证券代码：300765 证券简称：新诺威 公告编号：2025-071 石药创新制药股份有限公司 关于控股子公司仑卡奈单抗注射液 获得药物临床试验批准通知书的公告 本公司及董事会全体成员保证信息披露的内容真实、准确、完整，没有虚假 记载、误导性陈述或重大遗漏。 药物名称：仑卡奈单抗注射液 审批结论：根据《中华人民共和国药品管理法》及有关规定，经审查，2025 年 7 月 7 日受理的仑卡奈单抗注射液临床试验申请符合药品注册的有关要求，同 意本品开展"用于治疗由阿尔茨海默病引起的轻度认知障碍和阿尔茨海默病轻度 痴呆"适应症的临床试验。 三、药物的其他相关情况 该产品是一种重组抗人β淀粉样蛋白单克隆抗体药物，为乐意保®的生物类似 药，按照治疗用生物制品 3.3 类申报，适用于治疗由阿尔茨海默病引起的轻度认 知障碍和阿尔茨海默病轻度痴呆，为国内首家获得临床许可的仑卡奈单抗注射液 1 剂 型：注射剂 注册分类：治疗用生物制品 3.3 类 申请事项：临床试验 受 理 号：CXSL2500555 申请人：石药集团巨石生物制药有限公司 生物类似药。该产品的研发遵循生物类似药相关研究指南。药学及非临床研究结 果显示，该产品与原 ...

建议关注：①全球大单品：百济神州(06160)，科伦博泰生物(06990)，信达生物(01801)，康方生物 (09926)，三生制药(01530)，百利天恒(688506.SH)，新诺威(300765.SZ)，石药集团(01093)，翰森制药 (03692)，中国生物制药(01177)，一品红(300723.SZ)，映恩生物(09606)； ②全球BIC潜力：益方生物(688382.SH)，泽璟制药(688266.SH)，基石药业(01592)，苑东生物 (688513.SH)，科济药业(02171)，来凯医药(02105)，复宏汉霖(02696)，再鼎医药(09688)，和黄医药 (00013)，药捷安康(02617)，加科思(01167)，歌礼制药(01672)； ③国内大单品：舒泰神(300204.SZ)，艾力斯(688578.SH)，云顶新耀(01952)，恒瑞医药(600276.SH)，贝 达药业(300558.SZ)，华领医药(02552)； ④资产价值：和铂医药(02142)，和誉(02256)。 立足现在：进军全球商业化，大量优质项目将继续推高产业发展 中国创新药行业已形成以领头企业为引领、 ...

Group 1 - The A-share market saw all three major indices open lower but then rise, with the ChiNext Index reaching a new high of 3168.68 points on September 18, 2025, marking a 24.19% increase over the past month, outperforming other major indices [1] - The semiconductor sector experienced strong gains, with SMIC hitting a new high, while the CPO and humanoid robot concepts remained active [1] - As of September 18, 2025, the ChiNext Index was up 0.40%, and the ChiNext ETF (Guangfa, 159952) rose by 0.47%, achieving a four-day consecutive increase [1] Group 2 - The ChiNext ETF (Guangfa) reached a new high in scale at 15.037 billion yuan and a new three-month high in shares at 7.898 billion [2] - The ETF has seen continuous net inflows over the past four days, with a peak single-day net inflow of 360 million yuan, totaling 1.007 billion yuan [2] - Recent favorable developments in the new energy industry include breakthroughs in solid-state battery technology, rising demand for energy storage, and efforts to stabilize prices [2] Group 3 - The ChiNext Index is heavily weighted in the new energy sector, with battery (22.03%), communication equipment (16.30%), securities (7.84%), and photovoltaic equipment (4.98%) being the primary industries [1] - The ChiNext ETF closely tracks the ChiNext Index, consisting of 100 stocks with high market capitalization and liquidity, focusing on strategic emerging industries such as power equipment, biomedicine, and electronics [2]

（文章来源：每日经济新闻） 每经AI快讯，9月18日，创业板指强势翻红，现涨0.4%，盘初一度跌超1%；医药、芯片权重涨幅居前， 新诺威、智飞生物涨超6%。 ...

Group 1 - The three major indices opened lower on September 18, with the Tianhong ChiNext ETF (159977) down 0.67% and a trading volume exceeding 640 million yuan [1] - The Tianhong ChiNext ETF has seen a net inflow of nearly 485 million yuan over the past three days, with a total circulation of 5.96 billion shares and a market size of 9.733 billion yuan [1] - The ChiNext Index, which the Tianhong ChiNext ETF closely tracks, consists of 100 representative companies listed on the ChiNext board, reflecting the operational status of the ChiNext market [1] Group 2 - The Federal Reserve's recent FOMC meeting minutes revealed a 25 basis point reduction in the federal funds rate target range to 4.00%-4.25%, marking the first rate cut since December 2024 [2] - Market expectations suggest that further rate cuts may occur in the upcoming FOMC meetings in late October and early December [2] - The emergence of the Sci-Tech Innovation Board and the Beijing Stock Exchange has led to a more balanced industrial structure for the ChiNext, with current valuations remaining low despite the absence of a complete weight shift [2]

Company Overview - XinNuoWei is primarily engaged in the research, production, and sales of functional foods, with 88.93% of its revenue coming from this segment, followed by biopharmaceuticals at 8.91% and other sources at 2.16% [1][2] - The company was established on April 5, 2006, and went public on March 22, 2019 [1] Financial Performance - For the first half of 2025, XinNuoWei reported a revenue of 1.05 billion yuan, reflecting a year-on-year growth of 7.99%, while the net profit attributable to shareholders was a loss of 2.75 million yuan, a decrease of 102% compared to the previous year [2] - Since its A-share listing, XinNuoWei has distributed a total of 651 million yuan in dividends, with 500 million yuan distributed over the last three years [3] Stock Performance - As of September 17, XinNuoWei's stock price was 48.19 yuan per share, with a market capitalization of 67.69 billion yuan [1] - The stock has seen an increase of 81.37% year-to-date, but has experienced a decline of 13.95% over the last five trading days [1] - The company has appeared on the "Dragon and Tiger List" once this year, with a net buy of 39.71 million yuan on June 6 [1] Shareholder Structure - As of August 29, the number of shareholders for XinNuoWei was 15,400, a decrease of 8.22% from the previous period, with an average of 81,179 circulating shares per shareholder, an increase of 8.95% [2] - Major shareholders include Hong Kong Central Clearing Limited and various mutual funds, with notable changes in holdings among the top ten circulating shareholders [3]

Macro - Trump's intervention in the independence of the Federal Reserve is primarily through three avenues: 1) Nominating a Federal Reserve Chair who aligns with his views, expected to be nominated in November this year and take office in May next year; 2) Adjusting the personnel structure of the Federal Reserve Board to exclude "outsiders" like Cook, while appointing "loyalists" like Milan to strengthen his influence; 3) Intervening in the appointment of regional Federal Reserve presidents, whose terms will expire at the end of February next year [1] - With the new Federal Reserve Chair's appointment, 4 out of 7 members of the Federal Reserve Board will be "loyalists," giving Trump greater influence, which implies: 1) On a macroeconomic level, the expected rate cuts by the Federal Reserve in 2026 may exceed the current market pricing of three cuts, with policy rates potentially falling below the neutral level of 3%, leading to a shift from a soft landing to moderate expansion in the U.S. economic cycle; 2) On the asset class level, excessive rate cuts under political pressure may weaken dollar interest rate expectations and widen dollar credit risks, corresponding to declines in 2-year Treasury yields and the dollar index, while the decline in 10-year Treasury yields may be hindered by widening term premiums [1]

Core Insights - The company announced a decline in revenue from its functional raw materials business primarily due to a drop in caffeine prices compared to the highs of 2022 and 2023 [2] - Currently, caffeine prices have stabilized, and this business segment continues to maintain a high level of profitability [2] Summary by Category - **Revenue Performance** - The revenue decline in the functional raw materials segment is attributed to the decrease in caffeine prices [2] - **Market Conditions** - Caffeine prices have returned to a stable level after experiencing highs in previous years [2] - **Profitability** - Despite the revenue decline, the functional raw materials business segment remains profitable [2]

Core Viewpoint - The company XinNuoWei announced the progress of its SYS6010 product development, highlighting advancements in clinical research and ongoing studies in various cancer types [2] Group 1: Clinical Research Progress - The Phase 3 clinical study for EGFR mutation TKI-resistant non-small cell lung cancer officially started in March this year in China and is currently enrolling participants [2] - Overseas research progress is advancing smoothly [2] - The company is exploring multiple combination therapy studies covering esophageal squamous cell carcinoma, small cell lung cancer, and both EGFR mutation and wild-type non-small cell lung cancer in first-line patients [2] Group 2: Future Data Release Plans - There are no data release plans for the second half of this year, with expectations for data updates next year [2]

Core Viewpoint - The company announced advancements in its technology, particularly in the area of targeted conjugates, which have been clinically validated to significantly reduce blood toxicity in ADCs [2] Group 1: Technology Advancements - The company's targeted conjugate technology has been clinically validated, demonstrating a change in the toxicity profile of ADCs and significantly reducing blood toxicity [2] - Clinical development of products will require a balanced consideration of target and indication needs [2] Group 2: Intellectual Property - The LNP mRNA company possesses independent intellectual property rights [2]