1] - The buyback price per share ranges from HKD 11.53 to HKD 11.97 [1] Financial Implications - The total expenditure for the buyback reflects the company's strategy to enhance shareholder value [1]

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（不包括庫存股份）數 目 | | 佔有關事件前的現有已發 行股份（不包括庫存股 份）數目百分比 (註3) | 庫存股份數目 | 每股發行/出售價 (註4) | 已發行股份總數 | | 於下列日期開始時的結存(註1) | 2025年10月16日 ...

Core Viewpoint - Corning Jereh Pharmaceutical-B (09966) announced that JSKN003 has received Fast Track Designation (FTD) from the U.S. Food and Drug Administration (FDA) for the treatment of platinum-resistant recurrent epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer, marking a significant milestone in the global development of JSKN003 [1] Group 1 - JSKN003 has been granted FTD by the FDA for treating platinum-resistant recurrent epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer, indicating its clinical potential [1] - The FDA has also approved a Phase II clinical trial for JSKN003 targeting platinum-resistant recurrent epithelial ovarian cancer with no restrictions on HER2 expression levels [1] - JSKN003 has received breakthrough therapy designation from the National Medical Products Administration (NMPA) for both PROC and colorectal cancer (CRC), and orphan drug designation from the FDA for gastric/gastroesophageal junction cancer (GC/GEJ) [1] Group 2 - The Phase III clinical trial for JSKN003 in treating platinum-resistant recurrent epithelial ovarian cancer is currently progressing smoothly in China [1] - The FTD designation further underscores the confidence of international regulatory bodies in the clinical potential and importance of JSKN003 as a novel therapeutic candidate [1]

Core Insights - Corning Jereh Pharmaceutical-B (09966) announced that JSKN003 has received Fast Track Designation (FTD) from the U.S. Food and Drug Administration (FDA) for the treatment of platinum-resistant recurrent epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer (collectively referred to as PROC) regardless of HER2 expression levels [1] Group 1 - JSKN003 has been approved by the FDA to conduct a Phase II clinical trial for treating PROC with no restrictions on HER2 expression levels [1] - The drug has also received Breakthrough Therapy Designation from the National Medical Products Administration (NMPA) for both PROC and colorectal cancer (CRC) [1] - Additionally, JSKN003 has been granted Orphan Drug Designation by the FDA for gastric/gastroesophageal junction cancer (GC/GEJ) [1] Group 2 - The Phase III clinical trial for JSKN003 in treating PROC is currently progressing smoothly in China [1] - The FTD designation further underscores the confidence of international regulatory bodies in the clinical potential of JSKN003 and its significance as a novel therapeutic candidate [1]

Core Insights - Corning Jereh Pharmaceutical-B (09966.HK) announced that JSKN003 has received Fast Track Designation (FTD) from the FDA for the treatment of platinum-resistant recurrent epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer, marking a significant milestone in its global development process [1] - JSKN003 has also been approved by the FDA to conduct a Phase II clinical trial for the same indication and has received Breakthrough Therapy Designation from the National Medical Products Administration for both PROC and colorectal cancer, as well as Orphan Drug Designation for gastric/gastroesophageal junction cancer [1] - The FTD designation underscores the confidence of international regulatory agencies in the clinical potential of JSKN003 as a new treatment candidate [1] Clinical Data Summary - The FTD for JSKN003 is based on promising clinical data, with a summary analysis presented at the 2025 American Society of Clinical Oncology Annual Meeting, which included 46 PROC patients [2] - Among these patients, 21 had HER2 IHC 0 (45.7%) and 18 had HER2 IHC 1+, 2+, and 3+ (39.1%), with an overall objective response rate (ORR) of 63.0% and a median progression-free survival (mPFS) of 7.7 months [2] - In patients with HER2 IHC 1+, 2+, and 3+, the ORR was 72.2% and mPFS was 9.4 months, indicating robust PFS benefits across different HER2 expression levels [2] Market Need - Ovarian cancer is one of the most common malignant tumors of the female reproductive system, with most patients diagnosed at an advanced stage, leading to high recurrence rates and poor prognosis [3] - Treatment options for PROC patients are limited, with existing non-platinum single-agent chemotherapy regimens showing an ORR of only 10% to 15%, mPFS of approximately 3 to 4 months, and a median overall survival of about 12 months, highlighting a significant unmet clinical need [3] - The FTD is expected to accelerate the clinical development and regulatory review process for JSKN003, providing new treatment options for PROC patients globally [3]

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。 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 JSKN003獲美國FDA授予用於治療PROC的FTD 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，JSKN003已獲美國食品藥品監督 管理局（「FDA」）授予快速通道資格認定（「FTD」），用於治療不限人表皮生長因子 受體2（「HER2」）表達水平的鉑耐藥復發性上皮性卵巢癌、原發性腹膜癌或輸卵管 癌（統稱為「PROC」）。這標誌著JSKN003全球開發進程中的又一重要里程碑。 除此之外，JSKN003已獲美國FDA批准開展一項治療不限HER2表達水平的PROC 的II期臨床試驗，且分別在PROC和結腸直腸癌(CRC)上獲國家藥品監督管理局 （「國家藥監局」）藥品審 ...

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]

Core Viewpoint - Corning Incorporated announced the issuance of a total of 1,990,200 restricted stock units to three eligible participants, including the chairman and executive director, Dr. Xu Ting, and executive director, Ms. Liu Yang, as part of its restricted stock award plan [1] Summary by Relevant Sections - **Stock Award Details** - The company resolved to grant a total of 1,990,200 shares under the restricted stock award plan [1] - The shares have a nominal value of $0.000002 per share [1] - The issuance is contingent upon acceptance by the awarded directors and employees [1]

智通财经APP讯，康宁杰瑞制药-B(09966)发布公告，于2025年10月24日，根据限制性股份奖励计划，本 公司决议向3名合资格参与者(包括徐霆博士(公司董事长兼执行董事)、刘阳女士(公司执行董事)及集团 一名雇员)授出合共199.02万股奖励股份，以认购最多合共199.02万股每股面值0.000002美元的公司普通 股，但须待奖励董事及奖励雇员接纳后方可作实。 ...

Core Viewpoint - Corning Pharmaceutical-B (09966.HK) announced the decision to grant a total of 1,990,176 restricted shares to three eligible participants, including the chairman and executive director Xu Ting, executive director Liu Yang, and one employee, under the restricted share award plan, pending acceptance by the awarded directors and employees [1] Group 1 - The company will issue a total of 1,990,176 shares with a par value of $0.000002 per share [1] - The share award is part of a restricted share award plan [1] - The decision involves three participants, including key executives [1]