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]

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 授出獎勵股份之購買價 無 （於開曼群島註冊成立的有限公司） （股份代號：9966） 根據限制性股份獎勵計劃授出獎勵股份 本公告乃根據《香港聯合交易所有限公司證券上市規則》（「上市規則」）第17.06A、 17.06B及17.06C條而作出。 茲提述康寧傑瑞生物製藥（「本公司」，連同其附屬公司，統稱「本集團」）日期分別 為2020年4月14日及2021年3月23日的公告、日期為2024年5月21日的通函以及於 2024年6月12日舉行的股東週年大會的投票表決結果公告（「該等公告及通函」）， 內容有關（其中包括）採納限制性股份獎勵計劃（「限制性股份獎勵計劃」）、修訂計 劃規則及更新計劃授權限額。除另有界定者外，本公告所用詞彙與該等公告及通 函所界定者具有相同涵義。 根據限制性股份獎勵計劃授出獎勵股份 董事會欣然宣佈，於2025年10月24日（「授出日期」 ...

Core Insights - The article highlights the impressive clinical data of two core products from Kangning Jereh, KN026 and JSKN003, presented at the 2025 ESMO conference, showcasing the company's strength in innovative drug development [1][4][22] - The market reacted positively, with Kangning Jereh's stock price surging over 11% on the day of the ESMO conference, indicating a reassessment of the company's value based on its underlying technological platform rather than just individual products [1][22] - The article raises a strategic question about the future of innovative drug development: whether success will depend on luck with single molecules or on replicable, iterative platform innovation capabilities [1][22] Product Performance - KN026 demonstrated a remarkable objective response rate of 55.8% in patients with HER2-positive gastric cancer, significantly outperforming the control group at 10.8%, and achieved a disease control rate of 80% [4][5] - The safety profile of KN026 is also strong, with a 75% reduction in the risk of disease progression or death and a 71% reduction in mortality risk, supporting its application for market approval [5] - JSKN003 showed a 32.0% objective response rate in platinum-resistant ovarian cancer, achieving this across various HER2 expression levels, indicating its broad applicability [6][7] - In HER2-positive metastatic colorectal cancer, JSKN003 achieved an objective response rate of 68.8% and a disease control rate of 96.9%, with a median progression-free survival of 11.04 months [6][7] Strategic Shift - Kangning Jereh has successfully transitioned from a pipeline-driven approach to a technology-driven model, leveraging its CRIB dual antibody platform to develop KN026 and its glycosylation site-specific conjugation ADC platform for JSKN003 [10][11] - The company is building a robust core technology system that includes various platforms, enhancing its ability to produce innovative drugs and ensuring sustainable growth [10][11] - The article emphasizes the importance of platform capabilities in generating "best-in-class" or "first-in-class" drugs, which are seen as valuable assets for the company [9][10] Market Outlook - Kangning Jereh's financial performance is improving, with a revenue of 319 million yuan in the first half of 2025, representing an 84% year-on-year increase, and a net profit of 21.58 million yuan [13] - The company is expected to continue its growth trajectory, with analysts projecting significant revenue potential for its core products, including peak sales estimates of 4.56 billion yuan for KN026 in HER2-positive breast cancer and 3.27 billion yuan for JSKN003 in HER2-positive breast cancer [15][19] - The article suggests that Kangning Jereh's valuation remains undervalued compared to peers, despite its recent stock price increase, indicating potential for significant revaluation as the market recognizes its innovative capabilities [17][19]

Core Viewpoint - The pharmaceutical sector is experiencing significant pressure, with notable declines in stock prices for several companies [2]. Company Summaries - Rongchang Biopharmaceutical (09995.HK) has seen a decline of 11.2%, trading at 81.65 HKD [2]. - CStone Pharmaceuticals-B (09966.HK) has dropped by 8.2%, currently priced at 11.98 HKD [2]. - Junshi Biosciences (01877.HK) has decreased by 5.16%, with shares at 25 HKD [2]. - Kintor Pharmaceutical-B (02171.HK) has fallen by 4.63%, now at 16.07 HKD [2].