[Chipscreen Biosciences 2025 Semi-Annual Performance Forecast](index=1&type=section&id=Voluntary%20Disclosure%20Announcement%20by%20Shenzhen%20Chipscreen%20Biosciences%20Co.%2C%20Ltd.%20Regarding%20its%202025%20Semi-Annual%20Performance%20Forecast) The company expects significant growth and a turnaround to profitability in H1 2025, with revenue projected to increase by 35% to approximately RMB 407.29 million, and net profit attributable to shareholders by 173% to approximately RMB 30.06 million [Current Period Performance Forecast](index=1&type=section&id=I.%20Current%20Period%20Performance%20Forecast) The company anticipates substantial year-on-year growth and a return to profitability for its key financial metrics in the first half of 2025 [Performance Forecast Period](index=1&type=section&id=(I)%20Performance%20Forecast%20Period) This performance forecast covers the period from January 1, 2025, to June 30, 2025 - The statistical period for this performance forecast is from January 1, 2025, to June 30, 2025[2](index=2&type=chunk) [Performance Forecast Details](index=1&type=section&id=(II)%20Performance%20Forecast%20Details) Preliminary calculations indicate significant year-on-year growth across revenue, net profit, and non-recurring net profit, with both profit metrics achieving a turnaround to profitability 2025 Semi-Annual Performance Forecast Key Data | Indicator | 2025 Semi-Annual Estimate | Year-on-Year Growth | | :--- | :--- | :--- | | Operating Revenue | Approx. RMB 407.29 million | 35% | | Net Profit Attributable to Shareholders | Approx. RMB 30.06 million | 173% | | Non-Recurring Net Profit Attributable to Shareholders | Approx. RMB 21.19 million | 145% | [Unaudited Performance Forecast](index=1&type=section&id=(III)%20Unaudited%20Performance%20Forecast) The performance forecast data presented is a preliminary calculation by the company's finance department and has not yet been audited by a certified public accountant - This performance forecast data has not been audited by a certified public accountant[4](index=4&type=chunk) [Prior Period Performance Review](index=1&type=section&id=II.%20Prior%20Period%20Performance%20Review) In H1 2024, the company reported RMB 302.16 million in operating revenue, with net profit and non-recurring net profit both in a loss state, providing a baseline for current period improvements 2024 Semi-Annual Performance Data | Indicator | 2024 Semi-Annual | | :--- | :--- | | Operating Revenue | RMB 302.16 million | | Net Profit Attributable to Shareholders | -RMB 41.01 million | | Non-Recurring Net Profit Attributable to Shareholders | -RMB 47.18 million | [Primary Reasons for Performance Change](index=2&type=section&id=III.%20Primary%20Reasons%20for%20Performance%20Change) The strong performance growth is primarily driven by increased sales of two core products, Chidamide and Seglitaz, with the company achieving profitability in Q2 2025 - Core product sales growth is the main driver of performance improvement - **Chidamide**: New indication for diffuse large B-cell lymphoma included in the national medical insurance catalog - **Seglitaz**: Optimized sales strategy, with its unique "diabetes and liver co-management" advantage gaining market recognition[6](index=6&type=chunk) - Q2 2025 performance was strong, with revenue expected to grow by **43% year-on-year** and **51% quarter-on-quarter**, and net profit attributable to shareholders achieving a turnaround to profitability[6](index=6&type=chunk) [Risk Warning and Other Disclosures](index=2&type=section&id=IV.%20Risk%20Warning%20and%20Other%20Disclosures) The company confirms no significant uncertainties affecting the forecast's accuracy but reminds investors that the data is preliminary and subject to the final semi-annual report - The company states that no significant uncertainties affecting the accuracy of this performance forecast have been identified[7](index=7&type=chunk) - Investors are advised that the current forecast data is preliminary, and the specific financial data will be subject to the company's officially disclosed 2025 semi-annual report[7](index=7&type=chunk)

Core Viewpoint - Micron Biomedical expects to achieve approximately 407 million yuan in revenue for the first half of 2025, representing a year-on-year increase of 35% [1] - The company anticipates a net profit attributable to the parent company of about 30.06 million yuan for the same period, reflecting a significant year-on-year increase of 173% [1] - The net profit after deducting non-recurring gains and losses is projected to be around 21.19 million yuan, which is a 145% year-on-year increase [1] Revenue and Profit Projections - For the second quarter of 2025, the company expects a revenue increase of 43% year-on-year and a 51% increase quarter-on-quarter [1] - The company forecasts a turnaround in net profit attributable to the parent company, indicating a recovery from previous losses [1] Product Performance - The product "Sida Benamine" has recently been included in the medical insurance for diffuse large B-cell lymphoma, contributing to increased sales [1] - The sales strategy optimization for "Sigelet Sodium" and its unique advantage in "liver disease co-management" have gained market recognition, leading to significant sales growth for both products [1]

Group 1 - The hepatitis concept sector rose by 2.17%, ranking 7th among concept sectors, with 120 stocks increasing in value, including notable gainers such as Rundu Co., Wanbangde, and Lisheng Pharmaceutical, which hit the daily limit [1][2] - The top gainers in the hepatitis concept sector included Guangshantang, Furuishi, and Laimei Pharmaceutical, with increases of 16.55%, 9.55%, and 8.48% respectively [1][2] - The sector experienced a net inflow of 1.831 billion yuan, with 87 stocks receiving net inflows, and 16 stocks exceeding 50 million yuan in net inflow, led by Qianhong Pharmaceutical with a net inflow of 227 million yuan [2][3] Group 2 - The leading stocks by net inflow ratio included Rundu Co. at 42.20%, ST Weiming at 33.93%, and Zhejiang Zhenyuan at 29.25% [3] - The top stocks in the hepatitis concept sector based on net inflow included Qianhong Pharmaceutical, ST Weiming, and Hanyu Pharmaceutical, with respective net inflows of 226.89 million yuan, 168.20 million yuan, and 165.89 million yuan [3][4] - The overall performance of the hepatitis concept sector reflects strong investor interest and significant capital inflows, indicating potential growth opportunities within the sector [2][3]

Summary of Key Points Core Viewpoint - The financing balance of the Sci-Tech Innovation Board (STAR Market) increased by 34.57 million yuan compared to the previous day, with 54 stocks seeing a financing balance increase of over 10 million yuan, led by Shengyi Electronics, Lanke Technology, and Zhongkong Technology [1][2]. Financing Balance Overview - As of July 15, the total margin financing balance on the STAR Market reached 160.13 billion yuan, an increase of 42.96 million yuan from the previous trading day [1]. - The financing balance of 425 stocks exceeded 100 million yuan, with 17 stocks having balances over 1 billion yuan, and 112 stocks between 50 million to 100 million yuan [1]. Net Financing Inflows - The stocks with the highest net financing inflows included Shengyi Electronics (118.9 million yuan), Lanke Technology (84.26 million yuan), and Zhongkong Technology (53.14 million yuan) [2]. - Among the stocks with net inflows exceeding 10 million yuan, the average increase was 0.05%, with notable gainers including Zhiyuan Huilian (10.85%), Yifang Bio (7.89%), and Nanxin Pharmaceutical (6.21%) [2]. Industry Preferences - The most favored industries by financing clients included pharmaceuticals, electronics, and machinery, with 17, 16, and 8 stocks respectively [2]. - The average financing balance as a percentage of the circulating market value for stocks with significant net inflows was 4.00%, with Rongbai Technology having the highest ratio at 13.08% [2]. Notable Stock Movements - Stocks with significant financing balance increases included Shengyi Electronics (40.96%), Lanke Technology (2.98%), and Zhongkong Technology (3.01%) [2][3]. - Conversely, stocks with notable decreases in financing balance included Jinshan Office, Transsion Holdings, and Haiguang Information, with reductions of 165 million yuan, 138 million yuan, and 129 million yuan respectively [1].

Group 1 - The core viewpoint highlights the significant growth and performance of the Kexin Pharmaceutical ETF managed by Jiashi, with a notable increase in trading volume and fund size [2] - As of July 9, the Kexin Pharmaceutical ETF achieved a daily average trading volume of 34.95 million yuan over the past month, ranking first among comparable funds [2] - The fund's size increased by 16.76 million yuan in the past two weeks, also ranking first among comparable funds [2] - The ETF saw a total inflow of 12.84 million yuan over the last ten trading days, indicating strong investor interest [2] - The net value of the Kexin Pharmaceutical ETF rose by 36.83% over the past year, showcasing its strong performance [2] Group 2 - The top ten weighted stocks in the Shanghai Stock Exchange Science and Technology Innovation Board Biopharmaceutical Index account for 50.3% of the index, with leading companies including United Imaging Healthcare and BeiGene [2][4] - On July 9, Shanghai Pharmaceuticals announced an expected net profit of 4.45 billion yuan for the first half of 2025, representing a year-on-year increase of approximately 52% [4] Group 3 - Short-term market expectations for overseas transactions in innovative drugs are high, leading to a continuous rise in valuations [5] - China's innovative drug research and development capabilities are competitive globally, and the trend of innovative drugs going overseas is expected to persist [5] - The commercial health insurance sector in China is anticipated to see significant growth in premium income and payout rates, becoming an important source of funding for innovative drugs [5]

Core Viewpoint - MicuBio (688321.SH) announced the final top-line analysis data from its pivotal Phase III clinical trial (DEB study) for its self-developed drug, Sidanbamide, which significantly outperformed the control group in terms of event-free survival (EFS), achieving the primary endpoint of the study [2][4] Group 1: Product and Market Information - Sidanbamide is the world's first subtype-selective histone deacetylase (HDAC) inhibitor and belongs to the class of epigenetic regulators [4] - The drug received conditional approval for DLBCL indications from the National Medical Products Administration (NMPA) in April 2024 and is set to be included in the national medical insurance catalog by the end of 2024, making it the only oral innovative drug for first-line DLBCL within the insurance coverage [4] - DLBCL is the most common type of lymphoma in China, with approximately 60,000 to 80,000 new cases reported annually, and the incidence rate is gradually increasing [4] Group 2: Clinical Trial and Regulatory Information - The company previously received conditional approval based on interim analysis data, requiring completion of clinical trials within two years to obtain complete clinical data [4] - The announcement of the final results signifies an expansion of the existing indication range for the product, positively impacting the company [4] - Conditional approval allows for accelerated market entry of urgently needed drugs with significant clinical value, even before completing full clinical research [5] Group 3: Competitive Landscape - The treatment field for DLBCL has seen recent breakthroughs, including the approval of Tafasitamab, a CD19 monoclonal antibody for relapsed/refractory DLBCL, which does not directly compete with Sidanbamide as it is used for second-line or later treatments [5] Group 4: Financial Performance - The company reported a revenue of 658 million yuan for 2024, a year-on-year increase of 25.63%, but faced a net loss of 115 million yuan, a significant decline of 228.97% [6] - In the first quarter of 2025, revenue was 162 million yuan, up 24.24% year-on-year, but the net loss was 19 million yuan, a decrease of 4.64% compared to the previous year [6]

Core Insights - Micron Biotech announced the final top-line analysis data from the Phase III clinical trial of its self-developed drug, Sidabone, showing significant improvement in event-free survival (EFS) compared to the control group, achieving the primary endpoint of the study [1][6] - The stock price of Micron Biotech has surged by 103% since May 28, reaching a closing price of 31.3 yuan per share on July 9, with a market capitalization of 12.8 billion yuan [1] Group 1 - Sidabone is a novel mechanism drug and the first subtype-selective histone deacetylase (HDAC) inhibitor globally, representing a significant achievement in China's innovative drug development [3] - The drug has received conditional approval from the National Medical Products Administration for use in previously untreated DLBCL patients expressing MYC and BCL2, based on interim analysis data from the DEB study [4] - By the end of 2024, Sidabone will be included in the national medical insurance directory as the only oral innovative drug for first-line DLBCL treatment [5] Group 2 - The combination of Sidabone and R-CHOP (CR-CHOP) has shown a statistically significant improvement in complete response (CR) rates compared to R-CHOP alone in the Phase III clinical trial for DLBCL [6] - The company is preparing to submit for routine approval for this indication, with comprehensive analysis results expected to be presented at upcoming academic conferences or journals [6]

【导读】微芯生物自主研发的西达本胺相关Ⅲ期临床试验，获得最终结果的顶线分析数据 中国基金报记者 卢鸰 近期股价翻倍的创新药牛股又有大消息。 自5月28日至今，微芯生物股价震荡上涨，最高涨幅达103%。 7月9日，微芯生物股价以31.3元/股报收，最新市值为128亿元。 西达本胺是国家863及"重大新药创制"专项成果，是微芯生物独家发现的全新机制新分子实体 药物，是全球首个亚型选择性组蛋白去乙酰化酶（HDAC）抑制剂。 而且，西达本胺是中国首个授权美国等发达国家专利的原创新药，开创了中国创新药对欧美 进行专利授权（license-out）的先河。 2006年，微芯生物与沪亚生物达成西达本胺海外多个地区的专利授权。 2013年，微芯生物将西达本胺在中国台湾地区的权利授权给华上生技。目前，西达本胺已在 日本、中国台湾获批多项适应症。 2024年4月，基于DEB研究期中分析综合数据结果，西达本胺联合R-CHOP用于MYC和 BCL2表达阳性的既往未经治疗的DLBCL适应症获得国家药品监督管理局附条件批准。 微芯生物7月9日下午公告称，公司自主研发的西达本胺针对一线治疗弥漫大B细胞淋巴瘤 （DLBCL）关键性Ⅲ期临床试 ...

证券代码：688321 证券简称：微芯生物 公告编号：2025-042 一、药品的基本情况 西达本胺是公司独家发现的全新机制新分子实体药物，是全球首个亚型选择 性组蛋白去乙酰化酶（HDAC）抑制剂，属于表观遗传调控剂类药物。西达本胺 是国家 863 及"重大新药创制"专项成果。 深圳微芯生物科技股份有限公司 自愿披露关于西达本胺一线治疗弥漫大 B 细胞淋巴瘤的 III 期临床试验获得顶线分析数据的公告 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。 深圳微芯生物科技股份有限公司（以下简称"公司"）自主研发的西达本胺 针对一线治疗弥漫大 B 细胞淋巴瘤（DLBCL）关键性 III 期临床试验（DEB 研 究）已于近日获得最终结果的顶线分析数据，试验组无事件生存期（EFS）显著 优于对照组，达成研究主要终点。现将相关情况公告如下： 2024 年 4 月，基于 DEB 研究期中分析综合数据结果，西达本胺联合 R-CHOP 用于 MYC 和 BCL2 表达阳性的既往未经治疗的 DLBCL 适应症获得国家药品监 督管理局附条件批准。 ...

Core Viewpoint - Micron Biologics announced that the final results of the key Phase III clinical trial (DEB study) for its self-developed drug, Sidabone, targeting first-line treatment of diffuse large B-cell lymphoma (DLBCL), have shown that the event-free survival (EFS) of the trial group is significantly better than that of the control group, achieving the primary endpoint of the study [1] Group 1 - Sidabone combined with R-CHOP is the first treatment regimen in the world to demonstrate a significantly higher complete response (CR) rate than R-CHOP in a Phase III clinical trial for first-line DLBCL treatment [1] - The top-line analysis indicates that the EFS in the trial group shows statistically significant differences compared to the control group, further validating that the Sidabone combination regimen can provide significant and sustainable efficacy for newly treated MYC and BCL2 double-expressing DLBCL patients, with good safety [1] - The company is preparing to submit for routine approval for this indication [1] Group 2 - A comprehensive analysis of the final results of the study will be presented at upcoming academic conferences or journals [1]