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]

New Stock Offerings - 济川药业 (600566) has a tender offer period from June 18, 2025, to July 17, 2025[1] - *ST亚振 (603389) has a tender offer period from June 10, 2025, to July 9, 2025[1] - 中程退 (300208) has 7 trading days remaining until the last trading day[1] Delisting Notices - 退市锦港 (600190) has 7 trading days remaining until the last trading day[1] - 恒立退 (000622) has 4 trading days remaining until the last trading day[1] - 退市九有 (600462) has 3 trading days remaining until the last trading day[1] Abnormal Fluctuations - 北方长龙 (301357) reported severe abnormal fluctuations[1] - 浙江东日 (600113) reported abnormal fluctuations with an announcement time of June 28, 2025[1] - 诺德股份 (600110) reported abnormal fluctuations with an announcement time of June 27, 2025[1]

Market Overview - The net inflow of main funds in the Shanghai and Shenzhen markets reached 15.45 billion yuan, with the Sci-Tech Innovation Board seeing a net inflow of 456 million yuan [1] - A total of 248 stocks experienced net inflows, while 337 stocks faced net outflows [1] Sci-Tech Innovation Board Performance - On the Sci-Tech Innovation Board, 478 stocks rose, with one stock, Meidi Xi, hitting the daily limit, while 107 stocks declined [1] - Newly listed stock C Yitang closed with a remarkable increase of 174.56% and a turnover rate of 77.43% [2] Fund Flow Analysis - Among the stocks with net inflows, C Yitang led with a net inflow of 918 million yuan, followed by SMIC and Lanke Technology with net inflows of 157 million yuan and 137 million yuan, respectively [2] - The stock with the highest net outflow was Rui Lian New Materials, which fell by 9.93% and saw a net outflow of 173 million yuan [1][2] Continuous Fund Inflows and Outflows - There are 45 stocks that have seen continuous net inflows for more than three trading days, with Zhengfan Technology leading at 17 consecutive days [2] - Conversely, 141 stocks have experienced continuous net outflows, with Fudan Zhangjiang leading at 16 consecutive days [2] Top Fund Inflow Stocks - The top stocks by net inflow include: - C Yitang: 917.90 million yuan, 28.18% inflow rate, 174.56% increase, 77.43% turnover [2] - SMIC: 156.59 million yuan, 8.35% inflow rate, 1.47% increase, 1.09% turnover [2] - Lanke Technology: 137.03 million yuan, 8.22% inflow rate, 3.29% increase, 1.77% turnover [2] Top Fund Outflow Stocks - The stocks with the highest net outflows include: - Rui Lian New Materials: 173 million yuan outflow, 9.93% decrease [1] - Microchip Biotech: 162 million yuan outflow [1] - Shenzhou Cell: 131 million yuan outflow [1]

New Stock Listings - Yitang Co., Ltd. (688729) listed at an issue price of 8.45 on July 8, 2025[1] - Jichuan Pharmaceutical (600566) has a tender offer period from June 18 to July 17, 2025[1] - ST Yazhen (603389) has a tender offer period from June 10 to July 9, 2025[1] Delisting and Trading Reminders - Tui Shi Jin Gang (600190) has 8 trading days remaining until the last trading day[1] - Hengli Tui (000622) has 5 trading days remaining until the last trading day[1] - Tui Shi Jiu You (600462) has 4 trading days remaining until the last trading day[1] Market Volatility - North China Long Dragon (301357) reported severe abnormal fluctuations[1] - Multiple stocks including ST Zhengping (603843) and Hunan Tianyan (600698) have reported abnormal fluctuations[3]

New Stock Issuance - Huadian New Energy (证券代码: 730930) issued shares at a price of 3.18 on July 7, 2025[1] - Jichuan Pharmaceutical (证券代码: 600566) has a tender offer period from June 18 to July 17, 2025[1] - ST Yazhen (证券代码: 603389) has a tender offer period from June 10 to July 9, 2025[1] Trading Alerts - The last trading day for TSM Jinguang (证券代码: 600190) is in 9 trading days[1] - The last trading day for TSM Jinyou (证券代码: 600462) is in 5 trading days[1] - The last trading day for TSM Gongzhi (证券代码: 000584) is in 3 trading days[1] Abnormal Fluctuations - Northern Long (证券代码: 301357) is experiencing severe abnormal fluctuations[1] - ST Dongjing (证券代码: 002199) reported abnormal fluctuations[3] - ST Yunchuang (证券代码: 835305) reported abnormal fluctuations on July 4, 2025[3]