研究员：刘雅馨/张琎/朱言音 利生妥+阿扎胞苷髓系肿瘤数据更新，有望带来新的空间。本次ASH披露的APG2575AU101 研究数据表 明，利生妥+阿扎胞苷在47 例R/R AML/MPAL患者中ORR为40.4%，CR29.8%，mPFS7.6 个月；在15 例 初治高危MDS/CMML患者中ORR 80.0%，CR和骨髓CR各40%，mPFS未达到。 盈利预测与估值 机构：中金公司 公司近况 近日，公司公告：1）耐立克（奥雷巴替尼）1L治疗Ph+ ALL的全球注册III期研究POLARIS-1 获得美国 FDA和欧洲EMA批准开展；2）公司在12 月召开的2025 美国血液学会（ASH）年会上读出3 个品种的多 个数据，包括利生妥（APG-2575）的国内II期注册临床数据口头报告，以及耐立克POLARIS-1 数据的 首次读出等。 评论 POLARIS-1 成为欧美批准的第二个耐立克的全球注册III期研究，初步数据亮眼。本次ASH披露的 POLARIS-1 数据表明，截至2025 年7 月18 日，耐立克联合低强度化疗在53 例1L Ph+ ALL患者中， 94.3%在3 个月内实现了CR/CRi，最佳 ...

POLARIS-1成为欧美批准的第二个耐立克的全球注册III期研究，初步数据亮眼 本次ASH披露的POLARIS-1数据表明，截至2025年7月18日，耐立克联合低强度化疗在53例1L Ph+ALL 患者中，94.3%在3个月内实现了CR/CRi，最佳MRD阴性率和MRD阴性CR率分别为66.0%和64.2%。该 行认为耐立克作为公司第一款商业化的产品，适应症稳步拓展，数据读出亮眼，若武田行权则可能形成 重要催化，建议持续关注。 中金发布研报称，维持亚盛医药-B(06855)"跑赢行业"评级与目标价89港元，公司近期研发进展积极。 耐立克(奥雷巴替尼)一线治疗Ph+ALL的全球III期研究(POLARIS-1)已获欧美药监机构批准开展，并公布 亮眼初步数据；利生妥(APG-2575)针对高危基线人群亦显示出良好疗效与安全性，整体研发管线持续兑 现，国际化稳步推进。 中金主要观点如下： 公司近况 1)耐立克(奥雷巴替尼)1L治疗Ph+ALL的全球注册III期研究POLARIS-1获得美国FDA和欧洲EMA批准开 展;2)公司在12月召开的2025美国血液学会(ASH)年会上读出3个品种的多个数据，包括利生妥(A ...

智通财经APP获悉，中金发布研报称，维持亚盛医药-B(06855)"跑赢行业"评级与目标价89港元，公司近 期研发进展积极。耐立克(奥雷巴替尼)一线治疗Ph+ ALL的全球III期研究(POLARIS-1)已获欧美药监机 构批准开展，并公布亮眼初步数据；利生妥(APG-2575)针对高危基线人群亦显示出良好疗效与安全性， 整体研发管线持续兑现，国际化稳步推进。 中金主要观点如下： 公司近况 1)耐立克(奥雷巴替尼)1L治疗Ph+ ALL的全球注册III期研究POLARIS-1获得美国FDA和欧洲EMA批准开 展;2)公司在12月召开的2025 美国血液学会(ASH)年会上读出3个品种的多个数据，包括利生妥(APG- 2575)的国内II期注册临床数据口头报告，以及耐立克POLARIS-1数据的首次读出等。 风险提示 研发失败，商业化不及预期，竞争格局恶化，对外合作进展不及预期。 本次ASH披露的POLARIS-1数据表明，截至2025年7月18日，耐立克联合低强度化疗在53例1L Ph+ ALL 患者中，94.3%在3个月内实现了CR/CRi，最佳MRD阴性率和MRD阴性CR率分别为66.0%和64.2%。该 ...

Core Viewpoint - The announcement highlights the approval of the global Phase III clinical trial (POLARIS-1) for the novel drug Orebatin (brand name: Nairike) in treating newly diagnosed Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL) patients, which is expected to accelerate its market entry in Europe and the US [1][2]. Group 1: Clinical Trial Details - POLARIS-1 is an international, multicenter, randomized, open-label Phase III clinical trial aimed at evaluating the efficacy and safety of Nairike in combination with chemotherapy for newly diagnosed Ph+ ALL patients [1]. - The trial has received clinical trial approval from China's CDE in 2023 and has been rapidly initiated [1]. Group 2: Efficacy and Safety Data - Preliminary data from the POLARIS-1 study indicates that the molecular minimal residual disease (MRD) negative rate and complete response (CR) rate for patients treated with Nairike and low-intensity chemotherapy are approximately 65%, significantly higher than similar products under comparable conditions [2]. - The safety profile of the combination treatment is favorable, with a low and manageable incidence of adverse effects [2]. Group 3: Market Context and Product Background - Ph+ ALL accounts for about 20%-30% of adult ALL cases, characterized by high relapse rates and poor prognosis, particularly in older patients [2]. - Nairike is a third-generation TKI and the first of its kind approved in China, with commercial promotion in China being jointly managed by the company and Innovent Biologics [3]. - The drug has received multiple indications for treatment in the CML resistant field and is included in the national medical insurance drug list [3].

Core Viewpoint - Yasheng Pharmaceutical has transformed from an undervalued entity to a highly sought-after player in the pharmaceutical sector within six months, with its stock price doubling and a significant increase in sales of its core product, Nairike, by over 90% [1] Financial Performance - In the first half of 2025, Yasheng Pharmaceutical reported total revenue of RMB 234 million, a year-on-year decline of 71.6%, primarily due to a high base from significant overseas licensing milestone payments in H1 2024 [2] - Excluding one-time revenues, Nairike's sales reached RMB 217 million, reflecting a 93% year-on-year growth, driven by the inclusion of all approved indications in the national medical insurance catalog [2] - As of June 30, 2025, the company's cash and bank deposits amounted to RMB 1.661 billion, a 31.7% increase, largely due to approximately RMB 970 million raised from its IPO in the U.S. [2] Core Product Driving Growth - Nairike, Yasheng's first commercialized product, is the first third-generation BCR-ABL inhibitor approved in China, targeting patients with TKI resistance and T315I mutations [3] - Since January 2025, all approved indications for Nairike have been included in the national medical insurance drug list, with an annual reimbursement standard of RMB 174,500, enhancing patient affordability and accessibility [3] - By June 30, 2025, Nairike's sales in China increased from RMB 113 million in the previous year to RMB 217 million, with the number of hospitals carrying the product rising by 47% [3] Dual-Engine Commercialization Strategy - On July 10, 2025, Yasheng's second core product, Lishengtuo, was approved for the treatment of adult patients with chronic lymphocytic leukemia/small lymphocytic lymphoma [4] - Lishengtuo is the first domestically approved original Bcl-2 inhibitor in China and the second globally, indicating significant market potential [4] Rapid Commercialization of Lishengtuo - Following its approval, Yasheng quickly signed cooperation agreements with major pharmaceutical distribution companies to advance its commercialization efforts [5] - Within 15 days, the product was prescribed in over 40 hospitals across more than 30 cities, demonstrating swift market entry [6] Global R&D Pipeline - Yasheng is accelerating the global clinical development of its pipeline, with nine Phase III clinical studies underway, three of which have received FDA approval [7] - The Bcl-2 inhibitor APG-2575 is considered a promising candidate, targeting high-value indications such as CLL, AML, and MM [7] - Nairike has three global Phase III studies in progress, with one receiving FDA approval for use in Ph+ALL patients [7] Commercialization Strategy: From Single Product to Multi-curve Layout - Yasheng employs a hybrid model of "self-sales + cooperative licensing" to mitigate risks, optimizing its domestic coverage while sharing market and registration costs with partners abroad [9] - The company is diversifying its pipeline with IAP inhibitors and MDM2 inhibitors, aiming to reduce reliance on single products [10] - In the blood cancer sector, Yasheng aims to replicate the success of AbbVie's Venetoclax, which achieved significant sales through continuous indication expansion [11] Conclusion - The rapid growth of Nairike demonstrates a viable path for Yasheng in the commercialization of original domestic drugs, but future growth will depend on the clinical and registration pace of subsequent pipelines like APG-2575 and the effectiveness of its international expansion strategy [12]

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].

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]

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]

Core Insights - The core viewpoint of the article highlights the significant growth in sales of Ascentage Pharma's key product, Nairik (Orebatinib), which saw a 93% increase in revenue to RMB 217 million, driven by expanded coverage in the national medical insurance directory [1][3] - The company is transitioning from a research-focused biotech firm to a fully commercialized innovative pharmaceutical enterprise, with a strong emphasis on the commercialization of its innovative drugs [6][9] Financial Performance - As of June 30, the company reported cash and bank deposits of RMB 1.661 billion, a year-on-year increase of 31.7%, primarily due to net proceeds of RMB 970 million from its IPO in January 2025 [1] - The sales and distribution expenses increased by RMB 48.2 million, a 53.7% year-on-year rise to RMB 138 million, attributed to the commercialization of Nairik and preparations for the launch of another product, Lisengto [7] Product Development - Nairik is the first approved third-generation BCR-ABL inhibitor in China, with its sales revenue growing from RMB 113 million to RMB 217 million, following its inclusion in the national medical insurance directory [3][4] - Lisengto (Lisatrag) was approved for use in July 2025, becoming China's first domestically developed Bcl-2 inhibitor, which is expected to further enhance the company's product portfolio [4][6] Market Strategy - The company aims to balance high R&D investments with commercial output, with expectations of achieving breakeven by 2027 through the sales profits of its products [7] - The company has engaged in overseas licensing agreements, which have positively impacted cash flow and helped address short-term commercialization needs [8][9] Competitive Landscape - The company faces challenges in a competitive market, particularly in the context of similar products, but its innovative drugs have shown differentiated advantages in clinical data [5][6] - The ongoing support from national medical insurance for innovative products is expected to enhance market recognition for companies with strong commercialization capabilities [9]

Core Viewpoint - The stock price of Ascentage Pharma-B (06855) has reached a new high of HKD 95.35, marking a year-to-date increase of 100.88% [1][3] Group 1: Stock Performance and Market Context - Ascentage Pharma's stock performance reflects the current bull market for innovative drugs in Hong Kong, with significant room for further growth despite recent technical fluctuations [3] - The current bull market is driven more by the companies' fundamentals rather than policy changes, emphasizing "hardcore innovation, global monetization, and performance validation" as key investment criteria [3][4] Group 2: Financial Performance and Product Pipeline - Ascentage Pharma reported a revenue of RMB 234 million for the first half of 2025, with its core product, Olverembatinib (耐立克), generating sales of RMB 217 million, a year-on-year increase of approximately 93% [4] - The company has over RMB 3 billion in cash reserves, indicating strong cash flow and financial health [4] - The successful commercialization of Olverembatinib and the recent approval of the new drug, Lisatoclax (利生妥), are expected to replicate the success of Olverembatinib [4][5] Group 3: Clinical Development and Market Potential - Lisatoclax is the first domestically approved Bcl-2 inhibitor in China and has shown promising clinical data, indicating its potential in treating various hematological malignancies [5][6] - The global market for blood malignancy treatment drugs is projected to reach USD 40 billion by 2024, with a CAGR of 6% from 2024 to 2029, highlighting the unmet demand for Bcl-2 inhibitors [6] - Lisatoclax is expected to achieve sales exceeding USD 2 billion after global commercialization, alongside Olverembatinib, contributing significantly to Ascentage Pharma's revenue [6] Group 4: R&D and Innovation Strategy - Ascentage Pharma's R&D investment reached RMB 529 million in the first half of the year, supporting its innovative pipeline [7] - The company is advancing its research on Olverembatinib and Lisatoclax, with both drugs included in the 2025 Chinese Clinical Oncology Society guidelines [8] - Recent clinical trials for both drugs have shown promising results, further validating their therapeutic potential and safety [8] Group 5: Corporate Strategy and Management - The appointment of experienced executives is expected to enhance Ascentage Pharma's global commercialization efforts and financial management [9] - The company plans to raise approximately HKD 1.509 billion through a share placement to support commercialization and global clinical development [9] - The overall market sentiment is positive, with expectations of increased capital inflow into the pharmaceutical innovation sector due to favorable macroeconomic conditions [10]