Gan & Lee Pharmaceuticals' Once-Weekly Basal Insulin GZR4 Injection Meets Primary Endpoints in Two Pivotal Phase 3 Clinical Trials: SUPER-1 and SUPER-2 Accessibility StatementSkip Navigation BEIJING and BRIDGEWATER, N.J., March 31, 2026 /PRNewswire/ -- Gan & Lee Pharmaceuticals (SSE: 603087) today announced that two pivotal phase 3 clinical trials, SUPER-1 and SUPER-2, evaluating investigative once-weekly insulin GZR4 Injection, have successfully met their pre-specified primary endpoints. After 26 weeks ...

Investment Rating - The report maintains a "Positive" investment rating for the pharmaceutical and biotechnology industry [4]. Core Insights - The pharmaceutical and biotechnology sector is experiencing a significant data catalyst window with the upcoming AACR annual meeting, which is expected to enhance the global competitiveness of Chinese innovative drugs [5]. - The industry index declined by 1.26%, outperforming the CSI 300 index, with notable gains in medical research outsourcing and chemical preparations [2][13]. - The overall PE ratio for the pharmaceutical and biotechnology industry is 29.30x, down from 30.34x, indicating a valuation decline below the average [17]. Industry Review - The report highlights that the medical research outsourcing and chemical preparations sectors showed positive growth, while hospitals and blood products faced declines [2][13]. - The report notes that the innovative drug licensing transactions in China exceeded $60 billion in the first quarter of 2026, indicating a strong global recognition of Chinese innovative drug assets [5]. Important Industry News - The NMPA has launched a three-year "Spring Rain Action" to promote the transformation of clinical innovation achievements in medical devices [21][26]. - Johnson & Johnson's oral IL-23R antagonist "Icotrokinra" has received FDA approval, marking it as the first of its kind globally [41]. - Novo Nordisk's weekly insulin "Awiqli" has been approved by the FDA, providing a new treatment option for type 2 diabetes patients [44]. - AstraZeneca and Amgen's TSLP monoclonal antibody "Tezepelumab" has been approved in China, becoming the first of its kind domestically [46]. Investment Suggestions - The report suggests focusing on innovative drug companies with core technology platforms and differentiated pipeline layouts, especially those expected to achieve positive catalysts at major academic conferences like AACR [5]. - It also recommends attention to the CXO/CDMO industry chain, which is expected to benefit from improved overseas R&D demand and order recovery [5].

Investment Rating - The report maintains a "Positive" investment rating for the pharmaceutical and biotechnology industry [4]. Core Insights - The pharmaceutical and biotechnology sector is experiencing a significant data catalyst window with the upcoming AACR annual meeting, which is expected to enhance the global competitiveness of Chinese innovative drugs [5]. - The industry index declined by 1.26%, outperforming the CSI 300 index, with notable gains in medical research outsourcing and chemical preparations [2][13]. - The overall PE ratio for the pharmaceutical and biotechnology industry is 29.30x, down from 30.34x, indicating a valuation decline below the average [17]. Industry Review - The report highlights that the innovative drug sector is currently the core focus, supported by favorable domestic policies such as the NMPA's "Spring Rain Action" to promote clinical innovation in medical devices [4][5]. - The total amount of innovative drug licensing transactions in China exceeded $60 billion in the first three months of 2026, indicating a strong global recognition of Chinese innovative drug assets [5]. - The report suggests focusing on companies with core technology platforms and differentiated pipeline layouts, particularly those expected to achieve positive catalysts at major academic conferences like AACR [5]. Important Industry News - The NMPA has initiated a three-year "Spring Rain Action" to support the transformation of clinical innovation in medical devices [21][26]. - Johnson & Johnson's oral IL-23R antagonist "Icotrokinra" has been approved by the FDA, marking it as the first of its kind globally [41]. - Novo Nordisk's weekly insulin "Awiqli" has received FDA approval, providing a new treatment option for type 2 diabetes patients [44]. - AstraZeneca and Amgen's TSLP monoclonal antibody "Tezepelumab" has been approved in China, making it the first of its kind domestically [46]. Company Dynamics - Novartis plans to invest over 3.3 billion RMB in China to enhance its R&D, production, and operational capabilities [48].

证券代码：603087 证券简称：甘李药业 公告编号：2026-016 剩余被质押/冻结/标记股份数量占公司总股本比例 3.78% 二、股东累计质押股份情况 三、持股 5%以上股东质押事项对公司的影响 甘李药业股份有限公司 关于公司持股 5%以上股东部分股份解押的公告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述 或者重大遗漏，并对其内容的真实性、准确性和完整性承担法律责任。 重要内容提示: 北京旭特宏达科技有限公司（以下称"旭特宏达"）持有甘李药业股份 有限公司（以下简称"公司"）无限售条件流通股 32,073,734 股，占公司总股本 的 5.37%。2026 年 3 月 30 日公司收到通知，旭特宏达已于近日办理完毕 150,000 股公司股份的解押登记手续。本次股份解除质押后，旭特宏达累计质押公司股份 数量为 22,560,000 股，占其持股数量的 70.34%，占公司总股本的 3.78%。 控股股东、实际控制人甘忠如先生及其控制的北京旭特宏达科技有限公 司（以下简称"旭特宏达"）合计持有公司股份 237,717,491 股，占公司总股本 的 39.80%。本次股份解除质押后， ...

Summary of Eli Lilly's Exit from the Insulin Market Industry Overview - Eli Lilly plans to gradually exit the insulin market in Europe and Asia, Africa, and Latin America by Q2 2027, retaining only the high-profit U.S. market where factory prices remain above $20 [1][2] - Novo Nordisk and Eli Lilly are shifting their strategic focus towards GLP-1 and fourth-generation insulin, actively reducing the global supply of second and third-generation insulin through price increases or production cuts [1][2] Key Points - Eli Lilly's exit will release approximately $1.35 billion in market space outside of Europe and the U.S., with three Chinese companies expected to capture about $700 million in market value and a net profit increase of $300 million [1][3][4] - The demand for insulin in emerging markets like Asia and Africa is growing at 15%, significantly higher than the 5% growth in China, allowing Chinese companies to leverage their cost advantages for "China substitution" [1][6] - The global insulin supply is highly concentrated, with only a few companies, including Chinese, Russian, Indian, and Iranian firms, capable of large-scale production of raw materials and formulations [1][5] Competitive Landscape - The global insulin market has been dominated by Eli Lilly, Novo Nordisk, and Sanofi, which together held over 95% market share. Eli Lilly's exit will alter this landscape, particularly in developing countries where 80% of the global diabetes patient population resides [5][6] - Chinese companies are positioned to fill the gap left by Eli Lilly due to their significant cost advantages and large-scale production capabilities, allowing them to offer more affordable insulin options [5][6] Growth Opportunities for Chinese Companies - Chinese firms are expected to gain market share as they replace Eli Lilly's products, facing minimal competition in this transition [6][7] - The ability to offer insulin at half the price of Eli Lilly's products could lead to a market value of approximately $700 million and a net profit increase of around $300 million for Chinese companies [3][4] Future Market Trends - The global insulin market is expected to become stratified, with Chinese companies dominating the second and third-generation insulin markets while multinational corporations focus on high-value products like fourth-generation insulin and GLP-1 [7] - This shift will allow Chinese companies to become the primary suppliers of second and third-generation insulin globally, while multinational firms will concentrate on innovative products to capture higher profits [7]

Core Viewpoint - The article discusses Gan Li Pharmaceutical's strategic expansion of its drug GZR18 into the obesity-related market, particularly focusing on its application for obstructive sleep apnea (OSA) in obese patients, marking a significant shift from merely weight management to addressing obesity-related complications [5][8]. Group 1: GZR18's Clinical Development - Gan Li's subsidiary received approval from the National Medical Products Administration to conduct clinical trials for GZR18 in adult obesity patients with moderate to severe OSA, indicating a pivotal step in expanding the drug's indications [5]. - The clinical trial is a multi-center, randomized, double-blind, parallel, placebo-controlled Phase III study, aiming to enroll 140 participants with the primary endpoint being the change in the apnea-hypopnea index after 52 weeks of treatment [5]. Group 2: Unique Features of GZR18 - GZR18 is distinguished by its bi-weekly dosing regimen, which is expected to enhance patient adherence compared to traditional weekly injections, potentially making it the first bi-weekly GLP-1 receptor agonist globally [6][7]. - In a Phase IIb study involving 340 overweight or obese adults, the bi-weekly dosing groups showed significant weight loss, with the 48mg bi-weekly group achieving a weight reduction of 16.09% from baseline, demonstrating the drug's efficacy [7]. Group 3: Market Positioning and Competitive Landscape - The competitive landscape for GLP-1 drugs has evolved from merely achieving weight loss to encompassing broader obesity-related complications, with OSA being a key focus area due to its association with various metabolic issues [5][8]. - Gan Li aims to leverage the dual indication of GZR18 for both weight management and OSA, which could significantly enhance its market potential, especially given the limited competition in this specific indication within the domestic market [8]. Group 4: Future Considerations - The ultimate value of GZR18 will depend on its ability to demonstrate improvements in the apnea-hypopnea index, safety profile, and the real-world advantages of its bi-weekly dosing compared to traditional therapies [9]. - The article suggests that the next few years will see a shift in the GLP-1 market towards differentiation, with companies that can effectively address obesity-related complications likely to receive higher valuations [9].

证券代码：603087 证券简称：甘李药业 公告编号：2026-015 甘李药业股份有限公司 关于获得博凡格鲁肽（研发代号：GZR18）注射液新 增适应症《药物临床试验批准通知书》的公告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述 或者重大遗漏，并对其内容的真实性、准确性和完整性承担法律责任。 近日，甘李药业股份有限公司（以下简称"公司"、"甘李药业"）全资子 公司甘李药业山东有限公司收到国家药品监督管理局（以下简称"国家药监局"） 下发的关于在研药品博凡格鲁肽（研发代号：GZR18）注射液新增适应症"成人 肥胖患者的中度至重度阻塞性睡眠呼吸暂停"的《药物临床试验批准通知书》， 受 理 号 为 CXSL2600050 、 CXSL2600051 、 CXSL2600052 、 CXSL2600053 、 CXSL2600054、CXSL2600055、CXSL2600056、CXSL2600057，通知书编号为 2026LP00892、2026LP00893、2026LP00894、2026LP00895、2026LP00896、 2026LP00897、2026LP00898、202 ...

Investment Rating - The report suggests a positive investment outlook for the innovative drug sector, highlighting potential opportunities due to upcoming clinical data and successful overseas clinical progress of pipelines [2][4]. Core Insights - The chemical products sector is experiencing significant price increases due to rising international oil prices and high overseas energy costs, particularly affecting solvent products which are difficult to stockpile [1][10]. - The raw material pharmaceutical products are expected to see price increases as upstream raw material costs rise, with downstream clients maintaining low inventory levels since April 2023, indicating a potential for sustained price increases and profit elasticity [1][10]. - The report emphasizes the importance of the PI3K/AKT/mTOR signaling pathway in cancer treatment, with renewed focus on PI3K inhibitors, particularly following Novartis's acquisition of Synnovation Therapeutics' PI3Kα inhibitor SNV4818 [34][35][36]. Summary by Sections Raw Materials - The report notes that the pharmaceutical raw material sector is poised for price increases due to rising upstream costs and low inventory levels among clients, which could lead to sustained profitability [1][10]. Pharmaceuticals - Novartis announced a $2 billion upfront payment and up to $1 billion in milestone payments to acquire Synnovation Therapeutics' PI3Kα inhibitor SNV4818, indicating a strategic focus on differentiated therapies in the HR+/HER2- breast cancer market [2][34]. Medical Devices - Innovative products in the medical device sector are expanding into international markets, with companies like MicroPort receiving CE certification for pediatric applications of their surgical robots, enhancing their global brand presence [3][11]. Biologics - The report highlights the promising results of the oral GLP-1 Aleniglipron, which showed significant weight loss in clinical trials, suggesting a shift towards oral formulations that improve patient compliance and reduce logistics costs [3][12]. Traditional Chinese Medicine - The report suggests monitoring undervalued high-dividend assets within the traditional Chinese medicine sector as companies begin to release their performance results [3][12]. Healthcare Services and Consumer Healthcare - The report discusses the upcoming release of the DRG/DIP 3.0 version by the National Healthcare Security Administration, expected to be published around July 2023, which will provide insights into the evolving healthcare payment landscape [3][12]. Investment Recommendations - The report recommends focusing on core sectors such as small nucleic acids, bispecific antibodies, and ADCs, while also identifying opportunities during earnings forecast windows and major clinical data release events [2][4].

Investment Rating - The investment rating for the pharmaceutical and biotechnology industry is "Positive" and the rating has been maintained [1] Core Insights - The report highlights that the domestic policy environment is continuously releasing positive signals, with the 2026 government work report explicitly listing biomedicine as a "new pillar industry" [6][7] - The report indicates that the pharmaceutical and biotechnology industry index declined by 2.99%, underperforming the CSI 300 index, with medical consumables and in vitro diagnostics showing positive growth [5][15] - The report emphasizes the importance of focusing on "independent innovation" and "policy benefits" as the main investment themes in the pharmaceutical and biotechnology sector [7] Industry Review - The pharmaceutical and biotechnology industry index experienced a decline of 2.99%, ranking 14th among 31 primary industries, and underperformed the CSI 300 index, which declined by 0.88% [5][15] - Medical consumables and in vitro diagnostics had the highest growth rates of 1.42% and 0.93%, respectively, while medical devices and medical research outsourcing saw declines of 6.57% and 6.54% [5][15] - As of March 13, 2026, the industry’s PE (TTM overall method, excluding negative values) was 30.34x, down from 31.06x, indicating a downward trend in valuation [20] Important Industry News - The 2026 government work report has been released, emphasizing biomedicine as a "new pillar industry" and proposing to expand pilot programs in biotechnology and accelerate the development of innovative drugs and medical devices [25][26] - The "14th Five-Year Plan" has been published, mentioning the pharmaceutical industry multiple times, reinforcing support for innovative drugs and related sectors [25][26] - Notable approvals include the global first cAMP biased GLP-1 receptor agonist "Elnoglutide Injection" by Hangzhou Xianweida Biotech and a $30 billion investment by Eli Lilly in China [6][34][43] Investment Recommendations - The report suggests focusing on high-quality pharmaceutical assets with differentiated innovation capabilities and sustainable potential, particularly those benefiting from policy support and high-quality development of innovative drugs [7] - The investment themes should concentrate on companies with strong clinical advancement capabilities and global cooperation potential, as well as those benefiting from the optimization of review and approval processes and payment systems [7]

Investment Rating - The investment rating for the pharmaceutical and biotechnology industry is "Positive" and the rating has been maintained [1] Core Insights - The report highlights that the domestic policy environment is continuously releasing positive signals, with the 2026 government work report explicitly listing biomedicine as a "new pillar industry" [6][25] - The report indicates that the pharmaceutical and biotechnology industry index declined by 2.99%, underperforming the CSI 300 index, with medical consumables and in vitro diagnostics showing positive growth [5][15] - The report emphasizes the importance of focusing on "independent innovation" and "policy benefits" as the main investment themes in the pharmaceutical and biotechnology sector [7] Industry Review - The pharmaceutical and biotechnology industry index experienced a decline of 2.99%, ranking 14th among 31 primary industries, and underperformed the CSI 300 index, which declined by 0.88% [5][15] - The valuation of the pharmaceutical and biotechnology industry as of March 13, 2026, is 30.34x (TTM overall method, excluding negative values), down from 31.06x in the previous period, indicating a downward trend [20] - Among the sub-industries, the top three in terms of PE (TTM overall method, excluding negative values) are vaccines (54.84x), hospitals (41.28x), and medical consumables (39.52x), while the lowest is pharmaceutical circulation (14.66x) [20] Important Industry News - The 2026 government work report has been released, emphasizing biomedicine as a "new pillar industry" and proposing to further expand pilot programs in biotechnology and accelerate the development of innovative drugs and medical devices [6][25] - The "14th Five-Year Plan" outlines multiple references to the pharmaceutical industry, reinforcing support for innovative drugs and related sectors [25][26] - Notable approvals include the global first cAMP biased GLP-1 receptor agonist "Elnoglutide Injection" by Hangzhou Xianweida Biotech and a $30 billion investment by Eli Lilly in China [6][33][42] Investment Recommendations - The report suggests focusing on high-quality pharmaceutical assets with differentiated innovation capabilities and sustainable potential, particularly those benefiting from the high-quality development of innovative drugs and supportive policies [7] - It is recommended to pay attention to innovative drug companies with strong clinical advancement capabilities and global cooperation potential, as their valuation systems are expected to upgrade from single product logic to platform logic [7]