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亚盛医药加速,下一个重磅炸弹产品蓄势引爆
Xin Lang Cai Jing· 2025-08-25 06:58
Core Insights - The company achieved a revenue of 234 million RMB in the first half of 2025, with sales of its core product, Nairike® (Orebatinib), reaching 217 million RMB, a year-on-year increase of 93% due to its inclusion in the national medical insurance catalog [1][3] - The company has a strong cash position with over 3 billion RMB in total cash, indicating improved cash flow [1][10] - The approval of the core product, Lishengtuo® (APG-2575), by the National Medical Products Administration (NMPA) in July 2025 marks a significant milestone, entering a dual-engine growth phase for the company [1][5] Product Development and Clinical Trials - Lishengtuo® has received global registration for a Phase III clinical trial for treating high-risk MDS patients, approved by both the FDA and EMA, which is a significant step in accelerating its market entry [2][8] - Nairike® has been recognized in updated clinical guidelines, enhancing its clinical value and potential, particularly in treating pediatric patients with Ph+ ALL [4][7] - The company is advancing multiple Phase III clinical trials globally, with nine ongoing studies, three of which have received FDA approval [7][10] Commercialization Strategy - The commercialization of Nairike® has accelerated, with a 90% quarter-on-quarter growth in sales, reflecting strong clinical demand and increased accessibility due to insurance coverage [3][10] - The company has established partnerships with major pharmaceutical distributors to enhance the commercialization of Lishengtuo®, achieving rapid prescription issuance across multiple cities and hospitals [5][10] - The successful launch of Lishengtuo® positions the company to maximize product synergies and strengthen its commercialization framework [5][10] Market Potential - Lishengtuo® is positioned to fill a significant market gap as the only Bcl-2 inhibitor advancing in the high-risk MDS space, with the potential to become the first approved treatment in this category globally [8][9] - The failure of a competitor's Bcl-2 inhibitor in clinical trials enhances Lishengtuo®'s market prospects, potentially leading to a dominant position in a multi-billion dollar market [9][10] - The company is exploring Lishengtuo®'s potential in various hematological malignancies, with ongoing global Phase III trials in multiple indications [10]
亚盛医药-B(06855.HK):耐立克放量迅速 利生妥再加码差异化布局
Ge Long Hui· 2025-08-25 03:50
Core Viewpoint - The company's 1H25 performance aligns with expectations, showing significant revenue decline due to prior year licensing income, but new product approvals are expected to drive future growth [1][2]. Financial Performance - 1H25 revenue was 234 million yuan, a year-on-year decrease of 71.6%, primarily due to last year's licensing income [1]. - The net profit attributable to the parent company was a loss of 591 million yuan in 1H25 [1]. Development Trends - The entry of the new indication for Nairike into medical insurance has led to rapid growth in commercial revenue, with Nairike (Orebatin) generating 217 million yuan in 1H25, a year-on-year increase of 93% [1]. - The approval of Lisengsu (Lishazhuokela) for market launch is expected to contribute to new growth, being the first Bcl-2 inhibitor approved for CLL/SLL in China [1]. R&D Progress - The global Phase III clinical trial GLORA-4 for Lisengsu in combination with Azacitidine has received approval from both the FDA and EMA, marking it as the only Bcl-2 inhibitor advancing in this area [2]. - Data from the 2025 ASCO indicated an overall response rate (ORR) of 75% for Lisengsu combined with Azacitidine in treating newly diagnosed MDS, highlighting a significant unmet need in this patient population [2]. Profit Forecast and Valuation - The company maintains its profit loss forecast for 2025 and 2026 at 1.09 billion HKD and 304 million HKD, respectively [2]. - The target price has been raised by 19.3% to 105 HKD, indicating a potential upside of 15.8% from the current stock price [2].
中金:维持亚盛医药-B跑赢行业评级 升目标价至105港元
Zhi Tong Cai Jing· 2025-08-25 02:50
Core Viewpoint - CICC maintains the profit forecast for Ascentage Pharma-B (06855) for 2025 and 2026, reiterating an outperform rating, and raises the target price by 19.3% to HKD 105, indicating a 15.8% upside from the current stock price [1] Group 1 - The new indication for Olverembatin (耐立克) entering the medical insurance system has led to rapid growth in commercial revenue in the first half of the year, with a 93% year-on-year increase to CNY 217 million [2] - The approval of Lisavanbulin (利生妥) for marketing in China is expected to contribute to new growth, as it becomes the first Bcl-2 inhibitor approved for CLL/SLL patients who have received prior systemic therapy [2] - The global Phase III clinical trial GLORA-4 for Lisavanbulin in combination with Azacitidine has received approval from both the FDA and EMA, marking it as the only Bcl-2 inhibitor advancing in this indication [3] Group 2 - Future research and development progress to monitor includes the FDA registration trial POLARIS-2 for Olverembatin, the registration trial for Ph+ALL, and the GLORA clinical trials for Lisavanbulin in CLL/SLL and MDS [4]
中金:维持亚盛医药-B(06855)跑赢行业评级 升目标价至105港元
智通财经网· 2025-08-25 02:50
Core Viewpoint - CICC maintains the profit forecast for Ascentage Pharma-B (06855) for 2025/2026 and upgrades the target price by 19.3% to HKD 105, indicating a potential upside of 15.8% from the current stock price, driven by the progress of GLORA-4 and increased visibility in new indications [1] Group 1 - The commercial revenue of Nilotinib (Orelabrutinib) saw a significant increase of 93% year-on-year, reaching RMB 217 million in 1H25, attributed to its new indications being included in the medical insurance [2] - The approval of Lisavanbulin (Lisavan) for the treatment of CLL/SLL patients is expected to provide a new growth point for the company, as it becomes the first Bcl-2 inhibitor approved for CLL/SLL in China [2] Group 2 - The global Phase III registration trial GLORA-4 for Lisavanbulin in combination with Azacitidine has received approval from both the FDA and EMA, marking it as the only Bcl-2 inhibitor advancing in this indication [3] - The overall response rate (ORR) for Lisavanbulin combined with Azacitidine in treating newly diagnosed MDS patients reached 75%, indicating a strong safety profile and significant unmet needs in this patient population [3] Group 3 - Future research and development progress to monitor includes the FDA registration trial POLARIS-2 for Orelabrutinib, the registration trial progress for Ph+ ALL, and the GLORA and GLORA-4 studies for Lisavanbulin in the U.S. [4]
亚盛医药-B(06855.HK):药品商业化符合预期 临床推进潜力倍增
Ge Long Hui· 2025-08-23 11:49
Core Viewpoint - The company is experiencing significant growth in its core product, Orebacitinib, despite a decline in overall revenue due to previous collaborations and licensing income. The commercial team is effectively expanding patient access and driving sales growth [1][2]. Group 1: Financial Performance - In H1 2025, the company's main operating revenue was 234 million yuan, a year-on-year decrease of 71.6%, primarily due to 678 million yuan in licensing income recorded in the same period of 2024 [1]. - The gross margin for H1 2025 was approximately 91% [1]. - Sales revenue from Orebacitinib increased significantly by 92.4% year-on-year to 217 million yuan [1]. - Sales expenses rose by 53.7% to 138 million yuan, while R&D expenses increased by 19% to 529 million yuan [1]. Group 2: Product Development and Commercialization - Orebacitinib's sales growth is expected to double by the end of the year, with a 93% increase in H1 2025 aligning with expectations [1]. - The company has expanded its commercial team, with a 47% increase in patient admissions in H1 2025, and all approved indications are now covered by insurance [1]. - The company is advancing multiple global clinical trials for Orebacitinib, including treatments for CML and Ph+ALL [1]. - On July 10, 2025, the company received conditional approval for Lisatoclax for CLL/SLL patients, with the first prescription already issued [2]. - The company has built its domestic commercialization team, which has grown to over 140 people as of July 31, 2025, and is expected to exceed 200 by the end of the year [2]. Group 3: Leadership and Cash Reserves - The company appointed Dr. Veet Misra as CFO and Mr. Huang Zhi as Senior Vice President of Global Corporate Development & Finance, enhancing leadership in global development [3]. - Cash reserves reached 1.661 billion yuan in H1 2025, and after a 1.5 billion yuan placement in Hong Kong, total cash reserves exceeded 3 billion yuan, sufficient to support ongoing core pipeline development [3]. Group 4: Revenue Forecast - The company anticipates rapid revenue growth driven by Orebacitinib and Lisatoclax sales, revising revenue forecasts for 2025-2027 to 586 million, 3.266 billion, and 2.121 billion yuan respectively [3].
创新药股市狂欢 谁在“囤粮”谁在套现
经济观察报· 2025-08-22 10:59
Core Viewpoint - The Hong Kong innovative pharmaceutical sector has seen a significant increase in refinancing activities in 2025, with over 20 companies participating, raising more than 34 billion HKD, which is substantially higher than the same period last year [1][2]. Group 1: Financing Activities - As of August 20, 2025, Hansoh Pharmaceutical announced a plan to raise 3.9 billion HKD through a rights issue, marking its third refinancing since listing [2]. - The total refinancing amount for Hong Kong innovative pharmaceutical companies has exceeded 34 billion HKD, with some companies conducting multiple rounds of refinancing [2][5]. - WuXi AppTec has raised the highest amount in this refinancing wave, securing nearly 7.7 billion HKD through a placement of new shares [7]. Group 2: Comparison with A-Shares - In contrast, only two A-share innovative pharmaceutical companies have been approved for refinancing this year: Dizal Pharmaceutical raised approximately 1.8 billion HKD in April, and Baillie Tianheng's 3.9 billion HKD plan was approved in early August [5]. Group 3: Shareholder Actions - Some founders and major shareholders of innovative pharmaceutical companies are taking the opportunity to reduce their holdings and cash out [6][13]. - Notable reductions include the founders of BeiGene, who have sold shares worth over 70 million USD in the U.S. market since the beginning of the year [13]. - Temasek, the largest shareholder of Innovent Biologics, has reduced its stake three times, cashing out over 2.4 billion HKD [14]. Group 4: Innovative Financing Methods - Several companies are utilizing "old-for-new" financing methods, where founders sell their old shares to new investors and use the cash to subscribe to newly issued shares, making it more attractive for investors [9][10]. - For instance, Ascentage Pharma raised 1.5 billion HKD through this method, coinciding with the approval of its second drug [10]. Group 5: Market Trends - The innovative pharmaceutical sector has experienced a surge in stock prices, with many companies actively seeking financing to support future growth [13]. - Innovent Biologics has seen its stock price increase by over 2.5 times since the beginning of the year, while WuXi AppTec's stock price is close to its historical high [14].
亚盛医药-B(06855):公司产品销售增长强劲,研发进展推进顺利
Haitong Securities International· 2025-08-22 08:06
Investment Rating - The report maintains an "Outperform" rating for Ascentage Pharma with a target price of HKD 90.70, reflecting a potential upside from the current price of HKD 90.20 [2][24]. Core Insights - Ascentage Pharma reported strong product sales growth, with revenue from product sales reaching RMB 213 million, a 70.5% increase year-on-year, driven by a 93% increase in sales of Olverembatinib [3][15][17]. - The company achieved a gross profit of RMB 212 million with a gross margin of 90.7%, indicating improved operational efficiency [3][15]. - R&D expenses increased by 19% year-on-year to RMB 529 million, reflecting ongoing global clinical trials and the company's commitment to advancing its pipeline [3][18]. Financial Performance - For the first half of 2025, total revenue was RMB 234 million, down 71.6% year-on-year, primarily due to a one-off intellectual property income from Takeda in the previous year [3][15]. - The company recorded a net loss of RMB 591 million during the same period, with cash reserves totaling approximately RMB 3.15 billion [3][15][18]. - The report projects revenues for FY25, FY26, and FY27 to be RMB 730 million, RMB 3.16 billion, and RMB 3.02 billion, respectively, with corresponding net profits of RMB -1.09 billion, RMB 1.39 billion, and RMB 990 million [9][21]. R&D Progress - The approval of Lisaftoclax® for treating CLL/SLL patients was a significant milestone, and the initiation of the GLORA-4 Phase III trial for higher-risk MDS patients is expected to accelerate the drug's market entry [4][16][20]. - Efficacy data presented at the 2025 ASCO meeting showed promising results for Lisaftoclax® in MDS and CMML patients, with an overall response rate of 80% in newly diagnosed patients [20][21]. Market Dynamics - The report highlights the significant unmet medical need in the MDS treatment landscape, particularly for higher-risk patients, where current therapies have limited efficacy [19][20]. - The combination of National Reimbursement Drug List coverage and expanded hospital access has driven sales growth for Olverembatinib, with a 114% increase in sales volume [17][18].
创新药股市狂欢 谁在“囤粮”谁在套现
Jing Ji Guan Cha Wang· 2025-08-22 06:53
Core Viewpoint - Hansoh Pharmaceutical plans to raise HKD 3.9 billion through a placement, marking its third refinancing since its listing, with its stock price currently at approximately 80% of its historical high [2] Group 1: Financing Activities - Since the beginning of 2025, over 20 innovative pharmaceutical companies listed in Hong Kong have engaged in refinancing, significantly surpassing the same period last year, with total refinancing exceeding HKD 34 billion [2][4] - WuXi AppTec raised nearly HKD 7.7 billion through a share placement, making it the highest fundraising company in this round of refinancing [5] - Innovent Biologics raised approximately HKD 4.3 billion through the placement of 55 million new shares, with 90% of the funds allocated for global R&D and facility layout [5] Group 2: Stock Performance and Market Trends - The stock prices of many innovative pharmaceutical companies have doubled since the beginning of the year, indicating a market recovery [2] - Innovent Biologics' stock price has increased over 2.5 times since the start of the year, reflecting strong market interest [10] Group 3: Shareholder Actions - Some founders and major shareholders are taking the opportunity to reduce their holdings and cash out, despite the ongoing fundraising activities [4][10] - Notable reductions include Temasek's divestment of over HKD 2.4 billion from Innovent Biologics and significant sales by other major shareholders in various companies [10][11] Group 4: Alternative Financing Methods - Several companies are utilizing "old-for-new" financing methods, where founders sell their old shares to new investors and use the cash to subscribe to new shares, making it more attractive for investors [7][8] - Companies like Aisheng Pharmaceutical and others have successfully raised funds through this method, indicating a trend in the market [8]
亚盛医药-B(06855):药品商业化符合预期,临床推进潜力倍增
Soochow Securities· 2025-08-22 01:28
Investment Rating - The investment rating for the company is "Buy" (maintained) [1] Core Views - The company's drug commercialization is in line with expectations, and the potential for clinical advancement has significantly increased [1] - The core product, Orebate, has shown impressive sales growth, with a year-on-year increase of 92.4% to 217 million yuan in the first half of 2025, and is expected to double by the end of the year [7] - The company has successfully launched another product, Lisatoclax, which received conditional approval for marketing, indicating strong commercialization progress [7] - The company has a robust cash reserve of over 3 billion yuan, sufficient to support ongoing pipeline development [7] - Revenue forecasts for 2025-2027 have been revised upwards due to the anticipated sales growth of Orebate and Lisatoclax [7] Financial Summary - Total revenue for 2023 is projected at 225.09 million yuan, with significant growth expected in subsequent years, reaching 3,265.89 million yuan by 2026 [1] - The net profit for 2023 is expected to be a loss of 925.64 million yuan, with a forecasted recovery to a profit of 1,058.67 million yuan by 2026 [1] - The earnings per share (EPS) is projected to improve from a loss of 2.49 yuan in 2023 to a profit of 2.85 yuan in 2026 [1] - The company’s cash and cash equivalents are expected to reach 1,105.83 million yuan by 2025, supporting its operational needs [8]
亚盛医药:核心产品耐立克上半年收入同比增长93%
Zhong Zheng Wang· 2025-08-21 11:27
Group 1 - The company reported a revenue of 234 million yuan for the first half of 2025, with its core product, Nairike, generating sales of 217 million yuan, representing a 93% year-on-year increase, primarily due to all approved indications being included in medical insurance [1] - The company has over 3 billion yuan in cash, indicating improved cash flow and strong liquidity [1] - The company’s other core product, Lisengmo, was approved for market launch by the National Medical Products Administration (NMPA) in July 2025, marking the beginning of a dual-engine growth phase for the company [1] Group 2 - Lisengmo, in combination with Azacitidine (AZA), received approval to conduct a global Phase III clinical trial (GLORA-4) from both the FDA and EMA, which is currently underway with patient enrollment [2] - The GLORA-4 study has already completed the first patient enrollment in China and Europe, facilitating the clinical development and registration process for Lisengmo in myelodysplastic syndromes (MDS) [2] Group 3 - The company has signed cooperation agreements with major pharmaceutical distribution companies to advance the commercialization of Lisengmo, achieving rapid product rollout in over 30 cities and 40 hospitals within 15 days of approval [1] - The company is accelerating the global clinical development of its pipeline products, with nine Phase III clinical studies progressing steadily, three of which have received FDA approval [1]