ck Code : 1093) 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 of OSD ~30B tablets/year, production capacity of injection ~3B doses/year mRNA vaccine commercial produc ...

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]

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 ...

Core Insights - Baili Tianheng's BL-B01D1 has become the world's first dual antibody-drug conjugate (ADC) to complete Phase III clinical trials, targeting recurrent or metastatic nasopharyngeal carcinoma after failure of PD-1/PD-L1 monoclonal antibody treatment and at least two lines of chemotherapy [1][4][5] - The successful Phase III trial may position nasopharyngeal carcinoma as the primary indication for BL-B01D1, with potential for additional indications such as esophageal cancer to be analyzed in mid-2025 [1][2][5] Company Developments - Baili Tianheng's BL-B01D1 achieved a major clinical endpoint in its Phase III trial, marking a significant milestone for the company and the dual ADC category [2][3] - The company has over 30 ongoing clinical trials for BL-B01D1, including 9 Phase III trials, with the nasopharyngeal carcinoma indication being recognized as a breakthrough therapy by the National Medical Products Administration (NMPA) in April 2024 [2][5] - In 2023, Baili Tianheng entered a partnership with BMS, which included a total transaction value of $8.4 billion for the rights to BL-B01D1, making it the first dual ADC licensed from China [3][5] Industry Context - The success of BL-B01D1 in Phase III trials is seen as a validation of the quality and potential of dual ADCs globally, highlighting the strength of Chinese innovative drug assets [1][5] - The number of dual ADCs entering clinical stages globally remains limited, with only a few others, such as TQB2102 and JSKN003, also in Phase III trials [5][6] - The dual targeting nature of BL-B01D1, which targets EGFR and HER3, positions it favorably in the competitive landscape, with broad anti-tumor activity demonstrated across multiple cancer types [5]

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].