公司项目推进 POLARIS-1研究：针对Ph+急性淋巴细胞白血病（Ph+ ALL）的全球III期临床试验，计划于2026年在欧 美同步启动患者入组，为2028年向FDA/EMA提交上市申请奠定基础。 POLARIS-2研究：用于三线及以上慢性髓细胞白血病（3L+ CML）的全球III期试验，预计2026年完成 入组，主要终点为6个月细胞遗传学反应（CCyR）和主要分子学反应（MMR），可能成为首个海外申 报的国产第三代BCR-ABL抑制剂。 经济观察网 亚盛医药（06855.HK / AAPG.OQ）在2026年有多项关键业务里程碑值得关注，主要涉及核 心产品商业化、全球临床进展及创新管线突破。以下事件基于公司公开披露及行业报道整理，时间节点 均指向2026年及以后。 业绩经营情况 利生妥（APG-2575）医保谈判：作为中国首个国产Bcl-2抑制剂，该产品计划在2026年参与国家医保目 录谈判，若成功纳入有望提升市场渗透率。 耐立克（奥雷巴替尼）放量：第三代BCR-ABL抑制剂耐立克在医保扩容后持续加速销售，公司目标覆 盖医院超1,500家，进一步扩大患者可及性。 GLORA-4（高危骨髓增生异常综合征M ...

Group 1 - The core viewpoint is that multiple institutions maintain a positive rating for Ascentage Pharma-B (06855.HK), with 100% of market opinions suggesting buy or hold positions [1] - CICC's report from December 2025 highlights that the global Phase III study POLARIS-1 for Olverembatin (耐立克) has received approval from both the FDA and EMA, and the clinical data for APG-2575 (利生妥) is impressive, maintaining a target price of HKD 89 [1] Group 2 - Over the past 7 days (as of February 20, 2026), Ascentage Pharma-B's stock price fluctuated, closing at HKD 47.46 on February 20, a slight decrease of 0.08% from HKD 46.68 on February 16, with a trading range of 4.55% [2] - During the same period, the US stock (AAPG.OQ) closed at USD 24.34, reflecting a cumulative increase of 2.18% [2] - Capital flow data indicates a net inflow of HKD 993,600 into the Hong Kong stock market on February 20, with overall trading activity being light [2]

Core Insights - The article emphasizes the significant advancements and global presence of Chinese companies in the biopharmaceutical sector, particularly at the JPM 2026 conference, showcasing their capabilities in both service and innovation [7][10]. Group 1: Chinese Companies at JPM 2026 - WuXi Biologics reported a substantial increase in its CRDMO business, achieving 209 comprehensive project collaborations by 2025, up from 150 in 2024, with a focus on complex projects like bispecific antibodies and ADCs [7][8]. - Ascentage Pharma highlighted its global innovation pipeline, featuring key products like the third-generation BCR-ABL inhibitor and BCL-2 inhibitor, which are driving growth in hematological oncology [9]. - Approximately 24 Chinese innovative pharmaceutical companies presented their clinical data and R&D progress at the conference, indicating a shift from being followers to systemic innovators in the global market [9][10]. Group 2: Multinational Pharmaceutical Companies - AbbVie projected an 8% revenue growth for 2025, with a 19% increase in sales from growth platforms, emphasizing the potential of its core immunology products [11]. - Sanofi reiterated its commitment to commercializing respiratory and vaccine-related assets while enhancing its pipeline through external collaborations [11]. - Gilead focused on its long-term strategy in virology, aiming for extended dosing forms and broader disease coverage [12]. Group 3: Healthcare Services and Capital Markets - The third day of the conference saw a shift towards discussions on cash flow, asset quality, and operational resilience among healthcare systems, with many reporting progress in cost control and operational integration [13]. - There was a cautious approach to mergers and acquisitions, with executives indicating a preference for manageable, cash-flow-positive targets rather than high-premium, long-cycle assets [13]. Group 4: Overall Conference Signals - The overall tone of the conference shifted towards practicality, focusing on verifiable results and execution capabilities rather than speculative narratives [14].

Company Updates - The company announced that the global registration Phase III study POLARIS-1 for Narlik (Orelabrutinib) in 1L treatment of Ph+ ALL has received approval from the US FDA and European EMA [1] - The company will present multiple data sets for three products at the 2025 American Society of Hematology (ASH) annual meeting in December, including oral reports on domestic Phase II registration clinical data for Lisengrat (APG-2575) and the first readout of POLARIS-1 data [1] Clinical Data Highlights - POLARIS-1 has become the second global registration Phase III study for Narlik approved in Europe and the US, with preliminary data showing that as of July 18, 2025, 94.3% of 53 1L Ph+ ALL patients achieved CR/CRi within three months, with best MRD negative rates and MRD negative CR rates at 66.0% and 64.2% respectively [1] - Lisengrat demonstrated good efficacy in a high-risk population for R/R CLL/SLL, with an ORR of 62.5% and mPFS of 23.89 months as of July 25, 2025, with 21.8% achieving MRD negativity [2] - The combination of Lisengrat and Azacitidine in R/R AML/MPAL patients showed an ORR of 40.4% and CR of 29.8%, while in newly diagnosed high-risk MDS/CMML patients, the ORR was 80.0% [2] Financial Forecast and Valuation - The company maintains its net profit forecast for 2025 and 2026 at -1.09 billion and -0.30 billion respectively, and continues to outperform the industry model [2] - Based on DCF valuation, the target price is maintained at 89 HKD, indicating a potential upside of 56.3% from the current stock price [2]

Company Overview - CICC maintains a "outperform" rating and a target price of HKD 89 for Ascentage Pharma-B (06855), highlighting positive recent R&D progress [1] - The global Phase III study (POLARIS-1) of Olverembatinib (耐立克) for first-line treatment of Ph+ ALL has received approval from both the FDA and EMA [2] - The company is set to present multiple data points at the 2025 American Society of Hematology (ASH) annual meeting, including domestic Phase II clinical data for APG-2575 and initial results from POLARIS-1 [2] R&D Progress - POLARIS-1 data shows that as of July 18, 2025, 94.3% of 53 first-line Ph+ ALL patients achieved CR/CRi within three months, with best MRD negative rates at 66.0% and MRD negative CR rates at 64.2% [2] - The company views Olverembatinib as its first commercial product, with steady expansion of indications and promising data readouts [2] APG-2575 Efficacy - APG-2575 demonstrated a 62.5% overall response rate (ORR) in 72 R/R CLL/SLL patients, with a median progression-free survival (mPFS) of 23.89 months and 21.8% achieving MRD negativity [3] - Notably, nearly half of the patient population had complex chromosomal abnormalities, indicating a higher risk profile and underscoring the drug's efficacy potential [3] Combination Therapy Data - The combination of APG-2575 and Azacitidine showed an ORR of 40.4% in 47 R/R AML/MPAL patients, with a complete response (CR) rate of 29.8% and mPFS of 7.6 months [4] - In 15 newly diagnosed high-risk MDS/CMML patients, the ORR was 80.0%, with CR and bone marrow CR rates at 40%, although mPFS was not reached [4]

Company Overview - CICC maintains a "outperform" rating and a target price of HKD 89 for Ascentage Pharma-B (06855), citing positive recent R&D progress [1] - The global Phase III study (POLARIS-1) for Nilotinib (Orelabrutinib) as a first-line treatment for Ph+ ALL has received approval from both the FDA and EMA [1][2] - The company plans to present multiple data points for three products at the 2025 American Society of Hematology (ASH) annual meeting, including oral reports on APG-2575's domestic Phase II registration clinical data and the first readout of POLARIS-1 data [1] POLARIS-1 Study Results - The POLARIS-1 study shows promising initial data, with 94.3% of 53 first-line Ph+ ALL patients achieving complete response (CR) or complete response with incomplete blood count recovery (CRi) within three months [2] - The best minimal residual disease (MRD) negative rate and MRD negative CR rate were reported at 66.0% and 64.2%, respectively [2] APG-2575 Efficacy in High-Risk Populations - APG-2575 demonstrated a 62.5% overall response rate (ORR) in 72 patients with relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (R/R CLL/SLL), with a median progression-free survival (mPFS) of 23.89 months [3] - Notably, nearly half of the patient population had complex chromosomal abnormalities, indicating a higher risk profile, which underscores the drug's potential efficacy [3] Combination Therapy Data - The combination of APG-2575 and Azacitidine showed an ORR of 40.4% in 47 patients with R/R acute myeloid leukemia/mixed phenotype acute leukemia (AML/MPAL), with a complete response (CR) rate of 29.8% and mPFS of 7.6 months [4] - In 15 patients with newly diagnosed high-risk myelodysplastic syndromes/chronic myelomonocytic leukemia (MDS/CMML), the ORR was 80.0%, with CR and bone marrow CR rates of 40% [4]

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]