Core Viewpoint - Corning Jereh Pharmaceutical-B (09966.HK) has received acceptance for its IND application for JSKN022, a dual-targeting ADC aimed at treating advanced malignant solid tumors, marking a significant step in the development of innovative cancer therapies [1][2] Group 1: Product Development - JSKN022 is a globally pioneering dual-targeting ADC that simultaneously targets PD-L1 and integrin αvβ6, representing a novel approach in cancer treatment [2] - The drug is based on the company's self-developed Envafolimab and innovatively combines immune mechanisms with ADC technology [2] - JSKN022 utilizes glycosylation site-specific conjugation technology to enhance stability and uniformity, which is crucial for its therapeutic efficacy [2] Group 2: Clinical Research and Market Potential - The clinical trial for JSKN022 aims to provide new treatment options for patients with tumors that are resistant to PD-1/PD-L1 inhibitors or for whom existing treatments are ineffective, such as non-small cell lung cancer, head and neck squamous cell carcinoma, and colorectal cancer [1] - Currently, there are no ADCs targeting integrin αvβ6 or PD-L1 available in the global market, with all related investigational drugs still in clinical research stages [1]

Core Viewpoint - The company has received formal acceptance from the National Medical Products Administration (NMPA) of China for its Investigational New Drug (IND) application for JSKN022, a dual-specific antibody-drug conjugate targeting PD-L1 and integrin αvβ6, aimed at treating advanced malignant solid tumors [1] Group 1 - The company is developing JSKN022, which is a dual-specific antibody-drug conjugate [1] - The IND application for JSKN022 has been officially accepted by the NMPA's Center for Drug Evaluation (CDE) [1] - The first human clinical study for JSKN022 is planned to be conducted for the treatment of advanced malignant solid tumors [1]

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 JSKN022 IND申請獲CDE正式受理 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。 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，公司自主研發的程序性死亡配 體1（「PD-L1」）╱ 整合素αvβ6雙特異性抗體偶聯藥物（「ADC」）JSKN022新藥臨 床試驗（「IND」）申請，已獲中國國家藥品監督管理局（「NMPA」）藥品審評中心 （「CDE」）正式受理。本公司計劃開展用於治療晚期惡性實體瘤的JSKN022首次人 體臨床研究。 目前全球範圍內尚無靶向整合素αvβ6或PD-L1的ADC上市，相關在研藥物均處於 臨床研究階段。臨床前數據顯示，JSKN022在體外和體內模型中， ...

Core Viewpoint - Corning Jereh Pharmaceutical-B (09966) has received FDA approval for JSKN003 to conduct a Phase II clinical study in the U.S., marking a significant milestone in the company's global development of its innovative pipeline [1] Group 1: Clinical Study Details - JSKN003-202 is a randomized, open-label, multicenter Phase II clinical study aimed at treating platinum-resistant recurrent epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer, collectively referred to as platinum-resistant ovarian cancer (PROC) [1] - The study will evaluate the efficacy and safety of JSKN003 in the specified patient population and determine the recommended dose for Phase III trials [1] Group 2: Product Characteristics - JSKN003 is a targeted HER2 bispecific antibody-drug conjugate (ADC) that connects a topoisomerase I inhibitor to the antibody KN026 using glycoengineering technology, offering better serum stability compared to traditional coupling methods [2] - The bispecific HER2 targeting allows JSKN003 to induce stronger internalization and bystander killing effects, providing significant anti-tumor activity in HER2-expressing tumors [2] Group 3: Licensing and Ongoing Trials - In September 2024, the company entered into a licensing agreement with Shanghai Jinmant Biotechnology Co., Ltd. to develop and commercialize JSKN003 in mainland China for tumor-related indications [2] - Currently, JSKN003 is undergoing three Phase III clinical trials in China for treating HER2-positive breast cancer, HER2-low expressing breast cancer, and platinum-resistant recurrent epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer [2]

Core Viewpoint - Corning Jereh Pharmaceutical-B (09966) has received FDA approval for JSKN003 to conduct a Phase II clinical study in the U.S., marking a significant milestone in the company's global development of its innovative pipeline [1][2]. Group 1: Clinical Trial Details - JSKN003-202 is a randomized, open-label, multi-center Phase II clinical study aimed at treating platinum-resistant recurrent epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer, collectively referred to as platinum-resistant ovarian cancer (PROC) [1]. - The trial will evaluate the efficacy and safety of JSKN003 in the specified patient population and determine the recommended dose for Phase III trials [1]. Group 2: Product Information - JSKN003 is a targeted HER2 bispecific antibody-drug conjugate (ADC) that connects a topoisomerase I inhibitor to the antibody KN026 using glycosylation site-specific conjugation technology, offering better serum stability compared to traditional conjugation methods [2]. - The bispecific HER2 targeting of JSKN003 enhances its internalization and bystander killing effect, providing strong anti-tumor activity in HER2-expressing tumors [2]. Group 3: Licensing and Ongoing Trials - In September 2024, the company entered into a licensing agreement with Shanghai Jinmant Biotechnology Co., Ltd. for the development and commercialization of JSKN003 in mainland China for tumor-related indications [2]. - Currently, JSKN003 is undergoing three Phase III clinical trials in China for treating HER2-positive breast cancer, HER2-low expressing breast cancer, and platinum-resistant recurrent ovarian cancer, primary peritoneal cancer, or fallopian tube cancer [2].

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。 自願公告 JSKN003獲美國FDA批准開展一項治療不限HER2表達水平的 PROC的II期臨床研究 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（「美國」）食 品藥品監督管理局（「FDA」）批准，在美國開展一項I I期臨床研究（研究編號： JSKN003-202）。JSKN003-202是JSKN003的一項隨機、開放式標籤、多中心的 II期臨床研究，用於治療鉑耐藥復發性上皮性卵巢癌、原發性腹膜癌或輸卵管癌 （統稱為鉑耐藥卵巢癌，「PROC」），且不限人表皮生長因子受體2（「HER2」）表達 水平。此臨床試驗旨在評估JSKN003在上述人群中的療效和安全性，並確定推薦 III期劑量。此次JSKN003-202獲美國FDA批准，是 ...

Core Viewpoint - Corning Jereh Pharmaceutical-B (09966) has seen a significant stock increase of nearly 6%, with a cumulative rise of over 65% in the month, currently trading at 10.12 HKD with a transaction volume of 51.2966 million HKD [1] Group 1: Company Developments - Corning Jereh Pharmaceutical announced that its drug JSKN003 has received Orphan Drug Designation (ODD) from the U.S. Food and Drug Administration (FDA) for the treatment of gastric cancer and gastroesophageal junction cancer (GC/GEJ) [1] - JSKN003 is developed using Corning Jereh's proprietary glycosylation site-specific conjugation platform and is a HER2 dual-targeted antibody-drug conjugate (ADC) [1] Group 2: Regulatory and Market Implications - The ODD designation encourages the development of innovative drugs for diseases affecting fewer than 200,000 patients in the U.S. and provides various policy supports for research, development, registration, and commercialization [1] - Following the ODD recognition, JSKN003 is expected to benefit from funding for research expenses, tax reductions for clinical research costs, waivers for prescription drug user fees, and expedited review processes for market approval [1] - Upon approval, the drug is anticipated to receive a seven-year exclusivity in the U.S. market [1]

智通财经APP获悉，康宁杰瑞制药-B(09966)再涨近6%，月内累涨逾65%。截至发稿，涨5.86%，报10.12 港元，成交额5129.66万港元。 据悉，ODD是FDA鼓励开发用于治疗在美国患病人数低于20万的疾病的创新药措施。JSKN003获得该 认定后将有利于后续在美国的研究及开发、注册与商业化等方面获得相关政策支持，包括研发费用资 助、临床研究费用税收减免、处方药用户费用豁免、加速上市审评审批等，以及药物获批后有望获得美 国市场的7年独占权。 消息面上，康宁杰瑞制药发布公告，JSKN003已获美国食品药品监督管理局(FDA)授予孤儿药资格认定 (ODD)，用于治疗胃癌及胃食管结合部癌(GC/GEJ)。JSKN003是康宁杰瑞利用特有的糖基定点偶联平台 自主研发的HER2双抗ADC。 ...

Core Viewpoint - Corning Jereh Pharmaceutical-B (09966) has seen a significant stock increase of nearly 6%, with a cumulative rise of over 65% in the month, currently trading at 10.12 HKD with a transaction volume of 51.2966 million HKD [1] Group 1 - Corning Jereh Pharmaceutical announced that its drug JSKN003 has received Orphan Drug Designation (ODD) from the U.S. Food and Drug Administration (FDA) for the treatment of gastric cancer and gastroesophageal junction cancer (GC/GEJ) [1] - JSKN003 is developed using Corning Jereh's proprietary glycosylation site-specific conjugation platform and is an HER2 dual antibody ADC [1] Group 2 - The ODD designation encourages the development of innovative drugs for diseases affecting fewer than 200,000 patients in the U.S. and provides various policy supports for research, development, registration, and commercialization [1] - Following the ODD recognition, JSKN003 is expected to benefit from funding for research expenses, tax reductions for clinical research costs, waivers for prescription drug user fees, and expedited review processes for market approval [1] - The drug is anticipated to receive a seven-year exclusivity in the U.S. market post-approval [1]

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） JSKN003獲美國FDA授予用於治療GC/GEJ的孤兒藥資格認定 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」）授予孤兒藥資格認定（「ODD」），用於治療胃癌及胃食管結合部 癌（「GC/GEJ」）。 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。 自願公告 JSKN003是一種靶向人表皮生長因子受體2（「HER2」）雙表位抗體偶聯藥物 （「ADC」），其通過糖基定點偶聯技術將拓撲異構酶I抑制劑連接至抗體KN026 （重組人源化抗HER2雙特異性抗體）的N糖基化位點處。點擊反應偶聯物較馬來 醯亞胺－邁克爾反應的偶聯物具有更好的血清穩定性 ...