Re-listing - Enjie Co., Ltd. plans to acquire 100% of Zhongke Hualian, a high-tech enterprise specializing in the research and development of wet lithium-ion battery separator production equipment and other polymer material production equipment, leading to the resumption of its stock trading [1] - Guoao Technology's actual controller has changed to Xu Yinghui, resulting in the resumption of its stock trading [2] Capital Increase and Mergers - Tiens Wind Power plans to raise 1.95 billion yuan for the expansion of the Changfeng New Energy Equipment Manufacturing Base and other related projects [3] - Rese Intelligent plans to raise no more than 1.144 billion yuan for the development and industrialization of core components for intelligent equipment motion control and other projects [4] - Tiankang Biological intends to acquire 51% of Xinjiang Qiangdu Animal Husbandry Technology Co., Ltd. for 1.275 billion yuan in cash [5] Share Transfer and Buyback - Maide Medical plans to repurchase shares worth 20 million to 40 million yuan to reduce the company's registered capital [6] - Xice Testing's controlling shareholder Li Zexin intends to transfer 4.22 million shares at a price of 48.59 yuan per share, accounting for 5% [7] - Jintian Titanium Industry is inquiring about a share transfer price of 15.39 yuan per share for a total of 22.6625 million shares [8] External Investment and Daily Operations - Saiyi Information received approval for a major national science and technology project related to intelligent manufacturing systems and robotics [9] - Jiuan Medical's U.S. subsidiary received pre-market notification from the FDA for a home test kit for multiple viruses [10] - Jiazhe New Energy plans to invest in two wind power projects with a total installed capacity of 450 MW and an investment of approximately 2.366 billion yuan [11] - Junshi Biosciences received FDA approval for clinical trials of JS212 for the treatment of advanced malignant solid tumors [12] - Longsheng Technology plans to invest 350 million yuan in an innovative center for embodied intelligent robots [13] - Watson Bio's subsidiary received approval for clinical trials of a freeze-dried shingles virus mRNA vaccine [14] - Greeenmei plans to acquire 16.38% of Henan Circular Technology Industry Group for 400 million yuan [15] - Heng Rui Medicine's HRS9531 injection clinical trial has been approved, with no similar drugs approved globally for the MASH indication [16] - Guodian Power plans to invest 7.218 billion yuan in the expansion of the Guoneng Jianbi Phase 8 project [17] - Guorui Technology's subsidiary won a bid for the "GXLF Project Pump Source" project with a bid of 76 million yuan [18] - Xin Fengming plans to invest 280 million USD in a 360,000-ton functional fiber project in Egypt [19] - Chip Origin terminated the acquisition of 97% of Chip Lai Zhirong [20] - Moore Thread plans to use 7.5 billion yuan of idle raised funds for cash management [21]

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 ...

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。 2025年1月，JS212的臨床試驗申請獲得國家藥品監督管理局（「國家藥監局」）受 理，並於2025年3月獲得國家藥監局批准。截至本公告日期，JS212正在中國內地 開展一項開放標籤、劑量遞增和劑量擴展的I/II期臨床試驗，旨在晚期實體瘤患者 中評估JS212的安全性、耐受性、藥代動力學和初步療效。此外，JS212多隊列聯 合用藥的臨床試驗申請已於2025年11月獲得國家藥監局批准，計劃於近期開展相 關臨床研究。 SHANGHAI JUNSHI BIOSCIENCES CO., LTD.* 上海君實生物醫藥科技股份有限公司 （於中華人民共和國註冊成立的股份有限公司） （股份代號：1877） 自願性公告－ JS212臨床試驗申請獲得FDA批准 本公告由上海君實生物醫藥科技股份有限公司（「本公司」）自願作出。請亦參見本 公司於2025年12月14日刊發的海外監管公告。 本公司董事（「董事」）會（「董事會」） ...

Core Viewpoint - Junshi Biosciences (stock code: 688180) announced that its clinical trial application for the EGFR/HER3 bispecific antibody-drug conjugate (code: JS212) for the treatment of advanced solid tumors has been approved by the U.S. Food and Drug Administration (FDA) [1] Group 1 - JS212 is a recombinant humanized bispecific antibody-drug conjugate targeting epidermal growth factor receptor (EGFR) and human epidermal growth factor receptor 3 (HER3) [1] - The primary indication for JS212 is the treatment of advanced malignant solid tumors [1]

智通财经APP讯，君实生物(688180.SH)公告，公司收到美国食品药品监督管理局("FDA")的通知， EGFR/HER3双特异性抗体偶联药物(代号：JS212)用于治疗晚期实体瘤的临床试验申请获得FDA批准。 ...

格隆汇12月14日丨君实生物(688180.SH)发布公告，近日，公司收到美国食品药品监督管理局(以下简 称"FDA")的通知，EGFR/HER3 双特异性抗体偶联药物(代号：JS212)用于治疗晚期实体瘤的临床试验申 请获得FDA批准。 ...

君实生物(688180.SH)公告，公司收到美国食品药品监督管理局("FDA")的通知，EGFR/HER3双特异性 抗体偶联药物(代号：JS212)用于治疗晚期实体瘤的临床试验申请获得FDA批准。 ...