创新生物药研发
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第一上海:予康方生物-B“买入”评级 目标价为144.9港元
Xin Lang Cai Jing· 2025-12-15 08:50
第一上海发布研报称,康方生物-B(09926)在核心产品管线方面取得多项进展。卡度尼利已获批宫颈 癌和胃癌适应症并纳入医保,多个新适应症进入III期临床;依沃西在非小细胞肺癌领域数据积极,海外 上市申请推进中;派安普利单抗成功获得FDA批准上市。此外,多款产品纳入医保或处于临床后期阶 段。以DCF估值法,得出目标价144.9港元,较现价有23.4%上升空间,买入评级。 第一上海主要观点如下: 财务表现 2025年上半年,康方生物产品收入同比增长49.2%至14.0亿元,加上许可费收入,公司录得总收入14.1 亿元,毛利率为79.4%,研发开支增长23.0%至7.3亿元。2025年8月底,公司以每股149.54港元的价格配 售23.55亿股,获得净融资额34.93亿港元,预计配售后公司在手净现金为58亿元。 产品管线进展 (1)卡度尼利AK104(PD-1/CTLA-4):已获批用于1-3线宫颈癌和一线胃癌,并纳入医保;PD-(L) 1进展后胃癌、肝细胞癌术后辅助治疗、中晚期不可切除肝细胞癌、一线PD-L1表达阴性非小细胞肺癌 和同步/序贯放化疗后非小细胞肺癌处于III期临床阶段。其中,IO耐药鳞状非小细胞肺癌 ...
第一上海:予康方生物-B(09926)“买入”评级 目标价为144.9港元
智通财经网· 2025-12-15 08:18
(3)派安普利单抗AK105(PD-1):2025年4月,FDA批准其用于一线和二线鼻咽癌治疗,这是公司 第一个全程独立主导且成功获得FDA批准上市的创新生物药,标志着公司创新药研发实力与药品生产质 量管理保障体系获得国际最高标准的权威认证。 智通财经APP获悉,第一上海发布研报称,康方生物-B(09926)在核心产品管线方面取得多项进展。卡度 尼利已获批宫颈癌和胃癌适应症并纳入医保,多个新适应症进入III期临床;依沃西在非小细胞肺癌领域 数据积极,海外上市申请推进中;派安普利单抗成功获得FDA批准上市。此外,多款产品纳入医保或处 于临床后期阶段。以DCF估值法,得出目标价144.9港元,较现价有23.4%上升空间,买入评级。 (4)伊努西单抗AK102(PCSK)和依若奇单抗AK101(IL-12/IL-23)纳入2026年医保。 第一上海主要观点如下: (5)古莫奇单抗AK111(IL-17):用于中重度银屑病的上市申请已于2025年1月获受理。 财务表现 2025年上半年,康方生物产品收入同比增长49.2%至14.0亿元,加上许可费收入,公司录得总收入14.1 亿元,毛利率为79.4%,研发开支增长23 ...
博裕资本再出手!增持复宏汉霖(02696.HK)背后的价值逻辑
Ge Long Hui· 2025-11-13 01:00
Core Viewpoint - Boyu Capital has increased its stake in Shanghai Henlius Biotech, Inc. by purchasing 262,500 and 80,000 H-shares, raising its holding from 5.84% to 7% [1][2]. Group 1: Investment Activity - Boyu Capital previously invested HKD 21.27 million to increase its stake from 4.89% to 5.15% on June 18, 2023, crossing the 5% threshold [2]. - The recent purchases reflect Boyu Capital's confidence in the core value and sustainable development potential of Shanghai Henlius in the innovative biopharmaceutical sector [2][3]. Group 2: Product Development and Clinical Progress - Shanghai Henlius has a robust pipeline with key products such as the anti-PD-1 monoclonal antibody Hansizhuang and the PD-L1 ADC HLX43, which have received international recognition for their clinical value [2][3]. - Recent data presented at the "2025 International Lung Cancer Frontier and Innovation Forum" confirmed the efficacy of HLX43 and HLX07, further enhancing market confidence in the company's R&D capabilities [3][5]. Group 3: Commercialization and International Collaboration - The company has established a diverse product matrix and has received global approvals for nine products, with four applications accepted by regulatory agencies in China, the US, and Europe [5]. - Shanghai Henlius has formed commercial partnerships with over 20 international pharmaceutical companies, covering major markets in Europe and the US, which supports its revenue growth [6]. - The company reported a significant increase in overseas product profits, with a 280% year-on-year growth in cash flow from BD contracts, indicating strong future revenue potential [6]. Group 4: Industry Outlook - As the biopharmaceutical industry enters a phase of high-quality development, companies with strong R&D capabilities and mature commercialization systems will become increasingly competitive [8]. - The continuous investment by top-tier capital like Boyu Capital serves as a testament to the intrinsic value demonstrated by Shanghai Henlius through solid clinical data [8].
百利天恒于11月7日至11月12日招股 预计11月17日上市
Xin Lang Cai Jing· 2025-11-07 01:00
Group 1 - The company, Baili Tianheng, plans to conduct an initial public offering (IPO) from November 7 to November 12, 2025, with a global offering of 8.6343 million shares, where 10% is allocated for Hong Kong and 90% for international sales, with an additional 15% over-allotment option [1] - The expected share price range is between 347.5 and 389 HKD per share, with trading anticipated to commence on November 17, 2025 [1] - The company operates as a comprehensive medical enterprise group with capabilities in early-stage research, clinical development, production, and commercialization, focusing on innovative biopharmaceuticals and generic medicines, including traditional Chinese medicine [1] Group 2 - Ten years ago, the company established SystImmune in Seattle, USA, and began developing iza-bren (BL-B01D1), the world's first and only EGFR×HER3 bispecific antibody ADC to enter Phase III clinical development [2] - Recently, the company entered into a global strategic licensing and collaboration agreement with BMS for iza-bren, valued at 8.4 billion USD, with an upfront payment of 800 million USD, marking the largest single asset transaction in the ADC field to date [2] - Over the past decade, the company has built an innovative ADC drug development platform, successfully developing 10 ADC candidates that have entered clinical stages, conducting approximately 70 clinical studies, including 16 key registration trials in China and 3 global key registration trials [2]
百利天恒预计11月17日上市 引入富国基金等多家基石
Ge Long Hui· 2025-11-06 23:22
Core Viewpoint - The company is planning a global offering of 8.6343 million H-shares, with a price range of HKD 347.50 to HKD 389.00 per share, and aims to raise approximately HKD 3.0175 billion from the offering [1][3]. Group 1: Company Overview - The company is a comprehensive medical enterprise group with capabilities in early research and development, clinical development, production, and commercialization [2]. - It operates two main businesses: innovative biopharmaceuticals and generic drugs, including traditional Chinese medicine [2]. Group 2: Product Development - The company established SystImmune in Seattle in 2014, developing the world's first and only EGFR×HER3 bispecific antibody ADC, iza-bren (BL-B01D1), which is currently in Phase III clinical trials [2]. - Over the past decade, the company has developed a platform for innovative ADC drug research, successfully advancing 10 ADC candidates into clinical stages and conducting approximately 70 clinical studies [2]. Group 3: Strategic Partnerships - The company has entered into a global strategic licensing and collaboration agreement with BMS, valued at USD 8.4 billion, with an upfront payment of USD 800 million, marking the largest single asset transaction in the ADC field to date [2]. Group 4: Use of Proceeds - The net proceeds from the global offering are intended for various purposes: approximately 60% for R&D of biopharmaceutical candidates outside mainland China, 30% for establishing a global supply chain, and 10% for working capital and general corporate purposes [3].
百利天恒(02615.HK)预计11月17日上市 引入富国基金等多家基石
Xin Lang Cai Jing· 2025-11-06 23:21
Core Viewpoint - The company is planning a global offering of 8.6343 million H-shares, with a price range of HKD 347.50 to HKD 389.00 per share, and aims to raise approximately HKD 3.0175 billion from the offering [1][3]. Group 1: Company Overview - The company is a comprehensive medical enterprise group with capabilities in early research, clinical development, production, and commercialization [2]. - It operates two main businesses: innovative biopharmaceuticals and generic drugs, including traditional Chinese medicine [2]. Group 2: Key Developments - The company established SystImmune in Seattle in 2014, developing the world's first and only EGFR×HER3 bispecific antibody ADC, iza-bren, which is currently in Phase III clinical trials [2]. - A significant global strategic licensing and collaboration deal was reached with BMS for iza-bren, totaling USD 8.4 billion, with an upfront payment of USD 800 million, marking the largest single asset transaction in the ADC field to date [2]. Group 3: Clinical Research and Development - The company has developed an innovative ADC drug research platform, successfully advancing 10 ADC candidates into clinical stages and conducting approximately 70 clinical studies, including 16 key registration trials in China [2]. - It has also developed a multispecific T-cell engager platform, with four GNC innovative multispecific antibody drug pipelines entering clinical stages and 15 clinical studies ongoing [2]. - The company has an innovative ARC drug research platform, with an IND-approved innovative ARC candidate drug, BL-ARC001 [2]. Group 4: Investment and Fund Allocation - The company has entered into cornerstone investment agreements, with cornerstone investors agreeing to subscribe for shares totaling approximately USD 32 million or about HKD 248.6 million [3]. - Assuming a mid-range offering price of HKD 368.25 per share, cornerstone investors will subscribe for approximately 674,700 shares [3]. - The net proceeds from the global offering are intended for various uses: approximately 60% for R&D of candidate biopharmaceuticals outside China, 30% for establishing a global supply chain, and 10% for working capital and general corporate purposes [3].
百利天恒(02615)11月7日至11月12日招股 预计11月17日上市
智通财经网· 2025-11-06 22:57
Core Viewpoint - The company, Baili Tianheng, is set to launch an IPO from November 7 to November 12, 2025, aiming to issue 8.6343 million shares at a price range of HKD 347.5 to HKD 389 per share, with a significant portion allocated for international investors [1] Group 1: Business Overview - The company operates as a comprehensive medical enterprise with capabilities in early research, clinical development, production, and commercialization, focusing on innovative biopharmaceuticals and generic medicines [1] - The company has developed a unique dual-specific antibody ADC, iza-bren, which is the first of its kind to enter Phase III clinical trials, and has established a strategic partnership with BMS valued at USD 8.4 billion [2] - The company has built a robust pipeline of 10 ADC candidates and has conducted approximately 70 clinical studies, including key trials in China and globally [2] Group 2: Product Portfolio - The company has accumulated expertise in the generic and traditional Chinese medicine sectors, with a product portfolio covering anesthesia, parenteral nutrition, anti-infection, and pediatrics [3] - The revenue from over 100 specifications of 31 approved drugs, including 26 generic and 5 traditional Chinese medicine products, plays a crucial role in funding the development of innovative drugs [3] Group 3: Investment and Financials - The company has secured cornerstone investment agreements with several investors, committing to purchase shares worth approximately USD 32 million or about HKD 249 million [3] - The estimated net proceeds from the global offering, based on a median price of HKD 368.25 per share, are expected to be around HKD 3.018 billion, with allocations for R&D, supply chain establishment, and operational funding [4]
泰诺麦博融资10.87亿后拟再募15亿 三年多亏15.67亿仅一款产品商业化
Chang Jiang Shang Bao· 2025-08-11 07:52
Core Viewpoint - Zhuhai Tainuo Maibo Pharmaceutical Co., Ltd. (Tainuo Maibo) is attempting to go public on the STAR Market under the newly restarted fifth set of standards, despite not yet being profitable and only having one product approved for commercialization by 2025 [1][3][4]. Financial Performance - From 2022 to the first three months of 2025, Tainuo Maibo reported revenues of 4.34 million yuan, 0 yuan, 1.51 million yuan, and 0.1693 million yuan, with cumulative losses of 1.567 billion yuan [3][8]. - The company's R&D expenses totaled approximately 1.275 billion yuan over the same period, with specific annual figures of 323 million yuan, 393 million yuan, 425 million yuan, and 134 million yuan [3][6]. - Sales expenses amounted to 75.43 million yuan, with significant spending even in years with no revenue, such as over 12.42 million yuan in 2023 [6][7]. Product Development - Tainuo Maibo's only commercialized product, Staitouta Monoclonal Antibody Injection, was approved in February 2025 and generated only 16,930 yuan in sales within its first month [4][5]. Capital Raising and Financing - The company has raised at least 1.087 billion yuan through multiple rounds of financing over the past four years, including significant investments from notable firms like Hillhouse and Gree [8][9][11]. - Tainuo Maibo plans to raise up to 1.5 billion yuan through its IPO, with funds allocated for new drug development, expansion of antibody production facilities, and working capital [8][11]. Shareholder Structure - Prior to the IPO, Tainuo Maibo had 49 shareholders, with no single controlling shareholder, and the actual controllers hold a combined 33.10% of the shares [9][11].
天境生物上涨10.29%,报4.125美元/股,总市值4.74亿美元
Jin Rong Jie· 2025-08-07 14:28
Core Viewpoint - Tianjing Bio (IMAB) has shown significant stock performance and financial growth, indicating potential investment opportunities in the innovative biopharmaceutical sector focused on oncology and autoimmune diseases [1]. Financial Performance - As of December 31, 2023, Tianjing Bio reported total revenue of 27.644 million RMB, representing a year-on-year increase of 112.48% [1]. - The company recorded a net profit attributable to shareholders of -1.466 billion RMB, which is a year-on-year increase of 41.54% [1]. Upcoming Events - Tianjing Bio is scheduled to disclose its fiscal year 2024 mid-term report on August 28, 2023, before the market opens in the Eastern US [1]. Company Overview - Tianjing Bio is an offshore holding company that operates through its domestic subsidiary, focusing on the development of innovative biopharmaceuticals with "first-in-class" and "best-in-class" potential in the global market [1]. - The company's mission is to develop groundbreaking innovative biopharmaceuticals to address unmet clinical needs and improve the quality of life for patients worldwide [1].
科创板第五套标准重启后首家,泰诺麦博IPO获受理
3 6 Ke· 2025-08-01 07:33
Core Viewpoint - Zhuhai Tainuo Maibo Pharmaceutical Co., Ltd. has been accepted for IPO on the Sci-Tech Innovation Board, marking it as the first company to be accepted under the newly restarted fifth listing standard [1][10] Company Overview - Established in 2015, Tainuo Maibo focuses on the research, production, and sales of fully human monoclonal antibody drugs [2][3] - The company utilizes its proprietary high-throughput fully human monoclonal antibody research platform, HitmAb®, to develop safer and more effective antibody drugs [2] Key Products - The core product, Staitouta Monoclonal Antibody Injection, is the first-in-class recombinant monoclonal antibody drug for tetanus toxin, approved for sale in China in February 2025 [2][4] - Another key product, TNM001, is a long-acting monoclonal antibody for RSV prevention, currently undergoing Phase III clinical trials [2][4] Financial Performance - Tainuo Maibo has not yet achieved profitability, thus opting for the fifth listing standard, which requires a projected market value of no less than RMB 4 billion [3] - The company reported a revenue of RMB 16.93 million from drug sales in Q1 2025, following the launch of its core product [4][5] Research and Development - R&D expenditures from 2022 to Q1 2025 were RMB 323 million, RMB 393 million, RMB 425 million, and RMB 134 million, with a compound annual growth rate of 14.80% [6][7] - The company plans to accelerate the commercialization of its products and expand its pipeline, including advancing clinical trials for TNM009, TNM005, TNM006, and TNM035 [8] Shareholding Structure - Tainuo Maibo has no controlling shareholder, with actual control held by Huaxin Liao and Zheng Weihong, who collectively control 33.10% of the company [9][10] - The company has attracted investments from various institutional and foreign shareholders, including Zhuhai Hillhouse and several state-owned enterprises [10]