Investment Rating - The report gives a "Buy" rating for the company, marking its first coverage [1]. Core Views - The company is moving towards a harvest period with multiple licensing collaborations validating its platform value [1]. - The company achieved its first profit in 2024, driven by significant licensing income and a strong focus on R&D [6][22]. - The company has a robust pipeline of HER2-targeted products, with key candidates in late-stage clinical trials [6][25]. Summary by Sections 1. Technical Innovation as a Driver - The company focuses on antibody-drug conjugates (ADC) and bispecific antibodies, leveraging core technologies for differentiated cancer immunotherapy [11]. - The management team has extensive experience in research and development, ensuring innovation and operational efficiency [11][19]. - The company has secured multiple high-value licensing agreements, enhancing its platform and pipeline value [19][20]. 2. HER2-targeted Product Strategy - The company has three HER2-targeted products, including KN026 (HER2 bispecific antibody) and JSKN003 (HER2 bispecific ADC), positioned for various cancer indications [25][30]. - KN026 is expected to submit a domestic application for 2L+ HER2-positive gastric cancer by 2025, with promising clinical data [30][34]. - JSKN003 has a commercial collaboration with a partner, with a total transaction value of 30.8 billion RMB [39]. 3. JSKN016 (TROP2/HER3 ADC) Development - JSKN016 is being explored for both monotherapy and combination treatments, targeting high-expression TROP2 and HER3 in various tumors [7][25]. - The drug is in clinical phase 2, focusing on unmet needs in triple-negative breast cancer and EGFR-TKI resistant non-small cell lung cancer [7][25]. 4. Financial Performance and Projections - The company achieved a revenue of 6.4 billion RMB in 2024, a year-on-year increase of 192.6%, with a profit of 1.66 billion RMB [22][23]. - The R&D expenditure for 2024 was maintained at 4.04 billion RMB, ensuring continued investment in clinical development [22][24]. - Revenue projections for 2025-2027 are estimated at 4.58 billion RMB, 4.90 billion RMB, and 3.98 billion RMB respectively [6][25].

Core Viewpoint - The A-share market has reached a significant milestone with the Shanghai Composite Index surpassing 3,800 points, indicating a structural transformation driven by technology and innovation, particularly in the innovative pharmaceutical sector [1][2]. Company Overview - 康宁杰瑞制药 (Kangning Jereh) has emerged as a leading player in China's innovative drug industry, transitioning from a crisis to a strategic restructuring phase, focusing on core projects and enhancing its research and development capabilities [5][9]. - The company has successfully completed a strategic shift towards dual-targeted antibody drug conjugates (ADC), positioning itself for growth in the innovative drug development landscape [8][10]. Financial Performance - In the first half of 2025, 康宁杰瑞 reported revenue of 319 million yuan, a year-on-year increase of 84.05%, and a net profit of 21.58 million yuan, marking a return to profitability [22]. - The company's cash reserves reached 1.645 billion yuan, providing a solid financial foundation for future research and production [22]. Market Position and Potential - 康宁杰瑞's valuation is currently in a recovery phase, with its intrinsic value not fully recognized in the market, suggesting significant upside potential [23]. - The company is positioned favorably in the dual-targeted ADC sector, with its core products advancing ahead of industry peers, indicating a strong competitive edge [23]. Industry Context - The Chinese innovative drug sector is experiencing rapid growth, supported by favorable policies and a shift from imitation to independent innovation, with 康宁杰瑞 exemplifying this transition [20][25]. - The ongoing policy support for innovative drugs is expected to benefit companies with strong research capabilities and significant commercial potential [21].

Financial Performance - The company's revenue decreased by 18.5% from RMB 16,284 million in 2024H1 to RMB 13,273 million in 2025H1[35] - Gross profit decreased by 25.3% from RMB 11,655 million in 2024H1 to RMB 8,710 million in 2025H1[35] - Gross profit margin decreased by 6.0 percentage points from 71.6% in 2024H1 to 65.6% in 2025H1[35] - Reported profit attributable to shareholders of the Company decreased by 15.6% from RMB 3,020 million in 2024H1 to RMB 2,548 million in 2025H1[35] - Underlying profit attributable to shareholders of the Company decreased by 27.9% from RMB 3,217 million in 2024H1 to RMB 2,320 million in 2025H1[35] - Revenue from finished drugs decreased by 24.4% from RMB 13,549 million in 2024H1 to RMB 10,248 million in 2025H1[36] - Revenue from bulk vitamin C increased by 21.6% from RMB 984 million in 2024H1 to RMB 1,196 million in 2025H1[36] - Revenue from nervous system therapeutics decreased by 28.3% from RMB 5,236 million in 2024H1 to RMB 3,755 million in 2025H1[37] - Revenue from oncology therapeutics decreased significantly by 60.8% from RMB 2,683 million in 2024H1 to RMB 1,051 million in 2025H1[37] R&D and Pipeline - The company has 5 R&D centers located in China & the U S [6,99] - The company has approximately 200 innovative drugs and new formulations [6,99] - R&D expenses increased by 5.5% from RMB 2,542 million in 2024H1 to RMB 2,683 million in 2025H1[35] Business Development - The company has license-out agreements including a potential milestone payment of $105 billion for GLP-1, $522 billion for ROR1 ADC, $1955 billion for Irinotecan Liposome Injection, and $1225 billion for strategic collaboration [116]

ck Code : 1093) 2025 Interim Results Presentation Aug. 2025 ININI China's Leading Innovative Pharmaceutical Enterprise R&D Capabilities 00 5 capacity of 250,000L R&D centers located in R&D platforms China & the U.S. 201010 + - 2401 Innovative drugs and R&D professionals new formulations Manufacturing Capabilities Commercialization Capabilities 2 10+ Production bases for pharmaceutical products Nano formulation production capacity of 20M doses/year; Biologics fermentation Chemical drugs production capacity o ...

Investment Rating - The report assigns a "Buy" rating for the company with a target price of 18.63 HKD, based on a current price of 10.36 HKD [6]. Core Insights - The company is positioned as a leading innovative pharmaceutical enterprise in China, with a strong focus on research and development, and a robust commercialization capability [14][19]. - The recent performance has been impacted by price adjustments and centralized procurement policies, but new licensing revenues and additional product launches are expected to drive growth [19][20]. - The company has established eight major technology platforms, showcasing its research capabilities and potential for future growth through international licensing agreements [4][29]. Summary by Sections Company Overview - The company integrates research, production, and sales, focusing on innovative drugs as its core strategy, supported by a large international R&D team and a comprehensive marketing network [14][15]. Financial Performance - In Q1 2025, the company reported revenues of 70.15 billion CNY, a year-on-year decline of 21.9%, with a net profit of 14.95 billion CNY, down 8.3% [20][22]. - The traditional pharmaceutical business, which contributes approximately 80% of total sales, has faced pressure due to centralized procurement and price adjustments [19][22]. Product Pipeline and Innovation - The company has a diverse pipeline with over 200 innovative drugs and formulations, including 10 ADC products in clinical stages, highlighting its strong R&D capabilities [33][39]. - Key products like SYS6010 (EGFR ADC) have entered critical clinical phases, with significant potential for licensing and market impact [2][45]. Market Expansion and Licensing - The company has successfully executed multiple international licensing agreements, enhancing its global presence and generating substantial licensing revenue [35][36]. - Recent collaborations with major pharmaceutical companies, such as AstraZeneca, indicate a growing recognition of the company's innovative capabilities [37][38].

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。 ...