2025年，中美生物制药产业的发展似乎有些"时差"。 今年前三季度，尤其上半年，中国生物制药板块在BD热潮的催化下迅速修复估值，IPO窗口也随之打开，生物医药企业赴港上市的热潮延续至今。 Atlas Venture合伙人Bruce Booth将中国生物医药板块热度高涨列为今年最值得关注的现象之一。他指出，不论是港交所还是生物医药板块，都呈现出流动 性充沛、市场情绪乐观的态势。 相较于此，美股生物制药板块受制于宏观环境波动，走势和估值水平一度陷入低迷。直到第四季度，得益于宏观风险消散、投资者"避险"AI热潮，以及制 药企业的强劲盈利表现，板块整体才有所回弹。 中国创新药走出"独立行情"的2025年，Bruce Booth看到，在目前对于全球生物制药行业至关重要的几个问题中，中国当居其首，临床试验数量、BD交易 等方面大放异彩的背后，其实是人才、成本效益和监管改革的协同优势形成了发展机会；西方药企需要迎难而上，做出更快、更便宜、更好的创新。 以下为他的2025年度回顾及2026年展望全文： 但有几个问题的确有其正当性。药品定价就是其中之一。我们必须改革全球药品定价体系。过去四十年，美国一直比其它富裕发达国家支付更 ...

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Efficacy of Obefazimod in Ulcerative Colitis - In pooled ABTECT 1 & 2 trials, Obefazimod 50mg demonstrated a statistically significant clinical remission rate, with a 16.4% difference compared to placebo (p<0.0001)[19] - Obefazimod 25mg also showed a statistically significant clinical remission rate, with a 13.2% difference compared to placebo (p<0.0001)[19] - The 50mg dose achieved clinically meaningful improvements in all clinical endpoints, regardless of prior advanced therapy inadequate response (AT-IR)[23] - In patients *with* prior AT-IR, Obefazimod 50mg showed a 31% improvement in clinical remission compared to placebo (p<0.0001)[24] - In patients *without* prior AT-IR, Obefazimod 50mg showed a 26% improvement in clinical remission compared to placebo (p<0.0001)[24] - The 50mg dose also achieved clinically meaningful improvements in endoscopic and histologic endpoints regardless of prior AT-IR[27] - Clinical response with the 50mg dose was consistent across subgroups, including those with no prior AT-IR through 4+ AT-IR or JAK-IR[31] Safety Profile of Obefazimod - In the pooled ABTECT 1 & 2 full dataset, the most common treatment-emergent adverse event (TEAE) was headache, with an incidence of 24.1% in the Obefazimod 50mg group[36] - The rate of TEAEs leading to study drug discontinuation was 5.0% in the Obefazimod 50mg group[35] - Serious TEAEs occurred in 3.1% of patients in the Obefazimod 50mg group[35]

Investment Rating - The industry investment rating is "Outperform" [1] Core Viewpoints - The global market for Inflammatory Bowel Disease (IBD) drugs is expected to reach $37 billion by 2030, with major pharmaceutical companies investing in this area [4][26] - There is a significant unmet clinical need for new therapies due to the complexity of IBD mechanisms and the high percentage of patients who do not respond to initial treatments [4][18] - The report emphasizes the importance of new targets and mechanisms in drug development, particularly focusing on TL1A, which has garnered interest from multiple multinational corporations (MNCs) [4][32] Summary by Sections IBD Treatment Overview - IBD includes Ulcerative Colitis (UC) and Crohn's Disease (CD), affecting over 3 million patients in the US and Europe, with no current cure available [4][10] - The market for IBD drugs is projected to grow at a compound annual growth rate (CAGR) of 5.88% from $23.26 billion in 2022 to $37 billion by 2030 [26][29] Market Dynamics - The sales proportion of TNF inhibitors is declining, while IL-23 inhibitors and JAK inhibitors are increasing in sales [4][29] - Ustekinumab is expected to contribute approximately $7.8 billion to the market by 2024, while Vedolizumab is projected to reach $6.107 billion [4][29] Clinical Needs and Drug Development - There is a pressing need for new therapies as up to 30% of patients do not respond to initial treatments, and 40% lose response over time [4][18] - The report suggests focusing on new targets and mechanisms, including companies like Abivax, Chenxin Pharmaceutical, and others for potential investment opportunities [4][32] Long-term Investment Strategy - The report recommends a strategic focus on leading innovative drug companies and those involved in the development of new therapies for IBD, highlighting companies such as Innovent Biologics, BeiGene, and others [4][32] - The report also notes the potential for significant market transactions in the IBD space, with several deals exceeding $5 billion in value [4][30]

Investment Rating - The report assigns an "Overweight" rating to the pharmaceutical and biotechnology industry, indicating that the industry index is expected to outperform the CSI 300 index by 10% or more over the next six months [2][40]. Core Insights - The pharmaceutical and biotechnology sector saw an overall increase of 1.90% from July 21 to July 25, 2025, ranking 19th among 31 industries in the Shenwan index, outperforming the CSI 300 index by 0.21 percentage points [4][12]. - The current PE valuation of the pharmaceutical and biotechnology sector is 30.67 times, which is at the historical median level, with a valuation premium of 140% compared to the CSI 300 index [4][18]. - The top three performing sub-sectors during the same period were medical services (6.73%), medical devices (4.43%), and pharmaceutical commerce (1.84%) [4][12]. Market Performance - In the year-to-date, the pharmaceutical and biotechnology sector has increased by 18.81%, ranking 3rd among 31 industries, and outperforming the CSI 300 index by 13.92 percentage points [4][13]. - The sub-sectors that achieved significant gains include chemical pharmaceuticals (34.25%), medical services (32.34%), and biological products (13.49%) [4][19]. Industry News - The National Healthcare Security Administration (NHSA) held two meetings to support the high-quality development of innovative drugs and medical devices, emphasizing the need for comprehensive value assessments for innovative products [5][34]. - The NHSA introduced new measures to empower innovation in drug and device pricing, aiming to support genuine innovation and improve the quality of healthcare in China [5][36]. Investment Recommendations - The report suggests focusing on high-quality stocks in the following segments: innovative drugs, CXO (Contract Research Organization), chain pharmacies, medical services, and second-class vaccines [5][37][38]. - Recommended stocks include Betta Pharmaceuticals, Teva Biopharmaceuticals, Kaili Medical, Haier Biomedical, Huaxia Eye Hospital, and Lao Bai Xing [5][38]. Stock Performance - During the last week, 337 stocks in the sector increased in value (71.10%), while 127 stocks decreased (26.79%). The top five gainers were Haitai Biological (46.93%), Zhendong Pharmaceutical (42.89%), Saili Medical (31.73%), Chenxin Pharmaceutical (30.75%), and Rendu Biological (27.82%) [4][27].

Core Insights - Abivax (NASDAQ: ABVX) shares experienced a significant increase of 500% on July 23, 2025, due to the company achieving positive data in its clinical trials [2]. Company Analysis - Abivax is involved in the biotechnology sector and has recently reported promising results that have led to a substantial rise in its stock price [2]. - The company is part of a broader analysis service that includes a library of over 600 biotech investing articles and a model portfolio focused on small and mid-cap stocks [2].

Core Viewpoint - The article highlights the significant stock price surge of biotechnology company Abivax, which rose over 596% after announcing positive results for its oral drug Obefazimod in a Phase III trial for ulcerative colitis, with plans to submit for FDA approval in late 2026 [2][6]. Group 1: Company Performance - Abivax's stock price experienced a dramatic increase, reaching a peak rise of over 596% following the announcement of positive Phase III trial results for Obefazimod [2][5]. - The drug Obefazimod is a first-in-class oral small molecule that enhances miR-124 expression, which plays a role in anti-inflammatory responses, indicating potential applications for various inflammatory and viral diseases [6][7]. - Abivax faces challenges, including a small workforce of approximately 70 employees and significant annual losses, with a projected cash balance of €144.2 million, sufficient only until Q4 2025 [7]. Group 2: Market Context - The article notes a broader trend of retail investors driving up stock prices in the U.S. market, with significant increases in stocks like Krispy Kreme and GoPro, attributed to speculative trading [13][17]. - High levels of optimism among investors are indicated by a rise in the global fund manager confidence index from 3.3 to 4.3, the highest level since February [21]. - Retail investors have purchased approximately $50 billion worth of stocks in the past month, aligning with Barclays' estimates [22]. Group 3: Institutional Warnings - Several Wall Street institutions, including Goldman Sachs, have issued warnings about potential market corrections due to high-risk investor behavior and the surge in retail buying [20][21]. - Goldman Sachs identified two key warning signals: excessive optimism among investors and a significant influx of retail investor purchases [21][22]. - Despite these warnings, Goldman Sachs maintains a long-term positive outlook for the U.S. stock market, citing favorable monetary policy and tax reforms as potential growth drivers [25][27].