国家药监局11月4日发布新版《医疗器械生产质量管理规范》(简称《规范》)。新版《规范》将于2026 年11月1日起施行。新版《规范》是在2014年发布的《规范》基础上的修订版，是国家药监局贯彻落实 《国务院办公厅关于全面深化药品医疗器械监管改革促进医药产业高质量发展的意见》(国办发(2024〕 53号)以及相关法规规章规定，全面加强医疗器械企业质量管理体系建设，推动我国医疗器械行业质量 管理水平整体提升的重要举措。 方正证券认为，医疗器械行业进入调整周期尾声，行业及公司层面边际改善趋势明确，重视底部回升机 会。在医疗行业整顿、招标节奏延迟、集采扩面执行、医保控费等多重压力下，医疗器械板块股价持续 下调；2024年四季度设备更新的加速落地带来短期催化，但由于中标到收入确认存在周期，整体仍处于 底部波动，然而年初以来，该板块已出现一定回升趋势，一方面国家陆续出台政策支持高端创新器械发 展，同时管制价格"内卷"、优化国内招标采购环境，此外设备更新持续驱动采购需求释放；另一方面， 国产医疗器械企业业绩端压力因素逐步消化，加之出海业务的持续布局，二季度出现边际改善趋势。在 创新、出海和业绩修复的多重驱动下，医疗器械行业 ...

在科技巨头讲出新的叙事逻辑下，公募QDII正逐步回补美股仓位。 近期，英伟达、微软、谷歌、三星在美股密集发布对AI医疗的投资后，包括张坤等明星基金经理所管公募 QDII大举增加美股仓位，也使不少基金在近期港股调整中降低了回撤风险，借助AI医疗新叙事在近期的强 势，不少前期表现落后的QDII基金业绩加速提升。 驱动QDII基金经理在第三季度末增持美股的核心原因，是近期美股AI医疗赛道开始展现高弹性。 Wind数据显示，以近三个月的弹性收益排名计算，以美股为核心仓位的QDII基金几乎主导了业绩前五名。其 中，易方达基金旗下的易方达全球成长精选基金近三个月的收益率为39%，华夏新时代基金的同期收益率为 36%，嘉实基金旗下的嘉实全球产业基金同期收益为31%，天弘基金旗下的全球高端制造基金同期为30%，创 金合信全球医药生物基金同期收益率约28%。 根据最近一个月的收益率，几乎没有港股仓位的QDII基金，曾是业绩排名的主要受益者。建信基金旗下的建 信新兴市场混合基金近一个月收益率约为11%，在最近一个月内排名QDII第一，而创金合信全球医药生物基金 在最近一个月的收益排名第二，期间业绩回报为10%。 QDII基金强力 ...

Core Viewpoint - Public QDII funds are gradually increasing their positions in the US stock market, driven by the new narrative surrounding AI in healthcare, which has led to significant performance improvements for many funds [1][2]. Group 1: QDII Fund Positioning - Star fund managers, including Zhang Kun, have significantly increased their US stock holdings, with some funds reducing their exposure to Hong Kong stocks to mitigate risks during recent market adjustments [2][3]. - The GF Global Select Fund reported a 75% allocation to US stocks by the end of Q3, while the Hong Kong stock allocation dropped to approximately 3.72% [3]. - The E Fund Global Growth Select Fund also saw its US stock allocation rise to 52%, with only about 10% in Hong Kong stocks [3]. Group 2: Performance of QDII Funds - The core reason for the increase in US stock holdings among QDII fund managers is the high elasticity exhibited by the AI healthcare sector in the US market [5]. - QDII funds focusing on US stocks have dominated performance rankings, with the E Fund Global Growth Select Fund achieving a 39% return over the past three months [5]. - Funds with minimal exposure to Hong Kong stocks, such as the CCB New Emerging Markets Mixed Fund, reported an 11% return in the last month, ranking first among QDII funds [5]. Group 3: Investment in AI Healthcare - The recent surge in US AI healthcare investments by major companies like Nvidia, Microsoft, and Google has significantly contributed to the performance of QDII funds [6][7]. - The CCB Global Pharmaceutical Fund's manager completely liquidated its Hong Kong stock holdings, increasing its US stock allocation to 71% by the end of September [4]. - Fund managers are optimistic about the potential of AI healthcare, viewing it as a key area for growth, especially as the US leads in this sector [8][9].

Market Overview - The AI healthcare sector experienced a decline of 1.05% on November 4, with Qidi Pharmaceutical leading the drop [1][2] - The Shanghai Composite Index closed at 3960.19, down 0.41%, while the Shenzhen Component Index closed at 13175.22, down 1.71% [1] Stock Performance - Notable gainers in the AI healthcare sector included: - Langma Information (300288) with a closing price of 14.83, up 3.27% [1] - Sichuang Medical (300078) with a closing price of 3.65, up 1.67% [1] - Chuangye Huikang (300451) with a closing price of 4.92, up 1.65% [1] - Major decliners included: - Qidi Pharmaceutical (000590) with a closing price of 11.45, down 5.61% [2] - Hongbo Pharmaceutical (301230) with a closing price of 33.62, down 4.27% [2] - Chengdu Xian Dao (688222) with a closing price of 24.15, down 4.13% [2] Capital Flow - The AI healthcare sector saw a net outflow of 275 million yuan from institutional investors, while retail investors contributed a net inflow of 201 million yuan [2][3] - The capital flow for specific stocks showed: - Weining Health (300253) had a net inflow of 70.57 million yuan from institutional investors [3] - Langma Information (300288) experienced a net outflow of 18.86 million yuan from retail investors [3]

Group 1 - The core viewpoint of the reports indicates a significant market rebound in Q3, driven by delays in US-China trade negotiations, with the Shanghai Composite Index nearing 3900 points by the end of the quarter [1] - Key sectors such as technology, electronics, non-ferrous metals, new energy, communications, chemicals, and machinery saw index increases of over 30%, highlighting the dominance of AI-related, non-ferrous, electric new energy, and robotics sectors [1] - Conversely, sectors like banking, petrochemicals, transportation, food and beverage, and electricity lagged behind, reflecting a weaker performance in consumer-related stocks tied to macroeconomic conditions [1] Group 2 - In the healthcare sector, the A/H market experienced a broad-based rally, primarily led by technology and precious metals, with A-share trading volumes exceeding 2 trillion yuan daily towards the end of the quarter, indicating active market sentiment [2] - Despite the strong performance of technology sectors, innovative pharmaceuticals entered a correction phase due to rapid gains in the first half of the year and negative impacts from TMT sector funding, leading to a more significant pullback in A-share innovative pharmaceuticals compared to H-shares [2] - Many innovative pharmaceutical stocks are now considered highly cost-effective, presenting potential investment opportunities [2] Group 3 - The investment outlook remains positive for the integration of technology innovation and the pharmaceutical industry, supported by favorable global conditions and domestic policies [3] - The pharmaceutical sector is expected to benefit from long-term demographic changes, enhancing its attractiveness after significant price adjustments [3] - Although AI healthcare applications underperformed compared to AI hardware, the acceleration of AI infrastructure development is expected to drive advancements in medical applications, including diagnostics and innovative drug development [3]

Core Viewpoint - The domestic medical device industry is in a rapid development phase, despite short-term challenges from medical insurance cost control and international conditions, the sector remains optimistic [1] Group 1: Industry Outlook - Multiple negative impacts are expected to have been fully released, indicating that the medical device sector is entering a turning point [1] - Different sub-sectors within the medical device industry may experience varying turning point rhythms [1] Group 2: Investment Strategy - Continued optimism for domestic companies driven by policy support and innovation [1] - Favorable outlook for companies with global expansion and ongoing breakthroughs in overseas markets [1] - Emphasis on investment opportunities in AI healthcare and brain-computer interface themes [1]

Core Viewpoint - The domestic medical device industry is in a rapid development phase, with short-term challenges from medical insurance cost control and international conditions, but the outlook remains positive due to innovation-driven import substitution and globalization [1] Group 1: Industry Overview - The medical device sector is currently experiencing a turning point, with various sub-sectors showing different rhythms of change [1] - Multiple negative impacts are expected to be fully released at this time [1] Group 2: Investment Insights - There is a strong outlook for domestic companies to enhance competitiveness and accelerate import substitution due to policy support and innovation [1] - Companies with a well-established global layout and continuous breakthroughs in overseas markets are favored [1] - Investment opportunities in themes such as AI in healthcare and brain-computer interfaces are emphasized [1]

Core Viewpoint - The domestic medical device industry is in a rapid development phase, with short-term challenges from medical insurance cost control and international conditions, but the outlook remains positive due to innovation-driven import substitution and globalization [1] Group 1: Industry Overview - The medical device sector is expected to enter a turning point, with varying rhythms across different sub-sectors [1] - The revenue of medical device listed companies in the first three quarters of 2025 was 183.35 billion, a year-on-year decrease of 3.90%, while the net profit excluding non-recurring items was 22.70 billion, down 17.70% [2] - The revenue growth rates for different sub-sectors from high to low are high-value consumables (+5.12%), low-value consumables (-0.75%), medical devices (-1.02%), and in vitro diagnostics (-13.94%) [2] Group 2: High-Value Consumables - The high-value consumables sector has entered a post-collection phase, with revenue growth of 5.12% in the first three quarters of 2025 and a net profit increase of 1.18% [4] - In Q3 2025, the revenue growth for high-value consumables was 7.46%, while net profit decreased by 0.76%, indicating relative stability compared to other sectors [4] - The sector is benefiting from increased domestic market share and ongoing innovation and international expansion [4] Group 3: Medical Devices - The medical device sector saw a revenue decline of 1.02% in the first three quarters of 2025, but a significant recovery in Q3 with a revenue increase of 9.99% and a net profit growth of 4.87% [5] - The sector is experiencing a recovery due to improved bidding processes and low base effects, with expectations for continued growth as domestic conditions stabilize [5] Group 4: Low-Value Consumables - The low-value consumables sector experienced a revenue decline of 0.75% in the first three quarters of 2025, with a more significant net profit drop of 21.68% [6] - In Q3 2025, revenue decreased by 2.74% and net profit fell by 21.98%, primarily due to international market fluctuations affecting orders and profitability [6][7] - The sector's growth potential remains tied to international expansion, despite short-term challenges [7] Group 5: In Vitro Diagnostics - The in vitro diagnostics sector faced a revenue decline of 13.94% in the first three quarters of 2025, with a net profit drop of 32.20% [7] - The decline is attributed to the implementation of various negative policies, including DRGs and centralized procurement, leading to a drop in both volume and price [7] - Long-term growth prospects are supported by ongoing innovation and international market expansion [7]

Group 1 - The Hong Kong pharmaceutical stocks have surged, with Kangfang Biopharma rising over 6%, which has positively influenced the newly listed Hang Seng Biotechnology ETF (159105) that increased by 1.58% [1] - The Chinese biotechnology industry has shown strong performance this year, particularly in innovative drugs and AI healthcare, with expectations for continued growth in emerging sectors [2] - November is anticipated to be a critical period for innovative drugs, as Chinese companies have set records at the ESMO conference with 35 studies selected for oral presentations and 23 for breakthrough abstracts [2] Group 2 - A significant collaboration was established between Innovent Biologics and Takeda Pharmaceutical, with a total scale of $11.4 billion, highlighting the robust partnership potential in the industry [2] - The global biotechnology assets have performed well during the overseas easing cycle, with the Nasdaq Biotechnology Index rising by 13% since the interest rate cut on September 18 [2] - The Hang Seng Biotechnology ETF (159105) tracks the Hang Seng Biotechnology Index, which includes the 30 largest biotechnology companies within the Hong Kong Stock Connect, providing an effective tool for investors to allocate resources in the Hong Kong biotechnology sector [2]

Investment Rating - The report maintains an "Overweight" rating for the medical device sector [6] Core Insights - The medical device sector is entering a turning point, driven by innovation and international expansion as key growth drivers [12][29] - The overall revenue for medical device companies in the first three quarters of 2025 was 183.45 billion yuan, a year-on-year decrease of 3.90%, while the net profit excluding non-recurring items was 22.70 billion yuan, down 17.70% [8][15] - Different sub-sectors show significant divergence in performance, with high-value consumables showing a growth of 5.12%, while in vitro diagnostics faced a decline of 13.94% [8][15] Summary by Sections Medical Device Sector Overview - The medical device sector is experiencing a recovery with improved bidding processes and a gradual clearing of high-cost consumables [8][15] - The revenue growth rate for the medical device sector in Q3 2025 was 9.99%, with a net profit growth of 4.87% [9][16] High-Value Consumables - High-value consumables saw a revenue increase of 5.12% in the first three quarters of 2025, with a net profit growth of 1.18% [29] - The sector is stabilizing as it enters the post-collection phase, with significant growth driven by innovation and international expansion [29] Medical Equipment - The medical equipment sector's revenue decreased by 1.02% in the first three quarters of 2025, but showed a positive trend in Q3 with a revenue increase of 9.99% [9][16] - The sector is expected to experience structural differentiation in demand as bidding processes improve [9] Low-Value Consumables - Low-value consumables experienced a revenue decline of 0.75% in the first three quarters of 2025, with a significant drop in net profit by 21.68% [9][16] - The sector's performance is heavily influenced by international market conditions, but there is potential for recovery in Q4 2025 [9] In Vitro Diagnostics - The in vitro diagnostics sector faced a revenue decline of 13.94% in the first three quarters of 2025, with net profit down 32.20% [9][16] - The sector is expected to stabilize by the end of 2025 as negative impacts from policies begin to clear [9]