Group 1 - The stock price of Kehua Bio (002022) closed at 6.52 yuan on September 19, 2025, down by 0.91%, with a turnover rate of 1.3%, a trading volume of 66,700 shares, and a transaction amount of 43.46 million yuan [1] Group 2 - Tianlong Technology's key national research project on "Major Scientific Instrument and Equipment Development" has been accepted, focusing on the development of a fluorescence digital gene amplification single-molecule detection instrument [2] - The company emphasizes continuous investment in R&D and has accumulated rich experience in various diagnostic fields, maintaining a system advantage across multiple platforms and methodologies in in vitro diagnostics [2] - The company is facing unprecedented challenges in the in vitro diagnostics industry due to intensified competition and policy reforms, leading to a decline in revenue and increased losses [2] - The actual controller of the company holds 5% of the shares, while the controlling shareholder has a total voting power of 15.64% [2] Group 3 - On September 19, the net outflow of main funds was 4.18 million yuan, while retail investors saw a net inflow of 6.12 million yuan [3]

Group 1 - The core viewpoint is that the in vitro diagnostic industry is facing unprecedented challenges due to intensified competition and various policy reforms, including the continuous promotion of centralized procurement and the rapid implementation of DRG [2] - The company is actively optimizing human resource costs as part of its strategy to reduce expenses and enhance efficiency in response to market and policy challenges [2] - The company is committed to improving its operational performance and increasing its intrinsic value amidst the evolving industry landscape [2]

Group 1 - The company has received a medical device registration certificate for in vitro diagnostic reagents from the Shanghai Municipal Drug Administration [1] - The acquisition of this new product registration enriches the company's product line and is expected to have a positive impact on business development [1] - The company is currently unable to predict the future revenue impact of the new products and advises investors to pay attention to investment risks [1]

Policy Developments - The 2025 Pharmaceutical Digital Development Conference was held in Beijing on September 17-18, focusing on the modernization of drug regulation through information technology and digital collaboration [1] Drug and Device Approvals - Hengrui Medicine's SHR-1501 has been included in the list of proposed breakthrough therapy varieties by the National Medical Products Administration, aimed at treating non-muscle invasive bladder cancer [2] - Kehua Bio's ferritin assay kit received a medical device registration certificate, valid from September 17, 2025, to September 16, 2030, for the quantitative measurement of ferritin in human serum and plasma [3] - Shanghai Pharmaceuticals' Nicorandil tablets passed the consistency evaluation for generic drugs, with approximately 5.5352 million yuan invested in R&D [4] Capital Market - Roche announced a definitive agreement to acquire biopharmaceutical company 89bio for up to nearly $3.5 billion, focusing on innovative therapies for liver and heart metabolic diseases [5] Industry Events - The first national group standard for "Non-Clinical Safety Technical Guidelines for Oligonucleotide Drugs" was released during the 9th China (Tianjin) Nucleic Acid Drug Conference [6] Research and Development - Chinese researchers developed a new generation of brain-machine interface electrodes, marking a shift towards dynamic and intelligent detection in bioelectronic interfaces [7] - A new blood testing tool, "HPV-DeepSeek," can identify HPV-related head and neck cancers up to 10 years before symptoms appear, potentially improving patient outcomes [9] Corporate Governance - The independent director of Buchang Pharma, Cheng Hua, resigned due to personal reasons, leading to a temporary reduction in the number of independent directors on the board [10] Strategic Collaborations - Siemens Healthineers and Stryker announced a strategic partnership to develop a new robotic system for neurovascular interventions [8]

证券日报网讯 9月18日晚间，科华生物发布公告称，近日，公司收到上海市药品监督管理局颁发的医疗 器械注册证（体外诊断试剂），产品名称：铁蛋白测定试剂盒（胶乳免疫比浊法）。 （文章来源：证券日报） ...

Group 1 - Shudao Equipment's subsidiary signed a construction contract worth 24.68 million yuan for a hydrogen fuel cell manufacturing base project [1] - Zhongliang Technology received a land acquisition compensation of 30 million yuan from the government [2] - Palm Holdings won a bid for a high-standard farmland construction project in Lankao County, with a contract value of 433 million yuan, accounting for 14.12% of the company's audited revenue for 2024 [3] Group 2 - Changchun Yidong's subsidiary received a government subsidy of 2.85 million yuan, which is 122.78% of the company's audited net profit for the last fiscal year [4] - Wuzhou Transportation successfully issued 200 million yuan in medium-term notes with an interest rate of 2.10% [5][6] - Tiandi Source's subsidiary plans to apply for a trust loan of up to 500 million yuan from related parties [8] Group 3 - Tiandi Source's subsidiary acquired a residential land use right in Xi'an for 2.015 billion yuan [9] - Opcon Vision received a medical device registration certificate for its ultrasonic nebulizer [11] - Jingjiawei announced the resignation of its vice president due to personal reasons [13] Group 4 - Fulinh Precision's subsidiary received a prepayment of 1.5 billion yuan from CATL for securing lithium iron phosphate material supply [15] - Yunzhu Technology's subsidiary received a government subsidy of 20.12 million yuan [16] - Kehua Bio's ferritin test kit received a medical device registration certificate [17] Group 5 - Jinghua Pharmaceutical's medical sodium alginate wound dressing received a medical device registration certificate [18] - Lingwei Technology established a wholly-owned subsidiary with a registered capital of 1 million yuan [19] - Sanwei Co. won a bid for concrete sleeper procurement projects worth 158 million yuan [20] Group 6 - Shanghai Pharmaceuticals' Nicardipine tablets passed the consistency evaluation for generic drugs [21] - Lushan New Materials increased its idle fund management limit to 750 million yuan [24] - Huayi Technology announced the retirement of a core technical staff member [25] Group 7 - Yingli Environment plans to use up to 300 million yuan of idle raised funds for cash management [30] - Yong'an Forestry plans to develop a national reserve forest project in Putian, Fujian, with an estimated investment of 154 million yuan [32] - Xinyuan Technology's shareholders plan to reduce their holdings by up to 3.18% of the company's shares [60]

人民财讯9月18日电，科华生物（002022）9月18日晚间公告，近日，公司收到上海市药品监督管理局颁 发的医疗器械注册证(体外诊断试剂)。产品名称为铁蛋白测定试剂盒(胶乳免疫比浊法)，本试剂盒供医 疗机构用于体外定量测定人血清、血浆样本中铁蛋白(FER)的含量。临床上主要用于铁代谢的相关疾 病，如血色素沉着症和缺铁性贫血的辅助诊断。 ...

格隆汇9月18日丨科华生物(002022.SZ)公布，收到上海市药品监督管理局颁发的医疗器械注册证（体外 诊断试剂），产品名称：铁蛋白测定试剂盒（胶乳免疫比浊法）。以上新产品医疗器械注册证的取得， 丰富了公司产品线，将对公司业务发展具有正面影响。 ...

Core Viewpoint - Kehua Bio (002022.SZ) has received a medical device registration certificate from the Shanghai Municipal Drug Administration for its Ferritin Assay Kit, which is used for the quantitative measurement of ferritin levels in human serum and plasma samples [1] Group 1 - The Ferritin Assay Kit utilizes the latex immunoturbidimetric method [1] - The kit is intended for use in medical institutions for the auxiliary diagnosis of iron metabolism-related diseases, such as hemochromatosis and iron deficiency anemia [1]

Core Viewpoint - Kehua Bio (002022.SZ) has received a medical device registration certificate from the Shanghai Municipal Drug Administration for its Ferritin Assay Kit, which is used for the quantitative measurement of ferritin levels in human serum and plasma samples [1] Company Summary - The Ferritin Assay Kit utilizes the latex immunoturbidimetric method and is intended for use by medical institutions [1] - The kit is primarily used for the auxiliary diagnosis of iron metabolism-related diseases, such as hemochromatosis and iron deficiency anemia [1]