另外，对于临床急需境外已上市境内未上市的罕见病药品，鼓励申请人采取前置检验方式申请注册检 验。只进行样品检验的，注册检验时限由60日缩短至40日；同时进行标准复核和样品检验的，注册检验 时限由90日缩短至70日。 "对于临床急需境外已上市境内未上市的罕见病药品，注册检验所需样品量为商业规模生产1批次。"国 家药监局在发布的公告中明确表示。 这一新政将过去需多批次、大样本量的检验要求大幅简化。曾经因检验要求过高而难以进入中国市场的 罕见病药品，现在找到了可行的路径。 上海市卫生和健康发展研究中心主任金春林对21世纪经济报道记者表示，该新政的出台对医药产业影响 深远。临床急需的药品（特别是治疗罕见病的药品）将更快进入中国市场，不仅能解决患者无药可用的 困境，加速药品可及性，还能降低用药成本。通过引入境外仿制药申报机制，有望在原研药之外提供更 具经济性的治疗选择，进一步减轻患者负担。 "对制药企业而言，新政明确了研发与申报的目录导向，鼓励企业在中国开展全球同步研发与申报。这 将推动跨国企业更早将中国纳入全球研发计划，助力优化资源配置。通过接受境外临床数据、优化核查 流程等方式，可以帮助企业节省在中国重复开展临床试验 ...

港股三大指数全天震荡下行，午后跌幅进一步扩大，恒科指数一度跌超2%。截止收盘，恒生指数跌 0.94%或251.5点，报26458.95点，全日成交额为2761.34亿港元；恒生国企指数跌1.14%，报9138.75点； 恒生科技指数跌1.49%，报5738.52点。 浙商国际指出，港股市场基本面仍偏弱，资金面环境有所回落，政策面重点关注新质生产力和扩大内 需，情绪面短期回暖。高盛则维持对中国A股和H股的"超配"评级。该行认为，在当前盈利增长、估值 水平和投资者仓位普遍较低的背景下，中国股票的风险回报比具有吸引力。 蓝筹股表现 药明生物(02269)领涨蓝筹。截至收盘，涨5.92%，报36.12港元，成交额19.54亿港元，贡献恒指11.87 点。中泰证券（600918）研报指出，海外逐步进入降息节奏，投融资改善预期有望边际向好，且部分公 司订单已然看到恢复，该行预计外需CRO/CDMO有望迎来盈利与估值双抬升的"戴维斯双击"机会。 其他蓝筹股方面，信达生物(01801)涨5.38%，报89.05港元，贡献恒指11.79点；药明康德（603259） (02359)涨4.91%，报111港元，贡献恒指3.94点； ...

Investment Rating - The report maintains an "Overweight" rating for the pharmaceutical and biotechnology sector [5]. Core Insights - The report emphasizes the importance of seizing opportunities following market corrections, particularly in anticipation of improvements in 2026. It notes that the pharmaceutical sector's fundamentals remain strong despite recent market fluctuations, and it is currently at a valuation bottom. The report suggests focusing on innovative drugs and companies with potential for operational improvements in 2025 [7][11]. Summary by Sections Industry Overview - The pharmaceutical sector consists of 498 listed companies with a total market capitalization of approximately 70,594.11 billion [2]. - The sector has experienced a decline of 6.88% recently, with various sub-sectors such as pharmaceutical commerce and biopharmaceuticals also facing downturns [11]. Market Dynamics - The report highlights a significant market correction, with the Shanghai Composite Index down by 3.77% and the pharmaceutical sector underperforming [11]. - It notes that the overall performance of the pharmaceutical sector has been positive since the beginning of the year, with a return of 13.69%, slightly outperforming the broader market [18]. Investment Opportunities - The report identifies key companies to watch, including: - CDMO leaders: WuXi AppTec, WuXi Biologics, and WuXi AppTec [11]. - Front-end CROs: Tigermed, ProPhase, and Zhaoyan New Drug [11]. - Medical devices: United Imaging Healthcare and HaiTai New Light [11]. - Biopharmaceuticals: I-Mab Biopharma and Hualan Biological Engineering [11]. - It also suggests focusing on companies with innovative drug pipelines and those that are transitioning from biotech to biopharma [11]. Company Performance - The report provides a list of recommended stocks, including: - WuXi AppTec (66.45), rated "Buy" - Three Life Pharmaceuticals (29.34), rated "Buy" - Tigermed (49.59), rated "Buy" - Xiansheng Pharmaceutical (12.85), rated "Buy" - Betta Pharmaceuticals (48.60), rated "Buy" [5][31]. Regulatory and Market Trends - The report discusses recent regulatory developments, including a call from the vaccine industry association to avoid low-cost bidding practices to stabilize profit margins for leading vaccine companies [11][12]. - It also notes significant acquisitions and advancements in drug development, such as Johnson & Johnson's acquisition of Halda Therapeutics for $30.5 billion [11].

Core Viewpoint - A proposed executive order from the Trump administration is causing significant turmoil in the biopharmaceutical market, with major declines in stock prices for several companies [1][6]. Market Reaction - In the A-share market, companies such as Nossger, Huyou Pharmaceutical, and Tigermed saw declines exceeding 5%, with others like Yaoshi Technology and WuXi AppTec also following suit [1][2]. - The Hong Kong market's innovative drug concept index initially dropped over 7%, later narrowing to a 4.39% decline by midday [2]. Proposed Policy Impact - The New York Times reported that the proposed policy would require the FDA to conduct stricter reviews of clinical trial data from China, with companies submitting such data facing higher regulatory fees [3]. - If implemented, these restrictions could disrupt the U.S. pharmaceutical industry and affect the supply of all types of drugs, from generics to advanced therapies [6]. Industry Concerns - Analysts express that this "black swan" event could lead to a global supply chain restructuring, similar to the trade war during Trump's first term [7]. - The potential for drug shortages and rising prices in the U.S. market is a significant concern, particularly for generic drugs [7]. Investment Sentiment - Investor sentiment is divided, with some viewing the situation as a short-term emotional shock, while others worry that the end of the U.S. market could signal the end of the Chinese innovative drug bull market [9]. - Historical data suggests that after similar events, the pharmaceutical sector typically experiences a rebound within 2-4 weeks, with potential gains of 15%-20% [9].

Investment Rating - The investment rating for Genscript Biotech Corp. is "Buy" with a 12-month price target of HK$27.34, indicating an upside potential of 84.5% from the current price of HK$14.82 [8]. Core Insights - Management highlighted that ProBio revenues are expected to bottom out, driven by the LaNova deal, with a projected revenue of US$95 million in FY24, reflecting a 13% year-over-year decline [5]. - The protein segment is anticipated to become the second growth engine for the life science group, with a significant increase in revenue contribution from 23% in 2023 to nearly 30% [6]. - The company expects a steadily improving bottom line, with share buybacks and dividends under consideration as profitability improves starting from 2025 [6]. Summary by Sections ProBio Performance - ProBio revenues are projected to recover, with management confident that the revenue is bottoming out due to factors such as improved funding for biotech clients and stabilizing pricing in China [5]. - The LaNova/Merck deal is expected to contribute significantly, with US$235 million booked in the first half and an additional US$75 million milestone expected in 2H25 [5]. Life Science Group Growth - The life science group has shown steady growth of 10-20% over the years, with gene synthesis having a total addressable market (TAM) of US$1-2 billion, while customized protein synthesis is expected to have a TAM 10 times larger [6]. - The company is reallocating resources to enhance growth in the protein synthesis sector, which is expected to be a major growth driver in the coming years [6]. Financial Outlook - Excluding the impact from Legend deconsolidation, the adjusted net profit for the ex-Legend businesses is expected to reach US$60 million in FY24, with consistent profitability anticipated starting in 2025 [6]. - Management expects the EBITDA break-even point for ProBio to be achieved when revenues reach US$150-200 million, with Bestzyme remaining at break-even until 2027 [6].

Group 1 - The Hong Kong pharmaceutical ETF (513700.SH) has risen by 1.34%, reaching a new high of 1.038 billion yuan, with major constituent stocks like Kangfang Biotech up 6.07% and WuXi Biologics up 3.11% [1] - Recently, 3SBio entered a licensing agreement with Pfizer for the PD-1/VEGF dual antibody SSGJ-707, granting Pfizer global rights outside of mainland China, with 3SBio receiving an upfront payment of $1.25 billion and potential milestone payments of up to $4.8 billion, along with royalties [1] - The only remaining PD-1/VEGF pipeline in China currently in Phase II clinical trials is RC148 from Rongchang Biotech, which is based on the Hibody dual antibody technology platform and is expected to enter Phase I clinical trials for treating advanced malignant solid tumors by July 2024 [1] Group 2 - Rongchang Biotech is in discussions for multiple collaborations with various companies, and there is speculation that RC148 may also attract interest from overseas pharmaceutical giants, similar to other companies in the PD-1/VEGF dual antibody space [2] - According to Zhongtai Securities, the pharmaceutical and biotechnology industry is experiencing rapid thematic opportunities due to diverse external policy changes, with recent positive developments in US-China tariff policies alleviating pessimism [2] - The firm maintains an "overweight" rating for the pharmaceutical and biotechnology sector, particularly highlighting 3SBio among Hong Kong Stock Connect pharmaceutical constituents as a "buy" recommendation, suggesting that policy changes will create structural opportunities in the industry [2]

Group 1 - The company provides comprehensive technical solutions in various fields, including CRO/CDMO drug impurity analysis, medical testing, food safety testing, and environmental monitoring [2] - The company has a strong technical foundation and credibility, enabling it to serve global partners effectively [2] - The company has not reported any preferred stock profit distribution plan for the reporting period [2] Group 2 - The company has changed its accounting firm to Lixin Certified Public Accountants (Special General Partnership) for the current reporting period [1] - The company has not experienced any need to restate or adjust previous accounting data [3] - There are no significant differences between the financial indicators disclosed in the quarterly and semi-annual reports [3]

Group 1 - The biopharmaceutical industry is a rapidly growing strategic emerging industry globally, with significant government support and innovation driving its development [5][7] - The global biopharmaceutical market grew from $261.1 billion in 2018 to $363.8 billion in 2022, with a compound annual growth rate (CAGR) of 8.6%, and is expected to reach $783.2 billion by 2030, with a CAGR of approximately 10.1% from 2022 to 2030 [5] - In China, the biopharmaceutical market is projected to grow from $45.2 billion in 2019 to $66.5 billion in 2023, with a CAGR of 10.13%, and is expected to reach $162.8 billion by 2030, with a CAGR of approximately 13.64% from 2023 to 2030 [7] Group 2 - The company specializes in the production and sales of biopharmaceuticals, including the first commercialized nerve growth factor product, Jinlujie, which has been widely used in clinical applications for nerve injury repair [15][16] - The company’s subsidiary, Tianjin Hankan, is a well-known CRO-CDMO integrated service provider, offering a comprehensive range of drug development services from research to clinical trials and production [11][22] - The company has developed over 200 products for more than 600 enterprises, with significant achievements in the development of generic drugs and innovative drugs [12][11] Group 3 - The company has received various accolades, including being recognized as a "National Specialized and New 'Little Giant' Enterprise" and ranking among the top 50 innovative enterprises in the pharmaceutical industry [13] - The company’s product pipeline includes innovative drugs such as injection of Epinavamine, a targeted anti-tumor drug, and other pharmaceutical products that address various medical needs [17][18][20] - The company has made significant advancements in drug registration, with several products receiving approval from the National Medical Products Administration [37]