君实生物12月14日公告，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。JS212是重组人源化抗 表皮生长因子受体和人表皮生长因子受体3双特异性抗体偶联药物，主要用于晚期恶性实体瘤的治疗。 ...

人民财讯12月14日电，君实生物(688180)12月14日公告，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。JS212是重组人源化抗表皮生长因子受体和人表皮生长因子受体3双特异性抗体偶联药物，主要用于 晚期恶性实体瘤的治疗。 ...

每经AI快讯，12月14日，君实生物(688180.SH)公告称，公司收到FDA通知，EGFR/HER3双特异性抗体 偶联药物JS212用于治疗晚期实体瘤的临床试验申请获得FDA批准。JS212主要用于晚期恶性实体瘤的治 疗，与单一靶点ADC药物相比，有望对更广泛的肿瘤有效，同时有望克服耐药性问题。 ...

2025 年 1 月，JS212 的临床试验申请获得国家药品监督管理局（以下简称"国 家药监局"）受理，并于 2025 年 3 月获得国家药监局批准。截至本公告披露日， JS212 正在中国内地开展一项开放标签、剂量递增和剂量扩展的 I/II 期临床试验， 旨在晚期实体瘤患者中评估 JS212 的安全性、耐受性、药代动力学和初步疗效。 证券代码：688180 证券简称：君实生物 公告编号：临 2025-074 上海君实生物医药科技股份有限公司 自愿披露关于 JS212 临床试验申请 获得 FDA 批准的公告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述 或者重大遗漏，并对其内容的真实性、准确性和完整性依法承担法律责任。 近日，上海君实生物医药科技股份有限公司（以下简称"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。 由于药品的研发周期长、审批环节多，容易受到一些不确定性因素的影响，敬请 广大投资者谨慎决策，注意防范投资风险。现将相关情况公告如下： 一、药品 ...

Investment Rating - The investment rating for the pharmaceutical and biotechnology industry is "Positive" (maintained) [1] Core Insights - The 2025 National Medical Insurance Negotiation results were announced, with 114 new drugs added to the medical insurance directory, achieving an overall success rate of 88%, the highest in nearly seven years, with a maximum price reduction of 94 [4][19] - The newly added drugs include monoclonal antibodies, bispecific antibodies, ADCs, siRNA, and small molecules, indicating a strong focus on innovative therapies [19][32] - The commercial insurance directory has added 19 innovative drugs, which, while not reimbursed by medical insurance, receive support for innovative drug applications, enhancing patient access and benefiting the innovative drug industry [5][24] Summary by Sections 1. National Medical Insurance Negotiation Results - The 2025 medical insurance directory added 114 new drugs, with a success rate of 88% and a maximum price reduction of 94% [4][13] - The total number of drugs in the national medical insurance directory reached 3,253, including 1,857 Western medicines and 1,396 traditional Chinese medicines [16][17] - The directory reflects a significant increase in the inclusion of innovative drugs, with 50 of the new additions classified as category 1 innovative drugs [19][21] 2. Commercial Insurance Directory - The commercial insurance directory added 19 innovative drugs, highlighting their clinical value and innovation [24][28] - The directory includes treatments for diseases such as Alzheimer's, rare diseases in children, and other critical conditions, showcasing a focus on addressing unmet medical needs [24][28] - The support for innovative drugs in the commercial insurance directory aims to fill gaps in patient coverage and enhance the overall healthcare system [25][28] 3. Market Performance - In the second week of December, the pharmaceutical and biotechnology sector declined by 1.04%, underperforming the CSI 300 index by 0.96 percentage points [6][34] - The medical research outsourcing sector showed the highest increase, up by 3.69%, while offline pharmacy and medical circulation sectors experienced the largest declines [6][36] 4. Recommended Companies - The report continues to favor innovative drugs and their supply chain, recommending companies such as Sanofi, Innovent Biologics, and others for investment [7][32]

Core Viewpoint - Junshi Biosciences aims to establish itself as a global innovative pharmaceutical company with a complete industry chain capability from drug discovery to commercialization, focusing on quality and innovation [2][3]. Company Overview - Junshi Biosciences, founded on December 27, 2012, and listed on July 15, 2020, specializes in the research and commercialization of monoclonal antibody drugs and other therapeutic proteins [7]. - The company's main revenue sources include drug sales (90.67%), technology licensing (8.74%), and other services (0.59%) [7]. Product Development - The company has developed a promising drug portfolio, including its core product, Toripalimab, which is the first domestically approved PD-1 monoclonal antibody in China, with 11 approved indications and one supplemental NDA under review [2]. - Toripalimab is also the first innovative biologic drug developed and produced in China to receive FDA approval, with approvals in multiple regions including the US, EU, and Australia [2]. - Junshi's self-developed Tifcemalimab is the first anti-tumor anti-BTLA monoclonal antibody to enter clinical development, currently undergoing two Phase III trials [2]. Vaccine Development - The company's subsidiary, JunTuo Biotech, is developing vaccine-related products, including monkeypox and Zika vaccines, which are currently in the preclinical development stage [3]. - A collaboration has been established with several research institutions and universities to jointly develop a recombinant protein vaccine for monkeypox [3]. Financial Performance - For the period from January to September 2025, Junshi Biosciences reported revenue of 1.806 billion yuan, a year-on-year increase of 42.06%, while the net profit attributable to the parent company was -596 million yuan, reflecting a year-on-year growth of 35.72% [8]. Market Position - As of September 30, 2025, Junshi Biosciences had 35,900 shareholders, with an average of 21,361 circulating shares per person, a decrease of 12.96% from the previous period [8]. - The company is positioned within the pharmaceutical and biotechnology industry, focusing on innovative drugs, precision medicine, and cancer treatment [8].

来源：新浪证券-红岸工作室 融资方面，君实生物当日融资买入1056.73万元。当前融资余额13.61亿元，占流通市值的4.89%，融资 余额超过近一年70%分位水平，处于较高位。 截至9月30日，君实生物股东户数3.59万，较上期增加15.17%；人均流通股21361股，较上期减少 12.96%。2025年1月-9月，君实生物实现营业收入18.06亿元，同比增长42.06%；归母净利润-5.96亿元， 同比增长35.72%。 融券方面，君实生物12月10日融券偿还0.00股，融券卖出2807.00股，按当日收盘价计算，卖出金额 10.19万元；融券余量38.89万股，融券余额1411.87万元，超过近一年90%分位水平，处于高位。 机构持仓方面，截止2025年9月30日，君实生物十大流通股东中，易方达上证科创板50ETF（588080） 位居第七大流通股东，持股1939.29万股，相比上期减少282.03万股。华夏上证科创板50成份ETF （588000）位居第八大流通股东，持股1897.20万股，相比上期减少1074.47万股。 资料显示，上海君实生物医药科技股份有限公司位于上海市浦东新区平家桥路100弄6 ...

Core Viewpoint - In 2025, the Chinese A-share market is showing a steady upward trend supported by favorable policies, with the China Securities Regulatory Commission urging listed companies to increase dividends, buybacks, and shareholdings to solidify their value foundation [1] Group 1: Executive Buybacks - Since 2025, 27 companies in the A-share market have seen significant executive buybacks, particularly in high-growth sectors like healthcare, new energy, and semiconductors [2] - For instance, Kelly Tai's executives increased their holdings by 2.3 million shares, a 14% increase, benefiting from the growing orthopedic medical demand due to an aging population [2] - DeYe shares' executives bought 120,000 shares, while Tuojing Technology's executives increased their holdings by 210,000 shares, a 12% rise, aligning with national policies on technological self-reliance [2] Group 2: Policy Support - Multiple significant policies in 2025 have led to a surge in positive announcements from listed companies, with 14 companies benefiting from adjustments in the national medical insurance catalog and the encouragement of private investment [3][5] - The national medical insurance catalog added 114 new drugs, including 50 innovative drugs, significantly enhancing the market accessibility and sales scale for companies like Junshi Biosciences and Hengrui Medicine [5] - The release of 13 opinions by the State Council encourages private capital participation in key sectors like railways and nuclear power, with companies like China Railway Construction benefiting from substantial project contracts [5] Group 3: Performance Support - Many of the 14 companies have solid operational performance, signing significant contracts or achieving key technological breakthroughs that underpin their investment value [6][7] - For example, JinkoSolar's TigerNeo 3.0 components achieved a production efficiency of 24.8% and secured global orders worth 15 GW, showcasing its competitive edge in the solar market [7] - Research and development investments in A-shares reached 745.69 billion yuan in the first half of 2025, with sectors like electronics and biomedicine leading the way, indicating a strong foundation for future growth [7] Group 4: Investment Opportunities - Investors should focus on companies with executive buybacks in high-growth sectors, those benefiting from policy adjustments, and firms with significant contracts or R&D breakthroughs [8][9][10] - The combination of internal confidence from executives and favorable industry trends creates a strong investment rationale [8] - Companies directly benefiting from long-term policy releases, such as those in the medical and infrastructure sectors, present stable investment opportunities [9]

Group 1 - The 2025 National Medical Insurance Drug List includes 114 new drugs, with 50 being innovative drugs, showing an overall success rate of 88%, an increase from 76% in 2024 [1] - Nine innovative drugs from the Sci-Tech Innovation Board have been included in the medical insurance list, highlighting the strength and vitality of these companies [1] - The first version of the Commercial Health Insurance Innovative Drug List has been released, complementing the basic medical insurance and providing new possibilities for patients to access cutting-edge treatments [4] Group 2 - Nearly 90% of new drugs approved by Sci-Tech Innovation Board companies have received medical insurance support, indicating a shift towards value realization for these companies [2] - The drug "Junshi Biological's Junshida" is the only domestic PCSK9-targeted drug for patients intolerant to statins, now included in the medical insurance list [2] - The successful renewal negotiations for several innovative drugs confirm their clinical value and market position, benefiting a wider patient population [6][7] Group 3 - Innovative drugs from companies like Baiji Shenzhou and Junshi Biological have been recognized for their clinical value and patient benefits, leading to their inclusion in the medical insurance list [7] - The R&D investment of Sci-Tech Innovation Board companies reached a new high in the first three quarters of 2025, with a year-on-year increase of over 10%, indicating a strong commitment to innovation [7] - The cycle of "R&D investment - innovation results - insurance support - market return - reinvestment in R&D" is being established and strengthened within the industry [7]

（文章来源：证券日报） 证券日报网讯 12月10日，君实生物在互动平台回答投资者提问时表示，公司已获得JS207（PD-1/VEGF 双抗）与JS212（EGFR/HER3双抗ADC）联合用药的I/II期临床试验批准，并计划于近期开展相关临床 研究。JS207目前处于II期临床研究阶段，正在多个瘤种中开展与化疗、单抗、ADC等不同药物的联合 探索，公司将积极探索多种联用方案，以最大程度发挥管线协同作用。由于医药产品的前期研发以及产 品从研制、临床试验报批到投产的周期长、环节多，容易受到一些不确定性因素的影响。 ...