ADC(抗体偶联药物)

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映恩生物-B大幅回撤,ADC有“泡沫”?英派药业递表港交所,今年上半年净亏损1.29亿元 | 掘金创新药
Mei Ri Jing Ji Xin Wen· 2025-09-30 00:24
每经记者|金喆 每经编辑|魏官红 恒生医疗保健业指数 港股创新药ETF (HSCICH) (513120) 周内涨跌 - 2.76% 周内涨跌 -1.60% - A股当周涨跌幅 - 信立泰 博瑞医药 周内涨跌 | | | 30% | 周内涨跌 38.77% - 港股当周涨跌幅 - 晶泰控股 映恩生物 周内涨跌 ↑15.26% | 周内涨跌 | 15.42% 聚焦前沿 热门赛道 全球首个皮下注射抗体药物偶联物 启动II期临床 适应证为晚期非小细 胞肺癌 一周热股 映恩生物-B领跌创新药板块,ADC (抗体偶联药物)有"泡沫" 资本动向 英派药业递表港交所 1款产品上市、 今年上半年净亏损1.29亿元 | 《掘金创新药》 栏目由每日经济新闻推出,每周一期 | | --- | | 解读新药研发进展与趋势 剖析产品竞争力与市场前景 | | 洞察医药资本脉络 见证医药产业高质量发展 | | 数据来源:东方财富App、富途牛牛 | 资本眼 一周行情 9月22日至9月26日,医药生物指数下跌1.69%,跑输上证指数1.04个百分点。创新药(BK1106)周内下跌2.10%。恒生医疗保健业指数(HSCICH)周下跌 2.76 ...
以创新为底色 百利天恒共绘生物医药产业新图景
Xin Hua She· 2025-09-19 08:42
Core Insights - The 2025 World Lung Cancer Conference showcased significant advancements in innovative drugs from Chinese pharmaceutical companies, highlighting the increasing international recognition of Chinese innovation in the pharmaceutical sector [1] Group 1: Conference Highlights - The conference featured 35 oral presentations from Chinese scholars, with two participating in the chair discussion, indicating a strong presence of Chinese research [1] - Baili Tianheng's drug, iza-bren, is the world's first and only EGFR×HER3 dual antibody ADC to enter Phase III clinical trials, with two key research results selected for the conference's official news release program [1][3] Group 2: Clinical Research Results - In a Phase II study, 40 patients with advanced EGFR-mutant non-small cell lung cancer (NSCLC) treated with iza-bren and osimertinib showed effective tumor shrinkage, outperforming the current best drug's 86% shrinkage rate [2] - Another study reported that 94% of 50 patients with advanced EGFR-mutant NSCLC experienced tumor shrinkage, with a time to recurrence exceeding one year, nearly doubling the duration compared to existing global standards [2] Group 3: ADC Development and Market Trends - ADCs are recognized as a highly innovative and promising direction in cancer treatment, with over 120 Chinese pharmaceutical companies engaged in ADC research and more than 600 projects globally [2] - From 2018 to 2024, China has approved a total of 197 innovative drugs, with the annual approval rate increasing from 11 in 2018 to 48 in 2024, indicating a robust growth trend in innovative drug development [3] Group 4: Strategic Partnerships and Market Positioning - Baili Tianheng entered a global strategic partnership with Bristol-Myers Squibb for iza-bren, with a total deal value of up to $8.4 billion, marking a significant milestone for a Chinese dual antibody ADC [4] - The company's market capitalization surged from 9.9 billion yuan at its IPO to over 150 billion yuan, reflecting strong investor interest and confidence in its innovative drug pipeline [4] Group 5: Future Plans and Industry Advantages - Baili Tianheng plans to commercialize its innovative drugs in China by 2026 and aims for global market approval by 2029, aspiring to become a competitive multinational corporation (MNC) [5] - The company leverages China's unique advantages, including a growing number of biotech firms, robust clinical research infrastructure, and an efficient regulatory environment, to enhance its drug development capabilities [6]
“十四五”结硕果:我国创新药研发数量全球第二,细分赛道领跑
2 1 Shi Ji Jing Ji Bao Dao· 2025-09-12 02:04
Core Insights - China's innovative drug development has achieved significant milestones, with over 20% of global new drug research and development, ranking second globally [1] - The number of approved innovative drugs has accelerated, with 43 new drugs approved in the first half of 2025, marking a historical high for the same period [3][4] - The trend of "innovation + internationalization" in the pharmaceutical industry remains strong, with Chinese companies showing competitive advantages in various therapeutic areas [1][2] Industry Development - During the "14th Five-Year Plan" period, China approved 210 innovative drugs and 269 innovative medical devices, indicating a sustained growth trend [1] - The total amount of foreign licensing for innovative drugs reached nearly $66 billion in the first half of 2025, reflecting increasing global recognition of Chinese innovative drugs [1] - The biopharmaceutical industry is experiencing a resurgence, with significant growth potential remaining, driven by technological advancements and improved global competitiveness [2] Company Performance - Leading innovative pharmaceutical companies have reported strong revenue growth, with Hengrui Medicine achieving a revenue of 15.76 billion yuan, a year-on-year increase of 15.88% [3] - Innovent Biologics turned a profit in the first half of 2025, with a net profit of 1.21 billion yuan, compared to a loss of 160 million yuan in the same period last year [5] - The sales of innovative drugs are becoming a prominent feature of the industry, with companies like BeiGene and Fosun Pharma also reporting significant revenue increases [3][5] Regulatory Environment - The National Medical Products Administration (NMPA) has optimized the clinical trial review and approval process, reducing the review time from 60 days to 30 days [6] - Continuous improvements in the drug approval process are expected to further stimulate innovative drug development [6] R&D Investment - R&D investment among leading pharmaceutical companies has increased, with a total of 17.64 billion yuan spent on R&D in the first half of 2025, a year-on-year increase of 12.66% [7] - Companies like BeiGene and Hengrui Medicine are leading in R&D expenditures, emphasizing the importance of innovation in their growth strategies [7] Market Trends - The oncology drug segment remains the dominant area for innovative drugs, accounting for approximately 40% of the approved drugs [5] - The rapid commercialization of innovative drugs is driving performance breakthroughs for pharmaceutical companies [5][8] - ADC (antibody-drug conjugates) and other advanced therapies are gaining traction, with several companies making significant progress in these areas [9][10]
百利天恒股价创新高,实控人朱义坐稳四川新首富,持股市值1156亿元
Sou Hu Cai Jing· 2025-09-07 12:49
朱义坐稳四川新首富 上市以来,百利天恒股价持续上涨,2024年和2025年分别录得37.05%和102.38%的涨幅。截至9月5日收盘,百利天恒股价报收388.02元/股,总市值1555.96亿 元。公司实控人朱义持股74.35%,据此推算,朱义持有的百利天恒股份价值约1156.86亿元。 红星资本局9月7日消息,近日,百利天恒(688506.SH)股价创下历史新高,一度达到410元/股,市值突破1644亿元。截至9月5日收盘,百利天恒股价报 388.02元/股,市值超过1500亿元。 百利天恒于2023年1月登陆科创板,发行价为24.7元/股,上市以来股价涨幅超过14倍。股价的连续上涨也不断推高百利天恒实控人朱义的个人财富值。 目前,百利天恒实控人朱义持有的股份价值约为1156.86亿元,稳坐四川富豪头把交椅。 百利天恒实控人、董事长朱义 股价创下历史新高 2023年12月,百利天恒与全球制药巨头百时美施贵宝(BMS)签订了关于BL-B01D1的授权协议,双方将合作推动BL-B01D1在美国的开发和商业化。百利 天恒负责中国大陆的开发、商业化及生产,并部分供应中国大陆以外地区。BMS负责全球其他地区的开发和 ...
迈威生物上半年净亏损同比扩大、股价翻倍公司称今年创新药BD业务非常关键
Xin Lang Cai Jing· 2025-08-30 12:11
Core Viewpoint - Maiwei Biotech reported a decline in revenue and significant losses in the first half of 2025, despite a notable increase in stock price and market interest due to business development (BD) activities and the approval of its first self-developed innovative drug [1][2]. Financial Performance - The company achieved revenue of 101 million yuan in the first half of 2025, a year-on-year decrease of 12.43% [1]. - The net profit attributable to shareholders was -552 million yuan, indicating a larger loss compared to the previous year [1]. - The stock price reached a historical high of 50.36 yuan per share on August 29, 2025, with a year-to-date increase of over 137% [1]. Business Development Activities - Maiwei Biotech's first self-developed innovative drug, Mai Li Sheng (generic name: injection of Agrelistat α), was approved in May 2025, marking a shift from biosimilars to innovative drugs [2]. - The company entered into a BD collaboration with Qilu Pharmaceutical for the commercialization of Mai Li Sheng, potentially earning up to 500 million yuan in upfront and milestone payments [2]. - The company also licensed IL-11 targeted therapy rights to CALICO for regions outside China, with similar financial arrangements [2]. Product Pipeline and Challenges - The company has a total of 14 key products in various stages, including 10 innovative drugs and 4 biosimilars [5]. - The sales revenue of two biosimilars, including Dushuang (generic name: Dexamethasone), increased by 51.59% year-on-year, contributing significantly to the company's revenue [1]. - However, the company faces commercialization challenges, such as a 66.61% decrease in the shipment volume of Junmai Kang (generic name: Adalimumab) due to production capacity issues [2]. Research and Development Investment - The company reported R&D expenses of 392 million yuan in the first half of 2025, a year-on-year increase of 21.72%, accounting for 38% of its operating revenue [4]. - The increase in losses is attributed to substantial investments in clinical trials for multiple in-development products [4]. Market Position and Future Outlook - The ADC (antibody-drug conjugate) sector is a key focus for the company, with ongoing BD activities for three ADC drugs [5]. - The company plans to enhance its BD pipeline with new generation TCE (T-cell engager) platforms starting in 2026, indicating a strategic shift to maintain competitiveness in a crowded market [5].
映恩生物-B(09606):生而全球化 ADC创新引擎驱动价值增长
Mai Gao Zheng Quan· 2025-08-26 06:17
Investment Rating - The report initiates coverage with a "Buy" rating for the company [5] Core Insights - The company is positioned as a platform-based innovator in ADC (Antibody-Drug Conjugates) with a global strategy, achieving rapid accumulation and growth through efficient execution. It currently has 8 global clinical assets, with the fastest progressing pipeline nearing commercialization [1][2] - The company has three core competitive advantages: high efficiency in development, a global clinical and commercial strategy, and an innovative pipeline structure that includes both late-stage products and exploration of new ADC formats [2] - The company is advancing its lead product DB-1303 towards market submission in both the US and China, while DB-1311 shows significant potential across multiple tumor types [3][4] Summary by Sections Section 1: Company Overview - The company has established four innovative platforms and eight clinical pipelines within five years, with its first project DB-1303 set to submit for BLA in 2025 [15][18] - The management team has extensive experience in both investment and industry, enhancing strategic planning and operational execution [19][21] Section 2: ADC Industry - The ADC industry is characterized by high growth potential, with third-generation ADCs becoming the mainstream design due to their improved targeting and efficacy [45][48] Section 3: DITAC Platform - The DITAC platform has multiple leading pipelines, including DB-1303, which is in the global third phase of clinical trials, and DB-1311, which is positioned in the first tier of global development for B7H3 ADCs [3][4][26] Section 4: Financial Projections - Revenue projections for the company are estimated at 2.1 billion RMB in 2025, with a net profit forecasted to improve from a loss of 536 million RMB in 2025 to a loss of 127 million RMB in 2027 [4][5] Section 5: Investment Recommendations - The report emphasizes the company's strong business development capabilities and extensive partnerships, which have secured over 6 billion USD in collaboration projects, supporting its early-stage R&D activities [30][31]
再交硬核成绩单,药明生物回归高增长通道
Zhi Tong Cai Jing· 2025-08-19 11:28
Core Viewpoint - WuXi Biologics reported a strong performance for the first half of 2025, with revenue reaching 9.95 billion RMB, a year-on-year increase of 16.1%, and a net profit growth of 54.8% to 2.76 billion RMB, indicating robust business growth and a positive outlook for the future [1][2]. Financial Performance - The company achieved a gross margin of 42.7%, up 3.6 percentage points year-on-year [1]. - Adjusted net profit increased by 11.6% to 2.84 billion RMB, while profit attributable to shareholders rose by 56.0% to 2.34 billion RMB [1]. - WuXi Biologics raised its full-year revenue guidance for 2025 to a growth range of 14%-16% [1]. Business Development - The company signed 86 new comprehensive projects in the first half of 2025, setting a historical record and bringing the total number of projects to 864 [1]. - Over 70% of new projects focus on ADC (Antibody-Drug Conjugates) and bispecific/multispecific antibodies, highlighting the high demand in these areas [1]. - The conversion rate from R&D to development and manufacturing exceeds 90%, showcasing strong client relationships and business integration [4]. Market Position and Strategy - WuXi Biologics has a significant order backlog of 20.34 billion USD, with over 4.21 billion USD in unfulfilled orders expected in the next three years, reinforcing the stability and growth potential of its core business [2]. - The company has evolved from a traditional service provider to a platform company that empowers global innovative biopharmaceutical development [4]. - The firm’s unique CRDMO business model creates substantial competitive barriers that are difficult to replicate [4]. Technological Innovation - WuXi Biologics launched several advanced platforms in 2023, including EffiXTM and WuXiaHigh2.0, enhancing its production capabilities [6]. - The company’s automated production line has achieved a breakthrough in continuous production, significantly increasing output [6]. External Environment and Market Trends - The capital market for innovative drugs is recovering, with significant increases in financing activities in the healthcare sector [2]. - Policy updates in China are expected to stimulate domestic innovative drug development, benefiting WuXi Biologics as a leading CXO enterprise [7]. Valuation and Investment Potential - As of August 18, the company's PE ratio reached 35.35, indicating a recovery in valuation, yet it remains below the historical average, suggesting potential for further appreciation [8]. - The company’s stock buyback program has increased its net asset value per share to 11.28 HKD, enhancing its investment appeal [7].
恒生生物科技ETF(159615)量价齐升盘中涨超2%,京东健康涨超12%,中国创新药成果加速涌现
Xin Lang Cai Jing· 2025-08-15 03:50
Group 1 - The Hang Seng Biotechnology ETF (159615) has seen a 2.27% increase, marking a three-day rising streak with an active trading volume of 35.71% and a transaction value of 131 million yuan [1] - The Hang Seng Biotechnology Index, which the ETF tracks, rose by 1.67%, with notable increases in constituent stocks such as JD Health (up 12.22%) and Sihuan Pharmaceutical (up 8.49%) [1] - The ETF has accumulated a 2.72% increase over the past week, ranking first among comparable funds, and its latest scale reached 352 million yuan, a three-month high [1] Group 2 - According to Guojin Securities, China's innovative drugs are on the rise, entering the initial phase of innovation results realization, with significant opportunities for independent development and large-scale transactions in the future [2] - In the oncology field, two main directions are highlighted: the multidimensional iteration of ADCs (antibody-drug conjugates) and innovations in the combination of immune therapy molecular components [2] - The Hang Seng Biotechnology Index reflects the overall performance of the largest 50 biotechnology companies listed in Hong Kong, with top-weighted stocks including BeiGene, Innovent Biologics, and WuXi Biologics [2]
港股创新药板块持续冲高 7只个股市值突破千亿港元
Mei Ri Jing Ji Xin Wen· 2025-08-05 15:25
每经记者|陈星 每经编辑|董兴生 8月5日,科伦博泰生物(HK06990)报收433港元/股,总市值达到1010亿港元,新晋"身价"超千亿港元 的港股创新药公司。 《每日经济新闻》记者注意到,在港股创新药板块景气度持续提升的背景下,多只创新药个股股价近期 创下新高。目前,除了科伦博泰生物,港股创新药板块还有恒瑞医药、信达生物、翰森制药、百济神 州、康方生物、中国生物制药等6只个股市值超过千亿港元。 光大证券在研报中表示,7月是中报业绩密集披露的窗口期,部分创新药公司中报业绩在BD(商务拓 展)行情影响下或有积极变化,有望成为新一轮行情的催化剂。 科伦博泰生物处于向综合性生物医药平台进化的关键拐点 7只创新药个股市值突破千亿港元 8月5日,港股生物医药股尾盘持续冲高,君实生物股价飙升超30%;复宏汉霖、康诺亚股价涨超11%; 诺诚健华、科伦博泰生物、荣昌生物股价涨超7%;康方生物股价涨近7%。当日,港股创新药ETF (513120)收涨3.17%,涨幅在全市场ETF中居首位;全天成交额突破110亿港元,位居全市场ETF前 列。 截至8月5日收盘,市值超过千亿港元的创新药板块个股共有7只。市场人士认为,板块持续上 ...
信达生物(01801):IO及ADC在研管线具备较大潜力,期待玛仕度肽上量
CSC SECURITIES (HK) LTD· 2025-07-24 08:28
Investment Rating - The report assigns a "Buy" rating for the company, indicating a potential upside in the stock price [7]. Core Insights - The company aims to become a leading international biopharmaceutical firm, with significant achievements in commercialization and a robust pipeline in oncology and other therapeutic areas [7]. - The company has 16 products approved for sale, with projected sales revenue of RMB 8.2 billion in 2024, reflecting a year-over-year growth of 44% [7]. - The company has achieved positive Non-IFRS profit and EBITDA for the first time, with figures of RMB 330 million and RMB 410 million respectively for 2024 [7]. - The company expects to maintain positive EBITDA in 2025 and aims to launch 20 commercialized products by 2027, targeting revenue of RMB 20 billion [7]. Summary by Sections Company Overview - The company operates in the pharmaceutical and biotechnology sector, with a current H-share price of HKD 88.00 and a target price of HKD 107 [4]. - The company has a market capitalization of RMB 65.35 billion and a price-to-book ratio of 10.99 [4]. Product Portfolio - The revenue breakdown shows that 87% comes from drug sales, 12% from licensed products, and 1% from R&D income [5]. Financial Projections - The company is projected to achieve net profits of RMB 373 million, RMB 1.43 billion, and RMB 2.40 billion for the years 2025, 2026, and 2027 respectively, with year-over-year growth rates of 282% and 68.4% [9]. - The earnings per share (EPS) are expected to be RMB 0.22, RMB 0.84, and RMB 1.41 for the same years [9]. Market Position and Competitive Advantage - The company is recognized for its innovative drug pipeline, particularly in immune-oncology (IO) and antibody-drug conjugates (ADC), with promising clinical results for its PD-1/IL-2 dual-target drug [7]. - The recent launch of the weight-loss drug, Ma Shidu Peptide, is expected to significantly contribute to revenue growth, showing a weight loss of 18.6% over 48 weeks, outperforming existing competitors [7].