21世纪经济报道记者唐唯珂报道 IVD(体外诊断)的退市潮悄然来袭。 近日，浙江省药监局发布一纸公告，宣布注销浙江聚康生物工程有限公司(以下简称"聚康生物")5个荧 光免疫检测产品的医疗器械注册证。这是继7月浙江省一次性清理82张生化试剂证照后，年内该省IVD 领域第二次"批量退市"。 短短三个月，同一省份两度"挥刀"，且注销数量从"两位数"跃升到"三位数"在即，信号意义远超事件本 身。集采压价、监管趋严、创新门槛抬高等因素正加速改写行业格局——中国体外诊断产业从"证照红 利"时代迈入"精耕细作"时代。 6月13日，湖南省药监局发布公告，8家企业申请注销99个产品的医疗器械注册证。其中德荣生物注销了 83个IVD注册证，自此已将其持有的全部IVD产品注册证"清空"。 7月22日，浙江省发布公告，一次性注销浙江凯成生物科技有限公司共82个试剂产品的医疗器械注册 证。 9月28日，安徽省药监局发布公告，应企业申请同意注销复星诊断科技(合肥)有限公司医疗器械注册 证。 把时间轴拉回到"注销潮"之前，行业其实经历过一轮轰轰烈烈的"拿证竞赛"。湖南药监局数据显示， 2020—2023年短短四年，全省二类IVD注册证存量 ...

Core Viewpoint - The company, EasyReel Bio, is undergoing significant changes due to frequent shareholder reductions and a strategic shift away from its in vitro diagnostic business, which has seen a drastic decline in demand, particularly for respiratory infectious disease testing products [2][7]. Shareholder Reduction - EasyReel Bio's controlling shareholder, EasyReel (Hainan) Venture Capital Co., Ltd., plans to reduce its holdings by up to 11,521,758 shares, representing 2.84% of the total share capital [3] - Other shareholders, EasyDarui and EasyKairui, also plan to reduce their holdings by 288,500 shares (0.07%) and 341,800 shares (0.08%), respectively [3] - If the maximum reduction occurs, the total cash outflow for the shareholders could reach approximately 1.23 million yuan based on the closing price of 10.12 yuan per share on October 13 [3] Business Performance and Strategy Shift - EasyReel Bio's revenue has significantly declined in 2023, with total revenue of 253 million yuan, a year-on-year decrease of 63.01%, and a net loss of 185 million yuan [7] - The in vitro diagnostic business, which once contributed up to 70% of revenue, has seen a drastic reduction in income, dropping to 47.7 million yuan in 2023, a 90.45% decline [7][8] - The company has shifted its focus back to food safety rapid testing and animal diagnostics, with food safety revenue showing a slight increase of 5.29% in 2024 [8] Historical Financial Performance - From 2020 to 2022, EasyReel Bio's revenue grew significantly due to the COVID-19 pandemic, with total revenues of 259 million yuan, 598 million yuan, and 687 million yuan, respectively [6] - The in vitro diagnostic business revenue during this period surged, reaching 499 million yuan in 2022, accounting for 72.71% of total revenue [6] Future Outlook - The company plans to completely phase out its in vitro diagnostic products by 2025, focusing solely on food safety and animal diagnostics [7][8] - Despite a strategic pivot, the company has faced challenges, with non-recurring net profits remaining negative for two and a half years [8][9]

Group 1 - The core point of the news is that Sely Medical's stock price increased by 5.55% to 26.42 CNY per share, with a trading volume of 246 million CNY and a turnover rate of 4.62%, resulting in a total market capitalization of 5.553 billion CNY [1] - Sely Medical Technology Group Co., Ltd. is based in Wuhan, Hubei Province, and was established on February 23, 2004, with its listing date on October 31, 2016. The company's main business involves centralized marketing and service for medical testing, as well as the agency and independent research, production, and sales of in vitro diagnostic products [1] - The revenue composition of Sely Medical includes IVD business at 39.91%, SPD business at 38.01%, and pure sales at 22.08% [1] Group 2 - From the perspective of the top ten circulating shareholders, the Caitong Fund has one fund among the top shareholders of Sely Medical. The Caitong Advantage Industry Rotation Mixed A Fund (011201) entered the top ten circulating shareholders in the second quarter, holding 643,400 shares, which accounts for 0.34% of the circulating shares. The estimated floating profit today is approximately 894,300 CNY [2] - The Caitong Advantage Industry Rotation Mixed A Fund (011201) was established on February 9, 2021, with a latest scale of 536 million CNY. Year-to-date returns are 17.35%, ranking 4543 out of 8161 in its category; the one-year return is 8.66%, ranking 5742 out of 8015; and since inception, it has a loss of 28.59% [2]

Core Viewpoint - Lidman has shown a significant stock price increase of 54.29% year-to-date, with recent fluctuations indicating a mixed performance in the short term [2]. Group 1: Stock Performance - As of October 15, Lidman’s stock price rose by 2.02% to 7.56 CNY per share, with a total market capitalization of 4.113 billion CNY [1]. - The stock has experienced a slight increase of 0.13% over the last five trading days, a decline of 4.91% over the last 20 days, and a substantial increase of 40.78% over the last 60 days [2]. Group 2: Financial Performance - For the first half of 2025, Lidman reported a revenue of 160 million CNY, reflecting a year-on-year decrease of 14.80%, and a net profit attributable to shareholders of -4.2452 million CNY, a significant decline of 800.43% [3]. - The company has distributed a total of 143 million CNY in dividends since its A-share listing, with 5.4401 million CNY distributed over the last three years [4]. Group 3: Shareholder Information - As of September 30, the number of shareholders for Lidman was 32,900, a decrease of 1.79% from the previous period, while the average circulating shares per person increased by 1.82% to 16,487 shares [3]. - Among the top ten circulating shareholders, Jin Yuan Shun An Yuan Qi Flexible Allocation Mixed Fund increased its holdings by 424,900 shares, while Hua Xia Zhong Zheng 500 Index Enhanced A became a new shareholder with 2,200,700 shares [4]. Group 4: Business Overview - Lidman, established on November 5, 1997, and listed on February 16, 2012, specializes in in vitro diagnostic reagents, diagnostic instruments, and biochemical raw materials, with the majority of revenue (67.84%) coming from in vitro diagnostic reagents [3]. - The company operates within the pharmaceutical and biological industry, specifically in the medical device and in vitro diagnostic sectors, and is involved in various concept sectors including gene sequencing and cold chain logistics [3].

Group 1 - The core viewpoint of the news highlights the recent trading performance and financial metrics of Anbiping, indicating a decline in both revenue and net profit for the first half of 2025 [1][2] - As of October 14, Anbiping's stock price increased by 0.04%, with a trading volume of 39.51 million yuan, and a net financing buy of -1.11 million yuan [1] - The financing balance of Anbiping is 114 million yuan, accounting for 4.58% of its market capitalization, which is below the 40th percentile level over the past year, indicating a low financing level [1] Group 2 - As of June 30, the number of shareholders for Anbiping decreased by 10.55% to 9,221, while the average circulating shares per person increased by 11.80% to 10,147 shares [2] - For the first half of 2025, Anbiping reported a revenue of 159 million yuan, a year-on-year decrease of 30.11%, and a net profit attributable to shareholders of -12.5 million yuan, a significant decline of 176.38% [2] - Anbiping has distributed a total of 87.8 million yuan in dividends since its A-share listing, with 36.5 million yuan distributed over the past three years [3]

Core Points - Anbiping's stock price increased by 2.00% to 26.98 CNY per share, with a total market capitalization of 2.524 billion CNY as of October 14 [1] - The company has seen a year-to-date stock price increase of 56.77%, but a decline of 5.37% over the past 20 days and 7.29% over the past 60 days [2] - Anbiping's main business involves the research, production, and sales of in vitro diagnostic reagents and instruments, with 79.72% of revenue from self-produced products [2] Financial Performance - For the first half of 2025, Anbiping reported a revenue of 159 million CNY, a year-on-year decrease of 30.11%, and a net profit attributable to shareholders of -12.5 million CNY, a decrease of 176.38% [2] - The company has distributed a total of 87.8 million CNY in dividends since its A-share listing, with 36.5 million CNY distributed over the past three years [3] Shareholder Information - As of June 30, 2025, Anbiping had 9,221 shareholders, a decrease of 10.55% from the previous period, with an average of 10,147 circulating shares per shareholder, an increase of 11.80% [2] - Among the top ten circulating shareholders, Changcheng Consumption Value Mixed A (200006) is the eighth largest, holding 850,000 shares as a new shareholder [3]

Group 1 - Guangqi Technology's subsidiary signed mass production contracts for metamaterials totaling 516 million yuan, with products to be delivered by June 30, 2026 [1][2] - Mingyang Smart Energy plans to invest 1.5 billion pounds (approximately 14.21 billion yuan) to build a comprehensive wind power manufacturing base in Scotland, with the first phase expected to be operational by the end of 2028 [3][4] - Wentech Technology's control over Anshi Semiconductor is temporarily restricted due to a ministerial order from the Dutch government, affecting operational efficiency but not economic benefits [4][5] Group 2 - Baotailong's mine has officially resumed production with an annual design capacity of 900,000 tons [6] - New Lai Materials reported no significant changes in its operating environment, maintaining normal production and operations [7][8] - Tailing Micro plans to issue H-shares and list on the Hong Kong Stock Exchange [9] Group 3 - Times New Material announced a cash dividend of 0.07 yuan per share, totaling 65.18 million yuan, with the ex-dividend date set for October 17, 2025 [10] - Times New Material signed blade sales contracts totaling approximately 4.49 billion yuan, with 4.048 billion yuan from onshore wind projects and 442 million yuan from offshore projects [11][12] - Sunshine Nuohuo's new drug BTP4507 has received approval for clinical trials, targeting patients with poorly controlled primary hypertension [13] Group 4 - BGI Genomics expects to receive over 120 million USD in licensing fees for its CoolMPS sequencing technology [14] - Shandong Environmental Energy won a project for kitchen waste treatment in Xingtai, with an 8-year service period [15] - Kelun Pharmaceutical's product sac-TMT received approval for a third indication for treating advanced non-small cell lung cancer [16] Group 5 - Zhongzhi Holdings' major shareholder plans to publicly transfer 24.73% of the company's shares, which may lead to a change in control [17] - Yunnan Copper reported uncertainty regarding the future prices of cathode copper and gold, while maintaining normal operations [18] - Xiyang Co. announced that its tin smelting processing fees remain low despite rising tin prices [19] Group 6 - TEBIO's product Peginterferon has received approval for an additional indication for chronic hepatitis B treatment [20] - Yirui Biotech's major shareholder plans to reduce their stake by up to 3% due to personal funding needs [21] - China Nuclear Power reported a 14.95% year-on-year increase in power generation for the first three quarters, totaling 184.364 billion kWh [22] Group 7 - Shanghai Hejing's shareholder plans to reduce their stake by up to 1% due to personal funding needs [23] - Baili Tianheng's subsidiary triggered a milestone payment of 250 million USD from a collaboration with Bristol-Myers Squibb [24] - Hengdian East Magnetic expects a net profit increase of 50.1% to 65.2% year-on-year for the first three quarters [25]

Core Viewpoint - Beijing Beier Bioengineering Co., Ltd. has once again paused its IPO journey, marking the third attempt since 2020 without success [2][3] IPO Attempts - Beier Bio's IPO journey has been tumultuous, with multiple attempts since its first application in July 2020, which was withdrawn in February 2021. The company then shifted to the Shanghai Stock Exchange in October 2021, but this attempt also failed. In April 2025, it redirected its efforts to the Beijing Stock Exchange, where its IPO was accepted on June 30, but was halted three months later due to the need for updated financial reports [3][4] Fundraising Plans - The company plans to publicly issue up to 25 million shares, aiming to raise a total of approximately 537 million yuan, which will be allocated to the construction of an in vitro diagnostic reagent and instrument production base and a research and development center [4][5] Project Feasibility Concerns - Despite claiming to be a "national-level specialized and innovative small giant," the feasibility and return prospects of its fundraising projects are questioned due to tightening industry policies, increasing market competition, and rising tax burdens [4][6] Financial Performance - Beier Bio has experienced significant revenue fluctuations, with a 50.57% increase in revenue and a 237.21% increase in net profit in 2023, followed by a decline in both metrics in 2024, with revenue down 9.08% and net profit down 6.00% [7][8] Core Product Revenue Decline - The decline in revenue is primarily attributed to a drop in income from core product lines, particularly the respiratory pathogen detection series, which saw a 10.3% decrease in revenue from 2023 to 2024 [9][10] Market Competition and Risks - The in vitro diagnostic market is highly competitive, with major players like Roche and Abbott dominating. Beier Bio's lack of brand influence and market coverage raises concerns about its ability to maintain market share if competitors adopt aggressive pricing strategies [6][11] Tax Policy Impact - Starting in 2025, the company will face increased tax burdens as it transitions from a simplified tax method to a general tax method, significantly raising its tax costs and further squeezing profit margins [6][11] Technology Transition Challenges - The company heavily relies on traditional enzyme-linked immunosorbent assays and colloidal gold reagents, which are losing market share to newer technologies like chemiluminescence. If Beier Bio fails to adapt and innovate, it risks being outpaced by competitors [10][11]

2024年1至12月份，透景生命的营业收入构成为：体外诊断行业占比100.0%。 每经AI快讯，透景生命（SZ 300642，收盘价：22.92元）10月10日晚间发布公告称，截至本公告披露 日，公司本次回购股份已实施完毕，实际回购时间为2025年8月28日至2025年9月30日，期间公司通过回 购专用证券账户以集中竞价交易方式实施回购股份合计约74万股，占公司当前总股本的0.45%，本次回 购股份成交的最高价格为29.34元/股，成交的最低价格为23.89元/股，支付的总金额为人民币约2003万 元。 每经头条（nbdtoutiao）——天水麻辣烫、淄博烧烤、荣昌卤鹅⋯⋯"泼天流量"退去后，这些城市怎么 样了？ （记者 张明双） 截至发稿，透景生命市值为37亿元。 ...

Investment Rating - The report maintains a "Market Weight" rating for the pharmaceutical and biotechnology industry [2][24]. Core Viewpoints - The SW pharmaceutical and biotechnology industry underperformed the Shanghai and Shenzhen 300 index, declining by 0.23% from September 26, 2025, to October 9, 2025, lagging behind the index by approximately 2.76 percentage points [9][24]. - Most sub-sectors within the industry recorded negative returns during the same period, with the medical research outsourcing and in vitro diagnostics sectors showing gains of 1.99% and 0.55%, respectively, while the raw materials and chemical preparations sectors fell by 2.23% and 1.73% [10][24]. - Approximately 54% of stocks in the industry achieved positive returns, with the top performer, Zhendemedical, increasing by 21.43%, while the largest decline was seen in Guangshentang, which fell by 21.86% [11][14]. - The overall price-to-earnings (PE) ratio for the SW pharmaceutical and biotechnology industry was approximately 55.04 times as of October 9, 2025, indicating a decrease in industry valuation [15][24]. Summary by Sections 1. Market Review - The SW pharmaceutical and biotechnology industry underperformed the Shanghai and Shenzhen 300 index, with a decline of 0.23% from September 26, 2025, to October 9, 2025 [9]. - Most sub-sectors recorded negative returns, with medical research outsourcing and in vitro diagnostics performing better than others [10]. - About 54% of stocks in the industry recorded positive returns, with significant variations in individual stock performance [11]. 2. Industry News - The 11th batch of national procurement will begin accepting applications on October 21, 2025, with 55 major varieties included [22]. - The National Medical Products Administration issued guidelines for the quality management of medical device online sales [20][21]. 3. Company Announcements - Zhejiang Haizheng Pharmaceutical announced that its product achieved Self-GRAS certification in the U.S., allowing it to enter the U.S. market [23]. 4. Weekly Industry Perspective - The report suggests focusing on investment opportunities in innovative drugs and sectors with expected business development catalysts, including medical devices and pharmaceutical commerce [24][26].