Group 1 - The National Medical Products Administration (NMPA) has announced a reward system for internal whistleblowers reporting major violations in drug and medical device quality safety, reflecting a commitment to strengthen regulatory oversight in the industry [1] - The introduction of an internal whistleblower incentive mechanism is expected to enhance compliance management among pharmaceutical and medical device manufacturers, promoting long-term healthy development in the industry [1] Group 2 - Sanofi's new drug application for a recombinant anti-IL-1β humanized monoclonal antibody injection for acute gouty arthritis has been accepted by the NMPA, following successful Phase III clinical trials [2] - With over 80 million gout patients in China and a rapid annual growth rate of 9.7%, the market potential for this treatment is significant, and targeting IL-1β is a valuable therapeutic option [2] - The differentiated binding site of the new drug compared to existing products may provide a competitive edge, although its clinical efficacy needs to translate into market competitiveness [2] Group 3 - Zai Lab has signed an exclusive marketing service agreement with Merck's Swiss subsidiary for a recombinant human thyroid-stimulating hormone injection, with a potential maximum authorization fee of RMB 250 million [3] - The agreement includes an initial payment of RMB 50 million and a subsequent payment of RMB 200 million upon approval of the first indication for the product, which is currently in the registration phase [3] - The introduction of this product is expected to fill a gap in the market for post-operative diagnosis of thyroid cancer, leveraging the synergy with Merck's other recommended thyroid medications [3] Group 4 - Maipu Medical has announced plans to acquire 100% equity of Yijie Medical through a combination of share issuance and cash payment, aiming to expand its product offerings into the interventional field [4] - The acquisition is expected to enhance the company's competitive advantage in the research and development of interventional biomaterials and improve marketing efficiency in neurology departments [4] - The company's stock will resume trading on June 6 following the announcement of this acquisition [4]

Group 1 - Hansoh Pharmaceutical granted Regeneron Pharmaceuticals exclusive overseas licensing for its GLP-1/GIP dual receptor agonist HS-20094, which has completed multiple Phase II clinical trials and is currently in Phase III trials in China [1][2] - The licensing agreement includes an upfront payment of $80 million, potential milestone payments of up to $1.93 billion, and double-digit royalties on future sales [2][3] - Recent licensing deals by Chinese pharmaceutical companies indicate a growing trend, with 33 license-out transactions completed in Q1 2025, totaling $36.633 billion, a year-on-year increase of approximately 258% [1][6] Group 2 - The licensing deal with Pfizer for the PD-1/VEGF dual antibody SSGJ-707 includes a record upfront payment of $1.25 billion, with potential milestone payments reaching $4.8 billion [3] - Other companies, such as Sinovant and Ansai, have also announced licensing agreements, indicating a robust market for Chinese pharmaceutical innovations [3][4] - The 2025 ASCO annual meeting showcased over 70 original research results from China, highlighting the international competitiveness of Chinese innovative drugs [4][5] Group 3 - The overall trend shows that Chinese innovative drugs are gaining global value, with a significant increase in licensing transactions and amounts [6][7] - The pharmaceutical industry is expected to see steady recovery, driven by the growing demand for innovative therapies and the improvement in the quality and quantity of domestic innovative drugs [7]

Investment Rating - The report maintains a "Positive" outlook for the pharmaceutical and biotechnology industry in China [6] Core Insights - The ASCO conference showcased significant breakthroughs in both foreign and domestic innovative drugs, highlighting the competitive strength of domestic companies [4][9] - A total of 73 research data entries from domestic companies were included in this year's ASCO, marking a historical high [9][13] - The report emphasizes the potential of dual antibodies and antibody-drug conjugates (ADCs) in the treatment of non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC) [9][39] Summary by Sections Dual Antibodies - Domestic research is leading globally in dual antibodies, with products like PD-1/VEGF and PD-1/IL-2 showing promise as major drugs in the post-PD-1 era [9][10] - SSGJ-707 from Sanofi has shown impressive efficacy in treating advanced NSCLC, with a clinical data showing a cORR of 64.7% and DCR of 97.1% in specific patient groups [15][16] - IBI363, a first-in-class PD-1/IL-2 dual-specific antibody, has demonstrated significant efficacy in advanced NSCLC, with a median PFS of 9.3 months in squamous cell carcinoma patients [18][19] Antibody-Drug Conjugates (ADCs) - ADCs are expected to gradually replace existing standard of care (SOC) treatments, with domestic products poised to take a significant market share [10][39] - The TROP2 ADC combined with PD-(L)1 therapy has shown promising results in first-line treatment of advanced NSCLC, with an ORR of 55% and mPFS of 11.2 months [27][28] - Sac-TMT from Kelun Biotech has demonstrated superior efficacy compared to Dato-DXd, particularly in patients with high PD-L1 expression [30][31] Small Cell Lung Cancer (SCLC) - DLL3-targeted therapies have made significant progress, with domestic products showing international competitiveness [9][39] - Tarlatamab has achieved breakthroughs in both second-line and first-line maintenance treatment for SCLC, with promising clinical data [9][39] - The report highlights the potential of DLL3-targeted therapies to evolve from dual antibodies to ADCs, enhancing treatment options for SCLC patients [9][39]

证券代码：688336 证券简称：三生国健 公告编号：2025-028 三生国健药业（上海）股份有限公司 2025年第二次临时股东大会决议公告 本公司董事会及全体董事保证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。 重要内容提示： 本次会议是否有被否决议案：无 一、 会议召开和出席情况 （一） 股东大会召开的时间：2025 年 6 月 5 日 （二） 股东大会召开的地点：中国（上海）自由贸易试验区李冰 路 399 号公司会议室 （三） 出席会议的普通股股东、特别表决权股东、恢复表决权的 优先股股东及其持有表决权数量的情况： | 1、出席会议的股东和代理人人数 | 168 | | --- | --- | | 普通股股东人数 | 168 | | 2、出席会议的股东所持有的表决权数量 | 536,444,676 | | 普通股股东所持有表决权数量 | 536,444,676 | | 3、出席会议的股东所持有表决权数量占公司表决权 | 86.9742 | | 数量的比例（%） | | | --- | --- | | 普通股股东所持有表决权数量占公司表决权数 ...

法律意见书 国浩律师(上海)事务所 法律意见书 致:三生国健药业(上海)股份有限公司 根据《中华人民共和国公司法》(以下简称"《公司法》")、《中华人民 共和国证券法》(以下简称"《证券法》")和中国证券监督管理委员会《上市 公司股东会规则》（以下简称"《股东会规则》"）的规定,国浩律师（上海) 事务所接受三生国健药业(上海)股份有限公司(以下简称"公司")董事会的 聘请,指派律师现场见证了公司于 2025年 6 月 5 日 10:00 起在中国(上海)自由 贸易试验区李冰路 399 号公司会议室召开的公司 2025年第二次临时股东大会,并 依据有关法律、法规、规范性文件的规定以及《三生国健药业(上海)股份有限 公司章程》(以下简称"《公司章程》")的规定,对本次股东大会的召集、召 开程序、出席人员资格、大会表决程序等事宜进行了审查,现发表法律意见如下: 国浩律师(上海)事务所 一、股东大会的召集、召开程序 关于三生国健药业(上海)股份有限公司 公司董事会已于 2025 年 5 月 21 日在中国证监会指定信息披露网站上向公司 股东发出了召开 2025年第二次临时股东大会的会议通知。经核查,相关通知及公 告载 ...

近日，三生国健药业（上海）股份有限公司（以下简称"公司" 或"三生国健"）重组抗 IL-1β人源化单克隆抗体注射液（项目代 号"SSGJ-613"）用于急性痛风性关节炎适应症的 III 期临床试验达 到了主要疗效双终点，公司向国家药品监督管理局（NMPA）药品审评 中心（CDE）提交了新药上市申请并获得受理。 证券代码： 688336 证券简称：三生国健 公告编号：2025-029 三生国健药业（上海）股份有限公司 关于自愿披露公司重组抗 IL-1β人源化单克隆抗体 注射液新药上市申请获得受理的公告 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。 重要内容提示： 由于新药上市申请尚需经过审评、药品临床试验现场检查、药品 生产现场检查和审批等环节，产品能否成功上市及上市时间存在不确 定性。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： | 药品名称 | 重组抗 IL-1β人源化单克隆抗体注射液 | | --- | --- | | 剂型 | 注射剂 | | 申请事项 | 境内生产药品注册上市许可 | 一、药 ...

Core Viewpoint - Sanofi's application for the new drug SSGJ-613, a recombinant humanized monoclonal antibody targeting IL-1β for acute gouty arthritis, has been accepted by the National Medical Products Administration after achieving primary efficacy endpoints in Phase III clinical trials [1] Group 1 - The drug SSGJ-613 is developed independently by the company and represents a novel anti-IL-1β antibody with a completely different binding epitope compared to existing products on the market targeting the same pathway [1]

Core Viewpoint - The company has successfully completed the Phase III clinical trial for its innovative anti-IL-1β humanized monoclonal antibody injection (project code "GJ-613") for the treatment of acute gouty arthritis, achieving the primary efficacy endpoints and has submitted a new drug application to the National Medical Products Administration [1] Group 1 - The drug GJ-613 is developed independently by the company and possesses its own intellectual property rights, differentiating itself from existing products targeting the same pathway, such as Canakinumab and Gevokizumab, by having completely different binding epitopes [1] - The completed Phase III clinical study demonstrated that GJ-613 effectively alleviates pain in acute gouty arthritis and prevents recurrence, achieving dual primary efficacy endpoints comparable to the positive control drug, compound betamethasone injection, and significantly outperforming it [1]

Group 1: Market Performance - Major indices experienced a strong rebound, with the Shanghai Composite Index rising by 0.7%, Shenzhen Component Index by 1.24%, and ChiNext Index by 1.37% [2] - Over 4,200 stocks in the two markets saw gains, with a total trading volume of approximately 1.19 trillion yuan [2] Group 2: Digital Currency and Software Sector - The digital currency and software sectors led the market rally, with notable stocks like Lakala (300773.SZ) and Sifang Jingchuang (300468.SZ) hitting the daily limit with a 20% surge [2] - New Guodu (300130.SZ) rose over 14%, while Feitian Chengxin (300386.SZ) and Shenzhou Information (000555.SZ) also saw significant increases of 12.84% and 10%, respectively [2] Group 3: Autonomous Driving and Intelligent Connected Vehicles - Stocks related to autonomous driving and intelligent connected vehicles surged, with companies like Fulongma (603686.SH) and Jintour Environment (001230.SZ) hitting the daily limit [3] - A strategic cooperation agreement was signed between Xiaoma Zhixing and Guangzhou Public Transport Group, focusing on autonomous vehicle services [3] Group 4: Innovative Pharmaceuticals - The innovative pharmaceutical sector remains active, with companies like Sanofi Guojian (688336.SH) rising over 12% [4][3] - The sector is supported by policy backing, global competitiveness, and improving fundamentals, with a focus on "innovation + internationalization" [4] Group 5: Automotive Sector - The automotive sector showed strong performance, with Jinlong Automobile (600686.SH) and Dongfeng Co. (600006.SH) both increasing by 10% [5] - The launch of new models by XPeng and supportive government policies in Fujian province are contributing factors to the sector's growth [5] Group 6: Weak Sectors - The precious metals and food processing sectors experienced declines, with companies like Western Gold (601069.SH) and Laiyifen (603777.SH) seeing significant drops [5]

Group 1 - The innovative pharmaceutical ETF (560900) has seen a 2.20% increase as of May 29, 2025, with significant trading volume [1] - The CSI Innovative Pharmaceutical Industry Index (931152) rose by 2.32%, with notable gains from constituent stocks such as Zhixiang Jintai (688443) up 8.91%, Sangfor Technologies (688336) up 7.41%, and Maiwei Biotech (688062) up 5.78% [1] - Over the past two weeks, the innovative pharmaceutical ETF (560900) has accumulated a 3.94% increase, ranking it among the top comparable funds [2] Group 2 - CITIC Securities believes that leading innovative pharmaceutical companies have entered a profit phase, with potential for nonlinear profit explosions as commercialization expands [2] - The investment opportunities in the innovative pharmaceutical sector are linked to the clinical progress of molecules under research and the entire commercialization phase, which can last up to ten years [2] - The innovative pharmaceutical ETF closely tracks the CSI Innovative Pharmaceutical Industry Index, which selects no more than 50 representative listed companies involved in innovative drug research and development [2] Group 3 - Morgan Asset Management is integrating its "Global Vision Investment Technology" product line to help investors capitalize on quality technology companies amid a new wave of AI-driven technological advancements [2] - Various actively managed funds focus on emerging industry trends, including the Morgan Emerging Power Fund and the Morgan Smart Connectivity Fund, which targets opportunities in artificial intelligence [3] - The Morgan Hang Seng Technology ETF (513890) and the Morgan CSI Innovative Pharmaceutical Industry ETF (560900) provide passive investment options for technology and innovative pharmaceutical sectors, respectively [3]