新诺威8月19日公告，公司控股子公司巨石生物近日收到国家药品监督管理局核准签发的关于度普利尤 单抗注射液的《药物临床试验批准通知书》，将于近期开展临床试验。度普利尤单抗注射液是一款靶向 IL-4Rα的重组全人源单克隆抗体药物，为达必妥®的生物类似药，适用于治疗成人中重度特应性皮炎。 ...

Core Viewpoint - The company XinNuoWei (300765.SZ) announced that its subsidiary, Shiyao Group Jushi Biopharmaceutical Co., Ltd., has received approval from the National Medical Products Administration for the clinical trial of Dupilumab injection, which will commence shortly [1] Group 1 - Dupilumab injection is a recombinant fully human monoclonal antibody drug targeting IL-4Rα, developed as a biosimilar to Dupixent [1] - The drug is classified under Category 3.3 for therapeutic biological products and is intended for the treatment of moderate to severe atopic dermatitis in adults [1] - The research and development of this product adhere to the relevant guidelines for biosimilars, with pharmaceutical and non-clinical research results indicating high similarity in quality, safety, and efficacy compared to the reference drug [1]

新诺威公告，控股子公司石药集团巨石生物制药有限公司收到国家药品监督管理局核准签发的关于度普 利尤单抗注射液的《药物临床试验批准通知书》，将于近期开展临床试验。度普利尤单抗注射液为靶向 IL-4Rα的重组全人源单克隆抗体药物，为达必妥®的生物类似药，适用于治疗成人中重度特应性皮炎。 ...

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。 证券代码：300765 证券简称：新诺威 公告编号：2025-066 石药创新制药股份有限公司 关于控股子公司度普利尤单抗注射液 获得药物临床试验批准通知书的公告 一、概述 石药创新制药股份有限公司（以下简称"公司"）的控股子公司石药集团巨石 生物制药有限公司（以下简称"巨石生物"）于近日收到国家药品监督管理局核 准签发的关于度普利尤单抗注射液的《药物临床试验批准通知书》，将于近期开 展临床试验。现将相关情况公告如下： 二、药物的基本信息 结果显示，该产品与原研参照药在质量、安全性和有效性方面高度相似，支持开 展后续临床研究。 四、风险提示 药物名称：度普利尤单抗注射液 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6月5日受理的度普利尤单抗注射液两规格的临床试验申请均符合药品注册的 有关要求，同意本品在国内开展临床试验。 三、药物的其他相关情况 度普利尤单抗注射液是一款靶向 IL-4Rα的重组全人源单克隆抗体药物，为 达必妥®的生物类似药，按照治疗用生物制品 3.3 类申报，适用于治 ...

Core Viewpoint - The company reported a revenue of 1.05 billion yuan for the first half of 2025, marking a year-on-year growth of 7.99%. Despite a short-term net loss due to increased R&D expenses, breakthroughs in ADC drugs and mRNA vaccines are opening up significant growth opportunities in the biopharmaceutical industry [1] Group 1: Financial Performance - The company achieved a revenue of 1.05 billion yuan in the first half of 2025, reflecting a year-on-year increase of 7.99% [1] - The net profit was impacted by a surge in R&D expenses, leading to a temporary loss [1] Group 2: R&D and Innovation - R&D investment reached 455 million yuan, representing a substantial year-on-year increase of 80.81%, accounting for 43% of total revenue [4] - The company has established multiple differentiated technology platforms, including antibody engineering and ADC technology platforms, to meet diverse biopharmaceutical R&D needs [5] Group 3: Product Development and Market Position - The company’s subsidiary, Jushi Biopharma, made significant progress in commercializing key products, including the approval of Enyitan for treating moderate to severe persistent allergic asthma [2] - The company is actively expanding its product offerings in functional foods and raw materials, achieving sales revenue of 934 million yuan in this segment, remaining stable compared to the previous year [3] Group 4: International Collaboration - A strategic partnership was formed with Radiance Biopharma, granting exclusive rights for the development and commercialization of SYS6005 in major markets, with a total transaction value of up to 1.24 billion USD [2] Group 5: Clinical Trials and Regulatory Approvals - Several in-development products are at critical stages, with Ustinumab injection submitted for market approval and others in key clinical trial phases [6] - The company received multiple clinical trial approvals from the FDA, enhancing its global development capabilities [6]

Macro Strategy - The core viewpoint is that the "innovation bull market" in 2025 is driven by a positive cycle of capital pricing and industrial implementation under policy guidance, with macro policies anchoring industrial direction and capital markets facilitating value discovery [1] - The market liquidity and valuation have improved, with A-share trading volume exceeding 2 trillion yuan, indicating a positive trading structure and sentiment cycle [1] - The initial phase of the "innovation bull" is likely to extend towards financial sectors and technology industries, particularly in robotics, computing power, and innovative pharmaceuticals [1] Economic Outlook - The report anticipates that China's export growth may continue to exceed market expectations due to the dual easing of U.S. fiscal and monetary policies, suggesting resilience in external demand [2] - The expectation of interest rate cuts by the Federal Reserve is highlighted, with predictions of two cuts in September and December, although there is caution regarding overly optimistic market pricing [2] Fixed Income Market - The fixed income market has shown a "desensitization" to fundamental data, with the yield on 10-year government bonds rising to 1.745% despite disappointing economic indicators [4] - The report notes that structural policy tools may replace total monetary policies as the main line of easing in the third quarter [4] Company Performance - 瑞芯微 (Rockchip) reported a significant revenue increase of 63.85% year-on-year in H1 2025, with a net profit growth of 190.61%, driven by strong performance in AIoT products [8] - 禾赛科技 (Hesai Technology) achieved a revenue increase of 53.9% year-on-year in Q2 2025, with a net profit growth of 161.2%, supported by strong demand for ADAS and robotics [9] - 道通科技 (Dautong Technology) reported a revenue increase of 27.3% year-on-year in H1 2025, driven by advancements in digital repair and energy solutions [10] Industry Trends - The report emphasizes the growth potential in the AI and robotics sectors, with companies like 禾赛科技 and 瑞芯微 leading in their respective fields [9][8] - The demand for 3D vision technology is highlighted as a key growth driver for 奥比中光 (Orbbec), with expected rapid revenue growth in the coming years [20] Investment Ratings - The report maintains a "buy" rating for several companies, including 瑞芯微, 禾赛科技, and 道通科技, based on their strong performance and growth prospects in innovative sectors [8][9][10]

Financial Performance - In the first half of 2025, the company achieved operating revenue of 1.05 billion yuan, a year-on-year increase of 7.99% [1] - The net profit attributable to shareholders was -2.75 million yuan, compared to 137 million yuan in the same period last year [1] - The net profit attributable to shareholders after deducting non-recurring gains and losses was -41.14 million yuan, down from 134 million yuan year-on-year [1] - The net cash flow from operating activities was -152 million yuan, an improvement from -941 million yuan in the same period last year [1] Historical Financial Data - From 2022 to 2024, the company's operating revenues were 2.84 billion yuan, 2.54 billion yuan, and 1.98 billion yuan respectively [2] - The net profits attributable to shareholders for the same years were 503 million yuan, 434 million yuan, and 53.73 million yuan [2] - The net cash flow from operating activities for these years was 758 million yuan, 721 million yuan, and -1.235 billion yuan respectively [2] Fundraising and Stock Issuance - The company was listed on the Shenzhen Stock Exchange on March 22, 2019, with an issuance of 50 million shares at a price of 24.47 yuan per share [2] - The total amount raised from the IPO was 1.2235 billion yuan, with a net amount of 1.1424 billion yuan after deducting issuance costs [2] - The company has conducted two fundraising rounds, totaling 1.72 billion yuan [4] Recent Stock Activity - As of the latest closing, the company's stock price was 51.21 yuan, with a decline of 3.38%, and a total market capitalization of 71.929 billion yuan [2] Shareholder Returns - The company has announced several stock dividends and bonus shares, including a 10-for-11 bonus share issuance in April 2020 and a 10-for-8 bonus share issuance in April 2023 [4]

Core Viewpoint - Dongwu Securities report indicates that Xinowei achieved a net profit attributable to shareholders of -0.03 billion yuan (-102%) in the first half of the year, with a slight increase in revenue but a significant decline in profit [1] Group 1: Financial Performance - The company reported a net profit of -0.03 billion yuan, reflecting a 102% decline [1] - Revenue showed a slight growth despite the substantial drop in profit [1] Group 2: Research and Development Progress - The company continues to increase investment in R&D, with the EGFR ADC expected to initiate its first overseas registration clinical trial in the second half of the year [1] - Overseas clinical trials are accelerating, with over 100 patients enrolled to date, and the potential for a significant business development (BD) blockbuster [1] - SYSA1501 (HER2-MMAE) completed the last patient enrollment for the 2L+HER2+ breast cancer Phase 3 clinical trial in China in April [1] - The mRNA vaccine platform is progressing smoothly, with RSV, VZV, and HPV vaccines currently in Phase I clinical trials [1] - The PD1 monoclonal antibody completed the first patient enrollment for the domestic SCLC post-chemotherapy consolidation treatment Phase 2/3 clinical trial in June [1] - Omabuzumab for the treatment of moderate to severe allergic asthma was approved in February [1] - The pertuzumab analog completed Phase 3 clinical trials in June and achieved topline results, with expectations for production reporting in the second half of the year [1] Group 3: Business Stability - The company's biopharmaceutical R&D is progressing smoothly, while the functional food and raw material drug businesses are gradually stabilizing [1] - The company maintains a "buy" rating [1]

Market Overview - A-shares opened lower but closed higher, with the Shanghai Composite Index rising 0.83% to 3,696 points, and the Shenzhen Component Index increasing 1.6%, reaching a new high for the year[18] - The Hang Seng Index and the Hang Seng China Enterprises Index both fell by 0.98%, primarily dragged down by technology and banking stocks[13] - U.S. stock indices showed mixed performance, with the Dow Jones up 0.08% to 44,946 points, while the S&P 500 and Nasdaq fell by 0.29% and 0.40%, respectively[11] Economic Indicators - U.S. retail sales in July increased by 0.5%, with June's growth revised up to 0.9%[30] - The Michigan Consumer Sentiment Index unexpectedly dropped from 62 to 58.6, indicating concerns over inflation[30] - China's July retail sales growth slowed, influenced by extreme weather and a decline in manufacturing and real estate investment[6] Commodity and Forex Market - International oil prices fell over 1%, with NYMEX crude oil down 1.8% to $62.8 per barrel[28] - The U.S. dollar index decreased by 0.4%, reflecting a year-to-date decline of 9.8%[27] - The euro appreciated against the dollar, rising 0.5% to 1.170, with a year-to-date increase of 13.0%[27] Fixed Income Market - Long-term European government bonds saw significant declines, with Germany's 30-year bond yield rising 8 basis points to 3.35%, the highest since 2011[30] - U.S. Treasury yields also increased, with the 10-year yield up 3 basis points to 4.32%[30] - The market anticipates a 83% probability of a 25 basis point rate cut by the Federal Reserve in September[30]

Group 1 - The core viewpoint of the report is that Dongwu Securities has given a "buy" rating for XinNuoWei (300765.SZ) based on its performance and potential in the biopharmaceutical sector [2] - The company experienced a slight revenue growth in H1, but a significant decline in profits [2] - The EGFR ADC data presented at the AACR conference is seen as a potential "blockbuster" drug, indicating strong future prospects [2] - The company is actively increasing its investment in research and development, focusing on ADC, mRNA, and monoclonal antibody drugs [2]