Group 1 - The company has received FDA approval for its dual-specificity antibody-drug conjugate JS212, aimed at treating advanced solid tumors [1] - JS212 targets both EGFR and HER3, which are highly expressed in various tumor cells, including lung cancer, colorectal cancer, and head and neck tumors [1] - Preclinical studies have shown that JS212 exhibits high affinity and specificity for EGFR and HER3, demonstrating significant tumor suppression in multiple animal models [1] Group 2 - As of the announcement date, JS212 is undergoing an open-label, dose-escalation, and dose-expansion Phase I/II clinical trial in mainland China to evaluate its safety, tolerability, pharmacokinetics, and preliminary efficacy in patients with advanced solid tumors [2] - A clinical trial application for a multi-cohort combination therapy involving JS212 has also been approved by the National Medical Products Administration, with plans to initiate related clinical research soon [2]

Group 1 - Multiple pharmaceutical stocks announced positive news, including Jiuan Medical's FDA pre-market notification for home test kits for influenza and COVID-19, allowing normal sales in the U.S. market [1] - Junshi Bioscience received FDA approval for clinical trials of its EGFR/HER3 bispecific antibody drug for treating advanced solid tumors [1] - Innovent Biologics' BTK inhibitor, Orelabrutinib, reached primary endpoints in a Phase II trial for systemic lupus erythematosus and has been approved for Phase III trials [2] Group 2 - The Chinese innovative drug industry is at a critical turning point, with over $100 billion in licensing deals in the first three quarters of 2025, indicating significant potential for domestic innovative drugs [3] - Major collaborations between Chinese companies and multinational corporations include a $12 billion deal between Hengrui and GSK, and a $114 billion potential deal between Innovent and Takeda [3] - The Chinese innovative drug sector is expected to show a compound annual growth rate of 20.2% from 2024 to 2028, with the market size projected to reach 26.9 billion yuan by 2028 [1][4] Group 3 - The pharmaceutical industry is anticipated to thrive by 2025, with the Hang Seng Index expected to double in value [4] - The innovative drug sector's listed companies achieved a total revenue of 48.83 billion yuan in the first three quarters of 2025, a 22% year-on-year increase, marking the first quarterly profit since inception [4] - The investment landscape is shifting from a focus on academic backgrounds and preclinical data to a stronger emphasis on companies' tangible strengths and product quality [4]

Core Insights - Multiple pharmaceutical companies have recently announced positive developments, indicating a potential growth phase in the industry [1][2][4]. Group 1: Company Announcements - Jiuan Medical's U.S. subsidiary received pre-market notification from the FDA for its home testing kits for multiple viruses, including COVID-19, allowing for normal sales in the U.S. market [1]. - Junshi Bioscience's dual-specific antibody drug for treating advanced solid tumors has received FDA approval for clinical trials [1]. - Innovent Biologics announced that its BTK inhibitor, Orelabrutinib, has met primary endpoints in a Phase II study for systemic lupus erythematosus and has been approved for Phase III trials [1]. - Yipinhong's Qinxiang Qingjie oral solution has been approved as a national secondary protected traditional Chinese medicine, and the company is set to receive up to $15 billion (approximately 67.13 billion RMB) from Sobi for a new URAT1 inhibitor [2]. Group 2: Market Trends - The Chinese innovative drug sector is experiencing a significant turnaround after a challenging period from 2021 to 2024, with total external licensing amounts surpassing $100 billion in the first three quarters of 2025 [4]. - Major collaborations between Chinese innovative drug companies and multinational corporations (MNCs) are on the rise, exemplified by significant deals such as the $12 billion partnership between Hengrui Medicine and GSK [4]. - The speed and cost-effectiveness of Chinese drug development are becoming competitive advantages, with drug discovery processes being 2-3 times faster than international counterparts [4]. Group 3: Financial Performance - The innovative drug sector in China reported a total revenue of 48.83 billion RMB in the first three quarters of 2025, reflecting a year-on-year growth of 22% [5]. - The sector achieved its first quarterly profit since its inception, with a net profit of 1.1 billion RMB in the third quarter [5]. Group 4: Investment Landscape - The capital market for Chinese innovative drugs is undergoing a transformation, shifting from a focus on academic backgrounds and preclinical data to a stronger emphasis on tangible product capabilities [6].

Group 1 - The company, Shanghai Junshi Biosciences Co., Ltd., has received FDA approval for the clinical trial application of JS212, a bispecific antibody-drug conjugate targeting EGFR and HER3 for the treatment of advanced solid tumors [1] - JS212 is designed to target tumors with high expression of EGFR and HER3, such as lung cancer, colorectal cancer, and head and neck tumors, and aims to overcome drug resistance mechanisms associated with various anticancer therapies [1] - Preclinical studies have shown that JS212 exhibits high affinity and specificity for EGFR and HER3, demonstrating significant tumor suppression effects in multiple animal models, along with acceptable safety profiles [1] Group 2 - In January 2025, the clinical trial application for JS212 was accepted by the National Medical Products Administration (NMPA) of China, and it received approval in March 2025 [2] - As of the announcement date, JS212 is undergoing an open-label, dose-escalation, and dose-expansion Phase I/II clinical trial in mainland China to evaluate its safety, tolerability, pharmacokinetics, and preliminary efficacy in patients with advanced solid tumors [2] - A clinical trial application for a multi-cohort combination therapy involving JS212 was approved by the NMPA in November 2025, with plans to initiate related clinical research soon [2]

Core Viewpoint - Multiple pharmaceutical companies have announced positive developments, including FDA approvals and significant clinical trial milestones, indicating a robust growth trajectory in the pharmaceutical sector. Group 1: Company Announcements - Jiuan Medical announced that its U.S. subsidiary received FDA pre-market notifications for its four-in-one and three-in-one home testing kits for influenza and COVID-19, enhancing its product line in the IVD field [1][3]. - Junshi Biosciences reported that its dual-specificity antibody-drug conjugate (JS212) for treating advanced solid tumors received FDA approval for clinical trials [4]. - Innovent Biologics disclosed that its BTK inhibitor, Obutinib, achieved primary endpoints in a Phase II clinical trial for systemic lupus erythematosus and received approval for Phase III trials [4]. - Yipinhong announced that its Qinxing Qingjie oral solution was approved as a national secondary protected traditional Chinese medicine, which will strengthen its market position [5]. Group 2: Market Trends and Insights - The Chinese innovative drug industry is expected to experience rapid growth, with over $92 billion in outbound BD transactions in the first three quarters of 2025, indicating a significant opportunity for Chinese companies in the global market [7]. - The first version of the commercial health insurance innovative drug directory was released, highlighting the competitive landscape and the inclusion of several high-efficacy domestic drugs, which signals a positive trend for innovative drug development [8]. - Analysts suggest that the integration of innovative drugs into both medical insurance and commercial insurance will lead to rapid revenue growth for these products, benefiting patients and companies alike [8].

Core Viewpoint - Multiple pharmaceutical companies have announced positive developments, indicating a growing momentum in the industry and potential investment opportunities. Company Announcements - Jiuan Medical announced that its U.S. subsidiary received pre-market notifications from the FDA for several home and professional testing kits for influenza A, influenza B, COVID-19, and RSV, enhancing its product line in the IVD sector [2][3]. - Junshi Biosciences reported that its dual-specificity antibody-drug conjugate (JS212) for treating advanced solid tumors received FDA approval for clinical trials, marking a significant step in its oncology pipeline [4]. - Innovent Biologics disclosed that its BTK inhibitor, Orelabrutinib, achieved primary endpoints in a Phase IIb study for systemic lupus erythematosus and has been approved to proceed to Phase III trials, positioning it as a potential first-in-class treatment [4]. - Yipinhong announced that its Qinxing Qingjie oral solution has been approved as a national secondary protected traditional Chinese medicine, which will enhance its market competitiveness in pediatric medicine [5]. Industry Insights - The Chinese innovative drug industry is expected to experience rapid growth, with over $92 billion in outbound business development transactions in the first three quarters of 2025, indicating a significant expansion into the global market [6]. - The first commercial health insurance drug directory has been released, highlighting the competitive landscape for new drugs, with only 19 out of 121 new drugs passing the review, emphasizing the importance of clinical efficacy and innovation [7]. - The inclusion of innovative drugs in both medical insurance and commercial insurance is anticipated to lead to rapid revenue growth for these products, benefiting patients and driving growth for related pharmaceutical companies [7].

Core Viewpoint - Junshi Biosciences (01877) has received FDA approval for its clinical trial application of JS212, a bispecific antibody-drug conjugate targeting EGFR and HER3 for the treatment of advanced solid tumors [1] Group 1: Product Overview - JS212 is a recombinant humanized bispecific antibody-drug conjugate targeting epidermal growth factor receptor (EGFR) and human epidermal growth factor receptor 3 (HER3), primarily aimed at treating advanced malignant solid tumors [1] - EGFR and HER3 are highly expressed on the surface of various tumor cells, including lung cancer, colorectal cancer, and head and neck tumors [1] - JS212 is expected to have a broader efficacy against tumors and potentially overcome resistance issues compared to single-target ADCs, as it can exert tumor-suppressing effects through binding to either EGFR or HER3 [1] Group 2: Clinical Trials and Approvals - In January 2025, the clinical trial application for JS212 was accepted by the National Medical Products Administration (NMPA) and received approval in March 2025 [2] - As of the announcement date, JS212 is undergoing an open-label, dose-escalation, and dose-expansion Phase I/II clinical trial in mainland China to evaluate its safety, tolerability, pharmacokinetics, and preliminary efficacy in patients with advanced solid tumors [2] - A clinical trial application for a multi-cohort combination therapy involving JS212 was approved by the NMPA in November 2025, with plans to initiate related clinical research soon [2]

Core Viewpoint - Junshi Biosciences (01877.HK) has received approval from the U.S. Food and Drug Administration (FDA) for its clinical trial application of the EGFR/HER3 bispecific antibody-drug conjugate (code: JS212) for the treatment of advanced solid tumors [1] Group 1 - The FDA notification indicates a significant milestone for Junshi Biosciences in advancing its oncology pipeline [1] - The approval allows the company to initiate clinical trials, which could lead to potential market opportunities in the oncology sector [1] - JS212 represents a novel therapeutic approach targeting specific cancer pathways, highlighting the company's commitment to innovation in cancer treatment [1]

Core Viewpoint - Junshi Biosciences (01877) has received FDA approval for its clinical trial application of the EGFR/HER3 bispecific antibody-drug conjugate (JS212) for the treatment of advanced solid tumors [1] Group 1: Product Overview - JS212 is a recombinant humanized bispecific antibody-drug conjugate targeting epidermal growth factor receptor (EGFR) and human epidermal growth factor receptor 3 (HER3), primarily aimed at treating advanced malignant solid tumors [1] - EGFR and HER3 are highly expressed on the surface of various tumor cells, including lung cancer, colorectal cancer, and head and neck tumors [1] - JS212 is expected to have a broader efficacy against tumors and to overcome resistance issues compared to single-target ADC drugs, as it can exert tumor-suppressing effects through binding to either EGFR or HER3 [1] Group 2: Clinical Trials and Approvals - In January 2025, the clinical trial application for JS212 was accepted by the National Medical Products Administration (NMPA) and received approval in March 2025 [2] - As of the announcement date, JS212 is undergoing an open-label, dose-escalation, and dose-expansion Phase I/II clinical trial in mainland China to evaluate its safety, tolerability, pharmacokinetics, and preliminary efficacy in patients with advanced solid tumors [2] - A multi-cohort combination therapy clinical trial application for JS212 was approved by the NMPA in November 2025, with plans to initiate related clinical research soon [2]

（於中華人民共和國註冊成立的股份有限公司） （股份代號：1877） 海外監管公告 本公告乃根據香港聯合交易所有限公司證券上市規則第13.10B條規則作出。 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，概不對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。 SHANGHAI JUNSHI BIOSCIENCES CO., LTD.* 上海君實生物醫藥科技股份有限公司 茲載列上海君實生物醫藥科技股份有限公司在上海證券交易所網站刊發之《上海 君實生物醫藥科技股份有限公司自願披露關於JS212臨床試驗申請獲得FDA批准 的公告》，僅供參閱。 承董事會命 上海君實生物醫藥科技股份有限公司 熊俊先生 主席 中國，上海，2025年12月14日 於本公告日期，本公司董事會包括執行董事熊俊先生、李寧博士、鄒建軍博士、 李聰先生、張卓兵先生、姚盛博士、王剛博士及李鑫博士；非執行董事湯毅先 生；以及獨立非執行董事張淳先生、馮曉源博士、酈仲賢先生、魯琨女士及楊勁 博士。 * 僅供識別之用 证券代码：688180 证券简称：君 ...