一、药品基本情况 申请编号：IND 176942 适应症：晚期实体瘤 证券代码：688321 证券简称：微芯生物 公告编号：2025-046 深圳微芯生物科技股份有限公司 关于 CS231295 临床试验申请获得 FDA 批准的公告 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。 重要内容提示： 深圳微芯生物科技股份有限公司（以下简称"公司"）的全资子公司微芯生 物科技（美国）有限公司于 7 月 31 日收到美国食品药品监督管理局（以下简称 "FDA"）签发的关于允许公司自主研发的 CS231295 开展治疗晚期实体瘤的 I 期 临床试验的通知，现将相关情况公告如下： 根据美国药品注册相关的法律法规要求，药品在获得开展临床试验的批准后， 尚需开展临床试验，并经美国 FDA（美国食品药品监督管理局）批准后方可生 产上市。考虑到创新药的临床试验周期较长且不确定性较大，须在开展一系列临 床试验并经 FDA 批准后方可上市，短期内对公司经营业绩不会有重大影响。 临床试验、审批的结果以及时间都具有一定的不确定性。考虑到研发周期长、 ...

Summary of Key Points Core Viewpoint - The company has decided not to exercise the early redemption rights for its convertible bonds, "微芯转债," based on confidence in its sustainable development and intrinsic value, considering various factors including market conditions and investor expectations [4]. Group 1: Convertible Bond Issuance Overview - The company issued convertible bonds with a total amount of RMB 500 million, with a maturity period of six years from July 5, 2022, to July 4, 2028 [1]. - The initial conversion price for the bonds is set to be adjusted to RMB 25.26 per share starting from June 4, 2024 [2]. Group 2: Redemption Terms and Conditions - The redemption terms state that the company can redeem the bonds at 115% of the face value if the stock price exceeds 130% of the conversion price for at least 15 out of 30 consecutive trading days, or if the remaining balance of the bonds is less than RMB 30 million [2][3]. - The conditional redemption terms were triggered between July 11, 2025, and July 31, 2025, as the stock price met the required threshold [3]. Group 3: Decision-Making Process - The company's board of directors approved the decision not to redeem the bonds early during a meeting held on July 31, 2025, emphasizing the company's confidence in its future [4]. - The company will not propose a conditional redemption plan even if the redemption conditions are met again within three months following the decision [4]. Group 4: Stakeholder Trading Activity - There has been no trading of the convertible bonds by major stakeholders, including the actual controller, significant shareholders, and senior management, within six months prior to the redemption condition being met [4]. Group 5: Sponsor's Verification Opinion - The sponsor institution has verified that the decision not to redeem the bonds early has followed the necessary decision-making procedures and complies with relevant regulations and agreements [6].

Core Viewpoint - Shenzhen Microchip Biotech Co., Ltd. has decided not to exercise the early redemption rights for its convertible bonds, despite triggering the conditional redemption clause due to stock prices exceeding 130% of the conversion price for 15 trading days [1][3]. Group 1: Conditional Redemption Trigger - The company's stock price has met the condition for the conditional redemption of the convertible bonds, with a closing price not lower than 32.838 CNY per share for at least 15 out of 30 trading days [1][3]. - The company will not propose a conditional redemption plan for the next three months, even if the redemption conditions are triggered again [2][4]. Group 2: Convertible Bond Issuance Overview - The company issued convertible bonds totaling 500 million CNY, with a maturity of six years from July 5, 2022, to July 4, 2028 [2]. - The initial conversion price was set at 25.36 CNY per share, adjusted to 25.26 CNY per share as of June 4, 2024, due to share repurchase and cancellation [2][3]. Group 3: Redemption Terms and Procedures - The redemption terms state that the company can redeem the bonds at 115% of the face value if the stock price conditions are met or if the remaining bond balance is below 30 million CNY [3][4]. - The board of directors convened on July 31, 2025, to review and approve the decision not to redeem the bonds early, considering the company's sustainable development and market conditions [4][5]. Group 4: Stakeholder Trading Restrictions - Major stakeholders, including the actual controller and significant shareholders, have not traded the convertible bonds within the six months leading up to the redemption condition being met [5]. Group 5: Sponsor's Verification Opinion - The sponsor has confirmed that the decision not to redeem the convertible bonds has followed necessary decision-making procedures and complies with relevant regulations [5].

Group 1 - The company announced that it will not exercise the early redemption rights for the "Microchip Convertible Bonds" [2] - The decision was made during the 12th meeting of the third board of directors held on July 31, 2025 [2]

进一步统计，近3个月内该股累计发生36笔大宗交易，合计成交金额为1.92亿元。 微芯生物7月31日大宗交易平台出现一笔成交，成交量15.00万股，成交金额460.50万元，大宗交易成交 价为30.70元，相对今日收盘价折价17.58%。该笔交易的买方营业部为兴业证券股份有限公司福州新权 路香格里拉证券营业部，卖方营业部为国投证券股份有限公司深圳宝安海秀路证券营业部。 | 成交量 | 成交金 | 成交价 | 相对当日收盘 | | | | --- | --- | --- | --- | --- | --- | | （万 | 额（万 | 格 | 折溢价（%） | 买方营业部 | 卖方营业部 | | 股） | 元） | （元） | | | | | 15.00 | 460.50 | 30.70 | -17.58 | 兴业证券股份有限公司福州 | 国投证券股份有限公司深 | | | | | | 新权路香格里拉证券营业部 | 圳宝安海秀路证券营业部 | 注：本文系新闻报道，不构成投资建议，股市有风险，投资需谨慎。 （文章来源：证券时报网） 证券时报·数据宝统计显示，微芯生物今日收盘价为37.25元，上涨0.27%，日换手率 ...

Group 1: Artificial Intelligence Initiatives - The State Council approved the "Artificial Intelligence +" action plan to promote large-scale commercial applications of AI, leveraging China's complete industrial system and large market scale [1] - The National Development and Reform Commission emphasized the need to deepen the "Artificial Intelligence +" initiative and promote high-quality development of the low-altitude economy [2] - The National Medical Insurance Administration supports the clinical application and pricing of new technologies like brain-computer interfaces, establishing pricing for related medical services [2] Group 2: Corporate Developments - Tesla expanded its Robotaxi service to the California Bay Area, covering cities from San Francisco to San Jose [4] - Dongxin Co. clarified that its products are not used in large model computing clusters, indicating potential risks due to rapid stock price increases [5] - Dingtong Technology's major shareholder plans to transfer 3% of the company's shares due to personal funding needs [5] Group 3: Clinical Trials and Approvals - Yahui Pharmaceutical reported positive preliminary results from its Phase Ib clinical trial for APL-1401, aimed at treating moderate to severe ulcerative colitis [5] - Micron Biotech received FDA approval for a Phase I clinical trial of CS231295, a selective AuroraB inhibitor for treating advanced solid tumors [6] - ST Norate obtained drug registration certificates for two new products, indicating expansion in reproductive and mental health sectors [7] Group 4: Financing and Investments - "Zero Degree Robotics" completed two rounds of financing totaling over 100 million yuan, focusing on technology development and production acceleration [10] - Puliyan Medical completed nearly $50 million in Series C financing to enhance product development and market expansion [11]

Core Viewpoint - A significant number of convertible bonds are facing mandatory redemption, with over 10 bonds identified, prompting investors to pay attention to the last trading days and conversion details to avoid potential losses [1][2][3]. Group 1: Mandatory Redemption Announcements - Multiple companies, including China Shipbuilding Emergency (300527) and Lian De Equipment (300545), have issued announcements regarding the early redemption of their convertible bonds, indicating a trend of mandatory redemptions [2]. - China Shipbuilding Emergency's convertible bond will be redeemed at a price of 100.77 CNY per bond if not converted by August 27, 2025, highlighting a significant price difference from the current market price [2]. - Lian De Equipment's convertible bond will be redeemed at 101.70 CNY per bond if not converted by August 11, 2025, with a recommendation for holders to resolve any pledges or freezes before the conversion deadline [2]. Group 2: Last Trading and Conversion Dates - Over 10 convertible bonds are confirmed for early mandatory redemption, with specific last trading and conversion dates approaching, including North Lu Convertible Bond, which will stop trading on July 30, 2025, and has a last conversion date of August 4, 2025 [3][4]. - The last trading price of North Lu Convertible Bond was 133 CNY per bond, indicating a potential loss of 23.58% if not converted by the deadline [3]. - Many convertible bonds are priced above 110 CNY per bond, with some exceeding 150 CNY, suggesting that investors may incur significant losses if they do not act in time [4]. Group 3: Non-Redemption Decisions - Some companies, such as Microchip Biotech and Tongguang Cable (300265), have opted not to redeem their convertible bonds early, despite meeting the conditions for conditional redemption [5][6]. - Microchip Biotech's board decided not to exercise the early redemption option for its convertible bonds, while Tongguang Cable also announced it would not redeem its bonds early and plans to redeem them at maturity [6].

7月31日，微芯生物宣布，其全资子公司微芯生物科技（美国）有限公司申报的新一代透脑Aurora B选 择性抑制剂CS231295片用于治疗晚期实体瘤的临床试验申请（IND）已获得美国食品药品监督管理局 （FDA）批准。目前，全球尚无同类设计的药物进入临床试验阶段。 ...

Group 1 - Jiejia Weichuang expects a net profit of 1.7 billion to 1.96 billion yuan for the first half of 2025, representing a year-on-year increase of 38.65% to 59.85% [1] - Micron Biotech's CS231295 clinical trial application has been approved by the FDA for treating advanced solid tumors [1] - Sinopec anticipates a net profit of 20.1 billion to 21.6 billion yuan for the first half of 2025, a decrease of 39.5% to 43.7% year-on-year [2] Group 2 - High Energy Environment has obtained a loan commitment letter from a financial institution for share repurchase [2] - Electric Power Investment Energy received a warning letter from the Inner Mongolia Securities Regulatory Bureau for inadequate disclosure in its semi-annual report [3] - Zhejiang University Net New won a bid for an intelligent engineering project worth 94.2712 million yuan [5] Group 3 - Daodaoquan reported a net profit of 181 million yuan for the first half of 2025, a year-on-year increase of 563.15% [8] - New Light Optoelectronics expects a net loss of 19 million to 23 million yuan for the first half of 2025 [9] - Aihua Pharmaceutical's two probiotic powder registration applications have been accepted [10] Group 4 - Xinhui Electric's subsidiary signed a product sales framework contract for commercial and household robots [11] - Baida Precision Engineering's subsidiary obtained 134,500 square meters of industrial land use rights [12] - Haiyang Technology's chief engineer resigned for personal reasons [13] Group 5 - Tianhe Magnetic Materials received a project filing notice for a 12,000-ton magnetic material deep processing project [22] - Wanlima is the pre-selected unit for a procurement project worth 43.835 million yuan from China Southern Airlines [24] - Yipin Hong's subsidiaries obtained two drug registration certificates [25] Group 6 - Zhejiang Jiaoke's subsidiary signed new construction projects worth 4.783 billion yuan in the second quarter [27] - Shenglan Co. received approval for issuing convertible bonds [29] - Jimi Technology expects a net profit of 88.6622 million yuan for the first half of 2025, a year-on-year increase of 2062.33% [31] Group 7 - Dingtong Technology reported a net profit of 115 million yuan for the first half of 2025, a year-on-year increase of 134.06% [32] - Huaheng Biological is planning to list on the Hong Kong Stock Exchange [34] - Yuntian Lihui submitted an application for H-share issuance and listing on the Hong Kong Stock Exchange [36] Group 8 - Nanchip Technology expects a net profit of 108.8 million to 133.1 million yuan for the first half of 2025, a decrease of 35.09% to 47.03% year-on-year [43] - Anglikang's Mesobam injection has received a drug registration certificate [44] - Jida Zhengyuan's shareholder plans to reduce their stake by up to 0.998% [45]

智通财经APP讯，微芯生物(688321.SH)公告，的全资子公司微芯生物科技(美国)有限公司于7月31日收 到美国食品药品监督管理局("FDA")签发的关于允许公司自主研发的CS231295开展治疗晚期实体瘤的I 期临床试验的通知。 公告显示，CS231295作为透脑AuroraB选择性抑制剂，一方面通过精准抑制肿瘤特异性过表达的 AuroraB激酶，诱导合成致死效应，直击RB1基因脆弱性;另一方面，凭借良好的血脑屏障穿透能力，对 脑部原发或脑转移性肿瘤存在明显的治疗优势。同时，该分子还兼具改善肿瘤微环境的广谱抗肿瘤活 性，有望为存在类似遗传缺陷的不同类型肿瘤，以及肿瘤脑转移这一全球难题提供全新解题思路。 【免责声明】本文仅代表作者本人观点，与和讯网无关。和讯网站对文中陈述、观点判断保持中立，不 对所包含内容的准确性、可靠性或完整性提供任何明示或暗示的保证。请读者仅作参考，并请自行承担 全部责任。邮箱：news_center@staff.hexun.com ...