证 券 研 究 报 告 行业周报 医药行业周报 全球GLP-1市场稳定扩容，关注国内企 业的授权机会 投资评级： 报告日期： 推荐 （维持 ） 2025年08月17日 分析师：胡博新 SAC编号：S1050522120002 分析师：吴景欢 SAC编号：S1050523070004 医 药 行 业 观 点 1. 东升西落，出海将是长期趋势 根据医药魔方数据，2025年上半年，全球医药交易数量达456笔，同比增长32%；首付款总额达118亿美元，同比激增 136%；交易总金额高达1304亿美元，同比增长58%。全球交易数量与金额均呈现显著上升态势。其中，涉及中国的交易 贡献了近50%的总金额和超过30%的交易数量。无论交易金额和总数，中国企业在全球创新药中价值得到进一步认可。中 国的研发效率优势正逐步显现，而且工程师数量和临床资源优势叠加。展望未来十年，中国的效率优势还将持续扩大，中 国企业参与的创新药交易预计超过全球的50%以上。根据wind数据，医药生物行业最近1月涨幅为11.07%，跑赢沪深300指 数6.51个百分点，截止8月15日，医药生物行业指数当期PE（TTM）39.94倍；高于5年历史平均估值3 ...

Core Viewpoint - Kintor Pharmaceutical has shown significant stock performance, with an approximately eightfold increase since its low in September 2024, despite still being in a loss position [1] Financial Performance - For the first half of 2025, Kintor reported revenue of approximately 51 million yuan, a year-on-year increase of about 703.8%, primarily driven by sales of its CAR-T product, SaiKezai [1] - The net loss for the same period was approximately 75.48 million yuan, a reduction of over 78% compared to the previous year [1][2] - Cost control measures, including reduced R&D and administrative expenses, contributed to the narrowing of net losses [2] Product Development and Market Strategy - Kintor's first CAR-T product, SaiKezai, was launched on March 1, 2024, and has secured 111 effective orders from its commercial partner, East China Pharmaceutical [3] - The company is optimistic about the sales growth of SaiKezai due to ongoing marketing efforts and expanded insurance coverage [3] - Kintor is also advancing its CAR-T product, ShuRuiJiAoLunSai, aimed at treating solid tumors, with an NDA submission expected to be approved between Q1 and Q2 of next year [3] Cost and Accessibility Challenges - The high production costs of CAR-T therapies remain a significant barrier to accessibility, with domestic pricing generally around one million yuan [1][4] - Kintor is shifting its strategic focus towards developing universal CAR-T therapies, which are expected to have more significant economies of scale [5] Insurance and Policy Developments - The recent introduction of a dual-track system for insurance coverage, including a commercial insurance innovation drug directory, may improve patient access to CAR-T therapies [6] - SaiKezai is among five CAR-T products included in the initial review list for the commercial insurance innovation drug directory, which could lower patient financial burdens [6] - Kintor is actively collaborating with East China Pharmaceutical to secure policy support related to SaiKezai [6] Industry Context - The establishment of a national commercial insurance directory is expected to address disparities in drug coverage across regions, enhancing the sustainability of insurance support for innovative therapies [7]

Investment Rating - The report maintains a "Recommended" rating for the pharmaceutical industry [1] Core Insights - The global pharmaceutical transaction volume reached 456 deals in the first half of 2025, a 32% year-on-year increase, with total upfront payments soaring to $11.8 billion, up 136% year-on-year, and total transaction value hitting $130.4 billion, a 58% increase year-on-year. Chinese companies contributed nearly 50% of the total transaction value and over 30% of the transaction volume, indicating a growing recognition of their value in global innovative drugs [3] - The report highlights a strategic opportunity for Chinese companies in the weight loss sector, with significant clinical data and collaborations emerging. For instance, the oral GLP-1 molecule Orforglipron showed a weight reduction of 11% compared to the placebo group, providing a competitive edge for domestic firms [4] - Chinese innovative drug companies are leading breakthroughs in CAR-T technology, with significant sales figures reported. For example, the collaboration between Legend Biotech and Johnson & Johnson for Carvykti is expected to exceed $2 billion in annual sales [5] - The CXO industry is anticipated to gradually recover, with a notable increase in license-out transactions and funding for biotech companies, indicating a positive trend in order recovery [6] - The report emphasizes the continuous iteration and updates in TCE technology, with promising clinical data emerging from various trials, showcasing the potential for significant advancements in the field [7] Summary by Sections 1. Pharmaceutical Market Tracking - The pharmaceutical industry underperformed the CSI 300 index by 2.07 percentage points in the last week, ranking 31st among 31 primary industry indices [19] - In the past month, the pharmaceutical industry outperformed the CSI 300 index by 8.23 percentage points, ranking 3rd among the primary industry indices [25] 2. Pharmaceutical Sector Trends and Valuation - The pharmaceutical and biotechnology sector's index has a current PE (TTM) of 38.77, above the 5-year historical average of 31.9 [45] 3. Recent Research Achievements - The report includes various deep-dive studies on the pharmaceutical industry, highlighting trends in supply and demand, as well as the growth of specific sectors such as blood products and inhalation formulations [51] 4. Recent Industry Policies and News - Recent policies from the National Healthcare Security Administration aim to support the high-quality development of innovative drugs, including increased funding and support for clinical applications [54] - Notable industry news includes the approval of innovative treatments by major pharmaceutical companies, indicating a robust pipeline and ongoing advancements in the sector [56]

Investment Rating - The report does not explicitly state an investment rating for the synthetic biology industry Core Insights - The synthetic biology sector is experiencing a global technological revolution, providing innovative solutions to major challenges such as health, climate change, and food security, as highlighted by the National Development and Reform Commission's "14th Five-Year Plan for Bioeconomic Development" [4] - The Huazhong Securities Synthetic Biology Index, which includes 58 companies across various sectors, has seen a decline of 3.42% recently, underperforming compared to the Shanghai Composite Index and the ChiNext Index [5][17] - The first local regulations for synthetic biology manufacturing were passed in Changde, Hunan, aimed at promoting industry development and addressing issues like talent shortages and approval efficiency [8][10] Summary by Sections 1.1 Secondary Market Performance - The synthetic biology sector's stocks have shown poor performance, with a recent decline of 3.42%, ranking 32nd among sectors [17] - The top-performing companies include Jincheng Pharmaceutical (+11%), Xinhai Hengli (+10%), and Dongbao Biological (+7%) [18] 1.2 Company Business Progress - Kexin Pharmaceutical's CAR-T therapy targeting Claudin18.2 has received regulatory acceptance for market application, offering new treatment options for advanced gastric cancer patients [23] - Angel Yeast announced a significant investment of 5.56 billion yuan to expand its biological manufacturing center and enhance its product lines [23] - Internationally, Covestro acquired Swiss film technology company Pontacol to strengthen its specialty materials business [25] 1.3 Industry Financing Tracking - The synthetic biology sector is witnessing accelerated financing, with nearly 100 companies completing new funding rounds since the beginning of 2025 [31] - Zhejiang Rongrui Technology completed nearly 100 million yuan in Pre-A financing, focusing on green biological manufacturing [31] - Avantium, a Dutch biobased PEF company, secured 10 million euros to alleviate short-term liquidity pressures [31]

Investment Rating - The industry is rated as "Positive" for the next 12 months, indicating an expected increase in performance relative to the CSI 300 index [58][70]. Core Insights - The report highlights the approval of measures by the National Medical Products Administration (NMPA) to support the innovation of high-end medical devices, which is expected to enhance the industry’s growth [16][17]. - The report notes that from January to May 2025, there were 167 million instances of employee medical insurance personal account mutual aid, amounting to 22.026 billion yuan [4][16]. - Dupilumab has received FDA approval for the treatment of bullous pemphigoid, marking a significant advancement in targeted therapies [18]. Industry News - The NMPA has approved measures to optimize the lifecycle regulation supporting high-end medical device innovation, which includes ten specific actions aimed at enhancing the development of innovative medical technologies [16][17]. - The report mentions the upcoming ADA conference, where numerous pharmaceutical companies will showcase their innovative drug research, suggesting potential investment opportunities in related sectors [8][57]. - The report emphasizes the ongoing optimization of centralized procurement policies, which is expected to mitigate negative impacts on the industry and improve performance in related sectors [8][57]. Market Performance - The report indicates that during the week of June 20-26, 2025, the Shanghai Composite Index rose by 2.57%, while the pharmaceutical and biological sector increased by 1.34%, with all sub-sectors showing positive growth [6][47]. - As of June 26, 2025, the price-to-earnings ratio (TTM) for the pharmaceutical and biological industry was 27.45, with a valuation premium of 138% compared to the CSI 300 index [51][58]. Company Announcements - Kintor Pharmaceutical announced that the NMPA has accepted the new drug application for Shurike Aolun's injection for the treatment of advanced gastric/esophageal junction adenocarcinoma [27]. - HBM7020, developed by Hengrui Medicine, has entered a global strategic cooperation agreement with Otsuka Pharmaceutical for the treatment of autoimmune diseases [28][32]. - The report also highlights various collaborations and licensing agreements among companies, indicating a trend towards strategic partnerships in the industry [33][34][35].

Core Viewpoint - The article highlights the significant breakthrough of Kanjia Pharmaceutical in expanding CAR-T cell therapy from hematological cancers to solid tumors, with the submission of a new drug application for Shurijiaolun's injection [1][2][5][7]. Group 1: Company Developments - Kanjia Pharmaceutical submitted the new drug application (NDA) for Shurijiaolun's injection to the National Medical Products Administration (NMPA) on June 25, 2023, which was accepted on June 26 [1][3]. - The successful development of Shurijiaolun's injection positions Kanjia Pharmaceutical to potentially become the first company globally to offer CAR-T therapy for solid tumors, specifically targeting Claudin18.2 positive advanced gastric/esophageal junction adenocarcinoma patients [5][8][9]. - The company has seen its stock price surge nearly tenfold from a low of 2.48 HKD to around 25 HKD, driven by research advancements rather than market speculation [3][22]. Group 2: Clinical Trial Results - The NDA submission is based on a Phase II clinical trial (CT041-ST-01) that demonstrated significant improvements in progression-free survival (PFS) and overall survival (OS) compared to standard treatments for patients with advanced gastric cancer [9][10]. - The trial results have garnered international attention and recognition, providing a solid evidence base for the NDA application [10][12]. Group 3: Market Potential and Financial Health - The global market for CAR-T therapies is expected to expand significantly, as solid tumors account for approximately 90% of new cancer cases, compared to less than 10% for hematological cancers [11]. - Kanjia Pharmaceutical's financial health is robust, with cash reserves projected to remain above 1.08 billion HKD by the end of 2025, indicating a strong foundation for sustainable growth [12][13]. Group 4: Future Outlook - The company is preparing to build a commercialization team for Shurijiaolun's injection, aiming for a clear path to market and reduced trial costs [14]. - Kanjia Pharmaceutical is also developing universal CAR-T therapies using its THANK-u Plus™ platform, which shows promise in treating various cancers [18]. - The company is expected to leverage its successful commercialization of its first CAR-T product, Zewokaiolun's injection, to enhance the market entry of Shurijiaolun's injection [12][13]. Group 5: Industry Context - The Chinese innovative drug sector is experiencing a favorable environment, with increased investor enthusiasm and a trend of value reassessment among listed companies [16][22]. - Kanjia Pharmaceutical's unique approach contrasts with many peers that rely on overseas business development, as it focuses on self-sustaining growth through successful product commercialization [16].

Investment Rating - The report maintains a "Recommended" rating for the pharmaceutical industry [1] Core Insights - The revaluation of innovative drugs continues, driven by significant transactions and a trend towards differentiation in the market. The value of innovative drugs is increasingly recognized by multinational corporations (MNCs), particularly in the areas of EGFR and PD-1 dual antibodies. The number of pharmaceutical transactions in China increased by 34% year-on-year in Q1 2025, with total transaction value rising by 222% [3] - The upcoming ADA conference presents opportunities for Chinese companies to showcase their research, particularly in the areas of diabetes and weight loss. Notable collaborations and developments in GLP-1 drugs are expected to enhance the market presence of Chinese firms [4] - The gout treatment market shows significant potential, with a projected increase in patients from 170 million in 2020 to 240 million by 2030 in China. New drugs targeting URAT1 are entering critical clinical stages, indicating a strong market opportunity for innovative treatments [5] - Chinese companies are leading breakthroughs in CAR-T technology, with key developments expected in 2025. Recent clinical trials have shown promising results for CAR-T therapies in treating various cancers, indicating a strong future for these innovations [6] Summary by Sections 1. Pharmaceutical Market Tracking - The pharmaceutical industry outperformed the CSI 300 index by 0.25% in the past week, with a weekly increase of 1.13% [17] - Over the past month, the pharmaceutical sector's index rose by 6.48%, surpassing the CSI 300 index by 4.76%, ranking second among all sectors [22] 2. Pharmaceutical Sector Trends and Valuation - The pharmaceutical sector's current PE (TTM) is 34.41, slightly above the five-year historical average of 32.55 [41] 3. Recent Research Achievements - The research team has published several in-depth reports highlighting the growth trends in the blood products industry and the impact of policies on inhalation drug markets [44] 4. Recent Industry Policies and News - Recent policies aim to enhance the pricing and procurement evaluation system in the pharmaceutical sector, promoting a fair and transparent market environment [47] - Notable industry news includes several innovative drugs receiving clinical trial approvals and partnerships between Chinese companies and international firms, indicating a vibrant and evolving market landscape [48][49]

Investment Rating - The investment rating for the pharmaceutical industry is "Recommended" (maintained) [1] Core Insights - Significant transactions are driving the revaluation of innovation value in the pharmaceutical sector, with notable deals such as a $60 billion transaction by 3SBio and a $50 billion forecasted deal by CSPC Pharmaceutical Group [3] - The 2025 ASCO conference highlighted ADC, bispecific antibodies, and tri-specific antibodies as key areas of focus, with promising clinical results reported by Chinese companies [4] - Chinese innovative pharmaceutical companies are leading breakthroughs in CAR-T technology, with significant advancements expected in 2025 [6] - The gout treatment market presents substantial potential, with a projected increase in patients in China from 170 million in 2020 to 240 million by 2030 [8] - The oral weight loss drug market is seeing increased activity from leading companies, with notable collaborations and clinical advancements [10] - The approval of the world's first flu RNA polymerase PB2 protein inhibitor offers new treatment options for flu resistance [12] Summary by Sections 1. Pharmaceutical Market Tracking - The pharmaceutical industry outperformed the CSI 300 index by 2.21% over the past week, with a weekly increase of 3.30% [28] - Over the past month, the industry also outperformed the CSI 300 index by 4.57%, with a monthly increase of 6.42% [31] 2. Pharmaceutical Sector Trends and Valuation - The pharmaceutical sector's current PE (TTM) is 34.03, slightly above the five-year historical average of 32.54 [45] 3. Recent Research Achievements - Recent reports highlight the steady growth of blood products and the acceleration of the import substitution process in inhalation preparations [48] 4. Recent Industry Policies and News - The State Council announced a reduction in tariffs on imports from the U.S., which may impact the pharmaceutical sector [51] - Several innovative drugs have received approval for clinical trials and market entry, indicating a robust pipeline for the industry [52][53] 5. Recommended Companies and Earnings Forecast - Companies recommended for investment include Changchun High & New Technology, Yifan Biotech, and Zhongsheng Pharmaceutical, among others, with a focus on areas such as gout treatment and CAR-T technology [14]

Summary of Weekly Review on Pharmaceutical Sector Industry Overview - The pharmaceutical sector in A-shares showed a positive performance with the index (CITIC) increasing by 2.21% while the CSI 300 index decreased by 1.08% and the ChiNext index fell by 1.40% [1][2] - In H-shares, the Hang Seng Index for healthcare increased by 3.43%, contrasting with a decline of 1.32% in the Hang Seng Index and a drop of 1.46% in the Hang Seng Technology Index [1][2] Market Performance - The CSI 300 pharmaceutical index rose by 0.61% and the CSI 500 pharmaceutical index increased by 1.83% [3] - The overall daily trading volume for the market remained between 9,900 million and 12,000 million, with the pharmaceutical sector's market trading share fluctuating between 7.3% and 10.1% [3] - The pharmaceutical sector outperformed both the CSI 300 index and the ChiNext index during the week [3] Key Announcements and News - **WuXi AppTec**: The NMPA has accepted the application for the new indication of its cell immunotherapy product, Beiduo® (Regorafenib Injection), for second-line treatment of relapsed or refractory adult B-cell lymphoma patients [4] - **Hengrui Medicine**: The company received approval from the National Medical Products Administration for the clinical trial of SHR-4712 injection, which targets tumor-associated antigens and activates immune cells in the tumor microenvironment [4] - **Junshi Biosciences**: The company's HLX22 (recombinant humanized anti-HER2 monoclonal antibody injection) has been granted orphan drug designation for gastric cancer treatment by the European Commission [4] - **Kejia Pharmaceutical**: The candidate product targeting Claudin18.2 protein, "Shu Rui Ji Ao Lun Sai Injection," has been included in priority review by the NMPA for treating Claudin18.2 positive patients with advanced gastric and gastroesophageal junction adenocarcinoma who have failed at least second-line treatment [4] - **Rongchang Biologics**: The company announced that its dual-target fusion protein, Tai Ta Xi Pu, has been approved for listing in China for the treatment of acetylcholine receptor antibody-positive generalized myasthenia gravis (gMG), showing significant improvement in patient symptoms after 24 weeks of treatment [5]

Core Viewpoint - The company Kogei Pharmaceutical-B (02171.HK) announced that its CAR-T cell therapy candidate, Shurijiaolun Sai Injection (CT041), has been prioritized for review by the National Medical Products Administration for treating Claudin18.2 positive advanced gastric/esophagogastric junction adenocarcinoma patients who have failed at least two lines of treatment [1][2]. Group 1 - Shurijiaolun Sai Injection is a potentially first-in-class CAR-T cell therapy targeting Claudin18.2 protein, primarily for advanced gastric/esophagogastric junction adenocarcinoma and pancreatic cancer [2]. - Ongoing clinical trials include a researcher-initiated trial in China (CT041-CG4006, NCT03874897), a confirmatory Phase II trial for advanced gastric/esophagogastric junction adenocarcinoma (CT041-ST-01, NCT04581473), a Phase Ib trial for pancreatic cancer (CT041-ST-05, NCT05911217), and a post-operative consolidation therapy trial (CT041-CG4010, NCT06857786) [2]. - In March 2025, the injection received breakthrough therapy designation from the National Medical Products Administration in China for treating Claudin18.2 positive advanced gastric/esophagogastric junction adenocarcinoma after at least two lines of treatment failure [2]. Group 2 - In January 2022, the injection was granted Regenerative Medicine Advanced Therapy (RMAT) designation by the FDA in the United States for treating Claudin18.2 positive advanced gastric/esophagogastric junction adenocarcinoma [2]. - In September 2020, the injection received Orphan Drug designation from the FDA for treating gastric/esophagogastric junction adenocarcinoma [2].