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乐普生物-B(02157):MRG003 获批在即,联合 PD-1 大有可为:聚焦肿瘤免疫,ADC联合IO差异化竞争:首次覆盖
Haitong Securities International· 2025-10-24 09:22
Investment Rating - The report initiates coverage with an "Outperform" rating for Lepu Biopharma-B (2157) [4] Core Views - The company is a leading domestic innovative pharmaceutical enterprise focusing on ADC combined with IO in oncology, with expectations for rapid market penetration following the approval of MRG003 [1][4] - The product pipeline is expected to expand internationally, indicating strong long-term growth potential for the company [1] Financial Summary - Projected total revenue for 2024A, 2025E, 2026E, and 2027E is 368 million, 853 million, 1,204 million, and 1,665 million RMB respectively, reflecting growth rates of 63%, 132%, 41%, and 38% [3] - Gross profit is expected to increase from 292.97 million in 2024A to 1,415.20 million in 2027E, with a gross margin projected to be around 79.66% to 85% [3] - Net profit is forecasted to improve from -411 million in 2024A to -29 million in 2027E, indicating a significant reduction in losses [3] Company Overview - Lepu Biopharma was established in January 2018 and focuses on oncology, particularly targeted and immunotherapy [9] - The company has built a diverse product pipeline through acquisitions and partnerships, including PD-1 antibodies and ADCs [9] - The management team is experienced, with a high concentration of ownership, ensuring stability and strategic direction [13][15] Market Potential - The global and Chinese cancer immunotherapy market is expected to grow significantly, with a CAGR of 16.3% and 25.1% respectively from 2025 to 2030 [28][31] - The PD-1 therapy market in China is projected to reach 582 billion RMB by 2030, with a CAGR of 30.5% from 2020 to 2025 [33][35] ADC Market Growth - The global ADC market is anticipated to reach 66.2 billion USD by 2030, with a CAGR of 30.3% from 2023 to 2030 [41] - The ADC market in China is expected to grow at a CAGR of 72.6% from 2023 to 2028, reaching 38.3 billion RMB [44][45] Product Pipeline and Clinical Development - MRG003 is currently under NDA review and has shown promising results in clinical trials for R/M NPC, with a significant improvement in overall response rates compared to chemotherapy [56][61] - The company is actively exploring combination therapies with PD-1 inhibitors, which may enhance treatment efficacy [60][65]
国信证券:看好创新药长期逻辑 关注底部反转标的
智通财经网· 2025-10-24 02:09
Group 1: Medical Device Sector - The medical device sector is expected to see valuation recovery opportunities due to "policy optimization, economic recovery, and performance rebound" [1] - Since 2025, medical device bidding has been gradually improving, with some companies likely to see performance reversals in Q3 2025 as inventory is consumed [1] - High-value consumables have faced performance and valuation suppression due to centralized procurement and tariffs, but the easing of these factors presents significant valuation recovery opportunities [1] Group 2: Innovative Drugs - Multiple results of domestic innovative drugs will be showcased at the European Society for Medical Oncology (ESMO) in mid to late October 2025, highlighting the competitive clinical data of Chinese innovative drugs [2] - The trend of domestic innovative drugs going overseas is strengthening, with significant clinical progress and data readouts enhancing their global market commercialization certainty [3] - The Chinese innovative drug industry is showing a long-term positive development trend, particularly evident in the explosive growth of business development (BD) transactions in recent years [3]
乐普生物-B(02157):MRG003获批在即,联合PD-1大有可为:聚焦肿瘤免疫,ADC联合IO差异化竞争
GUOTAI HAITONG SECURITIES· 2025-10-17 12:38
Investment Rating - The report assigns an "Accumulate" rating to the company [5]. Core Insights - The company is a leading domestic innovative pharmaceutical enterprise focusing on ADC combined with IO, with expectations for rapid growth following the approval of MRG003 [2]. - The product pipeline includes plans for international business development, indicating a positive long-term outlook for the company [2]. Financial Summary - Projected total revenue for 2024A is 368 million RMB, with a growth rate of 63%. By 2027E, revenue is expected to reach 1,665 million RMB, with a growth rate of 38% [4]. - The company is projected to achieve a net profit of -411 million RMB in 2024A, improving to -29 million RMB by 2027E [4]. - The price-to-earnings (PE) ratio is expected to improve from -10.04 in 2024A to -389.49 in 2027E, while the price-to-book (PB) ratio is projected to increase from 5.87 to 18.86 over the same period [4]. Company Overview - The company was established in January 2018 and focuses on innovative treatments for cancer, particularly targeted therapies and immunotherapies [13]. - The company has built a robust product pipeline through acquisitions and partnerships, including PD-1 antibodies and ADC drugs [13][15]. - The management team is experienced, with a high concentration of ownership, ensuring stability and strategic direction [15][19]. Market Potential - The global and Chinese cancer immunotherapy market is expected to grow significantly, with a projected CAGR of 16.3% and 25.1% respectively from 2025 to 2030 [30]. - The PD-1 therapy market in China is anticipated to reach 582 billion RMB by 2030, with a CAGR of 30.5% from 2020 to 2025 [33]. Product Pipeline and Development - The company has multiple tumor product pipelines covering immunotherapy, ADC targeted therapy, and oncolytic virus drugs [20]. - MRG003 is currently under NDA review for treating R/M NPC, with potential for significant market impact [22]. - The company is also exploring combination therapies with PD-1 antibodies, which may enhance treatment efficacy [20]. Sales Growth - The company's first commercial product, the PD-1 antibody, has seen rapid sales growth, achieving 300 million RMB in revenue in 2024, three times the revenue of 2023 [23][36]. - The company has expanded its sales network across 118 cities in China, enhancing its market presence [36].
乐普生物-B(02157)上半年首次实现盈利 收入显著增长2.5倍 研发管线成果丰硕
智通财经网· 2025-08-20 08:59
Group 1: Financial Performance - The company reported a revenue of RMB 466 million for the six months ending June 30, 2025, representing a year-on-year increase of 249.59% [1] - Profit attributable to the owners of the company was RMB 41.75 million, a significant turnaround from a loss of RMB 192 million in the same period last year [1] - Basic earnings per share were RMB 0.02 [1] Group 2: Product Pipeline and Development - The company has strategically developed multiple oncology product pipelines, including one candidate drug in the clinical/commercialization stage and nine candidate drugs in clinical stages [2] - Among the nine clinical-stage candidates, seven are targeted therapies and two are immunotherapies, with several receiving FDA designations such as Breakthrough Therapy Designation (BTD) and Orphan Drug Designation (ODD) [2] - The company is focused on building and developing new technology platforms as part of its innovation engine [2] Group 3: Commercialization and Strategic Partnerships - The company aims to commercialize its product pipeline in China through a professional sales and marketing team while expanding into international markets via strategic partnerships [3] - The product "普佑恆®" (Putilizumab Injection) has completed the full commercialization process and is currently experiencing rapid sales growth [3] - The global rights for CMG901 have been licensed to AstraZeneca, and the rights for MRG007 outside Greater China have been licensed to ArriVent, establishing a solid foundation for future commercialization and global collaboration [3]
乐普生物-B(02157.HK)中期扭亏为盈至2930万元
Ge Long Hui· 2025-08-20 08:43
Core Viewpoint - Lepu Biopharma-B (02157.HK) reported significant revenue growth and achieved profitability for the first time, with revenue of approximately RMB 466 million for the six months ending June 30, 2025, representing 3.5 times the revenue of the same period in 2024, and a profit of approximately RMB 29.3 million compared to a loss of RMB 197 million in the previous year [1][2]. Group 1 - The company focuses on innovative biopharmaceuticals in the oncology treatment field, particularly targeted therapy and immunotherapy, utilizing advanced ADC technology [1]. - The company has established an integrated end-to-end capability covering all key aspects of the biopharmaceutical value chain, from drug discovery to clinical development and compliant production [1]. - The company aims to continuously develop differentiated product pipelines through strategic collaborations and its own innovation capabilities [1]. Group 2 - The company has strategically laid out multiple oncology product pipelines, including one clinical/commercial candidate, nine clinical candidates, and three combination therapy candidates [2]. - Among the nine clinical candidates, seven are targeted therapies and two are immunotherapies, with several candidates receiving FDA designations such as Breakthrough Therapy Designation (BTD), Orphan Drug Designation (ODD), and Fast Track Designation (FTD) [2]. - The company is actively working on establishing and developing new technology platforms as part of its innovation engine [2].
行业投资策略周报:司美MASH适应症获批-20250819
CAITONG SECURITIES· 2025-08-19 11:11
Core Insights - The report highlights the approval of semaglutide (Wegovy) for the treatment of metabolic dysfunction-associated steatotic liver disease (MASH) by the FDA, which is expected to enhance the market penetration of related products and diagnostic tools [7][10][15] - The report suggests that companies like Furuya Co., Ltd. will benefit from the growth opportunities in the MASH indication market due to the increasing prescription rates of semaglutide and the rising demand for diagnostic instruments [15][5] Industry Performance Review - As of August 15, 2025, the pharmaceutical and biotechnology sector's TTM-PE stands at 51.31 times, which is 110% higher than its historical low of 24.38 times [16] - The healthcare sector has shown a relative premium of 281% compared to the CSI 300 index, which is significantly above the average premium rate of 241% over the past decade [16] - The pharmaceutical and biotechnology sector experienced a 3.08% increase in the week from August 11 to August 15, 2025, ranking 10th among 27 sub-industries [20][24] Company Dynamics - Furuya Co., Ltd. is noted for its FibroScan series of liver fibrosis diagnostic instruments, which are the first globally to utilize transient elastography technology for non-invasive liver stiffness measurement [15] - The report emphasizes the strategic collaborations between Furuya and leading pharmaceutical companies to promote the clinical application and commercialization of new drugs [15] - The report identifies several companies that could be key players in the MASH treatment landscape, including innovative drug and device companies such as Furuya, Anglikon, and others [15]
海外消费周报:银河娱乐2Q25业绩点评-20250815
Shenwan Hongyuan Securities· 2025-08-15 11:35
Investment Rating - The report maintains a "Buy" rating for Galaxy Entertainment, highlighting the resilience of the gaming industry and the long-term growth potential of the company [6]. Core Insights - Galaxy Entertainment achieved a net revenue of HKD 12 billion in Q2 2025, representing an 8% quarter-on-quarter increase and a 10% year-on-year increase. The adjusted EBITDA was HKD 3.2 billion, with a 7% quarter-on-quarter increase but a 1% year-on-year decline. Key revenue metrics have recovered to 82%, 130%, 138%, and 31% of 2019 levels for total gross revenue, mass market revenue, slot machine revenue, and VIP turnover, respectively [6][8]. - The company has a net cash position of HKD 30.3 billion as of June 30, 2025, and announced an interim dividend of HKD 0.70 per share, with a payout ratio of 58%, up from 50% in 2024 [6][8]. Summary by Sections 1. Overseas Social Services - Galaxy Entertainment's Q2 2025 performance shows a recovery in various revenue streams, with EBITDA returning to 79% of 2019 levels. The Capella Hotel is in trial operation, with full opening expected soon. The Macau Galaxy Phase IV project is progressing, with completion expected in 2027 [6][8]. 2. Overseas Pharmaceuticals - The 2025 medical insurance directory and commercial insurance innovative drug directory preliminary review has been published, with 534 out of 718 submissions passing the initial review. The new directory includes several CAR-T products and other innovative drugs [10][12]. 3. Domestic Pharmaceutical Companies - Crystal Holdings expects a revenue of at least HKD 500 million in H1 2025, a year-on-year increase of approximately 387%. In contrast, Jinxin Reproductive expects a net loss of no more than HKD 1.09 billion due to asset impairments [11][12]. 4. Overseas Pharmaceutical Company Updates - Insmed's DPP-1 inhibitor, BRINSUPRI, has received FDA approval for treating non-cystic fibrosis bronchiectasis. Novartis's BAFF-R monoclonal antibody has met primary endpoints in two Phase III studies for treating active Sjögren's syndrome [13][14]. 5. Investment Recommendations - The report suggests focusing on innovative drugs and pharmaceutical companies with strong clinical pipelines, including companies like BeiGene, Innovent Biologics, and others [15]. 6. Market Performance - The Hang Seng Healthcare Index rose by 3.50%, outperforming the Hang Seng Index by 1.75 percentage points, indicating a positive market sentiment towards healthcare stocks [8].
港股异动 | 乐普生物-B(02157)涨超6% 自研TF ADC药物MRG004A纳入突破性治疗
Zhi Tong Cai Jing· 2025-08-13 06:20
据悉,MRG004A是针对差异化靶点、采用创新偶联技术的靶向组织因子(tissue factor,TF)的ADC药 物,通过Glyco Connect™定点偶联及Hydra Space™极性间隔技术连接TF靶向单抗与高效抗微管剂 MMAE,也是国内首款进入临床的TF ADC药物。 MRG004A已分别在中、美取得IND批准,并获FDA授予孤儿药资格认定和快速通道资格,用于治疗胰 腺癌。此前在美国及中国进行I期临床研究时已在胰腺癌、三阴乳腺癌及宫颈癌癌等适应症中观察到抗 肿瘤活性信号。 智通财经APP获悉,乐普生物-B(02157)涨超6%,截至发稿,涨5.81%,报9.66港元,成交额2.07亿港 元。 消息面上,8月11日,据国家药品监督管理局药品审评中心披露,乐普生物-B自主研发的TF ADC药物 MRG004A被纳入突破性治疗药物,这一重要进展标志着乐普生物在ADC药物研发领域取得又一重大突 破。 今年8月1日,乐普生物已启动MRG004A治疗胰腺癌的III期临床试验,期待MRG004A未来有望成为胰腺 癌患者的全新治疗选择。 ...
乐普生物-B涨超6% 自研TF ADC药物MRG004A纳入突破性治疗
Zhi Tong Cai Jing· 2025-08-13 06:17
Core Viewpoint - Lepu Biopharma-B (02157) has seen a significant stock increase of over 6%, currently trading at 9.66 HKD with a transaction volume of 207 million HKD, following the announcement of its ADC drug MRG004A being included in the list of breakthrough therapies by the National Medical Products Administration [1] Group 1: Drug Development Progress - MRG004A is a targeted tissue factor (TF) ADC drug developed by Lepu Biopharma, utilizing innovative coupling technology and is the first TF ADC drug to enter clinical trials in China [1] - The drug has received IND approval in both China and the United States, along with orphan drug designation and fast track designation from the FDA for the treatment of pancreatic cancer [1] - Initial Phase I clinical studies in the US and China have shown anti-tumor activity signals in pancreatic cancer, triple-negative breast cancer, and cervical cancer [1] Group 2: Clinical Trials - On August 1, Lepu Biopharma initiated a Phase III clinical trial for MRG004A targeting pancreatic cancer, aiming to provide a new treatment option for patients [1]
恒生创新药ETF(159316)迎资金逆势加仓,多款创新药进入拟突破性治疗公示
Mei Ri Jing Ji Xin Wen· 2025-08-12 03:36
Group 1 - The Hong Kong innovative drug sector experienced a decline, with the Hang Seng Innovative Drug Index dropping nearly 2.0% in early trading [1] - The Hang Seng Innovative Drug ETF (159316) saw a trading volume exceeding 200 million yuan, with a net subscription of 15 million units [1] - Six innovative drugs entered the proposed breakthrough treatment category, including BI 1810631, IN10018, MRG004A, ATG-022, LM-302, and RC148 [1] Group 2 - Industrial research indicates that the innovative drug sector's prosperity is sustainable, with "innovation + internationalization" remaining a core direction for the pharmaceutical industry [1] - Policy support for the industry is expected to continue, enhancing global competitiveness and commercial profitability [1] - The recent revision of the Hang Seng Innovative Drug Index's compilation scheme excludes CXO companies, resulting in a "pure" innovative drug index [1] Group 3 - Backtesting shows that the adjusted index has higher annualized returns and Sharpe ratios since its launch on July 10, 2023 [1] - The Hang Seng Innovative Drug ETF (159316) is currently the only product tracking this index, which is expected to better assist investors in seizing innovative drug investment opportunities [1]